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Last month, Mike Pence, the vice president, challenged by the government’s failure to contain the coronavirus in the United States, said: “We believe that there is a miracle around the corner.”
Pence could have been speaking beyond faith. On Wednesday, it emerged that the Centers for Disease Control and Prevention (CDC) had instructed states to prepare to distribute a coronavirus vaccine to healthcare workers and vulnerable populations, just in time to the elections of November 3.
For months, critics of the Trump administration have feared that the White House will pressure the Federal Drug Administration (FDA), CDC and other agencies to rush to market a coronavirus vaccine before the election.
Now it appears that Donald Trump could be in a position, as the confirmed death toll in the United States from Covid-19 approaches 200,000, and just as undecided voters look for a sign on which way to go, to announce that a vaccine is imminent.
Efforts to find a safe and effective US Covid-19 vaccine began the gold standard phase three testing stage in July.
The potentially autumn timing of a vaccine for Trump does not mean the vaccine or vaccines are illegitimate, although federal regulators would have to rush the approval process to get a coronavirus vaccine to market so quickly.
Scientifically respected voices in the administration, including Anthony Fauci, the federal leading expert on infectious diseases, have been saying for months that vaccine development is moving fast.
In late July, Fauci told Congress he was “cautiously optimistic” that a “safe and effective” coronavirus vaccine would be available to the public by the end of 2020.
Any launch in late October of an initial wave of vaccine doses, for those who need them most, could be in line with the more aggressive vaccination timelines proposed by experts last spring. However, such an event would also remarkably fit Trump’s political needs as the pandemic continues to spiral out of control in the US.
Critics have been warning for months that Trump could try to rush a vaccine, or exaggerate the magnitude of the initial launch of a vaccine, just as he has exaggerated national testability, to win re-election.
Those critics have pointed out that a key agency in the process, the FDA, which would have to grant emergency use approval for any candidate vaccine to be distributed before the full completion of trials, has proven vulnerable to political pressure.
After Trump touted the drug hydroxychloroquine as an effective coronavirus treatment, the FDA granted an emergency authorization for the drug to be used that way, only to revoke the authorization after two months.
Concerns about the FDA increased over the weekend when agency commissioner Stephen Hahn told the Financial Times that he was prepared to issue an emergency use authorization for a vaccine before the end of phase human trials. three, in which efficacy is tested in tens of thousands of human subjects.
Hahn said the agency’s decision would be based on whether “the benefit outweighs the risk in a public health emergency.”
The CDC did not appear to warn states that a general launch of a new vaccine was imminent, but instead warned them that the vaccine could be ready soon.
The CDC notified public health officials in all 50 states and five major cities to begin preparations to distribute vaccines, the New York Times first reported. The agency outlined guidelines for shipping, mixing, storing and administering two unnamed candidate vaccines, according to the report.
Days earlier, CDC Director Robert Redfield wrote a letter to state governors asking them to “consider waiving the requirements” to allow a company with a federal contract to distribute vaccines to establish local facilities.
Vaccine advocates worry that by potentially launching an ineffective or worse, dangerous vaccine to the market, the government could fuel vaccine skepticism and leave the population vulnerable to diseases once believed to be eradicated if this prompts them to avoid other vaccines.
“The president keeps telling us that the virus is going away,” Joe Biden said at the Democratic national convention last month.
“Keep waiting for a miracle. Well, I have news for him, no miracle is coming. “
Officials have also expressed concern that underfunded state health departments are not ready to be able to distribute and administer a vaccine to the waiting millions.
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