What It Means Now That Pfizer’s Vaccine Is Fully FDA Approved for Adults
The FDA announced today that Pfizer’s COVID-19 vaccine is fully approved for use in people 16 and older. Moderna and Johnson & Johnson vaccines continue to be covered by an Emergency Use Authorization, as are Pfizer vaccines for children 12 to 15 years of age.
What’s going on now?
Vaccines have remained the same, and vaccination recommendations have not changed.
Some people who did not receive the COVID vaccine were worried that all vaccines were only authorized in emergencies and were not fully approved, making them appear “experimental” and potentially dangerous, even though there is a wealth of safety data. … One hope is that full approval can reassure anyone who has held on and waited for more safety data.
The approval also means that more employers and organizations may be more inclined to accept the vaccine mandate. Legally, they may require the vaccine even if it is under the EUA rather than full approval , but some employers may feel more comfortable requiring it now that it is approved.
Generally, full authorization allows providers to use the drug or vaccine as they see fit; if it is different from what the vaccine was approved for, it is called off-label use. But COVID vaccines are provided by agreement with the government, which in most cases prohibits their use for off-label boosters or in other age groups (such as children).
Full approval also means that Pfizer can choose a brand name for its vaccine. Instead of being called the “Pfizer vaccine,” the vaccine can now be called Comirnaty. (Emphasis on the second syllable, as if the hermaggerd girl was trying to say community.)
What is the difference between EUA and approval?
Full approval of a vaccine requires more safety data than emergency approval (six months of follow-up instead of two months), and also requires inspections and more scrutiny of the process used to make the vaccine.
Most of the drugs and vaccines on the market are FDA-approved; this is the normal way of working. However , as the country has a COVID-19 emergency in the country, the FDA has authorized COVID vaccines to be “Emergency Use Authorization” (EUA), which constitutes a temporary authorization. If the emergency is lifted, the EUA vaccines will no longer be able to remain on the market.
EUA differs from approval in several other ways, including the fact that an EUA product is easy to take off the market by quickly repealing the EUA. We wrote about the difference last year as regulators considered which routes would be appropriate for delivering the COVID vaccine to the public.
What happens to Moderna and Johnson & Johnson vaccines?
Moderna filed for full approval back in June, about a month after Pfizer filed the application , so it’s likely Moderna will get full approval soon. Johnson & Johnson plans to apply for full approval of its vaccine soon.
EUAs are usually granted only in the absence of approved alternatives, leading to speculations that EUAs for other vaccines may be phased out. However, regulators have not announced anything about the withdrawal of existing EUAs.