Pfizer and BioNTech have reported that their Covid-19 vaccine demonstrated a favourable safety profile and strong neutralising antibody responses in children aged five to 11 years. The trial involved a smaller dose of the vaccine; children were given a two-dose 10µg regimen versus 30µg administered in studies involving people aged 12 years and above. The antibody responses with 10µg doses were similar to those observed in a prior Pfizer-BioNTech trial in individuals aged 16 to 25 years vaccinated with 30µg doses, the companies said. The latest data will be submitted to global regulatory authorities, including in the US and EU.
Clinical-stage biotech company Gritstone has dosed the first participants in a Phase I clinical trial of its second-generation, self-amplifying mRNA-based Covid-19 vaccine. The single-centre trial is being performed in collaboration with the University of Manchester in the UK, and will test the vaccine’s ability to boost and expand first-generation Covid-19 vaccines’ immunogenicity in people aged 60 years and above. Preliminary data from the Phase I trial are anticipated in the first quarter of next year.
Canadian biopharma firm Appili Therapeutics has signed an agreement with Fujifilm Toyama Chemical, securing $1m for the Phase III PRESECO clinical trial of its Avigan/Reeqonus (favipiravir) tablets to potentially treat and prevent Covid-19 in an outpatient setting. The funding will be used for multiple components of the trial, including study close-out activities. As part of the agreement, Fujifilm will gain access to the trial results to support regulatory submissions in Japan.