Johnson & Johnson's single-dose vaccine enters phase 3 trials

This September 2020 photo provided by Johnson & Johnson shows a single-dose COVID-19 vaccine being developed by the company.  Cheryl Gerber/Courtesy of Johnson & Johnson/AP

Johnson & Johnson’s Covid-19 vaccine candidate begins phase 3 trials in the United States on Wednesday. Trials for the single-dose vaccine, which uses a human adenovirus, will include up to 60,000 adult participants at nearly 215 sites in the US and internationally. 

 The vaccine candidate was developed by Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson. Phase 3 trials will begin immediately, with the first participants receiving doses Wednesday, Johnson & Johnson Chief Scientific Officer Dr. Paul Stoffels said on a call with reporters Tuesday.

Initial findings from the vaccine’s phase 1/2 trials in the US and Belgium suggest the vaccine provokes an immune response and is safe enough to move into large-scale trials. 

Phase 3 trials will examine the safety and effectiveness of a single dose against a placebo to prevent symptomatic Covid-19. The fact that the trial will examine the efficacy of a single dose of the vaccine, instead of two doses, should expedite results, said Stoffels.

Trials will run in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States. Johnson & Johnson intends to run a separate phase 3 trial in collaboration with the UK government to examine the effectiveness of two doses

If the vaccine is proven safe and effective, Johnson & Johnson said it expects the first doses to be available for emergency use authorization from the US Food and Drug Administration by early 2021. 

Where things stand: Moderna, Pfizer/BioNTech and AstraZeneca also have Covid-19 vaccine candidates in Phase 3 trials in the United States, although AstraZeneca’s trial is currently paused.

Johnson & Johnson’s phase 3 trial is being conducted in collaboration with Operation Warp Speed, the federal government’s coronavirus vaccine effort.

Dr. Gupta discusses Johnson & Johnson’s vaccine:

Dr. James Hamblin, a staff writer at The Atlantic, says he’s concerned about the upcoming winter during the coronavirus pandemic. 

Hamblin’s suggestions for winter include accepting reality, planning for more shutdowns and living like you are already contagious. 

“The worst mistake we can make is to assume that because things are going well or because a neighborhood or city where you are is opening, that's going to continue apace. It might level off, it might have to go back and shelter in place a little while,” he said. 

Hamblin said that families should consider not gathering indoors for long periods of time during the holiday season, which could create as “extremely dangerous situation.” 

Even if a vaccine is available, Hamblin said that should be taken along with “bundling” treatment and prevention of the virus — which includes wearing masks, social distancing and testing protocols. 

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China announced Wednesday that it would relax visa policies for some foreigners, in the latest sign of the government’s confidence in its containment of Covid-19.

Starting September 28, foreign nationals holding three types of long-term visas -- called residence permits -- are allowed to enter China without having to apply for a new visa, said the Chinese Foreign Ministry and National Immigration Administration in a notice posted online.

The new rule covers people who hold visas for work, personal matters and family reunions.

The latest policy, however, doesn’t apply to China-based foreign journalists, according to a Foreign Ministry official.

China effectively closed its borders to most foreign nationals in late March as part of its effort to fight the spread of coronavirus. That month it suspended all previously issued visas for foreigners not already in the country.  

Eligible foreigners who enter China under the new rule “shall strictly abide by the Chinese regulations on epidemic prevention and control,” the notice added. “While ensuring effective epidemic control, the Chinese government will continue resuming people-to-people exchanges in a step-by-step and orderly manner.”

A protester holds a sign depicting Israeli Prime Minister Benjamin Netanyahu with a face mask during a demonstration in Jerusalem on September 20. Amir Levy/Getty Images

Last week's signing ceremony on the south lawn of the White House, as Israel, the United Arab Emirates and Bahrain normalized relations, was the celebration Prime Minister Benjamin Netanyahu wanted -- and the distraction he needed.

"Let us pause for a moment to appreciate this remarkable day. Let us rise above any political divide. Let us put all cynicism aside. Let us feel on this day the pulse of history," he said last Tuesday. "For long after the pandemic is gone, the peace we make today will endure."

And while the coronavirus may be the most pressing challenge facing Netanyahu right now, it's far from the only one. The 70-year-old leader is being attacked from both left and the right, not only for his handling of the public health crisis, but also for mismanagement of the economy, his response to his criminal trials, and more.

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A ski resort advertisement in Ischgl, Austria, on September 9. Sean Gallup/Getty Images

A class action lawsuit has been filed against Austria and its federal state of Tyrol in connection with a mass coronavirus outbreak in the ski resort of Ischgl in March, and its subsequent spread to European countries and beyond. 

The Austrian Consumer Protection Association (VSV) has submitted a first description of the facts to the Public Prosecutor’s Office in Vienna for its investigation, a statement on the VSV website says. 

More than 1,000 people say they are joining the lawsuit, according to multiple reports. CNN has asked the cabinet of the Austrian chancellery for comment.

The class action aims to prove the authorities in Austria and Tyrol state did not do enough to shield visitors from the coronavirus prior to March 13 -- by not closing the resort or warning skiers the virus was circulating.

