Why it’s easier to find updated COVID boosters from Pfizer than ours

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.

The wait stems from a plant in Indiana operated by Catalent, one of two companies to package Moderna’s vaccine in the United States.

Following an inspection, the U.S. Food and Drug Administration this month faulted Moderna’s contractor for failing to meet 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 “potential supply restrictions,” Moderna provided additional data to the regulator requesting that 10 batches of its vaccine be removed from the Catalint plant.

The U.S. Food and Drug Administration approved that request on Tuesday. Moderna told the regulator that it intends to “submit similar requests for additional payments on a rolling basis” to release millions of additional doses.

“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.

The Washington Post reported the FDA’s move first.

“We expect these availability limitations to be resolved in the coming days. We remain on track to meet our commitment to deliver 70 million doses of our updated bivalent vaccine by the end of this year,” said Christopher Ridley, a spokesperson for Moderna. a permit.

Delays have resulted in a lopsided roll out of the updated reinforcements since they were officially approved for use on September 1.

Some states have moved to suspend ordering Moderna’s doses, citing delays. Others urged residents not to wait for the Moderna shots.

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,” a HHS spokesperson said. “Pfizer’s updated COVID-19 vaccine is already widely available across the country.”

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 to 15 million doses per week with the potential to increase this exponentially,” said Julia Michele Cohen, a spokeswoman for Pfizer.

Nationwide data on the number of shipped vaccine doses have been released, a Centers for Disease Control and Prevention official said at a webinar hosted by the COVID-19 Vaccine and Equity Project.

Early figures released by the agency last week indicated that vaccines had risen to their highest levels since early May, when the updated boosters came 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 planning documents shared with health departments this week, the Centers for Disease Control and Prevention said it expects to soon remove the divalent shots 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 I’m going to answer now, which might appear, 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 in Virtual event with the National Foundation for Infectious Diseases on Monday.

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

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