The director of the FDA, the US drug agency, has assured that he is willing to approve the use of a US vaccine for Covid-19 before the normal process of clinical trials is completed. The statements of Stephen Hahn, in an interview published on Sunday in the Financial Times, have caused alarm among a part of the scientific community, concerned by what they see as another indication of the FDA’s ceding to political pressure by the Government, and a president eager to announce a vaccine before the elections of the next 3 of November.
In the interview, Hahn talks about an eventual “authorization of the emergency use of the vaccine, which is not the same as a full approval.” Such authorization would allow the administration of the vaccine to certain groups of the population, before the end of phase 3 of clinical trials, which is the broadest and most rigorous phase of the process of testing a vaccine, in which it is tested in thousands of people, with a control group. In addition to the one developed by the American company Moderna, there are dozens of other experimental vaccines that are already in phase 3. Both Russia and China have recently announced, generating controversy in the scientific community, the approval of vaccines without having concluded this phase.
“The legal, medical and scientific standard [para la autorización del uso de emergencia] is that the benefit outweighs the risk in a public health emergency ”, explains Hahn in the Financial times. “This is going to be a science, medicine and data decision. This is not going to be a political decision ”.
Various experts, however, have publicly expressed their fear that political motivations lie behind the willingness to shorten the process. “We cannot tolerate or accept in any way an emergency authorization of a vaccine for covid without reliable data on safety and efficacy from phase 3 clinical trials,” said Angela, a virologist from Columbia University (New York), on Twitter. Rasmussen. “Only two countries have approved a vaccine before there is clear evidence of its safety and efficacy: Russia and China. Now Stephen Hahn has made it clear that he wants America to be third. The man without any credibility saying that he has no relation to the reelection of Trump ”, the prestigious cardiologist Eric Topol wrote in the same social network.
President Trump has tried insistently to downplay the severity of the pandemic, whose impact on the economy has taken away from the president what he saw as the first argument for his reelection; it has tried to marginalize scientific voices, ignored their guidelines, fueled unscientific theories, and often made striking claims contrary to medical consensus. Last week, during the Republican National Convention in which he officially accepted the nomination as a candidate, he practically spoke as a thing of the past of a pandemic of which the United States, with almost six million cases and more than 180,000 deaths, has become epicenter and is still far from free.
The solemn announcement that there is an American vaccine in circulation would provide the president with a valuable narrative shift ahead of the November 3 election. Something that Trump has barely concealed. The White House has allocated significant resources to Operation Maximum Speed, to fund and help accelerate experimental vaccines. Trump has also come to echo a conspiracy theory that denounces something like that the “deep state”, that entelechy referred to a supposed permanent government in the shadow of liberal bureaucrats, would have infiltrated the FDA to hinder the development of the vaccine in order to harm the president’s chances of reelection. “The Deep State, or whoever, at the FDA is making it very difficult for drug companies to recruit people to test vaccines. Obviously, they hope to delay the response until after November 3, ”the president tweeted on Saturday.
Amid that pressure, Hahn has come under fire for misleading the public about the therapeutic efficacy of blood plasma from covid survivors. On the 23rd, at the White House, Trump announced “a truly historic advance in the fight against the virus in China,” which is how he refers to the coronavirus. It was about the authorization of blood plasma transfusions of survivors as emergency treatment against covid. Alongside the president, Dr. Hahn offered some data on the supposed efficacy of the crudely manipulated treatment, and in the face of criticism he was forced to rectify. “The criticisms are completely justified,” he tweeted the next day.