Chief executive officers of nine biopharmaceutical companies signed an unprecedented joint pledge, entitled BIOPHARMA LEADERS UNITE TO STAND WITH SCIENCE, acknowledging the U.S. Food and Drug Administration’s (“FDA”) role in the development of a COVID-19 vaccine, and pledging to:
- Always make the safety and well-being of vaccinated individuals our top priority.
- Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
- Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.
- Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.
The pledge was issued in response to mounting concerns over the timing of a COVID-19 vaccine, and a day after President Trump suggested a vaccine could be approved before the presidential election on November 3. FDA Commissioner Dr. Stephen Hahn tweeted that the FDA “will not cut corners” in approving any COVID-19 vaccine. It also came on the same day that Dr. Anthony Fauci, director of U.S. National Institute of Allergy and Infectious Diseases, said it isn’t likely that a vaccine will be ready by the presidential election but is more likely to be ready by the end of the year. Last week the U.S. Centers for Disease Control informed governors and health departments they should be ready to distribute a COVID-19 vaccine by November 1. A poll conducted in August by Marist, National Public Radio, and the PBS NewsHour in August found that 60 percent of Americans would take a COVID-19 vaccine and 35% would decline.
In a discussion paper entitled The Contagion Externality of a Superspreading Event: The Sturgis Motorcycle Rally and COVID-19, the Institute of Labor Economics estimates that the annual “Sturgis Motorcycle Rally generated public health costs of approximately $12.2 billion.” Over 460,000 people attended the rally last month. The authors conclude that the rally caused over 260,000 COVID-19 cases and led to a spread of cases in the home counties of those who traveled to Sturgis. Last week the first COVID-19 death connected to the Sturgis motorcycle rally was announced in Minnesota.
Norton Rose Fulbright attorneys will continue to provide relevant updates for healthcare providers on the Health Law Pulse related to the COVID-19 pandemic.