The New England Journal of Medicine&nbsp;of Medicine&nbsp;on Thursday published the full results of the Pfizer-BioNTech(BNT162b2) <a href="https://www.wionews.com/india-news/indias-covid-19-tally-rises-to-9764-lakh-with-31521-fresh-cases-348829">coronavirus</a> vaccine trial declaring that it was "95 per cent effective in preventing COVID-19".

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The journal said the<a href="https://www.wionews.com/world/now-saudi-arabia-approves-pfizer-biontech-covid-19-vaccine-348889">&nbsp;Pfizer-BioNTech </a>vaccine efficacy was "(generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions."

<a href="https://www.wionews.com/world/european-medicines-agency-hacking-pfizer-biontech-confirm-vaccine-documents-unlawfully-accessed-348845">Also Read:&nbsp;Pfizer-BioNTech confirm vaccine documents 'unlawfully accessed'</a>

"The safety profile of the vaccine was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache," it said, adding,"the incidence of serious adverse events was low and was similar in the vaccine and placebo groups."

The medical journals said that vaccine ensured "protection" for persons 16 years of age or older. &nbsp;"Safety over a median of 2 months was similar to that of other viral vaccines," it informed.

Pfizer-BioNTech had declared last month that its vaccine was 95 per cent effective against COVID-19 beginning 28 days after the first dose. It had evaluated 170 confirmed cases of COVID-19 while asserting that "safety data milestone" required by US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) was achieved as it was "well tolerated across all populations with over 43,000 participants enrolled."

The report comes as US FDA officials are set to begin the process of approval from today as the United States which is the worst-hit country grapples with the virus. The UK began administering doses on Tuesday across the country starting with the elderly population and health workers.

According to the company, during the trial, there were 42 per cent global participants and 30 per cent US participants with racially and ethnically diverse backgrounds, and 41 per cent global and 45 per cent US participants who were 56-85 years of age.

"These results met our prespecified success criteria, which were to establish a probability above 98.6 per cent of true vaccine efficacy," the New England Journal said, adding, "two-dose regimen of BNT162b2 (30 μg per dose, given 21 days apart) was found to be safe and 95 per cent effective against COVID-19."

The report comes as the virus continues to ravage people's lives and destroy economies worldwide recording over 65 million infected cases and more than 1.5 million fatalities.

The New England Journal of Medicine of Medicine on Thursday published the full results of the Pfizer-BioNTech(BNT162b2) coronavirus vaccine trial declaring that it was "95 per cent effective in preventing COVID-19".

The New England Journal of Medicine of Medicine on Thursday published the full results of the Pfizer-BioNTech(BNT162b2) coronavirus vaccine trial declaring that it was "95 per cent effective in preventing COVID-19". Watch: The journal said the Pfizer-BioNTech vaccine efficacy was "(generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions." Also Read: Pfizer-BioNTech confirm vaccine documents 'unlawfully accessed' "The safety profile of the vaccine was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache," it said, adding,"the incidence of serious adverse events was low and was similar in the vaccine and placebo groups." The medical journals said that vaccine ensured "protection" for persons 16 years of age or older. "Safety over a median of 2 months was similar to that of other viral vaccines," it informed. Pfizer-BioNTech had declared last month that its vaccine was 95 per cent effective against COVID-19 beginning 28 days after the first dose. It had evaluated 170 confirmed cases of COVID-19 while asserting that "safety data milestone" required by US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) was achieved as it was "well tolerated across all populations with over 43,000 participants enrolled." The report comes as US FDA officials are set to begin the process of approval from today as the United States which is the worst-hit country grapples with the virus. The UK began administering doses on Tuesday across the country starting with the elderly population and health workers. According to the company, during the trial, there were 42 per cent global participants and 30 per cent US participants with racially and ethnically diverse backgrounds, and 41 per cent global and 45 per cent US participants who were 56-85 years of age. "These results met our prespecified success criteria, which were to establish a probability above 98.6 per cent of true vaccine efficacy," the New England Journal said, adding, "two-dose regimen of BNT162b2 (30 μg per dose, given 21 days apart) was found to be safe and 95 per cent effective against COVID-19." The report comes as the virus continues to ravage people's lives and destroy economies worldwide recording over 65 million infected cases and more than 1.5 million fatalities.

