US Food and Drug Administration Issues New Rules Likely To Delay COVID-19 Vaccine Approval Until After Presidential Election Medicines & Vaccines 07/10/2020 • Elaine Ruth Fletcher Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Pfizer is one of the front-runners in development of a COVID-19 vaccine. Acting on the advice of experts, the United States Food and Drug Administration on Tuesday issued new safety-focused guidelines for approval of new COVID-19 vaccines, that would almost certainly delay their emergency approval until after the November Presidential elections. Just hours after the rules were issued, United States President Donald Trump accused the FDA of carrying out a “political hit job” against him by releasing new standards that could delay authorization of a coronavirus vaccine until after the November election. “But in a subsequent video issued Wednesday evening, Washington DC time, Trump said he’d go along with the FDA vaccine timeline, and was switching his focus to accelerating rapid FDA emergency use approval of the new antibody-rich cocktail, Regeneron, that he himself had used as a treatment, while hospitalized for COVID-19 over the past week. In his video-taped message, issued on his personal Twitter account, the president described rapid approval of the antibody treatments as “much more important than a vaccine” since it could bring immediate relief to people who are already ill with the virus, in the way that it did for him. “We have Regeneron, we have a very similar drug from Eli Lilly and we are trying to get them on an emergency basis,” Trump said in the video. “We have to get them to the hospital where people are feeling badly, that is much more important than the vaccine….I want to get you what I got. I want to make it free,” he also said. “On the vaccines, we have many companies that are in final stages, Johnson & Johnson, Moderna, Pfizer… and we are going to have a great vaccine very very shortly. I think we should have it before the election. But frankly the politics gets involved, and that’s ok. They want to play their games, it’s going to be right after the election. “The FDA has acted as quickly as ever they acted in history, and no president has pushed them like I did. And so the FDA is approving things in a matter of weeks, that used to take them years,” Trump added in a 5-minute message that also lambasted the virus as “China’s fault.” The new FDA guidance on vaccine aprovals, posted on the Agency’s website, would require vaccine manufacturers to follow trial participants for at least two months after they completed their vaccine course, to ensure that major adverse effects did not emerge – at least immediately. Since the two leading vaccines in the most advanced stages of clinical trials, by Moderna and Pfizer, both require two doses, it appeared increasingly unlikely that either firm would have sufficient trial candidates having cleared that two-month milestone before November. COVID-19 vaccine research According to news reports, the White House had earlier tried to block the FDA’s plans to formally publish the new safety guidelines including the two-month data requirement, arguing there was “no clinical or medical reason” for it. President also had openly opposed any delays when he talked about the potential offered by forthcoming COVID vaccines in the Presidential debate with former Vice President Joe Biden, the Democratic Party candidate, last week. But on Tuesday, the FDA posted the guidance on the agency’s website anyway, pushing back against the president’s pressures. The requirements include a review by a panel of experts and two months of safety data. The guidelines are intended to reassure the American public any vaccine is safe and effective, amid fears that the President has been trying to accelerate approvals ahead of the elections – no matter what the data shows. FDA Commissioner Stephen Hahn said in a statement posted on the FDA’s website: “We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at stake.” Pharma companies have generally taken a prudent stand. Pfizer’s CEO Albert Bourla even spoke out publicly last week out about his concerns over the politicization of the vaccine approval timetable, saying that it was caught in the “crucible” of the presidential elections. Albert Bourla, CEO of Pfizer In an FDA press release introducing the new guidance, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research added: “Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available. The FDA’s new guidance on emergency use authorization of COVID-19 vaccines underscores that commitment by further outlining the process and recommended scientific data and information that would support an emergency use authorization decision. In addition to outlining our expectations for vaccine sponsors, we also hope the agency’s guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved.” The FDA said it will now convene on October 22 an open session of its Vaccines and Related Biological Products Advisory Commitee to discuss any upcoming emergency use authorization requests and processes for handling them: “The FDA plans to convene an open session of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) prior to issuance of any EUA for a COVID-19 vaccine to discuss the EUA request and whether the available safety and effectiveness data support the authorization. The VRBPAC is currently scheduled to meet on Oct. 22 to discuss the general development, authorization and/or licensure of COVID-19 vaccines,” said the press release. “While this meeting is not intended to discuss any particular vaccine candidate, the agency is prepared to rapidly schedule additional future meetings of this committee after submission of any BLA or request for EUA to further ensure transparency.” Trump, who is still recovering himself from a coronavirus infection, has been tweeting aggressively on a range of matters since returning from Walter Reed medical facility, where he was undergoing medical treatment, back to the White House earlier in the week. Meanwhile over a dozen of his staff are reported to be ill with COVID-19, while unconfirmed reports put the number closer to 30. Image Credits: Pfizer, Pfizer, Pfizer . 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