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August 9, 2021

Coronavirus company news summary – India approves J&J single-dose vaccine for emergency use – FDA clears AZ vaccine substance for export from Emergent’s Baltimore plant

By Chris Lo

The Government of India has approved the emergency use of Johnson & Johnson’s (J&J) single-shot Covid-19 vaccine, which will be made available in the country in partnership with Hyderabad-based vaccine manufacturer Biological E. J&J applied for the Emergency Use Authorization on 5 August 2021, supported by top-line results on the vaccine’s safety and efficacy in the Phase III ENSEMBLE clinical trial.

The US Food and Drug Administration (FDA) has said that some lots of AstraZeneca’s Covid-19 vaccine drug substance produced at Emergent BioSolutions’ Baltimore plant are fit for potential export. The regulator noted a detailed review of facility records and quality testing results submitted by Emergent. AstraZeneca vaccine is not approved for emergency use in the US but can be shipped to other markets. Vaccine production at the plant had been paused after a major vaccine contamination incident at the end of March, and FDA reports of poor standards at the facility.

A new laboratory study has demonstrated that fenofibrate, a drug commonly used to address abnormal fatty substance levels in the blood, and its active form fenofibric acid can lower SARS-CoV-2 infection by up to 70% in human cells. Led by the University of Birmingham and Keele University in the UK and the San Raffaele Scientific Institute in Italy, the study found that the activity against Covid-19 could be achieved with a standard clinical dose of fenofibrate. The team is now calling for additional clinical trials of the drug in hospitalised Covid-19 patients.

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