Morning Briefing
Summaries of health policy coverage from major news organizations
Ineffective Against Current Variants, Evusheld's FDA Authorization Revoked
AstraZeneca Plc鈥檚 Covid antibody drug is no longer authorized for use in the US, regulators said Thursday, as it鈥檚 unlikely to work against strains of the virus that are now dominant across the country. Astra鈥檚 drug, called Evusheld, was authorized in December 2021 to prevent Covid infection in high-risk people, but has been rendered less effective by the virus鈥 mutations. (Muller, 1/26)
Evusheld is also not effective against the BQ.1, BQ.1.1 and XBB subvariants. Taken together with XBB.1.5, versions of Covid that are resistant to Evusheld now represent nearly 93% of new cases in the U.S. 鈥淭oday鈥檚 action to limit the use of Evusheld prevents exposing patients to possible side effects of Evusheld such as allergic reactions, which can be potentially serious, at a time when fewer than 10% of circulating variants in the U.S. causing infection are susceptible to the product,鈥 the FDA said in a statement Thursday. (Kimball, 1/26)
In a statement, AstraZeneca said it has started trials of another antibody that, in lab studies so far, has been able to neutralize all variants. The therapy, which would similarly be given as a pre-exposure prophylaxis to immunocompromised people, could be available later this year if trials are successful, the company said. The company鈥檚 statement also noted that Evusheld remains authorized in other countries, including the European Union and Japan. (Joseph, 1/26)
