The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for a booster dose of Pfizer-BioNTech’s Covid-19 vaccine.
The regulatory agency approved the booster dose for individuals aged 65 years and above; people aged 18 to 64 years who are at high risk of severe Covid-19 or are more likely to get exposed to the virus.
The vaccine booster will be administered at least six months after the first two doses.
Pfizer noted that the approval is supported by data from the companies’ clinical programme which assessed the safety, tolerability and immunogenicity of the Covid-19 vaccine’s booster dose.
The data was reviewed by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).
It showed that the Pfizer-BioNTech vaccine booster elicits high neutralising antibody titers against the SARS-CoV-2 virus as well as all the currently tested variants.
Pfizer added that the reactogenicity profile within seven days after administering the booster was typically mild to moderate, with the frequency of reactions similar to or lower than after the second dose.
This booster dose is expected to help preserve a high level of protection against Covid-19.
US FDA acting commissioner Janet Woodcock said: “After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others.”
Last month, the regulatory agency approved additional doses of both Pfizer-BioNTech and Moderna’s Covid-19 vaccines for individuals aged at least 12 years who have received solid organ transplant, or those diagnosed with conditions that are similar to immunocompromise.
The authorisation of a third dose will allow immunocompromised people to receive the booster at least 28 days after getting their second shot of the same vaccine.