Pfizer and BioNTech are set to submit an application to the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA) of their mRNA vaccine candidate, BNT162b2, against Covid-19.
The latest development is backed by the companies’ recently concluded Phase III study of BNT162b2, which showed 95% efficacy rate and met all primary efficacy endpoints.
The trial data showed that the vaccine had an efficacy rate of 95% in participants without prior infection, which was the first primary objective, in each case after seven days of administering the second vaccine dose.
It also met the second objective, with the vaccine showing similar efficacy rate in participants with and without prior infection.
Solicited and unsolicited safety data from about 8,000 adults and 38,000 participants, respectively, who were followed up two months after the receiving second vaccine dose, also supported the submission.
It also includes solicited safety data on approximately 100 children aged between 12 and 15 years.
So far, no serious safety concerns related to the vaccine have been reported by the study’s data monitoring committee (DMC).
The EUA will enable the vaccine use in high-risk populations in the US by the middle to end of December.
Pfizer chairman and CEO Dr Albert Bourla said: “Filing in the US represents a critical milestone in our journey to deliver a Covid-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential.
“We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.”
In addition, Pfizer and BioNTech began rolling submissions with several regulatory agencies around the world.
The companies anticipate supplying up to 50 million doses of the vaccine this year and up to 1.3 billion doses by the end of next year.