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Tipsheet

FDA Approves Moderna and Johnson & Johnson Booster Shots for Elderly and High-Risk Adults

AP Photo/Rogelio V. Solis

The Food and Drug Administration (FDA) approved Emergency Use Authorization (EUA) for both the Moderna and Johnson & Johnson booster shots for fully vaccinated adults who are 65 and older or at high risk of contracting severe COVID-19.

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In an announcement on Wednesday, the FDA explained that the use of a single-dose Johnson & Johnson booster may be administered at least two months after the single-dose primary regimen to qualifying individuals. Qualifying Individuals who received the two-dose Moderna vaccine can receive a single-dose booster shot at least six months after their second shot.

In a statement, Acting FDA Commissioner Janet Woodcock said that the approval of the boosters is the next step to curbing the spread of the Wuhan coronavirus. She noted that available data suggests “waning immunity” in some who are fully vaccinated.

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

In the announcement, it is noted that the FDA approved the “mix and match” strategy, which I covered this week, which would allow individuals who received the Pfizer-BioNTech vaccine to receive a Moderna or Johnson & Johnson booster.

“The use of 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 announcement reads. In a statement, Director of the FDA’s Center for Biologics Evaluation and Research Peter Marks said this move is to address the “public health need” of stopping the spread of the virus.

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“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,” Marks said. “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 healthcare community and public with our determination in the coming weeks.”

In September, the FDA authorized the Pfizer-BioNTech booster shot to limited age groups after it rejected the Biden administration’s agenda to have boosters available to all fully vaccinated Americans.

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