No data to display.

FDA asks J&J to scrap 60 million doses of COVID-19 vaccine produced in Baltimore plant - NYT

By Arghyadeep on Jun 12, 2021 | 04:32 AM IST

j&jvaccine.jpg


The U.S. Food and Drug Administration have told Johnson & Johnson not to use about 60 million doses of its COVID-19 vaccine produced at a troubled Baltimore factory due to possible contamination, The New York Times reported, citing people familiar with the matter.

F.D.A. is planning to allow around 10 million doses to be distributed in the U.S. or to export to other countries, but with a warning that the drug regulator cannot assure that Emergent BioSolutions, the company that operates the plant, followed proper quality control, the report said.

For several weeks the drug regulator has been trying to figure out what to do with at least 170 million doses of vaccine that were left in limbo after discovering the major production mishap.

In March, more than 100 million doses of J&J and about 70 million doses of AstraZeneca were put on hold after Emergent found out that it had contaminated a batch of J&J’s vaccine with a key ingredient used to produce AstraZeneca’s.

After the incident, federal officials ordered the plant to cease production and stripped Emergent of its responsibility to produce AstraZeneca’s vaccine and instructed J&J to assert direct control over the manufacturing.

The agency has not yet decided whether Emergent can reopen the manufacturing facility or not, sources told NYT. The facility has been closed for two months because of improper production practices, which contaminated millions of drugs.

So far, J&J’s doses administered in the U.S. were manufactured at the firm’s plant in the Netherlands, not by Emergent.

The vaccine developed by J&J was once considered a potential game-changer because it required one shot and was particularly useful in vulnerable communities.

Experts told NYT that the agency’s decision to allow 10 million doses with a warning is somewhat unusual for a product under emergency authorization.

F.D.A. in a statement, said that before making its decision, it “conducted a thorough review of facility records and the results of quality testing performed by the manufacturer” and also considered the ongoing pandemic. The agency said they are trying to “work through issues” at the Baltimore plant with J&J and Emergent.

Johnson & Johnson’s share dropped 1.7% after the news was published.

Picture Credit: PBS

Stock View