The U.S. Food and Drug Administration (FDA), overcoming the White House’s initial opposition, released new safety guidelines Tuesday for drugmakers working for months on developing a Chinese virus vaccine. The move could prevent or delay introducing a potentially safe and effective final product before Election Day and beyond.
On Tuesday, the Wall Street Journal explained:
The White House cast aside its objections and endorsed the U.S. Food and Drug Administration’s plans for assessing whether a Covid-19 [coronavirus disease] vaccine should be given to the public, making it likely that a shot won’t be cleared until after the election, people familiar with the matter said. […] The White House had been simply holding the guidelines for review and then approved them without changes, a senior administration official said.
For two weeks, Trump administration officials had expressed opposition to the plan, in large part because it called for a two-month observation period to see whether people who got the vaccine had suffered negative effects.
That two-month waiting period would make it all but certain that any vaccine couldn’t be approved for use in the U.S. before the election, a target that President Trump had been aiming for.
After getting the White House’s approval, the FDA posted the new rules on its website on Tuesday, requiring drugmakers to follow trial participants for at least two months to rule out any significant side effects before seeking emergency approval.
The changes appear to mark a reversal after FDA Commissioner Stephen Hahn told the Financial Times last month his agency could greenlight a vaccine before it completes the final phase of clinical trials, stressing political pressure will not influence the decision.
President Donald Trump, currently recovering from COVID-19 (coronavirus disease), had indicated new guidelines could unreasonably delay the availability of the vaccine.
Asked about the FDA’s plans to stiffen guidelines to evaluate potential vaccines last month, Trump indicated the White House could overrule the agency on the issue.
“That has to be approved by the White House,” he proclaimed. “We may or may not approve it.”
The FDA plan “sounds like a political move.”
Nevertheless, Dr. Hahn updated the safety standards Tuesday, relatively late in the vaccine development process. Researchers are testing seven vaccine candidates in the United States, including four that have moved to the last stage of the three-phase clinical test process.
Vaccines are coming “momentarily,” Trump declared in a video recorded after returning to the White House Monday, a day before the FDA announced the changes.
For months, public health officials, including the National Institutes of Health Director Dr. Francis Collins, have stressed there are already protocols to ensure that there are no shortcuts and the vaccine is safe and effective.
Now, the FDA is talking about adding another hurdle to developing the vaccine when researchers are close to manufacturing one.
A senior Trump administration official confirmed the FDA’s plans to make the changes Monday evening, saying the White House opposed the move because there was “no clinical or medical reason” for the additional hurdle,” the Associated Press noted.
Still, the FDA posted the guidance on its website, leaving no doubt that regulators plan to stick with the new safety standards for any vaccine seeking an expedited path to market — an Emergency Use Authorization (EUA).
In a statement, FDA Commissioner Stephen Hahn reportedly defended the move, saying he hoped the guidelines would help “the public understand our science-based decision-making process that assures vaccine quality, safety, and efficacy.”
Some polls have shown some skepticism among the American public about whether they are willing to try the first batch of a vaccine on release.
The U.S. is just one of the dozens of countries participating in a global race towards a vaccine. Currently, there are no immunizations against any coronaviruses in humans.
Critics, including Democrat presidential candidate Joe Biden, have blasted Trump for saying there could be a vaccine by the November 3 presidential election, accusing him of rushing the process, a claim denied by the president and his administration.