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Before the election, the president of the United States wanted to present Americans with a corona vaccine. But the FDA has objections to the procedure. Donald Trump speaks of a “political attack”.
The James Brady Information Room in the White House is being disinfected.
Photo: Alex Brandon (Keystone)
With “Operation Warp-Speed”, the president of the United States, Donald Trump, wanted to increase his chances in the elections decisively, but nothing will come of it. One of my own Taskforce In the White House they must ensure that a vaccine against the coronavirus is ready before Election Day, which can be administered to large sectors of the population. But now the US FDA is slowing down and has prevailed in the fight for speedy approval.
Supervisors have issued new and stricter guidelines for testing than the White House wanted. Under this rule, it is highly unlikely that any of the drug companies will be able to successfully apply for an emergency approval before the end of November.
Voluntary subjects
Consequently, vaccine manufacturers must be able to provide data on potential side effects and other safety risks of at least half of the volunteers over a period of at least two months after receiving the second dose. For approval, both the efficacy and safety of a vaccine must be demonstrated.
Four of the vaccines in development in the United States have reached the crucial third stage of clinical trials and a fifth is nearing it. Volunteers receive two doses of the vaccine and a control group receives a placebo. Of the approximately 44,000 volunteers who participated in the trial, about half had received the second vaccine by the end of September.
Trump raged on Twitter that night, the decision was another “political attack”, new FDA rules made it difficult to get a vaccine approved before Election Day. In contrast, the White House denied trying to exert political influence in the approval process.
At least the American group Pfizer It had previously promised to send the necessary data on the effectiveness of its vaccine to the FDA this month and therefore before Election Day and then to continuously provide data on its safety and tolerability.
Donald Trump has been promising a Covid-19 vaccine before the election for months. Nothing will come of that.
Photo: Jonathan Ernst (Reuters)
The US media unanimously reported that Trump’s chief of staff, Mark Meadows, blocked publication of the new directive for more than two weeks and demanded a detailed justification from the FDA. The FDA then released the de facto text as part of an information letter to members of its independent vaccine advisory committee. A little later, the White House published the text.
Greater transparency
The White House would still have the option to bypass the directive through the Health Ministry and allow a vaccine in an emergency, even if it doesn’t meet the criteria. However, this would further shake the population’s already weakened confidence in the approval process and presumably also reduce the export possibilities of a vaccine that has reached the market in this way.
In a statement, the largest US pharmaceutical industry association welcomed the FDA’s decision. The authority was asked for greater transparency to gain confidence in the safety of the vaccine. Peter Marks, director of the FDA, whose department is responsible for the approval process, said that all Americans should have confidence in the approval process and be confident that the result will be something that “we at FDA are confident we can. do we can give to our families ». Then everyone else could vaccinate their families with confidence.
