> ## Content Index > Fetch the complete content index at: https://www.fdaweb.com/llms.txt > Use this file to discover other available public pages before exploring further. # Debate Over Vaccine EUA Described - URL: https://www.fdaweb.com/debate-over-vaccine-eua-described/ - Published: 2020-09-03T12:00:00.000Z - Updated: 2026-09-14T16:27:38.000Z - Author: David McFarland - Tags: Biologics, #legacy-id-D5147581 In a lengthy, detailed report, the *Washington Post* looks at the debate that has erupted around a nervous FDA over whether the agency should grant an emergency use authorization (EUA) to one or more coronavirus vaccines before clinical trials have been completed and analyzed. Proponents of an EUA say the action could save thousands of lives by speeding protection from the virus, the newspaper [writes](ttps://www.washingtonpost.com/health/2020/09/02/fda-coronavirus-vaccine-emergency-authority/), while opponents say it could pose safety dangers and inflame anti-vaccine sentiment. The agency is already reeling from problems with Covid tests that were not vetted before being released to the market, from an EUA for chloroquine and hydroxychloroquine that was subsequently revoked, and from the botched White House rollout of an EUA for convalescent plasma at which FDA commissioner **Stephen Hahn** misstated the expected benefit from plasma. (Hahn later corrected his mistake as the agency’s new public relations director was removed and a contract with a public affairs consultant was canceled.) Amid complaints that FDA was being pressured by President Trump to move quickly on Covid vaccines and therapeutics, it also had to fend off his complaint that some of its staff are “deep state” members who want to delay approvals for Covid items until after the 11/3 election. The *Post* says that Trump’s promise of a safe and effective vaccine this year “or maybe even sooner” has become a key element in his reelection campaign, leading to concerns voiced in the scientific community that regulators could be pressured to cut corners. The article notes that the Centers for Disease Control has advised state and city public health officials to prepare to distribute a vaccine to healthcare workers and other high-risk groups as early as 11/1. “I think it’s extremely critical that we have rigorous evidence of safety and effectiveness supporting a vaccine before FDA gives its okay,” Ohio State University law professor **Patricia Zettler**, a former FDA associate chief counsel, told the *Post*. While during the Covid-19 pandemic FDA has issued EUAs to authorize hundreds of tests and a few treatments, the article notes that it has only used an EUA for a vaccine once in its history — the 2005 anthrax vaccine. Former FDA commissioner **Scott Gottlieb**, who has become a major commentator on pandemic issues, has said it is “highly likely” that the first vaccine or vaccines will be cleared through an EUA for a select population such as healthcare workers. He has said such an approval would be appropriate “as long as the data show that the vaccine is safe and that it works.” In a 9/2 interview, CBER director **Peter Marks** reiterated that political considerations will not be part of the calculus and that FDA will insist on the same safety and efficacy standards for an EUA as for full approval. “Our intention … is not to give the American public anything less than a gold standard,” he said, while also stressing that it would be unethical to insist on completion of all the paperwork typically required for a full application if data showed a vaccine was safe and effective and people were dying of Covid-19. “We have an obligation to look at that and make a risk/benefit calculation,” he said. “We treat this as though the decisions we are making are decisions we are making for our own families.” Marks said that if an EUA is granted, FDA would require more monitoring afterward to compensate for the shorter time in which possible adverse reactions to the vaccine could appear. He also said FDA would consult with its vaccine advisory committee before making a decision. The committee has a 10/22 meeting scheduled to talk about “the development, authorization, and/or licensure of vaccines.” Former FDA principal deputy commissioner **Joshua Sharfstein** has said that one way to avoid the appearance of political pressure would be for the agency to insist on higher-than-required standards. Marks said FDA has already gone beyond the EUA legal standard of “may be effective” by telling vaccine developers that for either an EUA or full approval their products must be at least 50% more effective than a placebo in preventing Covid-19 or in decreasing the disease’s severity. Despite the threat of political pressure, many scientists say a lot has to happen if there is to be definitive data by October. While Pfizer and Moderna, reportedly the two leading candidates, have each enrolled more than half of the 30,000 participants required for their Phase 3 trials, their vaccines require two doses administered three to four weeks apart. And it then takes up to two weeks for the immune system to protect against infection. Researchers would have to wait for people to become infected and count the cases. The *Post* says that Pfizer officials have repeatedly said that they believe they will have data in October that they can present to regulators. Still, the company’s head of vaccine research and development, **Kathrin Jansen**, said that meeting the October schedule depends on how effective the vaccine is and how many people get sick over the next several weeks. “Everything has to go well, and nothing can get in the way,” she said. Meanwhile, the Biotechnology Innovation Organization (BIO) has issued a public [letter](https://www.bio.org/sites/default/files/2020-09/An%5FOpen%5FLetter%5Fto%5Fthe%5FBiopharmaceutical%5FIndustry.pdf?ref=fdaweb.com) to the biopharmaceutical industry laying out principles the trade group sees as essential for assessing the data on vaccines and therapeutics and determining their potential value. The principles are: - conduct clinical trials according to best practices to assure the credibility of the data as well as the ethical participation of a diverse population of subjects; - disclose important clinical data through well-respected scientific meetings or rigorous, independent peer-reviewed journals; - maintain FDA independence as the gold-standard international regulatory body free from external influence; - ensure that the appropriate use of any new products is data-driven; and - Republicans and Democrats alike should put aside political considerations and reassure the public that politics will not influence the development and approval of new medicines.