FDA expands COVID vaccine authorized boosters

The U.S. Food and Drug Administration approved Wednesday expanding the use of boosters for COVID-19 vaccinations in eligible populations, including an emergency use authorization for using a different vaccine as a booster than that with which people originally were vaccinated.

“Today’s actions demonstrate our commitment to public health in proactively fighting against the COVID-19 pandemic,” acting FDA Commissioner Janet Woodcock, M.D., said in a release issued by FDA. “As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death. The available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease.”

“The amendments to the emergency use authorizations to include a single booster dose in eligible populations are based on the available data and information and follow the input from the members of our advisory committee who were supportive of the use of a booster dose of these vaccines in eligible populations,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in the release. “We are also taking action today to include the use of mix and match boosters to address this public health need. We will work to accrue additional data as quickly as possible to further assess the benefits and risks of the use of booster doses in additional populations and plan to update the health care community and public with our determination in the coming weeks.”

The news comes as the delta variant-driven surge continues to hit this part of Montana and the rest of the state. Local health officials say most of the hospitalizations are in people who have not been vaccinated — with the officials stressing the need for everyone to do so — but some breakthrough cases of vaccinated people and reinfections of people who already had COVID-19 are requiring hospitalization.

The FDA approval comes on evidence from studies that the original vaccination series lose effectiveness over time, and the booster greatly increases resistance to the virus and greatly reduces the chance of serious illness or death.

Even without a booster, all of the vaccines have proven to greatly reduce the chance of serious illness or death in people exposed to the virus, but the boosters increase that resistance to even higher levels.

FDA authorized Sept. 22 giving a booster shot of the Pfizer-BioNTech vaccine to eligible populations which originally had been vaccinated with that vaccine.

Those eligible groups FDA has authorized using boosters are people 65 and older, people 18 to 64 at high risk of severe COVID-19 and people 18 to 64 years old who live or work in areas giving them frequent exposure to COVID-19.

People in those groups could get a booster shot of the Pfizer vaccine at least six months after the completion of the original vaccination series — the Pfizer vaccinations required two shots to be complete.

Wednesday’s authorization now allows a single booster shot of the Moderna vaccine at half the dosage of an original vaccination at least six months after completion of a vaccination series — he Moderna vaccine also used a two-shot series for full vaccination — and allows a single booster dose of the Janssen Johnson & Johnson vaccine, which only gave one shot for its vaccination, at least two months after completion of vaccination with that vaccine for anyone 18 and older.

And the authorization allows people to “mix-and-match” their booster, getting a booster with any of the authorized vaccines even if it is different than the vaccine used in the original vaccination.

The release gives an example that Janssen COVID-19 vaccine recipients 18 years of age and older may receive a single booster dose of Janssen COVID-19 Vaccine, Moderna COVID-19 Vaccine (half dose) or Pfizer-BioNTech COVID-19 Vaccine at least two months after receiving their Janssen COVID-19 vaccine primary vaccination. 

In another example, Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 vaccine recipients falling into one of the authorized categories for boosters may receive a booster dose of Moderna COVID-19 Vaccine — half dose — Pfizer-BioNTech COVID-19 Vaccine or Janssen COVID-19 Vaccine at least six months after completing their primary vaccination.

Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet today to discuss its recommendations on the booster shots, with formal recommendations from the CDC director likely to follow soon after.

The Pfizer vaccine, which has been fully approved for use in people 16 and older, has been given emergency authorization for use in children ages 12 to 15. The company it has submitted a request for FDA emergency use authorization on children 5 to 11 and a decision is expected by the end of the month.

The Johnson & Johnson and Moderna vaccines are only authorized for people 18 and older, although work is underway to have them authorized for younger children.

Studies also are underway on authorizing vaccines for children younger than 5.