June 7, 2023


Vaccinators across the country are reporting weeks of delays in shipments of Moderna’s updated COVID-19 vaccine booster. The delay came after the U.S. Food and Drug Administration raised concerns about a facility contracted to fill Moderna’s new injections into vials.

wait comes from Indiana A plant operated by Catalent, one of two companies in the U.S. to bottle Moderna’s vaccine

After inspection, Food and Drug Administration This month, Moderna contractors accused its quality control procedures of inadequate quality control procedures and a failure to “thoroughly investigate” the contaminated batches. Since September 2020, the company has received 179 complaints about impurities in its vials.

FDA inspections have tied together emergency use authorizations for all updated doses that Catalent filled and completed for Moderna.

However, Moderna submitted additional data to regulators, citing “potential supply constraints” request to clear 10 batches of vaccine from the Catalent facility.U.S. Food and Drug Administration indeed That request on Tuesday.

“This authorization is based on FDA’s determination that the batches met all applicable specifications, after careful review of the information provided by Moderna regarding the manufacture of these batches. The agency has no concerns about the safety, efficacy or quality of these batches,” an FDA spokesperson said. Michael Felberbaum said in a statement.

News of the FDA’s move was first reported by Washington post.

Moderna did not respond to multiple requests for comment.

Delays lead to uneven rollout of updated boosters as they are officially approved for use September 1.

some states have moved to order suspension For Moderna doses, citations are delayed.Others urged residents don’t wait Shots for Moderna.

A spokesman for the Department of Health and Human Services said 26 million doses of the updated vaccine have been distributed. Americans are eligible for either vaccine “regardless of the primary vaccine they receive.”

“We expect Moderna’s supply to continue to increase in the coming days and weeks. Pfizer’s updated COVID-19 vaccine is already widely available nationwide,” an HHS spokesperson said.

A Pfizer spokesman said the company has supplied “more than 21 million doses,” which so far equates to about 80 percent of the U.S. supply. The company plans to ship “as many as 100 million doses” of the vaccine by the end of November.

“Pfizer’s Kalamazoo, Michigan facility alone is currently producing 10-15 million doses of vaccine per week and has the capacity to significantly increase that number,” said Pfizer spokeswoman Julia Michelle Cohen.

A Centers for Disease Control and Prevention official said at a recent meeting that data on how many doses of the vaccine have been shipped nationwide is expected on Thursday. Internet Conference Hosted by the COVID-19 Vaccine and Equity Project.

Early data released by the agency last week The recommended vaccination dose climbed to its highest level since early May as newer boosters began rolling out.

The FDA action comes as the regulator said it is reviewing data submitted by Moderna, along with Pfizer and its partner BioNTech, to update booster shots for younger children.

In planning documents shared with the health department this weekthe CDC said the bivalent injectables are expected to be cleared soon, making them available to young adults “in early to mid-October.”

Moderna’s vaccine could be an easier option for family doctors and pharmacies, as the company plans to use the same vaccine vials for children under 6 as adults.

“One of the questions I’m going to answer now is probably, when can we get these vaccines for younger kids? I think we can say, for kids 5 and older, it’s a few weeks away,” the FDA said. Dr. Peter Marks speaks at virtual event with National Foundation for Infectious Diseases on Monday.

“For the youngest, maybe later this fall into early winter, as the data comes in, we can review it,” Marks said.





Source link

Leave a Reply

Your email address will not be published. Required fields are marked *