On August 23, the Food and Drug Administration (FDA) gave full approval to the Pfizer COVID-19 vaccine. This is an even faster approval than Pfizer had hoped for, as the most optimistic date had been early September.
Until now, the COVID-19 vaccines available in the United States have only had Emergency Use Authorization (EUA). But full approval of even one of these vaccines would immediately bring many important changes to the meaning and role of vaccines throughout the nation, including increased comfort for companies wishing to mandate vaccines.
Less than an hour after the announcement, the Pentagon followed suit and made the Pfizer vaccine mandatory for the U.S. military. All service members will need to be vaccinated on a timeline that will soon follow. This is just the beginning of a new type of COVID-19 wave — the vaccination wave.
With so many children already back to school or heading there very soon, full approval opens up the possibility for doctors to do something called “off-label use.” While this is forbidden with a vaccine that has only EUA, doctors can prescribe a fully approved vaccine to a child under 16 and administer the shot. (Full use of the Pfizer vaccine is now authorized for people aged 16 and older; the shot still has emergency authorization for 12- to 15-year-olds.)
For a lot of parents looking to have their younger children vaccinated as they head back to school, this is a very big deal.
John Lawlor, a South Florida lawyer, explains that full FDA approval benefits not only Pfizer but the whole vaccine industry: “With each COVID-19 vaccine that gets full approval, it’s a recognition of the rigorous testing that has been done over many months. In putting both the manufacturer’s and the government’s seals of approval on the vaccine, people will become more comfortable with vaccines as a whole each time one wins full FDA approval.”
It’s not just private employers who are instituting mandatory vaccine policies. Last week, New York announced that all health care workers in the state must receive at least one dose of a COVID-19 vaccine by September 27. The city of Chicago has also mandated that all employees, including public school teachers and staff, be fully vaccinated by October 15. Even Fox News, whose highest-rated personalities have consistently attacked the vaccines, has its own version of a vaccine passport, having informed its employees this week that they must disclose their vaccination status to the company.
“While states have had varying responses over the past weeks to employers mandating vaccines, the FDA’s full approval removes a hurdle, as courts across the nation will factor it into any case involving mandatory vaccines in the workplace.”
From a legal perspective, full approval will embolden many employers across the nation to make the vaccine mandatory for employees. While states have had varying responses over the past weeks to employers mandating vaccines, the FDA’s full approval removes a hurdle, as courts across the nation will factor it into any case involving mandatory vaccines in the workplace. In itself, it is not legally definitive, yet it’s one more piece of evidence that the medical community and levels of government are adopting the best currently available science around further controlling the global pandemic.
With approximately 50% of the full U.S. population not yet fully vaccinated, the news this week brings a collective hope among government officials and public health experts that the unvaccinated will be moved to action.