The new updated COVID-19 vaccines are designed to protect against the dominant version of Omicron in the United States and around the world.
Watch as White House COVID-19 Response Coordinator Dr. Jha explains why everyone should receive an updated COVID vaccine this fall: pic.twitter.com/qJVYrsFuih
– The White House (@Casa Bianca) September 16, 2022
The FDA inspection focused on manufacturing issues at a facility in Bloomington, Indiana, operated by Catalent, which is helping bottle and package Moderna’s vaccine. Inspectors last month began raising concerns that the facility was not sufficiently sterile and started check if the vials are packaged they may have been contaminated, as part of routine safety reviews, people familiar with the inspection said. FDA inspectors concluded that there were no problems with Moderna’s vaccine and that the agency will soon release more than 10 million doses which had been detained.
“On Tuesday, the FDA cleared the distribution of several batches of the updated Moderna COVID-19 vaccine, a bivalent booster manufactured at the Catalent facility,” FDA spokesman Michael Felberbaum said in a statement. “This authorization was based on the FDA’s determination that the batches met all applicable specifications, following a careful review of the information provided by Moderna on the production of these batches. The agency has no concerns about the safety, efficacy or quality of these batches. “
FDA inspectors found no safety concerns at a second facility, operated by Thermo Fisher Scientific, which is also working to help finish Moderna’s vaccines for distribution in the United States, officials said.
In a statement, Moderna said it was “working closely” with the government to provide additional doses of its bivalent booster shots – which include components targeting the latest sub-variants and the original virus identified in China that has long since disappeared – including “strong demand” in some parts of the country.
“We expect these availability constraints to be resolved in the coming days,” said spokesperson Chris Ridley. “We continue to be on track to meet our committed delivery of 70 million doses of our upgraded bivalent vaccine by the end of this year.”
The FDA on Aug.31 cleared new omicron-targeted coronavirus booster shots from Moderna and Pfizer, with experts saying the shots should improve protection against serious illness and death during a potential increase in covid-19 cases this fall. is winter. But suppliers across the country have been reporting Moderna shortages in recent weeks, prompting state officials to encourage consumers to seek the alternative.
“If your provider is waiting for booster doses of Moderna Omicron, there is a lot of Pfizer,” Don Herrington, acting director of the Arizona Department of Health Services wrote in a blog post on Monday. Herrington said federal officials warned the supply problems would be resolved “in about two weeks.”
FDA officials first became aware of potential safety concerns at the Catalent facility in late August, even as the agency was preparing to authorize the new boosters, three people aware of the inspection said they have spoke on condition of anonymity because they were not authorized to comment. Biden officials avoided publicly commenting on the delays in Moderna’s recall until the safety inspection is complete, amid concerns of undermining the confidence of the vaccine, people said.
According to the FDA, the agency initially did not include the Catalent facility when it cleared the booster shots due to the ongoing safety inspection.
Chris Halling, a spokesperson for Catalent, said in a statement Tuesday evening, “A recent FDA inspection at our Bloomington facility has led to observations that Catalent is already addressing as it seeks to continually improve its operations. Production in the plant continued without interruption ”.
In interviews this month, Biden officials said the Moderna heist heist would not significantly limit short-term supply for the recall campaign, as they had already planned to rely on Pfizer-produced hits and from its German partner, BioNTech. The administration this year ordered more than double the doses from Pfizer-BioNTech than Moderna for the recall campaign.
It is unclear whether some patients prefer Moderna shots, said Marcus Plescia, medical director of the Association of State and Territory Health Officers. “There appears to be adequate supplies from Pfizer to meet current demand,” added Plescia, although he said he was still collecting information from state officials.
The FDA inspection was another breakthrough in the vaccine manufacturing process, a problem that occurs quite frequently in the pharmaceutical industry. Problems at a Baltimore facility run by Emergent, another contract manufacturer, stopped production of the Johnson & Johnson coronavirus vaccine last year and prompted government officials to discard millions of doses. The Catalent plant in Indiana was also criticized by FDA inspectors in a 2018 inspection that found problems with quality control.
Public health experts have also expressed concern that Biden’s remark in “60 Minutes,” which aired Sunday, could be another factor dampening enthusiasm for the recall campaign. While the president acknowledged that the nation “stands still [has] a problem with covid, “his claim that the pandemic is over was amply amplified, including by Republicans who asked why the White House continues to promote vaccination campaigns if the threat has receded.
“It was already an uphill battle,” said Jennifer Kates, who leads global health policy for the Kaiser Family Foundation, a non-partisan think tank. “There is still confusion in the messages. People are unclear if they should get a new booster, when they should get it … [it’s] a very difficult landscape in an attempt to help the public understand that these vaccines are safe and effective ”.
Kates said she ran into Moderna shortage recently when she went for a booster. “If there are people who have a preference, that’s a wrinkle for them,” she said.
The White House said Tuesday Biden’s comments on “60 Minutes” were consistent with the administration’s position that covid deaths and serious illnesses have decreased and can be further reduced with vaccination.
“We know the tools available to combat covid,” White House press secretary Karine Jean-Pierre said in a briefing Tuesday.