The White House disagrees with the Food and Drug Administration’s new guidelines for approval of new crown vaccines, which will prevent manufacturers of vaccine candidates from seeking emergency authorization before the presidential election,media BGR reported. The FDA wants volunteers to follow up for at least two months after receiving the injection to identify potential side effects.
The White House and the FDA are reportedly at odds over new vaccine guidelines. Recent reports suggest that the Trump administration is seeking to quickly advance emergency approval for at least one COVID-19 vaccine in time for the November 3 presidential election. Public health officials, including Dr. Anthony Folch and FDA scientists, insist that vaccine safety should not be affected in order to speed up approval.
The COVID-19 vaccine is being developed so quickly that at least one candidate vaccine could be approved for emergency use by the end of the year. Folch confirmed this in a recent interview. The FDA has developed new emergency approval guidelines that will prevent vaccines from being made publicly available before the election. The White House disputes this, but it may not produce any results, as the FDA has shared the guidelines with companies that make vaccines.
Reports from The New York Times and the Associated Press detail the FDA’s new guidelines for vaccine approval. The FDA sent revised guidelines to the White House on September 21, but White House Chief of Staff Mark Meados raised concerns about the request, the New York Times reported.
The FDA wants vaccine researchers to follow up with volunteers for two months, which appears to be a major point of contentity. Trials of the state-of-the-art vaccine began in July, with most requiring volunteers to take two doses a few weeks apart. At least 30,000 volunteers are recruited for each phase of the three-phase trial. These rules, combined with the FDA’s requirement for two months of follow-up data, will prevent pharmaceutical companies from seeking emergency approval before the election.
Of the three front-runners, AstraZeneta/Oxford suspended tests in the US after a safety incident in early September – a phase 3 trial that is still being carried out in Europe and elsewhere. Moderna, the U.S. company that began the Phase 1 trial as early as March and was the first to begin Phase 3, recently said its mRNA vaccine would not be ready until 2021. The company will seek emergency approval after the election. That makes Pfizer/BioNTech the only company likely to provide early Phase 3 trial data this month and seek authorization. This is just speculation based on recent developments in the industry.
The proposed guidelines also include a detailed conclusion about what the FDA will look for. The agency said there should be at least five cases of severe infection in the placebo control to prove that the vaccine is effective in preventing disease.
Johnson and Johnson has begun its own large-scale vaccine trial, which will enroll 60,000 volunteers who need one shot of the vaccine. The company has publicly said it will follow the FDA’s advice regardless of the White House’s position on the matter.
Alex Azhar, the US secretary of health and human services, acknowledged but played down the conflict over the new guidelines. “The commissioner’s proposed guidelines for public emergency use authorizations for vaccines will be consistent with the letters that have been sent to manufacturers,” Mr Azhar said on Friday. “The FDA has told manufacturers what they’re looking for.”
Dr. Peter Marks, head of the FDA’s vaccine division, confirmed Azhar’s claims in an online interview last week. “There’s nothing there that’s exciting about this guidance,” the official said, according to the Associated Press. The company knows what we’re looking for. “
But Marks confirmed that the guidelines are “an attempt to help the public see what we need for the COVID-19 vaccine.” According to the New York Times, Marks privately acknowledged that Trump’s angry tweets attacking FDA scientists over the guidelines would further undermine public confidence in vaccines.
But despite rapid advances in new crown vaccine research, the prospect of an upcoming vaccination campaign in the United States has become more reluctant. A Pew Research Center survey last month found that 51 percent of Americans are likely or certain to get COVID-19, down sharply from 72 percent in May. Folch explained in various interviews that vaccinations will play an important role in fighting the epidemic. But vaccine-based group immunity depends on public trust in vaccines. If the U.S. is to have a chance to overcome the outbreak by 2021, a large percentage of the population must be vaccinated and security measures must be maintained.