FDA inspection found problems at factory making J&J vaccine; doses were not distributed
The Baltimore factory hired to help make Johnson & Johnson’s COVID-19 vaccine was dirty, didn’t follow proper manufacturing procedures and had poorly trained staff, resulting in contamination of material going into a batch of shots, U.S. regulators said Wednesday.
The Food and Drug Administration released a statement and a 13-page report detailing findings from its just-completed inspection of the idled Emergent BioSciences factory.
Agency inspectors said a batch of bulk drug substance for J&J’s single-shot vaccine was contaminated with material used to make COVID-19 vaccines for another Emergent client, AstraZeneca. The batch, reportedly enough to make about 15 million J&J vaccine doses, had to be thrown out.
Nothing made at the factory for J&J has been distributed, the FDA noted. The nearly 8 million doses of J&J vaccine given in the U.S. came from Europe.
In other developments:
- One of the largest reports on COVID-19 vaccination in pregnancy bolsters evidence that it is safe although the authors say more comprehensive research is needed.
- It looks like something to celebrate: small businesses posting “Help Wanted” signs as the economy edges toward normalcy. Instead, businesses are having trouble filling the jobs, which in turn hurts their ability to keep up with demand for their products or services.
- Health officials have released more evidence that COVID-19 infections in fully vaccinated people are uncommon.
- President Joe Biden on Wednesday announced new employer tax credits and other steps to encourage people reluctant to be inoculated to get the COVID-19 vaccine as his administration tries to overcome diminishing demand for the shots.
- The Indianapolis 500 is set to be the largest sporting event in the world since the start of the pandemic with 135,000 spectators permitted to attend “The Greatest Spectacle in Racing” next month.
- Burning Man festival organizers have said that they are considering requiring attendees to prove they have been vaccinated for COVID-19 if the organizers move forward with plans to hold this year’s counter-culture festival in the Nevada desert.
- Slow out of the gate, the European Union has ramped up its COVID-19 vaccination efforts, with the distribution of the Johnson & Johnson one-shot product this week adding to the momentum amid doggedly high infection rates on the continent.