The Food and Drug Administration on Friday said that it has concluded that the "overall benefits" of Pfizer's COVID-19 vaccine for children 5 to 11 years old "may still outweigh the risks."&nbsp;

However, there have been reports of Myocarditis and pericarditis, which are two different types of heart inflammation, after the mRNA-based Pfizer and Moderna vaccines, typically after the second dose. According to the reports by CDC, the symptoms include chest pain, faster heartbeat and shortness of breath. The official website says, "[m]ost patients with myocarditis or pericarditis who received care responded well to medicine and rest and felt better quickly."

Most of the cases after the vaccine have occurred in younger males and required hospitalisations, says federal health officials. Although the data suggests cases are&nbsp;"rare."

In its review, the FDA has come up with a variety of "benefit-risk outcome" situations, which are based on different estimates of vaccine effectiveness and rates of COVID-19 in the community. It has been estimated that Pfizer's COVID-19 vaccine would more frequently prevent COVID related cases in children than cause "excess myocarditis cases."&nbsp;

<a href="https://www.wionews.com/world/pfizers-kid-size-doses-91-effective-against-covid-19-study-423039">Also read |&nbsp;Pfizer's kid-size doses 91% effective against COVID-19: Study</a>

In case, the number of COVID-19 were to decrease in June, the FDA predicted the US might not see enough severe COVID-19 cases in children to outnumber the incidents of myocarditis or pericarditis. "The model results indicate that the benefits of the vaccine are highly dependent on the incidence of COVID-19," the FDA said.

Meanwhile, a recent study suggested that Pfizer's kid-size COVID-19 vaccine doses are 91 per cent effective against coronavirus and have been observed to be safe.

The study says that the kid-size doses of Pfizer’s vaccine are safe for children aged between 5 and 11. This study has come at a time when the US health experts have been mulling starting vaccine campaigns for younger children of the age group 5 to 11 years.

As of now, the US is already administering full-strength Pfizer shots to children aged 12 and above. However, experts and parents are anxiously awaiting kid-size doses.

This will help provide safety to children, especially as schools have started reopening and children are back in classrooms with their peers.

The Food and Drug Administration on Friday said that it has concluded that the "overall benefits" of Pfizer's COVID-19 vaccine for children 5 to 11 years old "may still outweigh the risks.

The Food and Drug Administration on Friday said that it has concluded that the "overall benefits" of Pfizer's COVID-19 vaccine for children 5 to 11 years old "may still outweigh the risks." However, there have been reports of Myocarditis and pericarditis, which are two different types of heart inflammation, after the mRNA-based Pfizer and Moderna vaccines, typically after the second dose. According to the reports by CDC, the symptoms include chest pain, faster heartbeat and shortness of breath. The official website says, "[m]ost patients with myocarditis or pericarditis who received care responded well to medicine and rest and felt better quickly." Most of the cases after the vaccine have occurred in younger males and required hospitalisations, says federal health officials. Although the data suggests cases are "rare." In its review, the FDA has come up with a variety of "benefit-risk outcome" situations, which are based on different estimates of vaccine effectiveness and rates of COVID-19 in the community. It has been estimated that Pfizer's COVID-19 vaccine would more frequently prevent COVID related cases in children than cause "excess myocarditis cases." Also read | Pfizer's kid-size doses 91% effective against COVID-19: Study In case, the number of COVID-19 were to decrease in June, the FDA predicted the US might not see enough severe COVID-19 cases in children to outnumber the incidents of myocarditis or pericarditis. "The model results indicate that the benefits of the vaccine are highly dependent on the incidence of COVID-19," the FDA said. Meanwhile, a recent study suggested that Pfizer's kid-size COVID-19 vaccine doses are 91 per cent effective against coronavirus and have been observed to be safe. The study says that the kid-size doses of Pfizer’s vaccine are safe for children aged between 5 and 11. This study has come at a time when the US health experts have been mulling starting vaccine campaigns for younger children of the age group 5 to 11 years. As of now, the US is already administering full-strength Pfizer shots to children aged 12 and above. However, experts and parents are anxiously awaiting kid-size doses. This will help provide safety to children, especially as schools have started reopening and children are back in classrooms with their peers.

FDA highlights risk of myocarditis in review of Pfizer's COVID-19 vaccine for kids 5-11

The US Food and Drug Administration (FDA) has approved a 'mix and match' strategy for all vaccines authorised in the country.

The agency said in a statement, "The FDA has determined that the known and potential benefits of the use of a single heterologous booster dose outweigh the known and potential risks of their use in eligible populations."&nbsp;

With the highly infectious Delta variant of coronavirus causing breakthrough infections among those who are fully vaccinated, the move will pave way for millions of Americans to ensure additional safety.

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/gravitas-should-you-mix-and-match-wuhan-virus-vaccines-is-it-safe-397930/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

Moderna and Johnson and Johnson have joined the Pfizer/BioNTech vaccine that had been granted authorisation for booster shots six months ago.

Now, people living in the United States have the freedom to choose a different shot for their booster dose than their original inoculation.

Also read |&nbsp;<a href="https://www.wionews.com/world/small-needles-short-lines-and-few-tears-bidens-plan-to-vaccinate-young-children-422493" hreflang="en">Small needles, short lines and few tears: Biden’s plan to vaccinate young children</a>

The advisory panel had conducted a study those that are 65 or older, over 18 and at high risk for Covid, or over 18 and have high occupational exposure.

The study was conducted by the US National Institutes of Health on 458 participants and showed that that "mixing and matching" booster shots of different types was safe in adults.

The Biden administration has announced a detailed plan for the vaccination of children aged 5-11 years.

''The vaccine will have packaging available in smaller configurations that will make it easier for physicians’ offices and other smaller, community-based providers to offer the vaccine to kids and their families,'' it said in a statement.

Last month, the White House had announced plans to bolster its vaccination campaign, focusing mainly on booster shots.

<a href="https://www.wionews.com/world/unvaccinated-people-can-get-infected-by-coronavirus-every-16-months-experts-422374">Also read |&nbsp;Unvaccinated people can get infected by coronavirus every 16 months: Experts</a>

This had added pressure on the US Centers for Disease Control and Prevention (CDC) and the FDA to approve more vaccines.

As per the CDC, approximately 11.2 million people in the United States have received a booster dose.

The mix and match strategy has been supported by several countries including the United Kingdom that has widely backed the use of the AstraZeneca COVID-19 vaccine. 
&nbsp;

The US Food and Drug Administration (FDA) has approved a 'mix and match' strategy for all vaccines authorised in the country. The agency said in a statement, "The FDA has determined that the known and potential benefits of the use of a single heterologous booster dose outweigh the known and potential risks of their use in eligible populations.

The US Food and Drug Administration (FDA) has approved a 'mix and match' strategy for all vaccines authorised in the country. The agency said in a statement, "The FDA has determined that the known and potential benefits of the use of a single heterologous booster dose outweigh the known and potential risks of their use in eligible populations." With the highly infectious Delta variant of coronavirus causing breakthrough infections among those who are fully vaccinated, the move will pave way for millions of Americans to ensure additional safety. Moderna and Johnson and Johnson have joined the Pfizer/BioNTech vaccine that had been granted authorisation for booster shots six months ago. Now, people living in the United States have the freedom to choose a different shot for their booster dose than their original inoculation. Also read | Small needles, short lines and few tears: Biden’s plan to vaccinate young children The advisory panel had conducted a study those that are 65 or older, over 18 and at high risk for Covid, or over 18 and have high occupational exposure. The study was conducted by the US National Institutes of Health on 458 participants and showed that that "mixing and matching" booster shots of different types was safe in adults. The Biden administration has announced a detailed plan for the vaccination of children aged 5-11 years. ''The vaccine will have packaging available in smaller configurations that will make it easier for physicians’ offices and other smaller, community-based providers to offer the vaccine to kids and their families,'' it said in a statement. Last month, the White House had announced plans to bolster its vaccination campaign, focusing mainly on booster shots. Also read | Unvaccinated people can get infected by coronavirus every 16 months: Experts This had added pressure on the US Centers for Disease Control and Prevention (CDC) and the FDA to approve more vaccines. As per the CDC, approximately 11.2 million people in the United States have received a booster dose. The mix and match strategy has been supported by several countries including the United Kingdom that has widely backed the use of the AstraZeneca COVID-19 vaccine.

FDA approves 'mix and match' strategy for all COVID-19 vaccines approved in US

US authorities are trying to cap the amount of salt food manufacturers and restaurants put in food. Many European countries already have salt limits. Palki Sharma tells you why India too must rethink the amount of salt and sugar it is consuming.

Gravitas: FDA issues salt guidelines for processed, restaurant food

For the first time, the Food and Drug Administration on Tuesday authorized an electronic cigarette to be sold in the United States, a significant turn in one of the most contentious public health debates in decades.

In greenlighting a device and tobacco-flavored cartridges marketed by R.J. Reynolds under the brand name Vuse, the agency signaled that it believed that the help that certain vaping devices offer smokers to quit traditional cigarettes is more significant than the risks of ensnaring a new generation.

“The authorized products’ aerosols are significantly less toxic than combusted cigarettes based on available data,” the FDA said in a statement announcing the decision.

The statement concluded, “The FDA determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth.”

The watershed decision could pave the way for authorization of some other electronic cigarettes, including those of the once-dominant maker Juul, to stay on the market. For more than a year, the manufacturers of e-cigarettes have been in a holding pattern — most of their products on the market but awaiting official authorization — as the FDA has investigated whether they were a benefit or a danger to public health.

“The importance of the FDA authorizing a vaping product as ‘appropriate for the protection of public health’ should not be understated,” said Gregory Conley, president of the American Vaping Association, an industry group. He added, “Now that the FDA has acted, we are hopeful that adult consumers and health communicators will begin to understand the harm reduction benefits offered by these and other smoke-free products.”

Over the past few months, as part of its review, the agency has also ordered thousands of vaping products off the market, including a brand that has surpassed Juul as a favorite among teenagers for its fruity and candy flavors, Puff Bars. On Tuesday, the agency also rejected 10 other Vuse flavored products but declined to say which ones.

Condemnation of the decision to authorize some products was swift.

“This throws young people under the bus,” said Erika Sward, national assistant vice president for advocacy at the American Lung Association. She said the concern was both with the broader logic endorsing these products and with Vuse, which in the government’s most recent survey on youth tobacco use was found to be one of the most popular vaping brands with young people.

Vuse’s owner, R.J. Reynolds, is one of the world’s largest cigarette companies. Another major cigarette company, Altria, owns a 35% stake in Juul.

Sward said an industry that lied about hooking generations on a deadly product that killed millions was now positioned to control the next iteration of the nicotine market. “The industry has been waiting for their next big thing, and they found it with e-cigarettes,” she said.

Kaelan Hollon, a spokesperson for Reynolds American, R.J. Reynolds’ parent company, said the decision “represents an important moment for Reynolds” and that it showed that the authorized products “are appropriate for the protection of the public health.”

