Public health experts are growing increasingly worried that the White House will pressure regulators to approve the first coronavirus vaccine candidate to show promise
“Public confidence in the FDA has really been eroded because of the EUA on hydroxychloroquine and then the mess that they’ve made with serology tests,” said Nicole Lurie, an assistant secretary for preparedness and response at HHS during the Obama administration.
The fastest vaccine ever developed, for mumps, took four years. Many experimental vaccines show promise in early human trials, which look at a shot’s safety and whether it prompts an immune response, but a significant chunk go on to flunk the broad final study of effectiveness known as a Phase III trial. Patients may produce antibodies in response to a dose of an experimental vaccine, but those are not always strong enough to protect against a disease.
Despite the pitfalls of drug development, manufacturers of potential coronavirus vaccines are pushing to accelerate the development timeline. Rather than beginning with preliminary studies in animals, companies are conducting the tests concurrently with early human trials — which regulators have allowed because of the urgency of the situation.
But those trials can only be accelerated so much. Moderna plans to enroll 30,000 people in its Phase III studies, Fauci said — and signing them all up could take the rest of the year. A pharmacist gives a volunteer the first shot in the first-stage safety study clinical trial of a potential Covid-19 vaccine developed by Moderna. | AP Photo/Ted S. Warren, File
Nationwide, pediatric vaccinations fell 42 percent this spring compared to a year earlier, in large part because of coronavirus lockdowns, according to research by the Epic Health Research Network. New York City Mayor Bill de Blasio last month called the decline ““There is a genuine concern, and a very understandable concern, from the vast majority of Americans on ‘Are we moving too quickly on this coronavirus vaccine?’” said Erica DeWald, director of advocacy at Vaccinate Your Family.
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