A prescription drug commonly called "gas station heroin" is causing concern in the United States with the Food and Drug Administration putting fresh focus on the issue. The drug named tianeptine is a synthetic drug approved in some countries for treatment of depression, and mimics opioids like fentanyl and has a potential to form habit. In the US, it is available easily in convenience stores, smoke shops, gas stations or even online.

Reports have said that in addition to having risk of addiction, tianeptine may cause withdrawal symptoms and carries risk of overdose. It has been reported that the drug may also cause seizures, psychosis, kidney damage and may even lead to death.

Since 2022, USFDA has been vocal about urging consumers in the US to avoid the drug. However, it has been seen that vendors continue to promote the drug as dietary supplement.&nbsp;

This has happened in spite of FDA explicitly saying that tianeptine "does not meet the statutory definition of a dietary ingredient and is an unsafe food additive."

Watch | Elon Musk's Neuralink implants brain chip in human for the first time

<div class="ui-state-default" contenteditable="false">
<div class="twitter-block" draggable="false">
<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/elon-musks-neuralink-implants-brain-chip-in-human-for-the-first-time-685134/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>
</div>
<a class="close-mark close-div" href="#" id="jqclosemark">×</a></div>

Last week, the USFDA cautioned consumers again about tianeptine, which is a component of products like Neptune's Fix, Za Za Red and Tianaa.

"These products may interact, in life-threatening ways, with other medications a consumer may be taking. The agency is actively investigating adverse event reports in conjunction with local and state health departments," USFDA warned in its report.

Also Read | <a href="https://www.wionews.com/science/nasas-hubble-telescope-finds-water-vapour-in-distant-planets-atmosphere-683925">NASA's Hubble Telescope finds water vapour in distant planet's atmosphere</a>

The agency also said that Neptune Resources&nbsp;LLC had voluntarily agreed to recall Neptune Fix Elixir, Neptune Fix Extra Strength Elixir and Neptune's Fix tablets from consumer level.

Also Read | <a href="https://www.wionews.com/trending/hermit-crabs-begin-to-use-human-discarded-plastic-waste-as-form-of-armour-684330">Hermit crabs found using discarded plastic waste as form of armour</a>

"Consumers, distributors and retailers that have these products should either dispose of them or return them to place of purchase immediately," USFDA warned.

"FDA sent a letter on Jan. 11, 2024, to convenience store, gas station and other organizations urging retailers to stop selling Neptune’s Fix and any other tianeptine-containing products," the agency added.

(With inputs from agencies)

A prescription drug commonly called "gas station heroin" is causing concern in the United States with the Food and Drug Administration putting fresh focus on the issue.

A prescription drug commonly called "gas station heroin" is causing concern in the United States with the Food and Drug Administration putting fresh focus on the issue. The drug named tianeptine is a synthetic drug approved in some countries for treatment of depression, and mimics opioids like fentanyl and has a potential to form habit. In the US, it is available easily in convenience stores, smoke shops, gas stations or even online. Reports have said that in addition to having risk of addiction, tianeptine may cause withdrawal symptoms and carries risk of overdose. It has been reported that the drug may also cause seizures, psychosis, kidney damage and may even lead to death. Since 2022, USFDA has been vocal about urging consumers in the US to avoid the drug. However, it has been seen that vendors continue to promote the drug as dietary supplement. This has happened in spite of FDA explicitly saying that tianeptine "does not meet the statutory definition of a dietary ingredient and is an unsafe food additive." Watch | Elon Musk's Neuralink implants brain chip in human for the first time × Last week, the USFDA cautioned consumers again about tianeptine, which is a component of products like Neptune's Fix, Za Za Red and Tianaa. "These products may interact, in life-threatening ways, with other medications a consumer may be taking. The agency is actively investigating adverse event reports in conjunction with local and state health departments," USFDA warned in its report. Also Read | NASA's Hubble Telescope finds water vapour in distant planet's atmosphere The agency also said that Neptune Resources LLC had voluntarily agreed to recall Neptune Fix Elixir, Neptune Fix Extra Strength Elixir and Neptune's Fix tablets from consumer level. Also Read | Hermit crabs found using discarded plastic waste as form of armour "Consumers, distributors and retailers that have these products should either dispose of them or return them to place of purchase immediately," USFDA warned. "FDA sent a letter on Jan. 11, 2024, to convenience store, gas station and other organizations urging retailers to stop selling Neptune’s Fix and any other tianeptine-containing products," the agency added. (With inputs from agencies)

‘Gas station heroin’ comes into renewed focus after USFDA warning

The United States on Thursday (November 9) greenlit the world's first chikungunya vaccine. Chikungunya is an ailment caused by a virus that is spread by infected mosquitoes. US Food and Drug Administration has called the disease "an emerging global health threat". The vaccine, named Ixchiq, has been developed by Europe's Valneva. USFDA has said that the vaccine has been approved for people 18 and over who face the risk of exposure to the disease.

The approval in the US is likely to boost the speed of the vaccine's rollout in countries where chikungunya is a public health issue.

Chikungunya results in fever and immense joint pain. The disease is more prevalent in regions of Africa, Asia and the Americas. It has been seen that the disease is more common in tropical and subtropical climates.