E-cigarettes first came on the U.S. market in the early 2000s as devices designed to give smokers the nicotine fix they craved without the carcinogens that come from burning cigarettes. But about six years ago, with the introduction of Juul’s sleek products with fruity and dessert flavors, use of e-cigarettes among teenagers began to soar, and public health officials worried that a generation of nonsmokers was becoming hooked on nicotine.

Allowing some vaping devices to stay on the market as an alternative to smoking, some public health experts believe, might make it easier for the government to impose more stringent regulation on traditional cigarettes, whose carcinogenic fumes can cause cancer and play a role in more than 400,000 deaths in the United States each year.

After resolving the vaping issue, the FDA’s tobacco division will push forward on a plan to reduce the amount of nicotine in combustible cigarettes. In its tobacco control strategy, announced in July 2017, the FDA said it would try to force tobacco companies to lower the nicotine in their products to nonaddictive levels. The cigarette industry opposes the move.

The FDA is also still working on its plan to eliminate menthol cigarettes from the market, a prospect the tobacco industry is vigorously lobbying against.

Clifford Douglas, director of the University of Michigan Tobacco Research Network, said that the authorization of Vuse was “good initial news in terms of the agency making clear its focus on providing well-assessed harm reduction alternatives for adults.”

“This decision makes clear the FDA’s scientific understanding that e-cigarettes are intrinsically significantly less hazardous than combustible tobacco products,” Douglas said. “And it makes equally clear that these products can be good for the protection of public health, and therefore potentially help millions of addicted adult smokers quit smoking.”

The specific products granted authorization by the FDA are the Vuse Solo Power Unit, and two tobacco-flavored replacement cartridges, each with around 5% nicotine.

In its announcement, the FDA said it was aware of the heavy use of Vuse products by youth but that it was approving “tobacco flavors,” which are less appealing to teenagers. The agency also said it was imposing digital, radio and television marketing restrictions, while critics argued that the FDA appeared to leave plenty of room for other marketing that could affect youth.

“They are just inadequate,” said Eric Lindblom,&nbsp;a former FDA tobacco policy official and a senior scholar at Georgetown Law’s O’Neill Institute for National and Global Health Law, said of the measures.

He took issue with the restrictions on television advertising, which allow only commercials on shows with a low percentage of teenage users. Lindblom said that teenagers could still see the Vuse ads, either on television or if they are copied and put on YouTube, as happened with Juul.

“They are allowing marketing through partners, celebrities and brand ambassadors. This is a real problem,” Lindblom said.

For the first time, the Food and Drug Administration on Tuesday authorized an electronic cigarette to be sold in the United States, a significant turn in one of the most contentious public health debates in decades.

For the first time, the Food and Drug Administration on Tuesday authorized an electronic cigarette to be sold in the United States, a significant turn in one of the most contentious public health debates in decades. In greenlighting a device and tobacco-flavored cartridges marketed by R.J. Reynolds under the brand name Vuse, the agency signaled that it believed that the help that certain vaping devices offer smokers to quit traditional cigarettes is more significant than the risks of ensnaring a new generation. “The authorized products’ aerosols are significantly less toxic than combusted cigarettes based on available data,” the FDA said in a statement announcing the decision. The statement concluded, “The FDA determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth.” The watershed decision could pave the way for authorization of some other electronic cigarettes, including those of the once-dominant maker Juul, to stay on the market. For more than a year, the manufacturers of e-cigarettes have been in a holding pattern — most of their products on the market but awaiting official authorization — as the FDA has investigated whether they were a benefit or a danger to public health. “The importance of the FDA authorizing a vaping product as ‘appropriate for the protection of public health’ should not be understated,” said Gregory Conley, president of the American Vaping Association, an industry group. He added, “Now that the FDA has acted, we are hopeful that adult consumers and health communicators will begin to understand the harm reduction benefits offered by these and other smoke-free products.” Over the past few months, as part of its review, the agency has also ordered thousands of vaping products off the market, including a brand that has surpassed Juul as a favorite among teenagers for its fruity and candy flavors, Puff Bars. On Tuesday, the agency also rejected 10 other Vuse flavored products but declined to say which ones. Condemnation of the decision to authorize some products was swift. “This throws young people under the bus,” said Erika Sward, national assistant vice president for advocacy at the American Lung Association. She said the concern was both with the broader logic endorsing these products and with Vuse, which in the government’s most recent survey on youth tobacco use was found to be one of the most popular vaping brands with young people. Vuse’s owner, R.J. Reynolds, is one of the world’s largest cigarette companies. Another major cigarette company, Altria, owns a 35% stake in Juul. Sward said an industry that lied about hooking generations on a deadly product that killed millions was now positioned to control the next iteration of the nicotine market. “The industry has been waiting for their next big thing, and they found it with e-cigarettes,” she said. Kaelan Hollon, a spokesperson for Reynolds American, R.J. Reynolds’ parent company, said the decision “represents an important moment for Reynolds” and that it showed that the authorized products “are appropriate for the protection of the public health.” E-cigarettes first came on the U.S. market in the early 2000s as devices designed to give smokers the nicotine fix they craved without the carcinogens that come from burning cigarettes. But about six years ago, with the introduction of Juul’s sleek products with fruity and dessert flavors, use of e-cigarettes among teenagers began to soar, and public health officials worried that a generation of nonsmokers was becoming hooked on nicotine. Allowing some vaping devices to stay on the market as an alternative to smoking, some public health experts believe, might make it easier for the government to impose more stringent regulation on traditional cigarettes, whose carcinogenic fumes can cause cancer and play a role in more than 400,000 deaths in the United States each year. After resolving the vaping issue, the FDA’s tobacco division will push forward on a plan to reduce the amount of nicotine in combustible cigarettes. In its tobacco control strategy, announced in July 2017, the FDA said it would try to force tobacco companies to lower the nicotine in their products to nonaddictive levels. The cigarette industry opposes the move. The FDA is also still working on its plan to eliminate menthol cigarettes from the market, a prospect the tobacco industry is vigorously lobbying against. Clifford Douglas, director of the University of Michigan Tobacco Research Network, said that the authorization of Vuse was “good initial news in terms of the agency making clear its focus on providing well-assessed harm reduction alternatives for adults.” “This decision makes clear the FDA’s scientific understanding that e-cigarettes are intrinsically significantly less hazardous than combustible tobacco products,” Douglas said. “And it makes equally clear that these products can be good for the protection of public health, and therefore potentially help millions of addicted adult smokers quit smoking.” The specific products granted authorization by the FDA are the Vuse Solo Power Unit, and two tobacco-flavored replacement cartridges, each with around 5% nicotine. In its announcement, the FDA said it was aware of the heavy use of Vuse products by youth but that it was approving “tobacco flavors,” which are less appealing to teenagers. The agency also said it was imposing digital, radio and television marketing restrictions, while critics argued that the FDA appeared to leave plenty of room for other marketing that could affect youth. “They are just inadequate,” said Eric Lindblom, a former FDA tobacco policy official and a senior scholar at Georgetown Law’s O’Neill Institute for National and Global Health Law, said of the measures. He took issue with the restrictions on television advertising, which allow only commercials on shows with a low percentage of teenage users. Lindblom said that teenagers could still see the Vuse ads, either on television or if they are copied and put on YouTube, as happened with Juul. “They are allowing marketing through partners, celebrities and brand ambassadors. This is a real problem,” Lindblom said.

FDA authorises e-cigarettes to stay on US market for the first time

In a new analysis, the Food and Drug Administration questioned the strength of evidence that Johnson &amp; Johnson provided in its application for booster shots. A key test used by the company was likely not sensitive enough, the agency suggested, adding that it did not have enough time to independently review much of the raw data from the trials.

The document, released before a Friday meeting of the agency’s vaccine advisers, could have significant influence on whether the 15 million Americans who have received the one-dose vaccine will be allowed to get a second shot or if they will instead be urged to get a different brand of vaccine for added protection.

The agency’s analysis follows a report released Tuesday in which Johnson &amp; Johnson argued in favor of a booster, presenting data from a number of trials.

“A booster dose is recommended at six months or later, based on the strength of the immune responses,” the company wrote.

But Wednesday, the FDA said that the test used by the company to measure the immune response of a six-month boost — known as a psVNA assay — is not sensitive enough for the task. The agency also questioned whether the increase in immune response was as big as the data suggested.

“It is likely that the results seen are due to the low sensitivity of the psVNA assay used,” the FDA stated in its report.

The FDA saw a potential improvement in protection from a J&amp;J booster given two months after the first shot, based on a large trial sponsored by the company.

“Although not independently confirmed by FDA from datasets, summaries of the data suggest there may be a benefit in a second dose administered approximately 2 months after the primary dose,” the agency said in its report.

The fact that the FDA had not independently confirmed key data was a departure from past briefing documents for other vaccines. The FDA said that it did not have time to vet much of Johnson &amp; Johnson’s material before the meeting later in the week.

The agency scheduled the meeting of its outside advisers before the company had even submitted its application for a booster dose — an unusual move, some public health experts said.

“Except where noted, datasets were not submitted in sufficient time for FDA to conduct an independent review to verify the Sponsor’s analyses,” the FDA said in its report.

A spokesperson for Johnson &amp; Johnson did not immediately respond to a request for comment.

The FDA has already authorized an additional shot of the Pfizer-BioNTech vaccine for people older than 65 or with health conditions or job exposures that put them at higher risk. Moderna has also submitted an application for a booster that will be evaluated by the FDA’s advisers Thursday. It may also win authorization, despite limited evidence that the protection provided by an initial two doses of Moderna is waning.

When Johnson &amp; Johnson’s vaccine was authorized in February, it had several advantages over the other two. As a single shot, it was more convenient than the two-dose formulation from Moderna and Pfizer-BioNTech. It also did not have to be frozen to stay viable. But it also provided less robust protection.

A clinical trial showed that one dose of J&amp;J had an efficacy rate of 66% against moderate to severe COVID-19 worldwide and 74&nbsp;per cent in the United States. Its efficacy against either severe or critical disease was stronger, at 85 per cent worldwide.

In its application for a booster, Johnson &amp; Johnson included the results of another large-scale trial that began in November in which they gave half their volunteers a second dose two months after the first. The other half received a placebo.

In August, the company announced that in the portion of the trial that took place in the United States, the efficacy rose to 94 per cent. But in its report, the FDA focused on the worldwide results in which the increase was more modest, rising to 75 per cent.

Against severe to critical COVID-19, two shots had an efficacy of 100 per cent. But regulators warned in the analysis posted Wednesday that there was little data from that trial on the delta variant, which now causes the vast majority of US&nbsp;infections.

“The small number of accrued cases confirmed to be caused by the delta variant precludes any conclusion regarding efficacy against that variant,” they wrote.

In a new analysis, the Food and Drug Administration questioned the strength of evidence that Johnson & Johnson provided in its application for booster shots. A key test used by the company was likely not sensitive enough, the agency suggested, adding that it did not have enough time to independently review much of the raw data from the trials.

