The US Federal authorities have dealt a huge blow to vaccine makers Johnson & Johnson as they said on Friday that 60 million doses of coronavirus vaccine produced by the pharmaceutical giant are unfit for use.
The vaccine doses to be thrown out as per the orders of the Food and Drug Administration were manufactured at the Baltimore factory where workers had contaminated J&J vaccine by accidentally using ingredients meant for AstraZeneca vaccine.
The Baltimore manufacturing facility is run by J&J partner Emergent BioSolutions, which was contracted to manufacture AstraZeneca vaccines as well. The mix-up that led to the contamination was discovered in March, following which the FDA ordered the shutdown of the plant.
The deadly goof-up literally killed the vaccine ambitions of the global pharmaceutical giant, which had blazed a trail by making a potent vaccine that needed only one shot to give defense against coronavirus.
Johnson & Johnson vaccine doses were administered in the United States but those were manufactured in the company's plant in the Netherlands.
More than 100 million doses of Johnson & Johnson vaccine and at least 70 million doses of AstraZeneca vaccine were put on hold following the discovery of the plant mix-up.
In an unusual decision, the FDA also said some 10 million doses of the vaccine can, however, be sold in the United States or abroad but with a warning that regulators cannot guarantee that Emergent BioSolutions followed good manufacturing norms.
The FDA said it conducted a "thorough review of facility records and the results of quality testing performed by the manufacturer" before taking the decision. The agency also said in a statement that it was working through issues at the Baltimore plant.
FDA is conducting an extensive review of batches of vaccine made at the plant, said Dr. Peter Marks, the FDA.'s top vaccine regulator. He also said Emergent BioSolutions is preparing to "resume manufacturing operations with corrective actions to ensure compliance with the F.D.A.'s current good manufacturing practice requirements," according to the NYT.
The paper reported that Johnson & Johnson and Emergent declined to comment on the FDA decision.
Millions of Doses Unused
Representatives from Johnson & Johnson and Emergent declined to comment on the agency's decision.
The latest FDA decision hit Johnson & Johnson hard just a day after the same agency extended the shelf life of its vaccine from three months to four-and-a-half months.
The extension of expiry date was a big boon for Johnson & Johnson as millions of vaccine doses are sitting unused with the vaccine maker.