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(CNN) – Nine vaccine manufacturers say they have signed a joint pledge to maintain “high ethical standards,” suggesting that they will not seek premature government approval for any COVID-19 vaccines they develop.
“We, the undersigned biopharmaceutical companies, want to make clear our continued commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles,” the pledge, published Tuesday, reads.
Companies that signed the pledge include AstraZeneca, BioNTech, Moderna, Pfizer, Novavax, Sanofi, GlaxoSmithKline, Johnson & Johnson, and Merck.
President Trump has repeatedly pushed for a quick vaccine schedule, even referencing Election Day in November.
“[It’s] it will be done in a very short period of time, it could even do it during the month of October, “the president said at a press conference on Monday. We will have the vaccine soon, perhaps before a special date. You know what date I’m talking about. “
On August 6, Trump said he was “optimistic” that a vaccine would be ready by November 3. This has caused widespread concern that the federal government may put a vaccine on the market before it has been properly tested.
And late last month, US Food and Drug Administration commissioner Dr. Stephen Hahn said in an interview with the Financial Times that the agency could consider emergency use authorization or approval for a vaccine. COVID-19 before critical Phase 3 trials are completed.
The nine companies wrote Tuesday that they commit to “submit for emergency use approval or authorization only after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet the requirements of expert regulatory authorities. like the FDA. “
There are qualifications in the promise. At the end of a press release on the engagement, the companies mention “risks and uncertainties” that could cause some different results in the future.
“These risks and uncertainties include, but are not limited to: competition to create a vaccine for COVID-19; the ability to produce comparable clinical results in larger and more diverse clinical trials; the ability to effectively scale our production capabilities; and other potential difficulties, “BioNTech said in a statement.
Pfizer and Moderna have vaccines in phase 3 clinical trials in the United States; Johnson & Johnson is preparing to start one. Vaccine manufacturers are looking to enroll at least 30,000 volunteers so they can find out if the vaccine is really safe and protects people from infection.
Vaccine developers engaged in a commitment to uphold high ethical standards for vaccines felt the need to reiterate their commitment to high ethical standards and scientific processes, Pfizer CEO Albert Bourla said on NBC’s Today show on Tuesday.
“With the public’s growing concern about the processes that we are using to develop these vaccines and, more importantly, the processes that will be used to evaluate these vaccines, we saw it as critical to go out and reiterate our commitment that we will develop our products. ., our vaccines, using the highest ethical standards and the most scientific [rigorous] processes, “Bourla said.
All nine vaccine manufacturers said they will support science, at a time when the world is looking to science, particularly a vaccine, to help us end the pandemic, Bourla said.
“The only rival here is the virus, and it is time to vaccinate it,” Bourla said.
He called the compromise between nine vaccine manufacturers “historic” and “an unprecedented moment.”
This story was first published on CNN.com, “9 Vaccine Manufacturers Sign Safety Pledge in Race for COVID-19 Vaccine”
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