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April 26, 2021

Coronavirus company news summary – J&J vaccine rollout to resume in US after safety review – Zydus Cadila’s Virafin receives EUA to treat moderate Covid-19 in India

By Chris Lo

Johnson & Johnson will restart the use of its single-shot Covid-19 vaccine in adults aged 18 years and older in the US, following a safety review by the US Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). The US CDC Advisory Committee on Immunisation Practices (ACIP) re-evalauted the data on possible links between the vaccine and blood clots in individuals with low platelet counts, a week or two after being vaccinated.

Indian pharma firm Zydus Cadila has been granted restricted emergency use authorisation (EUA) from the Drug Controller General of India (DCGI), for administering Virafin to fight moderate Covid-19 infection in adults. The pegylated interferon alpha-2b (PegIFN) drug showed promising results in a late-stage study which found 91.15% of Covid-19 patients tested negative after seven days of treatment. The 10-year-old drug was originally approved for Hepatitis C and is being repurposed to treat Covid-19.

Health Canada has received the first part of Quebec-based Medicago’s rolling submission for its plant-based adjuvanted Covid-19 vaccine candidate. The Interim Order (IO) rolling submission allows Medicago to submit all data related to the quality, clinical safety and efficacy of the first Canadian-made Covid-19 vaccine. While the review is underway, the company is conducting a Phase III trial and has sought regulatory approval to start the Phase III part of the Phase II/III clinical development in Brazil, Canada, the UK and US.

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