August 11 coronavirus news

By Joshua Berlinger, Adam Renton, Melissa Macaya, Meg Wagner and Mike Hayes, CNN

Updated 12:02 a.m. ET, August 12, 2020
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8:44 a.m. ET, August 11, 2020

Russia "certainly not ahead of us" when it comes to vaccines, former FDA head says

From CNN Health’s Naomi Thomas)

Dr. Scott Gottlieb, former commissioner of the US Food and Drug Administration, said on CNBC Tuesday that Russia is not ahead of the US when it comes to vaccine development.

“I think in terms of their development right now, they’re a little bit behind where we are with the vaccines that we have,” Gottlieb said.

US vaccines are now in phase three trials, having cleared phase one and phase two studies, being tested on hundreds, or in some cases a couple of hundred patients, which is about where Russia is right now, according to Gottlieb.

The amount of people who the Russian vaccine has been tested in means that it has cleared the equivalent of a phase one trial, but still needs to be evaluated in a large-scale clinical trial, Gottlieb said.

He said it was unclear to him what it meant for Russia to start giving some kind of preliminary approval to start vaccinating people outside of a clinical trial. Gottlieb added they might be trying to do a registry, where volunteers who take the vaccine outside of a trial who are then followed, but it’s not really cleared for general use in the market.

“There might be a little bit of semantics going on in terms of how they’re treating this from a regulatory standpoint,” Gottlieb said. “So, they’re claiming that it’s fully approved, but it’s not really fully approved.”

However, they are not ahead of the US, he said.

“They’re certainly not ahead of us, and we certainly wouldn’t allow a vaccine to be used for mass distribution at this point based on the data that we have in hand. We just don’t know that the vaccines are safe and effective at this point,” Gottlieb said.

8:39 a.m. ET, August 11, 2020

Florida’s Covid-19 cases in children have increased 137% in past month

From CNN's Rosa Flores and Sara Weisfeldt 

There has been a 137% increase in the number of Covid-19 cases in children age 17 and under in the past month in Florida, according to the state's department of health data.

On July 9, Florida reported 16,797 cases in children. By Aug. 9, that number increased to 39,735 infections, per the Florida Department of Health.

During that same time period hospitalizations jumped from 213 to 436, a 105% increase. Child deaths increased from 4 to 7 during the same time period.

Florida’s percentage increase in Covid-19 infections in children in the past month is higher than the nationwide metric among US children. 

The state's latest figures come after a report by the American Academy of Pediatrics and the Children’s Hospital Association stated there was a 90% increase in Covid-19 cases among US children over the last four weeks.

Some of the increase might be due to more testing, AAP said.

8:37 a.m. ET, August 11, 2020

Vaccines and asymptomatic spreaders may hold keys to answering Covid-19 mysteries, experts say

From CNN's Christina Maxouris

As US leaders work to control the spread of coronavirus, researchers across the country -- and globe -- are working to answer the mysteries that remain around infections.

One of those mysteries: why the experience can be so vastly different from person to person. One expert says the answer may mean taking a closer look at previous vaccines individuals have had.

"When we looked in the setting of Covid disease, we found that people who had prior vaccinations with a variety of vaccines -- for pneumococcus, influenza, hepatitis and others -- appeared to have a lower risk of getting Covid disease," Dr. Andrew Badley, an infectious disease specialist at Mayo Clinic told CNN's Anderson Cooper Monday night.

It's what immunologists call immune training: how your immune system creates an effective response to fight off infections, Badley says.

"A good analogy is to think of your immune system as being a muscle," he said. "The more you exercise that muscle, the stronger it will be when you need it."

There's been no definitive evidence of any other vaccines boosting immunity against Covid-19. But some researchers have suggested it's possible.

Read the full story:

8:55 a.m. ET, August 11, 2020

Covid-19 cases among US children increased 90% over the past 4 weeks, report says

From CNN’s Jen Christensen

There has been a 90% increase in the number of Covid-19 cases among US children over the past four weeks, according to a report published Monday by the American Academy of Pediatrics and the Children’s Hospital Association.

According to this new report, expected to be updated weekly, there were 179,990 new Covid-19 cases among US children between July 9 and August 6. The data comes from case numbers provided by state health departments of 49 states, New York City, the District of Columbia, Puerto Rico and Guam. 

Some of the increase may be due to more testing, AAP said. Early in the pandemic, testing was reserved for the sickest. A broader number of tests may be identifying children that have fewer or milder symptoms than those who were tested earlier in the pandemic.

Children make up just over 9% of the total cases in states that report cases by age, according to the report. At least 380,174 total child Covid-19 cases had been reported as of August 6.

