Moderna Releases Groundbreaking Case Data Supporting Need for Third Doses

Moderna on Wednesday released more data on the so-called breakthrough cases that it says is supporting the push for widespread use of booster shots of the Covid-19 vaccine.

The US drug maker shared new analysis from its phase three study that showed the incidence of cases of rupture of Covid, which occur in fully vaccinated people, was less common in a group of trial participants. which were more recently inoculated, suggesting that immunity for the previous groups had started to wane.

There were 88 breakthrough cases identified out of 11,431 people vaccinated between December and March, the company said in a statement, compared to 162 breakthrough cases out of 14,746 participants in trials vaccinated from July through October last year.

There were also fewer severe cases of Covid-19 cases in the group that received the vaccine more recently, according to a results manuscript shared by the company. Three Covid-19-related hospitalizations occurred in the group that received the vaccines early on, resulting in two deaths, the data shows. There have been no hospitalizations or deaths in the group that recently received the vaccine, Moderna chairman Stephen Hoge said in a telephone interview.

“There is a big debate, we all know, about whether or not vaccine boosters will be needed in the fall,” Hoge said. “This debate, what makes it really difficult, is not 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The analysis has not yet been peer reviewed.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 comes two days before a key meeting of the Food and Drug Administration’s Vaccine Advisory Committee, when an external expert panel will debate whether there is enough data to support wide distribution. booster shots across the United States.

The group, known as the agency’s Vaccines and Related Biologics Advisory Committee, is expected to debate the administration of third doses of the vaccine from Pfizer and BioNTech, as federal health regulators say they need more time to review the request for additional Moderna doses.

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

“If you take that number, which in the document is about 28 cases per 1,000 people, and you extrapolate it to the 60 million Americans who have received this vaccine. The additional number of Covid-19 cases that would occur between here and the hospitals are around 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 Pfizer’s Covid vaccine booster shots, saying U.S. regulators had not verified all available evidence.

The FDA appears to be skeptical of some of the data provided, including efficacy figures in Israel, where researchers have published observational studies showing that the effectiveness of the Pfizer vaccine against the infection worsened over time.

That sets the stage for a tense meeting on Friday as the Biden administration said it wanted to start offering booster shots to the general public as early as next week, pending FDA clearance. The move is part of President Joe Biden’s broader plan to deal with a higher number of Covid cases fueled by the fast-spreading delta variant.

The administration cited three studies, published by the Centers for Disease Control and Prevention, which showed that vaccine protection against Covid declined over several months. The administration’s plan calls for people to receive a third dose eight months after receiving their second injection of 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 calling the Biden administration’s recall request premature.

A group of leading scientists published an article in The Lancet on Monday claiming that booster shots are not necessary for the general public at this time. While the effectiveness of the Covid vaccine against mild illness may decline over time, protection against serious illness appears to persist, scientists said.

Large-scale distribution of booster doses to the general public is “not appropriate” at this time, the authors, including two senior FDA officials and several World Health Organization scientists, wrote in the journal .