1 September 2021

• Merck and development partner Ridgeback Pharmaceuticals issue a press release to announce a phase III trial of molnupiravir, a nucleoside analog, for post-exposure Prophylaxis of COVID-19. The 1,332-person trial will compare molnupiravir versus placebo in people age 18 and over who live in the same household as a person with symptomatic COVID-19. The trial will run in Argentina, Brazil, Colombia, France, Guatemala, Hungary, Japan, Mexico, Peru, Philippines, Romania, Russia, South Africa, Spain, Turkey, Ukraine, and the US. Source

• Pfizer issues a press release to announce that the first study volunteer in a phase II/III trial has been given PF-07321332 a protease inhibitor designed to fight COVID-19. The 1,140-person randomized, double-blinded trial will compare the twice-daily oral protease inhibitor, which will be boosted with a drug called ritonavir, versus placebo in outpatients with COVID-19 who are not at risk for progression to severe illness. An ongoing trial, which is looking at the drug in outpatients with COVID-19 who are at risk for progression to severe illness, opened in July of 2021. Source

• Moderna issues a press release announcing that it has submitted data to the US FDA for a 50 µg booster dose of its coronavirus vaccine. The submission is based on data from a phase II trial in which 344 people were given a booster dose six months after initial vaccination. Source 

• Japan’s Ministry of Health suspended 1.63 million doses due to contamination with stainless steel particles – which they said did not pose health risks. Moderna, Rovi (which operated the plant where the vaccine was produced) and Takeda (who distributes the vaccine) conducted a joint investigation, concluding that the contamination happened during production and that the deaths of two young men  (which occurred shortly after their second dose of Moderna’s vaccine, and were from a contaminated batch)  were unrelated to the vaccine. Moderna and Takeda have recalled three batches of the vaccine; 500,000 people already received shots from them. Source