In a new analysis, the Food and Drug Administration questioned the strength of evidence that Johnson & Johnson provided in its application for booster shots. A key test used by the company was likely not sensitive enough, the agency suggested, adding that it did not have enough time to independently review much of the raw data from the trials. The document, released before a Friday meeting of the agency’s vaccine advisers, could have significant influence on whether the 15 million Americans who have received the one-dose vaccine will be allowed to get a second shot or if they will instead be urged to get a different brand of vaccine for added protection. The agency’s analysis follows a report released Tuesday in which Johnson & Johnson argued in favor of a booster, presenting data from a number of trials. “A booster dose is recommended at six months or later, based on the strength of the immune responses,” the company wrote. But Wednesday, the FDA said that the test used by the company to measure the immune response of a six-month boost — known as a psVNA assay — is not sensitive enough for the task. The agency also questioned whether the increase in immune response was as big as the data suggested. “It is likely that the results seen are due to the low sensitivity of the psVNA assay used,” the FDA stated in its report. The FDA saw a potential improvement in protection from a J&J booster given two months after the first shot, based on a large trial sponsored by the company. “Although not independently confirmed by FDA from datasets, summaries of the data suggest there may be a benefit in a second dose administered approximately 2 months after the primary dose,” the agency said in its report. The fact that the FDA had not independently confirmed key data was a departure from past briefing documents for other vaccines. The FDA said that it did not have time to vet much of Johnson & Johnson’s material before the meeting later in the week. The agency scheduled the meeting of its outside advisers before the company had even submitted its application for a booster dose — an unusual move, some public health experts said. “Except where noted, datasets were not submitted in sufficient time for FDA to conduct an independent review to verify the Sponsor’s analyses,” the FDA said in its report. A spokesperson for Johnson & Johnson did not immediately respond to a request for comment. The FDA has already authorized an additional shot of the Pfizer-BioNTech vaccine for people older than 65 or with health conditions or job exposures that put them at higher risk. Moderna has also submitted an application for a booster that will be evaluated by the FDA’s advisers Thursday. It may also win authorization, despite limited evidence that the protection provided by an initial two doses of Moderna is waning. When Johnson & Johnson’s vaccine was authorized in February, it had several advantages over the other two. As a single shot, it was more convenient than the two-dose formulation from Moderna and Pfizer-BioNTech. It also did not have to be frozen to stay viable. But it also provided less robust protection. A clinical trial showed that one dose of J&J had an efficacy rate of 66% against moderate to severe COVID-19 worldwide and 74 per cent in the United States. Its efficacy against either severe or critical disease was stronger, at 85 per cent worldwide. In its application for a booster, Johnson & Johnson included the results of another large-scale trial that began in November in which they gave half their volunteers a second dose two months after the first. The other half received a placebo. In August, the company announced that in the portion of the trial that took place in the United States, the efficacy rose to 94 per cent. But in its report, the FDA focused on the worldwide results in which the increase was more modest, rising to 75 per cent. Against severe to critical COVID-19, two shots had an efficacy of 100 per cent. But regulators warned in the analysis posted Wednesday that there was little data from that trial on the delta variant, which now causes the vast majority of US infections. “The small number of accrued cases confirmed to be caused by the delta variant precludes any conclusion regarding efficacy against that variant,” they wrote.

FDA analysis suggests J&J has not presented robust evidence for boosters

The US Food and Drug Administration on Wednesday (September 22) authorized a booster dose of the Pfizer Inc and BioNTech COVID-19 vaccine for those aged 65 and older and some high-risk Americans, paving the way for a quick rollout of the shots.

The booster dose is to be administered at least six months after completion of the second dose, and the authorisation would include people most susceptible to severe disease and those in jobs that left them at risk, the FDA said.

A US Centers for Disease Control and Prevention (CDC) advisory panel could vote on Thursday on the use of a third shot of the vaccine, an agency official said at a public meeting of the panel on Wednesday.

President Joe Biden announced in August the government's intention to roll out booster shots for people aged 16 and older this week, pending approval by the FDA and CDC.

Advisers to the FDA voted on Friday to recommend COVID-19 vaccine booster shots for Americans 65 and older and those at high risk of severe illness, after overwhelmingly rejecting a call for broader approval.

The advisory panel said there was not enough evidence to support booster shots for all those aged 16 and older who had received a second dose at least six months earlier and also sought more safety data.

The agency could revisit the issue of additional shots for a broader authorization in the future. Top FDA members have been split on the need for boosters for the general population, with interim head Janet Woodcock backing them and some of the agency's senior scientists arguing current evidence does not support them.

Johnson &amp; Johnson said on Tuesday a second shot of its COVID-19 vaccine increased its effectiveness in the United States against moderate to severe forms of the disease.

Data from Moderna Inc's COVID-19 vaccine on booster doses is just weeks away, President Joe Biden's chief medical adviser, Dr. Anthony Fauci, said on Sunday.

Some countries, including Israel and Britain, have already rolled out COVID-19 booster campaigns. The United States authorized extra shots for people with compromised immune systems last month and over 2 million people had already received a third shot, CDC data showed.

The US Food and Drug Administration on Wednesday (September 22) authorized a booster dose of the Pfizer Inc and BioNTech COVID-19 vaccine for those aged 65 and older and some high-risk Americans, paving the way for a quick rollout of the shots.

The US Food and Drug Administration on Wednesday (September 22) authorized a booster dose of the Pfizer Inc and BioNTech COVID-19 vaccine for those aged 65 and older and some high-risk Americans, paving the way for a quick rollout of the shots. The booster dose is to be administered at least six months after completion of the second dose, and the authorisation would include people most susceptible to severe disease and those in jobs that left them at risk, the FDA said. A US Centers for Disease Control and Prevention (CDC) advisory panel could vote on Thursday on the use of a third shot of the vaccine, an agency official said at a public meeting of the panel on Wednesday. President Joe Biden announced in August the government's intention to roll out booster shots for people aged 16 and older this week, pending approval by the FDA and CDC. Advisers to the FDA voted on Friday to recommend COVID-19 vaccine booster shots for Americans 65 and older and those at high risk of severe illness, after overwhelmingly rejecting a call for broader approval. The advisory panel said there was not enough evidence to support booster shots for all those aged 16 and older who had received a second dose at least six months earlier and also sought more safety data. The agency could revisit the issue of additional shots for a broader authorization in the future. Top FDA members have been split on the need for boosters for the general population, with interim head Janet Woodcock backing them and some of the agency's senior scientists arguing current evidence does not support them. Johnson & Johnson said on Tuesday a second shot of its COVID-19 vaccine increased its effectiveness in the United States against moderate to severe forms of the disease. Data from Moderna Inc's COVID-19 vaccine on booster doses is just weeks away, President Joe Biden's chief medical adviser, Dr. Anthony Fauci, said on Sunday. Some countries, including Israel and Britain, have already rolled out COVID-19 booster campaigns. The United States authorized extra shots for people with compromised immune systems last month and over 2 million people had already received a third shot, CDC data showed.

US FDA authorises third dose of Pfizer COVID-19 vaccine for older Americans

The United States Food and Drug Administration (FDA) granted full approval to Pfizer-BioNTech’s coronavirus vaccine for people 16 and older. This becomes the first vaccine to receive a complete nod.

US FDA grants full approval to Pfizer-BioNTech COVID-19 vaccine

The US Food and Drug Agency (FDA) has issued a warning to people who are self-medicating with ivermectin tablets to treat COVID-19 symptoms, saying that it has not authorised the use of drugs for treating the infection as it is “intended to treat livestock.”

The agency was reacting to reports from the Mississippi Start Department of Health that people have been poisoned by consuming ivermectin drugs, commonly used to de-worm cattle.

“You are not a horse. You are not a cow. Seriously, y'all. Stop it,” the FDA tweeted, adding, “It’s perhaps not surprising that some consumers are looking at unconventional treatments” in a state where only 37% of the population is fully vaccinated. 
 
<a href="https://www.wionews.com/world/hundreds-of-anti-lockdown-protesters-arrested-in-australia-as-daily-cases-hit-record-high-407599">Also read | Hundreds of anti-lockdown protesters arrested in Australia as daily cases hit record high</a> 
 
Mississippi’s health department issued a warning that over 70 per cent of the recent calls to the poison department were from people who took Ivermectin bought at livestock supply centres, Bloomberg reported.

“These animal drugs are often highly concentrated because they are used for large animals like horses and cows, which can weigh a lot more than a human,” the FDA said in a statement. 
 
Also read |<a href="https://www.wionews.com/world/fantastic-news-uk-approves-first-ever-covid-antibody-treatment-407215">&nbsp;'Fantastic news': UK approves first ever Covid antibody treatment</a>

“Such high doses can be highly toxic in humans.” It added.

According to the FDA, patients who overdose with ivermectin can experience nausea, vomiting, diarrhoea, low blood pressure, allergic reactions, dizziness, problems with balance, seizures, coma and even death. 
 
(With inputs from agencies)

The US Food and Drug Agency (FDA) has issued a warning to people who are self-medicating with ivermectin tablets to treat COVID-19 symptoms, saying that it has not authorised the use of drugs for treating the infection as it is “intended to treat livestock.

The US Food and Drug Agency (FDA) has issued a warning to people who are self-medicating with ivermectin tablets to treat COVID-19 symptoms, saying that it has not authorised the use of drugs for treating the infection as it is “intended to treat livestock.” The agency was reacting to reports from the Mississippi Start Department of Health that people have been poisoned by consuming ivermectin drugs, commonly used to de-worm cattle. “You are not a horse. You are not a cow. Seriously, y'all. Stop it,” the FDA tweeted, adding, “It’s perhaps not surprising that some consumers are looking at unconventional treatments” in a state where only 37% of the population is fully vaccinated. Also read | Hundreds of anti-lockdown protesters arrested in Australia as daily cases hit record high Mississippi’s health department issued a warning that over 70 per cent of the recent calls to the poison department were from people who took Ivermectin bought at livestock supply centres, Bloomberg reported. “These animal drugs are often highly concentrated because they are used for large animals like horses and cows, which can weigh a lot more than a human,” the FDA said in a statement. Also read | 'Fantastic news': UK approves first ever Covid antibody treatment “Such high doses can be highly toxic in humans.” It added. According to the FDA, patients who overdose with ivermectin can experience nausea, vomiting, diarrhoea, low blood pressure, allergic reactions, dizziness, problems with balance, seizures, coma and even death. (With inputs from agencies)

'You are not a cow, You are not a horse': FDA warns against using ‘animal drug’ ivermectin to treat COVID-19

The Food and Drug Administration (FDA) may have a strategy on Covid vaccine boosters within a few weeks. This plan will lay out the details of when an individual should get the third shot.

Sources, quoted by WSJ, who are familiar with the work in progress said the FDA might be able to release a strategy on booster shots as early as September.

Also read |&nbsp;<a href="https://www.wionews.com/world/after-germany-and-israel-france-announces-plans-for-booster-shots-despite-whos-warning-403134">After Germany and Israel, France announces plans for booster shots despite WHO's warning</a>

The Biden administrati0on has been pushing for a quick plan regarding the booster shots. The experts believe that some people over the age of 65 or people with medical conditions or weak immunity would need the booster shot as soon as the end of this month, two sources claimed, as quoted by WSJ.

