September 7 coronavirus news

By Ben Westcott, Adam Renton, Amy Woodyatt, Meg Wagner and Mike Hayes, CNN

Updated 12:00 a.m. ET, September 8, 2020
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10:31 a.m. ET, September 7, 2020

Pfizer and BioNTech approved to start phase 2/3 trial of Covid-19 vaccine

From CNN’s John Bonifield and Frederik Pleitgen

The German regulatory authority, the Paul-Ehrlich-Institut, has approved a phase 2/3 clinical trial in Germany of a Covid-19 vaccine candidate being developed by US pharmaceutical company Pfizer and German biotechnology company BioNTech.

“The integration of sites in Europe, and now especially in Germany, is aimed at supporting an approval in Europe," said Ugur Sahin, CEO and cofounder of BioNTech, in a news release on Monday. 

The BNT162b2 mRNA-based vaccine candidate is already in similar large-scale trials in the United States. The trial involves giving the participants two doses of a 30 microgram vaccine – one on the first day and one 28 days later – with participants being followed up for up to two years after they receive the second dose. 

In August, the companies presented "promising" results in early data on safety and immune responses in their ongoing Phase 1/2 study in the United States. Among both younger and older adults in the trial, the companies said the vaccine "was well tolerated with mild to moderate fever in fewer than 20% of the participants." The companies also noted in their news release that seven days after participants were given a second dose of the vaccine at 30 micrograms, the vaccine was able to elicit neutralizing antibodies in younger adults ages 18 to 55, and in older adults ages 65 to 85.

Remember: The data has not yet published in a peer-reviewed medical journal.

The companies plan to seek regulatory authorization or approval for the drug as early as October if it is successful in clinical trial testing. They plan to supply up to 100 million doses worldwide by the end of 2020 and 1.3 billion doses by the end of 2021.

Many infectious disease experts say, however, that it’s highly unlikely Pfizer will have enough data to allow for an emergency use authorization from the US Food and Drug Administration in October.

 

9:45 a.m. ET, September 7, 2020

Trump claims, without evidence, he's getting "get VERY high marks in our handling of the Coronavirus"

From CNN's Allie Malloy

President Trump is again claiming, without evidence, that he is “starting to get VERY high marks” in the “handling of the Coronavirus.”

It is unclear what source Trump is using to make the erroneous claim but follows a pattern of Trump’s desperation to stamp an end date on the deadly pandemic before November 3.

 

Some context: According to a new CBS News/YouGov poll, only 21% of voters nationwide said they would immediately seek out a vaccine if one was made available in 2020.

That number is down from 32% in July. 65% said they believed a vaccine announced this year would, by definition, be the product of a "rushed" process. Only 35% would regard it positively, as a "scientific achievement."

Trump announced on Twitter this morning that he'll be holding a news conference later today.  

9:52 a.m. ET, September 7, 2020

New York's coronavirus infection rate has been under 1% for the past month

From CNN's Kristina Sgueglia

People walk in New York City on August 21.
People walk in New York City on August 21. Cindy Ord/Getty Images

New York has had an infection rate below 1% for the last 31 days, New York Gov. Andrew Cuomo said on Labor Day.

There were two additional coronavirus deaths reported, the governor said in a press release.

"Thanks to the hard work of New Yorkers, our state has now gone a full month with our COVID infection rate remaining below one percent," Cuomo said in a press release Monday. 

He added: "Our numbers have continued to remain stable even as we reach new milestones in our phased, data-driven reopening. As we close out this Labor Day Weekend, I urge everyone to remain smart so we can continue to celebrate our progress in the weeks and months ahead.

Additionally the State Liquor Authority and State Police Task force visited over 1,000 establishments in New York City and on Long Island and observed 7 in noncompliance.

One thing to note: These numbers were released by the state’s public health agency, and may not line up exactly in real time with CNN’s database drawn from Johns Hopkins University and the Covid Tracking Project

9:38 a.m. ET, September 7, 2020

Two English players sent home from soccer tournament for breaking quarantine rules in Iceland

From CNN’s Richard Parr in London

This combination of pictures shows Manchester United's Mason Greenwood, left, and Manchester City's English midfielder Phil Foden.
This combination of pictures shows Manchester United's Mason Greenwood, left, and Manchester City's English midfielder Phil Foden. Hector Retamal/Adrian Dennis/Pool/AFP/Getty Images

Two English footballers — Manchester City midfielder Phil Foden and Manchester United forward Mason Greenwood — have been sent home for breaching coronavirus protocols.

England national team manager Gareth Southgate confirmed the players broke quarantine rules, in a news conference ahead of England’s UEFA Nations League match away at Denmark on Tuesday.

Southgate said: “Unfortunately this morning [it] was brought to my attention that two boys had broken the Covid guidelines in terms of our secure bubble And so we had to decide, very quickly, that they couldn't have any interaction with the team, rest of the team, wouldn't be able to travel to training. And given the procedures that we have to follow now they'll have to travel back to England separately.”

England were in Reykjavik following a 1-0 victory over Iceland in the Nations League. Since the win, Icelandic media outlet DV reported the two England players were visited by two Icelandic girls in their hotel. Southgate says that no other players have been affected. 

“Nothing has happened in the areas that we occupy in the hotel, we're still getting to the depths of all the information because as I said this was only brought to my attention a couple of hours before training.

“Nobody from outside our party has been into the areas of the hotel that we're occupying.”

