FDA clears booster doses of Moderna and Johnson & Johnson vaccines, says mix and match OK

The FDA has granted emergency use authorization for a half-dose of Moderna’s vaccine as a booster for people fully vaccinated at least six months ago who are also at least 65 years old, or who are at least 18 years old and who are at high risk for severe Covid-19 or have frequent institutional or occupational exposure to SARS-CoV-2.

He also authorized booster doses of the Johnson & Johnson vaccine.

“The use of a single booster dose of the Janssen (Johnson and Johnson) COVID-19 vaccine can be given at least 2 months after the end of the primary single-dose regimen to people aged 18 and over,” said the FDA in a statement.

And he said one of the three licensed vaccines could be used to boost. “Use of each of the available COVID-19 vaccines as a heterologous (or ‘mix and match’) booster dose in eligible individuals after completion of the primary series with a different available COVID-19 vaccine,” the FDA said .

“To clarify that a single booster dose of Pfizer-BioNTech COVID-19 vaccine can be given at least 6 months after the end of the primary series to people aged 18 to 64 with frequent institutional or occupational exposure to SARS- CoV-2, he added.

“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 illness, such as hospitalization and death. Available data suggests a decline. immunity in some populations that are fully vaccinated. The availability of these authorized recalls is important for continued protection against COVID-19 disease, ”FDA Acting Commissioner Dr. Janet Woodcock said in a statement.

“The changes to emergency use authorizations to include a single booster dose in eligible populations are based on available data and information and follow feedback from members of our advisory committee who have supported the use of a booster dose of these vaccines in eligible populations, ”added Dr. Peter Marks, director of the vaccines arm of the FDA, the Center for Biologics Evaluation and Research.

“We are also taking steps today to include the use of mix and match boosters to address this public health need. and plan to update the healthcare community and the public with our resolve in the coming weeks. “

Vaccine advisers from the U.S. Centers for Disease Control and Prevention, the Advisory Committee on Immunization Practices, meet on Thursday to decide whether to recommend FDA clearance for the American people, then the director of the CDC will decide whether to approve the ACIP guidelines.

The FDA said it decided to allow mixed boosters after researchers at the National Institutes of Health presented their findings last week to its vaccine advisers. Although the results were limited, they made it clear that mixing the different vaccines was safe.

The agency gave some examples of how this might work

“For example, Janssen COVID-19 vaccine recipients aged 18 and over may receive a single booster dose of Janssen COVID-19 vaccine, Moderna COVID-19 vaccine (half dose), or Pfizer-BioNTech COVID vaccine. -19 for at least two months. after receiving their primary Janssen COVID-19 vaccine, ”he said.

“In another example, recipients of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine falling into one of the categories allowed for recalls (65 years and over, 18 to 64 years at high risk of COVID- 19 severe- 19 and 18 to 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2) may receive a booster dose of Moderna COVID-19 vaccine (half dose), Pfizer-BioNTech COVID-19 vaccine or of Janssen COVID-19 Vaccinate at least six months after completing their primary vaccination, ”he added.

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