Unsanitary practices among issues at US plant making J&J's vaccine

WASHINGTON/BERLIN • An American plant that was making Johnson & Johnson's Covid-19 vaccine must fix a long list of problems including peeling paint, unsanitary conditions and practices to resume operation, according to a highly critical report by the Food and Drug Administration (FDA).

Experts said addressing the issues raised in the scathing FDA report could take months.

Neither J&J nor the FDA has said when vaccine production could restart at the Baltimore plant owned by Emergent Biosolutions.

There are only two other plants equipped to supply the world with the key drug substance for J&J's vaccine.

"It may take many months to make these changes," said Dr Prashant Yadav, a healthcare supply chain expert at the Centre for Global Development. He described some of the issues raised by the FDA as "quite significant".

J&J said it will exercise its oversight authority to ensure all of the FDA observations are addressed promptly and comprehensively.

The healthcare conglomerate has drawn scrutiny for months over its halting process to scale up production of a Covid-19 vaccine that is easier to handle and, by virtue of being a single shot, easier to use than other authorised vaccines.

Its use in the United States has been paused since last week as health officials study a possible link to a very rare but serious blood clot condition.

Emergent has been seeking regulatory authorisation to make the J&J vaccine in the US. It stopped production at the plant recently, saying the FDA had asked it to do so after an inspection.

J&J's plant in Leiden, the Netherlands, is still producing doses for the world. The company has another facility in India, which is curtailing exports of the shot as it struggles to vaccinate its own population.

The FDA in its final 12-page inspection report said it had reviewed security camera footage in addition to an in-person site visit to the Emergent plant.

It found failure to train personnel to avoid cross contamination of Covid-19 vaccines from J&J and AstraZeneca, which had also used the site to produce its shots.

The agency also cited staff carrying unsealed bags of medical waste in the facility, bringing it in contact with containers of material used in manufacturing.

Meanwhile, the J&J shot has been backed by Europe's drug regulator and deliveries have started trickling in after a week-long pause as European countries on Wednesday prepared to begin using the American company's Covid-19 vaccine in their inoculation campaigns.

Just over 320,000 doses had arrived in 10 countries across the 30-member European Economic Area as of Wednesday, according to the European Centre for Disease Prevention and Control.

REUTERS