The US regulator authorised the third dose of Comirnaty based on review by its Vaccines and Related Biological Products Advisory Committee (VRBPAC)
Comirnaty booster dose authorised in US. (Credit: pearson0612 from Pixabay.)
The US Food and Drug Administration (FDA) has authorised a booster dose of Pfizer-BioNTech Covid-19 Vaccine (Comirnaty) for emergency use in certain populations.
FDA indicated the third dose vaccine for people aged 65 years and above, and people aged 18-64 years, at high risk of severe Covid-19, along with serious complications.
Comirnaty booster dose is authorised to be administered at least six months after completion of the primary series, with the same formulation and dosage strength as the primary series.
The US health regulator previously authorised a third dose of the vaccine for individuals aged 12 years and above, who has undergone organ transplant, or immunocompromised.
Its current EUA is based on the scientific evidence shared by the companies and reviewed by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC).
It includes data from Pfizer-BioNTech’s clinical trial programme that assessed the safety, tolerability and immunogenicity of a booster dose of the Covid-19 vaccine.
In the study, the third dose triggered higher levels of neutralising antibody titers against the SARS-CoV-2 virus, along with the Beta and Delta variants, compared to the initial two doses, said Pfizer.
Its reactogenicity profile was typically mild to moderate within seven days, and the adverse event profile was generally consistent with other clinical safety data.
Pfizer chairman and CEO Albert Bourla said: “This first FDA authorisation of a Covid-19 vaccine booster is a critical milestone in the ongoing fight against this disease.
“Over the last year and a half, we have aimed to stay vigilant as the pandemic has evolved – including evaluating the impact of a booster dose.
“We believe boosters have an important role to play in addressing the continued threat of this disease, alongside efforts to increase global access and uptake among the unvaccinated.
“Today’s FDA action is an important step in helping the most vulnerable among us remain protected from Covid-19.”
In a separate development, Pfizer and BioNTech are set to expand their agreement with the US government by providing an additional 500 million doses of the Covid-19 vaccine.
The companies will provide the additional doses at a not-for-profit price for donation to low- and lower-middle-income countries, and their supportive organisations.
With the expanded agreement, Pfizer and BioNTech’s total number of vaccine doses to be supplied to the US government reach one billion.
In line with the initial agreement, the US government intends to allocate the Covid-19 Vaccine doses to 92 low- and lower-middle-income countries.
The additional doses of the vaccine are planned to be manufactured at Pfizer’s facilities located in Kalamazoo, Michigan, Andover, Massachusetts, Chesterfield, Missouri, and McPherson, Kansas.
BioNTech CEO and co-founder Ugur Sahin said: “BioNTech, Pfizer and our partners are working day and night to make our vaccine available to people around the world.
“We are therefore particularly excited and grateful to mark the next milestone in collaboration with the US government, which will further accelerate the delivery of our vaccine to people in the poorest regions.
“In the short term, we have pledged to deliver at least one billion doses this year and at least one billion doses next year to low- and middle-income countries.
“In parallel, we are exploring how to build a sustainable mRNA production infrastructure in low-income countries to democratise access to vaccines in the mid- and long-term. This applies to both individual production steps and complete manufacturing.”