"However, chikungunya virus has spread to new geographical areas causing a rise in global prevalence of the disease," the FDA said. The agency has reported that more than 5 million cases were found in the last 15 years.

"Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions," senior FDA official Peter Marks said in a statement.

"Today's approval addresses an unmet medical need and is an important advancement in the prevention of a potentially debilitating disease with limited treatment options."

The recipient of the vaccine receives the vaccine in one dose. The vaccine contains a weakened but live chikungunya virus.&nbsp;

Before the approval, two clinical trials of the vaccine were carried out. A total of 3,500 people were involved in these clinical trials. Commonly reported side effects were fatigue, headache, muscle and joint pain, fever and nausea.

Reuters reported that serious reactions were found in 1.6 per cent of Ixchiq recipients. Two of the patients required hospitalisation.

FDA has also asked the company to conduct a post-marketing study to check whether there was a risk of severe reactions that were similar to chikungunya after the vaccine is administered.

(With inputs from agencies)

The United States on Thursday (November 9) greenlit the world's first chikungunya vaccine. Chikungunya is an ailment caused by a virus that is spread by infected mosquitoes.

The United States on Thursday (November 9) greenlit the world's first chikungunya vaccine. Chikungunya is an ailment caused by a virus that is spread by infected mosquitoes. US Food and Drug Administration has called the disease "an emerging global health threat". The vaccine, named Ixchiq, has been developed by Europe's Valneva. USFDA has said that the vaccine has been approved for people 18 and over who face the risk of exposure to the disease. The approval in the US is likely to boost the speed of the vaccine's rollout in countries where chikungunya is a public health issue. Chikungunya results in fever and immense joint pain. The disease is more prevalent in regions of Africa, Asia and the Americas. It has been seen that the disease is more common in tropical and subtropical climates. "However, chikungunya virus has spread to new geographical areas causing a rise in global prevalence of the disease," the FDA said. The agency has reported that more than 5 million cases were found in the last 15 years. "Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions," senior FDA official Peter Marks said in a statement. "Today's approval addresses an unmet medical need and is an important advancement in the prevention of a potentially debilitating disease with limited treatment options." The recipient of the vaccine receives the vaccine in one dose. The vaccine contains a weakened but live chikungunya virus. Before the approval, two clinical trials of the vaccine were carried out. A total of 3,500 people were involved in these clinical trials. Commonly reported side effects were fatigue, headache, muscle and joint pain, fever and nausea. Reuters reported that serious reactions were found in 1.6 per cent of Ixchiq recipients. Two of the patients required hospitalisation. FDA has also asked the company to conduct a post-marketing study to check whether there was a risk of severe reactions that were similar to chikungunya after the vaccine is administered. (With inputs from agencies)

US: First chikungunya virus vaccine approved by FDA for those 18 and above

The United States Food and Drug Administration (USFDA) has flagged more than two dozen eyedrop&nbsp;products saying there was a risk of eye infection which can lead to partial vision loss or even blindness. The alert was issued on Friday (October 27). The USFDA has flagged 26 over-the-counter eye care products. These include eyedrops and gels from companies Leader (Cardinal Health), Rugby (Cardinal Health), Velocity Pharma, Rite Aid and Target up&amp;up.

The FDA has recommended that manufacturers recall all these products. The agency has reportedly found unsanitary conditions in a manufacturing plant. The press release from the FDA says that the bacterial test came back positive. The FDA did not immediately say which company operated the plant.

The agency has said that even though it had not received any reports of infection in connection with these products, it was still encouraging doctors and patients to report any such cases.

It is very important that medical products like eye drops are sterile as drugs applied to the eye bypass some of the body's defence mechanisms.

Also Read | <a href="https://www.wionews.com/entertainment/lifestyle/news-extreme-heat-related-heart-casualties-in-us-projected-to-double-by-midcentury-at-current-emission-pace-study-653078">Extreme heat-related heart casualties in US projected to double by midcentury at current emission pace: Study</a>

The FDA has also said that consumers should safely discard these products by handing them over at the drug take-back site or by discarding them at home provided the product was included in the FDA's "flush list" of drugs.

The regulator has mentioned that Rite Aid, Target and CVS were in the process of removing the products from the stores and websites. It said that products with the branding of Rugby, Velocity and Leader may still be available but shouldn't be purchased.

Also Read | <a href="https://www.wionews.com/entertainment/lifestyle/news-juvenile-arthritis-affects-more-than-220000-kids-in-us-heres-what-you-must-know-about-the-disease-653155">Juvenile arthritis affects more than 220,000 kids in US; here's what you must know about the disease</a>

The New York Times quoted a Rite Aid spokesperson as saying that the company was removing “applicable Rite Aid branded products” from stores. The news outlet also reported a CVS spokesperson as saying that the company has “immediately stopped the sale in-store and online of all products supplied by Velocity Pharma within the CVS Health Brand Eye Products portfolio.”

