FDA OKs Moderna, J&J Boosters, Mixing Vaccinations

LONG ISLAND, NY — The U.S. Food and Drug Administration gave approval Wednesday to expand coronavirus booster shots to the Moderna and Johnson & Johnson vaccinations — and to allow mixing of the different vaccinations.

The FDA amended the emergency use authorizations for COVID-19 vaccines to allow for the use of a single booster of the Moderna COVID-19 vaccine that may be administered at least six months after completion of the primary series to individuals:

- 65 and older

- 18 to 64 at high risk of severe COVID-19

-18 through 64 with frequent institutional or occupational exposure to SARS-CoV

The FDA also green-lighted the use of a single booster dose of the Janssen, or Johnson and Johnson, COVID-19 vaccine at least two months after completion of the single-dose primary regimen to individuals 18 years of age and older.

Also, the FDA gave its okay to use each of the available COVID-19 vaccines as a heterologous, or “mix and match", booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.

The eligible populations and dosing interval for a heterologous booster dose are the same as those authorized for a booster dose of the vaccine used for primary vaccination. For example, 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 dose, the FDA said.

Also, the FDA said a single booster dose of the Pfizer-BioNTech COVID-19 vaccine may be administered at least six months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.

“Today’s actions demonstrate our commitment to public health in proactively fighting against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D. “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.”

Wednesday's news came after an advisory committee voted unanimously Friday to recommend a booster shot of the J & J vaccine to the U.S. Food and Drug Administration — on the same day that the Centers for Disease Control and Prevention issued new holiday guidance.

According to the New York Times, now that the FDA and the Centers for Disease Control and Prevention accepted the recommendation, the 15 million who received the one-dose J & J shot could be lining up for their next dose as soon as this week..

The FDA's Vaccines and Related Biological Products Advisory Committee also voted Thursday to allow for the Moderna booster.

The push for boosters kicked off last month after the Food and Drug Administration authorized third doses of the Pfizer vaccine for seniors and younger adults with health problems, jobs or living conditions that place them at higher risk from the coronavirus.