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June 7, 2021

Coronavirus company news summary – Pfizer vaccine authorised for children aged 12-15 in UK – FDA halves dosage of Regeneron antibody cocktail in EUA update

By Chris Lo

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the administration of Pfizer-BioNTech Covid-19 vaccine among 12 to 15-year-olds, following clearances in the EU and US. This follows a review of the safety, efficacy and quality of the vaccine for the age group by the MHRA and the government’s Commission on Human Medicines (CHM).

The US Food and Drug Administration (FDA) has updated the emergency use authorisation (EUA) for Regeneron Pharmaceuticals’ antibody cocktail REGEN-COV for treating Covid-19. As a result, the agency has lowered the dose to 1,200 mg (600 mg casirivimab and 600 mg imdevimab), half of what was previously authorised for use. The update notes that REGEN-COV should be administered by intravenous (IV) infusion, with subcutaneous administration authorised as an alternative when IV infusion is not possible or would lead to delays in treatment.

National Institutes of Health (NIH) researchers have suggested that the experimental drug TEMPOL may be a potential oral antiviral treatment for Covid-19. According to a cell culture study conducted by the researchers and published in Science, the drug can limit the infection by changing the activity of a viral enzyme called RNA replicase. Experts from NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) said the drug works in tissues such as the lungs and salivary glands, which are the main targets of the virus.

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