FDA leans toward authorizing Moderna booster at half dose

Following prior authorization of Pfizer Inc.-BioNtech SE Shot, authorization will set the stage for further broadening of the US booster campaign. About 170 million fully vaccinated people in the US received Moderna or Pfizer shots, or 92% of total vaccinations so far.

People spoke on condition of anonymity ahead of a possible announcement. It is not clear when the announcement will be made.

Shares of Moderna gained 3.6 per cent in morning trading in New York on Wednesday. The stock had fallen in the last three sessions.

Any authority will also offer different dosage levels for the booster. Moderna’s initial vaccination consisted of 100-microgram doses, and submission to the company’s regulators led to a push to authorize a half-dose booster.

For comparison, Pfizer’s shot has a 30-microgram starting dose and a 30-microgram booster. Boosters are still being given with, or are being planned for, the same vaccine that a person initially received, although studies are ongoing about combining vaccines.

Going forward with a dosage of 50 micrograms could reduce the risk of side effects from the booster, and would also allow Moderna to produce more doses globally in the near term. This would ease supply constraints and launch campaigns promoting potential criticism of rich countries before many countries give them a widespread first shot.

Moderna declined to comment Tuesday night. The White House and the FDA declined to comment.

The US is applying boosters to dispel what President Joe Biden’s health advisers have warned are a couple of related trends: signs that vaccine efficacy wanes over months, and that two-dose The rules for the delta version are generally weaker than those of the other iterations. Virus.

The US has dealt with a summer and fall wave of new cases, hospitalizations and deaths, which have spread among unvaccinated people, but at increased exposure to vaccination.

The booster campaign was widely expanded last weekend when Rochelle Valensky, director of the Centers for Disease Control and Prevention, dismissed an advisory panel calling for Pfizer to broaden eligibility for booster shots. The World Health Organization has called for a moratorium on the booster this year, a request the US has ignored.

As of now, only people who have received Pfizer shots are eligible for a booster in the US.” We will continue to evaluate the data as it becomes available in real time and with urgency, and will update our recommendations to ensure that everyone at risk has the protection they need,” Valensky said Tuesday.

The US has donated approximately 160 million shots overseas, and the vast majority were surplus domestic supplies from Moderna. Biden has also announced deals for a total of 1 billion Pfizer shots purchased specifically for charity. Whose shipping started in August and will be delivered by September of 2022.

People said the FDA was seeking information on the effectiveness of the full third dose of the Moderna vaccine, but is now ready to move on and the half-dose booster Moderna has proposed.

Biden, who received his Pfizer booster on Monday, has said it remains an unvaccinated pandemic.

Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, has said he believes Pfizer and Moderna will eventually be considered three-dose vaccines.

As vaccination campaigns expand, the sites administering them will have to add different versions. In addition to potentially adding a half-dose booster, Pfizer is seeking authorization of a vaccine for children ages 5 to 11 that has a 10-microgram dose — a third given the strength of those 12 and up.

Fauci has indicated that progress will soon be made on booster shots for Moderna as well as Johnson & Johnson’s one-dose vaccine. “I believe it will be the week and not the month,” he told NBC’s “Meet the Press” earlier this month.