December 1 coronavirus news

BioNTech and Pfizer have submitted an application of their Covid-19 vaccine to the European Medicines Agency (EMA) that could enable its use before the end of the year, according to a news release. 

This submission completes a rolling review process that began on October 6. The vaccine candidate will now be assessed according to EMA’s normal stringent standards for quality, safety and efficacy, the drug makers said.

Ugur Sahin, CEO and co-founder of BioNTech, said it was an important step "as we continue to seek to enable a worldwide supply upon potential approval" of the vaccine.

Earlier this month, BioNTech and drug giant Pfizer submitted their mRNA coronavirus vaccine candidate to the US Food and Drug Administration (FDA).

The companies have now submitted to the EMA, FDA and UK Medicines and Healthcare Products Regulatory Agency, and have initiated rolling submissions in countries including Australia, Canada and Japan.

Drugmaker Moderna yesterday announced it will become the second pharmaceutical company to apply to the FDA for emergency use authorization of its Covid-19 vaccine.

The Dutch government is mandating the use of of face masks in all publicly accessible, covered places from today.

The mandate applies in stores, public transportation (including platforms), barbers, and schools (though not primary schools).

Those who do not adhere to the mandate face the possibility of a 95 euro ($114) fine.

The mandate does not apply to children under 13 years old, or to buildings not accessible to the general public and places of worship.

Austria has launched a mass Covid-19 testing program for its 9 million citizens, as infections surge across Europe.

According to the country's health ministry, the mass testing aims to achieve an "inventory of active infections, faster and broader localization of active cases of infection and thus a more efficient break in the chains of infection.” 

Inhabitants started getting tested Tuesday morning, according to the website of the Salzburg federal state. All those registered in Salzburg can voluntarily get checked.

In Annaberg-Lungötz, the mayor went door-to-door to alert people that the test was available, according to CNN affiliate NTV.

Austria has recorded 282,456 infections and 3,184 virus-related deaths so far, according to its interior ministry.

CORRECTION: An earlier version of this post misidentified where the mayor knocked door-to-door to inform people about the testing program. It happened in Annaberg-Lungötz.

German chancellor Angela Merkel has warned of a third coronavirus wave if people don't follow precautions, as cases surge across Europe.

"We still have to be very, very careful this winter. Otherwise we are immediately sitting in the next wave again," she said on a video call with police officers on Monday.

The country has a total of 1,067,473 confirmed cases and 16,636 related deaths, according to the Robert Koch Institute, Germany's center for disease control and prevention. Germany passed the 1 million mark on Friday, as new restrictions came into effect nationwide.

Hong Kong and Singapore's air travel bubble (ATB), which was supposed to launch in November, has been deferred until next year as a fourth wave of coronavirus infections hits Hong Kong. 

Hong Kong officials said on Tuesday that they would review later this month whether the travel corridor could open next year.

How the travel bubble works: Under the scheme, travelers between Singapore and Hong Kong will be subject to Covid-19 tests but not to mandatory quarantine in either location.

The bubble was scheduled to launch on Nov. 22 but was canceled less than 24 hours before flights were due to take off, as cases began to rise in Hong Kong. 

Formula One champion Lewis Hamilton, who wrapped up a record-equaling seventh world title last month, will miss this weekend’s Sakhir Grand Prix in Bahrain after testing positive for Covid-19, his Mercedes team confirmed on Tuesday.

In a statement, the team said that the Briton had three negative test results last week including on Sunday at the Bahrain International Circuit, where he won the Bahrain Grand Prix.

The 35-year-old took a further test that returned a positive result, which was later confirmed by a retest.

Hamilton is “now isolating in accordance with COVID-19 protocols and public health authority guidelines in Bahrain.”

The team added that “apart from mild symptoms, he is otherwise fit and well” and as a result will miss this weekend’s race.

Mercedes said a replacement driver to fill Hamilton’s seat for this coming weekend will be announced in due course.

Virus in F1: Other F1 drivers have tested positive this season -- Racing Point's Sergio Perez contracted the virus in August ahead of the British Grand Prix. His teammate, Lance Stroll, also tested positive in October after the Eifel Grand Prix.

The coronavirus may invade the brain through nerve cells in the nose, German researchers reported Monday.

Autopsy results from 33 people who died of coronavirus showed the virus in the brain and in the nasopharynx -- the upper part of the throat where it connects to the nasal cavity. The researchers found high concentrations of virus in the tissue associated with smell (the olfactory mucosa).

Why this matters: The findings can help explain some of the neurological symptoms of coronavirus infection -- notably, the loss of smell that so many people experience, the researchers reported in the journal Nature Neuroscience.

They might also help explain symptoms such as headache, fatigue, vomiting and nausea, according to Frank Heppner of the Berlin Institute of Health.

How the study was done: The researchers sampled tissue from the patients and used imaging to see RNA from the virus. They found evidence the virus travels along the nerves from the cells lining the throat and sinuses to the brain.

It’s not a surprising finding -- researchers have suspected the coronavirus gets into the central nervous system this way. Other viruses do, too, including flu. The German study is unique in that imaging was used to catch the virus in the act.

White House Chief of Staff Mark Meadows is scheduled to meet with FDA Commissioner Dr. Stephen Hahn Tuesday, as President Donald Trump has privately demanded to know why his agency hasn't granted emergency use for Pfizer's coronavirus vaccine yet, according to two sources. 

Meadows summoned Hahn for a progress update over the weekend. Hahn requested their meeting happen over the phone, one source said, but was told by the White House that the chief of staff preferred to meet in person. That appears to have led to concern within the FDA that the meeting could become tense, leading Hahn to issue a statement to Axios tonight defending the FDA's timeline. 

Pfizer applied for the EUA on Nov. 20. 

Emergency use authorization from the FDA is not the same as full approval, but allows products to be used under particular circumstances before all the evidence is available for approval, according to previous CNN reporting. 

The FDA has previously said it has scheduled a meeting of its outside advisory panel to discuss Pfizer and BioNTech's application for emergency use authorization for a coronavirus vaccine for Dec. 10.

But Trump has become privately frustrated over how long the process is taking, sources told CNN. He has proudly and publicly admitted to pressuring the FDA to move faster. 

It's not clear how the meeting between Meadows and Hahn will go until it takes place. A sense of distrust between Trump's closest advisers and career scientists on the FDA already existed before the FDA issued public statements about the meeting on Monday night. 

Friday is the “locked and loaded” date for states to have their dose requests for Pfizer's Covid-19 vaccine, Claire Hannan, executive director of the Association of Immunization Managers, told CNN Monday.

After that, they won’t be able to change their requests, said Hannan, whose group is helping states with their immunization plans.  

Friday is also the deadline for states to submit physical locations for the Pfizer vaccine, according to Gen. Gustave Perna, who is helping to oversee Operation Warp Speed.

Another Covid-19 vaccine maker, Moderna, has a similar deadline set for Dec. 11, according to Perna. 

Pfizer and Moderna have both submitted requests for emergency use authorization to the US Food and Drug Administration. The FDA has called meetings of its advisers for Dec. 10 to discuss Pfizer’s application and Dec. 17 to discuss Moderna’s. 

Health and Human Services Secretary Alex Azar said Monday it was possible people could begin receiving vaccines by Christmas.