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Real-world data shows that vaccines are fought, including vaccines against terrible variants



On Thursday, April 1, 2021, a medical worker injects a dose of Pfizer-BioNTech Covid-19 vaccine in the Viejas Arena on the campus of San Diego State University, San Diego, California, USA.
enlarge / On Thursday, April 1, 2021, a medical worker injects a dose of Pfizer-BioNTech Covid-19 vaccine in the Viejas Arena on the campus of San Diego State University, San Diego, California, USA.

In a small trial, the Pfizer/BioNtech vaccine completely protected people from the symptomatic COVID-19 caused by the worrisome mutation of the B.1.351 coronavirus that is widespread in South Africa.

Although researchers will need more data to confirm the results, this is only the latest news this week about how the vaccine performs under real conditions and real-world environments.

On Monday, the Centers for Disease Control and Prevention released real data showing that Pfizer/BioNTech mRNA vaccine and Moderna mRNA vaccine have a combined effective rate of 90% in fully vaccinated health care, frontline and important workers.

On Wednesday, Pfizer and BioNtech announced that their vaccine is very effective in 12 to 15-year-old teenagers, not just adults in the population. And on Thursday, the two companies announced B.1.351 news and new data on durability. In other words, the latest monitoring data on the population vaccinated in the third phase of the trial showed that the vaccine can still effectively prevent symptomatic diseases within six months after the second dose of inoculation, reaching 91%. This is longer than the previously established efficacy, but researchers still need more data to evaluate the efficacy of more than six months.

“The most important message is that the vaccine works very well in the real environment,” Anthony Fauci, a top infectious disease expert, said at the White House COVID-19 press conference on Friday. “Although they need other data to confirm this, they can fight against various variants. They are durable for at least six months and work during adolescence. Everyone can be vaccinated as soon as they get the vaccine, which is very, very interesting. Good reason.”

Strong advice

Although all the data is good news, the variant data is particularly exciting. A large number of laboratory experiments have shown that the antibodies produced by the vaccine are less effective in knocking out certain variants (especially B.1.351). However, according to new data released by Pfizer and BioNTech, their mRNA vaccine shows “100% efficacy.”

This assertion is based on data from 800 test participants in South Africa, which is widely circulated in B.1.351. Among the 800 participants, there were 9 COVID-19 cases, all of which were among patients receiving placebo. Among these 9 cases, genetic analysis found that 6 of them were caused by the B.1.351 variant.

Fauci pointed out at today’s press conference that this number is small.However, “they showed that in the case of the troublesome B.1.351 South African variant, there were 6 cases in the placebo [group] The vaccination group is zero, which strongly indicates the efficacy of the vaccine we are using against the problematic variant. “

However, earlier this week, the National Institutes of Health announced that the National Institute of Allergy and Infectious Diseases (NIAID) has begun clinical trials of the conditioned Moderna vaccine, which is specifically designed for the B.1.351 variant. . At the time, Fauci, the head of NIAID, said that the trial was “out of cautious consideration.”

Armed with mutation data and durability findings, Pfizer and BioNTech are now applying for the vaccine to obtain full approval from the U.S. Food and Drug Administration (FDA). Currently, regulatory agencies have only granted “emergency use authorization”, which is a classification issued in public health emergencies and bypasses the need for normal data volumes to obtain full approval. Once the emergency is over, the EUA will expire.

Pfizer CEO Albert Bourla said in a press release: “These data confirm the good efficacy and safety of our vaccines, and make us eligible to submit a Biologics License application to the US FDA. “The high vaccine efficacy observed for up to six months after the second dose and the variants against the South African epidemic provide further confidence in the overall efficacy of our vaccine.”


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