09-08-2020, 01:59 PM
Nine rival companies have pledged that any coronavirus vaccine they produce will be developed and tested with “high ethical standards and sound scientific principles.” The statement appears to be an effort by the pharmaceutical industry to quell public concerns that the vaccine approval process may be influenced by politics or other interests instead of safety.
The statement, signed by the CEO of each company says: “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 companies’ plans for the pledge were first reported by The Wall Street Journal on Friday. Among other things, the statement promises that the companies will “always make the safety and well-being of vaccinated individuals our top priority.”
The statement comes a week after the Centers for Disease Control and Prevention’s preliminary plans for vaccine distribution surfaced. Those documents asked local and state governments to start drawing up their initial plans for vaccine distribution, and they mentioned that “limited COVID -19 vaccine doses may be available by early November 2020” or by late October 2020.
“Always make the safety and well-being of vaccinated individuals our top priority.”
Experts have since said that they consider that timeline “extremely unlikely” and have emphasized the importance of preparing a complex distribution system in advance. But the timing, right before the US presidential election, exacerbated existing fears that the race to find a vaccine was becoming politicized. Even before the CDC documents were published, 78 percent of Americans worried that the approval process for the coronavirus vaccine was being driven more by politics than science, according to a poll from STAT News.
Four of the companies that have signed the pledge— Pfizer, BioNTech, Moderna, and AstraZeneca — have vaccines in large phase three clinical trials. (Pfizer and BioNTech are working together on one candidate that has reached this level.) This phase, which involves tens of thousands of volunteers, is used to prove that the vaccine candidates are both safe and effective.
If data from one of those trials shows promise, the developer can choose to send the information to the Food and Drug Administration, which has the power to approve vaccines in the United States. The approval process is rigorous, and usually, it can take years. But the FDA has indicated that it may be willing to issue an Emergency Use Authorization for this vaccine, which takes much less time.
Recent emergency authorizations for COVID-19 treatments have proven highly controversial
Recent emergency authorizations for COVID-19 treatments have proven highly controversial. Less than two weeks after the FDA authorized the use of convalescent plasma, a panel at the National Institutes of Health said there wasn’t enough data for them to recommend plasma as a treatment for COVID-19 patients. Earlier this year, the FDA issued an emergency authorization for hydroxychloroquine, then revoked the order, finding that it wasn’t likely to be effective and had serious side effects.
If a vaccine gets emergency authorization, the company (or companies) that produce it don’t want to go through the same back-and-forth. That’s one reason that the vaccine developers are making a public pledge that they won’t ask the FDA for approval until they have data from these phase three trials that shows a vaccine is both safe and effective.
They already have an idea of what benchmarks they need to meet. In addition to demonstrating that the vaccine is safe, to get FDA approval, a vaccine will have to show that it is 50 percent more effective than a placebo, FDA head Stephen Hahn said in June.
In addition to the promises to put the well-being of vaccinated people first and to not ask the FDA to approve or authorize a vaccine without strong data from phase three trials, the companies also made two other pledges:
- To “continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes”
- And to “work to ensure a sufficient supply and range of vaccine options, including those suitable for global access”
Approximately 37 vaccines are in various stages of human trials, according to The New York Times’ vaccine tracker, with many others still being tested in animals or in development.