Health & Fit: Trump, without evidence, accuses FDA of delaying coronavirus vaccine trials and pressures agency chief

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  COVID-19 vaccines are on the fast-track to approval. How will we know they're safe? The first COVID-19 vaccine must pass rigorous human trials.Experts told Live Science that all candidate COVID-19 vaccines must pass through the same phases of clinical trials before earning approval from the U.S. Food and Drug Administration (FDA), as would any other vaccine. Provided that the trials include many participants, numbering in the thousands, and include thorough protocols to track side effects, the public can be confident that the approved vaccines are safe, they said.

President Donald Trump on Saturday accused, without providing any evidence, the US Food and Drug Administration of deliberately delaying coronavirus vaccine trials, pressuring the man he had picked to head the agency.

Donald Trump wearing a suit and tie: U.S. President Donald Trump listens to FDA Commissioner Stephen Hahn (R) speak on the latest developments of the coronavirus outbreak, in the James Brady Press Briefing Room at the White House March 19, 2020 in Washington, DC. © Chip Somodevilla/Getty Images U.S. President Donald Trump listens to FDA Commissioner Stephen Hahn (R) speak on the latest developments of the coronavirus outbreak, in the James Brady Press Briefing Room at the White House March 19, 2020 in Washington, DC.

"The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics," Trump tweeted, continuing to push his unfounded theory that there is a "deep state" embedded within the government bureaucracy working against his reelection.

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  The global risk of “vaccine nationalism” A Covid-19 outbreak in one country is a threat to all. What happens if the vaccine race is every nation for itself?The United Kingdom, along with its American and Canadian counterparts, said it was “95 percent sure” that hackers tied to Russian intelligence tried to probe their drug companies and research groups. US officials told the New York Times that Russia didn’t seem to be sabotaging efforts to find a vaccine. Instead, the Russians wanted to pilfer the research, to help themselves speed up their vaccine development.

He accused the agency of delaying a vaccine for the virus until after the fall election, tweeting, "Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!" Trump ended his tweet by tagging the Twitter account of FDA Commissioner Dr. Stephen Hahn, who he nominated last year to take up the role.

Hahn assured Americans earlier this month that the agency "will not cut corners" to approve a vaccine.

CNN has reached out to the FDA for comment.

House Speaker Nancy Pelosi on Saturday called Trump's tweet "very scary" and "a very dangerous statement," saying that "even for him, it went beyond the pale."

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  2020 GasGas TXT Racing 250 First Ride Review Contrary to President Trump's predictions, experts tell CNN it's unlikely there will be a coronavirus vaccine ready by Election Day. CNN's Elizabeth Cohen reports on data from Moderna, the first company to begin its Phase 3 clinical trials of a coronavirus vaccine in the United States.

"The FDA has a responsibility to approve drugs, judging on their safety and their efficacy, not by a declaration from the White House about speed and politicizing the FDA," Pelosi told reporters on Capitol Hill.

Trump has promised that a vaccine would be available by the end of the year, though vaccinologists told CNN that timeline is unrealistic. And his latest comments won't allay the fears some experts and Americans have that the administration will rush to prepare a vaccine at the expense of science and safety.

A CNN poll in May found one-third of Americans said they would not try to get vaccinated against Covid-19, even if the vaccine is widely available and low-cost.

The FDA doesn't conduct the trials itself, but instead oversees the people who do, according to the agency. As CNN previously reported, one vaccine candidate, developed by Moderna and the National Institute of Allergy and Infectious Diseases, moved to phase 3 clinical trials late last month.

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  Why it’s unlikely we’ll have a Covid-19 vaccine before Election Day Even the appearance of political pressure could hurt public confidence in a coronavirus vaccine.The Food and Drug Administration approving a vaccine by then would certainly be a monumental October surprise, one that could help speed the pandemic’s end and may give Trump a much-needed boost.

Trump, throughout the pandemic, has undercut or dismissed guidance from government health experts, including FDA officials.

Trump promoted the antimalarial drugs hydroxychloroquine and chloroquine as a Covid-19 treatment, even as the FDA warned the public that the drugs should only be used in hospitals or clinical trials because they can kill or cause serious side effects. in June, the agency revoked its emergency use authorization for hydroxychloroquine and chloroquine for coronavirus treatment, saying the drugs are unlikely to be effective in treating the virus based on the latest scientific evidence.

After the FDA reportedly put a hold on its emergency use authorization for convalescent plasma, the President on Wednesday also suggested that it could've been a "political decision."

"Because you have a lot of people over there that don't want to rush things because they want to do it after November 3rd," Trump claimed.

The President is no stranger to publicly questioning the medical advice of his administration's top health officials, or taking aim at them on Twitter.

Though he maintains he has a good relationship with the nation's top infectious disease expert, Dr. Anthony Fauci, Trump has called Fauci "a little bit of an alarmist," retweeted a post that called Fauci a "fraud," and the White House appeared to make a concerted effort to discredit Fauci early in the pandemic.

Trump also criticized Dr. Deborah Birx earlier this month after the coordinator of the White House coronavirus task force warned that the pandemic is "extraordinarily widespread" in the United States.

Second coronavirus vaccine is 94.5% effective in clinical trial .
US-based Moderna has got a deal to supply 100million doses to the US and potentially 160million to the European Union but the jab is not one of the six pre-ordered by British officials.Early results from the company's final stage of clinical trials bring another landmark success in the global race to end the pandemic after Pfizer's vaccine, which works the same way, was found to be 90 per cent effective. But there won't be any Moderna doses available in Europe until spring 2021, while the US will get it this year.

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