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US COVID-19 booster programme expanded

The FDA and CDC have given the green light to an expansion of the US COVID-19 booster programme to include another shot of the Moderna and J&J vaccines as well as a ‘mix and match’ approach

Johnson and Johnson

The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have both given the go-ahead for an expansion of the US booster programme against COVID-19.

Following an unanimous endorsement from its advisory board, the FDA has amended the emergency use authorisations for a third dose of the Moderna and Johnson & Johnson vaccines in vulnerable populations.

The Moderna booster can offered to those 65 or over or younger adults at high risk of severe COVID-19 or with 'frequent institutional or occupational exposure to SARS-CoV-2' at least six months after the second dose.

The indication for a booster to the single-shot Johnson & Johnson is wider, covering any adult that received the first shot and with a much shorter space of two months between the first single-shot and the booster.

The move comes after J&J announced new data 'reinforcing the strong and long-lasting protection of its COVID-19 vaccine' that covers both the original single-shot dose and a booster.

In the largest real-world evidence study into a COVID-19 vaccine to date, the J&J vaccine demonstrated 'stable vaccine effectiveness' of 79% against infection and 81% against hospitalisation. The company points out that the real-world data is consistent with its phase 3 ENSEMBLE trial results.

J&J also reported results from a second trial, the phase 3 ENSEMBLE 2 study, which looked at a second, booster shot of the vaccine given 56 days after the first. In the trial, the booster offered 100% protection against severe/critical COVID-19 and 94% protection against moderate to severe/critical COVID-19 in the US. The protection against moderate to severe/critical disease was lower when looking at the global population, offering 75% protection.

The FDA has also listened to its advisory board over the use of ‘mix and match’ boosters. Now, Americans can receive any of the available COVID-19 vaccines as a booster regardless of which vaccine they received originally, it says.

While the FDA’s authorisations are important, the expanded booster programme could not be initiated until it was approved by the CDC. After an independent CDC advisory panel voted unanimously to recommend the boosters this week, CDC Director Dr Rochelle Walensky signed off on the panel's recommendation, clearing the way for vaccine boosters to be administered nationwide.

Article by
Hugh Gosling

22nd October 2021

From: Regulatory



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