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June 14, 2021

Coronavirus company news summary – Moderna and Tabuk Pharmaceutical partner to commercialise Covid-19 vaccine – FDA authorises Emergent Biosolutions’ Covid-19 vaccine drug substance

By Darcy Jimenez

Moderna and Tabuk Pharmaceutical Manufacturing Company have entered into an agreement to commercialise Moderna’s Covid-19 vaccine and other variant-specific booster doses in Saudi Arabia. Under the agreement, Tabuk Pharmaceuticals holds the exclusive marketing authorisation for the vaccine in the country, with the possibility to distribute other Moderna mRNA products if approved in the future.

The US Food and Drug Administration (FDA) has authorised two batches of Emergent BioSolutions’ Covid-19 vaccine developed at the company’s Baltimore Bayview facility, as part of Johnson & Johnson’s emergency use authorisation. Emergent plans to resume manufacturing of the Johnson & Johnson Covid-19 vaccine drug substance after both the companies and the FDA confirm that relevant steps have been taken to resolve shortcomings.

The European Medicines Agency (EMA) has identified a new rare blood condition associated with AstraZeneca’s Covid-19 vaccine, and stated that it is looking into cases of heart inflammation following vaccination from all Covid-19 vaccines. The EMA said capillary leak syndrome (CLS) must be included as a new side effect to the labelling on AstraZeneca’s Vaxzevria vaccine. It added that individuals having experienced CLS, where fluids leak from the smallest blood vessels causing inflammation and a blood pressure drop, should not receive the jab.

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