This has come a few days after the World Health Organization (WHO) urged countries to not start administering the third shot. WHO stressed the unequal distribution of vaccine rollout in different countries and urged first-world nations to let the financially weaker countries procure enough vaccines to administer at least for the vulnerable population, and then only start the process of booster shot.

Also read |&nbsp;<a href="https://www.wionews.com/india-news/white-fungus-abscess-found-in-the-brain-of-a-covid-recovered-patient-403525">White fungus abscess found in the brain of a COVID-recovered patient</a>

Some countries such as France, Israel and Germany, however, have either rolled out a tentative starting date for booster campaigns or have expressed strong approval for the same. Recently, French President Emmanuel Macron said his government will be offering the third 'booster' shot of the&nbsp;<a href="https://www.wionews.com/topics/coronavirus-vaccine">coronavirus vaccine</a>&nbsp;to elderly and vulnerable people from September.

In the US, nearly half of the country has been fully vaccinated as per local reports but the vaccination rate has been declining in the past few weeks, creating a worrisome situation for the government.

With the spread of the Delta variant (which is also dubbed as the ‘variant of concern’), the government is hoping to roll out a booster shot as soon as possible to protect the elderly and people with weak immunity.

The Food and Drug Administration (FDA) may have a strategy on Covid vaccine boosters within a few weeks. This plan will lay out the details of when an individual should get the third shot.

The Food and Drug Administration (FDA) may have a strategy on Covid vaccine boosters within a few weeks. This plan will lay out the details of when an individual should get the third shot. Sources, quoted by WSJ, who are familiar with the work in progress said the FDA might be able to release a strategy on booster shots as early as September. Also read | After Germany and Israel, France announces plans for booster shots despite WHO's warning The Biden administrati0on has been pushing for a quick plan regarding the booster shots. The experts believe that some people over the age of 65 or people with medical conditions or weak immunity would need the booster shot as soon as the end of this month, two sources claimed, as quoted by WSJ. This has come a few days after the World Health Organization (WHO) urged countries to not start administering the third shot. WHO stressed the unequal distribution of vaccine rollout in different countries and urged first-world nations to let the financially weaker countries procure enough vaccines to administer at least for the vulnerable population, and then only start the process of booster shot. Also read | White fungus abscess found in the brain of a COVID-recovered patient Some countries such as France, Israel and Germany, however, have either rolled out a tentative starting date for booster campaigns or have expressed strong approval for the same. Recently, French President Emmanuel Macron said his government will be offering the third 'booster' shot of the coronavirus vaccine to elderly and vulnerable people from September. In the US, nearly half of the country has been fully vaccinated as per local reports but the vaccination rate has been declining in the past few weeks, creating a worrisome situation for the government. With the spread of the Delta variant (which is also dubbed as the ‘variant of concern’), the government is hoping to roll out a booster shot as soon as possible to protect the elderly and people with weak immunity.

FDA to release booster shot strategy within next few weeks: Reports

Health regulators in several countries have been investigating whether the Pfizer/BioNTech and Moderna shots using new mRNA technology present a risk

FDA to add warning about heart inflammation to COVID vaccines

The&nbsp;US Food &amp; Drug Administration on Friday, June 11,&nbsp;said Johnson &amp; Johnson must throw away&nbsp;millions&nbsp;of&nbsp;doses&nbsp;of its&nbsp;COVID-19&nbsp;vaccine&nbsp;that were manufactured at a problem-plagued Baltimore factory but also cleared&nbsp;millions&nbsp;for use.

Two sources familiar with the situation told Reuters that the agency had cleared about 10 million&nbsp;doses. The New York Times said that the batches being&nbsp;discarded amount to around 60 million&nbsp;doses, citing people familiar with the matter.

Without disclosing or confirming the number of&nbsp;vaccine&nbsp;doses, the&nbsp;FDA&nbsp;said in a news release that it had authorized two batches of the&nbsp;vaccine&nbsp;for use, that several other batches were not suitable for use, and that others were being evaluated.

The agency said it was not yet ready to authorize Emergent BioSolutions Inc's plant for manufacturing the J&amp;J&nbsp;vaccine. Production of J&amp;J's&nbsp;vaccine&nbsp;at the Baltimore site was halted by&nbsp;US authorities in April and J&amp;J was put in charge of manufacturing at the plant.

One source familiar with the matter told Reuters that the J&amp;J&nbsp;doses&nbsp;are expected to be exported to other countries. The&nbsp;doses&nbsp;are already in vials and ready for use, the other source said.

Safety concerns about the J&amp;J&nbsp;vaccine&nbsp;paired with flagging&nbsp;US demand for vaccinations, in general, have slowed the rollout of the one-shot&nbsp;vaccine&nbsp;to a crawl. Close to half of the 21 million&nbsp;doses&nbsp;produced for the United States sit unused.

The&nbsp;FDA&nbsp;said its decision allows for the J&amp;J&nbsp;doses&nbsp;to be used in the United States or exported. The agency said the drugmaker and Emergent must agree that the&nbsp;FDA&nbsp;can share relevant information about the manufacturing of the&nbsp;doses&nbsp;with regulators where the&nbsp;vaccine&nbsp;is shipped.

<a href="https://www.wionews.com/world/us-says-g7-may-reallocate-100-billion-from-imf-funds-to-covid-ravaged-nations-390990">Also Read |&nbsp;US says G7 may reallocate $100 billion from IMF funds to COVID-ravaged nations</a>

J&amp;J, in a statement, confirmed that the&nbsp;FDA&nbsp;authorized the two batches, but did not acknowledge the&nbsp;doses&nbsp;regulators decided should be tossed.

The&nbsp;FDA&nbsp;declined to comment beyond its statement.

Last month, Emergent Chief Executive Robert Kramer said it was his understanding that there are 100 million&nbsp;doses&nbsp;of J&amp;J's&nbsp;vaccine&nbsp;ready for&nbsp;FDA&nbsp;review and that regulators had begun the review process.

The April halt followed the discovery that ingredients from AstraZeneca's&nbsp;COVID-19&nbsp;vaccine, also being produced at the plant at the time, contaminated a batch of J&amp;J's&nbsp;vaccine. AstraZeneca's shot is no longer being made there.

An&nbsp;FDA&nbsp;inspection also turned up a long list of sanitary problems and bad manufacturing practices at the Emergent plant.

Separately, Europe's drug regulator said on Friday that batches of J&amp;J&nbsp;COVID-19&nbsp;vaccine&nbsp;made for the region around the time the contamination issues&nbsp;were revealed at the Baltimore plant would, as a precaution, not be used.

The European Medicines Agency did not say how many shots were affected, but Reuters has reported it involves&nbsp;millions&nbsp;of&nbsp;doses, making it harder for J&amp;J to meet a target of delivering 55 million to Europe by end of June.

The US Food & Drug Administration on Friday, June 11, said Johnson & Johnson must throw away millions of doses of its COVID-19 vaccine that were manufactured at a problem-plagued Baltimore factory but also cleared millions for use.

The US Food & Drug Administration on Friday, June 11, said Johnson & Johnson must throw away millions of doses of its COVID-19 vaccine that were manufactured at a problem-plagued Baltimore factory but also cleared millions for use. Two sources familiar with the situation told Reuters that the agency had cleared about 10 million doses. The New York Times said that the batches being discarded amount to around 60 million doses, citing people familiar with the matter. Without disclosing or confirming the number of vaccine doses, the FDA said in a news release that it had authorized two batches of the vaccine for use, that several other batches were not suitable for use, and that others were being evaluated. The agency said it was not yet ready to authorize Emergent BioSolutions Inc's plant for manufacturing the J&J vaccine. Production of J&J's vaccine at the Baltimore site was halted by US authorities in April and J&J was put in charge of manufacturing at the plant. One source familiar with the matter told Reuters that the J&J doses are expected to be exported to other countries. The doses are already in vials and ready for use, the other source said. Safety concerns about the J&J vaccine paired with flagging US demand for vaccinations, in general, have slowed the rollout of the one-shot vaccine to a crawl. Close to half of the 21 million doses produced for the United States sit unused. The FDA said its decision allows for the J&J doses to be used in the United States or exported. The agency said the drugmaker and Emergent must agree that the FDA can share relevant information about the manufacturing of the doses with regulators where the vaccine is shipped. Also Read | US says G7 may reallocate $100 billion from IMF funds to COVID-ravaged nations J&J, in a statement, confirmed that the FDA authorized the two batches, but did not acknowledge the doses regulators decided should be tossed. The FDA declined to comment beyond its statement. Last month, Emergent Chief Executive Robert Kramer said it was his understanding that there are 100 million doses of J&J's vaccine ready for FDA review and that regulators had begun the review process. The April halt followed the discovery that ingredients from AstraZeneca's COVID-19 vaccine, also being produced at the plant at the time, contaminated a batch of J&J's vaccine. AstraZeneca's shot is no longer being made there. An FDA inspection also turned up a long list of sanitary problems and bad manufacturing practices at the Emergent plant. Separately, Europe's drug regulator said on Friday that batches of J&J COVID-19 vaccine made for the region around the time the contamination issues were revealed at the Baltimore plant would, as a precaution, not be used. The European Medicines Agency did not say how many shots were affected, but Reuters has reported it involves millions of doses, making it harder for J&J to meet a target of delivering 55 million to Europe by end of June.

US FDA says J&J should discard millions of defected doses

The US Food and Drug Administration (FDA) has authorised a monoclonal antibody drug against <a href="https://www.wionews.com/topics/coronavirus">COVID-19</a>, developed by GlaxoSmithKline and Vir, which claims to reduce hospitalisation and death among <a href="https://www.wionews.com/topics/coronavirus-vaccine">Coronavirus</a> patients by 85 per cent and is also effective against the variants. 
 
The drug Sotrovimab has been given an emergency use authorisation (EUA) for the treatment of mild-to-moderate COVID-19 in adults and children 12 years of age and older, weighing at least 40 kg.

Also Read |&nbsp;<a href="https://www.wionews.com/world/seeking-a-pill-to-cure-covid-drugmakers-eye-alternative-to-vaccines-387717">Seeking a pill to cure Covid: Drugmakers eye alternative to vaccines</a> 
 
The drug has shown positive results among patients 65 years of age and older or individuals who have certain medical conditions and are at high risk for progression to severe COVID-19, including hospitalisation or death. 
 
Laboratory tests have shown that Sotrovimab is able to neutralise the current circulating variants of Covid first reported in the UK, South Africa, Brazil, California, New York and India.

Also Read |&nbsp;<a href="https://www.wionews.com/india-news/black-fungus-drug-amphotericin-b-to-be-priced-at-rs-1200-for-each-vial-in-india-387750">Black fungus drug Amphotericin B to be priced at Rs 1200 for each vial in India</a> 
 
"With the authorisation of this monoclonal antibody treatment, we are providing another option to help keep high-risk patients with COVID-19 out of the hospital," Patrizia Cavazzoni, Director of the FDA`s Center for Drug Evaluation and Research, said in a statement on Wednesday. 
 
