Federal regulators will allow Emergent BioSolutions to resume production of the Johnson & Johnson COVID-19 vaccine after critical production errors halted activity three months ago, officials said Thursday.
The U.S. Food and Drug Administration ordered the plant to pause production of the vaccine in April after ingredient mix-ups ruined 75 million doses. The FDA’s review of the plant found problems with cross-contamination and mismanagement. About 50 million doses produced at the factory were salvaged, an Emergent spokesman said.
The green light from the FDA is just the first step in the plant’s return. The vaccines produced still must receive authorization from the agency to be released to the public.
“The American people should have high expectations of the partners its government chooses to help prepare them for disaster, and we have even higher expectations of ourselves,” Emergent CEO Robert Kramer said. “We have fallen short of those lofty ambitions over the past few months but resumption of manufacturing is a key milestone and we are grateful for the opportunity to help bring this pandemic to an end.”
An FDA spokesperson said the agency “was not opposed” to the facility resuming production of Johnson & Johnson’s COVID-19 vaccine after conducting a limited investigation there earlier this week. The inspection aimed to verify the progress made toward improving conditions and tightening up procedures at the East Baltimore facility since April.
“The vaccine substance being manufactured at this plant will not be distributed until the FDA confirms the plant’s conditions meet the FDA’s rigorous standards for safety, effectiveness and manufacturing quality,” the spokesperson said in a statement.
Johnson & Johnson confirmed it would restart production at the plant and said the company would work toward earning emergency use authorization from the federal government “as quickly as possible.”
A study released this month found that the single-dose Johnson & Johnson vaccine could be less effective against the rapidly spreading delta variant of COVID-19 than mRNA vaccines such as those created by Pfizer/BioNTech and Moderna. That study conflicted with earlier, smaller studies released by the company, which indicated a single shot remained effective against the variant about eight months post-vaccination.
In a statement released July 1, Johnson & Johnson said the single-dose vaccine held up against the delta variant at even higher levels than what was observed against the beta variant, which was first discovered in South Africa.
Only a small portion of what’s been administered in the U.S. so far has been the Johnson & Johnson vaccine, but it remains a key part of the global vaccination campaign, given that inoculations are scarce in many parts of the world, and variants are presenting a new threat.
Dr. Kawsar Talaat, associate professor in the department of international health at the Johns Hopkins Bloomberg School of Public Health, said Johnson & Johnson will have a role to play in both the domestic and global vaccine market.
“For some people it’s still a good option or the best option,” said Talaat, adding that people who are fearful of needles, who live in remote areas or who live in transient conditions may benefit greatly from a one-dose regimen. “Worldwide, we are so short of vaccine doses and so few vaccines have been given, especially in low- and- middle-income countries.”
Less than 15% of the global population has been fully vaccinated, and less than a third of the world has gotten one dose of vaccine, Talaat said.
Data shows only about 13.3 million of the more than 340 million doses injected in the U.S. were Johnson & Johnson. The majority were Pfizer/BioNTech doses, which are authorized to be used in children aged 12 and up, followed by Moderna, which is available for the 18 and older population.
The resumption of Johnson & Johnson production may come as a relief for some countries fighting to contain the more contagious delta variant, which may account for as many as 83% of all COVID-19 cases in the U.S, according to the latest data from the U.S. Centers for Disease Control and Prevention. It was first discovered in India, where a deadly surge caused more than 200 million infections.
More batches of J&J and AstraZeneca vaccines made at the facility could be cleared for use and add tens of million more doses into circulation, The Wall Street Journal and others reported Thursday. AstraZeneca has not yet been authorized for use in the U.S.
The CDC updated its guidelines Tuesday to encourage people to resume wearing masks indoors in areas with high or substantial transmission, even among those already fully vaccinated. The agency continued to strongly encourage vaccinations among those who have not yet received them.
“All of these vaccines prevent hospitalization and death in almost everybody who gets them,” Talaat said. “The important thing is we get as many vaccines in as many people as possible.”
The troubles at the plant, built with millions of dollars in federal funds to address the nation’s emergency vaccine needs, sent Emergent BioSolutions stock price into a tailspin. Its shares, which closed over $125 each in February, have fallen since, closing Thursday at $65.22, up just 9 cents for the day.