Pfizer-BioNTech 'full results' appear in New England Journal of Medicine

President Donald Trump claimed on Wednesday that catching the coronavirus was “a blessing from God” and portrayed as a miracle cure the unproven therapeutic drug he was given after testing positive last week for the virus.

Trump said he planned to make the antibody cocktail being developed by the drug maker Regeneron, which does not yet have government approval, free to anyone who needs it. He did not explain how he would do it.

The president’s statement, in a video released early Wednesday evening by the White House, was his latest effort to repair the political damage he has suffered after months of trying to minimize the effects of a pandemic that has killed more than 211,000 Americans.

In remarks he made while he was at Walter Reed National Military Medical Center, where he was taken by helicopter on Friday night, and then when he returned to the White House on Monday, Trump did his best to play down the virus’s effects, telling Americans, “Don’t be afraid of it,” and saying that he felt “better than 20 years ago.”

But in the video released Wednesday night Trump, whose skin appeared darkened by makeup and who appeared to struggle to get air at times, seemed to be saying that he had discovered, without evidence, a new drug that suddenly made him feel better and could do the same for everyone else with COVID-19.

“I call that a cure,” said Trump, adding that everyone should have access to the not-yet-approved drug for “free” and that he would make sure it was in every hospital as soon as possible. Regeneron has received more than $500 million from the federal government to develop and manufacture its experimental treatment as part of “Operation Warp Speed,” the federal effort to come up with viable vaccines and treatments for the virus, in order to help distribute it once it is available.

“I think this was a blessing from God that I caught it,” Trump said, apparently referring to the fact that he had learned about the benefits of the drug as a result of becoming ill.

It was the first time that Trump tacitly acknowledged another appearance problem — that he has received the kind of intensive and costly medical care for coronavirus that is not available to any member of the general public.

In an interview on Wednesday, Dr. George Yancopoulos, Regeneron’s president and chief scientific officer, said it was possible that Trump responded to the treatment and that the level of virus had declined. “That’s a logical conclusion,” Yancopoulos said. “Based on his symptomology, that has to have happened.”

But neither Yancopoulos nor Trump can definitively say whether the treatment worked because any drug must be proved in large clinical trials that compare the outcomes of people who got the product with those who received a placebo. Those trials have not yet been completed.

Dr. Peter Chin-Hong, an infectious disease specialist at UCSF Health in San Francisco, said in his opinion there was “1 million percent no” chance that the Regeneron treatment could have cured Trump in 24 hours, as the president claimed.

Another explanation, he said, is that the president is experiencing the effects of the steroid dexamethasone, which he has been receiving since Saturday, which is known to reduce fever and can create feelings of well-being and euphoria in patients. “This is all in keeping with the dexamethasone speaking,” Chin-Hong said.

The president has been desperate to announce some kind of definitive treatment, or a vaccine, ahead of the Nov. 3 election, in which nearly all polls show him trailing Joe Biden, the Democratic nominee, nationally, and in key states.

He has also been looking for a type of miracle cure for the virus for months, initially seizing on hydroxychloroquine as an answer before health experts raised concerns about its use. But his disdain for those experts has been consistent with his general refusal to believe in science, a refusal that led The New England Journal of Medicine, in an editorial published on Wednesday, to say the Trump administration had responded so poorly to the coronavirus pandemic that it had “taken a crisis and turned it into a tragedy.”

The journal did not explicitly endorse Biden, but that was the only possible inference, other scientists noted.

