The FDA is expected to ask the manufacturers applying for approval to follow people in the study for a median of at least two months, beginning with their second vaccine shot, the newspaper reported, citing two people familiar with the situation.
The agency also is likely to look for at least five severe Covid-19 cases in patients who got the placebo and not the vaccine, and some cases of the disease in older people, the Post reported.
That would make it difficult to have a vaccine available by the time of the November 3 election, the Post pointed out.
The country should have good data on the safety and effectiveness of a vaccine sometime in November, Dr. Ashish Jha told the US Joint Economic Committee Tuesday, adding he believes there will be a vaccine before the end of the year.
Jha, dean of Brown University’s public health school, said he has been “immensely supportive” of Operation Warp Speed, the White House’s efforts to speed up the production of vaccines and Covid-19 treatments.
“I think that’s been the right thing to do, because once we have the evidence of safety and efficacy we will not want to wait,” Jha said.
The new guidance may be issued this week, according to the Washington Post. CNN has reached out to the FDA for comment.
A call for vaccine trials for children
Vaccine developers should begin testing their vaccines in children, a group of pediatric infectious disease specialists said.
There are three large-scale vaccine trials for adults in the US, but none has begun for children, who are “stuck in neutral,” eight physicians said in a commentary published Friday in the medical journal Clinical Infectious Diseases.
“This is really a call to say rather than waiting to see if we have an effective vaccine for adults, let’s begin that work of at least evaluating the vaccines in adolescents and ever-decreasing ages, so that we get a good bead on the dosing, the dose schedule, and the potential effectiveness of that kind of a vaccine,” said Dr. Buddy Creech, a pediatric infectious disease specialist at Vanderbilt University and one of the authors of the commentary.
Fauci: Country’s division is hampering the messaging
“We are in such a divisive state in society that it tends to get politicized,” the country’s leading infectious disease expert said Monday night on “The Daily Show with Trevor Noah.”
“It’s almost the one side versus the other,” Fauci said.
“People take sides, like wearing a mask or not is a political statement and that’s really unfortunate, totally unfortunate because this is a purely public health issue. It should not be one against the other,” Fauci said.
“It’s extremely confusing,” Dr. Leana Wen, a CNN medical analyst and emergency medicine physician at George Washington University, told CNN. “And that type of whiplash — especially without an explanation directly from the CDC — creates confusion and unfortunately leads to lack of trust in the CDC overall.”
How confusion could contribute to spike
“It’s happening because we’re forcing schools to reopen in areas of high transmission,” said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine. “We’re forcing colleges to reopen, and we don’t have the leadership nationally, telling people to wear masks and to social distance and do all the things we need to do.”
Dr. Jeanne Marrazzo, an infectious diseases expert at the University of Alabama at Birmingham, says there are several factors that could be contributing to the rise in numbers — including the public’s fatigue of pandemic-like conditions.
“And then the second thing is … the completely contradictory messages that we’re getting — not just the misinformation, but also the confusion about how things are spread.”
More than 4,000 students and school staff infected in Texas
A rise in cases also comes after many students across the country returned to class — both in schools and colleges.
Colleges and universities across all 50 states have reported infections — prompting local leaders to set new measures in place in hopes of controlling the spread of the virus on college campuses and in college towns.
Infections have increased among younger students as well — and those around them.
More than 2,300 of those cases are students.
CNN’s Steve Almasy, John Bonifield, Shelby Lin Erdman, Jamie Gumbrecht, Madeline Holcombe and Holly Yan contributed to this report.