Pfizer’s Covid-19 vaccine is currently only authorized for emergency use in the United States, however, its full approval by the US Food and Drug Administration could happen within weeks and this could alter the course of the pandemic in several ways.
First, the full approval, by the FDA, of a Covid-19 vaccine would persuade more people to get vaccinated and more than 30% of the eligible population in the United States still hasn’t gotten vaccinated.
This is as a result of insufficient data to convince some Americans that the vaccines are not dangerous.
For a vaccine to qualify for emergency use authorization, their makers have to submit about three months of clinical trial data which includes at least 2 months of safety data on fully vaccinated participants, since most vaccine side effects occur 2-3 months after the vaccination.
The full FDA approval of a vaccine requires much more data, including safety and efficacy data generated in the real-world, outside of a clinical trial. The CDC has been tracking real-world data on the vaccines and more than 165 million people in the US are now vaccinated against the virus and this extra data may help convince more people that the vaccines are not dangerous.
An associate professor in the division of infectious disease epidemiology at Johns Hopkins Bloomberg School of Public Health, Dr David Dowdy, has said that the approval by the FDA will go a long way to reassure some people about the safety of the vaccine. He said, “For some, getting a full FDA approval will help allay that fear. Even if it’s just a relatively small number of people. Every little bit helps against this virus”.
Dr. Paul Offit, a prominent member of the FDA’s vaccine advisory committee and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, says that the agency is “working around the clock” on the approval of the Covid-19 vaccine.
According to Dr. Offit, the approval should not really matter since a large part of the population have already been vaccinated, which tells you that this is not experimental, however, he agrees that it does matter to some people who are hesitant because they are unsure on whether to view the vaccines as a licensed product or just approved through the EUA and happen to have more faith in the FDA.
“I think from the standpoint of the public, it really shouldn’t matter,” Offit said. “It’s been given to half of the American population. We have more than 300 million doses out there. This is far from experimental. We have a tremendous safety and efficacy portfolio on these vaccines — I mean, it’s more than most licensed products that are out there now.”
“I think they realize that at least there’s a psychological issue with how these vaccines are viewed, in terms of whether they’re a licensed product or just approved through EUA,” Offit added.