It still appears that severe symptoms are rare among children with Covid-19 infections. Children were between 0.5% and 5.3% of total hospitalizations, according to data from the states that record that information. Children were 0% to 0.4% of all Covid-19 deaths. 

Nineteen states have reported no child deaths. In states that tracked the details, 0% to 0.5% of all child Covid-19 cases resulted in death.

The AAP called for an effective testing strategy so that communities can make the right choice about opening schools. 

“The data – while limited because of its reliance on how each state reports its cases – underscores the urgent need to control the virus in communities so schools may reopen,” a news release from the AAP said.

“In areas with rapid community spread, it’s likely that more children will also be infected, and these data show that,” AAP President Dr. Sally Goza said in the news release.  “As a pediatrician, I urge people to wear cloth face coverings and be diligent in social distancing and hand-washing. It is up to us to make the difference, community by community.”

The World Health Organization said last week that the pandemic is starting to move into the younger population globally, while most cases, by far, are among people ages 25 to 64. 

CNN Chief Medical Correspondent Dr. Sanjay Gupta answered viewers' questions on this worrying statistic:

8:30 a.m. ET, August 11, 2020

Former FDA commissioner says he wouldn’t take Russian vaccine

From CNN Health’s Naomi Thomas

Dr. Scott Gottlieb, former commissioner of the US Food and Drug Administration, testifies during a House Energy and Commerce Committee hearing in Washington, D.C. in this 2017 file photo.
Dr. Scott Gottlieb, former commissioner of the US Food and Drug Administration, testifies during a House Energy and Commerce Committee hearing in Washington, D.C. in this 2017 file photo. Drew Angerer/Getty Images

Dr. Scott Gottlieb, former commissioner of the US Food and Drug Administration, said on Tuesday that he would not take the Russian vaccine outside of a clinical trial.

“I wouldn’t take it, certainly not outside of a clinical trial right now,” Gottlieb said on CNBC. “It appears that it’s only been tested in several hundred patients, at most. There’s some reports that it’s been in as few as 100 patients.”

Gottlieb explained that it was an adenoviral vector vaccine, which is “not a trivial vaccine in terms of the technical complexity that goes into manufacturing.”

China is also developing an adenoviral vaccine, which is in clinical trials in Canada, but early data from that vaccine isn’t very encouraging, he said.

There are more things that can go wrong from a safety standpoint with this type of vaccine, Gottlieb said, including that people could have a reaction to the viral vector itself.

“It’s not clear how efficacious the Russian vaccine is going to be and whether or not people have some prior immunity to the adenovirus that they’re using to deliver the coronavirus gene sequence,” he said.

Gottlieb said that at this point he was worried about both the safety and the efficacy of the Russian vaccine. Something that has only been tested in several hundred patients, which is effectively a phase one clinical trial, is not something you would want to take outside of a clinical trial where you are closely monitored, he said.

“In a lot of these situations, you might only get one shot at taking a vaccine within a season, so if you put a vaccine on the market that’s not efficacious, it’s going to be hard to revaccinate the population, so you want to make sure it works,” he said. 

Gottlieb also tweeted a clip of his interview with CNBC, with the caption: “Russia was reported to be behind disinformation campaigns to sow doubts in U.S. about our Covid vaccines; and today’s news that they “approved” a vaccine on the equivalent of phase 1 data may be another effort to stoke doubts or goad U.S. into forcing early action on our vaccines.” 

Read his tweet:

8:14 a.m. ET, August 11, 2020

US Food and Drug Administration releases guidance for temporary production of hand sanitizer

From CNN's Naomi Thomas

Shutterstock
Shutterstock

The US Food and Drug Administration (FDA) has released three sets of guidance to help companies meet increased demand for hand sanitizer during the Covid-19 pandemic.

"Hand hygiene is an important part of the U.S. response to Covid-19," the FDA website says.

"If soap and water are not readily available, the Centers for Disease Control and Prevention (CDC) recommends consumers use an alcohol-based hand sanitizer that contains at least 60 percent alcohol."

Provided that they follow the FDA guidance, companies that are not currently registered drug manufacturers can register as over-the-counter drug manufacturers to make alcohol based hand sanitizers during the pandemic.

Pharmacies and registered outsourcing facilities can also compound certain alcohol-based hand sanitizers, and alcohol production firms can produce alcohol for making hand sanitizer.

The three sets of guidance provide a list of specific ingredients that should be used in production, considerations for testing and other guidance in areas of production such as preparation and labelling.

The FDA recommends that the public check any hand sanitizer in their home, as well as any that they plan to buy, against its list of products that are potentially contaminated with methanol.

8:09 a.m. ET, August 11, 2020

It's just after 1 p.m. in London and 8 a.m. in New York. Here's the latest on the pandemic

The novel coronavirus has infected more than 20 million people worldwide and killed more than 736,000. Here's what you need to know.

