September 24 coronavirus news

In an interview Thursday on WPHT’s The Rich Zeoli Show, US Food and Drug Administration Commissioner Dr. Stephen Hahn responded to questions about the agency considering new guidelines for the authorization of a Covid-19 vaccine.

“We're building upon our June 30 guidance. This isn't really new information, per se,” said Hahn. “What it is, is providing clarity to the developers of vaccines about what are we going to need to see to have assurances around safety and effectiveness.”

The FDA issued guidance on June 30 about the requirements for emergency use authorization of vaccines. Sources have told CNN that the updated guidance would likely push approval of a Covid-19 vaccine candidate Election Day.

“We're trying to give manufacturers a sense of what would need to be seen in order to assure our scientists and then the American people that the vaccine is safe and effective,” said Hahn.

“This is evolving,” Hahn added. “We haven't seen the data from the clinical trials, and we won't until they come to us.”

President Trump suggested Wednesday that the FDA may be politically motivated to delay the approval of a Covid-19 vaccine, and that the White House may not approve FDA’s guidelines. 

When asked if politics will interfere in the vaccine development process, Hahn said that the FDA’s conversations with vaccine manufacturers are not political. 

On Thursday, Hahn declined through an FDA spokesperson to comment to CNN about Trump’s remarks.

The decision to change the criteria under which a coronavirus vaccine would get approval or be given an emergency use authorization is, under normal circumstances, up to the US Food and Drug Administration.

And while there might be some legitimate scientific considerations to override the FDA’s proposal, any interference that comes from outside of science is “troublesome,” Dr. Anthony Fauci said Thursday during an online conversation with CNN Chief Medical Correspondent Dr. Sanjay Gupta. 

Fauci was asked about President Trump trying to make an “end run” around an FDA’s proposal to wait at least 60 days after at least 50% of trial participants were vaccinated to evaluate any vaccine for safety. Most adverse events happen within that two-month window.

“But remember there is some degree of flexibility,” said Fauci. “The thing that could modify that, and modify it within the scientific realm of being scientifically justifiable, is that if the vaccine is so overwhelmingly effective that you would say the risk-benefit of having adverse events override the benefit of getting a 98% effective vaccine earlier rather than waiting 60 days. That's something that even we scientists would say, 'You know, we should really take a look at that; you might want to shorten that.'”

##Vaccines

An ensemble forecast published Thursday by the US Centers for Disease Control and Prevention now projects there will be 214,000 to 226,000 coronavirus deaths in the United States by Oct. 17.

Unlike some individual models, the CDC’s ensemble forecast only offers projections a few weeks into the future. The previous ensemble forecast, published Sept. 17, projected up to 218,000 coronavirus deaths by Oct. 10.

At least 202,344 people have already died from Covid-19 in the United States, according to data compiled by Johns Hopkins University.

As the second wave of the pandemic grips Europe, the United Kingdom has recorded 6,634 new coronavirus cases in the last 24 hours – the highest daily increase since the start of the pandemic.

This brings the total number of cases confirmed across the country to at least 416,363, Public Health England tweeted on Thursday.

The latest government data comes after the UK had registered on Wednesday another record in coronavirus cases since May.

At least 40 more deaths were reported on Thursday. The total death toll now stands at 41,902.  

CORRECTION: An earlier version of this story and headline incorrectly described the timeframe for the previous highest daily increase in coronavirus cases. The previous highest daily increase was at the beginning of the pandemic.

Dr. Anthony Fauci, the nation's leading infectious disease expert, believes “there's good enough data to say that aerosol transmission does occur.”

Speaking to New Jersey Gov. Phil Murphy on Thursday, Fauci explained, “Aerosol means the droplets don't drop immediately – they hang around for a period of time.”

This becomes “very relevant” when you are inside where there is poor ventilation. 

Fauci said we shouldn’t be “getting bent out of shape,” about whether Covid-19 aerosolizes or not. “Act like it's occurring – and then do the same thing you've been doing otherwise.” 

“Which means: Wear the mask,” he added.

While confirmed Covid-19 cases and death rates remain low in many African countries, early results in some communities suggest a higher number of infections than those reported, said Dr. Matshidiso Moeti, the WHO Regional Director for Africa.

"Preliminary analysis suggests that over 80% of cases in Africa are asymptomatic," she said during a press briefing Thursday. 

The swift action of governments on the continent to impose early lockdowns, and the public's general adherence to movement restrictions, created a "window of opportunity" to keep cases low, Dr. Moeti said. Since many countries have begun easing restrictions and opening economies back up, there has been an uptick of cases.

But experts are unable to conclusively explain the low death rates on the continent. "We don't know the exact factors that are causing it, we just know that some of the factors are more probable," said Dr. Sam Agatre Okuonzi from Uganda.

The panel described probable factors such as a majority youthful population, the frequency with which many Africans spend outdoors and the less movement and interaction in rural areas, as potential explanations. 

Another potential factor scientists are studying is the level of potential cross-immunity that has developed from exposure to previous coronaviruses. 

"Research is required to characterize the disease and the pandemic in Africa and this work is just beginning," Dr. Okuonzi said.

US Food and Drug Administration Commissioner Dr. Stephen Hahn on Thursday declined to comment on statements from President Trump that the White House could override the agency if it released tougher standards for the authorization of a Covid-19 vaccine candidate.

Some background: The FDA is considering new guidelines for the authorization of a Covid-19 vaccine, according to three sources familiar with the situation. The rules would allow additional time to evaluate the safety of the vaccine.

Calculations show the rules would push an emergency authorization of a vaccine beyond Election Day.

The President said Wednesday, "We may or may not approve" the guidelines, casting them "as a political move more than anything else."

In explaining his reasoning, the President said, "I have tremendous trust in these massive companies. ... When they come back and they say that we have something that works and absolutely works, and they're coming back with great numbers and statistics and tests and everything else that they have to come back with, I don't see any reason why it should be delayed further. Because if they delay it a week or two weeks or three weeks, that's a lot of lives you're talking about."

The FDA on Wednesday told CNN it was "respectfully" declining to comment when asked about President Trump's statement.

As Europe endures its second wave of the coronavirus pandemic, thousands of students in several universities across Europe are self-isolating following mass outbreaks of Covid-19 that local officials blame on partying.

Here's a look at some of the schools:

Google Maps will soon show how prevalent coronavirus is in geographic areas with a new color-coded update.

Beginning this week, the Maps app will display seven-day averages of new Covid-19 cases per 100,000 people. The chosen areas will show if cases are increasing or decreasing and be shaded with one of six colors to signify how many new cases were reported

Google is pulling data from three sources: Johns Hopkins University, the New York Times, and Wikipedia. They receive their data from the World Health Organization and other public or government health organizations. Information is available for all 220 countries that Google Maps works in. 

Read the full article here.