Before authorizing or licensing any COVID-19 vaccine, the U.S. FDA will hold a public advisory committee meeting on that vaccine, FDA Commissioner Stephen Hahn said at a Sept. 23 hearing before the Senate Health, Education, Labor and Pensions Committee.
The Astrazeneca plc and Oxford University phase III trial of their adenovirus-based coronavirus vaccine is back up and running in the U.K. after a week’s worth of study and decision-making. The company said it still plans to report data from the study by the end of this year.
LONDON – The U.K. government has signed a €1.4 billion (US$1.7 billion) advance purchase agreement with French biotech Valneva SE, for the supply of up to 190 million doses of its attenuated COVID-19 vaccine, VLA-2001.
With phase III COVID-19 vaccine trials each enrolling 30,000 participants or more in the U.S. and randomizing half of them to a placebo arm, only 150 incidents of the coronavirus infection are needed in a trial to show if the vaccine is at least 50% effective, NIH Director Francis Collins testified at a Senate Health, Education, Labor and Pensions (HELP) Committee hearing Sept. 9.
LONDON – CEOs of five leading biopharma companies have hit back against any suggestion COVID-19 vaccines and therapies could be approved in advance of phase III data, saying it is imperative the highest standards of quality, safety and efficacy are upheld everywhere. The most important thing is to reinforce to the public the commitment to safety as the number one priority, said Kenneth Frazier, CEO of Merck & Co. Inc.
The idea of patent pools such as the COVID-19 Technology Access Pool (C-TAP) created by the World Health Organization a few months ago has drawn a lot of support from low- and middle-income countries and a handful of wealthier ones, but not so much from industry.
With strong results in hand from the phase I stage of its phase I/II study testing a would-be COVID-19 subunit vaccine, Novavax Inc.’s president of R&D, Gregory Glenn, said “it’s possible we could go down in the dose” as work proceeds and get similar efficacy.
The share prices of blue-chip biopharmaceutical companies continued on their lackluster trajectory, which started in June and collectively lost ground last month, with the BioWorld Biopharmaceutical index slipping about 1.3% as investors took a break in order to digest the deluge of COVID-19 vaccine data released during the period and the impact on the bottom lines that the pandemic has exerted among those companies that have reported their second-quarter results.
As Pfizer Inc. and Biontech SE start their massive phase II/III safety and efficacy trial evaluating a single nucleoside-modified messenger RNA candidate from their BNT-162-based vaccine program against SARS-CoV-2, smaller, privately held Codagenix Inc. plans a different approach.