"It is important to expand the arsenal of monoclonal antibody therapies that are expected to retain activity against the circulating variants of COVID-19 in the United States," Cavazzoni added.

Also Read |&nbsp;<a href="https://www.wionews.com/india-news/modernas-single-dose-vaccine-in-india-likely-next-year-pfizer-ready-with-50-mn-doses-for-2021-387438">Moderna's single-dose vaccine in India likely next year; Pfizer ready with 50 mn doses for 2021</a> 
 
However, Sotrovimab is not authorised for patients who are hospitalised due to COVID-19 or require oxygen therapy due to the disease, the FDA said. 
 
This treatment has not shown benefit in patients hospitalised due to COVID-19 and monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalised patients requiring high flow oxygen or mechanical ventilation.

Also Read |&nbsp;<a href="https://www.wionews.com/india-news/as-india-is-troubled-with-fresh-covid-wave-a-drug-and-therapy-bring-hope-379586">As India is troubled with fresh Covid wave, a drug and therapy bring hope</a> 
 
Monoclonal antibodies are laboratory-made proteins that mimic the immune system`s ability to fight off harmful antigens such as viruses. Sotrovimab is a monoclonal antibody that is specifically directed against the spike protein of <a href="https://www.wionews.com/topics/coronavirus">SARS-CoV-2</a> and is designed to block the virus` attachment and entry into human cells. 
 
The EUA is based on an interim analysis from a Phase 1/2/3 randomised, double-blind, placebo-controlled clinical trials in 583 non-hospitalised adults with mild-to-moderate COVID-19 symptoms and a positive SARS-CoV-2 test result.

Also Read |&nbsp;<a href="https://www.wionews.com/world/drug-prevents-coronavirus-infection-in-nursing-homes-maker-claims-358546">Drug prevents coronavirus infection in nursing homes, maker claims</a> 
 
Of these patients, 291 received Sotrovimab and 292 received placebo within five days of onset of COVID-19 symptoms. The primary endpoint was progression of COVID-19 (defined as hospitalisation for greater than 24 hours for acute management of any illness or death from any cause) through day 29. 
 
Hospitalisation or death occurred in 21 (7 per cent) patients who received placebo compared to 3 (1 per cent) patients treated with Sotrovimab, an 85 per cent reduction.

Also Read |&nbsp;<a href="https://www.wionews.com/world/us-grants-emergency-use-authorisation-to-regeneron-covid-19-antibodies-344588">US grants emergency use authorisation to Regeneron Covid-19 antibodies</a> 
 
The drug will be distributed and administered as a 500 milligram single dose intravenously by health care providers. Potential side effects of Sotrovimab include anaphylaxis and infusion-related reactions, rash and diarrhoea, the FDA said.

The US Food and Drug Administration (FDA) has authorised a monoclonal antibody drug against COVID-19, developed by GlaxoSmithKline and Vir, which claims to reduce hospitalisation and death among Coronavirus patients by 85 per cent and is also effective against the variants.

The US Food and Drug Administration (FDA) has authorised a monoclonal antibody drug against COVID-19, developed by GlaxoSmithKline and Vir, which claims to reduce hospitalisation and death among Coronavirus patients by 85 per cent and is also effective against the variants. The drug Sotrovimab has been given an emergency use authorisation (EUA) for the treatment of mild-to-moderate COVID-19 in adults and children 12 years of age and older, weighing at least 40 kg. Also Read | Seeking a pill to cure Covid: Drugmakers eye alternative to vaccines The drug has shown positive results among patients 65 years of age and older or individuals who have certain medical conditions and are at high risk for progression to severe COVID-19, including hospitalisation or death. Laboratory tests have shown that Sotrovimab is able to neutralise the current circulating variants of Covid first reported in the UK, South Africa, Brazil, California, New York and India. Also Read | Black fungus drug Amphotericin B to be priced at Rs 1200 for each vial in India "With the authorisation of this monoclonal antibody treatment, we are providing another option to help keep high-risk patients with COVID-19 out of the hospital," Patrizia Cavazzoni, Director of the FDA`s Center for Drug Evaluation and Research, said in a statement on Wednesday. "It is important to expand the arsenal of monoclonal antibody therapies that are expected to retain activity against the circulating variants of COVID-19 in the United States," Cavazzoni added. Also Read | Moderna's single-dose vaccine in India likely next year; Pfizer ready with 50 mn doses for 2021 However, Sotrovimab is not authorised for patients who are hospitalised due to COVID-19 or require oxygen therapy due to the disease, the FDA said. This treatment has not shown benefit in patients hospitalised due to COVID-19 and monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalised patients requiring high flow oxygen or mechanical ventilation. Also Read | As India is troubled with fresh Covid wave, a drug and therapy bring hope Monoclonal antibodies are laboratory-made proteins that mimic the immune system`s ability to fight off harmful antigens such as viruses. Sotrovimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2 and is designed to block the virus` attachment and entry into human cells. The EUA is based on an interim analysis from a Phase 1/2/3 randomised, double-blind, placebo-controlled clinical trials in 583 non-hospitalised adults with mild-to-moderate COVID-19 symptoms and a positive SARS-CoV-2 test result. Also Read | Drug prevents coronavirus infection in nursing homes, maker claims Of these patients, 291 received Sotrovimab and 292 received placebo within five days of onset of COVID-19 symptoms. The primary endpoint was progression of COVID-19 (defined as hospitalisation for greater than 24 hours for acute management of any illness or death from any cause) through day 29. Hospitalisation or death occurred in 21 (7 per cent) patients who received placebo compared to 3 (1 per cent) patients treated with Sotrovimab, an 85 per cent reduction. Also Read | US grants emergency use authorisation to Regeneron Covid-19 antibodies The drug will be distributed and administered as a 500 milligram single dose intravenously by health care providers. Potential side effects of Sotrovimab include anaphylaxis and infusion-related reactions, rash and diarrhoea, the FDA said.

US FDA authorises GSK-Vir monoclonal antibody drug for Covid

According to reports, the US Food and Drug Administration is expected to authorize Pfizer’s COVID-19 vaccine for young adults age 12 and older by next week. The announcement is set to come a month after the company founded the vaccine is already authorized for those age 16 and older, also provided protection for the younger group.

US: FDA to approve Pfizer COVID-19 vaccine for teens by next week

The US Food and Drug Administration announced that they are temporarily halting use of Johnson & Johnson’s COVID-19 vaccine after developing six cases of rare blood-clotting in the country, that left one woman dead and another in critical condition.

Temporary halt on Johnson & Johnson vaccination in US over blood clot concerns

The U.S. Food and Drug Administration has approved Bristol-Myers Squibb Co and bluebird bio Inc`s multiple myeloma therapy, ide-cel, acquired as part of its $74 billion buyout of Celgene, the drugmakers said in a joint statement late on Friday.

Ide-cel is a CAR-T therapy that involves taking immune cells from a patient, engineering them to attack tumor cells and infusing them back into the patient.

Bristol Myers Squibb and partner bluebird bio Last year resubmitted its application for ide-cel after the U.S. drug regulator declined to review the treatment and sought more information.

As part of the Celgene-Bristol Myers deal, Celgene shareholders would have received a $9 per share payment if three of Celgene`s top pipeline assets were approved by certain dates.

However, the FDA did not approve blood cancer therapy, liso-cel, by the end of 2020 and as a result the CVR agreement was terminated.

The U.S. Food and Drug Administration has approved Bristol-Myers Squibb Co and bluebird bio Inc`s multiple myeloma therapy, ide-cel, acquired as part of its $74 billion buyout of Celgene, the drugmakers said in a joint statement late on Friday.

The U.S. Food and Drug Administration has approved Bristol-Myers Squibb Co and bluebird bio Inc`s multiple myeloma therapy, ide-cel, acquired as part of its $74 billion buyout of Celgene, the drugmakers said in a joint statement late on Friday. Ide-cel is a CAR-T therapy that involves taking immune cells from a patient, engineering them to attack tumor cells and infusing them back into the patient. Bristol Myers Squibb and partner bluebird bio Last year resubmitted its application for ide-cel after the U.S. drug regulator declined to review the treatment and sought more information. As part of the Celgene-Bristol Myers deal, Celgene shareholders would have received a $9 per share payment if three of Celgene`s top pipeline assets were approved by certain dates. However, the FDA did not approve blood cancer therapy, liso-cel, by the end of 2020 and as a result the CVR agreement was terminated.

US FDA approves Bristol-Myers Squibb's multiple myeloma therapy

The single-shot Johnson and Johnson vaccine is highly effective in preventing severe Covid-19, including the South African and Brazil variants, new documents released by the US Food and Drug Administration have said.

In large clinical trials, the vaccine efficacy against severe disease was&nbsp;85.9 per cent in the United States, 81.7 per cent in South Africa, and 87.6 per cent in Brazil.

An independent panel of the Food and Drug Administration (FDA) will meet to discuss its merits on Friday and an emergency use authorisation is likely to follow soon after.

That would bring a third vaccine into the fight against the outbreak in the United States, the world's hardest-hit country where more than 500,000 people have lost their lives.

"The vaccine was effective in preventing COVID-19 using a less restrictive definition of the disease and for more severe disease, including COVID-19 requiring medical intervention, considering all cases starting 14 days after vaccination," the new FDA summary said.

"Although a lower efficacy overall was observed in South Africa, where there was a predominance of B.1.3.5 lineage during the time period of this study, vaccine efficacy against severe/critical COVID-19 was similarly high across the United States, South Africa, and Brazil."

The J&amp;J vaccine uses a common-cold causing adenovirus, which has been modified so that it can't replicate, to carry the gene for a key protein of the coronavirus into human cells.&nbsp;This makes those cells produce that protein, which in turn trains the human immune system.

The fact that it requires only one dose, and that it can be stored at fridge temperature rather than in freezers like the Pfizer and Moderna shots, gives it an operational advantage.

The vaccine was effective in reducing the risk of Covid-19 and preventing PCR-test confirmed COVID-19 at least 14 days after vaccination, the FDA said in its briefing documents.

J&amp;J tested its single-dose option in 44,000 people in the US, Latin America and South Africa. Because different mutated versions of the virus are circulating in different countries, researchers analysed the results geographically.&nbsp;

(with inputs from agencies)

The single-shot Johnson and Johnson vaccine is highly effective in preventing severe Covid-19, including the South African and Brazil variants, new documents released by the US Food and Drug Administration have said.

