Health Canada has granted full approval for the use of Moderna’s Spikevax and Pfizer-BioNTech’s Comirnaty to protect against Covid-19 in people aged 12 years and above. This is the first full approval for Spikevax and is based on data from the Phase III COVE clinical trial. Comirnaty already holds full approval in the US and Health Canada granted the approval after the review of an extensive data package, including Phase III results.
The US Food and Drug Administration has updated its Emergency Use Authorization (EUA) for bamlanivimab plus etesevimab to include use for post-exposure prophylaxis in some people to prevent Covid-19. Eli Lilly’s antibody combination is now authorised for people aged 12 years and above who are at increased risk, not fully vaccinated against Covid-19 or may have an inadequate immune response to full inoculation and have been exposed to a SARS-CoV-2 infected individual. Lilly expects the expanded EUA to aid in preventing Covid-19’s spread to certain high-risk people in the US.
A University of Oxford-led Phase II clinical trial, called Com-COV3, has expanded to assess mixed Covid-19 vaccine schedules in adolescents aged 12 to 16 years. The trial will enrol 360 adolescents, who will receive a first dose of the Pfizer-BioNTech vaccine and then a repeat of Pfizer at full or half dose, a full dose of Novavax’s vaccine candidate or a half dose of Moderna’s jab a minimum of eight weeks later. The study’s aim is to compare immune responses from a heterologous regimen to those from a homologous regimen.