As expected, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) looked favorably upon the latest COVID-19 entry: Ad26.COV2.S, a one-shot product that emerged from the same Johnson & Johnson (J&J) platform, AdVac, that let the firm devise an Ebola vaccine cleared in Europe last year.
Briefing documents released by the FDA related to the Vaccines and Related Products Advisory Committee meeting slated for Friday suggest that the COVID-19 vaccine from Johnson & Johnson (J&J) will sail smoothly to an emergency use authorization.
In the shadow of the COVID-19-related deaths of more than half a million Americans and far more deaths across the world, the Biden administration is reportedly rethinking its position on a proposal before the World Trade Organization to waive intellectual property protection for SARS-CoV-2 vaccines.
Pfizer Inc. and Biontech SE submitted new data to the FDA showing its COVID-19 vaccine’s stability can be maintained at temperatures often found in pharmaceutical freezers and refrigerators: -13°F to 5°F (-25°C to -15°C). That’s cold but not nearly as cold as the mRNA-based vaccine’s emergency use authorization label calls for, which is storage in an ultra-cold freezer at temps of between -112 to -76 degrees Fahrenheit (-80 and -60 degrees Celsius).
LONDON – South Africa has decided against using the 1 million doses of Astrazeneca plc’s COVID-19 vaccine already in the country to start the rollout of its national vaccination program, in favor of opening a phase IIIb study of Johnson & Johnson’s single shot product. “Over the next few days, we expect to announce a plan to expedite vaccination using [J&J’s] investigational vaccine in health care professionals in South Africa,” said Glenda Gray, CEO of the South African Medical Research Council and chair of the country’s research committee on COVID-19.
LONDON – A follow-up study of participants in the phase II/III U.K. trial of Astrazeneca plc’s COVID-19 vaccine has shown it remains effective against the new B.1.1.7 variant of SARS-CoV-2.
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.
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.
Johnson & Johnson has been looking to make a big splash in robotics. Now, its Depuy Synthes unit has made progress on this front, gaining U.S. FDA clearance for the Velys robotic-assisted solution designed for use with the Attune total knee system. The solution aims to help simplify surgeons’ existing workflow around total knee replacement.
