The US Food and Drug Administration (FDA) has authorised additional doses of Pfizer-BioNTech and Moderna Covid-19 vaccines for certain people with compromised immune systems.
The regulatory agency has amended the emergency use authorisations (EUAs) for both the companies’ vaccines to allow a booster dose to certain individuals, specifically the recipients of solid organ transplantation or those diagnosed with conditions that are similar to compromised immune systems.
FDA stated that these individuals have less ability to fight infections and are specifically vulnerable to infections such as Covid-19.
The regulator has evaluated the data regarding the use of a booster dose of the Pfizer-BioNTech or Moderna Covid-19 vaccines in these individuals and determined that the additional dose may increase protection.
FDA acting commissioner Janet Woodcock said: “The country has entered yet another wave of the Covid-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease.
“After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines.
“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from Covid-19.”
It has also noted that the other individuals who are fully vaccinated do not require an additional Covid-19 vaccine dose at this time.
The FDA is working on a science-based process with federal partners to consider whether an additional dose may be needed for other individuals in the future.
The regulatory agency stated that the eligible recipients are required to receive a third dose at least 28 days after getting their second shot of the same vaccine.
Currently, the Pfizer-BioNTech Covid-19 vaccine is authorised for emergency use in individuals aged 12 and above, while the Moderna vaccine is authorised in individuals aged 18 and above.