Johnson & Johnson To Oversee Vaccine Production At Baltimore Facility

See first dose of Johnson & Johnson Covid-19 vaccine being administered

See first dose of Johnson & Johnson Covid-19 vaccine being administered

J&J said in a statement that it was "assuming full responsibility regarding the manufacturing of drug substance for its COVID-19 vaccine at the Emergent BioSolutions Inc". Although the company did not note how the vaccine doses were contaminated or what they were contaminated with, an Emergent spokesperson said "human error" was to blame, The New York Times reports.

The top USA infectious disease doctor told Reuters on Thursday that the country may not need AstraZeneca's vaccine, even if it wins approval.

The Department of Health & Human Services facilitated the move, the health official said in an email, asking not to be named due to the sensitivity of the matter.

So far, none of the Johnson & Johnson doses made by Emergent have been released by the F.D.A. for distribution. "This batch was never advanced to the filling and finishing stages of our manufacturing process", the vaccine manufacturer said.

Emergent said the quality control systems in place worked as planned and it will continue to work toward FDA approval.

UK AstraZeneca recipients die of clots; regulator: Benefits outweigh risks
Several nations, including Canada, France, Germany and Spain, limited its use after similar reports. Overall, about one in every million people have this clot every year anyway, the GP explained.

J&J confirmed over the weekend that it will take a more hands-on approach at the Baltimore facility, and will increase "the number of manufacturing, quality and technical operations personnel to work with the Company specialists already at Emergent".

Emergent's facility was recruited by the federal government in 2020 to produce enough vaccines from both companies for nationwide distribution, although the AstraZeneca vaccine has not yet been approved for use in the U.S. The accidental conflux of the two vaccines' ingredients into the Johnson & Johnson vaccine was discovered after a quality control check.

Experts in vaccine manufacturing said that in the past, the F.D.A. had a rule to prevent such mishaps by not allowing a plant to make two live viral vector vaccines, because of the potential for mix-ups and contamination.

Last month, Mr. Biden canceled a visit to Emergent's Baltimore plant, and his spokeswoman announced that the administration would conduct an audit of the Strategic National Stockpile, the nation's emergency medical reserve.

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