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Modern releases data on advanced cases supporting the need for third doses

A health worker filled a syringe with the Modern COVID-19 vaccine at the Giorgio Companies site in Blandon, PA where the CATE Mobile Vaccination Unit was on site to administer the COVID-19 Modern Vaccine to workers Wednesday morning, April 14, 2021 .

Ben Hasty | MediaNews Group | Reading Eagle via Getty Images

Mercury has released more data on the so-called advanced cases that say it supports the push for widespread use of Covid-19 vaccine-enhancing vaccines.

The American pharmacist shared a new analysis from his third-phase study that showed the incidence of advanced Covid cases, which occur in fully vaccinated people, was less frequent in a group of participants in the trial who were inoculated. more recently, suggesting immunity for previous groups had begun to fade.

There were 88 discovery cases identified on 11,431 people vaccinated between December and March, the company said in a statement, compared with 162 discovery cases of 14,746 participants in the vaccination process from July to October last year .

There were also fewer severe cases of Covid-19 in the group that received the vaccine more recently, according to a manuscript of the results shared by the company. Three hospitalizations related to Covid-19 were done in the group that had the blows at first, resulting in two deaths, according to the data. There was no hospitalization or death in the group that recently received the vaccination, although the detection of severe cases was not statistically significant.

“There’s a big debate, we all know, over whether vaccine boosters will be needed or not in the fall,” Modern President Stephen Hoge said in a telephone interview. “That debate, what makes it really difficult is that it’s not really about whether the vaccine worked last month. It’s really about whether it works this winter.”

The analysis has not yet been peer-reviewed.

The new data comes two days before a key meeting of the Food and Drug Administration’s vaccine advisory committee, when a panel of external experts will discuss whether there is enough data to broadly support the distribution of booster shots in the United States

The group, called the Agency’s Vaccines and Related Biological Products Advisory Committee, is scheduled to debate the administration of third-dose Pfizer and BioNTech vaccines as federal health regulators say they need more time to review the application of Modern for extra doses.

The data show that “we see a significant increase in the risk of Covid-19 for those who were vaccinated a year ago versus six months ago,” Hoge said.

“If you take that number, that’s on paper it’s about 28 cases per 1,000 people, and you extrapolate that to the 60 million Americans who received that vaccine. The incremental number of cases of Covid-19 that would happen between that and the ‘hospitals have about 600,000, more than half a million cases of Covid-19, “he said.

Earlier Wednesday, FDA scientists declined to take a position on whether to support reinforcements for Pfizer’s Covf vaccine, saying U.S. regulators have not verified all the available evidence.

The FDA appears skeptical about some of the data provided, including numbers of efficacies outside of Israel, where researchers have published observational studies showing the effectiveness of the Pfizer vaccine against infections decreased over time.

It sets the stage for a tense meeting on Friday that the Biden administration said it wants to start offering a boost to the general public starting next week, pending authorization from the FDA. The move is part of President Joe Biden’s broader plan to address a higher number of Covid cases fueled by the rapidly spreading delta variant.

The administration cited three studies, published by the Centers for Disease Control and Prevention, that show that the protection of vaccines against Covid has been diminished for several months. The White House plan calls on people to get a third dose eight months after getting their second shot of the Pfizer or Modern vaccine.

Scientists and other health experts have repeatedly criticized the plan, saying the data cited by federal health officials was unconvincing and that it characterized the Biden administration’s push for boosters as premature.

A leading group of scientists published an article Monday in the journal The Lancet arguing that refreshments are not necessary at this time for the general public. While the effectiveness of Covid vaccination against minor diseases may decline over time, protection against serious diseases seems to persist, scientists say.

The wide distribution of cooling blows to the general public is “not appropriate” at this time, the writers, including two senior FDA officials and several World Health Organization scientists, wrote in the journal.


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