FDA Authorizes Moderna, J&J Booster Shots, ‘Mix and Match’ Approach

Vocational nurse Christina Garibay displays a syringe with Johnson & Johnson's Janssen Covid-19 vaccine at a Skid Row community outreach event where Covid-19 vaccines and testing were offered in Los Angeles, California on August 22, 2021. (Photo by Frederic J. BROWN / AFP) Photo by FREDERIC J. BROWN/AFP via Getty Images

The Food and Drug Administration (FDA) on Wednesday authorized booster shots for Moderna and Johnson & Johnson vaccines for certain eligible populations, adding that people can take a different vaccine brand than the ones they'd taken originally.

The booster campaign for those aged 65 and over and those at high risk aims to increase protection against COVID-19 amid signs that vaccine efficacy decreases over time.

“Today the currently available data suggest waning immunity in some populations of fully vaccinated people,” FDA’s acting commissioner Janet Woodcock said. “The availability of these authorized boosters is important for continued protection against COVID-19 disease.”

The FDA on Wednesday authorized a third COVID-19 vaccine dose from Moderna for seniors and those at risk of severe disease, and those who may be exposed at their residence or work to the CCP (Chinese Communist Party) virus. The booster is authorized six months after a person’s last inoculation and will be half the dose used for the first two shots.

The agency said that for Johnson & Johnson’s single-shot vaccine, people of any eligible ages can get a second dose at least two months after their first shot.

Previously, the FDA authorized third doses of the Pfizer-BioNtech COVID-19 vaccine for at least six months after people received the first two doses. The authorization was for people aged 65 and older, and others at high risk from COVID-19 due to health conditions or jobs.

The Centers for Disease Control and Prevention (CDC) will consult a panel on Thursday before finalizing official recommendations about who should get a third dose, and when. The recommendations are subject to approval by CDC Director Rochelle Walensky.

About 65 million eligible Americans remain completely unvaccinated. Of the nearly 190 million Americans who are fully vaccinated, about 15 million have received the J&J vaccine while the rest have received the mRNA-based Pfizer-BioNTech or Moderna shots. About 11.2 million people have so far received a booster dose.

Mix and Match

The FDA said people can take any brand for the booster shots regardless of which vaccine brand they took initially.

The FDA advisory panel meeting included a presentation of data (pdf) on the mix and match of booster vaccines from a study under the National Institutes of Health. The 458 participants in the study took varying combinations of the three brands of vaccines.

Results suggest that an extra dose of any brand will increase levels of antibodies against COVID-19.

“This is only antibody data. Cellular immune responses are still being analyzed,” the presentation noted.

FDA officials said it was not immediately clear from the data whether any shot combination should be preferred.

“Because we don’t have those data right now, I think we just have to be noncommittal about what is the best,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

“Being able to interchange these vaccines is a good thing—it’s like what we do with flu vaccines,” Marks told reporters late Wednesday. “Most people don’t know what brand of flu vaccine they received.”

An FDA advisory panel on Sept. 17 had voted 16–3 against approving the Pfizer-BioNtech shot for most people except for those aged 65 and over, and those in high-risk situations.

FDA regulators said they would move quickly to expand boosters to lower age groups, such as people in their 40s and 50s, if warranted. “We are watching this very closely and will take action as appropriate to make sure that the maximum protection is provided to the population,” said Marks.

Two top vaccine officials penned a paper published Sept. 13 in The Lancet medical journal saying that no evidence is available to support COVID-19 booster shots for the general population.

“[A]lthough the benefits of primary COVID-19 vaccination clearly outweigh the risks, there could be risks if boosters are widely introduced too soon, or too frequently, especially with vaccines that can have immune-mediated side-effects … If unnecessary boosting causes significant adverse reactions, there could be implications for vaccine acceptance that go beyond COVID-19 vaccines. Thus, widespread boosting should be undertaken only if there is clear evidence that it is appropriate,” the two officials, Dr. Marion Gruber, the head of the FDA’s Office of Vaccines Research and Review, and her deputy, Dr. Philip Krause, wrote.

The two announced in late August they will be leaving the FDA in October and November.

The Associated Press contributed to this report.