FDA expected to issue stricter guidelines on vaccine emergency approval, Washington Post reports
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."Even though things are moving at unprecedented speed for adults and older adults for Covid-19 vaccines, we haven't yet made inroads to have pediatric trials starting," said Dr. Buddy Creech, a pediatric infectious disease specialist at Vanderbilt University and one of the authors of the commentary."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," Creech said.Pfizer, who is in the last phase of trials for its vaccine, is "working actively with regulators on a potential pediatric study plan," a spokesperson for the company told CNN.Moderna, another company with a vaccine in Phase 3 trials in the US, plans to start pediatric trials "in the near future, subject to regulatory approval," a spokesperson said in a statement to CNN.So far, more than 6.89 million Americans have been infected since the start of the pandemic and at least 200,710 have died, according to Johns Hopkins Universit
FDA considering measures that would put vaccine well past Election Day
The US Food and Drug Administration is considering new rules for emergency authorization of a Covid-19 vaccine that would push authorization beyond Election Day, according to three sources familiar with the situation. The sources described two different scenarios that the FDA is assessing before a pharmacy company can be given an emergency use authorization for its vaccine."Either way, it's going to be Thanksgiving at the earliest before a company gets an EUA," or emergency use authorization, the first source said.One source said the FDA is expected to require vaccine makers to wait two months after giving all their study participants in Phase 3 trials their second doses of the vaccine before applying for authorization. A second source, a senior administration official, said the agency is expected to require that companies wait 60 days after giving half their trial participants their second dose before the vaccine can be authorized. The move is designed to monitor the safety of the vaccine, even if the trial has already determined the vaccine's efficacy. 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.A recent poll from the Kaiser Family Foundation found that more than half of respondents — 54% — said they would not get the vaccine if it was available for free before the November 3 presidential election. Along party lines, 60% of Republicans and 56% of independents said they would not. Half of Democrats said they would.
Fauci: Country's division is hampering the messaging
The country's current divided state is one of the things that's getting in the way of clear and consistent messaging when it comes to Covid-19 in the US is the country's current divided state, Dr. Anthony Fauci said. "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. The US is now months-deep into navigating the Covid-19 pandemic and several safety measures remain points of contention — including face masks. While many across the country have embraced experts' recommendations to wear face coverings to protect against the virus' spread, others have protested their use."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.But even Americans who want to follow guidance from experts about Covid-19 ran into a muddied message this week. The US Centers for Disease Control and Prevention updated its guidance to say Covid-19 can spread through the air but days later abruptly reverted back to guidance posted months ago — saying the virus is thought to spread mainly between people in close contact and "through respiratory droplets produced when an infected person coughs, sneezes or talks."Several studies have shown the virus can spread through small particles in the air. "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
With fall rolling in, the US is heading into what CDC Director Dr. Robert Redfield predicted could be one of the "most difficult times" in American public health. One expert told CNN this week the next months may make for an "apocalyptic fall." "It'shappening because we're forcing schools to reopen in areas of high transmission," sRead More – Source