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NEW YORK: Pfizer said on Monday (November 9) that its experimental COVID-19 vaccine was more than 90% effective, a major victory in the fight against a pandemic that has killed more than a million people, has hit the world economy and has collapsed daily. lifetime.
Pfizer and its German partner BioNTech are the first drug manufacturers to publish successful data from a large-scale clinical trial of a COIVD-19 vaccine. The companies said they have found no serious safety concerns so far and hope to apply for US authorization this month for emergency use of the vaccine.
If authorized, the number of doses will initially be limited and many questions remain, including how long the vaccine will provide protection. However, the news offers hope that other COVID-19 vaccines in development may also prove effective.
“Today is a great day for science and humanity,” said Albert Bourla, Pfizer president and CEO.
POSITION TO OFFER HOPE
This interim analysis, from an independent data monitoring board, looked at 94 infections recorded so far in a study that has enrolled nearly 44,000 people in the US and five other countries.
Pfizer did not provide further details on those cases and cautioned that the initial protection rate could change when the study ends. Even revealing data this early is very unusual.
“We’re in a potential position to be able to offer some hope,” Dr. Bill Gruber, Pfizer’s senior vice president of clinical development, told The Associated Press. “We are very excited.”
BioNTech CEO Ugur Sahin told Reuters he was optimistic that the immunization effect of the vaccine would last for a year, although that was not yet certain.
“The efficacy data is really impressive. This is better than most of us anticipate,” said William Schaffner, an infectious disease expert at Vanderbilt University School of Medicine, Nashville, Tennessee. “The study has not yet been completed, but the data looks very strong nonetheless.”
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Injections by Pfizer and BioNTech are among 10 potential vaccine candidates in advanced stage trials worldwide, four of them so far in large studies in the US.
Another American company, Moderna, has also said it hopes to be able to file an application with the Food and Drug Administration later this month.
Volunteers in end-stage studies and researchers do not know who received the actual vaccine or a sham injection. But a week after their required second dose, the Pfizer study began counting the number of people who developed COVID-19 symptoms and were confirmed to have the coronavirus.
Because the study is not over, Gruber could not say how many in each group had infections. Doing the math, that would mean that almost all of the infections counted so far had to have occurred in people who received the fake injections.
Pfizer does not plan to stop its study until it records 164 infections among all volunteers, a number that the FDA has agreed to is enough to know how well the vaccine is working. The agency has made clear that any vaccine must be at least 50 percent effective.
So far, no participant has become seriously ill, Gruber said. It was also unable to provide a breakdown of how many of the infections had occurred in older people, who are at higher risk of contracting COVID-19.
Participants were tested only if they developed symptoms, leaving unanswered whether vaccinated people could become infected but show no symptoms and spread the virus without knowing it.
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, those studies should also include other high-risk groups, including minorities and people with chronic health problems.
And he told companies to track half of their participants for side effects for at least two months, the time period in which problems generally arise. Pfizer expects to reach that milestone later this month, but said Monday that no serious safety problems have been reported.
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RAISED CONCERNS
Pfizer and BioNTech have a $ 1.95 billion contract with the United States government to deliver 100 million doses of vaccines starting this year. They have also reached supply agreements with the European Union, the United Kingdom, Canada and Japan.
As the pandemic still continues, manufacturers hope to obtain permission from governments around the world for emergency use of their vaccines while further testing continues, allowing them to get to market faster than normal, but prompting concerns about how much scientists will know about vaccines.
Scientific advisers to the FDA said last month they were concerned that allowing the emergency use of a COVID-19 vaccine could damage confidence in the injections and make it difficult to know how well they actually work. Those advisers said it is critical that these massive studies can be completed.
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