A health worker fills a syringe with the Modern COVID-19 vaccine at the Giorgio Companies site in Blandon, Pennsylvania, where the CATE Mobile Vaccination Unit was located to administer Modern COVID-19 vaccines to workers on Wednesday, April 14, 2021 .
Ben Hasty | MediaNews Group | Reading Eagle via Getty Images
Moderna on Wednesday released more data on alleged advanced cases, it says, that support the push for widespread use of Covid-19 vaccine booster vaccines.
The US drug manufacturer shared a new analysis of its phase three study that showed that the incidence of advanced Covid cases, which occur in fully vaccinated people, was less common in a group of trial participants. which were inoculated more recently, suggesting that immunity had been initiated for earlier groups. diminish.
There were 88 identified advanced cases of 11,431 people vaccinated between December and March, the company said in a statement, compared to 162 advanced cases of 14,746 participants in vaccinated trials from July to October last year.
There were also fewer severe cases of Covid-19 cases in the group that received the vaccine most recently, according to a manuscript of the results shared by the company. According to the data, three Covid-19-related hospitalizations occurred in the group that received the shots at first. There were no hospitalizations or deaths in the group that recently received the vaccine, Moderna president Stephen Hoge said in a telephone interview.
“We all know there’s a big debate about whether or not vaccine boosters will be needed in the fall,” Hoge said. “This debate, what makes it really tough, isn’t really whether the vaccine worked last month. It’s really about whether it will work this winter.”
The analysis has not yet been peer-reviewed.
The new data is presented two days before the key meeting of the Food and Drug Administration’s vaccine advisory committee, when a group of external experts will discuss whether there is enough data to support the wide distribution of shots reinforcement in the US
The group, known as the agency’s Advisory Committee on Vaccines and Related Biological Products, plans to discuss administering third-dose Pfizer and BioNTech vaccine as federal health regulators say they need more time to review the vaccine. Modern application for additional doses.
The data show that “we are seeing a significant increase in the risk of Covid-19 for people vaccinated a year ago compared to six months ago,” Hoge said.
“If you take that number, which in the newspaper represents about 28 cases per 1,000 people, and extrapolate it among the 60 million Americans who have received this vaccine. The incremental number of cases of Covid-19 that would happen in hospitals are about 600,000, more than half a million cases of Covid-19, ”he said.
Earlier Wednesday, FDA scientists declined to take a stand on whether they should support Pfizer’s Covid vaccine booster shots, saying U.S. regulators have not verified all available evidence.
The FDA appears skeptical about some of the data provided, including Israeli efficacy figures, where researchers have published observational studies showing the effectiveness of the Pfizer vaccine against infection decreased over time.
The stage is set for a tense meeting on Friday, as the Biden administration has said it wants to start offering booster shots to the general public as early as next week, pending FDA approval. . The move is part of President Joe Biden’s broader plan to tackle a higher number of Covid cases fueled by the rapidly spreading delta variant.
The administration has cited three studies, published by the Centers for Disease Control and Prevention, that showed that vaccine protection against Covid decreased in several months. The administration’s plan calls for people to take a third dose eight months after getting the second vaccine from the Pfizer or Moderna vaccine.
Scientists and other health experts have repeatedly criticized the plan, saying the data cited by federal health officials was unconvincing and characterized the Biden administration’s push toward proponents.
A leading group of scientists published a diary in The Lancet on Monday arguing that no reinforcement shots are needed at this time for the general public. While the effectiveness of the Covid vaccine against mild diseases may decrease over time, protection against serious diseases seems to persist, scientists said.
The wide distribution of booster shots to the general public “is not adequate” at this time, the authors wrote in the journal, including two senior FDA officials and several World Health Organization scientists.