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FDA grants Pfizer/BioNTech expanded EUA for an additional COVID-19 vaccine booster

The second booster authorisation is for those aged 50 years and older to promote high levels of protection against COVID-19 in the most vulnerable groups

Coronavirus vaccine

Pfizer/BioNTech have been given an expanded emergency use authorisation (EUA) by the US Food and Drug Administration (FDA) for its COVID-19 vaccine. This allows the vaccine to be given to adults ages 50 years and older as a second booster. Eligible adults can have had any authorised COVID-19 vaccine as their first booster.

A second booster dose has also authorised for those aged 12 years and older who are immunocompromised, and have had a first booster dose of any authorised COVID-19 vaccine.

The second booster should be given at least four months after the initial booster and could potentially restore antibody levels and improve protection in older people. It is the same formulation and strength as previous Pfizer/BioNTech COVID-19 vaccine doses.

The companies’ vaccine already has EUA authorisation for use as a single booster for those aged 12 and older who have already had two doses of the vaccine. Those aged 18 and older could have received any approved COVID-19 vaccines for their initial two doses.

The FDA’s decision is based on data from an ongoing study of 154 healthcare workers aged 18 years and older at a single centre in Israel. The group received two booster doses during a period when Omicron was the predominant variant. No new safety concerns were recorded.

Data given to the FDA by Pfizer/BioNTech showed vaccine effectiveness against COVID-19 declined three to six months after the initial booster, while evidence from Israel shows that an additional booster can improve protection against severe disease and death.

The data emphasises the importance of getting an additional booster dose for those aged 50 and older and highlights that there is a public medical need for those who are most vulnerable to be given an additional booster.

Article by
Fleur Jeffries

31st March 2022

From: Regulatory



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