The U.S. Food and Drug Administration (FDA) granted full approval to Pfizer-BioNTech’s coronavirus vaccine for those aged 16 and older on Monday.
The two-dose immunization was the first to receive emergency use authorization from federal regulators in December 2020 and will now be first to be licensed.
Full approval by the FDA could push more Americans to get the COVID-19 vaccine because it might reduce their fears about the safety of the shot.
It may also lead to more vaccine mandates with businesses feeling more comfortable requiring workers to get a jab that has full authorization despite it being contentious.
Pfizer said on Monday the vaccine will continue to be available for 12-to-15-year-olds and as third doses for immunocompromised people under emergency use only.
President Joe Biden shared the news on Twitter and encouraged Americans to keep rolling up their sleeves.
The FDA has officially approved the Pfizer COVID-19 vaccine. While all three COVID vaccines have met FDA’s strict standards for emergency use, this FDA approval should give added confidence that this vaccine is safe and effective,’ he wrote.
‘If you’re not vaccinated yet, now is the time.’
The FDA gave the Pfizer-BioNTech COVID-19 vaccine full approval by Monday. Pictured: A nurse hold a vial of the Pfizer-BioNTech vaccine at a clinic in Atlanta, Georgia, August 17
The full approval may help convince vaccine hesitant Americans to get the shot. Pictured: A student at California State University Long Beach receives a first dose of the Pfizer COVID-19 vaccine on campus, August 11
‘The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,’ acting FDA commissioner Dr Janet Woodcock said in a statement.
‘While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.
‘Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.’
Prior to Monday, Pfizer’s vaccine was only approved for use on an emergency basis, meaning it was considered somewhat experimental despite data showing it is safe and effective.
Emergency use authorization requires less clinical trial data, with the FDA only requiring two months of follow-up before approving the shot for those 16 and older last year compared to six months for full approval.
President Joe Biden celebrated the news and encouraged Americans to keep getting vaccinated
The data came from Pfizer’s trial last year of 44,000 people, of whom half received the shots.
‘Based on the longer-term follow-up data that we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,’ said Pfizer CEO Albert Bourla in a statement.
‘I am hopeful this approval will help increase confidence in our vaccine.’
The emergency use designation is also intended to be temporary.
With full approval, companies and schools may feel more comfortable requiring employees and students to get it.
‘The biggest argument that anti-vaccine people had against mandates was that the vaccine was not fully approved,’ Dr Arthur Caplan, a bioethicist at New York University, told DailyMail.com.
‘A lot of employers are now more willing to impose mandates, not just schools and government groups. A lot of companies I’ve been talking to have been waiting on this.’
At a news conference on Monday morning, Pentagon Press Secretary John Kirby confirmed that the full approval will lead to COVID-19 vaccines being mandated for the U.S. military.
‘Now that the Pfizer vaccine has been approved, the department is prepared to issue updated guidance requiring all service members to be vaccinated. A timeline for vaccinated completion will be provided in the coming days,’ he said.
And Louisiana State University President William Tate announced two weeks ago that the school will mandate that student receive the vaccine following full FDA authorization.
After lagging vaccination rates over the summer, the pace has increased again with a seven-day rolling average of more than 889,00, according to data from the Centers for Disease Control and Prevention (CDC).
That figure is 23 percent higher than the 718,000 average recorded one week earlier and the highest number seen since July 5.
A recent report from the Kaiser Family Foundation found three in ten unvaccinated adults said they would be more likely to get vaccinated if one of the vaccines were fully approved.
Experts believe the full approval will help boost vaccination numbers even further but will not change the minds of most vaccine hesitant people.
‘It will help but not the core people who have a deep distrust for science,’ Dr Peter Chin-Hong, a professor of medicine and infectious disease specialist at the University of California, San Francisco, told DailyMail.com.
‘I don’t think that group will be hit at all. You can say anything to them and they won’t budge. But it will hit some who are on the fence, but not as high as Kaiser says.’
Dr Ali Mokdad, an epidemiologist with the University of Washington’s Institute for Health Metrics and Evaluation, agreed and said he doesn’t think full FDA approval will make a huge difference in vaccination rates.
‘The survey from Kaiser recommended 30 percent would get vaccinated if the vaccine were approved, but I’m not that optimistic,’ he told DailyMail.com.
‘People refusing to get the vaccine are strong in that belief. It won’t be a major gamechanger [overall], but it will be a major gamechanger in mandates.’
The decision will also allow the vaccine makers to market their shots directly to the general public.
According to the FDA, the vaccine will be marketed under the name Comirnaty.
Critics had been pushing the FDA to move more quickly to approve the vaccine, after Pfizer filed the application on May 7, as COVID-19 cases rose in the U.S.
Experts had said the fact that 204 million doses had been administered since December 2020 with few reports of side effects showed the vaccine is safe and effective.
‘It’s very important to handle [the approval process] carefully,’ Caplan said.
‘Critics are waiting to poke holes in any approval. They studied vaccines in recipients over a long time and the data out there are overwhelmingly convincing’ that vaccines are safe and effective.
Chin-Hong added: ‘I can’t even remember the last time the FDA has hundreds of data points to help with approval.
For cholesterol medicine, the trial was in few thousand and then they looked at that in real life. Now you have hundreds of millions of people and that gives a very robust data point.’
The doctors say they hope the FDA approval helps convince people who have not had their shots yet to get vaccinated.
‘We are 100 percent sure with no doubt this is a safe vaccine,’ said Mokdad.
‘We played by the rules, we waited and monitored and didn’t see anything that warranted concern in the community.’
Source: Daily Mail | Health News