Covid-19 Vaccine Won’t Be Available Until January, Fauci Says
A vaccine to help control the coronavirus outbreak isn’t likely to be available in the U.S. until January, if then, Fauci siad.
(Bloomberg) -- A vaccine to help control the coronavirus outbreak isn’t likely to be available in the U.S. until January, if then, according to Anthony Fauci, the nation’s top infectious-disease doctor.
President Donald Trump, pharmaceutical industry leaders and some public-health officials had said previously that an immunization to prevent Covid-19 could be available before the Nov. 3 election. That date has been consistently pushed back, however, as clinical studies -- which are running at unprecedented speed -- started to hit a few hurdles.
The trials are designed to run until a predetermined number of people who are enrolled get sick. The studies currently underway are unlikely to hit those benchmarks until sometime in December, Fauci said in an online interview with Howard Bauchner, the editor-in-chief of the Journal of the American Medical Association.
Once the data are available, the companies must analyze the findings, file with the U.S. Food and Drug Administration for emergency use and participate in an advisory committee hearing.
“Somewhere around December you will start to see companies with enough events” to have a data safety monitoring board look at the details, Fauci said. “Then it’s up to them to recommend that the company can then move forward. By moving forward, they can apply for an emergency use authorization from the FDA,” he said.
“Exactly when the EUA will be granted – could be January, could be later – we don’t know,” Fauci said.
There are five companies in the final stages of study for a coronavirus vaccine, with Pfizer Inc. and Moderna Inc. having fully enrolled their trials, Fauci said. At least one and maybe two of the companies will have enough safety data and perhaps even sufficient prolonged efficacy findings to apply for emergency use of their vaccines by December, he said.
Pfizer said Tuesday that the late-stage study of its experimental Covid-19 vaccine hadn’t yet reach the milestone number needed to determine if the shot is showing signs of benefit. The monitoring board of scientists overseeing the trial hasn’t conducted the first of four planned interim reviews because there haven’t yet been 32 cases of coronavirus infections among its 42,000 participants.
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