Some J&J vaccine doses must be destroyed |

Some J&J vaccine doses must be destroyed

Some J&J vaccine doses must be destroyed Photo: Johnson & Johnson

ZEKE MILLER and LINDA A. JOHNSON, Associated Press
Updated: June 11, 2021 06:00 PM
Created: June 11, 2021 10:53 AM

U.S. regulators are allowing the release of 10 million doses of Johnson & Johnson's COVID-19 vaccine from a troubled Baltimore factory, but many other doses can't be used and must be thrown out.

The Food and Drug Administration announced Friday that it had determined that two batches from the plant, which is owned by Emergent BioSolutions and has been shuttered for weeks, could be released.

But it said several other batches are not suitable for use and additional batches are still under review.

"Each lot is produced independently, each the equivalent of each batch of brownies and their separate sets of records, so they whatever the FDA did release, they would have the confidence in the quality of the product," John Grabenstein of the a non-profit organization Immunization Action Coalition said.

The agency wouldn't specify why those batches can't be used, but a person familiar with the decision told The Associated Press that it was due to possible contamination.

The person wasn't authorized to release details about the decision and spoke to the AP on condition of anonymity.

"Each of the raw materials needs to be replaced and they'll need to do more production runs, which will take more months for that part of for the for the newly started lots to go all the way through the process from A to Z," Grabenstein said.

That contamination led the FDA to shut down the factory in mid-April and send in a team of inspectors.

They spent a week going through the factory and reviewing security camera footage that showed employees carelessly handling vaccine materials.

The inspectors reported unsanitary conditions, poorly trained employees and other problems.

The lapses have hampered J&J's efforts to be a major player in vaccinating people, particularly in remote areas and poor countries, given that it's the only drugmaker with an authorized vaccine that only requires one dose and standard refrigeration.

It's also cheaper than some other vaccines.

"So for the fact that there was any potential contamination and they're willing to then discard those doses to really give the U.S. population comfort in the fact that we're actively looking, we're sharing that these medications are safe and effective for continual use," Dr. Onisis Stefas, the chief pharmacy officer for Northwell Health, a healthcare network based in New York, said.

The productions problems have forced J&J to import millions of doses from its factory in the Netherlands to the U.S. and to miss supply commitments.

The FDA's decision means that the two batches from the factory, known as Bayview, can be used in the U.S. or exported to other countries.

They are the first J&J vaccines from Bayview approved for use.

The FDA, however, stopped short of allowing the plant to restart vaccine production.


ZEKE MILLER and LINDA A. JOHNSON, Associated Press

Copyright 2021 The Associated Press. All rights reserved.

What to know about sentencing hearing for Chauvin

Woman dies in fatal Iron Range crash

Many feared dead after Miami building collapse

Minnesota COVID-19 Update Thursday

Wisconsin COVID-19 Update Thursday

Michigan COVID-19 Update Thursday