F.D.A. Releases One other Batch of Johnson & Johnson’s Vaccine

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WASHINGTON – Federal regulators on Friday released a batch of vaccine that could deliver up to 15 million doses of Johnson & Johnson’s one-of-a-kind coronavirus vaccine and decided they would safely distribute it despite production downtime at the factory that ruined 75 million other doses can be.

The move brings the total number of Johnson & Johnson cans manufactured at the Baltimore facility and cleared for distribution in the United States by the Food and Drug Administration to approximately 40 million. However, Johnson & Johnson falls far short of its promise to deliver 100 million cans to the federal government by the end of June. European Union officials said the company missed its delivery targets there too.

The vaccine released on Friday is not yet bottled and the Biden government’s plans for it remain unclear. However, as new coronavirus cases decline and the country floods with vaccines from two other authorized manufacturers, most of the new Johnson & Johnson cans made in the United States are likely to be for export.

Johnson & Johnson has been unable to manufacture much of its vaccine since April when regulators shut down the Emergent BioSolutions-operated Baltimore factory due to serious manufacturing errors. Johnson & Johnson relied on Emergent, its subcontractor, to manufacture vaccines for use in the United States and fulfill its obligations overseas, while the company expanded its own facility in Leiden, the Netherlands.

Even with the newly released batch, Johnson & Johnson remains nearly 40 million doses below the 100 million doses required in its federal treaty. The FDA didn’t reveal the exact number of doses released on Friday, but several people familiar with Emergent’s surgery said the batch was up to 15 million doses.

Also on Friday, European regulators approved the reopening of Johnson & Johnson’s Dutch plant, good news for the company given its delivery problems. “Today’s approval represents a step forward in expanding our global manufacturing network to deliver our Covid-19 vaccine worldwide,” the company said in a statement.

The Baltimore factory is expected to remain closed for at least a few more weeks while Emergent attempts to update it, according to people familiar with the operation who spoke on condition of anonymity. The FDA said in a statement Friday that it is not yet ready to certify that the facility follows proper manufacturing practices.

After discovering in March that Emergent employees had contaminated a batch of Johnson & Johnson’s vaccine with a major ingredient for AstraZeneca’s Covid vaccine, which was manufactured at the same facility, regulators cited Emergent for a number of violations of the law. Emergent was forced to throw away the equivalent of 75 million doses of the Johnson & Johnson vaccine. European authorities have discarded another 17 million doses and South Africa, desperate for vaccines, withdrew two million more doses.

The Biden government also had to stop relying on AstraZeneca cans to deliver on its promise to donate vaccines to poorer nations and trade in supplies from other manufacturers. The FDA has yet to decide whether the equivalent of more than 100 million doses of the Johnson & Johnson and AstraZeneca vaccines manufactured by Emergent are eligible for use.

The FDA carefully reviewed each batch of vaccine from the Emergent facility and checked records of deviations from manufacturing standards against production batches to determine if the batches could be released. In a letter to Johnson & Johnson released late Friday, the agency said the batch it released was eligible for distribution even though the factory was not following proper manufacturing practices at the time of manufacture.

When deliveries of Johnson & Johnson’s vaccine stalled, the Biden government ultimately relied almost entirely on doses from Pfizer-BioNTech and Moderna. As the U.S. pandemic subsided, demand for shots has plummeted. Johnson & Johnson has partnered with pharmaceutical giant Merck to make more cans, but the factory they plan to use is not expected to open until fall.

Although the Johnson & Johnson vaccine was once considered a landmark in the country’s vaccination campaign, state health officials struggled to use up even the limited amount they received that spring. Approximately 12.5 million people in the United States have taken the vaccine, which is just over half of the supply available, and millions of doses are expected to expire by August. State officials said it is still used in doctors’ offices and at smaller events.

Enthusiasm for the Johnson & Johnson vaccine declined in part due to a federally recommended break in use in April after a rare bleeding disorder was discovered in some recipients.

But federal health officials are still hoping that excess doses of Johnson & Johnson’s vaccine will be useful overseas, where vaccine doses are still in dire straits. White House officials said this week that some countries have requested the vaccine because it is easier to store and transport than others, and because some people prefer a one-time treatment. The vaccine has been used in 27 countries so far.

On Thursday, Johnson & Johnson reported that initial results of unpublished studies showed that their vaccine was effective against the highly contagious Delta variant eight months after being vaccinated. That was a reassuring finding for those who got the company’s chance.

The news came after previous data showed that Pfizer and Moderna’s mRNA vaccines were effective against the Delta variant, which is much more contagious than previous variants and is expected to quickly become the dominant version of the virus in the United States. Because the Johnson & Johnson vaccine was slower to introduce, information about its effectiveness against variants also remained behind.