Real-world data shows vaccines kicking the butt – including against the scary variant

A healthcare professional administers a dose of the Pfizer-BioNTech Covid-19 vaccine inside the Viejas Arena on the San Diego State University campus in San Diego, California, USA on Thursday, April 1, 2021.
Extend / A healthcare professional administers a dose of the Pfizer-BioNTech Covid-19 vaccine inside the Viejas Arena on the San Diego State University campus in San Diego, California, USA on Thursday, April 1, 2021.

In a small trial, the Pfizer / BioNtech vaccine completely protected people from the symptomatic COVID-19 caused by the worrying variant of the coronavirus B.1.351 that circulates widely in South Africa, the companies announced in a press release.

Although the researchers need more data to confirm the result, it is just the last positive news to come out this week about vaccine performance in real-world conditions and scenarios.

On Monday, the Centers for Disease Control and Prevention released real-world data showing that the mRNA vaccine from Pfizer / BioNTech and the mRNA vaccine from Moderna were collectively 90 percent effective in preventing infections in healthcare services. fully vaccinated, frontline and essential workers.

On Wednesday, Pfizer and BioNtech announced that their vaccine is highly effective in teenagers aged 12 to 15 – not just in the adult population. And on Thursday, companies announced B.1.351 news as well as new durability data. That is, the most recent monitoring data on people vaccinated in a Phase III trial suggests that the vaccine is still 91 percent effective in preventing symptomatic illnesses up to six months after the second dose. It is a longer effectiveness than previously established, but researchers will still need more data to assess effectiveness beyond six months.

“The main message is that vaccines work very well in the real world scenario,” infectious disease specialist Anthony Fauci said at a COVID-19 press conference at the White House on Friday. “They work against variants, although we need more data to confirm this. They last at least six months and work on teenagers. Very, very good reason for everyone to be vaccinated as soon as it is available to you. “

Strong suggestions

While all the data is good news, the variant data is particularly encouraging. Numerous laboratory experiments have suggested that antibodies produced by vaccines are less potent in repelling some of the variants, particularly B.1.351. But according to new data released by Pfizer and BioNTech, their mRNA vaccine has shown “100 percent effectiveness”.

The claim is based on data from 800 trial participants living in South Africa, where B.1.351 is circulating widely. Among the 800 participants, there were nine cases of COVID-19, all in people who received a placebo. Of these nine cases, genetic analysis found that six of them were caused by variant B.1.351.

The numbers are small, Fauci said at today’s press conference. However, “they showed in the problematic South African variant B.1.351 scenario that there were six cases in the placebo [group] and zero in the vaccinated group, strongly suggesting the effectiveness of the vaccines we are now using against problematic variants. “

However, earlier this week, the National Institutes of Health announced that the National Institute of Allergy and Infectious Diseases (NIAID) started a clinical trial of an adjusted version of the Modern vaccine, which is specifically designed to target variant B.1.351. At the time, Fauci, who is the director of NIAID, said the trial was being made “very cautiously”.

With variant data and durability discoveries, Pfizer and BioNTech are now applying to have the vaccine fully approved by the Food and Drug Administration. Currently, the regulatory agency has only granted an Emergency Use Authorization, which is a classification issued during public health emergencies and ignores the need for the normal amount of data used to guarantee full approval. EUAs expire as soon as the emergency ends.

“This data confirms the favorable efficacy and safety profile of our vaccine and positions us to submit an application for a biological license to the US FDA,” said Pfizer CEO Albert Bourla in the statement. “The high effectiveness of the vaccine seen within six months after a second dose and against the variant prevalent in South Africa provides more confidence in the overall effectiveness of our vaccine.”

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