- Giving a coronavirus vaccine candidate an emergency use authorization before the final data is available would jeopardize the entire effort, said Dr. Anthony Fauci in a new interview.
- Fauci is just one of many health officials worried that the Trump administration might pressure the FDA into approving a vaccine for emergency use before the November presidential election.
- The comments came were after the FDA just gave an emergency use authorization to plasma therapy despite concerns from health officials that the move was premature.
Vaccine development typically takes years of testing, but the first coronavirus vaccines may be available within a year of the initial discovery of the virus. We’re not counting the Russian vaccine that’s already “out” without any research data to prove that it’s safe and effective. There are as many as a dozen experimental drugs out of more than 150 vaccine candidates have reached Phase 3 of testing, and some of them might receive emergency use authorization (EUA) in the coming months, once Phase 3 trials are complete. However, some scientists, like the director of the National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci, are worried that President Trump will pressure the US Food and Drug Administration (FDA) to approve a vaccine before the November election. Trump on Sunday announced a “COVID-19 breakthrough” that’s not actually a breakthrough at all: convalescent plasma therapy. That type of treatment works in infectious diseases and has been used for more than 100 years. But recent studies have shown that plasma is only suitable for coronavirus cases under specific conditions, and it won’t save all the COVID-19 patients who experience severe cases.
In light of the pressure Trump applied to get the FDA’s stamp on plasma therapy despite the lack of supporting data, Fauci now warns that getting an EUA for a vaccine before the research is completed could jeopardize the entire effort.
The final stage of trials will include 30,000 volunteers for each vaccine candidate divided into various groups. But half of those people will only receive a placebo so that scientists can determine the efficacy and safety of the drug. Moderna, AstraZeneca/Oxford, and Pfizer/BioNTech are the vaccines that are currently in Phase 3 testing in the US, Europe, and other countries. China also has its own vaccines that are in Phase 3 tests, and other projects will soon be added to that growing list. Johnson & Johnson wants to include 60,000 volunteers in its Phase 3 trials once it reaches that stage.
AstraZeneca has only enrolled 10,000 volunteers so far, short of the 30,000 it needs to pass the requirements. The Oxford vaccine might be the one to be fast-tracked when it comes to EUA, The Financial Times reported.
But pressuring the FDA to issue an EUA to a drug without having the proper research is dangerous. “The one thing that you would not want to see with a vaccine is getting an EUA (emergency use authorization) before you have a signal of efficacy,” Fauci told Reuters without addressing Trump’s recent remarks. “One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial.”
Fauci continued, “To me, it’s absolutely paramount that you definitively show that a vaccine is safe and effective, both. We would hope that nothing interferes with the full demonstration that a vaccine is safe and effective.”
Over the weekend, Trump made the ridiculous and baseless claim that the “deep state” at the FDA will delay progress on drugs and vaccines until after the November 3rd election to hurt his chances of winning.
Fauci isn’t the only health expert worried about an early EUA for coronavirus vaccines. Fauci was also just one of the officials who thought the EUA for plasma should be halted because the available data was not strong enough. “I would be very worried about using an EUA mechanism for something like a vaccine. It’s very different from plasma therapy,” Baylor College of Medicine infectious disease expert Dr. Peter Hotez told Reuters.
Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, told Reuters earlier this week that he would resign if the agency were to approve the vaccine before enough data is available. “I could not stand by and see something that was unsafe or ineffective that was being put through,” Dr. Marks said. “You have to decide where your red line is, and that’s my red line. The center is responsible for assessing the vaccines.”
Fauci explained that the FDA’s guidance for vaccine approval and EUA requires a demonstration that the drug is both safe and effective. EUAs are used for products to “diagnose, prevent and treat serious or life-threatening diseases where the known benefits outweigh the potential risks of the product,” Fauci said. He explained that EUA might be appropriate once studies have shown the safety and efficacy of the vaccine, but before the FDA has completed its formal review.
One other problem that comes with rushing an EUA for a vaccine before enough data proves it’s efficacy is the anti-vaxxer movement. People who are vaccine-hesitant might not be too encouraged to go for COVID-19 immunization using a drug with safety and efficacy that aren’t proven. Surveys have shown that Americans aren’t too enthusiastic about coronavirus vaccines, and that was well before Phase 3 trials started.
Fauci previously explained that vaccine research will not cut corners when it comes to safety, even if the plan is to have a vaccine ready for use by frontline healthcare workers sometime this year. He also revealed that some of the companies involved in COVID-19 vaccine development would start production of the drugs even before they finish Phase 3 trials. But the drugs will only be used if the research proves they work as intended. Fauci explained that the only thing the parties involved in vaccine research should be willing to risk is money, not the health of patients. The vaccines that are produced before the research is done will be destroyed if the data says they’re not effective.