Enlarge /. The headquarters of the Food and Drug Administration in White Oak, Maryland.
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President Donald Trump said Wednesday he could oppose the Food and Drug Administration's plan to issue stricter safety and efficacy standards for COVID-19 vaccines, calling the plan a "political move."
The new standards aim to build public confidence in the FDA and its vaccine review process, which has been badly damaged by many reports of political interference and interference from the Trump administration. These reports contain allegations that the FDA has been pressured by the White House to allow COVID-19 patients to receive treatment with unproven blood plasma and the malaria drug, hydroxychloroquine, which Trump has personally touted. (The approval of hydroxychloroquine was later revoked by the FDA.) Just last week, Trump's Minister for Health and Human Services, Alex Azar, revoked the FDA's authority to sign new regulations.
Trump himself has consistently undercut state health advice and government scientists, notably Robert Redfield, its director of the Centers for Disease Control and Prevention. Trump has also repeatedly pushed for a vaccine to be released before the elections, although again experts have repeatedly pointed out that such a quick release is next to impossible based on the schedule of ongoing clinical trials and the amount of data required, even preliminary assessments of safety and effectiveness .
As a result, public confidence in the FDA's vaccine review process has decreased. The percentage of people who said they were ready to receive an FDA-cleared COVID-19 vaccine declined from 72 in May to 51 this month, according to a survey by the Pew Research Center.
To push those numbers up again, the FDA planned to expedite its approval process. It was announced earlier this week that the agency was ready to introduce new, stringent standards for a COVID-19 vaccine in order to gain approval for an emergency. This is generally a faster and less stringent process than obtaining full regulatory approval. The agency had already announced that a vaccine must demonstrate at least 50 percent of the effectiveness of COVID-19 in order to receive full approval.
Although the new standards for approval have not yet been released, those familiar with them told the Washington Post that they would require vaccine developers to provide participants with a median of at least two months after their final vaccine dose (several of the vaccines) Currently in late-stage studies, two doses are required. The standards would also require vaccine developers to identify at least five cases of severe COVID-19 in study participants who received a placebo instead of an experimental vaccine. The new standards also require studies to identify cases in older participants who received a placebo.
Given the additional requirements, two-month follow-up, as well as the required data analysis and FDA filing, experts say it is next to impossible for a vaccine to get approved before a choice. Some of the earliest, late-stage studies began in late July, and it took weeks before only half of the required participants were enrolled.
When asked about the standards proposed by the FDA in a press conference on Wednesday, Trump said he could oppose them. "We're looking at this and it has to be approved by the White House," he said. “We can approve it or not. That sounds like a political step. "
He said the new standards could delay the release of a vaccine and that they were unnecessary because "I have great faith in these massive (pharmaceutical) companies" that are developing the vaccines.
"When you have Pfizer, Johnson & Johnson, Moderna, these great companies come up with this – the vaccines," Trump said, "and they did tests and everything else. I say," Why should they be? Do you know how to add great length to the process? & # 39; ”
Before leaving the press conference, Trump added again that the FDA's plan "sounded extremely political".
In a statement on Thursday, the presidents of the National Academy of Sciences and the National Academy of Medicine said they were "alarmed" by the political conclusions amid the pandemic. "Our nation is at a critical time in the course of the COVID-19 pandemic and important decisions lie ahead of us, particularly regarding the effectiveness and safety of vaccines," wrote the top scientific couple. “We find ongoing reports and incidents of the politicization of science, particularly the overwriting of evidence and advice from public health officials and the ridicule of government scientists, alarming. It undermines the credibility of public health authorities and the public's trust in them when we need it most … Any effort to discredit the best scientists and scientists threatens the health and well-being of all of us. "