FDA okays Moderna, J&J, 'mix and match' boosters

Regulatory NewsRegulatory News | 20 October 2021 |  By 

The US Food and Drug Administration has authorized booster doses of both the Moderna COVID-19 vaccine and the vaccine made by Janssen, the vaccines arm of Johnson & Johnson. The agency has also taken a “mix and match” approach, authorizing heterologous booster doses for all populations eligible for boosters under today's expansion of the emergency use authorizations for COVID-19 vaccines.
A booster is recommended for all recipients of the one-dose Janssen vaccine, and recipients may choose to receive either an additional full dose of Janssen’s vaccine, a full dose of the Pfizer mRNA vaccine, or the half-strength dose of Moderna’s mRNA vaccine that was submitted for consideration as a booster.
Similarly, Moderna vaccine recipients now have the option to receive a half-strength dose of Moderna’s offering, or to receive a Janssen or Pfizer vaccine as a booster. However, the booster dose for Moderna recipients is currently authorized for individuals 65 years of age and older as well as those aged 18 through 64 who are at high risk of severe disease, or who live or work in settings putting them at risk of exposure to SARS-CoV-2. (RELATED: Unanimous thumbs up from FDA committee for Moderna booster, Regulatory Focus 14 October 2021)
A booster dose was authorized in September for Pfizer vaccinees who are aged 65 and up or are aged 18 through 64 years and at high risk of severe disease. In today’s announcement, FDA included a mix and match strategy for Pfizer vaccine recipients; the agency also clarified that Pfizer recipients with occupational or residential risk for SARS-CoV-2 qualify for boosters.  (RELATED: Comirnaty booster gets adcomm thumbs up, for limited population, Regulatory Focus 17 September 2021)
Janssen vaccine recipients may seek a booster dose beginning two months after they received their singe-dose primary regimen; as with the already authorized Pfizer booster, Moderna’s booster dose can be administered 6 months or later after completing the 2-dose primary series. (RELATED: FDA adcomm unanimous on J&J boosters for all, Regulatory Focus 15 October 2021)
“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 follows 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,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a Wednesday evening announcement of the agency’s expanded authorizations.
“We are also taking action today to include the use of mix and match boosters to address this public health need,” Marks added. “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 healthcare community and public with our determination in the coming weeks.” Today’s press release includes links to updated fact sheets for all three authorized vaccines.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (CDC’s ACIP) meets tomorrow to review the available data on boosters and the ongoing Mix and Match booster study being conducted by the National Institutes of Health and the University of Maryland.
The committee will also hear updated real-world vaccine safety data, to include a report on the potentially increased risk for pericarditis and myocarditis in younger men who receive mRNA vaccines. ACIP will then vote on their recommendations for implementation of a booster strategy.
Last week, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of booster doses for both Janssen and Moderna vaccine recipients under the guidelines included in today’s expanded authorizations. The committee also heard and discussed, but did not vote on, interim data from the Mix and Match study; the study showed that booster doses of all vaccines increased immune titers, regardless of which primary series the booster preceded.
“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,” said acting FDA commissioner Janet Woodcock in the press statement. “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.”


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