Last month, the US regulator has expanded the EUA for a booster dose of the vaccine to include people aged 18 years and above, who received the primary dose, even with a different vaccine
Pfizer-BioNTech Covid-19 vaccine. (Credit: Jan Felix Christiansen from Pixabay.)
Pfizer and BioNTech announced that the US Food and Drug Administration (FDA) has expanded the emergency use authorisation (EUA) for a booster dose of their Covid-19 vaccine to include people aged 16 and 17 years.
A booster dose of the Pfizer-BioNTech Covid-19 vaccine, also called Comirnaty, was previously authorised in the US for emergency use in certain populations.
It was indicated for people aged 65 years and above, and people aged 18-64 years, at high risk of severe Covid-19, along with serious complications.
Last month, the US regulator has expanded the EUA for a booster dose of the vaccine to include people aged 18 years and above, who received the primary dose, even with a different vaccine.
The current expanded EUA allows for the administration of a booster dose six months after the primary vaccination, with the same formulation and dosage strength as in the primary series.
Pfizer claimed that it is the first FDA EUA for a Covid-19 booster dose in individuals aged 16 years and older.
Pfizer chairman and CEO Albert Bourla said: “Today’s decision by the FDA to further expand the Emergency Use Authorisation of a booster dose of our Covid-19 vaccine is a critical milestone as we continue to stay vigilant in addressing the virus.
“From the beginning, we aimed to provide strong, safe protection to as many people as possible in an effort to end this pandemic.
“While new variants, including Omicron, emerge across the globe, we believe that the best way to minimize the spread of Covid-19 and any future variants is getting all eligible people fully vaccinated with the first two-dose series and a booster dose as recommended.”
FDA stated that the expanded authorisation in this age group was based on its previous analysis of the data on the use of a booster dose in individuals 18 years of age and older.
The analysis included immune response data from around 200 participants, aged 18 to 55 years, who received a Comirnaty booster dose, six months after the primary vaccination.
In the analysis, a Comirnaty booster dose triggered superior antibody responses against the SARS-CoV-2 virus after one month, compared to that of the two-dose primary vaccination.
Pfizer and BioNTech are planning to submit a supplemental Biologics License Application (sBLA) for regulatory approval of the booster dose in 16 and 17-year-olds.
The sBLA will include efficacy and safety data from a Phase 3 trial, in which a 30µg booster dose showed 95% relative vaccine efficacy in people 16 years and above.
BioNTech co-founder and CEO Ugur Sahin said: “The booster vaccination increases the level of immunity and dramatically improves protection against Covid-19 in all age groups studied so far.
“In the current situation, it is important to offer everyone a booster, particularly against the background of the newly-emerging variants such as Omicron.”
Pfizer and BioNTech have recently announced that three doses of their Covid-19 vaccine neutralise the newly circulating SARS-CoV-2 variant Omicron.
The effectiveness of the vaccine was established in an initial laboratory study, in which the serum antibodies induced one month after the booster dose neutralised the Omicron variant.