Novavax and its partner Serum Institute of India have made a regulatory submission to the World Health Organization (WHO) for emergency use listing of Novavax’s recombinant, adjuvanted Covid-19 vaccine. The submission is based on the prior regulatory filing to the Drugs Controller General of India, Novavax said. The listing by the WHO is required for exports to countries participating in the COVAX Facility, an equitable Covid-19 vaccine access initiative run by the WHO, the Coalition for Epidemic Preparedness Innovations and Gavi, the Vaccine Alliance.
Valneva has expanded the Phase III Cov-Compare clinical trial of its inactivated Covid-19 vaccine candidate, VLA2001, in the UK with the initiation of adolescent enrolment. Top-line results from the trial are anticipated in the fourth quarter of this year and could support potential regulatory approval in adults. The trial is enrolling adolescents aged 12 to 17 years who will receive two VLA2001 or placebo doses at a gap of 28 days, and then a booster dose seven months post-enrolment. The company plans to further expand the trial to include subjects aged below 12 years. News of the trial’s development comes after the UK government terminated its vaccine supply agreement with Valneva.
Tonix Pharmaceuticals has extended its research alliance with Columbia University in the US to develop tailored Covid-19 vaccines and therapies with precision medicine. The partners will focus on analysing immune responses to Covid-19 in healthy people who have recovered from the infection or were asymptomatic. In addition, in vitro T cell and antibody responses to the SARS-CoV-2 virus will be assessed. The data on immune responses is expected to enable new and specialised vaccines for the disease.