“We are potentially in a position to offer some hope,” Dr. Bill Gruber, senior vice president of clinical development at Pfizer, told The Associated Press. “We are very encouraged. ”
Authorities stressed that a vaccine is unlikely to arrive long before the end of the year and that limited initial supplies will be rationed.
US President Donald Trump and President-elect Joe Biden commented on the Pfizer news Monday morning.
Biden enthusiastically welcomed the initial results, but warned that widespread vaccination remains for months and Americans must continue to wear masks and maintain physical distance.
“Today’s news is great news, but that doesn’t change that fact,” Biden said in a statement. “Today’s announcement promises a chance to change that next year, but the tasks ahead remain the same. ”
Trump praised the development on Twitter.
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No serious safety issues reported
The snapshots taken by Pfizer and its German partner BioNTech are among 10 possible vaccine candidates in advanced testing around the world – four of them so far in huge studies in the U.S. Another U.S. company, Moderna Inc., has also said it hopes to do so. be able to file a claim with the Food and Drug Administration later this month.
Final study volunteers and researchers don’t know who got the real vaccine or a dummy vaccine. But a week after their second required dose, the Pfizer study began counting the number of people who developed symptoms of COVID-19 and confirmed to be carriers of the coronavirus.
As the study is not complete, Gruber could not say how many people in each group had infections. By doing the math, that would mean that almost all of the infections counted so far must have occurred in people who received the dummy injections.
Pfizer doesn’t plan to stop its study until it registers 164 infections among all volunteers, a number the FDA has agreed is enough to say how well the vaccine works. The agency has made it clear that any vaccine must be at least 50% effective.
No attendee so far has fallen seriously ill, Gruber said. He could not provide a breakdown of the number of infections that have occurred in older people, who are most at risk for COVID-19.
US vaccines must be studied in at least 30,000 people
Participants were only tested if they developed symptoms, leaving unanswered whether vaccinated people could be infected but had no symptoms and spread the virus unknowingly.
The FDA has required that US vaccine candidates be studied in at least 30,000 people. In addition to an adequate number of older adults, these studies should also include other high-risk groups, including minorities and people with chronic health conditions.
And he told companies they need to follow half of their participants for side effects for at least two months, the time when problems usually arise. Pfizer expects to reach that milestone later this month, but said on Monday that no serious security issues had been reported.
Because the pandemic is still raging, manufacturers are hoping to get permission from governments around the world for emergency use of their vaccines while additional testing continues – allowing them to reach the market faster than usual. , but raising concerns about how much knowledge scientists will have of vaccines.
Last month, FDA science advisers said they feared allowing emergency use of a COVID-19 vaccine could undermine confidence in vaccines and make it harder to find their effectiveness. These advisers said it was essential that these massive studies could come to an end.