This week the Pfizer vaccine completed the U.S. Food and Drug Administration’s (FDA) approval process. This is an important step forward to convince the still large number of Americans who are vaccine-hesitant or straight out anti-vaxxers, a group that will be much harder to convince.
The vaccine is now officially approved for adults, after having been brought to the population under emergency use authorisation in December 2020.
Under this emergency authorisation the FDA required only two months of safety monitoring data on study subjects. Along with the Moderna and Johnson & Johnson vaccines, these tests were carried out on tens of thousands of people, and covered the time period in which side effects are most likely to arise.
This allowed the vaccine to be brought to populations much sooner, saving lives and beginning the long process of recovery from the pandemic. As of today, more than 204 million doses have been administered in the U.S., and many more globally.
The FDA concluded their review of six months of follow-up data this week. Their review conducted clinical trials as well as monitoring the quality and safety of the manufacturing process.
The full approval is the FDA’s strongest endorsement of the jabs safety and effectiveness.
On Monday, President Biden urged the population to take confidence in this decision: “If you’re one of the millions of Americans who said that they will not get the shot until it has full and final approval of FDA: It has now happened. The moment you’ve been waiting for is here.”
The FDA’s full approval has bolstered confidence from organisations to take the controversial step in mandating vaccination. New York City said it would require vaccination for all teachers before the school year. The Pentagon said it would mandate vaccination for 1.4 million troops on active duty by September.
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While some have insisted that the approval is meaningless given the hundreds of millions of people who have been given the vaccine, John Moore, a virologist at Weill Cornell Medicine, sees this as an important milestone:
“I think a substantial number of people will be stepping up and taking the vaccine now that there’s full approval. Employers, a significant number of them, are going to have more legal and moral confidence in putting in vaccine mandates.”
Personal sovereignty clashes with collective well-being in the issue of COVID vaccine mandates and COVID passports. In a non-emergency situation, it would be illegal for governments or companies to mandate a medical product to their employees.
The central question is whether or not the pandemic justifies the waiving of this freedom in the name of the greater good.
Full FDA approval of the Pfizer vaccine is another step forward – to convince more people to get vaccinated, to facilitate mandates, and to save more lives.
Moderna's full approval shouldn't be far behind – just a matter of timing and paperwork.
— Dr. Tom Frieden (@DrTomFrieden) August 23, 2021
This approval only applies to its use for over-16s, and it leaves some basic questions still unanswered. For one thing, it does not apply to booster jabs. Moreover, a big slice of the population – the 12- to 15-year-olds – are still authorised to receive the jab under the emergency use authorisation granted to Pfizer in the early stages of this year.
In short, the FDA’s approval process is not done yet. And if it is true that it will help in convincing anti-vaxxers to submit to vaccination, then there is still work ahead for the FDA to provide the assurance sought by people who are still vaccine-hesitant.
Editor’s Note: The opinions expressed here by Impakter.com columnists are their own, not those of Impakter.com. — In the Featured Photo: Vials of the Pfizer vaccine. Featured Photo Credit: Marco Verch.