It’s Time For FDA To Fully Approve mRNA Vaccines

Eric J Topol NYT HERE’S a paradox: A new drug for Alzheimer’s disease, aducanumab, gets approved by the Food and Drug Administration through an accelerated...

Eric J TopolNYTHERE’S a paradox: A new drug for Alzheimer’s disease, aducanumab, gets approved by the Food and Drug Administration through an accelerated process without sufficient data, although there was limited evidence that it works, leading three advisory board members to resign in protest. Meanwhile, mRNA coronavirus vaccines are not yet fully licensed despite massive evidence of their benefits.In December 2020, the FDA approved the distribution of mRNA coronavirus vaccines made by Pfizer and Moderna under the agency’s emergency use authorization provision, which permits an accelerated approval process for medications and treatments during a public health emergency. The approvals were granted after the agency reviewed the results of clinical trials that involved more than 70,000 participants. Until the coronavirus pandemic, the agency had never given an EUA to a new vaccine.Now more than 180 million doses of the Pfizer vaccine and 133 million of Moderna’s have been administered in the United States, with millions more doses distributed worldwide. In the history of medicine, few if any biologics (vaccines, antibodies, molecules) have had their safety and efficacy scrutinized to this degree. First, clinical trials showed the vaccines were 95 percent effective at preventing symptomatic illness. Since then, a number of peer-reviewed reports in leading journals have substantiated the vaccines’ safety and efficacy, using data collected in Israel, Qatar, the United Kingdom, the United States and other countries.In other words, the mRNA vaccines have overwhelmingly been proved safe and effective by clinical trials, independent research and the experience of millions of people around the world who received them.But the vaccines’ approvals remain conditional, and the urgency of full approvals cannot be overstated.Vaccination rates in the United States have hit a plateau, dropping to fewer than one million shots per day in recent weeks. That rate has persisted despite the approval of the vaccines for children ages 12 to 15 and an array of incentives and strategies to promote immunizations. More than 54 percent of Americans have received at least one dose of a coronavirus vaccine, and 96 percent of those have been the mRNA variety.Still, that leaves almost half of Americans without protection. Some people who understand that the “E” in “EUA” stands for “emergency” are waiting for full FDA approval before they receive a shot. Others may not get immunized unless their employers require it, and many organizations — including, reportedly, the military — are waiting for the vaccines to be fully approved before instituting such mandates.In theory, full approval should be imminent, since Pfizer applied for full approval in early May, and Moderna asked for full approval on June 1. This process is often long, requiring the agency to inspect manufacturing plants and review considerable amounts of documentation for vaccine production. But in this case, because of the urgency of the pandemic, the vaccine makers began to submit this material, called a biologics licensing application, in late 2020, and they’ve continued to submit more information. The FDA has already reviewed some of the submissions and has provided feedback to the manufacturers. The emergency authorizations were granted more than six months ago. That’s more than ample time for the agency to conduct plant inspections and review the applications.The stakes could not be higher.The Delta variant, which appears to be 40 percent more transmissible than the Alpha variant, is now responsible for 30 percent of Covid-19 cases in the United States. The Delta variant’s prevalence is accelerating quickly, and it’s likely to become dominant in the United States in the coming weeks. This variant has already swept through India, Britain, Russia, Indonesia and other countries, triggering abrupt rises in infections in all of them and hospitalizations and deaths in countries with low vaccination rates and in people who are not vaccinated.Fortunately, two doses of the mRNA vaccines appear to provide nearly full protection from Covid-related hospitalization and death, and the shots substantially reduce infections.The lives and health of millions of Americans rest on the FDA’s decision to fully license these vaccines. In the wake of its approval of aducanumab, it’s frankly unfathomable that mRNA vaccines have been proved safe and effective in hundreds of millions of people and yet still have a scarlet “E”.While the FDA has vigorously defended its decision to approve aducanumab, it has yet to present any timeline for the mRNA vaccine approvals. The agency should make full approval its No. 1 priority, and its leadership should communicate its plans to the public.(Eric J Topol is a professor of molecular medicine at Scripps Research and has served on multiple FDA advisory committees)