The Food and Drug Administration (FDA) is currently investigating mistakes at a vaccine plant run by Johnson & Johnson partner Emergent BioSolutions that led to 15 million spoiled doses several weeks ago, according to a Wednesday report from The New York Times. The error has resulted in the pausing of shipments of the one-dose vaccine until the FDA investigation is complete. Continuing shipments of the other U.S.-authorized vaccines, two-dose shots from Moderna and Pfizer/BioNTech, should ensure that more than enough doses to meet Biden’s previously-announced goal remain available.
Federal officials reportedly cited human error as the cause of the mistake, which happened at facility in Baltimore, Maryland. The error occurred due to confusion over ingredients used to make the vaccine. Doses of the Johnson & Johnson vaccine that are currently being delivered and used in the U.S. were manufactured in the Netherlands and are unaffected by the mishap. However, tens of millions of vaccine doses that had been expected may now be in doubt.
Johnson & Johnson insists that it will still meet a goal of delivering 100 million doses of the vaccine to the U.S. by the end of May, with 1 billion doses expected globally by the end of the year. The company said in a statement on Wednesday that it had met a goal of delivering enough U.S. doses to vaccinate 20 million people by the end of March. The discovery of the spoiled batch was said to be the result of “quality checks to ensure manufacturing is validated and the end product meets our high-quality standards.”
“This quality control process identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine,” Johnson & Johnson said. “This batch was never advanced to the filling and finishing stages of our manufacturing process. This is an example of the rigorous quality control applied to each batch of drug substance.”
The company added that it would be providing “additional experts in manufacturing, technical operations and quality” to supervise future vaccine production at the Baltimore facility. An additional 24 million doses of the Johnson & Johnson vaccine are expected by the end of April.
An FDA spokesperson told Newsweek that the “FDA is aware of the situation” but declined to comment further. Newsweek reached out to the White House for comment.
Regardless of manufacturing difficulties with the single-dose vaccine, the Moderna and Pfizer/BioNTech vaccines are continuing to be quickly manufactured and distributed. Both companies had delivered more than 90 million doses each as of Wednesday, according to the Centers for Disease Control and Prevention (CDC).
The Biden administration easily met an initial goal of providing at least 100 vaccine doses during the president’s first 100 days office. Last week, Biden said that the new goal was 200 million doses, while directing states to make every adult eligible to receive the vaccine by May 1. The president announced that he expected enough vaccine supplies for all adults by the end of May during a televised address on March 11, the one-year anniversary of the pandemic.
“Now because of all the work we’ve done, we’ll have enough vaccine supply for all adults in America by the end of May,” Biden said. “That’s months ahead of schedule.”
With 30 days left in Biden’s first 100 days, CDC figures indicated that at least 195 million doses of vaccine had already been delivered, with 150 million doses administered. If there are no other major supply-chain issues, the administration will likely meet the goal of providing enough doses for every eligible adult by the end of May.
