August 11 coronavirus news

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9:04 a.m. ET, August 11, 2020

US health secretary: "The point is to have a vaccine that is safe," not be first

From CNN's Naomi Thomas

US Health and Human Services Secretary Alex Azar reacted to the announcement from Russia that it has approved a “world first” Covid-19 vaccine.

“The point is not to be first with the vaccine,” Azar said on ABC’s “Good Morning America” today. “The point is to have a vaccine that is safe and effective for the American people and the people of the world.” 

Azar said that transparent data is needed, and that this data has to be from phase three trials that shows that a vaccine is safe and effective.

“That’s what President Trump is leading with the historic Operation Warp Speed initiative, with six vaccines in development,” Azar said.

He said they believe they are on track to having tens of millions of doses of FDA gold-standard vaccine by December, and hundreds of millions of doses going into 2021. 

When asked how he stands by the timeline of December, Azar said that two of the six vaccines are in phase three clinical trials to prove safety and efficacy, and it will depend on the speed at which the clinical trials enroll, people are vaccinated and then exposed to the virus.

“So, we believe, Dr. Fauci believes, that it is very credible that we will have – we have multiple that will be delivering results, and we could have FDA-authorized or approved vaccines by December,” Azar said.

9:14 a.m. ET, August 11, 2020

Dr. Sanjay Gupta: "Of course I wouldn't take" Russian vaccine

From CNN's Adrienne Vogt

CNN’s Dr. Sanjay Gupta speaks on “New Day” on Tuesday, August 11.
CNN’s Dr. Sanjay Gupta speaks on “New Day” on Tuesday, August 11. CNN

Russian President Vladimir Putin says Russia has approved a “world-first” Covid-19 vaccine, but experts are skeptical about safety and effectiveness.

“We have no data on this,” CNN’s Dr. Sanjay Gupta said on “New Day.”

Gupta said he would not feel comfortable taking the vaccine, dubbed Sputnik-V, because of the lack of information about it. 

Gupta said it reminds him of when Russia said it was developing an Ebola vaccine, yet he never saw any phase three data at that time. 

“This is starting to sound very familiar to previous sort of vaccine campaigns out of Russia," he said. "… Of course I wouldn't take this. I know nothing about this vaccine.”  

Watch Dr Gupta's full assessment:

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.