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Pfizer says a quick look at its vaccine data suggests the shots could be 90% effective in preventing COVID-19, indicating the company is on track later this month to file an emergency use application with authorities. United States regulatory framework. The vaccine is among seven that Canada has pre-ordered.
Monday’s announcement doesn’t mean a vaccine is imminent: This interim analysis, by an independent data monitoring committee, looked at 94 infections recorded so far in a study that enrolled nearly 44,000 people in the United States and five other countries. .
Pfizer Inc. did not provide further details on such cases and warned that the initial protection rate could change after the study ends. The disclosure of such early data is also extremely unusual.
“We have the potential to offer some hope,” Dr. Bill Gruber, Pfizer’s senior vice president of clinical development. “We are very encouraged.”
Authorities have pointed out that a vaccine is unlikely to arrive long before the end of the year and that limited initial supplies will be rationed.
Both US President Donald Trump and President-elect Joe Biden commented on the news from Pfizer early Monday.
Biden welcomed the first results with enthusiasm but warned that widespread vaccination is months away and that Americans must continue to wear masks and keep physical distance.
“Today’s news is great news, but it doesn’t change that fact,” Biden said in a statement. “Today’s announcement promises the possibility of changing that next year, but the tasks ahead of us now remain the same.”
Trump hailed the development on Twitter.
STOCK MARKET BIG, VACCINE COMING. 90% EFFECTIVE RATIO. SUCH GREAT NEWS!
& mdash;@realDonaldTrump
No serious security issues reported
The shots taken by Pfizer and its German partner BioNTech are among 10 possible late stage vaccine candidates worldwide – four of them so far in large studies in the U.S. Another U.S. company, Moderna Inc., has also said he hopes to. be able to submit an application to the Food and Drug Administration at the end of the month.
The volunteers in the final phase studies and the researchers don’t know who got the real vaccine or a dummy shot. But a week after the second required dose, Pfizer’s study began counting the number of those who developed symptoms of COVID-19 and confirmed they had the coronavirus.
As the study did not end, Gruber was unable to say how many in each group had infections. Doing the math, this would mean that nearly all of the infections counted so far must have occurred in people who received the sham shots.
Pfizer does not plan to stop its study until it records 164 infections among all volunteers, a number the FDA has agreed is enough to tell how well the vaccine is working. The agency made it clear that any vaccine must be at least 50% effective.
So far, no participant has been seriously ill, Gruber said. It hasn’t been able to provide a breakdown of how many of the infections have occurred in older people, who are at higher risk for COVID-19.
US vaccines need to be studied on at least 30,000 people
Participants were only tested if they developed symptoms, leaving no response if vaccinated people could be infected but show no symptoms and unknowingly spread the virus.
The FDA has required that US vaccine candidates be studied on at least 30,000 people. In addition to an adequate number of older adults, such studies must also include other high-risk groups, including minorities and people with chronic health problems.
And he told companies that they need to monitor half of the participants for side effects for at least two months, the length of time that problems typically occur. Pfizer expects to hit this milestone at the end of the month, but said no serious security issues were reported on Monday.
As the pandemic is still ongoing, manufacturers hope to seek permission from governments around the world for emergency use of their vaccines as additional testing continues, allowing them to get to market faster than normal, but raising concerns. about how much scientists will know about the shots.
FDA scientific advisors last month said they fear that allowing emergency use of a COVID-19 vaccine could damage confidence in the injections and make it more difficult to find out how they really work. Those consultants said it is imperative that these huge studies can be completed.
On August 5, Canada announced that it had pre-ordered the Pfizer / BioNTech vaccine. Subsequently he specified that he had reserved 20 million doses, with the possibility of buying more. Given that the vaccine is given in two doses, 28 days apart, Canada would initially have enough to vaccinate 10 million people if approved.
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