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9 Pharma Companies Join to Release Open Letter Promising COVID-19 Vaccine Safety

  • Nine vaccine makers released a joint pledge to listen to the science in their development of COVID-19 vaccines.
  • The companies that signed the pledge include AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi.
  • In a survey, 72 percent of Republicans and 82 percent of Democrats thought the process was driven more by politics than science.

Nine vaccine makers signed a joint pledge holding themselves to “high ethical standards and sound scientific principles” in the development and testing of potential vaccines for COVID-19.

They also pledged to apply for government approval of a vaccine only “after demonstrating safety and efficacy through a Phase 3 clinical study.”

The companies that signed the pledge include AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi.

Concerns about politicized vaccine process

This statement comes as President Donald Trump continues to push for quick approval of a vaccine against the coronavirus that causes COVID-19.

“We are going to have a vaccine very soon, maybe even before a special date. You know what date I’m talking about,” he said at a press briefing on Monday according to CNN referencing Election Day on November 3.

Trump’s comments and others made by top U.S. health officials have raised concerns that a COVID-19 vaccine may be rushed for political reasons.

Food and Drug Administration (FDA) Commissioner Dr. Stephen Hahn said in an interview with the Financial Times that the agency could consider an emergency use authorization for a COVID-19 vaccine before phase 3 clinical trials are complete.

However, he said it is up to the vaccine developers to apply for this authorization.

Herschel Nachlis, PhD, a research assistant professor of government and a policy fellow in the Nelson A. Rockefeller Center for Public Policy and the Social Sciences at Dartmouth College, notes that political pressure on the FDA is not uncommon.

“Regulatory decisions are often combinations of both policy and politics,” he said, “and this time will be no different.”

However, he says the vaccine makers seem to understand the need for COVID-19 vaccine decisions to be based on the quality of the data and the integrity of the regulatory processes.

“An important feature of the pledge is that firms are saying that they will not be pressured into submitting bad data, or into submitting data that does not show evidence of vaccines’ safety and efficacy, to the FDA,” he said.

Peter Loge, an associate professor of media and public affairs at The George Washington University, says that it is in the vaccine makers’ best interest to insist on a rigorous review of their vaccines.

“Real cures cost real money [for pharmaceutical companies] to develop,” he said. “If there is no national or international standard for safe and effective treatments, companies that spend the resources to get it right will quickly lose market share to companies that don’t bother to ensure their claims are true.”

The nine vaccine makers’ news release called their pledge “historic” because it is unusual for competing companies to work together.

However, Loge says this collaboration is no substitute for independent federal regulation.

Public health observers should be “worried that industry self-regulation could make independent review even tougher,” he said. “The [vaccine makers’] pledge is probably good for public health, but there’s a reason the FDA exists.”

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