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Public Policy Newsletter Article

Senate Health Committee Examines COVID-19 Vaccines

  • 2020-09-24T14:30:00.000+0000
  • Author: Brittany Blocker

On September 9, the Senate Health, Education, Labor & Pensions (HELP) Committee held a hearing on the role of vaccines in preventing infectious disease outbreaks and the current status of vaccines for COVID-19. The committee heard testimonies from Surgeon General, Dr. Jerome Adams, and National Institutes of Health Director Dr. Francis Collins.

Dr. Collins shared with the committee that there are six vaccine candidates engaged in large-scale U.S. trials for COVID-19. Each vaccine has already undergone rigorous testing in animals followed by phase 1 safety testing in a small group of humans. Three of the six vaccines are in phase 3 of testing where the goal is to inject 30,000 volunteers located in areas where the virus is actively spreading. He expects the other three candidates to enter phase three in the coming weeks and months. He emphasized to the committee that the rigor of the scientific evaluation on safety and efficacy will not be compromised. He explains that they have accelerated vaccine development by carrying out steps in parallel that are traditionally done in sequence. They have also eliminated downtime by moving into new phases before data from the previous phase is completely analyzed.

Chairman Alexander asked if the COVID-19 vaccine will be 100% effective. Dr. Collins says that they will not know until the trials are completed. Chairman Alexander also asked if hand washing, masking, and staying six feet apart practices will mean that will have fewer deaths from the flu this year. Dr. Collins says that it’s possible but encourages the public to get the flu shot. Dr. Adams emphasized that this will be the most important flu season of our lifetime and also expressed the importance of the flu shot to reduce hospitalizations and conserve health care resources.

Senator Murray asked what steps the federal agencies are taking to build trust with the American people and develop airtight practices to ensure science and public health. Dr. Collins explains that all trial data must be reviewed first by the Data and Safety Monitoring Board (DSMB) before it is reviewed by the Food and Drug Administration (FDA). The CEOs of the nine vaccine candidates signed a statement that they will not put forward something to FDA until they're convinced that it meets the highest standards of safety and efficacy. Dr. Adams explained that the Department of Health and Human Services is using a three-tiered approach to improve vaccine confidence through research and evaluation, collaboration and partnerships, communication strategy, and knowledge dissemination. He pledged that there will be no shortcuts and the vaccine will safe and effective or it won’t get moved along.
Senator Murray expressed concerns about the lack of transparency around the role of DSMB in evaluating the safety and efficacy of COVID-19 and asked who sets the standard to determine whether data from a Phase III trial show a vaccine is safe and effective enough to end that trial early. Dr. Collins stated that when the trial is first proposed the FDA has to review whether the demonstration of safety and efficacy is going to meet the FDA’s standard that the vaccine is at least 50 percent effective.

Senator Kaine expressed concerns regarding patient adherence for the vaccine candidates that require two doses. He explained that studies show that for vaccines that require two doses, roughly 40 and 65 percent of people who get the first dose will not get the second dose, and then a significant percentage of the people who get the second dose doesn't get it in time. Dr. Collins shared that in the two-dose trials, the first dose does give some response but the second dose will provide the range of antibodies needed. He believes the ideal vaccine will be a single dose that does not require refrigeration and can be easily transported.