Pfizer and BioNTech have announced positive topline results from a pivotal Phase III trial of BNT162b2, their Covid-19 vaccine, in adolescents aged between 12 and 15 years who may or may not have had prior SARS-CoV-2 infection. The vaccine, tested in 2,260 adolescents, showed 100% efficacy and robust antibody responses exceeding those recorded earlier in vaccinated individuals aged between 16 and 25 years.
A new Phase I clinical trial has been initiated to evaluate the safety and immunogenicity of Moderna’s Covid-19 vaccine candidate, mRNA-1273.351, in adult volunteers. The investigational vaccine is expected to provide protection against the B.1.351 SARS-CoV-2 variant. The trial is being led and funded by the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
Biopharma company Kamada has announced topline results from a Phase I/II clinical trial of its anti-SARS-CoV-2 plasma-derived hyperimmune globulin (IgG) treatment for Covid-19 in a single-arm, multi-centre clinical trial held in Israel. Interim results of the study were announced in September 2020. The trial evaluated the safety, anti-SARS-CoV-2 IgG levels, virus neutralisation activity, and other outcomes in hospitalised, non-ventilated Covid-19 patients suffering with pneumonia. The treatment showed a favourable safety profile, with two serious adverse events considered not related to the study drug. Eleven of the 12 patients dosed with the treatment went on to recover, while one patient died on day 37 post-treatment due to Covid-19 complications.