Pfizer COVID-19 Vaccine Protects and Effective for 6 Months
The COVID-19 vaccine developed by Pfizer and BioNTech remains highly protective against the novel coronavirus for at least six months after the second dose, the companies announced Thursday (April 1).
Pfizer and BioNTech said Thursday that trials suggest that their vaccine is effective against a coronavirus variant that first emerged in South Africa, which some experts worry might evade existing shots.
The drugmakers also said in a statement that 12,000 people involved in their Phase 3 trial experienced high levels of protection against Covid-19 six months after their second doses, with no serious safety concerns.
"It is an important step to further confirm the strong efficacy and good safety data we have seen so far," BioNTech CEO Uğur Şahin said.
"These data also provide the first clinical results that a vaccine can effectively protect against currently circulating variants, a critical factor to reach herd immunity and end this pandemic for the global population," he said.
The vaccine, developed by the American pharmaceutical giant Pfizer and its German partner, BioNTech, received emergency use authorization in December from the Food and Drug Administration, which is granted only in special circumstances.
Thursday's trial results will allow the drugmakers to submit a full Biologics License Application to the FDA, Pfizer Chairman and CEO Albert Bourla said in the statement. They also plan to share the results with regulators around the world and to submit the data for peer review.
This analysis, based on an ongoing trial of more than 44,000 volunteers, included 800 participants in South Africa, where a coronavirus variant with some ability to evade antibodies, called B.1.351, is causing the majority of new cases. Nevertheless, the vaccine still appeared highly protective against this variant, according to a statement from Pfizer.
Supporting this trial data, laboratory studies of vaccinated individuals' blood also showed that the shot induces a robust neutralizing antibody response against B.1.351, according to a report published March 8 in The New England Journal of Medicine.
"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," Pfizer chairman and chief executive officer Albert Bourla said in the statement.
The vaccine has now been evaluated in more than 44,000 participants ages 16 years and older, and more than 12,000 vaccinated participants have now had at least six months of follow-up after their second dose. The companies plan to submit these data for publication in a scientific journal "in the near future."
Thursday's trial results will allow the drugmakers to submit a full Biologics License Application to the FDA, Pfizer Chairman and CEO Albert Bourla said in the statement. They also plan to share the results with regulators around the world and to submit the data for peer review.
The CDC reported Monday that both the Pfizer and the Moderna vaccines are extremely effective in the real world, reducing infections by 90 percent in fully vaccinated people.
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