In a statement to CNN, Tyrol state said people are "free to bring actions to court in a constitutional state" and it "has the greatest possible interest in re-evaluating all developments over the past few months."

However, the statement continues, the pandemic put "many countries and regions around the world ... in an exceptional situation unimaginable just a few months ago," adding that it is working closely "with the judiciary" and an expert commission tasked with looking into Ischgl's coronavirus crisis management.

The class action will also aim to prove that the sudden quarantine order issued for Ischgl and surrounding areas on March 13 allowed the virus to spread across Europe.

The VSV report says: “If you were at the ski resorts of Ischgl, Paznauntal, St. Anton am Arlberg, Sölden or Zillertal on 5 March 2020 or later, and shortly afterwards were diagnosed with the coronavirus, then you may be entitled to claim damages against the Tyrolean authorities and also against the Republic of Austria, provided we can produce evidence for negligence through relevant reports or in criminal proceedings."

Ischgl and its neighboring villages draw around 500,000 visitors each winter, with high-profile celebrities and politicians among them in previous years.

Chinese Foreign Ministry spokesman Wang Wenbin speaks during a daily media briefing in Beijing on September 18. Wu Hong/EPA-EFE/Shutterstock

China's Ministry of Foreign Affairs hit back after US President Donald Trump blamed the Asian country for the coronavirus crisis, and for unleashing a "plague" on the world, in his pre-recorded United Nations General Assembly (UNGA) address.

Wang said the virus "is a common enemy to all. China has suffered from this epidemic and contributed to the global response," adding that "lies cannot replace truth." 

He said that China shared data about the virus at the "earliest time possible" and had also suffered because of the pandemic.

A woman places flags at a COVID Memorial Project installation of 20,000 American flags on the National Mall in Washington, DC, on September 22. The flags are displayed on the grounds of the Washington Monument facing the White House. Win McNamee/Getty Images

More Americans have now died of Covid than of five wars combined.

Or, the US Covid deaths are the equivalent of US deaths on 9/11 occurring every day for 66 days.

Or, the US has suffered an average of 858 deaths every day since February 6, the date of the first known US coronavirus death.

Or, Covid is now the second-leading cause of death in the US this year, behind only heart disease.

Many, many more deaths are on the way: Prediction models, which fluctuate, currently suggest the US could see 180,000 more deaths by the end of 2020 -- 380,000 deaths total. If fatalities approach that level, they'll far eclipse even Civil War battle deaths.

Infectious disease expert and government official Dr. Anthony Fauci said at the Citizen by CNN conference on Tuesday that he's concerned about the country not having control of the virus' spread ahead of a winter season that could exacerbate it.

"The idea of 200,000 deaths is really very sobering, and in some respects, stunning," he told CNN chief medical correspondent Dr. Sanjay Gupta. Fauci argued that the country is in a pivotal moment to slow the spread right now with simple measures -- frequent hand washing and wearing masks, the same as the recommendation has been for months -- before winter comes, when people spend more time inside and transmission could increase.

He added that he'd like to see the US go into the fall and winter months "at such a low level that when you have the inevitable cases, you can handle them."

Yet President Donald Trump says Covid affects virtually nobody: Rather than publicly mourning, Trump was arguing this week that Covid affects "elderly people with heart problems" and very few other people. "It affects virtually nobody. It's an amazing thing," he said in Ohio.

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US Rep. Raja Krishnamoorthi (D-IL) asks questions during a hearing before the House Intelligence Committee on Capitol Hill in Washington, DC, on November 20, 2019 Samuel Corum/Pool/Getty Images

The posting and removal of US Centers for Disease Control and Prevention guidelines on airborne transmission for coronavirus prompted a flurry of questions from Capitol Hill this week, with both sides of the aisle reaching out for answers on what happened.

And Democrats were not buying the CDC's innocuous explanation of an unfortunate mistake. They argue it is just the latest example in a long pattern of confusing behavior where the CDC makes one decision and then days later backs off.

"The CDC just published scientifically valid information and then pulled it off their website, and this is very likely a scandal," Sen. Brian Schatz, a Democrat from Hawaii, said Tuesday.

The CDC guidance pertained to the way the novel coronavirus is spread. While it's known that Covid-19 can spread through droplets among people standing less than six feet apart, research has continued to explore how the virus suspends in aerosolized particles in the air and transmits to people more than six feet away.

The CDC said the retraction of new guidance about airborne coronavirus transmission was the result of a confused staffer who hit "publish" without approval, according to the most detailed explanation yet of the agency's website mishap.

Several other current and former federal health officials also told CNN the document was posted in error before it had gone through the full review process.

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Israel reported 6,861 new coronavirus cases on Tuesday, surging past the previous daily high of 5,523 new infections set last week.

The new daily high in recorded cases comes as Israel’s government considers imposing tighter restrictions during the country’s second general lockdown, including limitations on prayer and protests, and scaling back work in the public and private sector.

Israel imposed the lockdown last Friday as it tried to curtail the rising number of cases throughout the country, but critics said the restrictions have too many loopholes and exceptions to adequately stop the spread of the virus.