Pfizer Receives Full FDA Approval For Its Covid Vaccine: Here Is More

OOn Monday, the Food and Drug Administration granted full approval of Pfzer / BioNTech’s Covid-19 vaccine, now marketed as Comirnaty, for anyone aged 16 and over. “This is a pivotal moment for our country in the fight against the pandemic,” said Acting FDA Commissioner Janet Woodcock. The move comes 8 months after the FDA first cleared the vaccine for emergency use.

While it may seem like a long time for the first full approval of a vaccine given the scale of the pandemic, it is actually record time. It took 97 days from when Pfizer finished submitting its entire application, which is about 40% faster than usual, the FDA said. “Our efforts to go as quickly as possible have by no means sacrificed scientific standards or the integrity of our process,” added Woodcock. About 170.8 million people, or 60% of the eligible U.S. population, have been fully immunized. But as the delta variant continues to spread and the number of Covid-19 cases increases, the only way out will be for even more people to get vaccinated. Here’s what full FDA approval means for these efforts.

What does full approval mean, anyway?

Until now, the Pfizer vaccine has been available for those 16 and over under a so-called emergency use authorization granted in December 2020. Generally speaking, this means that the FDA can grant an emergency use authorization. authorization for as long as it waits, based on available data. data, that the benefit outweighs the risk, for the duration of a public health emergency. Full approval means Pfizer will be able to continue manufacturing the vaccines after the Covid-19 emergency ends, which may be necessary, given that the decline in immunity has led some experts to believe that booster injections will be needed. Full approval also means Pfizer can market the vaccine and also allows doctors to prescribe “off-label” uses for the vaccine, although this is discouraged by the FDA.

Will there be more vaccination mandates?

Many governments, employers and universities have started to adopt “flexible mandates”, in other words, get vaccinated or face consequences. This could mean additional testing, masking or social distancing requirements for unvaccinated staff. It may also mean that more government agencies will require vaccinations with a few exceptions, as New York City did today for teachers, and the Pentagon should do for the military.

While most employers will have broad authority to demand that their staff get vaccinated, unionized workplaces will likely have to negotiate with their respective unions. “There must be a way out for people who have medical reasons not to be vaccinated and religious reasons not to be vaccinated. This will now continue until the full approval situation, ”Mark McClellan, former FDA commissioner and director of the Duke-Margolis Center for Health Policy, said at a press briefing. “Companies that could do it before, I think they’re going to be more confident now and I think they’ll be better accepted by their workers. This is likely to gain the support of many unions. The Food and Commercial Workers’ Union, which represents 1.3 million workers, welcomed full approval of the Covid-19 vaccine in a statement released on Monday.

Are more people getting vaccinated now?

Some people who have not yet been vaccinated have expressed concern about the ’emergency use authorization’ status of Covid-19 vaccines, saying they are waiting for the full seal of approval. “Vaccines are one of our greatest weapons against the virus and we know that approval of a vaccine promises to change the course of the pandemic in the United States,” said Woodcock “For some an approved vaccine by the FDA can instill in them the confidence to go out and get vaccinated.

While it is impossible to predict the impact of the change on vaccination rates, a number of surveys suggest that some people who are on the fence could be influenced. Nearly half of American adults were unsure of the regulatory status of vaccines with respect to full approval for emergency use in a survey conducted in June by the Kaiser Family Foundation. Thirty-one percent of unvaccinated people said they would be more likely to receive a Covid-19 vaccine if fully approved. About half of those in the “wait and see” category said they might change their mind, while 8% of those in the “definitely not” category might change their mind.

What does this approval mean for the immunization of children 15 years of age and under?

The FDA approval for Pfizer’s vaccine covers anyone 16 years of age and older. The FDA has cleared, but not yet fully approved, the vaccine for adolescents between the ages of 12 and 15, meaning there is enough evidence that the vaccines are considered safe and effective for this age group. One of the issues the FDA will continue to study is the risk of myocarditis, or heart inflammation, resulting from the vaccine. The agency found an increased risk for men aged 40 and under, with the greatest risk in men aged 12 to 17. (That said, myocarditis is also a complication of Covid-19 itself for people in this age group, appearing at a much higher rate than for people vaccinated and at more serious risk.)

While in the ordinary course of business, FDA approval means that doctors can prescribe a vaccine or drug for “off-label” use, such as in a different age group if they deem it medically appropriate. Woodcock pointed out that this is not the case for Covid-19 vaccines. “We do not have data on the appropriate dose and on safety in children younger than what is in the [emergency use authorization], “she said.” We need to get information and data on uses in young children. They are not just little adults. Covid-19 vaccines are being distributed as part of a national effort through of the CDC, which is why the federal government can dictate off-label use, she said. Ongoing trials are examining safety and effectiveness in children aged 5 to 11. FDA has refused to specify a deadline.

What about the vaccines from Johnson & Johnson and Moderna?

Moderna submitted an application for full approval of its vaccine about a month after Pfizer did so last June. The FDA has not commented on Moderna’s vaccine approval timeline, but if it follows a similar path, full approval of Moderna’s vaccine would take place in late September or October. Johnson & Johnson has yet to file a full approval application for its vaccine, although it expects to do so this year.

Will I need a booster if I have been vaccinated before?

Pfizer / BioNTech submitted data to the FDA in support of a Covid-19 recall last week, amid growing concerns about the Delta variant and declining immunity. Two days later, federal health officials, including Woodcock and CDC director Rochelle Walensky, issued a statement in support of booster shots for the Pfizer and Moderna vaccines. “Current protection against serious illness, hospitalizations and death may wane in the coming months, especially among those who are at higher risk or who have been vaccinated in the early stages of the vaccination rollout,” says the press release. “For this reason, we conclude that a booster will be necessary to maximize vaccine-induced protection and prolong its durability.”

While the booster rollout is still subject to FDA clearance, the Biden administration is hoping to start giving the injections the week of September 20. More data is needed to determine whether the Johnson & Johnson vaccine will require a booster because it was not available. in the United States until March 2021, while Pfizer and Moderna were available at the end of 2020.