Covid-19 roundup: Merck submits molnupiravir for EUA; India resumes vaccine exports after Delta surge
Merck’s oral antiviral drug for Covid-19 has been submitted to the FDA for emergency use authorization, the company announced Monday morning.
The company, which collaborated with Ridgeback Biotherapeutics, announced last week that molnupiravir reduced death and hospitalizations by 50%. The submission for EUA is based on positive results from the Phase III trial. Of 385 patients in the trial, just 28 were hospitalized after receiving molnupiravir, compared to 53 out of 337 patients on the placebo. No patients who received molnupiravir died, compared with eight who were on the placebo.
If authorized, it will be the first pill given the go-ahead to treat Covid-19 and provide doctors an easily administered tool to prevent newly diagnosed patients from progressing into more serious cases. Right now, the only treatment authorized to keep patients from being hospitalized is monoclonal antibodies.
Several countries have already inked supply deals for the drug, including Thailand, South Korea, Malaysia and the US, with which Merck agreed to supply 1.7 million doses earlier this year.
Before it was licensed out to Merck and Ridgeback, a non-profit biotech at Emory University developed the drug for the flu pandemic, but shifted when the coronavirus broke out.
“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” Robert Davis, Merck’s CEO, said in a statement. “We are grateful to the patients and investigators in our study, and of course to our own colleagues who have exemplified Merck’s high standards of scientific excellence and our unwavering commitment to patients.
India resumes vaccine exports after Delta surge
After a nearly eight-month delay, the Serum Institute of India has shipped another batch of vaccines. On Saturday, those vaccines arrived in Bangladesh.
The Bangladesh government, distributor Beximco Pharmaceuticals and the Serum Institue have a deal for 30 million doses of the AstraZeneca jab. India had stopped exports while it experienced a brutal wave of the pandemic earlier this year.
Daily case numbers skyrocketed from around 25,000 in mid-March to more than 400,000 a day by May. Since then, however, the vaccine output has more than doubled, and minister Mansukh Mandaviya said that it was set to quadruple to more than 300 million doses in October. The timeline has held strong. Almost 50% of people in India have received at least one shot of the vaccine.
Companies in India have the capacity to produce almost 3 billion Covid-19 vaccines a year, the Arab News reported. The country sold or donated nearly 66 million doses before the export halt in April.