November 18 coronavirus news

By Nectar Gan, Adam Renton, Mike Hayes, Melissa Macaya and Meg Wagner, CNN

Updated 12:00 a.m. ET, November 19, 2020
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10:15 p.m. ET, November 17, 2020

France becomes first country in Europe to reach 2 million coronavirus cases

From Pierre Bairin in Paris

A doctor speaks with a patient infected with Covid-19 in the infectious diseases unit of the Gonesse hospital in Gonesse, north of Paris, on October 22.
A doctor speaks with a patient infected with Covid-19 in the infectious diseases unit of the Gonesse hospital in Gonesse, north of Paris, on October 22. Christophe Archambault/AFP/Getty Images

France has become the first country in Europe to top 2 million confirmed cases of coronavirus, according to data from Johns Hopkins University and the French national health agency.

In a statement on Tuesday evening, France's health agency director Jerome Salomon confirmed at least 2,036,755 total cases had been reported in the country.

“Whether in cities or in rural areas, all regions, all metropolitan departments, are affected,” Salomon said. 
“This second wave, which we are all facing, is massive, deadly and is straining all of our caregivers and our health system as a whole.”

While France has now registered the highest cumulative number of Covid-19 cases in Europe overall, Salomon noted that the current coronavirus reproduction rate in the country is now below one, while the daily number of new cases has declined in the past week.

“In recent days, the number of new cases has declined, redoubling efforts to regain control of the epidemic,” Salomon said, adding that public adherence to national coronavirus restrictions is now “beginning to bear fruit” in France.
“All collective efforts, respect for curfews and national confinement measures serve to explain this positive trend. It is by maintaining a very high level of vigilance and mobilization that we will be able to spend the end-of-year celebrations and the winter months in the safest conditions,” he added.

According to the latest data from the national health agency, a total of 33,139 coronavirus patients are currently in hospital -- down by 327 since Monday -- with 4,838 of those in intensive care.

A further 1,219 coronavirus patients have died since Monday, the national health agency added, bringing the total death toll in France to 46,273.

8:03 p.m. ET, November 17, 2020

FDA sets meeting for vaccine advisory committee

From CNN’s Elizabeth Cohen

The US Food and Drug Administration has called for a meeting of its vaccine advisory committee in three weeks to consider whether the agency should authorize two Covid-19 vaccines, according to a source familiar with the process. 

The FDA reached out last week to members of its Vaccines and Related Biological Products Advisory Committee, a group of outside experts, asking them to hold Dec. 8, 9 and 10 for meetings, according to the source. 

The agency could make a decision at the end of the meeting on Dec. 10 about whether to issue emergency use authorizations for the vaccines, the source said. 

Two companies, Pfizer and Moderna, say they will soon apply to the FDA for authorization for their Covid-19 vaccines, both of which have shown in initial data to be more than 90% effective against Covid-19. 

“It will make sense that in all likelihood the FDA will consider both applications together,” the source said, considering that both vaccines use the same technology and appear to have very similar safety and efficacy results from their large-scale Phase 3 clinical trials. 

If the FDA authorizes the vaccines, they can then be immediately distributed to states, according to a presentation made last month at the US Centers for Disease Control and Prevention.

However, no one can be vaccinated until a CDC advisory committee reviews the data, recommends the vaccine, and says which groups will receive it first. 

If the FDA authorizes the vaccines, the CDC’s Advisory Committee on Immunization Practices (ACIP), an independent panel of experts, will meet within 24 to 48 hours, according to a CDC spokesperson. 

At that meeting, the committee will determine if everyone should get the vaccine, or if some people should be excluded. It will also decide which groups should get the vaccine first. 

“We have all been alerted on ACIP we should be very flexible with our calendars because it’s likely there won’t be a lot of advanced notice given for this meeting. It will be done very, very quickly,” said Dr. William Schaffner, a committee member. 

Once ACIP issues its recommendations, vaccinations can be given. 

Next steps: The nation’s top infectious disease physician, Dr. Anthony Fauci, told CNN earlier this week the first vaccinations in the US could take place “towards the latter part of December.” 

States are currently working out the details of running vaccination clinics. The Pfizer vaccine is particularly complicated, since it must be stored at minus 75 degrees Celsius, and doctors’ offices and pharmacies typically do not have freezers that go that low. 

The first groups expected to receive the vaccine are health care workers, the elderly, essential workers such as police officers, and those with underlying medical conditions. 

10:45 p.m. ET, November 17, 2020

Pfizer prepares to file for emergency use authorization after vaccine reaches safety milestone, CEO says

From CNN's Lauren Mascarenhas

Pfizer CEO Albert Bourla attends 2019 Forbes Healthcare Summit at the Jazz at Lincoln Center on December 5, 2019 in New York City.
Pfizer CEO Albert Bourla attends 2019 Forbes Healthcare Summit at the Jazz at Lincoln Center on December 5, 2019 in New York City. Steven Ferdman/Getty Images

The Pfizer vaccine trial has reached its safety milestone and the company is preparing to file for emergency use authorization, Pfizer CEO Albert Bourla said Tuesday.

Pfizer announced on Nov. 9 that its coronavirus vaccine appears to be more than 90% effective, based on early data.

But the company did not yet have enough data to seek emergency use authorization from the US Food and Drug Administration, which said it also wanted at least two months of safety data on at least half of a vaccine trial’s volunteers starting from when they got their second immunization.

“I think the questions about the safety at large also have been answered,” Bourla said in an interview hosted by The New York Times. “Our safety milestone has been achieved already, and we are preparing now for submissions.”

Bourla said they are not yet sure how durable the protection from their vaccine will be. The Pfizer vaccine uses a messenger RNA, or mRNA, platform to produce an immune response.

“With the mRNA technology, you can boost as soon as you want,” said Bourla. People can be given an additional dose of a vaccine once immunity wears off, referred to as a boost.

Bourla said that a boost, if needed, would likely require only one dose.