The New England Journal of Medicine’s editors join those of another influential journal, Scientific American, who last month endorsed Biden.

The Regeneron antibody cocktail is not the only drug that Trump was prescribed. He has also been taking the antiviral drug remdesivir, as well as the steroid dexamethasone, which the World Health Organization and National Institutes of Health recommend only for people who have severe or critical cases of COVID-19.

Doctors have declined to say what other medications Trump is taking as he fights off the virus.

Most people with COVID-19 eventually recover, and medical experts have also said that Trump is most likely still battling it.

Outside medical experts have said that the next week will be pivotal because many patients who do poorly take a turn for the worse in the second week after symptoms arise.

With the federal assistance, Regeneron has said it can produce up to 300,000 doses of the treatment, which is expected to be provided to Americans free of charge. It is one of several similar antibody therapies — another is being developed by Eli Lilly — that seek to give people powerful antibodies in the hopes of boosting their immune response.

But although both companies have reported promising early results, clinical trials are still underway. Although Trump credited the Regeneron treatment with having improved his illness, there is no way to know if a drug is safe and if it works without testing it in large groups of people, some who receive the drug, and some who get a placebo.

Regeneron and Eli Lilly have said the therapies could be available before the end of the year. Some medical experts have seen the therapies as a sort of bridge until vaccines are available — the infusion of antibodies could be given to people who have been exposed to the virus in order to prevent infection, as well as to people who are still early in the course of the disease.

In his video, Trump suggested that the treatments could soon be authorized for emergency use. “We have to get them done, we have to get them approved,” he said. But that is a potentially risky move because it could allow the treatments to become widely used before they have been proven. Broader access to the drugs could then jeopardize enrollment in clinical trials, because people may be reluctant to participate if there is a chance they could receive a placebo.

The president also used the video as another opportunity to push for the emergency approval of a vaccine before the election, even though the Food and Drug Administration has issued guidelines to companies that would mean meeting such a deadline is not possible. “I think we should have it before the election, but frankly, the politics gets involved, and that’s OK,” he said.

A handful of vaccine makers are testing their candidates in large clinical trials and have said they could have an answer before the end of the year, but they have also made an unusual pledge to not bring their vaccines to market before they are thoroughly vetted.

Monoclonal antibodies like the ones that Regeneron is developing are difficult and expensive to manufacture, and some have raised questions about whether the companies will be able to make enough to meet global demand if they are proven to work. In August, the company announced it was teaming up with a larger company, Roche, to ramp up production.

The video was not the only way Trump tried on Wednesday to put the best spin on his illness.

In mid afternoon he resumed working in the Oval Office, defying the aides who had hoped he would remain in his private quarters in the White House or a work space specially set up him for him because he is sick.

The president had made clear that was his intention from the time he returned from the hospital on Monday. The presence of a Marine guard outside the office shortly after 3 p.m. signaled that he had gotten his wish, flouting the safeguards sought by his aides at a time when a wave of infections has left the White House thinned out of staff.

Melania Trump, the first lady, has remained in the White House residence since last week when it was announced that she had also tested positive.

A White House official said that Trump had entered the Oval Office by walking along the colonnade outside, meaning there was a smaller amount of viral load he would have been shedding indoors. Only two aides were said to be with him — Mark Meadows, the White House chief of staff, and Dan Scavino, a deputy chief of staff — and wearing personal protective equipment like masks and gloves.

An “isolation cart” filled with such equipment was put next the indoor entrance to the Oval Office.

Earlier in the day, the White House physician, Dr. Sean Conley, whose reports on the president have been unfailingly upbeat, released a memo saying that Trump began the day saying, “I feel great!” and that he had been symptom-free for more than 24 hours and fever-free for more than four days.

Conley said the president’s oxygen and respiratory levels were normal and stable, and that blood drawn from him two days earlier showed the presence of antibodies for the coronavirus. Medical experts and Regeneron itself later said that the antibody test most likely revealed nothing more than that Trump had received a large dose of the experimental antibody cocktail.

