Efforts to develop a COVID-19 vaccine must not skip important steps during clinical evaluation, experts explain.
What would you do for $2.1 billion?
That’s the US government funding, awarded collectively, to 2 biotech firms—Novavax and Moderna Therapeutics—to develop a vaccine for coronavirus 2019 (COVID-19) under the Trump administration program called “Operation Warp Speed.” Neither firm, it’s worth noting, has ever successfully brought a drug or vaccine to market.
Which in and of itself shouldn’t disqualify them for funding under the program. Track record and experience are nice to have; competency and innovation may be more important.
However, while we all want a vaccine for COVID-19, the disease caused by the new coronavirus, SARS-CoV-2, as soon as possible, we also want one that is safe and effective, as demonstrated by thorough and considered clinical trials. And that is essentially the take-home message of a commentary published in JAMA Network Open.
“The rigorous processes to assure vaccine safety and efficacy should be followed and we should not cut corners,” coauthor Nicole Lurie, MD, MSPH, strategic advisor to the chief executive officer at the Coalition for Epidemic Preparedness Innovations (CEPI), told Contagion®.
“If a vaccine is going to be made available before it is licensed, it should be with informed consent and with robust monitoring systems in place,” said Lurie, who served as Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services (HHS) from 2009 to 2015 and is a Distinguished Health Policy Fellow at the University of Pennsylvania.
On the surface, at least, Operation Warp Speed is certainly well intentioned. Established by HHS in April, its goal is to deliver 300 million doses of a “safe and effective vaccine” by January 2021. At present, it’s focused on 5 “core candidates,” according to the authors of another JAMA Network Open commentary.
However, Lurie and her colleagues note that for the initiative to be successful, the independence of the US Food and Drug Administration (FDA) must “be respected, standards maintained, and politicians kept from pronouncements that create the appearance of interference.” They cite the results of a recent survey, which found that less than half of all Americans would be willing to receive a COVID-19 vaccine, and that 1 in 5 had concerns about the safety of a shot.
To respond to these legitimate concerns, they write, vaccine development efforts must be built on clinical trials that provide strong evidence of efficacy and safety, particularly in key populations (including the elderly and those with underlying health conditions, who are increased risk for serious illness and death from COVID-19).
In addition, should a vaccine receive FDA approval under an emergency use authorization (EUA), they advise that the agency “require informed consent using a process that explains why the product is only available under an EUA, helping ensure all users understand the vaccine is not yet approved.” Otherwise, “trust in all vaccines may be seriously compromised” if safety and efficacy issues emerge, they suggest.
“We’re all in a rush to bring the pandemic to an end, but rushing the authorization of vaccines, before they are shown to be safe and effective, has additional risks, including destroying confidence in the vaccine system globally," Lurie said. “If we do that, we will lose many, many more lives than we will save.”
Indeed, “warp speed” is nice but, as the old saying goes, “safety first.”