December 8, 2022

Vaccine companies across the country are reporting weeks of delays in shipments of updated COVID-19 vaccine boosters from Moderna. The delays come after the Food and Drug Administration indicated there were concerns at a facility contracted to fill Modena’s new shots into vials.

wait stems from Indiana Factory operated by Catalent, one of two companies that bottle Moderna vaccine in the US

after inspection, Food and Drug Administration This month, Moderna’s contractor erred for shortcomings in quality control procedures, and for failing to “comprehensively investigate” batches that were found to be contaminated. Since September 2020, the company has received 179 complaints about impurities in its vials.

An FDA examination has linked an emergency use authorization to all updated doses filled and terminated by Catalent for Moderna.

However, citing “possible supply restrictions”, our moderators provided additional data to the regulator asks for clarification 10 batches of her vaccine from the Catalent factory. Food and Drug Administration granted This request is on Tuesday.

“This authorization was based on the FDA’s decision that the batches meet all applicable specifications, after careful review of the information Moderna provided about the manufacture of these batches. The Agency has no concerns about the safety, efficacy, or quality of these batches,” an FDA spokesperson said. FDA Michael Philberbaum 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 have resulted in a lopsided rollout of updated boosters since their use was officially allowed on September 1.

Some countries have moved to Request comment For Moderna doses, indicating delays. Others urged residents do not wait Our snapshots.

A spokesperson for the Department of Health and Human Services said that 26 million doses of the updated shots have been distributed. Americans are eligible to receive either vaccine “regardless of which initial vaccine they received.”

“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 across the country,” a HHS spokesperson said.

A Pfizer spokesperson said the company had supplied “more than 21 million doses,” which amounts to about 80% of US supplies so far. The company plans to ship “up to 100 million” doses by the end of November.

“Pfizer’s Kalamazoo, MI location alone manufactures 10-15 million doses per week with the potential to increase this exponentially,” said Julia Michele Cohen, a spokeswoman for Pfizer.

A Centers for Disease Control and Prevention official said recently that nationwide data on the number of shipped vaccine doses shipped is expected to be released Thursday. Web Talk Hosted by the COVID-19 Vaccine and Equity Project.

Published early figures from the agency last week Suggested vaccines have risen to their highest levels since early May, as the updated boosters went into effect.

The FDA move also comes as the regulator said it is examining data provided by Moderna as well as Pfizer and its partner BioNTech about updating the booster shots for younger children.

In joint planning documents with health departments .this weekThe Centers for Disease Control and Prevention (CDC) said it expects the bivalent shots to soon be cleared for use “in early to mid-October” for younger age groups.

Moderna shots could be a simpler option for family doctors and pharmacies, given the company’s plans to use the same vials of vaccine as adults for children up to six years old.

“One of the questions that I’m going to answer now, and that might come up, is, when are we going to get these vaccines for the younger kids? And I think we can say, for the age group of five and up, that’s a couple weeks later,” said Dr. Peter Marks of the FDA at Virtual event with the National Foundation for Infectious Diseases on Monday.

“For younger children, it will probably be later this fall to early winter as the data comes in and we can review them,” Marks said.

Source link

Leave a Reply

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