- Coronavirus vaccine emergency approval might come before Phase 3 trials are finished, said FDA Commissioner Stephen Hahn.
- The remark came days after a report claimed the FDA might be pressured to issue an emergency use approval for one of the vaccines that are in the final stage of testing before the presidential election.
- Hahn said in his remarks that emergency approval would still be based on scientific merit and would not have anything to do with politics.
No matter how scary the novel coronavirus pandemic might be, the officials who are managing it should not approve drugs and therapies before they’re efficacy and safety is proven through rigorous scientific testing. The entire hydroxychloroquine disaster proved that point, yet the US Food and Drug Administration is ready to walk down the same road. The agency did the same thing with blood plasma a few days ago, giving it emergency use approval (EUA) before all the facts are in. Plasma from convalescent COVID-19 patients does work in some cases, though, and plasma doesn’t have life-threatening side-effects like hydroxychloroquine.
But giving vaccine candidates emergency approval before Phase 3 trials are completed might be even more hazardous. It’s not just about the safety of patients, as these drugs have already shown that they do not elicit severe side-effects in the earlier phases. But the vaccines might not work. Plus, having drugs in circulation before the work is done might motivate vaccine skeptics to avoid COVID-19 vaccines altogether. Not to mention that it could hinder future COVID-19 research, not just by setting a precedent, but by preventing people from volunteering for other projects. Yet FDA Commissioner Stephen Hahn says that a vaccine EUA might be coming before the end of trials anyway.
I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.
— Dr. Stephen M. Hahn (@SteveFDA) August 25, 2020
Hahn explained that a company might choose to seek EUA before the end of the trial, at which point the FDA will have to decide if the drug can be more widely distributed.
“It is up to the sponsor [vaccine company] to apply for authorization or approval, and we make an adjudication of their application,” he said. “If they do that before the end of Phase 3, we may find that appropriate. We may find that inappropriate, we will make a determination.”
That ruling, Hahn added, will not be political. “We have a convergence of the COVID-19 pandemic with the political season, and we’re just going to have to get through that and stick to our core principles,” he said. “This is going to be a science, medicine, data decision. This is not going to be a political decision.”
Recent reports had suggested that the Trump administration might pressure the FDA to issue an EUA for at least one vaccine before the presidential election in early November. Dr. Anthony Fauci cautioned about the dangers of such actions in an interview last week.
Separately, Fauci said that we might have the first data about vaccine efficacy and safety by November. Currently, three vaccines are in the final stage of testing in the US, Europe, and other countries, but others will follow. Even if some of these drugs fail, it’s possible that others will succeed. Over 170 vaccine candidates are in the works.
Hahn also said that emergency approval isn’t equal to full approval. “Our emergency use authorization is not the same as a full approval,” he said. “The legal, medical, and scientific standard for that is that the benefit outweighs the risk in a public health emergency.”
Russia and China have already approved their own COVID-19 vaccines. Russia did so without sharing any research about the drug. China went a different direction, publishing several papers about three vaccines that have reached Phase 3 trials, and which received emergency approval status recently.