The US Food and Drug Administration (FDA) has granted Pfizer-BioNTech an expanded emergency use authorisation (EUA) for the companies’ COVID-19 booster vaccine to include those aged 12 years and older in the United States.
With the FDA announcement, the time between the completion of the primary series and booster doses is significantly reduced for all eligible individuals. Moreover, the authorisation includes individuals aged between five and 11 who are immunocompromised in certain ways.
As with Pfizer/BioNTech’s initial vaccine, the booster dose will have the same dosage strength of 30-µg.
For those aged 5 years and older, the timeline given for the vaccine to be administered as part of a two-dose series is a total of three weeks between each jab.
In the same age group, 28 days must be allowed before a third dose can be given to those who are immunocompromised in certain ways.
The FDA authorisation is based on information provided by an independent evaluation, assessing the safety and effectiveness of a third dose in adults who have had solid organ transplants.
Previously, FDA authorisation was provided for a booster dose of the Pfizer/BioNTech COVID-19 vaccine for individuals aged 16 and older, while those eligible in the 18-and-older age groups also come under the authorisation, even if they have completed their primary vaccination with a different authorised COVID-19 vaccine.
Chairman and CEO of Pfizer, Albert Bourla said: “The recent rise in COVID-19 cases is concerning to all and today’s decision by the FDA to further expand the Emergency Use Authorization of a booster dose of our vaccine is critical to help us ultimately defeat this pandemic.”
Bourla added that Pfizer “continue to believe that broad use of boosters is essential to preserving a high level of protection against this disease and reducing the rate of hospitalisations”.
In 2021, Pfizer/BioNTech successfully fulfilled their target of delivering one billion COVID-19 vaccine doses to low and middle-income countries, with an expected projection to deliver an additional one billion doses to the same countries in 2022.
CEO and co-founder of BioNTech, Ugur Sahin, commented: “The booster vaccination increases the level of immunity and improves protection against COVID-19 across all age groups that have been authorised to receive one.”
Sahin added: “In the current situation, it is important to offer all eligible individuals a booster, particularly against the backdrop of the newly-emerging variants such as Omicron.”