WATCH WION LIVE HERE

<div class="ui-state-default" contenteditable="false">
<div class="twitter-block" draggable="false"><iframe allow="accelerometer; autoplay; encrypted-media; gyroscope; picture-in-picture" allowfullscreen="" frameborder="0" height="350" loading="”lazy”" src="https://www.wionews.com/live-tv/embed?autoplay=1&amp;mute=1" width="100%"></iframe></div>
<a class="close-mark close-div" href="#" id="jqclosemark">×</a></div>

&nbsp;

The United States Food and Drug Administration (USFDA) has flagged more than two dozen eyedrop products saying there was a risk of eye infection which can lead to partial vision loss or even blindness.

The United States Food and Drug Administration (USFDA) has flagged more than two dozen eyedrop products saying there was a risk of eye infection which can lead to partial vision loss or even blindness. The alert was issued on Friday (October 27). The USFDA has flagged 26 over-the-counter eye care products. These include eyedrops and gels from companies Leader (Cardinal Health), Rugby (Cardinal Health), Velocity Pharma, Rite Aid and Target up&up. The FDA has recommended that manufacturers recall all these products. The agency has reportedly found unsanitary conditions in a manufacturing plant. The press release from the FDA says that the bacterial test came back positive. The FDA did not immediately say which company operated the plant. The agency has said that even though it had not received any reports of infection in connection with these products, it was still encouraging doctors and patients to report any such cases. It is very important that medical products like eye drops are sterile as drugs applied to the eye bypass some of the body's defence mechanisms. Also Read | Extreme heat-related heart casualties in US projected to double by midcentury at current emission pace: Study The FDA has also said that consumers should safely discard these products by handing them over at the drug take-back site or by discarding them at home provided the product was included in the FDA's "flush list" of drugs. The regulator has mentioned that Rite Aid, Target and CVS were in the process of removing the products from the stores and websites. It said that products with the branding of Rugby, Velocity and Leader may still be available but shouldn't be purchased. Also Read | Juvenile arthritis affects more than 220,000 kids in US; here's what you must know about the disease The New York Times quoted a Rite Aid spokesperson as saying that the company was removing “applicable Rite Aid branded products” from stores. The news outlet also reported a CVS spokesperson as saying that the company has “immediately stopped the sale in-store and online of all products supplied by Velocity Pharma within the CVS Health Brand Eye Products portfolio.” WATCH WION LIVE HERE ×

USFDA flags eyedrops from major brands for infection threat

US Food and Drug Administration (USFDA), on Friday (June 4), voiced concern over potential myocarditis link to Novavax Covid-19 vaccine. Experts will soon weigh its use in the United States.&nbsp;

The Novavax vaccine is already authorized in other countries, particularly in Europe.&nbsp;

An independent committee is due to meet on Tuesday to evaluation the vaccine and give its recommendation. The committee has been convened at the request of USFDA.

USFDA has published a lengthy document analysing data about the vaccine. It has done the same in past for three other vaccines which are already authorised in the country.

After USFDA's document, Novavax stock dropped 20 per cent on New York Stock Exchange.

Novavax's vaccine was found to be 90 percent effective against symptomatic cases of the disease, in trials conducted before the appearance of the Omicron variant, according to the FDA.&nbsp;

However in the group which was given the vaccine, six cases of myocarditis were found. Mysocarditis is inflammation of heart muscles. In the placebo group, one such case was found.

Five cases occurred within two weeks of vaccination.&nbsp;

"Identification of multiple potential vaccine-associated cases" out of 40,000 clinical trial participants "raises concern that if causally associated, the risk of myocarditis following" the Novavax shot "could be higher than reported" on other vaccines such as Pfizer or Moderna, the FDA said.

(With inputs from agencies)

You can now write for wionews.com and be a part of the community. Share your stories and opinions with us <a href="https://www.wionews.com/content-contribution-registration-form">here</a>.

WATCH WION LIVE HERE

<div class="ui-state-default" contenteditable="false">
<div class="twitter-block" draggable="false"><iframe allow="accelerometer; autoplay; encrypted-media; gyroscope; picture-in-picture" allowfullscreen="" frameborder="0" height="350" src="https://www.wionews.com/live-tv/embed?autoplay=1&amp;mute=1" width="100%"></iframe></div>
<a class="close-mark close-div" href="#" id="jqclosemark">×</a></div>

&nbsp;

US Food and Drug Administration (USFDA), on Friday (June 4), voiced concern over potential myocarditis link to Novavax Covid-19 vaccine. Experts will soon weigh its use in the United States.

US Food and Drug Administration (USFDA), on Friday (June 4), voiced concern over potential myocarditis link to Novavax Covid-19 vaccine. Experts will soon weigh its use in the United States. The Novavax vaccine is already authorized in other countries, particularly in Europe. An independent committee is due to meet on Tuesday to evaluation the vaccine and give its recommendation. The committee has been convened at the request of USFDA. USFDA has published a lengthy document analysing data about the vaccine. It has done the same in past for three other vaccines which are already authorised in the country. After USFDA's document, Novavax stock dropped 20 per cent on New York Stock Exchange. Novavax's vaccine was found to be 90 percent effective against symptomatic cases of the disease, in trials conducted before the appearance of the Omicron variant, according to the FDA. However in the group which was given the vaccine, six cases of myocarditis were found. Mysocarditis is inflammation of heart muscles. In the placebo group, one such case was found. Five cases occurred within two weeks of vaccination. "Identification of multiple potential vaccine-associated cases" out of 40,000 clinical trial participants "raises concern that if causally associated, the risk of myocarditis following" the Novavax shot "could be higher than reported" on other vaccines such as Pfizer or Moderna, the FDA said. (With inputs from agencies) You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here. WATCH WION LIVE HERE ×

USFDA expresses concern over possible Novavax myocarditis link

US Food and Drug Administration on Wednesday gave a go-ahead to Pfizer's Covid pill for its use among high-risk people aged 12 and above.

