CDMO Error Ruins Batch of J&J COVID-19 Vaccines

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A manufacturing mistake at an Emergent Biosolutions, a contract development and manufacturing organization (CDMO) seeking authorization to produce COVID-19 vaccines for the U.S., ruined a 15 million-dose batch of Johnson & Johnson (J&J)’s Vaxzevria in production.

The error has caused delays in the expected regulatory authorization of the Baltimore-based plant, but J&J said it was still on pace to deliver 24 million doses of its one-shot vaccines by the end of April and a billion by the end of the year. The company did not say whether the snafu would prevent the company from its intermediate goal of delivering 100 million to the U.S. market by the end of June or sooner.

According to unnamed sources who reported in the New York Times, Emergent’s staff used the wrong adenoviral vector in preparing the batch. J&J’s vaccine is manufactured with Ad26, a human adenovirus. But the Maryland-based CDMO swapped in a chimpanzee adenovirus, ChAdOx1, used to deliver AZD1222, AstraZeneca’s COVID-19 vaccine.

AZD1222 has not yet been approved for emergency use in the U.S. but is available for Europe and manufactured by Emergent. Unnamed federal officials attributed the switch to human error, reported the Times.

J&J said the problems were identified during routine quality control checks at the site, before vials were filled or finished. The plant has not yet been approved by the U.S. Food and Drug Administration (FDA) to manufacture Vaxzevria, which received an Emergency Use Authorization in February. The company will provide additional experts for oversite of manufacturing in Emergent’s Baltimore facility.

Last summer, Emergent signed a five-year contract to manufacture J&J’s vaccine, valued at $480 million in the first two years, and additional deals worth $261 million to manufacture AstraZeneca’s vaccine.

J&J has delivered over 20 million doses of the vaccine in the U.S. to date, imported from manufacturing facilities in the Netherlands. The Biden Administration has committed to ensuring enough vaccines will be available to immunize every adult in the U.S. by the end of May.

Last week, the CDMO Catalent announced that the FDA has authorized the company’s Indiana facility to fill and finish J&J’s vaccines, helping J&J overcome a manufacturing bottleneck. Another such “fill-finish” facility that J&J plans to use for its vaccine, a Merck & Co. plant in North Carolina, is coming under increased scrutiny following complaints from an whistleblower that FDA ignored inspection procedures following the discovery of health and safety violations at the plant in 2017.

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