President Donald Trump claimed on Wednesday that catching the coronavirus was “a blessing from God” and portrayed as a miracle cure the unproven therapeutic drug he was given after testing positive last week for the virus.

President Donald Trump claimed on Wednesday that catching the coronavirus was “a blessing from God” and portrayed as a miracle cure the unproven therapeutic drug he was given after testing positive last week for the virus. Trump said he planned to make the antibody cocktail being developed by the drug maker Regeneron, which does not yet have government approval, free to anyone who needs it. He did not explain how he would do it. The president’s statement, in a video released early Wednesday evening by the White House, was his latest effort to repair the political damage he has suffered after months of trying to minimize the effects of a pandemic that has killed more than 211,000 Americans. In remarks he made while he was at Walter Reed National Military Medical Center, where he was taken by helicopter on Friday night, and then when he returned to the White House on Monday, Trump did his best to play down the virus’s effects, telling Americans, “Don’t be afraid of it,” and saying that he felt “better than 20 years ago.” But in the video released Wednesday night Trump, whose skin appeared darkened by makeup and who appeared to struggle to get air at times, seemed to be saying that he had discovered, without evidence, a new drug that suddenly made him feel better and could do the same for everyone else with COVID-19. “I call that a cure,” said Trump, adding that everyone should have access to the not-yet-approved drug for “free” and that he would make sure it was in every hospital as soon as possible. Regeneron has received more than $500 million from the federal government to develop and manufacture its experimental treatment as part of “Operation Warp Speed,” the federal effort to come up with viable vaccines and treatments for the virus, in order to help distribute it once it is available. “I think this was a blessing from God that I caught it,” Trump said, apparently referring to the fact that he had learned about the benefits of the drug as a result of becoming ill. It was the first time that Trump tacitly acknowledged another appearance problem — that he has received the kind of intensive and costly medical care for coronavirus that is not available to any member of the general public. In an interview on Wednesday, Dr. George Yancopoulos, Regeneron’s president and chief scientific officer, said it was possible that Trump responded to the treatment and that the level of virus had declined. “That’s a logical conclusion,” Yancopoulos said. “Based on his symptomology, that has to have happened.” But neither Yancopoulos nor Trump can definitively say whether the treatment worked because any drug must be proved in large clinical trials that compare the outcomes of people who got the product with those who received a placebo. Those trials have not yet been completed. Dr. Peter Chin-Hong, an infectious disease specialist at UCSF Health in San Francisco, said in his opinion there was “1 million percent no” chance that the Regeneron treatment could have cured Trump in 24 hours, as the president claimed. Another explanation, he said, is that the president is experiencing the effects of the steroid dexamethasone, which he has been receiving since Saturday, which is known to reduce fever and can create feelings of well-being and euphoria in patients. “This is all in keeping with the dexamethasone speaking,” Chin-Hong said. The president has been desperate to announce some kind of definitive treatment, or a vaccine, ahead of the Nov. 3 election, in which nearly all polls show him trailing Joe Biden, the Democratic nominee, nationally, and in key states. He has also been looking for a type of miracle cure for the virus for months, initially seizing on hydroxychloroquine as an answer before health experts raised concerns about its use. But his disdain for those experts has been consistent with his general refusal to believe in science, a refusal that led The New England Journal of Medicine, in an editorial published on Wednesday, to say the Trump administration had responded so poorly to the coronavirus pandemic that it had “taken a crisis and turned it into a tragedy.” The journal did not explicitly endorse Biden, but that was the only possible inference, other scientists noted. The New England Journal of Medicine’s editors join those of another influential journal, Scientific American, who last month endorsed Biden. The Regeneron antibody cocktail is not the only drug that Trump was prescribed. He has also been taking the antiviral drug remdesivir, as well as the steroid dexamethasone, which the World Health Organization and National Institutes of Health recommend only for people who have severe or critical cases of COVID-19. Doctors have declined to say what other medications Trump is taking as he fights off the virus. Most people with