9:24 a.m. ET, September 7, 2020

Mexico has the world's 4th highest coronavirus death toll

From CNN’s Natalie Gallon in Mexico City

Workers unload coffins from a truck outside a funeral home in Mexico City on August 20.
Workers unload coffins from a truck outside a funeral home in Mexico City on August 20. Alfredo Estrella/AFP/Getty Images

Mexico has the world’s fourth highest coronavirus death toll, but remains No. 8 on the list of most-infected countries globally.

Mexico announced 232 new deaths on Sunday, taking the total death toll to 67,558, the world’s fourth highest count of coronavirus deaths, following the US, Brazil and India, according to Johns Hopkins University.

Mexico also recorded at least 4,614 new coronavirus cases on Sunday, taking the country’s total case count to at least 634,023. 

Mexico therefore has the world’s eighth highest count of total Covid-19 cases, and the fourth-highest number of cases in Latin America proper, following Brazil, Peru and Colombia, according to Johns Hopkins University.

9:29 a.m. ET, September 7, 2020

Likelihood US will have Covid-19 vaccine available this year is "extremely low," former FDA head says

From CNN Health's Jacqueline Howard

A person receives an injection while taking part in a vaccine trial at the Research Centers of America in Hollywood, Florida, on August 13.
A person receives an injection while taking part in a vaccine trial at the Research Centers of America in Hollywood, Florida, on August 13. Chandan Khanna/AFP/Getty Images

It's unlikely the United States will have a Covid-19 vaccine available for widespread use this year, Dr. Scott Gottlieb, former commissioner of the US Food and Drug Administration, said on CBS' Face the Nation on Sunday.

"The likelihood that we're going to have a vaccine for widespread use in 2020 is extremely low. I think we need to think of that as largely a 2021 event, and if we do have a vaccine available in 2020, it's likely to be used in a much more targeted fashion – almost in a therapeutic sense, to protect very high-risk populations," Gottlieb told CBS anchor John Dickerson.

"In terms of thinking about the vaccine, at least as far as this year is concerned – in 2020, the fall and the winter – I think that if there is a vaccine made available, it's likely to be a very staged introduction of the vaccine under an emergency use authorization, where there's going to be a lot of data collection around the use of that vaccine," Gottlieb said.

"And it's just going to be very select groups of people who are either at very high risk of contracting the coronavirus because of what they do. For example, health care workers, or very high risk of a bad outcome – think of people for example in a nursing home," Gottlieb said. "So you can almost think of the vaccine being used in a therapeutic sense to try to protect very high-risk populations, and not in a way we traditionally think about a vaccine in terms of trying to provide broad-based immunity in a population and really quell an epidemic."

8:50 a.m. ET, September 7, 2020

Miami Mayor says mask mandate is the "single biggest weapon" in fighting coronavirus

Miami Mayor Francis Suarez speaks with CNN on Monday, September 7.
Miami Mayor Francis Suarez speaks with CNN on Monday, September 7. CNN

Miami Mayor Francis Suarez said the coronavirus situation in his city has "stabilized" after local officials implemented a number of measures, including curfews and a mandate to wear masks in public.

"For me, the mask-in-public rule is the single biggest weapon that we could use to try to get the numbers down," he said on CNN's "New Day."

Suarez said the mask mandate will likely be needed through flu season because flu and coronavirus threats at the same time "could potentially create another wave."

Watch more:

9:56 a.m. ET, September 7, 2020

US is heading into fall with "a lot of infection" from coronavirus, former FDA head warns

From CNN Health's Jacqueline Howard

FDA Commissioner Scott Gottlieb speaks at the Newseum on March 6, 2019 in Washington, DC. 
FDA Commissioner Scott Gottlieb speaks at the Newseum on March 6, 2019 in Washington, DC.  Mark Wilson/Getty Images

The upcoming fall and winter seasons will be "more difficult" for controlling the coronavirus in the United States, which already has "a lot of infection," Dr. Scott Gottlieb, former commissioner of the US Food and Drug Administration, said on CBS' Face the Nation on Sunday.

"We're heading into a more difficult season. We're heading into the fall and the winter, when we would expect a respiratory pathogen like a coronavirus to start spreading more aggressively than it would in the summer time," Gottlieb told CBS anchor John Dickerson.

"If you look at where we are heading into Labor Day, relative to where we were heading into Memorial Day, we have an equivalent amount – if not more infection – heading into Labor Day right now," Gottlieb added.

"Looking at Memorial Day, we had about 40,000 people hospitalized, we were diagnosing about 21,000 new cases a day, and we had about 1100 deaths," Gottlieb added. "As of yesterday, we had about 35,000 people hospitalized. We're diagnosing about 40,000 infections a day. On a seven-day moving average, we have about 850 tragic deaths a day. So that's a lot of infection to be taking into a season when we know a respiratory pathogen is going to want to spread more aggressively."

Months into the pandemic, people across the United States are "exhausted," Gottlieb said. He warned that there might be a reduction in mask-wearing and social distancing heading into the fall because of that fatigue.

"People are exhausted. People have been social distancing and wearing masks and staying home for a long period of time right now. Small businesses are hurting," Gottlieb said. "So I think that people's willingness to comply with the simple things that we know can reduce spread is going to start to fray as we head into the fall and the winter – and that's another challenge, trying to keep up our vigilance at a time when we know this can spread more aggressively."

 

8:30 a.m. ET, September 7, 2020

Nearly 1 million travelers at US airports were screened on Friday

From CNN's Pete Muntean:

The number of air travelers climbed going into the Labor holiday weekend – enough to set a new pandemic-era high.  

The Transportation Security Administration said it screened 968,673 people on Friday of Labor Day weekend. For comparison, the agency saw nearly 2.2 million people on the same weekday a year ago.

On Saturday, the amount of travelers were far less: TSA only screened 664,640 people compared to 1.7 million the year before.