"Today's authorization introduces the first treatment for Covid-19 that is in the form of a pill that is taken orally -- a major step forward in the fight against this global pandemic," said FDA scientist Patrizia Cavazzoni.

Paxlovid, Pfizer's treatment is a combination of two pills taken over five days. The treatment was shown to be safe and reduced the risk of hospitalizations and deaths among at-risk people by 88 percent. The clinical trial included 2,200 people.

In an unusual move, the FDA did not convene its customary panel of independent experts to review in depth data surrounding Pfizer's pill ahead of authorization.

Also Raed | <a href="https://www.wionews.com/world/boosters-cannot-be-seen-as-a-ticket-to-go-ahead-says-who-chief-tedros-amid-omicron-threat-439113">Boosters cannot be seen as a ticket to go ahead, says WHO chief Tedros amid Omicron threat</a>

Pfizer's treatment has previously been authorized in the European Union.

The US has already paid for 10 million courses.

The authorization comes as cases are surging across the United States, driven by Omicron, the most infectious variant seen to date.

The highly-mutated variant is better able to bypass immunity conferred by prior infection, and health authorities are urging the public to get boosted with mRNA vaccines in order to restore a higher degree of protection.

Unlike vaccines, the Covid pill does not target the ever-evolving spike protein of the coronavirus, which it uses to invade cells. It should in theory be more variant proof, and Pfizer has said preliminary studies have backed up that hypothesis.

Authorization is still awaited for another Covid pill, developed by Merck, which is also taken over five days and has been shown to reduce the same outcomes by 30 percent among high-risk people.

(With inputs from agencies)

US Food and Drug Administration on Wednesday gave a go-ahead to Pfizer's Covid pill for its use among high-risk people aged 12 and above. "Today's authorization introduces the first treatment for Covid-19 that is in the form of a pill that is taken orally -- a major step forward in the fight against this global pandemic," said FDA scientist Patrizia Cavazzoni.

US Food and Drug Administration on Wednesday gave a go-ahead to Pfizer's Covid pill for its use among high-risk people aged 12 and above. "Today's authorization introduces the first treatment for Covid-19 that is in the form of a pill that is taken orally -- a major step forward in the fight against this global pandemic," said FDA scientist Patrizia Cavazzoni. Paxlovid, Pfizer's treatment is a combination of two pills taken over five days. The treatment was shown to be safe and reduced the risk of hospitalizations and deaths among at-risk people by 88 percent. The clinical trial included 2,200 people. In an unusual move, the FDA did not convene its customary panel of independent experts to review in depth data surrounding Pfizer's pill ahead of authorization. Also Raed | Boosters cannot be seen as a ticket to go ahead, says WHO chief Tedros amid Omicron threat Pfizer's treatment has previously been authorized in the European Union. The US has already paid for 10 million courses. The authorization comes as cases are surging across the United States, driven by Omicron, the most infectious variant seen to date. The highly-mutated variant is better able to bypass immunity conferred by prior infection, and health authorities are urging the public to get boosted with mRNA vaccines in order to restore a higher degree of protection. Unlike vaccines, the Covid pill does not target the ever-evolving spike protein of the coronavirus, which it uses to invade cells. It should in theory be more variant proof, and Pfizer has said preliminary studies have backed up that hypothesis. Authorization is still awaited for another Covid pill, developed by Merck, which is also taken over five days and has been shown to reduce the same outcomes by 30 percent among high-risk people. (With inputs from agencies)

USFDA gives go-ahead to Pfizer's Covid pill

The United States Food and Drug Administration (USFDA) is a 115-year-old federal organisation in America. It is the world's most powerful regulatory body, with an annual budget of $6.1 billion.

USFDA: Pharma regulator is among world's most powerful bodies

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

An advisory panel to US Food and Drug Administration (FDA) on Friday (February 26) greenlit Johnson &amp; Johnson's &nbsp;COVID-19 vaccine. The vaccine has gort nod for emergency use. This brings it one step closer to its rollout in the US. The FDA will now decide on emergency use of the vaccine on Saturday. This would be third vaccine available in the US &nbsp;and it is the only vaccine that requires a single shot.&nbsp;

The outside panel consisting of doctors, infectious disease experts and medical researchers voted unanimously that the benefits of the vaccine outweigh its risks in people age 18 and over.

Johnson &amp; Johnson said that it was prepared to supply the vaccine immediately if it received emergency use authorisation (EUA). The company said that it will be able to ship three to four million doses of vaccine next week.

The company expects to have enough supply to vaccinate 20 million people by the end of March.

More than 50 million vaccine shots have been administered nationwide, a milestone highlighted by President Joe Biden on Thursday.