COVID-19 eventually recover, and medical experts have also said that Trump is most likely still battling it. Outside medical experts have said that the next week will be pivotal because many patients who do poorly take a turn for the worse in the second week after symptoms arise. With the federal assistance, Regeneron has said it can produce up to 300,000 doses of the treatment, which is expected to be provided to Americans free of charge. It is one of several similar antibody therapies — another is being developed by Eli Lilly — that seek to give people powerful antibodies in the hopes of boosting their immune response. But although both companies have reported promising early results, clinical trials are still underway. Although Trump credited the Regeneron treatment with having improved his illness, there is no way to know if a drug is safe and if it works without testing it in large groups of people, some who receive the drug, and some who get a placebo. Regeneron and Eli Lilly have said the therapies could be available before the end of the year. Some medical experts have seen the therapies as a sort of bridge until vaccines are available — the infusion of antibodies could be given to people who have been exposed to the virus in order to prevent infection, as well as to people who are still early in the course of the disease. In his video, Trump suggested that the treatments could soon be authorized for emergency use. “We have to get them done, we have to get them approved,” he said. But that is a potentially risky move because it could allow the treatments to become widely used before they have been proven. Broader access to the drugs could then jeopardize enrollment in clinical trials, because people may be reluctant to participate if there is a chance they could receive a placebo. The president also used the video as another opportunity to push for the emergency approval of a vaccine before the election, even though the Food and Drug Administration has issued guidelines to companies that would mean meeting such a deadline is not possible. “I think we should have it before the election, but frankly, the politics gets involved, and that’s OK,” he said. A handful of vaccine makers are testing their candidates in large clinical trials and have said they could have an answer before the end of the year, but they have also made an unusual pledge to not bring their vaccines to market before they are thoroughly vetted. Monoclonal antibodies like the ones that Regeneron is developing are difficult and expensive to manufacture, and some have raised questions about whether the companies will be able to make enough to meet global demand if they are proven to work. In August, the company announced it was teaming up with a larger company, Roche, to ramp up production. The video was not the only way Trump tried on Wednesday to put the best spin on his illness. In mid afternoon he resumed working in the Oval Office, defying the aides who had hoped he would remain in his private quarters in the White House or a work space specially set up him for him because he is sick. The president had made clear that was his intention from the time he returned from the hospital on Monday. The presence of a Marine guard outside the office shortly after 3 p.m. signaled that he had gotten his wish, flouting the safeguards sought by his aides at a time when a wave of infections has left the White House thinned out of staff. Melania Trump, the first lady, has remained in the White House residence since last week when it was announced that she had also tested positive. A White House official said that Trump had entered the Oval Office by walking along the colonnade outside, meaning there was a smaller amount of viral load he would have been shedding indoors. Only two aides were said to be with him — Mark Meadows, the White House chief of staff, and Dan Scavino, a deputy chief of staff — and wearing personal protective equipment like masks and gloves. An “isolation cart” filled with such equipment was put next the indoor entrance to the Oval Office. Earlier in the day, the White House physician, Dr. Sean Conley, whose reports on the president have been unfailingly upbeat, released a memo saying that Trump began the day saying, “I feel great!” and that he had been symptom-free for more than 24 hours and fever-free for more than four days. Conley said the president’s oxygen and respiratory levels were normal and stable, and that blood drawn from him two days earlier showed the presence of antibodies for the coronavirus. Medical experts and Regeneron itself later said that the antibody test most likely revealed nothing more than that Trump had received a large dose of the experimental antibody cocktail.

Trump touts unproven drug as cure; calls his illness a ‘blessing from God’

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Pfizer-BioNTech 'full results' appear in New England Journal of Medicine

Trump touts unproven drug as cure; calls his illness a ‘blessing from God’