Rival Vaccine Makers Band Together For Safety Pledge
Nine pharmaceutical companies are expected to sign a statement intended to reassure the public that they will not seek premature approval of COVID-19 vaccines due to pressure from the Trump administration.
The Wall Street Journal:
Covid-19 Vaccine Developers Prepare Joint Pledge On Safety, Standards
Several drug makers developing Covid-19 vaccines plan to issue a public pledge not to seek government approval until the shots have proven to be safe and effective, an unusual joint move among rivals that comes as they work to address concerns over a rush to mass vaccination. A draft of the joint statement, still being finalized by companies including Pfizer Inc., Johnson & Johnson and Moderna Inc. and reviewed by The Wall Street Journal, commits to making the safety and well-being of vaccinated people the companies’ priority. The vaccine makers would also pledge to adhere to high scientific and ethical standards in the conduct of clinical studies and in the manufacturing processes. (Loftus and Hopkins, 9/4)
Stat:
Amid Broad Mistrust Of FDA And Trump Administration, Drug Companies Seek To Reassure Public About Covid-19 Vaccine Safety
In a statement, the companies pledged to “make the safety and well-being of vaccinated individuals our top priority.” The vaccine developers said they would continue to impose high ethical and scientific standards on the vaccine-testing process, and apply for government authorizations only “after demonstrating safety and efficacy through a Phase 3 clinical study.” The group of nine companies includes Moderna, AstraZeneca, and the ongoing collaboration between Pfizer and BioNTech — three of the Covid-19 vaccine efforts that have advanced into late-stage clinical trials, and whose vaccine candidates are likely to be considered for emergency approvals in the coming months. Top executives at Merck, GlaxoSmithKline, Johnson & Johnson, Sanofi, and Novavax also signed the pledge. (Facher, 9/8)
The New York Times:
Pharma Companies Plan Joint Pledge On Vaccine Safety
The pharmaceutical companies are not the only ones pushing back. Senior regulators at the Food and Drug Administration have been discussing making their own joint public statement about the need to rely on proven science, according to two senior administration officials, a move that would breach their usual reticence as civil servants. (Thomas, Weiland and LaFraniere, 9/4)
The Hill:
Vaccine Scientist: 'Smart Business Practice' For Companies To Not Seek Premature FDA Approval
Vaccine scientist Peter Hotez on Monday called a safety pledge by pharmaceutical companies for the development of a coronavirus vaccine “smart business.” “They want this vaccine to work and they want people to trust their pharmaceutical company,” Hotez, the dean of Baylor College of Medicine’s National School of Tropical Medicine, told CNN. (Budryk, 9/7)