But the emergence of highly contagious new virus variants has heightened the urgency to get hundreds of millions more people inoculated against the coronavirus. COVID-19 has claimed the lives of more than a half a million people in the United States.

The head of the U.S. Centers for Disease Control and Prevention on Friday expressed concern that a recent decline in U.S. COVID-19 cases may be stalling.

In a 44,000-person trial, the J&amp;J vaccine overall was 66% effective at preventing moderate-to-severe cases of COVID-19 compared with a placebo.

Two-dose vaccines made by Pfizer Inc with BioNTech SE and Moderna Inc were about 95% effective in their pivotal trials. Experts cautioned against drawing too much of a distinction between the vaccines because the trials had somewhat different goals, and importantly, the Pfizer/BioNtech and Moderna studies were conducted before the more transmissible virus variants had emerged in South Africa, Brazil and the UK.

J&amp;J's trial was underway when the new variants were circulating and even prevalent in some countries where it was tested.

Still, its vaccine was 100% effective at preventing hospitalizations 28 days after vaccination and there were no COVID-19 deaths among those who received the shot.

During the meeting, a J&amp;J vaccine executive said the company was developing a second-generation vaccine that would target the concerning South African variant and will be ready to start Phase I trials by this summer.

The J&amp;J vaccine can be stored in normal refrigerator temperatures, making distribution easier than for the Pfizer/BioNTech and Moderna shots that use messenger RNA technology and are shipped frozen.

J&amp;J's vaccine uses a common cold virus known as adenovirus type 26 to introduce coronavirus proteins into cells in the body and trigger an immune response.

(With Reuters inputs)

An advisory panel to US Food and Drug Administration (FDA) on Friday (February 26) greenlit Johnson & Johnson's COVID-19 vaccine. The vaccine has gort nod for emergency use.

An advisory panel to US Food and Drug Administration (FDA) on Friday (February 26) greenlit Johnson & Johnson's COVID-19 vaccine. The vaccine has gort nod for emergency use. This brings it one step closer to its rollout in the US. The FDA will now decide on emergency use of the vaccine on Saturday. This would be third vaccine available in the US and it is the only vaccine that requires a single shot. The outside panel consisting of doctors, infectious disease experts and medical researchers voted unanimously that the benefits of the vaccine outweigh its risks in people age 18 and over. Johnson & Johnson said that it was prepared to supply the vaccine immediately if it received emergency use authorisation (EUA). The company said that it will be able to ship three to four million doses of vaccine next week. The company expects to have enough supply to vaccinate 20 million people by the end of March. More than 50 million vaccine shots have been administered nationwide, a milestone highlighted by President Joe Biden on Thursday. But the emergence of highly contagious new virus variants has heightened the urgency to get hundreds of millions more people inoculated against the coronavirus. COVID-19 has claimed the lives of more than a half a million people in the United States. The head of the U.S. Centers for Disease Control and Prevention on Friday expressed concern that a recent decline in U.S. COVID-19 cases may be stalling. In a 44,000-person trial, the J&J vaccine overall was 66% effective at preventing moderate-to-severe cases of COVID-19 compared with a placebo. Two-dose vaccines made by Pfizer Inc with BioNTech SE and Moderna Inc were about 95% effective in their pivotal trials. Experts cautioned against drawing too much of a distinction between the vaccines because the trials had somewhat different goals, and importantly, the Pfizer/BioNtech and Moderna studies were conducted before the more transmissible virus variants had emerged in South Africa, Brazil and the UK. J&J's trial was underway when the new variants were circulating and even prevalent in some countries where it was tested. Still, its vaccine was 100% effective at preventing hospitalizations 28 days after vaccination and there were no COVID-19 deaths among those who received the shot. During the meeting, a J&J vaccine executive said the company was developing a second-generation vaccine that would target the concerning South African variant and will be ready to start Phase I trials by this summer. The J&J vaccine can be stored in normal refrigerator temperatures, making distribution easier than for the Pfizer/BioNTech and Moderna shots that use messenger RNA technology and are shipped frozen. J&J's vaccine uses a common cold virus known as adenovirus type 26 to introduce coronavirus proteins into cells in the body and trigger an immune response. (With Reuters inputs)

USFDA advisory panel clears Johnson & Johnson's COVID-19 vaccine

US Food and Drug Administration (USFDA) has warned that Oximeters may not always give accurate measurement of oxygen levels in blood if used for patient with 'skin pigmentation'. This almost entirely translates to Oximeters not providing accurate results 100 per cent of the time for patients with dark skin. USFDA has issued a warning in this regard. It uses a study published in The New England Journal of Medicine. The study has been carried out by researchers from University of Michigan Medical School.

Oximeters are devices that are typically attached to fingertips of patients. Oximeters are non-invasive in their measurement of blood oxygen levels. In times of coronavirus pandemic, use of Oximeters has increased many times around the world. Drop in blood Oxygen levels may indicate that a person may be infected by COVID-19 virus.

