USA TODAY US Edition
Guideline shift misinterpreted, CDC head says
The director of the Centers for Disease Control and Prevention said Wednesday that since-reversed changes to the agency’s testing guidelines that drew sharp criticism last month from infectious disease experts were misinterpreted.
The CDC posted revised guidelines in August that said asymptomatic people may not need a test – even if they’ve been exposed to the coronavirus. The CDC on Friday walked back that revision, reinforcing the need for all people who have been exposed to someone with COVID-19 to get tested.
CDC head Dr. Robert Redfield told a Senate panel the changes in August “were not interpreted in the manner in which we had intended them to be interpreted.” Redfield said the August revisions were intended to “reengage the medical and public health community as part of testing so that there was a public health action that happened as a consequence of every test.”
The U.S. has more than 6.9 million cases and 201,000 deaths, according to Johns Hopkins University data. Minnesota, Montana, Utah, Wisconsin and Wyoming set records for new cases; Montana had a record number of deaths in a week.
Parts of NYC see virus uptick
Several neighborhoods have seen an uptick in cases that is causing city officials “significant concern.” New York’s health department identified multiple neighborhoods in Brooklyn and Queens that account for 20% of all cases citywide as of Sept. 19. The uptick in the areas began Aug. 1. “These increases could potentially evolve into more widespread community transmission and spread to other neighborhoods unless action is taken,” the department said.
Late-stage trial of single-shot vaccine begins
The final stage of Johnson & Johnson’s trial for its vaccine candidate, which would require only one dose, was set to begin Wednesday, the company said. The trial will be one of the largest in the world, with 60,000 volunteers in the U.S., South Africa, Argentina, Brazil, Chile, Colombia, Mexico and Peru. A few other companies already have candidates in the final stage of trials to test whether they’re safe and effective, but those require two shots. “A single-shot vaccine, if it’s safe and effective, will have substantial logistic advantages for global pandemic control,” Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, who partnered with Johnson & Johnson on the vaccine, told The Washington Post.
FDA on emergency authorization of vaccine
The Food and Drug Administration is expected to announce a higher standard for emergency authorization of a vaccine in an effort to gain public trust, the New York Times and Washington Post reported. The new requirement would make it highly unlikely a vaccine would be available before the Nov. 3 election.
Manufacturers will have to follow participants in Stage 3 clinical trials for at least two months after they receive a second shot. Surveys show many Americans are skeptical a new vaccine would be safe and effective, with as many as half the respondents saying they would not get the immunization today.
The FDA granted emergency authorization to hydroxychloroquine and convalescent plasma, two treatments for the virus touted by Trump but questioned by public health experts. The vaccine guidelines, drafted by a team of career scientists at the FDA and being reviewed by the White House, could come as early as this week.