August 14, 2022

WASHINGTON – Federal regulators said Friday that millions of doses of Johnson & Johnson’s coronavirus vaccine, made in a troubled Baltimore factory, could not be used, the latest in a series of setbacks for a company whose vaccine is single Once considered crucial to the nation, vaccination campaign was held.

The Food and Drug Administration will continue to allow approximately 10 million doses to be distributed from the factory in the United States or shipped to other countries, provided that regulators cannot guarantee that Emergent BioSolutions, the company that runs the Operates a system that has followed proper manufacture according to information from persons who are familiar with the agency’s decision. About 60 million cans will be unusable because of possible contamination.

The agency has not yet decided whether Emergent can reopen the factory, which closed two months ago due to concerns about cross-contamination with another vaccine manufactured at the same site. According to people familiar with the situation, this verdict can most likely be expected in a few weeks’ time.

All of the 21 million Johnson & Johnson vaccine doses sold in the United States to date have been manufactured at Johnson & Johnson’s plants in the Netherlands, not Emergent. Still, the shot fell in popularity after the government investigated its possible link to a rare coagulation disorder. And state health officials have made an effort over the past few weeks to use Johnson & Johnson cans before they expire.

Regulators have been scrutinizing the Baltimore facility since March when they discovered that a major manufacturing spill had contaminated a batch of Johnson & Johnson vaccines. Emergent later discarded the equivalent of 15 million cans. The New York Times has documented problems at the plant for months, including failure to properly disinfect equipment and protect it from viral and bacterial contamination.

The federal government has agreed to pay Emergent around $ 200 million to make coronavirus vaccines so far, but as of Friday regulators had not approved a single dose made by Emergent for use in the United States.

In a statement, Johnson & Johnson described Friday’s decision as “advancement in our ongoing efforts to make a difference on a global scale in this pandemic.” And Robert G. Kramer, President and CEO of Emergent, said in a statement: “We are delighted that these starting doses of the Johnson & Johnson Covid-19 vaccine will be available to protect millions of people from this deadly disease.”

But both companies had hoped that the FDA would not only agree to release tens of millions of doses, but allow the facility to reopen, according to people familiar with the companies’ operations who refused to be identified because they were not empowered to comment take public.

With the United States now flooded with third-party vaccines, the 60 million doses discarded may have been picked up by other countries that have been asking the United States for weeks to share their surpluses. Johnson & Johnson’s vaccine is used in 24 countries, including Africa.

The FDA’s move brings the total number of cans Johnson & Johnson had to discard due to manufacturing defects to 75 million. The fate of more than 100 million other doses of the Johnson & Johnson and AstraZeneca vaccines manufactured by Emergent has yet to be decided.

The regulators comb through the records to see if they can be safely released. “The agency will keep the public informed of the completion of these reviews,” the FDA said in a statement.

Emergent’s problems have become a serious concern for the Biden government, which had anticipated the export of tens of millions of Johnson & Johnson and AstraZeneca cans produced at the facility. Federal officials cracked down on Emergent in April, disrupting operations, depriving Emergent of responsibility for manufacturing AstraZeneca’s vaccine, and instructing Johnson & Johnson to take control of manufacturing at the site.

Because of Emergent’s troubles, Johnson & Johnson has fallen far behind on its promise to deliver 100 million doses to the US government by the end of June. Johnson & Johnson also experienced a significant setback in April when federal health officials recommended states temporarily stop using their vaccine while the FDA and the Centers for Disease Control and Prevention investigated possible links to a rare blood clotting disorder.

Although officials reversed that recommendation about 10 days later, the hiatus appears to have helped dampen interest in the Johnson & Johnson inclusion. Dr. Rupali J. Limaye, a Johns Hopkins University researcher studying vaccine use, said Emergent’s failures could further diminish public confidence in Johnson & Johnson’s shot and lead to caution with other coronavirus vaccines.

“It’s a great product – it’s safe, effective, and allows us to reach people who are more temporary,” she said. “But that generally undermines trust in the product.”

President Biden announced in late April that the US would send up to 60 million doses of AstraZeneca’s vaccine overseas once FDA approval is received, although the emergent facility has already been scrutinized by regulators. The agency continues to assess the safety of at least 70 million AstraZeneca cans made there, people familiar with the matter said.

After arriving in the UK for the Group of 7 summit this week, Mr Biden announced another donation plan: Pfizer 500 million cans, which the company will sell to approximately 100 countries at cost over the next year. While this is significant, it is still well below the 11 billion doses the World Health Organization claims will be needed worldwide to eradicate the pandemic.

Dr. Luciana Borio, who oversaw public health preparations for the National Security Council under President Donald J. Trump and was acting chief scientist of the FDA under President Barack Obama, said the rejection of the Johnson & Johnson cans should stress the Biden administration Risks of Leaning on Emergent.

“It’s a company we have relied on to make bio-defense products,” she said. “It’s important to go back now and ask what we know about their craftability.”

Experts described the FDA’s plan to approve 10 million doses in the US or abroad, with a warning before manufacturing, as unusual for a product that is only approved for emergency use. The agency has typically taken these measures for fully approved drugs that are in short supply, they said. The agency’s guidelines for emergency-approved vaccines make it clear that regulators expect sites that manufacture shots to use standard manufacturing processes.

In its statement, the FDA said that Emergent Johnson & Johnson doses may only be exported on condition that both companies share how the doses are “under an appropriate confidentiality agreement with regulatory agencies in the countries where the vaccine is available.” were used. “Experts said this was practically a warning from the agency that it was concerned that workers were adhering to proper manufacturing standards.

“The fact that they cannot say for sure that they are okay contributes to the fact that this is not the best,” said Dr. Limaye, the Johns Hopkins vaccine researcher, on Johnson & Johnson vaccination.

The FDA said that before deciding what to do with the Johnson & Johnson cans, regulators “did a thorough review of the facility’s records and the results of quality tests performed.” They also took into account the ongoing public health emergency.

The agency also said it will continue to “solve problems” with Johnson & Johnson and Emergent at the Baltimore facility.

Sheryl Gay Stolberg contributed the reporting.