  • Russia approves world's first coronavirus vaccine: Russian President Vladimir Putin says the vaccine, developed by the Moscow-based Gamaleya Institute, has been authorised for use. But there are widespread concerns over its safety and efficacy, and fears that corners may have been cut in the testing process.
  • New Zealand records first cases in 102 days: The government will temporarily reinstate lockdown restrictions in the city of Auckland after four new cases -- all in the same household -- were recorded in the city.
  • Denmark reports spike in cases: The country was one of the first in Europe to reopen. Seventy-six new cases were recorded in Denmark on Monday, according to its health ministry.
  • At least 66 NFL players opt out of season: More than 60 NFL players have opted out of the 2020 season because of the coronavirus pandemic. Players had until 4 p.m. ET on Thursday to decide whether or not to participate.
  • Nearly 5.1 million US cases: At least 5,094,400 coronavirus cases and 163,463 virus-related deaths have been identified in the United States since the pandemic began, according to Johns Hopkins University.

7:30 a.m. ET, August 11, 2020

Denmark sees spike in Covid-19 cases, after being one of the first countries in Europe to reopen

From CNN's Niamh Kennedy in Dublin

Medical staff members prepare a coronavirus test swab on May 6 at Herlev Hospital, Copenhagen, Denmark.
Medical staff members prepare a coronavirus test swab on May 6 at Herlev Hospital, Copenhagen, Denmark. Ólafur Steinar Gestsson/Ritzau Scanpix/AFP/Getty Images

Denmark has reported a rise in Covid-19 cases, after being one of the first European countries to reopen.

The virus is moving through our society once again," Health Minister Magnus Heunicke told a press conference Monday.

New cases have been recorded in 67 out of Denmark's 98 municipalities, a press advisor for the Danish Ministry of Health told CNN.  

Seventy-six new cases were recorded Monday, according to the ministry. 

Denmark's second biggest city, Aarhus, recorded the highest number of new infections.

The spike means the country's virus reproduction rate, or "R," has risen to 1.4 -- meaning each person with the virus infects an average of 1.4 other people.

Denmark has recorded 14,815 confirmed cases and 620 deaths since the beginning of the pandemic.

The country first closed its borders to non-citizens on March 13, it also restricted public gatherings and closed schools.

Denmark was one of the first European countries to reopen schools with the first students returning in mid-April. 

Due to the rise in case numbers, the Danish government last week decided to postpone a decision on lifting restrictions on the number of people allowed at some public gatherings.

The press advisor told CNN that Denmark's political parties are to meet on Wednesday to discuss the delay and the plans for Phase Four of the country's lockdown exit, under which nightclubs and concert venues are set to reopen.

8:14 a.m. ET, August 11, 2020

Russia names coronavirus vaccine "Sputnik-V," says 20 countries have requested more than a billion doses

From CNN's Zahra Ullah in Moscow

Twenty countries around the world have requested more than a billion doses of Russia's newly-approved coronavirus vaccine, according to the head of the Russia Direct Investment Fund (RDIF).

The vaccine has been named "Sputnik-V" -- a reference to the surprise 1957 launch of the world's first satellite by the Soviet Union.

"We’ve seen considerable interest in the Russian vaccine developed by the Gamaleya Institute abroad. Moreover, we have received preliminary applications for over 1 billion doses of the vaccine from 20 countries," RDIF head Kirill Dmitriev said Tuesday.
"Along with our foreign partners, we are already prepared to manufacture over 500 million doses of vaccine per year in five countries, and the plan is to ramp-up production capacity even higher."
He added: "So far, countries in Latin America, the Middle East and Asia have displayed the greatest interest in the vaccine, and we are about to finalize a number of contracts for the purchase of the vaccine."

The Russian vaccine is yet to pass the crucial Phase 3 testing stage. Phase 3 trials, typically involving thousands of participants, assess a drug's safety and effectiveness.

Dmitriev said those trials would take place abroad.

"We have already reached agreements on conducting the relevant trials of the Gamaleya vaccine with partners from the UAE, Saudi Arabia, and a number of other countries," he said.

The Gamaleya vaccine is the first in the world to be approved but there are widespread concerns that essential corners may have been cut in its development.

Critics say the country's push for a vaccine is partly due to political pressure from the Kremlin, which is keen to portray Russia as a global scientific force.

On Tuesday, Dmitriev hit out at criticisms of the vaccine and the lack of testing and trials.

"Coordinated and carefully-orchestrated media attacks on the Russian vaccine have attempted to discredit and conceal the correctness of Russia’s approach to the drug’s development," he said.

Russia has released no scientific data on its testing, and CNN is unable to verify the vaccine's claimed safety or effectiveness.