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The success rate of the vaccine, which was worked on by American Pfizer and its German partner, Biontech, is the highest of all vaccines tested in the late clinical stages so far, and experts say it is a great achievement in the race to end the pandemic.
Biontech CEO Ugur Shaheen told Reuters TV that the US Food and Drug Administration may grant approval for the emergency use of the vaccine before the end of the first half of December or early December. second fortnight of the month.
He added that conditional approval from the European Union would likely be obtained in the second half of December.
He continued saying "If all goes well, I can wait for approval in the second half of December and the start of distribution before Christmas, but only if it goes well.".
Pfizer said 170 volunteers in the trial, which included more than 43,000, were infected with Covid-19, but 162 of them received a placebo vaccine, meaning the vaccine’s effectiveness is 95 percent. Of the ten who were seriously infected with Covid-19, one received the vaccine.
Said Enrico Pucci, a biologist at Temple University in Philadelphia. "For the first time in human history: a large-scale clinical trial of a vaccine is being conducted in less than a year of knowing the sequence (genome) of the virus, and more than that, it is based on an entirely new technology.".
Shaheen said an application will be submitted on Friday for US permission for emergency use of the vaccine.
A source familiar with the matter said the FDA’s Vaccine Advisory Committee plans to meet in principle on Dec. 8-10, but these dates are subject to change.
The final analysis of the trial comes just one week after initial results showed the vaccine to be more than 90 percent effective. On Monday, Moderna released preliminary data on its vaccine, showing its 94.5 percent effectiveness.
And it turns out that the Pfizer / Biontech vaccine has been 94 percent effective among people 65 and older, which experts described as very important at a time when the virus is spreading around the world with record cases.
Andrew Hill, Visiting Research Fellow in the Department of Pharmacology, University of Liverpool "This is the evidence we needed to ensure that those most at risk were protected".
The better-than-expected results of the two vaccines have rekindled hopes of ending a pandemic that has killed more than 1.3 million people and wreaks havoc on the economy and daily life.
Pfizer said it expects to produce up to 50 million doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.
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The vaccine’s effectiveness was found to be stable across different age groups and ethnicities, which is a promising sign given that the disease has affected the elderly and certain groups, including people with black skin, more than others.
The success rate of the vaccine, which was worked on by American Pfizer and its German partner, Biontech, is the highest of all vaccines tested in the late clinical stages so far, and experts say it is a great achievement in the race to end the pandemic.
Biontech CEO Ugur Shaheen told Reuters TV that the US Food and Drug Administration may grant approval for the emergency use of the vaccine before the end of the first half of December or early December. second fortnight of the month.
He added that conditional approval from the European Union would likely be obtained in the second half of December.
“If things go well, I can expect to get approval in the second half of December and start distribution before Christmas, but only if things go well,” he said.
Pfizer said 170 volunteers in the trial, which included more than 43,000, were infected with Covid-19, but 162 of them received a placebo vaccine, meaning the vaccine’s effectiveness is 95 percent. Of the ten who were seriously infected with Covid-19, one received the vaccine.
Enrico Pucci, a biologist at Temple University in Philadelphia, said: “For the first time in human history: a large-scale clinical trial of a vaccine is being conducted in less than a year to find out the sequence (genome ) of the virus, and more than that, it’s based on a completely new technology. “
Shaheen said an application will be submitted on Friday for US permission for emergency use of the vaccine.
A source familiar with the matter said the FDA’s Vaccine Advisory Committee plans to meet in principle on Dec. 8-10, but these dates are subject to change.
The final analysis of the trial comes just one week after initial results showed the vaccine to be more than 90 percent effective. On Monday, Moderna released preliminary data on its vaccine, showing its 94.5 percent effectiveness.
And it turns out that the Pfizer / Biontech vaccine has been 94 percent effective among people 65 and older, which experts described as very important at a time when the virus is spreading around the world with record cases.
“This is the evidence that we needed to make sure people at highest risk were protected,” said Andrew Hill, a visiting researcher in the department of pharmacology at the University of Liverpool.
The better-than-expected results of the two vaccines have rekindled hopes of ending a pandemic that has killed more than 1.3 million people and wreaks havoc on the economy and daily life.
Pfizer said it expects to produce up to 50 million doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.
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