Pfizer and BioNTech said on Thursday that trials have shown that their vaccine is effective against the first coronavirus variant in South Africa, and some experts worry that this variant may avoid existing vaccines.
The drug manufacturer also stated in a statement that the 12,000 people who participated in their phase 3 trial experienced a high level of protection against Covid-19 six months after the second dose without serious safety risks.
Ugur Sahin, CEO and co-founder of BioNTech, said: “This is an important step to further confirm the powerful efficacy and good safety data seen so far.”
These data also provide the first clinical result, that the vaccine can effectively defend against the currently spreading variant, which is a key factor in achieving herd immunity and ending the global pandemic. “
The vaccine developed by the US pharmaceutical giant Pfizer and its German partner BioNTech received emergency use authorization from the U.S. Food and Drug Administration (FDA) in December and can only be approved under special circumstances.
Pfizer Chairman and CEO Albert Bourla said in a statement that Thursday’s test results will enable drugmakers to submit a complete “Biologics License” application to the FDA. They also plan to share the results with regulators around the world and submit the data for peer review.
The study included about 44,000 people, some of whom were vaccinated, and some were placebos. The statement issued by the non-peer-reviewed press release stated that there were a total of 927 symptomatic Covid-19 cases, of which only 77 were vaccinated-an efficacy of 91.3%.
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The statement said that using the US Food and Drug Administration’s definition of severity, only one vaccine was vaccinated in 21 serious cases, indicating an efficacy of 95.3%.
It said that according to the definition of the Centers for Disease Control, there were no serious cases in the vaccination group, indicating a 100% curative effect on serious diseases.
The CDC reported on Monday that both Pfizer and Moderna vaccines are very effective in the real world, reducing the infection rate of fully vaccinated people by 90%.
These findings are the first real-world data from the United States and are consistent with similar studies from other countries.
Data from the Centers for Disease Control and Prevention (CDC) show that Pfizer-BioNTech vaccines have been administered more than 76 million times in the United States, surpassing Moderna’s 69 million times and Johnson & Johnson’s 3 million times.
Part of the experiment was carried out in South Africa, where a variant first appeared, namely B.1.351. Some scientists worry that this variant may be able to escape the existing vaccine.
According to the latest data from the US Centers for Disease Control and Prevention (CDC), 312 cases of this strain have been confirmed in the United States.
Pfizer observed six cases of this mutation in the BioNTech company’s trial, but no one had been vaccinated with the vaccine, and its efficacy was 100%.
The drugmakers welcomed this because in February they said that laboratory tests showed that their vaccines produced low levels of antibodies against this strain.
The statement said that despite the low antibody level, it “does not seem to affect the high efficacy observed against the variant.”
The two companies stated that their Covid-19 vaccine is safe and effective in 12 to 15-year-old teenagers, and this is a day away.
They plan to apply for emergency use authorization for users of these age groups in the next few weeks.
Pfizer is also studying how effective the vaccine is in children between 6 months and 11 years of age. The first dose of the trial was taken last week.