FDA, CDC COVID jab decisions 'will simplify booster messaging'

Three hurdles to allowing booster COVID-19 vaccinations for all adults in the US fell in swift succession on Friday, clearing the way for wider use of the Pfizer/BioNTech and Moderna shots.

The FDA cleared emergency use of the two vaccines on Friday, which was swiftly followed by a recommendation from a Centres for Disease Control and Prevention (CDC) advisory committee that was swiftly signed off by CDC director Rochelle Walensky.

The Advisory Committee on Immunization Practices (ACIP) recommended that a third dose of Pfizer/BioNTech's Comirnaty or Moderna's mRNA-1273 be given at least six months after the second dose.

The panel also strengthened its recommendations for fully vaccinated people in the 50 to 64 age group, saying that all people in this age group should receive a booster whether or not they have an underlying health condition that could make them vulnerable to severe COVID-19.

Walensky said in a statement that the ACIP's decision "carefully considered the current state of the pandemic, the latest vaccine effectiveness data over time, and review of safety data from people who have already received a COVID-19 primary vaccine series and booster."

The CDC also said that it had been reassured by safety data that is being collected through monitoring systems. There have been cases of heart inflammation (myocarditis and pericarditis) reported with both of the mRNA-based vaccines.

The broad recommendations suggest that Pfizer/BioNTech and Moderna are set fair for further handsome revenues from their vaccines in 2022 – assuming the US government can encourage take-up of the booster programme.

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The Biden administration welcomed the approvals, which allow the messaging about booster shots to be simplified from the earlier recommendations based on different age brackets. Now, for any adult the advice is if you have been fully vaccinated, you should get a third dose.

Previously, a booster dose of the Moderna and Pfizer/BioNTech vaccines was authorised for people aged 65 and older, individuals aged 18 to 64 years at high risk of severe COVID-19 and/or frequent institutional or occupational exposure to SARS-CoV-2.

"If you're one of the approximately 100 million people in this country already eligible for a booster, our recommendation is that you get the extra protection afforded by a booster as soon as possible," said the White House. "They are widely available across the country and accessible."

Around 32 million Americans have already had a booster, it added, and progress is also being made on vaccination younger children with 10% of 5- to 11-year-olds having received their first shot.