Pfizer and its partner BioNTech have submitted the initial data of an early-stage trial to the US Food and Drug Administration (FDA) to support the authorisation of a booster dose of their Covid-19 vaccine.
The latest move follows the recent authorisation of a third dose of Covid-19 vaccines by Pfizer -BioNTech and Moderna for people with compromised immune systems.
The companies have submitted the data from the first phase of a three-part clinical trial programme, which will evaluate the tolerability, immunogenicity and safety of the booster dose in adult subjects who received their first two doses as part of their earlier trial of the two-dose series.
The data showed that the third dose elicited significantly high neutralising antibodies against the initial SARS-CoV-2 virus compared to the first two doses as well as against the Beta and the Delta variants.
In the coming weeks, Pfizer and BioNTech will also submit the data to the European Medicines Agency (EMA) as well as other regulatory authorities.
Pfizer chairman and CEO Albert Bourla said: “Vaccination is our most effective means of preventing COVID-19 infection – especially severe disease and hospitalization – and its profound impact on protecting lives is indisputable.
“Still, with the continuing threat of the Delta variant and possible emergence of other variants in the future, we must remain vigilant against this highly contagious virus.
“The data we’ve seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule.”
The data of Phase 3 evaluating the third dose are expected shortly and will be submitted to the FDA along with the EMA and other regulatory authorities across the world.
The companies are planning to seek licensure of the third dose of their Covid-19 vaccine in the US through a supplemental Biologics License Application (BLA) in individuals aged 16 years and above.