The study carried out by researchers from University of Michigan compared Oxygen readings from Oximeters to those obtained by a more accurate method called Arterial blood gas. These 'pairs' of readings, taken from 10,001 patients were analysed. The patients had White as well as Black patients. It was found that occurrence of wrong reading of blood oxygen levels was three times more in Black patients than it was in White patients. In these patients, Oximeters gave a wrong reading about blood Oxygen levels being normal whereas it was not so.

Based on this study, USFDA has issued a warning that "pulse oximeters have limitations". It has then advised health care providers to supplement their readings with data from other tests and other information that may forthcoming during the examination of the patient.

US Food and Drug Administration (USFDA) has warned that Oximeters may not always give accurate measurement of oxygen levels in blood if used for patient with 'skin pigmentation'.

US Food and Drug Administration (USFDA) has warned that Oximeters may not always give accurate measurement of oxygen levels in blood if used for patient with 'skin pigmentation'. This almost entirely translates to Oximeters not providing accurate results 100 per cent of the time for patients with dark skin. USFDA has issued a warning in this regard. It uses a study published in The New England Journal of Medicine. The study has been carried out by researchers from University of Michigan Medical School. Oximeters are devices that are typically attached to fingertips of patients. Oximeters are non-invasive in their measurement of blood oxygen levels. In times of coronavirus pandemic, use of Oximeters has increased many times around the world. Drop in blood Oxygen levels may indicate that a person may be infected by COVID-19 virus. The study carried out by researchers from University of Michigan compared Oxygen readings from Oximeters to those obtained by a more accurate method called Arterial blood gas. These 'pairs' of readings, taken from 10,001 patients were analysed. The patients had White as well as Black patients. It was found that occurrence of wrong reading of blood oxygen levels was three times more in Black patients than it was in White patients. In these patients, Oximeters gave a wrong reading about blood Oxygen levels being normal whereas it was not so. Based on this study, USFDA has issued a warning that "pulse oximeters have limitations". It has then advised health care providers to supplement their readings with data from other tests and other information that may forthcoming during the examination of the patient.

Oximeters may not always give accurate reading on dark skin: Study

US Food and Drug Administration (USFDA) on Saturday denied that the emergency approval to Pfizer-BioNTech COVID vaccine was not given under political pressure. The regulator granted the approval on Saturday paving the way for mass vaccination in USA, the worst affected country in the global coronavirus pandemic.

"The representations in the press that I was threatened to be fired if we didn't get it done by a certain date is inaccurate," said Stephen Hahn, USFDA Commissioner refuting claims of political pressure.

He added that the decision, which had been expected a few days later, was "based on the strongest scientific integrity."

The agency also released new information for health care providers and for patients as the US shipped millions of doses of the vaccine across the country.&nbsp;

The United States has the highest pandemic death toll of any in the world, with fatalities now approaching 300,000 and nearly 16 million cases of infection.

FDA is now warning people who have a history of severe allergic reaction to ingredients in the vaccine, which are included on a patient fact sheet, not to take it.

If they receive the first dose and have a severe allergic reaction, they are advised to not take the second dose.

The FDA has made no definitive ruling regarding whether pregnant women or the immunocompromised should be given the shots, instead punting that call to people to make for themselves in consultation with their doctors.&nbsp;

"There were not enough pregnant women in the trials, or women who became pregnant in the trials to actually know, and make any statement about that," said FDA scientist Peter Marks.

"It will be something that providers will need to consider on an individual basis for patients."

Marks also voiced support for Pfizer's plan to allow people involved in the clinical trial to find out whether they had received the vaccine or placebo.

Under this proposal, if they received the placebo, they can request the vaccine when their demographic group's turn comes up.

US Food and Drug Administration (USFDA) on Saturday denied that the emergency approval to Pfizer-BioNTech COVID vaccine was not given under political pressure. The regulator granted the approval on Saturday paving the way for mass vaccination in USA, the worst affected country in the global coronavirus pandemic.

US Food and Drug Administration (USFDA) on Saturday denied that the emergency approval to Pfizer-BioNTech COVID vaccine was not given under political pressure. The regulator granted the approval on Saturday paving the way for mass vaccination in USA, the worst affected country in the global coronavirus pandemic. "The representations in the press that I was threatened to be fired if we didn't get it done by a certain date is inaccurate," said Stephen Hahn, USFDA Commissioner refuting claims of political pressure. He added that the decision, which had been expected a few days later, was "based on the strongest scientific integrity." The agency also released new information for health care providers and for patients as the US shipped millions of doses of the vaccine across the country. The United States has the highest pandemic death toll of any in the world, with fatalities now approaching 300,000 and nearly 16 million cases of infection. FDA is now warning people who have a history of severe allergic reaction to ingredients in the vaccine, which are included on a patient fact sheet, not to take it. If they receive the first dose and have a severe allergic reaction, they are advised to not take the second dose. The FDA has made no definitive ruling regarding whether pregnant women or the immunocompromised should be given the shots, instead punting that call to people to make for themselves in consultation with their doctors. "There were not enough pregnant women in the trials, or women who became pregnant in the trials to actually know, and make any statement about that," said FDA scientist Peter Marks. "It will be something that providers will need to consider on an individual basis for patients." Marks also voiced support for Pfizer's plan to allow people involved in the clinical trial to find out whether they had received the vaccine or placebo. Under this proposal, if they received the placebo, they can request the vaccine when their demographic group's turn comes up.

