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Moderna released data on breakthrough cases supporting the need for a third dose

Healthcare workers syringe the Moderna COVID-19 vaccine at the Giorgio Companies site in Brandon, PA, on Wednesday morning, April 14, 2021, in order for the CATE Mobile Vaccination Unit to administer the Moderna COVID-19 vaccine to workers onsite. Fill.

Ben Hasty | Media News Group | Read Eagle at Getty Images

Moderna released more data on so-called breakthrough cases on Wednesday, stating that it supports the promotion of widespread use of Covid-19 vaccine booster shots.

U.S. pharmaceutical companies have found that the incidence of breakthrough Covid cases in fully vaccinated people is less frequent in the group of recently vaccinated study participants, and immunization in the previous group has begun. We shared a new analysis from a Phase 3 study that suggests waning.

The company found that 11,431 people were vaccinated between December and March, compared to 162 breakthrough cases out of 14,746 study participants who were vaccinated between July and October last year. It was announced that 88 breakthrough cases were identified.

According to the results manuscript shared by the company, there were fewer severe cases of Covid-19 in the recently vaccinated group. Data show that three Covid-19-related hospitalizations occurred in the group that fired early, killing two. In a telephone interview, Modana president Stephen Hogue said the recently vaccinated group had not been hospitalized or died.

“Everyone knows if we need a vaccine booster in the fall, but there’s a lot of debate,” Hooge said. “The argument, the real challenge, is not whether the vaccine worked last month, but whether it works this winter.”

The analysis has not yet been peer reviewed.

The new data will be provided two days prior to the meeting of the Vaccine Advisory Board of the major Food and Drug Administrations. At this meeting, a panel of outside experts will discuss whether there is sufficient data to distribute booster shots widely throughout the United States.

The group, known as the Agency’s Vaccine and Related Biopharmaceutical Advisory Board, said Pfizer and BioNTech said more time would be needed for federal health regulators to consider applying for additional doses of Modana. We will discuss the third dose of the vaccine.

The data “confirm that people who were vaccinated a year ago have a significantly increased risk of Covid-19 compared to six months ago,” Hooge said.

“Taking this number, the treatise estimates that it’s about 28 cases per 1,000 people, and that’s estimated for all 60 million Americans who received the vaccine. Here and in hospitals, there are about 600,000 cases, 500,000 cases. The above Covid-19 has occurred. “

Last Wednesday, FDA scientists refused to take a position on whether to support Pfizer’s Covid vaccine booster shot, saying U.S. regulators haven’t examined all available evidence. Stated.

The FDA seems skeptical of some of the data provided, including validity figures from Israel. Researchers there have published observational studies showing that the effectiveness of the Pfizer vaccine against infection has diminished over time.

The Biden administration has said it wants to wait for FDA approval and start offering booster shots as early as next week, so it’s ready for a tense meeting on Friday. This move is part of President Joe Biden’s broader plan to confront more Covid cases fueled by the rapidly expanding Delta variant.

The government cited three studies published by the Centers for Disease Control and Prevention that showed that vaccine protection against Covid was reduced over the course of several months. Government plans require a third dose of Pfizer or Moderna vaccines eight months after the second dose.

Scientists and other health experts have repeatedly criticized the plan, saying the data quoted by federal health officials are unconvincing and characterize the Biden administration’s promotion of boosters prematurely.

A major group of scientists published a treatise in the journal The Lancet on Monday, arguing that booster shots are not needed by the general public at this time. Scientists say that the effectiveness of the Covid vaccine against mild illness may decline over time, but protection against severe illness seems to be persistent.

At this time, widespread distribution of booster shots to the general public is “inappropriate,” the author wrote in the journal, including two FDA officials and several scientists from the World Health Organization.

Moderna released data on breakthrough cases supporting the need for a third dose

Source link Moderna released data on breakthrough cases supporting the need for a third dose

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