The single-shot Johnson and Johnson vaccine is highly effective in preventing severe Covid-19, including the South African and Brazil variants, new documents released by the US Food and Drug Administration have said. In large clinical trials, the vaccine efficacy against severe disease was 85.9 per cent in the United States, 81.7 per cent in South Africa, and 87.6 per cent in Brazil. An independent panel of the Food and Drug Administration (FDA) will meet to discuss its merits on Friday and an emergency use authorisation is likely to follow soon after. That would bring a third vaccine into the fight against the outbreak in the United States, the world's hardest-hit country where more than 500,000 people have lost their lives. "The vaccine was effective in preventing COVID-19 using a less restrictive definition of the disease and for more severe disease, including COVID-19 requiring medical intervention, considering all cases starting 14 days after vaccination," the new FDA summary said. "Although a lower efficacy overall was observed in South Africa, where there was a predominance of B.1.3.5 lineage during the time period of this study, vaccine efficacy against severe/critical COVID-19 was similarly high across the United States, South Africa, and Brazil." The J&J vaccine uses a common-cold causing adenovirus, which has been modified so that it can't replicate, to carry the gene for a key protein of the coronavirus into human cells. This makes those cells produce that protein, which in turn trains the human immune system. The fact that it requires only one dose, and that it can be stored at fridge temperature rather than in freezers like the Pfizer and Moderna shots, gives it an operational advantage. The vaccine was effective in reducing the risk of Covid-19 and preventing PCR-test confirmed COVID-19 at least 14 days after vaccination, the FDA said in its briefing documents. J&J tested its single-dose option in 44,000 people in the US, Latin America and South Africa. Because different mutated versions of the virus are circulating in different countries, researchers analysed the results geographically. (with inputs from agencies)

Johnson & Johnson Covid vaccine poised for FDA decision

President-elect Joe Biden on Saturday filled out his State Department team with a group of former career diplomats and veterans of the Obama administration, signalling his desire to return to a more traditional foreign policy after four years of uncertainty and unpredictability under President Donald Trump.

Biden will nominate Wendy Sherman as deputy secretary of state and Victoria Nuland as undersecretary of state for political affairs the second-and third-highest ranking posts, respectively.

They were among the officials chosen to serve under the incoming secretary of state, Antony Blinken.

The team embodies my core belief that America is strongest when it works with our allies, Biden said in a statement.

He said he was confident "they will use their diplomatic experience and skill to restore America’s global and moral leadership. America is back.

Among the others are longtime Biden Senate aide Brian McKeon, to be deputy secretary of state for management former senior diplomats Bonnie Jenkins and Uzra Zeya, to be undersecretary of state for arms control and undersecretary of state of democracy and human rights, respectively.

Derek Chollet, a familiar Democratic foreign policy hand, to be State Department counselor.

Former UN official Salman Ahmed, as director of policy planning.

Suzy George, who was a senior aide to former Secretary of State Madeleine Albright, will be Blinken's chief of staff.

Ned Price, a former Obama administration National Security Council staffer and career CIA official who resigned in protest in the early days of the Trump administration, will serve as the public face of the department, taking on the role of spokesman.

Jalina Porter, communications director for Rep. Cedric Richmond, D-La., who is leaving Congress to work in the White House, will be Price's deputy.

Price and Porter intend to return to the practice of holding daily State Department press briefings, officials said.

Those briefings had been eliminated under the Trump administration.

Jeffrey Prescott, a former national security aide when Biden was vice president, is Biden's pick to be deputy ambassador to the United Nations, He would serve under U.N. envoy-designate Linda Thomas-Greenfield.

Five of the 11 are either people of colour or LGBTQ.

Although most are not household names, all are advocates of multilateralism and many are familiar in Washington and overseas foreign policy circles.

Their selections are a reflection of Biden's intent to turn away from Trump's transactional and often unilateral America First&nbsp;approach to international relations.

Sherman led the Obama administrations negotiations leading to the 2015 nuclear deal with Iran, from which Trump withdrew, and had engaged in talks over ballistic missiles with North Korea during President Bill Clinton's second term.

Nuland served as assistant secretary of state for European Affairs during the Ukraine crisis.

Sherman, McKeon, Nuland, Jenkins and Zeya will require Senate confirmation to their posts while the others will not.

President-elect Joe Biden on Saturday filled out his State Department team with a group of former career diplomats and veterans of the Obama administration, signalling his desire to return to a more traditional foreign policy after four years of uncertainty and unpredictability under President Donald Trump.

President-elect Joe Biden on Saturday filled out his State Department team with a group of former career diplomats and veterans of the Obama administration, signalling his desire to return to a more traditional foreign policy after four years of uncertainty and unpredictability under President Donald Trump. Biden will nominate Wendy Sherman as deputy secretary of state and Victoria Nuland as undersecretary of state for political affairs the second-and third-highest ranking posts, respectively. They were among the officials chosen to serve under the incoming secretary of state, Antony Blinken. The team embodies my core belief that America is strongest when it works with our allies, Biden said in a statement. He said he was confident "they will use their diplomatic experience and skill to restore America’s global and moral leadership. America is back. Among the others are longtime Biden Senate aide Brian McKeon, to be deputy secretary of state for management former senior diplomats Bonnie Jenkins and Uzra Zeya, to be undersecretary of state for arms control and undersecretary of state of democracy and human rights, respectively. Derek Chollet, a familiar Democratic foreign policy hand, to be State Department counselor. Former UN official Salman Ahmed, as director of policy planning. Suzy George, who was a senior aide to former Secretary of State Madeleine Albright, will be Blinken's chief of staff. Ned Price, a former Obama administration National Security Council staffer and career CIA official who resigned in protest in the early days of the Trump administration, will serve as the public face of the department, taking on the role of spokesman. Jalina Porter, communications director for Rep. Cedric Richmond, D-La., who is leaving Congress to work in the White House, will be Price's deputy. Price and Porter intend to return to the practice of holding daily State Department press briefings, officials said. Those briefings had been eliminated under the Trump administration. Jeffrey Prescott, a former national security aide when Biden was vice president, is Biden's pick to be deputy ambassador to the United Nations, He would serve under U.N. envoy-designate Linda Thomas-Greenfield. Five of the 11 are either people of colour or LGBTQ. Although most are not household names, all are advocates of multilateralism and many are familiar in Washington and overseas foreign policy circles. Their selections are a reflection of Biden's intent to turn away from Trump's transactional and often unilateral America First approach to international relations. Sherman led the Obama administrations negotiations leading to the 2015 nuclear deal with Iran, from which Trump withdrew, and had engaged in talks over ballistic missiles with North Korea during President Bill Clinton's second term. Nuland served as assistant secretary of state for European Affairs during the Ukraine crisis. Sherman, McKeon, Nuland, Jenkins and Zeya will require Senate confirmation to their posts while the others will not.

Biden fills out State Department team with Obama veterans

President-elect <a href="https://www.wionews.com/topics/joe-biden">Joe Biden</a> has chosen Dr. David Kessler to help lead Operation Warp Speed, the program to accelerate development of <a href="https://www.wionews.com/topics/coronavirus-vaccine">COVID-19 vaccines</a> and treatments, according to transition officials.

Kessler, a pediatrician and lawyer who headed the Food and Drug Administration during the presidencies of George Bush and Bill Clinton, has been a key adviser to Biden on<a href="https://www.wionews.com/topics/coronavirus"> COVID-19</a> policy and is co-chair of the transition team’s COVID-19 task force.

He will replace Dr. Moncef Slaoui, a researcher and former drug company executive, who will become a consultant to Operation Warp Speed. Kessler will share top responsibilities for the initiative with Gen. Gustave F. Perna, who will continue as chief operating officer, according to a Biden transition spokesman. Kessler’s responsibilities will cover manufacturing, distribution and the safety and efficacy of vaccines and therapeutics.

Also read|&nbsp;<a href="https://www.wionews.com/world/amid-security-concerns-joe-bidens-inauguration-rehearsal-postponed-356952" hreflang="en">Amid security concerns, Joe Biden's inauguration rehearsal postponed</a>

Kessler will join Operation Warp Speed at a critical time. Although the program is widely credited with making possible the development of two highly effective coronavirus vaccines in record time, it has been much less successful at actually delivering the shots to the public — a complex task it shares with numerous federal, state and local authorities.

The Trump administration had vowed to vaccinate 20 million people by the end of 2020, but as of Thursday, just over 11 million inoculations had been given, according to the Centers for Disease Control and Prevention.

In the late fall, Kessler warned Biden that Operation Warp Speed was not prepared for getting the shots into people’s arms. The transition team said last week that the president-elect intended to create vaccination sites in high school gyms, convention centers and mobile units to reach high-risk populations.

Also read|&nbsp;<a href="https://www.wionews.com/world/ahead-of-bidens-inauguration-trump-approves-emergency-declaration-for-washington-356146" hreflang="en">Biden inauguration: Trump approves emergency declaration for Washington</a>

In addition to working to speed delivery of vaccines throughout the country, Kessler is expected to increase the emphasis on development of treatments, and he plans to begin a major antiviral development program for treatment of COVID-19, according to transition officials.

Kessler is close to Dr. Anthony Fauci, the nation’s top infectious disease doctor who became the leading governmental voice on the coronavirus pandemic. The two worked closely to speed the development and approval of drugs that changed the course of the AIDS epidemic in the 1990s.

President-elect Joe Biden has chosen Dr. David Kessler to help lead Operation Warp Speed, the program to accelerate development of COVID-19 vaccines and treatments, according to transition officials.

President-elect Joe Biden has chosen Dr. David Kessler to help lead Operation Warp Speed, the program to accelerate development of COVID-19 vaccines and treatments, according to transition officials. Kessler, a pediatrician and lawyer who headed the Food and Drug Administration during the presidencies of George Bush and Bill Clinton, has been a key adviser to Biden on COVID-19 policy and is co-chair of the transition team’s COVID-19 task force. He will replace Dr. Moncef Slaoui, a researcher and former drug company executive, who will become a consultant to Operation Warp Speed. Kessler will share top responsibilities for the initiative with Gen. Gustave F. Perna, who will continue as chief operating officer, according to a Biden transition spokesman. Kessler’s responsibilities will cover manufacturing, distribution and the safety and efficacy of vaccines and therapeutics. Also read| Amid security concerns, Joe Biden's inauguration rehearsal postponed Kessler will join Operation Warp Speed at a critical time. Although the program is widely credited with making possible the development of two highly effective coronavirus vaccines in record time, it has been much less successful at actually delivering the shots to the public — a complex task it shares with numerous federal, state and local authorities. The Trump administration had vowed to vaccinate 20 million people by the end of 2020, but as of Thursday, just over 11 million inoculations had been given, according to the Centers for Disease Control and Prevention. In the late fall, Kessler warned Biden that Operation Warp Speed was not prepared for getting the shots into people’s arms. The transition team said last week that the president-elect intended to create vaccination sites in high school gyms, convention centers and mobile units to reach high-risk populations. Also read| Biden inauguration: Trump approves emergency declaration for Washington In addition to working to speed delivery of vaccines throughout the country, Kessler is expected to increase the emphasis on development of treatments, and he plans to begin a major antiviral development program for treatment of COVID-19, according to transition officials. Kessler is close to Dr. Anthony Fauci, the nation’s top infectious disease doctor who became the leading governmental voice on the coronavirus pandemic. The two worked closely to speed the development and approval of drugs that changed the course of the AIDS epidemic in the 1990s.

