Coronavirus company news summary – US FDA expands Covid-19 booster eligibility to all adults - EMA recommends Lagevrio pill for high risk Covid-19 patients
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Coronavirus company news summary – US FDA expands Covid-19 booster eligibility to all adults – EMA recommends Lagevrio pill for high risk Covid-19 patients

22 Nov 2021

The US Food and Drug Administration has expanded eligibility for Covid-19 booster shots to all adults amid a rise in daily cases. The regulator authorised a booster dose of Moderna and Pfizer-BioNTech Covid-19 vaccines for all adults who have completed their primary inoculation at least six months before. Previously, a single booster dose of the two vaccines was approved for older people above 65 years of age, individuals at higher risk categories and those with frequent exposure to SARS-CoV-2.

The European Medicines Agency (EMA) has recommended that oral antiviral medicine Lagevrio can be used to treat high-risk Covid-19 adult patients who do not need supplemental oxygen. The EMA’s human medicines committee said that the medicine should be administered in such cases within five days of first symptoms. The Lagevrio capsule should be taken twice a day for five days, the recommendation added. Lagevrio is being jointly developed by Merck Sharp & Dohme and Ridgeback Biotherapeutics. The medicine is yet to receive authorisation in the EU.

Akston Biosciences has initiated an open-label bridging study of its protein subunit Covid-19 vaccine candidate AKS-452 in India. The company has dosed the first 100 subjects in the study. AKS-452 is based on Akston’s Fc fusion protein platform and is shelf-stable for at least six months at room temperatures (up to 25°C). The company claims that the vaccine maintains its potency for one month at 37°C. Following this study, Akston will conduct a larger multi-site, double-blind Phase II/III study of the vaccine candidate with around 1,500 adults in India.