Public health experts are raising red flags that the Trump administration may put political pressure on the Food and Drug Administration (FDA) to approve a COVID-19 vaccine before one is ready.
President TrumpDonald John Trump Trump’s nomination will be held in private: the Graham report defends Trump on TikTok, supports the purchase of Microsoft The federal appeal court rejects the libel case of Stormy Daniels against Trump OTHER, in search of a political victory just over three months after the elections, he stuck to the push for the development of a vaccine in record time and promoted it in numerous recent appearances.
Trump spoke optimistically about a vaccine̵
The president made similar comments Thursday, propagating progress without dwelling on the fact that over 150,000 Americans died from the pandemic, a huge toll higher than that of any other country.
“We are far ahead of the vaccines, far ahead of the therapies. And when we have them, we are all ready with our platforms to deliver them very, very quickly,” Trump said at a White House press conference. “We are ready to deliver them as soon as we have them and it will be very soon.”
The president sought to take credit for Operation Warp Speed, the administration’s multi-billion dollar effort to fund the development and distribution of potential vaccines for COVID-19 and make them available as soon as they prove safe and effective.
The administration was supported by some early success reports of the best vaccine candidates and political officials confidently confident that a hit will be available before the end of the year.
Anthony FauciAnthony FauciSunday shows the preview: the White House, the democratic leaders fight for an agreement on the account of the coronavirus Trump fight to stay on the script, frustrating again the GOP Tucker Carlson defines Fauci a ‘fraud’ after a tense listening OTHER, the country’s leading infectious disease doctor, said Friday that he was “cautiously optimistic”, a vaccine will be ready by the end of 2020 and will be widely distributed next year.
Although there is hardly any chance that a vaccine will be ready for widespread distribution before election day in early November, some of the companies with vaccine candidates entering Phase 3 of the clinical trial may now begin to show the initial results since then.
Researchers and experts have said they are worried that Trump may pick up those early results to push public health agencies to approve a vaccine before it’s ready.
“You have seen the issue of politicization around hydroxychloroquine and the pressure exerted on the FDA at that time. There is a legitimate concern that is never repeated,” said Jesse Goodman, a professor at Georgetown University, who was previously the scientific director of the FDA.
Many external observers believed that the FDA bowed to political pressure earlier this year when the agency issued an emergency authorization for hydroxychloroquine, an antimalarial drug that Trump, his allies and members of his administration continued to propose as a miracle cure for COVID-19 despite the evidence.
Rick Bright, an agency whistleblower, made similar accusations and said he lost his job to oppose widespread drug promotion.
The FDA subsequently revoked the authorization.
In another case, the White House reportedly pressured the Centers for Disease Control and Prevention (CDC) to change its guidelines on the reopening of schools in order to emphasize the importance of children going to school. school while minimizing any risks.
Goodman said that although there is no political pressure on a COVID-19 vaccine, there is still “a legitimate problem in public perception” due to past administration actions in other areas of the crisis.
An ABC News / Washington Post poll released in July found that more than half the country is wary of Trump while six out of ten Americans disapprove of his management of the virus outbreak in general.
A separate survey released this week found that 64% prefer to fully test any potential vaccine, although doing so delays its release and allows the disease to spread further.
Health experts warn of the danger of a widespread portion of the population refusing a vaccine once available.
Senior administration officials are working hard to reassure the public that they will not cut corners.
“Data and science. These are the ones that will guide us,” said FDA commissioner Stephen Hahn during a recent interview with the Journal of the American Medical Association. “We can’t have a situation where people lose faith in the FDA and in the clinical trial process.”
Hahn said that FDA decisions have implications worldwide, in addition to a simple COVID-19 vaccine.
“America and global public trust in the FDA are really important. It’s worth it because people depend on us every day of their lives and we can’t do anything that can break that trust, and that’s a solemn promise,” he said. said Hahn.
FDA The guide requires that any approved vaccine be at least 50 percent more effective than a placebo in preventing disease, among other criteria.
Drug executives said they didn’t believe the FDA would lower its standards for approval.
However, there is a potential alternative solution: the agency could issue an emergency use authorization, which requires less rigorous data than a full approval, as soon as officials are convinced that a vaccine is safe and effective.
Goodman said that all the agencies involved in the decision-making process must be as transparent as possible.
“I don’t think authorization for emergency use should be trivialized on very limited data and I think the data should be explained to people,” said Goodman.
Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, said he believed there are enough external players involved that the Trump administration would find it difficult to find a vaccine based on limited evidence.
“My trust is not in the White House that runs this, but in the pharmaceutical companies that have delivered hundreds and millions of doses of vaccines for many different problems over time,” Adjala said.
However, he said that public skepticism will be difficult to overcome.
“If politicians are involved in the decision-making process on vaccines, it will be contaminated, because everything that politicians have touched so far in this pandemic has been compromised by their involvement in it,” Adjala said.
“This is not a place where politicians really need to fit in. This is a medical decision between doctors and patients.”