USFDA denies political pressure to approve Pfizer COVID vaccine quickly

The commissioner of the US Food and Drug Administration on Sunday refused to comment on President Donald Trump's claim that 99 per cent of coronavirus cases are "totally harmless". He repeatedly declined to say whether Trump's remark was true or false.

"I'm not going to get into who is right and who is wrong," Dr Stephen Hahn, a member of the White House coronavirus task force, told CNN.

Trump claimed without evidence that 99% of coronavirus cases "are totally harmless," during his remarks on Saturday at the White House Independence Day event.

The US Centers for Disease Control and Prevention estimates that 35% of cases are asymptomatic, but even people with mild or no symptoms can spread the virus to others.

"I totally support the CDC and the information that they're putting out with respect to this pandemic," Hahn said on Sunday.

<a href="https://www.wionews.com/world/despite-surge-in-covid-19-cases-us-president-donald-trump-says-tremendous-victory-nearby-in-fight-against-pandemic-310766">Also read |&nbsp;Despite surge in COVID-19 cases, Trump says 'tremendous victory' nearby in fight against pandemic</a>

"What I'll say is that we have data in the White House task force. Those data show us that this is a serious problem. People need to take it seriously," Hahn said, adding, "if you don't follow local and state guidelines about what to do, if you're not following the CDC and White House task force guidelines, you are putting yourselves and you're putting your loved ones at risk."

While the World Health Organization has said the global fatality rate is likely less than 1%, it also stated that about 20% of all people who are diagnosed with coronavirus are sick enough to need oxygen or hospital care.

There have been more than 2.8 million cases of coronavirus in the United States and at least 1,29,000 people have died.

Trump celebrated the Fourth of July at Mount Rushmore on Friday and at the White House's "Salute to America" on Saturday, where many attendees were seen neither socially distancing nor wearing masks.

<a href="https://www.wionews.com/world/chinas-secrecy-deception-and-cover-up-allowed-coronavirus-to-spread-all-over-world-trump-310775">Also read |&nbsp;China’s secrecy, deception and cover-up allowed coronavirus to spread all over world: Trump</a>

This year the Fourth of July celebrations were marred by a couple of factors -- rising number of coronavirus cases, the Black Lives Matter movement and Trump's Mt Rushmore speech.

The commissioner of the US Food and Drug Administration on Sunday refused to comment on President Donald Trump's claim that 99 per cent of coronavirus cases are "totally harmless".

The commissioner of the US Food and Drug Administration on Sunday refused to comment on President Donald Trump's claim that 99 per cent of coronavirus cases are "totally harmless". He repeatedly declined to say whether Trump's remark was true or false. "I'm not going to get into who is right and who is wrong," Dr Stephen Hahn, a member of the White House coronavirus task force, told CNN. Trump claimed without evidence that 99% of coronavirus cases "are totally harmless," during his remarks on Saturday at the White House Independence Day event. The US Centers for Disease Control and Prevention estimates that 35% of cases are asymptomatic, but even people with mild or no symptoms can spread the virus to others. "I totally support the CDC and the information that they're putting out with respect to this pandemic," Hahn said on Sunday. Also read | Despite surge in COVID-19 cases, Trump says 'tremendous victory' nearby in fight against pandemic "What I'll say is that we have data in the White House task force. Those data show us that this is a serious problem. People need to take it seriously," Hahn said, adding, "if you don't follow local and state guidelines about what to do, if you're not following the CDC and White House task force guidelines, you are putting yourselves and you're putting your loved ones at risk." While the World Health Organization has said the global fatality rate is likely less than 1%, it also stated that about 20% of all people who are diagnosed with coronavirus are sick enough to need oxygen or hospital care. There have been more than 2.8 million cases of coronavirus in the United States and at least 1,29,000 people have died. Trump celebrated the Fourth of July at Mount Rushmore on Friday and at the White House's "Salute to America" on Saturday, where many attendees were seen neither socially distancing nor wearing masks. Also read | China’s secrecy, deception and cover-up allowed coronavirus to spread all over world: Trump This year the Fourth of July celebrations were marred by a couple of factors -- rising number of coronavirus cases, the Black Lives Matter movement and Trump's Mt Rushmore speech.

US FDA commissioner declines to defend Trump's claim that 99% of COVID-19 cases are 'harmless'

The US Food and Drug Administration on Friday cautioned against the use of malaria drug hydroxychloroquine, which US President Donald Trump constantly and strongly advocates to treat coronavirus.&nbsp;

The FDA on Friday said that it was aware of increased use of HCQ and chloroquine through outpatient prescriptions and malaria drugs could lead to abnormal heart rhythms and dangerously rapid heart rate.&nbsp;

Also read |&nbsp;<a href="https://www.wionews.com/world/with-over-50000-fatalities-us-witnesses-lowest-coronavirus-death-toll-in-three-weeks-294668">With over 50,000 fatalities, US witnesses lowest coronavirus death toll in three weeks</a>

After the FDA's announcement, US President Donald Trump said, "You hear it both ways," in a White House briefing on Friday. &nbsp;

Also read |&nbsp;<a href="https://www.wionews.com/world/world-leaders-unite-to-accelerate-covid-19-tests-vaccine-us-stays-away-from-who-initiative-294673">World leaders unite to accelerate COVID-19 tests, vaccine; US stays away from WHO initiative</a>

"I'm not a doctor. A study has to be done. If it helps, it's great. If it doesn't work, don't do it," Trump said.

