SPECIAL REPORT #20.24
COVID Vaccine Development
Earlier this week two important events, dealing with COVID vaccine development occurred and both went almost unnoticed to the mainstream media.
The first one is a “historic pledge” by nine leading European and American Pharma companies outlining a united commitment to “uphold the integrity of the scientific process as they work towards potential regulatory filings and approval of the first COVID-19 vaccines”.
The second one is the suspension of AstraZeneca’s late-stage trials AZD1222, its COVID-19 vaccine, after an illness in a participant in Britain. The patient was reportedly suffering from symptoms associated with a rare spinal inflammatory disorder called transverse myelitis.
The CEOs of AstraZeneca, BioNtech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi made their common statement after a rise in concern that safety and efficacy standards might slip in the rush to find a vaccine. The pledge** indicates clearly that the top priority will be safety and that the companies will continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes. “We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved” stated the nine CEOs. The issue emerged because several companies could unveil early pivotal trial data in October, potentially placing them in a political fierce debate, before the November 3rd US presidential election. President Donald Trump has already stated that he believes the United States will have a vaccine before the election.
“My biggest fear is that we will approve vaccines that are not safe and that will have a negative impact on the concept of vaccination in general” said Michael Scholl the CEO of Leukocare, a German based vaccine company, who did not sign the pledge.
The clinical hold placed on AstraZeneca COVID-19 vaccine trial highlights serious issues with the rush to approve a new COVID vaccine and the safety issues already identified with the limited use for the Russian and the Chinese vaccines. AstraZeneca’s CEO, Pascal Soriot nevertheless said that his company is still aiming for its vaccine to be ready by this year-end, although he stated that it is unclear how long the trial will remain on hold.
** The complete pledge
“We the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles. The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (US FDA). FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.”
Paris, September 11, 2020