August 11 coronavirus news

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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.

6:27 a.m. ET, August 11, 2020

New Zealand reinstates some lockdown restrictions after recording first locally-transmitted coronavirus case in 102 days

From CNN's Isaac Yee in Hong Kong

New Zealand Prime Minister Jacinda Ardern, left, and Director-General of Health Ashley Bloomfield, right, attend a news conference on August 11 in Wellington, New Zealand.
New Zealand Prime Minister Jacinda Ardern, left, and Director-General of Health Ashley Bloomfield, right, attend a news conference on August 11 in Wellington, New Zealand. TVNZ

New Zealand has recorded four new locally transmitted coronavirus cases, breaking its 102-day streak without a local infection.

All four of the cases were found within one household in South Auckland according to New Zealand’s Director-General of Health Dr. Ashley Bloomfield. He added that none of the new cases had recently travelled outside of New Zealand.

"We have been preparing for that time, and that time is now," said Dr Bloomfield, adding that the "health system is well prepared" for such an outbreak.

New Zealand Prime Minister Jacinda Ardern announced that Auckland, the country's most populous city, would temporarily be placed under level three pandemic restrictions for three days, beginning at midday on Wednesday.

"In line with our precautionary approach we will be asking Aucklanders to take swift actions with us. As of 12 noon tomorrow, Wednesday August 12, we will be moving Auckland to level 3 restrictions," Ardern said Tuesday.

She added that the lockdown would allow health officials to conduct urgent contact tracing and assess the situation.

Under the new restrictions businesses including restaurants, bars and non-essential shops will close. People will only be allowed to leave their homes to conduct essential activities such as picking up supplies from grocery stores. Gatherings over 10 people will also be restricted and schools will be closed for three days.

Outside Auckland, the rest of New Zealand will go into level two restrictions.

Under these rules groups of no more than 100 people can gather in one place. Social distancing must also be practiced at hospitality businesses, while public venues such as museums, libraries and pools can open if they comply with public health measures and ensure one meter physical distancing and record keeping.  

The new restrictions will last for at least three days, until midnight on Friday.

6:16 a.m. ET, August 11, 2020

Hong Kong records 33 coronavirus cases -- its lowest count since mid-July

From Vanesse Chan in Hong Kong

A medical worker hands out Covid-19 test kits to local residents on August 7 in Hong Kong, China.
A medical worker hands out Covid-19 test kits to local residents on August 7 in Hong Kong, China. Photo by Qin Louyue/China News Service/Getty Images

Hong Kong reported 33 cases of Covid-19 on Tuesday, its lowest number of new infections since July 15.

The tally is composed of 32 local infections and one imported case from India, according to information given at Hong Kong's daily health briefing.

Among the local cases, 17 are related to previous infections, of which 10 were transmitted within families. The others were work-related, including two new cases in Kwong Wah Hospital.

Three deaths were also recorded, bringing Hong Kong's death toll to 58. The total number of cases stands at 4,181.

Hong Kong officials have scrambled in recent weeks to suppress a third wave of the virus in the city.

Dr. Chuang of the health department's Communicable Disease Branch said she has noticed an overall decreasing trend but added that the daily number may fluctuate.

Although we have 33 cases today, we still have around 50 preliminary positive cases," she said. 
"I hope the trend will continue with all efforts from the community as well as from the government. But still, there are a lot of unknown cases in our community," she added.
6:13 a.m. ET, August 11, 2020

This 21-year-old thought he had overcome a mild case of Covid-19. Then he went into organ failure

From CNN's Christina Maxouris

Spencer Rollyson speaks with CNN ON
Spencer Rollyson speaks with CNN ON CNN

Spencer Rollyson says he didn't think much of it when he experienced mild coronavirus symptoms in May. Weeks later, the disease almost took his life.

I never thought, at 21, I would be on the verge of death," he said.

Initially, the infection seemed just like the flu or a cold, he said, and the symptoms lasted for a few days.

"About a week and a half, two weeks later, I started feeling bad," he said.

Rollyson said he went to the emergency room with a 103.4-degree fever and doctors conducted several tests including chest X-rays and CT scans to find the root of the problem. Everything came back clear, he says, but within 48 hours Rollyson was in the ICU.

"That's when everything started shutting down," he said. "In two days, my body rapidly declined."

Read more here.

8:18 a.m. ET, August 11, 2020

Putin says Russia has registered "world first" coronavirus vaccine

From CNN's Zahra Ullah in Moscow

A lab technician works on production of the 'Medgamal' Covid-19 vaccine, developed by the Gamaleya National Research Center for Epidemiology on August 6 in Moscow, Russia.
A lab technician works on production of the 'Medgamal' Covid-19 vaccine, developed by the Gamaleya National Research Center for Epidemiology on August 6 in Moscow, Russia. Andrey Rudakov/Bloomberg/Getty Images

Russia has approved a coronavirus vaccine developed by the Moscow-based Gamaleya Institute for use, President Vladimir Putin said on Russian state TV on Tuesday.

Speaking in a live teleconference with his cabinet ministers, Putin said the vaccine had gone through all the necessary checks.

"A vaccine against coronavirus has been registered for the first time in the world this morning," Putin said, adding: "I know that it works quite effectively, it forms a stable immunity."
"So we're the first to have registered. I hope our foreign colleagues' work will move as well, and a lot of products will appear on an international market that could be used," Putin said.

The Russian President revealed that one of his daughters has taken the vaccine; he said she had a slightly higher temperature following the injections, but that she now feels better.

"I know this very well too, as one of my daughters has been inoculated with the vaccine," he said.
"I think that this way she participated in the experiment. After the first injection her temperature was 38 [degrees Celsius], the next day 37-something and that's it. After the second injection the temperature also got a bit higher but that's it, then it went back down. Now she feels well."

Reports about Russia's vaccine have come amid concerns about its safety, effectiveness and allegations that the country has cut essential corners in its development. 

Russian officials told CNN previously that crucial Phase 3 trials would take place after state registration of the vaccine. 

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

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