FDA authorizes about 10M J&J vaccine doses, trashes 60M more from troubled Emergent plant
The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.
The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.
“This review has been taking place while Emergent BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with the FDA’s current good manufacturing practice requirements,” said CBER director Peter Marks.
Emergent previously ruined 15 million doses of J&J’s Covid-19 vaccine in March due to the cross-contamination with the AstraZeneca vaccine, which was previously made at the same Baltimore site. In April, Emergent slammed the brakes on all production there, at the FDA’s behest, and J&J took control of the plant.
Now, the 10 million doses that are OK to be used may also be exported, but the FDA said Friday that will come with conditions. For instance, for any export of these two batches OKed for use, or of vaccine manufactured from these batches, J&J and Emergent agreed that the FDA may share relevant information, under an appropriate confidentiality agreement, with the regulatory authorities of the countries in which the vaccine may be used.
Additional batches are still under review, FDA said, but the agency declined to say how many or even how many doses are in one batch. The New York Times first reported on Friday that the FDA would not allow the use of the 60 million doses. J&J did not respond to a request for comment.
The European Medicines Agency also released a statement on Friday, saying that based on available information, batches of the vaccine released in the EU are not affected by the cross-contamination that occurred at the Emergent facility.
“However, as a precaution and to safeguard the quality of vaccines, the supervisory authorities [the medicines authorities in Belgium and the Netherlands who are responsible for batch release in the EU] have recommended not releasing vaccine batches containing the active substance made at around the same time that the contamination occurred,” the EMA said.
Additionally, the FDA has extended the expiration dating for the refrigerated J&J doses, after reviewing information and determining that the vaccine can be stored at 2-8 degrees Celsius for 4.5 months, instead of 3 months.
More than 10 million people in the US have now received the J&J vaccine, all of whom received vaccines made at the company’s plant in the Netherlands. Another 10 million more doses have been delivered across the country but not administered yet, according to the CDC.
As of the end of May, 2 million doses of the J&J vaccine have been administered in the EU, EMA said.