Big Pharma Makes Unusual Ethics Pledge on Vaccine Work

The first patient enrolled in Pfizer’s Covid-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore receives an injection on May 4. (Credit: University of Maryland School of Medicine)

(CN) — In a bid to assuage safety misgivings in the public imagination, nine drug company CEOs signed a rare pledge Tuesday attesting to strict ethical standards and scientific principles being followed in work on the coronavirus vaccine.

In their statement, officials from pharmaceutical giants AstraZeneca, GlaxoSmithKline, Johnson & Johnson, Merck, BioNTech, Moderna, Novavax, Sanofi and Pfizer said they will only submit vaccines for approval or emergency-use authorization with the Food and Drug Administration after the products have been proven safe and effective in Phase 3 clinical trials.

The letter calls “the safety and well-being of vaccinated individuals our top priority,” and says the companies will “continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.”

With more than 6 million confirmed infections, and nearly 190,000 lives lost to Covid-19, America has the highest coronavirus case tally of any country in the world. The country is also just two months out from an election where the Covid-19 pandemic, and President Trump’s handling of it, is all consuming.

Trump has repeatedly said an immunization could be ready before the November 3 election while talking publicly about “Operation Warp Speed,” a public-private partnership initiated by the Trump administration to rapidly develop a Covid-19 vaccine. Against this rhetoric, however, Trump’s public pressure on the FDA has led some to worry that a vaccine will be approved before the election, regardless of whether it has been proven safe and effective.

Speaking to this concern Monday, Democratic candidate Joe Biden expressed a need for “full transparency” with vaccine testing.

“He has said so many things that aren’t true I am worried that if we do have a really good vaccine people are going to be reluctant to take it,” Biden said. 

Underscoring the threat of public distrust when it comes to the vaccine, an AP-NORC poll conducted in May showed that only half of those surveyed planned to get the vaccine when it becomes available.

The FDA’s credibility has taken considerable hits since then, most recently when it granted emergency-use authorizations, at President Trump’s urging, of convalescent plasma and the malaria drug hydroxychloroquine to treat for Covid-19.

Last week the Centers for Disease Control and Prevention told state officials to be ready for a vaccine by November 1 — two days before the election. The agency asked governors and health departments to fast-track construction permitting for distribution sites.

The Biotech Innovation Organization meanwhile released a letter calling for the FDA to “maintain its historic independence as the gold-standard international regulatory body, free from external influence.”

“The public’s trust in new medical products, are dependent upon the integrity, transparency and objective assessment of new data as they emerge,” the group said on Sept. 3.

According to the New York Times, researchers across the globe are testing 37 vaccines in clinical trials on humans while at least 91 preclinical vaccines are being tested on animals.

“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,” Tuesday’s letter from the pharmaceutical executives states.

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