The World Health Organization is awaiting full clinical data on the antiviral pill made by Merck & Co. Inc. to treat mild-to-moderate Covid-19 patients, a WHO spokesperson said on Tuesday, a day after the company said it had applied for U.S. emergency use authorization.
Merck has submitted data to the U.S. Food and Drug Administration for Emergency Use Authorization (EUA) for the company’s antiviral pill molnupiravir.
A World Health Organization spokesperson said on Oct. 8 that the health agency was “near” to resolving issues on Russia’s Sputnik V Covid-19 vaccine, without giving a date for a potential emergency use listing.
Immunology is one of the more complicated areas of the life sciences, and recent studies on the long-term efficacy of the mRNA vaccines against Covid-19 are prime examples of just how complicated it can be.
Pfizer Inc. and BioNTech SE asked U.S. regulators to authorize emergency use of their Covid-19 vaccine for children ages 5 to 11, a group for whom no shot is allowed, Pfizer said on Oct. 7.
Johnson & Johnson submitted data to the U.S. Food and Drug Administration for emergency use authorization of a booster shot of the company’s Covid-19 vaccine in people aged 18 and older.
AstraZeneca requested emergency use authorization from U.S. regulators for the company’s new treatment to prevent Covid-19 for people who respond poorly to vaccines because of a weakened immune system.
A World Health Organization (WHO) panel on Sept. 24 recommended the use of Regeneron and Roche’s Covid-19 antibody cocktail for patients at high risk of hospitalizations and those severely ill with no natural antibodies.
External advisors to the U.S. Food and Drug Administration will meet on Sept. 17 to consider data from Pfizer and BioNTech in support of booster shots. Meanwhile, a timeline is being presented on the authorization of Covid-19 vaccines for children.
Drugmaker Merck & Co. Inc. sees potential U.S. emergency use authorization for the company’s experimental Covid-19 antiviral treatment, molnupiravir, before year-end 2021.