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FDA and CDC authorise COVID booster shots for all US adults

Both the US Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) have given the nod for fully vaccinated Americans aged 18 and older to receive a COVID-19 booster shot, reports MedicalBriefs.

The emergency use authorisation for a third dose of the COVID vaccines, which had already been available to people 65 and older and to anyone 18 years and older who were at elevated risk of contracting COVID-19, was granted last Friday (19 November).

Ironically, the blanket permission for a third dose of any approved vaccine, not just Pfizer and Moderna, came after multiple states had already authorised booster shots for all adults, without waiting for federal approval, reports Cnet. Several states — including California, Kansas, Maine, Rhode Island and Louisiana — had moved ahead of federal health authorities in recent days and independently authorised booster shots for their adult residents.

“The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older,” said Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “Streamlining the eligibility criteria and making booster doses available to people 18 and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one.”

NPR reports that people who had received the Pfizer or Moderna immunisations would be eligible for a booster six months after their second shot. People who got the Johnson & Johnson vaccine would be eligible for a booster two months after their first shot.

Both Pfizer and Moderna have shown data that an additional shot improves the efficacy of their vaccines in adults. Pfizer and Moderna first made their request for boosters in September, but advisers to the FDA initially resisted the idea of boosters for all adults. The FDA narrowed the authorisation to groups of people at elevated risk. Earlier this month, Pfizer and Moderna renewed their requests for broader use of their boosters.

The latest FDA authorisation comes nearly two months after the agency first gave the green light to booster shots for Americans 65 and older and for others considered at high risk for COVID-19. In September, the agency granted its initial authorisation for the additional shot to Pfizer, and a month later it followed suit with the Moderna and Johnson & Johnson vaccines.

The vast majority of hospitalisations and deaths due to COVID-19 are among unvaccinated individuals. But protection against coronavirus infection among the fully vaccinated has also been waning, partly due to the more infectious delta variant of the virus.

The vaccine manufacturers announced the approvals on their websites early on Friday — less than a week before Thanksgiving and ahead of increased travel and colder weather that will send millions of Americans into closer quarters, reports New York Post.

“The CDC and FDA decision is supported by clinical data showing robust immune responses after a booster dose of our vaccine, exceeding what has been seen even after the completion of the highly-effective two-dose primary schedule,” said Dr Ugur Sahin, CEO and co-founder of BioNTech. “These data suggest a booster dose of our vaccine has the potential to maintain a high-level of protection against tested variants, including Delta.”

“This emergency use authorisation comes at a critical time as we enter the winter months and face increasing COVID-19 case counts and hospitalisations across the country,” said Moderna’s CEO Stéphane Bancel in a statement.

 

NRP article – The FDA authorizes COVID booster shots for all U.S. adults (Open access)

 

New York Post article – CDC panel, FDA OKs Moderna, Pfizer COVID-19 boosters for all US adults (Open access)

 

Cnet article – Moderna COVID booster recommended for all adults: What to know about new CDC guidelines (Open access)

 

FDA announcement – Coronavirus (COVID-19) Update: FDA Expands Eligibility for COVID-19 Vaccine Boosters (Open access)

 

See more from MedicalBrief archives:

Biden administration wants boosters for most people 8 months after vaccination

 

FDA green-lights third jab for immunocompromised people

 

CDC panel backs third Pfizer and Moderna shot for the immunocompromised

 

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