Pfizer says an early tracking of its vaccine data suggests the shots could be 90% effective at stopping COVID-19, indicating that the company is due later this month in the U.S. An emergency use application with regulators is on track to be filed.
Monday’s announcement does not mean that a vaccine is imminent: this interim analysis of an independent data monitoring board looked at 94 infections recorded so far in a study that led to the U.S. And has enrolled about 44,000 people in five other countries.
Pfizer Inc. did not provide much information about those cases, and cautions that the initial safety rate may change by the time the study ends. Even revealing such early data is highly unusual.
Pfizer’s senior vice president of the Associated Press, Drs. “We are potentially in a position to be able to offer some hope,” said Bill Gruber. “We are very encouraged.”
Officials have insisted that no vaccine will arrive before the end of the year, and limited initial supplies will be rationed.
Shots made by Pfizer and its German partner Biotech are among 10 potential vaccine candidates in late testing worldwide – four of them so far in a massive study at another US company Modern Inc. in the US, it also hopes Being able to file an application with the Food and Drug Administration later this month.
Volunteers in the final stage study, and researchers do not know who has received the real vaccine or dummy shot. But a week after his second required dose, Pfizer’s study began counting the number that had developed COVID-19 symptoms and was confirmed to be coronavirus.
Because the study is not finished, Gruber could not say how many people in each group had the infection. While doing the math, this means that almost all infections counted by now should have been in people getting dummy shots.
Pfizer does not plan to stop its study until it has recorded 164 infections among all volunteers, a number the FDA has agreed to, enough to tell how well the vaccine is working. is. The agency has clarified that any vaccine must be at least 50% effective.
Gruber said that so far no participant had become seriously ill. Nor could he deny how many infections occurred in older people who are most at risk from COVID-19.
Participants were tested only when symptoms developed, remaining unanswered as to whether those vaccinated could be infected but showed no symptoms and inadvertently spread the virus.
The FDA requires that at least 30,000 people study American vaccine candidates. In addition to a sufficient number of older adults, those studies should also include other groups at high risk, including minorities and those with chronic health problems.
And it asked companies to half-track their participants for side effects for at least two months, the time period when problems typically crop up. Pfizer is expected to reach that milestone later this month, but no serious safety concerns have been reported on Monday.
Because the pandemic is still raging, manufacturers expect governments around the world to seek permission for emergency use of their vaccines, while additional testing continues – allowing them to hit the market faster than usual but scientists There is growing concern about how much will be known about the shots.
The FDA’s scientific advisors said last month that they worried that emergency use of the COVID-19 vaccine could damage the confidence in the shots and make it harder to find out how well they actually work. Those advisors said that it is important that these larger studies are allowed to run. link