9 drugmakers pledge not to rush COVID-19 vaccine to approval

Sept. 8 (UPI) -- The leaders of nine companies developing COVID-19 vaccines signed a pledge Tuesday to "uphold the integrity of the scientific process" amid political pressure for quick regulatory approval.

The CEOs vowed in the pledge to maintain "high ethical standards and sound scientific principles" and said they won't seek government approval at any time before their vaccine candidates begin large-scale late-stage studies.

The statement was signed by the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Pfizer and Sanofi, each of whom have vaccines that are in late-stage clinical trials.

President Donald Trump has repeatedly pushed for a quick vaccine timeline, which has alarmed some health experts who worry he's pressuring regulators for premature approval to gain a political advantage before the Nov. 3 election.

Echoing those concerns, Democratic vice presidential candidate Sen. Kamala Harris said she would not trust a vaccine based on Trump's word alone.

"I would not trust Donald Trump and it would have to be a credible source of information that talks about the efficacy and the reliability [of a vaccine]," she said Sunday.

"We'll have the vaccine soon, maybe before a special date," Trump said Monday. "You know what date I'm talking about."

Government and civilian experts have said large-scale Phase III trials for any vaccine are unlikely to be finished until very late this year or early next.

In their pledge, the nine CEOs pledged to submit vaccines for approval or emergency use authorization only "after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities."

"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," they said.