USA TODAY US Edition

Experts: Politics can’t infect science of vaccine

Developmen­t process is well regulated, they say

- Elizabeth Weise and Karen Weintraub

Despite the public’s legitimate concerns about political rhetoric, politics is not influencin­g the developmen­t of a COVID-19 vaccine, several public health experts testified to Congress Wednesday.

Both government and independen­t researcher­s provide strong oversight of vaccine developmen­t, said Dr. Mark McClellan, director of the Duke-Margolis Center for Health Policy at Duke University and a former Food and Drug Administra­tion commission­er.

“This is not an easy process to disrupt just because somebody says something about it,” he said. “It does undermine confidence, though.”

President Donald Trump has said frequently that a coronaviru­s vaccine could be available “soon,” “within weeks” and before Election Day. That has raised fears that the White House might pressure the FDA to authorize a vaccine before it has gone through the full regulatory oversight process, as has happened with at least two COVID-19 treatments.

The public health and medical experts testifying before the House Committee on Energy and Commerce on Wednesday said they didn’t think that would be possible, though they didn’t discount it entirely.

If a COVID-19 vaccine were to be released before it had been fully and appropriat­ely vetted, the public will know because scientists and researcher­s will tell them, said Dr. Paul A. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelph­ia.

“You will also hear from people like Drs. Francis Collins and Tony Fauci, both of whom are trusted by the American public, as well as many other academicia­ns and researcher­s who wouldn’t stand for this,” said Offit, who also sits on an independen­t vaccine review committee that advises the FDA.

McClellan noted that on Tuesday, seven former FDA commission­ers published an opinion piece in The Washington Post saying that while the Trump administra­tion has undermined the credibilit­y of the FDA, they continued to have confidence in the integrity and high-quality scientific work of agency staff.

A vaccine could be approved within the next month, even under an Emergency Use Authorizat­ion, only if there were a “home run” when it comes to the science, with everything in the studies and the process going perfectly. Even then there will have been strict FDA oversight, McClellan said.

Having politician­s talking about timelines only muddies the waters and leads to confusion that is not helpful, said Dr. Ashish Jha, dean of the School of Public Health at Brown University.

If career scientists at the FDA and the Centers for Disease Control and Prevention are allowed to do their job and speak freely to the public, the process will be sound, he said.

“What I’ve been asking is for politician­s to basically be quiet, to knock it off, to stop talking about a date and let the scientific process move forward,” he said. “That would be enormously helpful and would go a long way to offering assurance to the American people that this is a process with integrity.”

 ?? GETTY IMAGES ?? Some fear political pressure on the FDA to authorize a vaccine too early.
GETTY IMAGES Some fear political pressure on the FDA to authorize a vaccine too early.

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