The US government has bought 50 million additional doses of Pfizer-BioNTech’s Covid-19 vaccine. These doses will aid in boosting readiness for inoculating the paediatric population, including procuring shots for children aged below five years on obtaining regulatory authorisation. The companies anticipate delivering these doses by 30 April 2022. The latest order takes the number of Pfizer-BioNTech Covid-19 vaccine doses procured by the US government to 600 million.
ARCA biopharma has reported that the Phase IIb ASPEN-COVID-19 clinical trial of small recombinant protein, rNAPc2, to treat severe Covid-19 patients in hospital will advance without modifications. The move comes after the Data and Safety Monitoring Committee (DSMC) concluded a pre-specified interim assessment and advised progressing the trial without any changes in study design. The company expects to reach target enrolment of 160 subjects by the year-end and report topline results from the trial in the first quarter of 2022.
Indian companies Optimus Pharma, Natco Pharma and Hetero have sought regulatory approval to manufacture a generic version of Merck’s (MSD) oral Covid-19 drug, molnupiravir in the country. Optimus Pharma intends to ramp up manufacturing to produce 80 million capsules per month on obtaining Emergency Use Authorization, Reuters reported. The Subject Expert Committee (SEC) of the Indian regulatory agency is anticipated to review the applications in the coming days, Economic Times reported.