The United States Food and Drug Administration has reportedly told Johnson & Johnson that the company must scrap around 60 million doses of its one-shot COVID-19 vaccine.
The New York Times reports that the Baltimore plant run by Emergent BioSolutions that was closed in April following an inspection, which suggested possible contamination of J&J vaccines, is responsible for producing the vaccines that will be destroyed. The FDA has said that several batches of the coronavirus vaccine from the plant are not “suitable for use,” although at least at least two batches—which is approximately 10 million doses—have been cleared.
“The FDA has determined several other batches are not suitable for use, but additional batches are still under review and the agency will keep the public informed as those reviews are completed," the FDA said in a statement on the matter, although it did not confirm or deny the 60 million figure as reported by the Times. Despite the setback, it should be noted that the United States still has enough vaccine doses from Pfizer and Moderna to vaccinate the entire population of the country.
10 million doses of the J&J vaccine that were cleared will come with a warning from the FDA, suggesting that it cannot gurantee that the plant followed appropriate manufacturing procedures. “Before making this decision, the FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer,” the FDA added. “While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management.”
The news comes as the Joe Biden administration pledged to donate a total of 500 million doses to other countries around the world. "We’re going to help lead the world out of this pandemic working alongside our global partners," Biden said at the G-7 Summit, which takes place in the Southwest of England. Per the European Medicines Agency, it should be noted that EU authrotities have not approved use of the J&J vaccine in Europe.
