Drug firms: Vaccines won't be rushed

Pledge comes amid political pressure; White House says corners won’t be cut.

The top executives of nine drugmakers likely to produce the first vaccines against the new coronavirus unveiled an unprecedented pledge Tuesday meant to boost public confidence in any approved vaccines.

The companies said they will stick to the highest ethical and scientific standards in testing and manufacturing and will make the well-being of those getting vaccinated their top priority.

The announcement comes amid concerns that the Trump administration will pressure the U.S. Food and Drug Administration to approve a vaccine before it’s proven to be safe and effective.

President Donald Trump has repeatedly said a vaccine could be ready by the end of the year, or even as early as October. His administration also is pressing ahead with Operation Warp Speed, a program meant to accelerate the development and manufacture of vaccines.

The White House said in a statement before the drug makers issued their pledge that Trump has no intention of cutting corners.

“The American people can rest assured that any approval will maintain the FDA’s gold standard for safety and testing to ensure a vaccine or therapeutic is effective,” said White House spokesman Judd Deere, in an email. “This false narrative that the media and now the Democratic nominee for vice president (Sen. Kamala Harris) are suggesting that politics is influencing approvals is not only false but is a danger to the American public.”

Harris, D-Calif., said on CNN’s “State of the Union” Sunday that she would “not take his word for it” and would “not trust” Trump’s declarations about the safety of a vaccine.

Public health officials have expressed doubt that adequate data on vaccine safety and effectiveness would be available before November. They also worry if Americans stay away from the vaccine because they don’t trust it, COVID-19 will be harder to control.

The pledge announced

Tuesday was signed by the chief executive officers of American drugmakers Johnson & Johnson, Merck, Moderna, Novavax and Pfizer, and European companies AstraZeneca, BioNTech, GlaxoSmithKline and Sanofi. BioNTech has partnered with Pfizer on one of the three vaccines now in the final round of human testing.

The companies said they will seek approval or authorization for emergency use only after they have confirmed the vaccines work and are safe through a large, final round of human testing.

“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 pledge states.

The CEOs also promised to “ensure a sufficient supply and range of vaccine options, including those suitable for global access.” The statement noted the nine companies previously created more than 70 new vaccines against deadly diseases, helping to eradicate some of them.

The executives likely worry that skepticism about the their medicines could limit sales, given an AP-NORC poll in May found that only about half of those surveyed planned to get the vaccine. The country already has a small, but vocal, group of “anti-vaxxers” who oppose giving their children the many standard vaccines.

Last week, the Merck and Pfizer CEOs joined chief executives of three other companies that are testing COVID-19 drugs and vaccines to pledge that they won’t seek even emergency approval without solid results in final stage human testing. They added that extra transparency on testing results and the approval process is needed.

Trump’s own top vaccine adviser, Operation Warp Speed co-chief Moncef Slaoui, has said in a recent interview on NPR last week that it is “very unlikely” a vaccine would be authorized before Election Day.

Slaoui was responding to reports that the Trump administration had told states to prepare to distribute vaccine by Nov. 1, two days before the election.

“There is a very, very low chance that the trials that are running as we speak could [be completed] before the end of October and therefore there could be — if all other conditions required for an Emergency Use Authorization are met — an approval,” Slaoui told NPR. “I think it’s extremely unlikely but not impossible, and therefore it’s the right thing to do to be prepared, in case.”

Slaoui said in a separate interview with the news site Science that he would not remain in the administration if he detected “undue” political pressure in vaccine approval.

“I would immediately resign if there is undue interference in this process,” he said, adding: “I have to say there has been absolutely no interference.”