LONDON –The Russian COVID-19 vaccine Sputnik V now has validation from the Western science establishment, after The Lancet published full interim results of the phase III trial on Feb 2. The peer-reviewed paper confirms the 91%-plus efficacy that the vaccine’s developer, Gamaleya National Center of Epidemiology and Microbiology, claimed in its own announcement of the results in December.
DUBLIN – Amid a bitter dispute between the European Commission (EC) and Astrazeneca plc over supplies of the latter’s SARS-CoV-2 vaccine, the EC’s drug regulator, the EMA, recommended approval of the product in question, COVID-19 Vaccine Astrazeneca (formerly AZD-1222).
Sweeping in behind Novavax Inc.’s positive phase III COVID-19 vaccine data is Johnson & Johnson’s single-shot COVID-19 vaccine, which met all the primary endpoints and key secondary endpoints in its phase III study, according to an interim analysis that found it to be 85% effective overall in preventing severe disease.
LONDON – A fourth COVID-19 vaccine is on the road to approval in Europe, with Novavax Inc. announcing positive interim data from the phase III U.K. trial of NVX-CoV2373. The vaccine was 89.3% effective at a time when there was a high rate of infection in the country, and in the face of the newly identified variant, B 1.1.7, which is more transmissible. There also was positive data, though slightly less sparkly, from a phase IIb study in South Africa, where NVX-CoV2373 showed 60% efficacy in preventing mild, moderate and severe COVID-19 disease.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Pfizer Australia Pty Ltd. for its COVID-19 vaccine, branded Comirnaty, making it the first COVID-19 vaccine to receive approval in Australia.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Pfizer Australia Pty Ltd. for its COVID-19 vaccine, branded Comirnaty, making it the first COVID-19 vaccine to receive approval in Australia.
LONDON – There is “a realistic possibility” that infection with the B 1.1.7 variant of SARS-CoV-2 is associated with a 30% to 40% increased risk of death compared to earlier variants of the virus, according to scientists on the U.K. government’s New and Emerging Respiratory Virus Threats Advisory Group. That conclusion is based on studies by three university groups, linking community PCR testing to mortality.
Merck & Co. Inc. dropped a bombshell Jan. 25, announcing that it was terminating its two COVID-19 vaccine programs, V-590 and V-591, because neither demonstrated convincing levels of efficacy in phase I trials. As a relatively late entrant to the COVID-19 vaccine race, Merck, of Kenilworth, N.J., was never a leading contender in the effort to bring safe and efficacious vaccines to market. Even so, the failure of these programs is a significant setback, given the company’s scale and experience as a global vaccine manufacturer.
With worrisome COVID-19 variants cropping up, developers including the likes of Gritstone Oncology Inc. and Vir Biotechnology Inc. continue their efforts to invent new vaccines that may get around the drawbacks of existing shots if they turn up.
LONDON – There’s mixed news about emerging variants of SARS-CoV-2, with Pfizer Inc. and Biontech SE reporting their vaccine Comirnaty maintains its protective effect against B 1.1.7, first detected in the U.K., while researchers in South Africa say virus variant 501Y.V2 is able to escape neutralization by both monoclonal antibodies and convalescent plasma from previously infected individuals.
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