Joe Biden picks former FDA Chief to lead federal vaccine efforts

A panel of outside advisers to the U.S. Food and Drug Administration on Thursday (December 17) overwhelmingly endorsed emergency use of Moderna coronavirus vaccine, virtually assuring a second option for protecting against COVID-19 for a pandemic ravaged nation.

FDA expert panel endorses Moderna coronavirus vaccine

US experts will meet Thursday to decide whether to recommend approval of Moderna's Covid-19 vaccine for emergency use.

Moderna vaccine inches closer to emergency use approval in United States

The first COVID-19 test that can be performed entirely at home was cleared by U.S. regulators on Tuesday, and it can be acquired without a prescription.

FDA approves first non-prescription COVID-19 test kit

The United States Food and Drugs Administration (FDA) has approved the country's first at home COVID -19 testing kit. This is the first over the counter covid testing kit to be approved by the drug regulator.

United States FDA approves country's first at home COVID-19 testing kit

United States' Food and Drug Administration (FDA) has authorized the Pfizer-BioNTech vaccine against the infection of COVID-19 for emergency use. This will be the first Coronavirus vaccine to get an approval in the United States of America.

United States' FDA authorises Pfizer-BioNTech vaccine for emergency use

U.S. Food and Drug Administration’s Commissioner Stephen Hahn has said that it is realistic to expect that 20 million Americans could be vaccinated against Coronavirus by the end of this year. Hahn declined to give a specific timeline for vaccine approvals.

US FDA Chief: 20 mn to be vaccinated this year

The US Food & Drugs Administration (FDA) advisors will meet on the December 10 to discuss whether to authorise the Pfizer COVID-19 vaccine for emergency use. The advisory committee will discuss the safety & effectiveness of the vaccine candidate.

FDA panel to discuss Pfizer vaccine on December 10

The Food and Drug Administration on Tuesday gave an emergency green light to the first rapid coronavirus test that can run from start to finish at home, paving a potential path for more widespread testing outside of health care settings.

The test, developed by California-based company Lucira Health, requires a prescription from a health care provider. People under age 14 also can’t perform the test on themselves. But with a relatively simple nasal swab, the test can return results in about half an hour, and is projected by the company to cost $50 or less, according to the product’s website. Clinicians can also run the test on their patients, including children under 14, potentially delivering answers during a single visit to a care center or pharmacy, instead of routing a tough-to-collect sample through a lab.

A handful of other tests have been cleared by the FDA for at-home collection of samples, which are then shipped to a lab for processing. But Lucira’s test is the first to remove the need for an intermediary.

“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19,” Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement. “Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them.”

People who test positive for the coronavirus are expected to isolate themselves from others for 10 days from the day their symptoms started, or the day they tested positive, per guidelines from the Centers for Disease Control and Prevention.

Laboratory tests that look for the coronavirus’s genetic material using a technique called polymerase chain reaction, or PCR, are still considered the gold standard for detecting the virus. But the new at-home test relies on similar principles by using a method called a loop mediated amplification reaction, or LAMP. Like PCR, LAMP repeatedly copies genetic material until it reaches detectable levels, making it possible to identify the virus even when it is present at only very low levels in the respiratory tract. While faster and less cumbersome than PCR, LAMP is generally thought to be less accurate.

People taking the battery-powered test must swirl a swab in both of their nostrils, then dip and stir the swab into a vial of chemicals. That vial is then plugged into a test cartridge that processes the sample. Within half an hour, the test cartridge will light up as “positive” or “negative.” Federal guidelines note that people taking the test should report the results to their health care providers, who must then inform public health authorities to help track the virus’s spread.

An at-home test for the virus “was going to happen,” said Omai Garner, a clinical microbiologist and diagnostics expert at the University of California, Los Angeles Health System. “I am hopeful that it works well.”

Garner noted that the news should be taken with a note of caution, however. In recent months, several experts have called for more widespread at-home testing as a way to help curb the virus’s spread. But others have raised concerns about the practicality of a strategy that would likely rely on tests that sacrifice a degree of accuracy for convenience and a more affordable price tag.

According to the product’s instructions, Lucira’s LAMP test was able to accurately detect 94% of the infections found by a well-established PCR-based test. It also correctly identified 98% of the healthy, uninfected people. This study, which was conducted by the company, was small, including fewer than 100 samples in total.

Representatives at Lucira Health did not respond immediately to requests for comment.

The Food and Drug Administration on Tuesday gave an emergency green light to the first rapid coronavirus test that can run from start to finish at home, paving a potential path for more widespread testing outside of health care settings.

The Food and Drug Administration on Tuesday gave an emergency green light to the first rapid coronavirus test that can run from start to finish at home, paving a potential path for more widespread testing outside of health care settings. The test, developed by California-based company Lucira Health, requires a prescription from a health care provider. People under age 14 also can’t perform the test on themselves. But with a relatively simple nasal swab, the test can return results in about half an hour, and is projected by the company to cost $50 or less, according to the product’s website. Clinicians can also run the test on their patients, including children under 14, potentially delivering answers during a single visit to a care center or pharmacy, instead of routing a tough-to-collect sample through a lab. A handful of other tests have been cleared by the FDA for at-home collection of samples, which are then shipped to a lab for processing. But Lucira’s test is the first to remove the need for an intermediary. “Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19,” Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement. “Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them.” People who test positive for the coronavirus are expected to isolate themselves from others for 10 days from the day their symptoms started, or the day they tested positive, per guidelines from the Centers for Disease Control and Prevention. Laboratory tests that look for the coronavirus’s genetic material using a technique called polymerase chain reaction, or PCR, are still considered the gold standard for detecting the virus. But the new at-home test relies on similar principles by using a method called a loop mediated amplification reaction, or LAMP. Like PCR, LAMP repeatedly copies genetic material until it reaches detectable levels, making it possible to identify the virus even when it is present at only very low levels in the respiratory tract. While faster and less cumbersome than PCR, LAMP is generally thought to be less accurate. People taking the battery-powered test must swirl a swab in both of their nostrils, then dip and stir the swab into a vial of chemicals. That vial is then plugged into a test cartridge that processes the sample. Within half an hour, the test cartridge will light up as “positive” or “negative.” Federal guidelines note that people taking the test should report the results to their health care providers, who must then inform public health authorities to help track the virus’s spread. An at-home test for the virus “was going to happen,” said Omai Garner, a clinical microbiologist and diagnostics expert at the University of California, Los Angeles Health System. “I am hopeful that it works well.” Garner noted that the news should be taken with a note of caution, however. In recent months, several experts have called for more widespread at-home testing as a way to help curb the virus’s spread. But others have raised concerns about the practicality of a strategy that would likely rely on tests that sacrifice a degree of accuracy for convenience and a more affordable price tag. According to the product’s instructions, Lucira’s LAMP test was able to accurately detect 94% of the infections found by a well-established PCR-based test. It also correctly identified 98% of the healthy, uninfected people. This study, which was conducted by the company, was small, including fewer than 100 samples in total. Representatives at Lucira Health did not respond immediately to requests for comment.

FDA authorizes the first at-home coronavirus test

The U.S. Food and Drug Administration on Monday (November 9) authorized emergency use of Eli Lilly and Co's experimental COVID-19 antibody treatment for non-hospitalized patients older than 65 or who have certain chronic medical conditions.

US allows emergency use of first COVID-19 antibody drug

US President Donald Trump on Monday accused the Food and Drug Administration (FDA) and Pfizer of withholding the announcement on the COVID-19 vaccine before elections to prevent him from getting a "vaccine win".

The US Food and Drug Administration "and the Democrats didn't want to have me get a Vaccine WIN, prior to the election, so instead, it came out five days later? As I've said all along!" Trump said in a tweet.

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The <a href="https://twitter.com/US_FDA?ref_src=twsrc%5Etfw">@US_FDA</a> and the Democrats didn’t want to have me get a Vaccine WIN, prior to the election, so instead it came out five days later – As I’ve said all along!
— Donald J. Trump (@realDonaldTrump) <a href="https://twitter.com/realDonaldTrump/status/1325962203346972678?ref_src=twsrc%5Etfw">November 10, 2020</a></blockquote>
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Earlier, pharma major Pfizer announced that its vaccine, as per preliminary estimates, has been found to be 90 per cent effective in preventing COVID-19.

Also read:&nbsp;<a href="https://www.wionews.com/world/pfizer-biontech-claim-their-coronavirus-vaccine-is-90-effective-341931" hreflang="en">Pfizer, BioNTech claim their coronavirus vaccine is 90% effective</a>

Pfizer said that the vaccine candidate was found to be more than 90 per cent effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis. Analysis evaluated 94 confirmed cases of COVID-19 in trial participants, it said.

Trump alleged, "If Joe Biden were President, you wouldn't have the Vaccine for another four years, nor would the @US_FDA have ever approved it so quickly. The bureaucracy would have destroyed millions of lives!" 
Previously, Trump had said that he worked on removing a large number of bureaucratic obstacles to fast-track development and approval of a vaccine.

"As I have long said, @Pfizer and the others would only announce a Vaccine after the Election, because they didn't have the courage to do it before. Likewise, the @US_FDA should have announced it earlier, not for political purposes, but for saving lives!" he tweeted. 
Earlier in the day, President-elect Joe Biden said the announcement promises the chance to change that next year, but the tasks before them now remain the same.

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As I have long said, <a href="https://twitter.com/pfizer?ref_src=twsrc%5Etfw">@Pfizer</a> and the others would only announce a Vaccine after the Election, because they didn’t have the courage to do it before. Likewise, the <a href="https://twitter.com/US_FDA?ref_src=twsrc%5Etfw">@US_FDA</a> should have announced it earlier, not for political purposes, but for saving lives!
— Donald J. Trump (@realDonaldTrump) <a href="https://twitter.com/realDonaldTrump/status/1325961445062938625?ref_src=twsrc%5Etfw">November 10, 2020</a></blockquote>
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"I congratulate the brilliant women and men who helped produce this breakthrough and to give us such cause for hope," he said. "At the same time, it is also important to understand that the end of the battle against COVID-19 is still months away," Biden said.

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Statement by President-elect Biden on Pfizer's vaccine progress: <a href="https://t.co/eOiLZnqO8N">pic.twitter.com/eOiLZnqO8N</a>
— Biden-Harris Presidential Transition (@Transition46) <a href="https://twitter.com/Transition46/status/1325816759690129412?ref_src=twsrc%5Etfw">November 9, 2020</a></blockquote>
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House Speaker Nancy Pelosi said that the world welcomes good news about a vaccine that could be a giant leap forward in the fight against the coronavirus.

"We are all praying that this early evidence of extraordinary efficacy and safety holds true so that the vaccine can be approved and distributed soon but not one day sooner or one day later than it is ready," she said.

US President Donald Trump on Monday accused the Food and Drug Administration (FDA) and Pfizer of withholding the announcement on the COVID-19 vaccine before elections to prevent him from getting a "vaccine win".

