New Delhi: US pharma company Johnson & Johnson documented serious contamination risks at a Baltimore biodefence plant seven months before a cross-contamination incident ruined 15 million doses of its Covid vaccine, the Washington Post reported Thursday.
The incident, first reported on 31 March, occurred at a plant in Baltimore, Maryland, where workers accidentally mixed ingredients of Johnson & Johnson and AstraZeneca vaccines.
The plant is run by Emergent BioSolutions, a manufacturing partner to both Johnson & Johnson and AstraZeneca, the latter of which is yet to get approval for the use of its vaccine in the US.
A staff report by a government oversight committee released Wednesday said Emergent was “aware” of the problems but “failed to take sufficient action”.
Though Emergent has shouldered much criticism for recent lapses, documents disclosed by a House of Representatives panel Wednesday revealed that Johnson & Johnson conducted a virtual audit of the facility in June 2020. The audits found mold, inadequate gowning and wipe-down procedures and “deficient” contamination-control measures. On 24 July 2020, the audit findings were sent to Emergent.
The Baltimore incident delayed future shipments of Johnson & Johnson doses in the US and abroad.
Speaking to reporters earlier this month, US Chargé D’Affaires in Delhi Daniel Smith said while Washington is concerned about the “human catastrophe” in India, it is not yet in a position to send readymade doses of vaccines — produced by AstraZeneca and Johnson and Johnson — that are lying unused in the country.
This is because they are still being screened by the FDA, he said.
In August 2020, the Trump administration said it will invest $1 billion in a vaccine developed by Johnson & Johnson, guaranteeing 100 million doses.
100 million J&J vaccine doses on hold
Emergent BioSolutions CEO Robert G. Kramer has said more than 100 million doses of Johnson & Johnson’s vaccine are now on hold as regulators check them for possible contamination.
In late April, the company temporarily shut down operations at the plant at the request of the US Food and Drug Administration (FDA) and acknowledged it needs to “restore confidence” in its work.
While testifying before a House of Representatives subcommittee Wednesday, Kramer said the facility is expected to resume work “in a matter of days”, and that the firm accepted “full responsibility” of the recent lapses.
President Joe Biden announced Monday the US will export 80 million vaccine doses — 60 million doses of the AstraZeneca jab that are awaiting USFDA approval and another 20 million other Covid vaccines that are approved but are lying unused. However, it is still unclear how many of those doses will come to India.