July 1, 2020 - Washington, D.C. – Speaker Nancy Pelosi released this statement after the U.S. Food and Drug Administration released guidance on the development and licensure of vaccines to prevent COVID-19:
“The whole world is praying for a coronavirus vaccine, but it must be effective and safe to be the answer to our prayers. I therefore welcome 
the standards in the guidance released by the FDA today which are critical to ensuring that Americans can have confidence that any vaccine that is approved for the U.S. will be effective and safe.
“Especially in light of the immense political pressure on the FDA to deliver a vaccine as soon as possible, it is essential that FDA meet their standards to protect the American people. These include:
- The vaccine must have a trial size of 30,000, including diverse populations in all phases of clinical development, especially racial and ethnic minorities.
- It must be found to be at least 50 percent more effective than a placebo.
- There must be full transparency throughout the vaccine approval process, including public advisory committee review by FDA before an emergency use authorization for a new vaccine is approved.
- The FDA should also track the health of those vaccinated for at least a year after vaccination, to ensure we understand the long-term safety of the vaccine.
“Anything less than the FDA’s ‘Development and Licensure of Vaccines to Prevent COVID-19’ guidance would jeopardize the confidence the American people have in the vaccine. We are grateful for this guidance, which gives us hope.”
Source: Speaker Nancy Pelosi
