Pfizer says its Phase 3 clinical trial confirmed COVID-19 vaccine protection lasts at least six months after the second dose and covers emerging variants.
Originally, the company could only guarantee 90 days of protection for vaccinated patients, making six months of protection the best estimate offered to date, according to a Pfizer/BioNTech readout.
"These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the U.S. FDA," Albert Bourla, Pfizer's chairman and CEO, wrote.
A BLA serves as an application for full approval. The vaccine currently only has emergency use authorization, EUA, which falls just shy of full approval.
PFIZER STUDY SHOWS 100% EFFICACY IN ADOLESCENT COVID-19 VACCINATIONS
The announcement follows a previous study released on Wednesday, which showed the Pfizer vaccine has a 100% efficacy in adolescents who receive doses of the shot.
The Pfizer vaccine takes two injections separated weeks apart in order for a recipient to become immunized.
Researchers said the six-month efficacy test conducted on emerging variants of COVID-19 showed promising signs of protection.
"The high vaccine efficacy observed through up to six months following a second dose and against the variant prevalent in South Africa provides further confidence in our vaccine's overall effectiveness," Bourla said.
Pfizer has been studying vaccine testing among more than 46,000 volunteers. The company said out of the volunteers in South Africa, where the B.1.351 lineage is prevalent among 800 participants, nine cases of the virus were observed and came from the placebo group, meaning a "vaccine efficacy of 100%," Pfizer wrote.
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The company said vaccine safety has been evaluated in more than 44,000 participants aged 16 years and older. Over 12,000 vaccinated participants have had at least six months of follow-up checkups after their second dose.
According to Johns Hopkins University data, over 51 million people in the United States have been fully vaccinated, amounting to 15% of the population.