Pharma Companies Promised Not to Bow to Political Pressure to Rush Vaccine Production
c0lo writes:
A little bit old, but I don't remember the info being given attention by the media at the time. See below for additional information.
Covid-19: Pharma companies promise not to bow to political pressure to rush vaccine production
The chief executive officers (CEOs) of nine drug companies working towards a covid-19 vaccine have issued a joint statement promising to "only submit [a vaccine] for approval or emergency use authorisation after demonstrating safety and efficacy through a Phase 3 clinical study."
"We pledge to always make the safety and well-being of vaccinated individuals our top priority," wrote the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi on 8 September in a statement entitled Biopharma Leaders Stand With Science.
The statement follows an open letter by seven drug industry CEOs last week urging that "political considerations should be put aside" in covid-19 drug and vaccine development and that clinical data should be publicly disclosed.
The US president, Donald Trump, who pledged a vaccine before the year's end at his party convention, has alleged that "deep state" actors at the Food and Drug Administration are slowing down the vaccine development process to hurt him politically. The FDA commissioner, Stephen Hahn, said on 30 August that his agency might not wait for full phase III trial results-the normal standard required in approving medicines-before granting emergency use authorisation to a covid-19 vaccine.
[...] The CEOs' promise came as Trump reiterated his frequent claim that a vaccine could be ready before the presidential election on 3 November, a claim refuted by his own government's health officials. "We'll have the vaccine soon, maybe before a special date," Trump said at a 7 September press conference. "You know what date I'm talking about."
The developers' public refusal to submit vaccines without phase III results is widely seen as an implicit rebuke of the administration, as well as an effort to shore up public confidence in vaccines at a time when suspicion and misinformation are rife in the United States.
See also:
FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines
NYT Coronavirus Vaccine Tracker
NYT Covid in the U.S.: Latest Map and Case Count
Worldometers' Coronavirus Update (Live)">COVID-19 Map - Johns Hopkins Coronavirus Resource Center.
Maybe this is an explanation of why Trump picked Regeneron?
[Ed Note -
The basic phases of a clinical trial:
Phase I: Is the treatment safe?
Phase II: Does the treatment work at all?
Phase III: How effectively/safely does it work?
See Phases of clinical research.]
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