FDA sets standards for approval of new vaccines, Fauci says concerns are about the increase in cases in some states

Infectious disease expert Anthony Fauci told a Senate committee that he was “very hopeful” that the COVID-19 vaccine would be ready by early 2021, and that the U.S. Food and Drug Administration (FDA) had set standards for approval of the vaccine. The FDA says any candidate vaccine must be at least 50 percent more effective than a placebo.

Several drugmakers are racing to complete clinical trials of candidate vaccines, some of which they hope will be developed in months, compared with years previously.

Some health experts say they are concerned that the FDA will rush to approve a vaccine before it knows enough about safety or efficacy. But the agency is trying to allay those concerns by issuing the guidelines.

FDA sets standards for approval of new vaccines, Fauci says concerns are about the increase in cases in some states

But Fauci, director of the National Institute of Allergy and Infectious Diseases, warns that there is no guarantee that a safe vaccine will be developed. He told the Senate health committee Tuesday that he was “quite concerned” about the recent increase in cases in the southern and western states.

Some states are experiencing a surge in new crown cases, prompting many to delay reopening plans. Arizona suspended operations of bars, gyms and movie theaters on Monday. As Texas becomes the new epicenter of the outbreak, the state has postponed a new phase of reopening. New York leaders are considering postponing plans to allow visits to provide in-room dining.

Robert Redfield, director of the Centers for Disease Control and Prevention, noted that in addition to the increase in confirmed cases, there were also increases in hospitalizations in 12 states. Nearly 2.7 million Covid-19 cases have been confirmed in the United States, of which nearly 130,000 have died from the virus.

Fauci also said schools may need to consider online classes or staggered arrangements to safely bring students back to school. The Centers for Disease Control and Prevention will issue guidelines for schools on Tuesday.

Senator Lamar Alexander of Tennessee, the committee’s chairman, commented on wearing a mask at the hearing, saying the issue should not be politicized as it is now, and that he had asked President Donald J. Trump to do so. Trump put on a mask to lead by example. Vice President Mike Pence appeared in Texas over the weekend wearing a mask to talk about the value of covering his face to fight the virus.