The four life science companies leading the race to develop an American COVID-19 vaccine will this week issue a statement promising not to be pressured by President Donald Trump into releasing vaccines for use unless they are safe and effective.
The promise will be made by Pfizer, Inc., Johnson & Johnson, Moderna and AstraZeneca PLC. All four companies and their respective partners are now conducting phase-3 human trials that will determine the safety and efficacy of their vaccines in several countries worldwide. At least 30,000 people have to be enrolled in each phase-3 trial.
The vaccines being developed are mRNA-1273 by Moderna and the National Institute of Allergy and Infectious Diseases; BNT162b2 from Pfizer-BioNTech; hAdOx1 nCoV-19 from AstraZeneca-University of Oxford and Ad26.COV2.S (adenovirus serotype 26) from Johnson & Johnson.
All four companies are receiving U.S. federal government funds under "Operation Warp Speed" to develop their vaccines. Launched in April, the operation intends to facilitate and accelerate the development, production and distribution of COVID-19 vaccines, therapeutics and diagnostics.
Leading American public-health experts worry Trump will rush vaccine development to boost his bid for re-election in November. On Friday, Trump said a coronavirus vaccine would probably be available for distribution in October despite experts asserting this will only take place in 2021.
In a draft leaked to the news media all four companies promised to seek emergency use authorization for their vaccines only after final phase-3 trials showed "substantial evidence of safety and efficacy."
"We believe this pledge will help ensure public confidence in the COVID-19 vaccines that may ultimately be approved and adherence to the rigorous scientific and regulatory process by which they are evaluated," according to the statement.
Trump believes a vaccine before the election Nov. 3 will be needed to ensure his re-election. Several administration officials quoted in news reports have confirmed this. Some White House officials agree Trump's re-election hinges on a vaccine being in circulation before the election.
"This timeline of the initial deployment at the end of October is deeply worrisome for the politicization of public health and the potential safety ramifications," University of Arizona epidemiologist Dr. Saskia Popescu said. "It's hard not to see this as a push for a pre-election vaccine."
Trump previously boasted a vaccine could become available "right around" Nov. 3. "I'm rushing it," Trump said. "I am. I'm pushing everybody."
The goal of Operation Warp Speed is to deliver 300 hundred million doses of a safe and effective COVID-19 vaccine by the end of the year.
