Buzz
The FDA has now fully approved Pfizer’s COVID-19 vaccine for individuals 16 years and older. Meanwhile, the Moderna and Johnson & Johnson vaccines are still under emergency use authorization, along with the Pfizer vaccine for children aged 12 to 15.
What steps follow this approval?
There are no changes to the vaccines themselves or the guidance on who should receive them.
A common concern among those hesitant to get the COVID vaccine was the fact that the vaccines had only been granted emergency use authorization, not full approval. This gave some people the impression that the vaccines were experimental and possibly unsafe, even though there is a wealth of safety data. Full approval is hoped to alleviate these fears and encourage those who are waiting for more evidence to get vaccinated.
Full approval of the vaccine may encourage more employers and organizations to implement vaccine mandates. While employers can require the vaccine even under EUA, some may have been hesitant to do so. With full approval, they may feel more confident in requiring the vaccine.
When a drug or vaccine is fully authorized, providers typically have more flexibility to use it as they see fit. This is known as 'off-label' use. However, COVID vaccines are being distributed through a government agreement that prevents them from being used off-label for booster doses or in other age groups, like children, in most cases.
With full approval, Pfizer can now choose a brand name for their vaccine. Instead of simply calling it 'the Pfizer vaccine,' it will now be known as Comirnaty. The pronunciation places emphasis on the second syllable, reminiscent of the way the 'ehrmagerd' meme would pronounce 'community.'
What exactly distinguishes EUA from full approval?
A vaccine's full approval requires more comprehensive safety data compared to its emergency authorization, which involves a longer follow-up period (six months versus two months). It also demands inspections and a closer look at the manufacturing process.
Most drugs and vaccines on the market are FDA-approved, which is the standard procedure. However, given the ongoing national emergency due to COVID-19, the FDA has allowed vaccines for the virus to be temporarily authorized under an Emergency Use Authorization (EUA). If the emergency is called off, these EUA vaccines would no longer be permitted for use.
An Emergency Use Authorization (EUA) differs from full approval in several ways, including the fact that it’s much easier to withdraw an EUA product from the market by simply revoking the EUA. We discussed this difference last year when regulators were deliberating on the best routes for delivering a COVID vaccine to the public.
What is the future of the Moderna and Johnson & Johnson vaccines?
Moderna submitted its request for full approval in June, about a month after Pfizer made their submission, so it’s probable that Moderna will receive full approval soon. Johnson & Johnson is also planning to apply for full approval for their vaccine in the near future.
Emergency Use Authorizations (EUAs) are typically issued only when no approved alternatives are available, which has led to speculation that the EUAs for other vaccines may eventually be revoked. However, regulators have not made any announcements regarding the potential revocation of the current EUAs.
