NEW YORK — Aiming to boost public trust in a coronavirus vaccine, the heads of 9 pharmaceutical companies have pledged together not to rush out a vaccination before it is proven safe and effective.
The joint statement was issued Tuesday by the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi.
“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 statement said.
The pledge comes less than two weeks after the the Centers for Disease Control and Prevention notified health officials in all 50 states and five large cities to prepare to distribute a coronavirus vaccine around Nov. 1, two days before Election Day. That has heightened concerns that President Donald Trump could be pressuring companies and health officials to speed up the release of a vaccine to help score political points.
Meanwhile, a recent USA Today/Suffolk Poll found that, despite 6.3 million coronavirus cases and nearly 190,000 deaths in the U.S., two-thirds of Americans say they won’t get the vaccine as soon as it becomes available.
In their statement, the vaccine makers promised to:
Always make the safety and well-being of vaccinated individuals their top priority
Continue to meet high scientific and ethical standards regarding clinical trials and the manufacturing process
Only request approval or emergency use authorization from the Food and Drug Administration after a vaccine has proven to be safe and effective through a Phase 3 clinical trial
Work to ensure there is a sufficient supply and range of vaccine options, include those suitable for global access.
"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," the vaccine makers said.
The CEOs stressed that vaccinations are reviewed by the FDA, whose approval is “based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines.”
FDA Commissioner Stephen Hahn said last week the agency is prepared to fast-track a vaccine if officials believe the benefits outweigh the risks. But he has repeatedly insisted his agency won’t allow politics to interfere with its approval process and noted that it cannot authorize a vaccine until after a pharmaceutical company has submitted it for consideration.
Moderna and Pfizer began Phase 3 clinical trails in late July with their vaccine candidates. AstraZeneca announced last week that its vaccine has also entered the final stage of testing, and CNN reported that Johnson & Johnson is also preparing to start Phase 3 testing, which requires enrolling 30,000 volunteers.