Lawmakers Urge Drugmakers to Include Trial Transparency in COVID Vaccine Pact

In letters sent yesterday, leaders of the House Energy and Commerce committee urged nine companies developing COVID-19 vaccines to uphold their pledge to maintain high ethical standards and to commit to transparency in making all clinical trial data on their vaccines publicly available.

The companies pledged last week to “uphold the integrity of the scientific process” when filing for approval of their vaccines, in a move meant to ease public doubts about the approval process (DID, Sept. 9).

Energy and Commerce Committee Chair Frank Pallone, Jr. (D-N.J.), Health Subcommittee Chair Anna G. Eshoo (D-Calif.) and Oversight and Investigations Subcommittee Chair Diana DeGette (D-Colo.) noted that the president, who has repeatedly suggested a vaccine could come as early as next month, has accused FDA officials of intentionally delaying a decision on a vaccine until after the election on Nov. 3.

The lawmakers said the political pressure is eroding public trust in a vaccine, noting that only one in five people say they would get vaccinated if its available. In July, one in three people suggested they would take one.

The three Democrats also asked if the companies would object if a federal agency filed for Emergency Use Authorization of their vaccines rather than them doing it.

“Dire consequences could result if any eventual authorization or approval of a vaccine is influenced by political pressure and is not based on sound science,” the lawmakers wrote, giving the companies until Oct. 2 to respond to their concerns.

The letters were sent to AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Sanofi and Pfizer. Of the nine vaccine developers, AstraZeneca, Moderna and Pfizer/BioNTech currently have candidates is late-stage trials. — Jordan Williams