Pfizer and BioNTech said Thursday that studies suggest their vaccine is effective against a variant of coronavirus that first appeared in South Africa. Some experts fear they could dodge existing shots.
The drug makers also said in a statement that 12,000 people involved in their Phase 3 study experienced high levels of protection against Covid-19 six months after their second dose, with no serious safety concerns.
“It is an important step to further validate the potent efficacy and good safety data that we have seen so far,” said Ugur Sahin, CEO and co-founder of BioNTech.
“These data also provide the first clinical results that a vaccine can effectively protect against currently circulating variants. This is a critical factor in achieving herd immunity and ending this pandemic for the world’s population.”
The vaccine developed by the American pharmaceutical giant Pfizer and its German partner BioNTech received an emergency approval from the Food and Drug Administration in December, which is only granted under special circumstances.
Thursday’s study results will allow drug makers to file a full application for a biologics license with 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 submit the data for peer review.
The study enrolled around 44,000 people, some of whom received the vaccine and some received a placebo. There have been 927 symptomatic cases of Covid-19, of which only 77 received the vaccine – an efficacy level of 91.3 percent, according to the statement published in an unaudited press release.
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Only one in 21 severe cases had received the vaccine – indicating 95.3 percent effectiveness, the statement said using the Food and Drug Administration’s definition of severity.
According to the definition of the Centers for Disease Control, there were no severe cases in the vaccinated group, which indicates 100 percent effectiveness against severe diseases.
The CDC reported Monday that both Pfizer and Moderna vaccines are extremely effective in the real world, reducing infections by 90 percent in fully vaccinated people.
The results were the first real data from the US and are in line with similar research from other countries.
The Pfizer BioNTech vaccine has been administered more than 76 million times in the US, more than 69 million by Moderna and 3 million by Johnson & Johnson, according to the CDC.
Part of the experiment took place in South Africa, where a variant called B.1.351 first appeared, which some scientists fear could escape existing vaccines.
According to the latest figures from the CDC, 312 cases of this strain have been identified in the United States.
Six cases of this variant were seen in the Pfizer BioNTech study, but none of them were people who had been given the vaccine – indicating 100 percent effectiveness, it said.
This was welcomed by drug makers as they said in February a lab test suggested their vaccine was producing lower levels of antibodies to this strain.
Although the antibody levels were lower, “this does not seem to affect the high observed effectiveness against this variant,” the statement said on Thursday.
This comes a day after the companies state that their Covid-19 vaccine is safe and effective in teenagers between the ages of 12 and 15.
They plan to apply for an emergency permit for this age in the coming weeks.
Pfizer is also studying how well the vaccine works in children aged 6 months to 11 years. The first doses in this study were given last week.