September 22 coronavirus news

The US Food and Drug Administration is considering new authorization rules for a Covid-19 vaccine, according to three sources familiar with the situation -- and calculations show these rules would push an authorization beyond Election Day. 

That would dash the hopes of President Donald Trump, who has said repeatedly the vaccine could be ready by November 3.  

The sources described two different scenarios that the FDA is assessing before a pharmacy company can be given an emergency use authorization (EUA) for its vaccine. 

That source said the FDA is expected to tell vaccine makers that they need to wait two months after giving all their study participants the second doses of the vaccine until they can apply for an EUA. 

Pfizer and Moderna, the two companies that began Phase 3 clinical trial for coronavirus vaccines in the US in July, have given second doses to fewer than half of their participants. 

There’s a second scenario that might happen instead: 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 they can secure an EUA. The move is designed to monitor the safety of the vaccine, even if the trial has already determined the vaccine’s efficacy. 

Under that rule, the two companies still wouldn’t get an EUA by Election Day, since they have not yet given second doses to half their volunteers.  

A third source said the FDA was considering making the 50% requirement, but that it was still in the discussion stage.  

Vaccine trials: Pfizer plans to enroll 44,000 volunteers in its clinical trial, and as of Monday it had given second doses to 19,210 participants. Moderna plans to enroll 33,000 volunteers in its clinical trial, and as of Friday, it had given second doses to 11,879 participants.

Both companies expect an initial readout of efficacy data, called an interim analysis, to occur in the coming weeks.

A third clinical trial by AstraZeneca is currently paused in the United States, after a participant in the UK developed a neurological condition.

News that the agency is expected to issue the new guidance to Covid-19 vaccine developers was first reported by the Washington Post on Tuesday.

China’s ambassador to the United Nations hit out at the United States on Tuesday, calling the country's handling of the coronavirus pandemic “a complete failure.”

He also defended his own country’s response to the crisis, which he says is now under control after “great effort and enormous sacrifice.”

The news conference was held solely in response to US President Donald Trump’s attack on China at the UN General Assembly (UNGA) Tuesday.

During his pre-recorded address to the UNGA, Trump said the United Nations must hold China accountable for their actions. He accused the country of spreading the virus and falsely declaring that there was no evidence of human-to-human transmission. 

Zhang called Trump’s accusations lies.

The ambassador also criticized the US’ health care system, saying: “This is the country with the most advanced medical system with the most advanced medical technology but still they have ranked #1 in confirmed cases and lost lives."

Ambassador Zhang said China will exercise its right of reply in accordance with the rules of the General Assembly, which means a China delegate will address the session at some point this week to officially respond to Trump’s speech.

Read more about the UN General Assembly:

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Leaders spar at UN General Assembly amid global crisis

White House Coronavirus Task Force member Dr. Anthony Fauci says reporting an additional 40,000 coronavirus cases each day is "unacceptable" -- and that rate of infection needs to come down before winter.

Fauci, director of the National Institute of Allergy and Infectious Diseases, noted that some parts of the United States are doing well because they are following simple public health measures -- and said other areas should use them as a models.  

“Universal wearing of masks, physical distancing, avoiding crowds, doing things outdoor more than indoors, if possible, and washing your hands. That sounds like it's very simplistic, but we know when we do that consistently, we prevent surges, and we turn them around,” he said. 

At least 33,778 new Covid-19 cases have been reported in the US on Tuesday, as of 9 p.m. ET, according to Johns Hopkins University.

School reopening policies will be crucial to fixing the economy, but schools should only open if Covid-19 case levels are low enough, experts told the US Joint Economic Committee Tuesday. 

Economist Austan Goolsbee told the committee that a lack of daycare and an inability to send kids back to schools is a significant barrier to fixing the economy, particularly for families that make a median income or less.

“That’s a tremendously critical issue because such a high share of those occupations must physically be at their location of work to do the job,” said Goolsbee, the Robert P. Gwinn professor of economics in the Booth School of Business at the University of Chicago. 

Dr. Jeffrey Singer, a physician and senior fellow at the Cato Institute, pointed to countries like Taiwan that has kept schools open during the pandemic. Some countries in Europe, he added, have kept schools open for younger students without problems. In the US, he’s not seeing the same commitment to reopening from teachers.

“What we see happening is, in many instances, the teachers themselves are saying, I’m not comfortable going back,” Singer said.

Dr. Ashish Jha told the committee that while many European countries have been able to keep schools open, the levels of transmission of the virus in those communities is much lower than the rate of infection in the United States.

