The gap between science and politics continues to grow, with Russian President Putin announcing this week that an accelerated vaccine for 2019 coronavirus disease (COVID-19) is ready for use, and President Trump indicated days earlier that a vaccine could be ready in the United States ahead of the November 3 presidential election.
There has been a dangerous rush to get to the vaccine finish line first.
In a race of ‘Sputnik’ proportions (as Putin puts it), swift regulatory approval is needed to ‘win’.
This is dangerous thinking driven by political goals and instant gratification: Short-lived ways to test for the safety and efficacy of vaccines endanger millions of lives in the short term and will increase public confidence in vaccines and in science for a long time. harm.
The Russian vaccine remains shrouded in mystery – there is no published information on it, and what has been touted comes from politicians.
In the United States, the pressure exerted by the government on government scientists regarding any aspect of the pandemic is increasingly being felt, as they have been criticized or shut down in plain sight by the government and Trump.
Anthony Fauci, the nation’s foremost infectious-disease leader and member of the White House Coronavirus Task Force, was most willing to make matters clear, but he has dealt with muzzles and outright abuse of Trump and Peter Navarro, White House adviser. (not to mention embarrassing threats of violence against him and his family).
The majority of infectious disease epidemiologists worldwide are firmly committed to randomized controlled trials (“Phase 3”) for all interventions, but especially for vaccines given to healthy people.
This method allows comparison with a control group receiving a placebo. The ongoing phase 3 studies of promising COVID-19 vaccine candidates involve approximately 30,000 patients.
A randomized controlled trial is especially important for determining the effectiveness of the vaccine, and the trial should be continued until individuals in the control group become infected.
It is impossible to predict how long that will take. Doctors who want to advise healthy patients on how to take the vaccine will rightly need this data.
The U.S. Food and Drug Administration (FDA) has an Advisory Committee on Vaccines and Related Biologics to consult on vaccine approvals and any associated emergency use authorizations.
It is requested to ensure that no such authorization for COVID-19 will come; the only emergency use authorization ever granted for a vaccine was for an anthrax vaccine because of the alleged threat of biological warfare involving it.
In any case, the scientific community in the United States should insist that emergency use license or COVID-19 vaccine approvals should be made itself in consultation with the FDA committee – and actions around the world should be similar scientific supervision are involved.
Premature approval of a vaccine in the United States (or wherever) could be a disastrous repeat of the hydroxychloroquine fiasco, but with much higher stakes.
Approval of a vaccine that is harmful or ineffective can be exploited by political forces already propagating fears about vaccines.
So far, scientists from the US government are holding out.
Francis Collins, director of the National Institutes of Health, strongly called for phase 3 trials of vaccines, and FDA director Stephen Hahn has also stated he will follow the science.
A lot rides on Hahn, and as long as he holds on to the science, the scientific community should support him.
He made a mistake in licensing hydroxychloroquine for emergency use, but withdrew it when he saw the data – randomized clinical trials that showed the drug was useless against COVID-19.
Now the other faces of the U.S. government’s scientific apparatus – Robert Redfield (Director of the Centers for Disease Control and Prevention), Deborah Birx (White House Coronavirus Task Force Response Coordinator), and Brett Giroir (Assistant Secretary for Public Health) – need to put all their chips on the table in favor of a phase 3 randomized controlled trial with any COVID19 vaccine.
Despite their periodic squiggles and ambiguity, these leaders all deserve the country’s support as long as they continue to respect science in this area.
Countless lives are at stake – no compromises on the vaccine.