Statement by Vice President Joe Biden and Senator Kamala Harris on Ensuring a Safe and Effective COVID-19 Vaccine

We are deeply grateful to scientists working around the clock to deliver a safe and effective COVID-19 vaccine as soon as possible. Their work has the potential to save countless lives.

President Donald Trump and Vice President Mike Pence see a COVID-19 vaccine as a political tool. We see it as a product of science and research. Its timing, approval, and distribution should be without regard to political calculation.

In the last seven months, Trump has abdicated his duty and failed to lead on every significant aspect of the COVID-19 response — making promises he's never kept, giving preferences to political allies, and threatening to punish political enemies. We cannot allow a repeat of Trump's testing and personal protective equipment (PPE) fiascos when it comes to a COVID-19 vaccine. The stakes are too high for working families across the country.

That is why, over a month ago, Vice President Biden called on President Trump to follow scientific independence, transparency, and accountability in the development of a COVID-19 vaccine.

Today, we are laying out three questions this Administration must answer to assure the American people that politics will play no role in the approval and distribution of a safe and effective COVID-19 vaccine. Given his track record, no one can take Trump's word alone on a COVID-19 vaccine. But with satisfactory answers to the following questions, every American — including us and our families — can have confidence in a safe and effective COVID-19 vaccine.

1. What criteria will be used to ensure a COVID-19 vaccine meets the scientific standard of safety and efficacy? In June, the U.S. Food and Drug Administration (FDA) laid out the criteria under which it will, if appropriate, issue an Emergency Use Authorization (EUA) for a COVID-19 vaccine. As Election Day has approached, FDA Commissioner Dr. Stephen Hahn has made conflicting comments regarding the standards the Trump Administration will follow. There must be no confusion on this matter. The FDA must clarify what criteria it will use, and President Trump must publicly commit to respecting the independent judgment of the non-political professional staff at the FDA to make this determination. These non-partisan officials — not political appointees — should be given the opportunity to present their analysis publicly and transparently. The American people need confidence in the vaccine to ensure adoption.

2. Who will validate that the Administration's decision to greenlight a COVID-19 vaccine is driven by science and not political motivation? There have been multiple egregious examples of President Trump exerting political pressure on the FDA and undermining public confidence in COVID-19 treatments. The FDA's leadership appears to have bent to White House pressure to issue an emergency authorization for hydroxychloroquine — which it had to withdraw. Dr. Hahn himself contributed to this distrust a few weeks ago by overstating the results for convalescent plasma to treat COVID-19. The Administration must ensure that no decision is finalized unless and until the following people have indicated that such an action is warranted. Specifically, we want to see and hear:

• An uncensored written report on efficacy and safety by the career scientific staff in the Center for Biologics Evaluation and Research;
• An uncensored statement from the relevant advisory committee at the FDA attesting to the safety and efficacy of the vaccine;
• A public statement from Dr. Tony Fauci of the National Institute of Allergy and Infectious Diseases.
• All relevant safety and efficacy data should be made available to the public at the time a final decision is made so that independent medical authorities can evaluate it.

3. What is the plan to allocate and distribute the COVID-19 vaccine to Americans cost-free, safely, equitably, and without politics? The decision to clear a vaccine means little if Americans cannot get a vaccination on a timely basis. The distribution of a COVID-19 vaccine will be a major endeavor, requiring seamless coordination among many officials — a logistical and implementation challenge of the highest order. Given the Trump Administration's track record on testing and PPE, we have deep cause for concern about its ability to see this mission through to success. The Trump Administration should release a detailed distribution plan to ensure every American — not just the wealthy and well-connected — receives the vaccine and communities of color are not left out. The Administration needs to commit that all states will be treated fairly without regard to whether they are "red" states or "blue" states. It needs to tell us who will get the vaccine, in what order, and how many days after the FDA's decision. And, the Administration needs to ensure there are robust data systems in place to track vaccine administration and to monitor post-marketing safety data.