Pfizer CEO Albert Bourla said the company will soon seek full FDA approval and authorization for further age groups for its COVID-19 vaccine.
Speaking during the company’s first-quarter earnings call yesterday, transcribed by The Motley Fool, Bourla outlined the regulatory pathways that the company is pursuing for the vaccine it developed with BioNTech, which is currently available to Americans 16 years of age and older through FDA emergency use authorization (EUA).
Bourla said the company is submitting a Biologics License Application to the FDA in search of full approval for the vaccine in individuals 16 years of age and older and plans to submit for EUA for two cohorts — children between age 2-5 and children between age 5-11 — in September 2021.
The company is awaiting a response from the FDA regarding its application for expanded EUA that would extend the availability of the COVID-19 vaccine to individuals between 12-15 years old as well, Bourla noted.
Institutions such as the U.S. Military, among others, have indicated that they will not consider making vaccinations mandatory until it receives full FDA approval as opposed to the emergency use label. Full approval for the vaccine could result in more mandates and may further convince those who are hesitant about the vaccine that it is not “experimental,” given the potentially full-fledged approval instead of the EUA.
In addition to the regulatory pursuits, Bourla said Pfizer is conducting a number of evaluations for the vaccine, including one for the safety and immunogenicity of a third dose of the existing formulation to understand the effect of a booster on immunity against the COVID-19 variants circulating the world right now.
The company has also begun an evaluation of an updated prototype variant version of the vaccine. Bourla said it encodes the spike protein of the lineage B.1.351 SARS-CoV-2 variant, which includes the mutation E484K, first identified in South Africa. That study is set to establish the regulatory pathway to update the current vaccine in response to any future variant of potential concern, with immunogenicity data for both studies expected in early July.
Pfizer and BioNTech’s pediatric study evaluating the vaccine in children aged six months to 11 years old is currently ongoing, too, with definite readouts expected for the two aforementioned cohorts in September, at which point the companies will seek EUA. The 6-month to 2-year-old cohort’s readout and submission are expected in the fourth quarter, while Pfizer also anticipates presenting Phase 2 safety data from its study of the vaccine in pregnant women by late July/early August.
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Infectious Disease