A dangerous rush for vaccines

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Science  21 Aug 2020:
Vol. 369, Issue 6506, pp. 885
DOI: 10.1126/science.abe3147

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The chasm between science and politics continues to grow, with Russian President Putin announcing this week that a fast-tracked vaccine for coronavirus disease 2019 (COVID-19) is ready for use, and President Trump indicating days earlier that a vaccine could be ready in the United States before the 3 November presidential election. There's been a dangerous rush to get to the vaccine finish line first. In a race of “Sputnik” proportions (as Putin puts it), quick approval by regulatory agencies is needed to “win.” This is dangerous thinking, driven by political goals and instant gratification: Shortcuts in testing for vaccine safety and efficacy endanger millions of lives in the short term and will damage public confidence in vaccines and in science for a long time to come.

The Russian vaccine remains shrouded in mystery—there is no published information about it, and what has been touted comes from the mouths of politicians. In the United States, the pressure applied to government scientists by the administration on any aspect of the pandemic is becoming increasingly palpable, as they have been criticized or quieted in plain sight by the administration and Trump. Anthony Fauci, the nation's foremost leader on infectious diseases and a member of the White House Coronavirus Task Force, has been the most willing to state things clearly, but he has had to deal with muzzling and outright abuse from Trump and White House adviser Peter Navarro (not to mention shameful threats of violence against him and his family).

The majority of epidemiologists worldwide who work on infectious diseases are firmly committed to randomized controlled trials (“phase 3”) for all interventions, but especially for vaccines to be given to healthy people. This method allows comparison to a control group that receives a placebo. The phase 3 studies now under way on promising COVID-19 vaccine candidates involve approximately 30,000 patients. A randomized controlled trial is particularly important for determining the effectiveness of the vaccine, and the trial must continue until individuals in the control group become infected. It is impossible to predict how long that will take. Physicians who seek to advise healthy patients on taking the vaccine will rightfully require these data.

The U.S. Food and Drug Administration (FDA) has a Vaccines and Related Biological Products Advisory Committee to consult on the approval of vaccines and any associated emergency use authorizations. There are calls for assurances that there will not be any such authorization for COVID-19; the only emergency use authorization ever granted for a vaccine was for one against anthrax because of the purported threat of biological warfare involving this agent. In any event, the scientific community in the United States must insist that approvals of an emergency use authorization or for a COVID-19 vaccine itself should be made in consultation with the FDA's Committee—and actions around the world should involve similar scientific oversight.

Premature approval of a vaccine in the United States (or anywhere) could be a disastrous replay of the hydroxychloroquine fiasco but with much higher stakes. Approval of a vaccine that is harmful or isn't effective could be leveraged by political forces that already propagate vaccine fears.

So far, U.S. government scientists are holding strong. Francis Collins, director of the National Institutes of Health, emphatically called for phase 3 trials of vaccines, and FDA director Stephen Hahn also has stated that he will follow the science. There's a lot riding on Hahn, and as long as he holds firm with the science, the scientific community should support him. He made a mistake in granting an emergency use authorization for hydroxychloroquine but withdrew it once he saw the data—randomized clinical trials showing that the drug was useless against COVID-19. Now the other faces of the U.S. government's science apparatus—Robert Redfield (director of the Centers for Disease Control and Prevention), Deborah Birx (response coordinator of the White House Coronavirus Task Force), and Brett Giroir (assistant secretary for Health)—need to push all their chips onto the table in favor of a phase 3 randomized controlled trial on any COVID-19 vaccine. Despite their periodic squirming and equivocation, these leaders all deserve and need the nation's support as long as they continue to respect the science on this issue.

Countless lives are at stake—no compromises on the vaccine.

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