US President Donald Trump on Monday accused the Food and Drug Administration (FDA) and Pfizer of withholding the announcement on the COVID-19 vaccine before elections to prevent him from getting a "vaccine win". The US Food and Drug Administration "and the Democrats didn't want to have me get a Vaccine WIN, prior to the election, so instead, it came out five days later? As I've said all along!" Trump said in a tweet. The @US_FDA and the Democrats didn’t want to have me get a Vaccine WIN, prior to the election, so instead it came out five days later – As I’ve said all along! — Donald J. Trump (@realDonaldTrump) November 10, 2020 × Earlier, pharma major Pfizer announced that its vaccine, as per preliminary estimates, has been found to be 90 per cent effective in preventing COVID-19. Also read: Pfizer, BioNTech claim their coronavirus vaccine is 90% effective Pfizer said that the vaccine candidate was found to be more than 90 per cent effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis. Analysis evaluated 94 confirmed cases of COVID-19 in trial participants, it said. Trump alleged, "If Joe Biden were President, you wouldn't have the Vaccine for another four years, nor would the @US_FDA have ever approved it so quickly. The bureaucracy would have destroyed millions of lives!" Previously, Trump had said that he worked on removing a large number of bureaucratic obstacles to fast-track development and approval of a vaccine. "As I have long said, @Pfizer and the others would only announce a Vaccine after the Election, because they didn't have the courage to do it before. Likewise, the @US_FDA should have announced it earlier, not for political purposes, but for saving lives!" he tweeted. Earlier in the day, President-elect Joe Biden said the announcement promises the chance to change that next year, but the tasks before them now remain the same. As I have long said, @Pfizer and the others would only announce a Vaccine after the Election, because they didn’t have the courage to do it before. Likewise, the @US_FDA should have announced it earlier, not for political purposes, but for saving lives! — Donald J. Trump (@realDonaldTrump) November 10, 2020 × "I congratulate the brilliant women and men who helped produce this breakthrough and to give us such cause for hope," he said. "At the same time, it is also important to understand that the end of the battle against COVID-19 is still months away," Biden said. Statement by President-elect Biden on Pfizer's vaccine progress: pic.twitter.com/eOiLZnqO8N — Biden-Harris Presidential Transition (@Transition46) November 9, 2020 × House Speaker Nancy Pelosi said that the world welcomes good news about a vaccine that could be a giant leap forward in the fight against the coronavirus. "We are all praying that this early evidence of extraordinary efficacy and safety holds true so that the vaccine can be approved and distributed soon but not one day sooner or one day later than it is ready," she said.

Trump accuses FDA and Pfizer of withholding COVID-19 vaccine announcement before elections

A federal panel will decide Friday whether to recommend approval of a controversial but potentially promising Alzheimers drug, which would be the first to come to market in nearly two decades.

The drug, aducanumab, would not stop or reverse dementia, but some evidence suggests it can slow the progression of memory and thinking problems in people with mild or early symptoms of cognitive decline, giving them a little extra time before they develop Alzheimer’s. It would be the first medication to do so by attacking the core biology of Alzheimer’s disease.

Many Alzheimer’s experts, however, are skeptical that aducanumab, made by Biogen, has exhibited strong enough evidence that it can slow cognitive decline. The drug, given as a monthly intravenous infusion — would also be costly, about $50,000 a year. And some experts say that it would be challenging for doctors trying to appropriately prescribe and monitor its use and that approval of such a drug would make it less likely that patients would participate in studies for other Alzheimer’s drugs that might ultimately work better.

The drug’s path through clinical trials has been rocky, with only one of two Phase 3 trials showing positive results — and those results emerged only from an analysis of additional data after the trials were stopped in March 2019 by an independent data monitoring committee because the drug didn’t appear to be working.

Several experts, including a Mayo Clinic neurologist who was a site investigator for an aducanumab trial, have said that the evidence is too weak for the drug to warrant approval now and that another rigorous clinical trial should be conducted before a decision is made on whether the drug should be made available.

The panel, a committee of medical experts that advises the Food and Drug Administration, will review evidence of the effectiveness and safety of aducanumab. If it endorses the drug Friday, that would not guarantee its approval, but the FDA often follows the recommendations of its advisory panels.

Documents posted by the FDA in advance of the hearing gave the impression that most of the agency’s reviewers were satisfied that data from the successful trial was strong and that safety issues, which mostly involved a type of brain swelling, were manageable.

A federal panel will decide Friday whether to recommend approval of a controversial but potentially promising Alzheimers drug, which would be the first to come to market in nearly two decades.

A federal panel will decide Friday whether to recommend approval of a controversial but potentially promising Alzheimers drug, which would be the first to come to market in nearly two decades. The drug, aducanumab, would not stop or reverse dementia, but some evidence suggests it can slow the progression of memory and thinking problems in people with mild or early symptoms of cognitive decline, giving them a little extra time before they develop Alzheimer’s. It would be the first medication to do so by attacking the core biology of Alzheimer’s disease. Many Alzheimer’s experts, however, are skeptical that aducanumab, made by Biogen, has exhibited strong enough evidence that it can slow cognitive decline. The drug, given as a monthly intravenous infusion — would also be costly, about $50,000 a year. And some experts say that it would be challenging for doctors trying to appropriately prescribe and monitor its use and that approval of such a drug would make it less likely that patients would participate in studies for other Alzheimer’s drugs that might ultimately work better. The drug’s path through clinical trials has been rocky, with only one of two Phase 3 trials showing positive results — and those results emerged only from an analysis of additional data after the trials were stopped in March 2019 by an independent data monitoring committee because the drug didn’t appear to be working. Several experts, including a Mayo Clinic neurologist who was a site investigator for an aducanumab trial, have said that the evidence is too weak for the drug to warrant approval now and that another rigorous clinical trial should be conducted before a decision is made on whether the drug should be made available. The panel, a committee of medical experts that advises the Food and Drug Administration, will review evidence of the effectiveness and safety of aducanumab. If it endorses the drug Friday, that would not guarantee its approval, but the FDA often follows the recommendations of its advisory panels. Documents posted by the FDA in advance of the hearing gave the impression that most of the agency’s reviewers were satisfied that data from the successful trial was strong and that safety issues, which mostly involved a type of brain swelling, were manageable.

Controversial Alzheimer’s drug faces critical test before FDA panel

Gilead Science's antiviral drug remdesivir has been given the green light by the Food and Drug Administration as the first officially approved COVID-19 treatment.

FDA approves remdesivir as first COVID-19 treatment

Democrat's vice-presidential candidate Kamala Harris on Saturday said that if a vaccine for COVID-19 &nbsp;is available before November's election, she would not take President Trump's word on its safety and efficacy.

Also read:&nbsp;<a href="https://www.wionews.com/world/multiple-vessels-during-pro-trump-boat-parade-in-texas-sink-no-injuries-reported-325470" hreflang="en">Multiple vessels during pro-Trump boat parade in Texas sink</a>

Trump administration has been under scrutiny over its handling of the virus which has sparked fears of his government rushing the vaccine research to release it before the elections.&nbsp;

"I would not trust Donald Trump and it would have to be a credible source of information that talks about the efficacy and the reliability of (a vaccine)," Harris told CNN.

"I will not take his word for it."

The head of the US Food and Drug Administration recently claimed that a COVID-19 vaccine would be rolled out in the US before completing its trials.

In an interview with The Financial Times on Sunday, Stephen Hahn, the commissioner of FDA said that he was ready to allow “emergency use” for a coronavirus vaccine, even before stage 3 of the human trials come to a close.

Also read:&nbsp;<a href="https://www.wionews.com/world/expect-drive-thrus-stadiums-to-be-converted-to-in-person-polling-places-for-us-election-325456">Expect stadiums to be converted to in-person polling places for US election</a>

Hahn added that the “benefit outweighs the risk in a public health emergency”, as the US nears 6 million cases.

Many analysts believe that Trump wants to fast track a vaccine before the upcoming November elections to sway the vote in his favour. Medical professionals are also wary of the risks posed by using an untested vaccine.

Currently, Trump’s Operation Warp Speed is underway, which a public-private partnership to develop a coronavirus vaccine.

However, on Monday, The White House said that "no one is pressuring the FDA to do anything" after reports said there is increasing pressure on the agency to pass the coronavirus vaccine ahead of the US election to be held on November 3.

"The priority here is saving lives," White House spokesperson Kayleigh McEnany said.

Meanwhile drugmaker Pfizer said it should know by the end of October whether the coronavirus vaccine it is developing with BioNTech is safe and effective. The drugmaker said that it will seek approval immediately if trial results show positive results.

Pfizer and Moderna had begun final phase-3 clinical trials on July 27 with the US Food and Drug Administration(FDA) likely to give emergency use approval for critically ill patients to allow an early release to the public.

US infections diseases expert Anthony Fauci said that initial results could come in "November or December."

Democrat's vice-presidential candidate Kamala Harris on Saturday said that if a vaccine for COVID-19 is available before November's election, she would not take President Trump's word on its safety and efficacy.

Democrat's vice-presidential candidate Kamala Harris on Saturday said that if a vaccine for COVID-19 is available before November's election, she would not take President Trump's word on its safety and efficacy. Also read: Multiple vessels during pro-Trump boat parade in Texas sink Trump administration has been under scrutiny over its handling of the virus which has sparked fears of his government rushing the vaccine research to release it before the elections. "I would not trust Donald Trump and it would have to be a credible source of information that talks about the efficacy and the reliability of (a vaccine)," Harris told CNN. "I will not take his word for it." The head of the US Food and Drug Administration recently claimed that a COVID-19 vaccine would be rolled out in the US before completing its trials. In an interview with The Financial Times on Sunday, Stephen Hahn, the commissioner of FDA said that he was ready to allow “emergency use” for a coronavirus vaccine, even before stage 3 of the human trials come to a close. Also read: Expect stadiums to be converted to in-person polling places for US election Hahn added that the “benefit outweighs the risk in a public health emergency”, as the US nears 6 million cases. Many analysts believe that Trump wants to fast track a vaccine before the upcoming November elections to sway the vote in his favour. Medical professionals are also wary of the risks posed by using an untested vaccine. Currently, Trump’s Operation Warp Speed is underway, which a public-private partnership to develop a coronavirus vaccine. However, on Monday, The White House said that "no one is pressuring the FDA to do anything" after reports said there is increasing pressure on the agency to pass the coronavirus vaccine ahead of the US election to be held on November 3. "The priority here is saving lives," White House spokesperson Kayleigh McEnany said. Meanwhile drugmaker Pfizer said it should know by the end of October whether the coronavirus vaccine it is developing with BioNTech is safe and effective. The drugmaker said that it will seek approval immediately if trial results show positive results. Pfizer and Moderna had begun final phase-3 clinical trials on July 27 with the US Food and Drug Administration(FDA) likely to give emergency use approval for critically ill patients to allow an early release to the public. US infections diseases expert Anthony Fauci said that initial results could come in "November or December."

'Will not trust him': Kamala Harris on Donald Trump's pre-election vaccine

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