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Moderna publishes information on breakthrough circumstances demonstrating the necessity for third doses

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A healthcare worker fills a syringe with Moderna COVID-19 vaccine at the Giorgio Companies site in Blandon, PA, where the CATE mobile vaccination unit was on site, to deliver Moderna COVID-19 to workers on Wednesday morning April 14, 2021 -To give vaccines.

Ben Hasty | MediaNews Group | Reading Eagle via Getty Images

Moderna published further data on so-called breakthrough cases on Wednesday, which allegedly support the use of Covid-19 vaccine booster vaccinations.

The US drug maker shared a new analysis from its Phase 3 study that showed the incidence of breakthrough Covid cases occurring in fully vaccinated individuals was less common in a group of study participants who were recently vaccinated suggesting immunity had begun to wane for previous groups.

There were 88 identified breakthrough cases in 11,431 people vaccinated between December and March, the company said in a press release, compared to 162 breakthrough cases in 14,746 study participants vaccinated between July and October last year.

There were also less severe cases of Covid-19 cases in the group who received the vaccine recently, according to a manuscript of the results shared by the company. Three Covid-19-related hospitalizations occurred in the group that received the shots early, which data suggests resulted in two deaths. There were no hospital admissions or deaths in the group who recently received the vaccine, although the finding was not statistically significant in severe cases.

“We all know that there is a big debate about whether or not a booster will be necessary in the fall,” Moderna President Stephen Hoge said in a telephone interview. “This debate that makes it really difficult is that it’s not really about whether the vaccine worked last month. It’s really about whether it will work this winter.”

The analysis has not yet been reviewed.

The new data comes two days before an important meeting of the Food and Drug Administration’s Vaccine Advisory Committee, where a panel of external experts will debate whether there is enough data to support the widespread adoption of booster vaccinations in the United States

The group, known as the Agency’s Vaccines and Related Biological Products Advisory Committee, is due to discuss the administration of third doses of Pfizer and BioNTech’s vaccine as federal health officials need more time to approve Moderna’s request for additional doses check.

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

“If you take that number, which is about 28 cases per 1,000 in the newspaper, and you extrapolate that to the 60 million Americans who have received this vaccine in the hospitals, it’s about 600,000, more than half a million cases Covid-19, ”he said.

Earlier Wednesday, FDA scientists declined to take a stance on whether Pfizer should support booster shots of the Covid vaccine, saying U.S. regulators had not reviewed all of the evidence available.

The FDA appears to be skeptical of some of the data provided, including the effectiveness numbers from Israel, where researchers there have published observational studies showing that the Pfizer vaccine’s effectiveness against infections has waned over time.

It sets the stage for a tense meeting on Friday as the Biden government has announced that it will offer booster injections to the public as early as next week pending FDA approval. The move is part of President Joe Biden’s broader plan to confront a higher number of Covid cases fueled by the rapidly spreading Delta variant.

The government has cited three studies published by the Centers for Disease Control and Prevention that showed that vaccines protection against Covid has waned over several months. The White House plan is for people to receive a third dose eight months after the second shot of the Pfizer or Moderna vaccine.

Scientists and other health experts have repeatedly criticized the plan, saying the data cited by federal health officials are non-mandatory and characterize the Biden government’s pressure on boosters as premature.

A leading group of scientists published an article in The Lancet on Monday arguing that no booster vaccination is currently required for the general public. While the Covid vaccine’s effectiveness against minor illnesses may decline over time, protection against serious illnesses appears to persist, the scientists said.

The widespread distribution of booster vaccinations to the general public is currently “not appropriate,” the authors, including two senior FDA officials and several World Health Organization scientists, wrote in the journal.

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