Since mid-March, Trump has strongly supported the use of chloroquine, despite a lack of studies to substantiate his claims.&nbsp;

He has described the drug as a "gift of God" and a "game-changer" to treat COVID-19.&nbsp;

Dr. Rick Bright, who was the head of the US agency responsible to develop coronavirus vaccine, said on Wednesday that he was sacked as he was opposing the chloroquine treatment promoted by Trump.

The results of the largest study yet on hydroxychloroquine, funded by the US government, said that the drug showed no benefit against the virus over standard care, and in fact caused more deaths.&nbsp;

The US Food and Drug Administration on Friday cautioned against the use of malaria drug hydroxychloroquine, which US President Donald Trump constantly and strongly advocates to treat coronavirus.

The US Food and Drug Administration on Friday cautioned against the use of malaria drug hydroxychloroquine, which US President Donald Trump constantly and strongly advocates to treat coronavirus. The FDA on Friday said that it was aware of increased use of HCQ and chloroquine through outpatient prescriptions and malaria drugs could lead to abnormal heart rhythms and dangerously rapid heart rate. Also read | With over 50,000 fatalities, US witnesses lowest coronavirus death toll in three weeks After the FDA's announcement, US President Donald Trump said, "You hear it both ways," in a White House briefing on Friday. Also read | World leaders unite to accelerate COVID-19 tests, vaccine; US stays away from WHO initiative "I'm not a doctor. A study has to be done. If it helps, it's great. If it doesn't work, don't do it," Trump said. Since mid-March, Trump has strongly supported the use of chloroquine, despite a lack of studies to substantiate his claims. He has described the drug as a "gift of God" and a "game-changer" to treat COVID-19. Dr. Rick Bright, who was the head of the US agency responsible to develop coronavirus vaccine, said on Wednesday that he was sacked as he was opposing the chloroquine treatment promoted by Trump. The results of the largest study yet on hydroxychloroquine, funded by the US government, said that the drug showed no benefit against the virus over standard care, and in fact caused more deaths.

US FDA warns against use of Donald Trump-backed hydroxychloroquine to treat coronavirus

The US health regulator has proposed to lift the import alert on Sun Pharma&#39;s Mohali&nbsp;based manufacturing plant in the Indian state of Punjab..

The drug major has been informed by the US Food and Drug Administration (USFDA) that it will lift the import alert imposed on the Mohali plant and remove the facility from the Official Action Initiated (OAI) status, Sun Pharmaceutical Industries said in a regulatory filing.

&quot;This proposed action will clear the path for Sun Pharma to supply approved products from the Mohali facility to the US market, subject to normal USFDA regulatory requirements,&quot; it added.

The Mumbai-based drug major had inherited the Mohali facility as part of its acquisition of Ranbaxy Laboratories Ltd in 2015.

The USFDA had taken action against the Mohali facility in 2013 when it ordered the facility to be fully subject to Ranbaxy&#39;s Consent Decree of Permanent Injunction.

Certain conditions of the consent decree will continue to be applicable to the Mohali facility, Sun Pharma said.

&quot;This development illustrates Sun Pharma&#39;s commitment to work closely with the USFDA and strive for 100 per cent current good manufacturing practices (cGMP) compliance at its manufacturing facilities.

The stock of Sun Pharma was trading up 3.80 per cent at Rs 709.50 on BSE.

(PTI)

The action will allow the drug major to supply approved products from its Mohali plant to the US market

The US health regulator has proposed to lift the import alert on Sun Pharma's Mohali based manufacturing plant in the Indian state of Punjab.. The drug major has been informed by the US Food and Drug Administration (USFDA) that it will lift the import alert imposed on the Mohali plant and remove the facility from the Official Action Initiated (OAI) status, Sun Pharmaceutical Industries said in a regulatory filing. "This proposed action will clear the path for Sun Pharma to supply approved products from the Mohali facility to the US market, subject to normal USFDA regulatory requirements," it added. The Mumbai-based drug major had inherited the Mohali facility as part of its acquisition of Ranbaxy Laboratories Ltd in 2015. The USFDA had taken action against the Mohali facility in 2013 when it ordered the facility to be fully subject to Ranbaxy's Consent Decree of Permanent Injunction. Certain conditions of the consent decree will continue to be applicable to the Mohali facility, Sun Pharma said. "This development illustrates Sun Pharma's commitment to work closely with the USFDA and strive for 100 per cent current good manufacturing practices (cGMP) compliance at its manufacturing facilities. The stock of Sun Pharma was trading up 3.80 per cent at Rs 709.50 on BSE. (PTI)

USFDA to lift import alert on Sun Pharma's Mohali plant

usfda

Usfda, News on Usfda, stories on Usfda, articles on Usfda, Usfda stories at Wion, Usfda news, Usfda latest news