Jha thinks a third of the country could go back safely given the level of spread in certain regions, if everyone wore a mask. For another third, where there is more disease, districts would have to be more careful and open up kindergarten through sixth grade. For another third of the country, the level of the virus is so high, schools should remain closed until the level of transmission declines. 

“I would close bars and I’d close indoor dining before I close schools,” Jha said. “I think we can get most schools open if we let the data drive our decision.”

Asked about the coronavirus death toll reaching 200,000 in the US today, President Trump said, “Well, I think it’s a shame."

After ignoring a question from CNN's Nikki Carvajal on his message to the American people, Trump was pressed on passing the 200,000 death threshold, and turned the conversation to his standard response on the virus, blaming China and saying the death count could have been much worse had he not taken action.

“I think if we didn’t do it properly and do it right, you’d have two and a half million deaths. If you take a look at alternatives, you could have two and a half million deaths or something thereabouts. You could have a number that would be substantially more,” Trump told reporters before departing the White House on Tuesday. “And you saw my United Nations speech, China should have stopped it at their border. They should have never let this spread all over the world and it’s a terrible thing.”

Trump went on to say had he not closed the country down, there could have been upwards of 3 million deaths.

“It’s a horrible thing. Should have never ever happened. China let this happen and just remember that,” Trump added.

Facts First: It’s misleading for Trump to say he closed the US border to travel from China and Europe because both policies contained multiple exemptions, including for US citizens and permanent residents; the Europe policy exempted entire countries. Only foreign nationals who had been in China, Europe's Schengen area, the UK or Ireland within the past 14 days were outright banned from entering the US.

As the US passes the grim milestone of more than 200,000 Covid-19 deaths, Dr. Sanjay Gupta said at the beginning of the pandemic, he never thought this many people would die from the virus.

He said when early models were predicting even 60,000 deaths by August, he thought that was a high number.

Comparing the coronavirus pandemic to the 1918 influenza pandemic, he said there are a lot of parallels.

In 1918 there were three major peaks of infection. One of them was in October when thousands of people died in a single month as people started gathering indoors again, Gupta said.

"That model for 1918 is a little bit of a cautionary tale," he said, pointing to the importance of wearing masks and continuing safety measures as we enter into the fall season.

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The University of North Carolina at Charlotte announced today that “after careful consideration of available data and consultation with both county health officials and the UNC System,” they will resume select in-person instruction on Oct. 1, according to a statement from the university.

The school is placing an emphasis on the return to on-campus instruction in specific areas of academic study, including programs like engineering, science lab classes, studio and performance art classes, clinical programs in the College of Health and Human Services, architecture, and courses serving primarily first-year students in order to ensure that those students can “successfully transition to University instruction, build community and access campus support.”

According to the statement, all undergraduate classes will be suspended on Sept. 28 and 29 to allow for campus move-in dates.

Following multiple positive Covid-19 tests among student-athletes at Notre Dame, the Fighting Irish have postponed Saturday’s game against Wake Forest. Seven football players tested positive out of 94 tested. They are in isolation and contact tracing is underway.

In a statement, Notre Dame Athletics announced that the football program has decided to pause all football-related activities until further testing can be completed. Combined with testing results from last week, a total of 13 football players are now in isolation, with 10 in quarantine.

Notre Dame, which is 2-0 so far this season, is currently the seventh ranked football team in the nation.

North Carolina Gov. Roy Cooper on Tuesday announced that large outdoor venues will be allowed to open at 7% capacity starting October 2 if stable Covid-19 trends continue. 

"Because of our continued stability, we plan to take another step toward Phase 3 in the coming days if our progress holds," Cooper said during a news briefing. 

The state defines large venues as those with the capacity of seating more than 10,000 people, according to a news release. Cooper said during the news briefing today's announcement will allow these facilities to start putting safety measures in place. 

State and health officials will continue monitoring trends over the next week to decide if other restrictions can be eased. The current executive order that allowed North Carolina to move to a 2.5 reopening phase is set to expire on October 2nd. 

Cooper said the state has reported 195,549 laboratory-confirmed coronavirus cases to date, and at least 3,286 deaths. The state reported 1,168 new cases since yesterday, Cooper added. 

One thing to note: The numbers below were released by the North Carolina Department of Health and Human Services and may not line up exactly in real time with CNN’s database drawn from Johns Hopkins University and the Covid Tracking Project.