The latest on the coronavirus pandemic

The US Food and Drug Administration is in the "early stages" of looking into whether expanded access — a regulatory pathway typically used for investigational drugs — could be used as a way to make a potential Covid-19 vaccine available to the public, an FDA official said on Friday.

Among the regulatory pathways for making a potential Covid-19 vaccine available, emergency use authorization has been the most discussed so far.

"Emergency use authorization is one of those mechanisms and is dependent upon declaration of a public health emergency, which is the situation we're currently in with Covid-19. Expanded access does not require the declaration of a public health emergency but it does have additional requirements for use," Fink said on Friday. "Expanded access is not an approval process."

Some background: If expanded access were to be considered for a potential Covid-19 vaccine, the vaccine manufacturer would need to have an active "investigational new drug" application on file with the FDA. Then the manufacturer would need to "submit a protocol for use of the vaccine under expanded access regulations and would work potentially with public government agencies" to organize and implement the expanded access protocol, Fink said.

Expanded access has been used before for vaccines, Fink added, just not on the massive scale that would be needed for a potential Covid-19 vaccine.

"We do have recent examples of expanded access treatment protocols that have been used to provide vaccine to thousands of individuals or tens of thousands of individuals," Fink said. "One example was to address meningococcal B disease outbreak on several college campuses prior to FDA licensure of meningococcal vaccines, and then more recently, there's been an expanded access protocol for use of non-US-licensed yellow fever vaccine."

Just days before Election Day, White House strategic communications director Alyssa Farah called Nov. 3 an "arbitrary deadline" for a coronavirus vaccine, despite President Trump pushing for a pre-election development for months.

Asked by CNN about the 250-person limit at the President’s rally today in Rochester, Minnesota, due to guidance from the Minnesota Health Department, Farah declined to speak on behalf of the campaign and said she was not involved in planning.

The city-state of Monaco will introduce a 8 p.m. to 6 a.m. local time curfew to control spread of Covid-19 starting midnight on Saturday. The curfew will run for at least a month.

Prince Albert II of Monaco announced the new measures in a televised address on Thursday evening.

Businesses and shops “will remain open with a certain number of arrangements” and “remote work will be encouraged in the public and private sectors,” he said adding that schools and universities will remain open whilst respecting social distancing measures.

The announcement comes after the principality reported 10 new positive cases and eight recoveries on Thursday, according to a government tweet. 

Some background: Monaco is located on the French riviera, in Western Europe. Despite its independence, it has close economic ties with neighbor France, which started a four-week lockdown this Friday.

The move in France, in response to spiraling coronavirus case numbers, was announced by President Emmanuel Macron on Wednesday, just hours after German Chancellor Angela Merkel declared a similar four-week nationwide lockdown in her own country.

Read more about the French and German lockdowns:

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Dr. Paul Casey, emergency department medical director at Bellin Hospital in Green Bay, Wisconsin, said it’s “mind-boggling” that President Trump is holding a campaign event today in the city as Covid-19 cases skyrocket in the state.

“We're seeing a steady stream of patients needing to be admitted to the hospital. So far, we've been able to keep up, but that is more than likely going to change fairly quickly,” he added.

Amid soaring cases, Trump is set to hold a campaign event in Green Bay today, which Casey said “simply boggles my mind.” 

Casey said there is an entire ward in his hospital set aside for coronavirus patients right now. 

“20% of our hospital capacity is currently filled with Covid patients. And in my 34-year career, that's unprecedented. I have never, ever seen a time where we had a single ward devoted to a single disease. … It takes back memories of the foregone times when we saw things like smallpox, that kind of thing, where we had a single disease overrunning the hospital,” he said. 

Nurses are working 12-hour shifts and are exhausted, Casey said. 

“It's also extremely hard to see patients without family members in the last days of their life, having to comfort them. It takes a human toll on the nursing staff,” he said. 

WATCH:

Over the past six months pharmaceutical companies have made various predictions about their Covid-19 vaccine timelines that have turned out not to be true.

In one recent example, Pfizer has said repeatedly it would know by the end of October if its vaccine works or not – but Tuesday on an investor call, the company’s CEO essentially ruled that out. 

Scientists say that should guide us as we move closer to having a vaccine: Don’t believe everything you hear, because testing and manufacturing vaccines are notoriously unpredictable.    

In May, University of Oxford researchers predicted they would have data from their clinical trials by September at the latest, but that did not happen. Their clinical trial is still underway. 

While at times Pfizer, Oxford and other vaccine developers have couched their statements, at other times, they have been more definitive about their timelines. 

There are 45 candidate vaccines currently at the clinical evaluation stage of development and 156 in preclinical evaluation, according to the World Health Organization.

"We help with hygiene, sometimes we draw blood, we do..." mid-sentence, Barbara Sásová looks over for help finding the right English word to describe her duties. "Sanitary work," she says, nervously giggling. At just 18 years old, she's a nurses' assistant at a hospital in Kyjov, a small town in eastern Czech Republic less than half an hour from the Slovakian border.

The teenager attends a healthcare-focused high school nearby, but with schools shut down across the country to stem the spread of the Covid-19 pandemic, she's been catapulted into the adult world, inside a hospital where she is badly needed. Some of her colleagues are only 16, unable to vote, or even drive.

"The situation is very serious. The Czech health system never faced such a challenge before," said Dr. Milan Kubek, president of the Czech Medical Chamber.

As of October 28, according to Kubek, 15,433 health care workers have been sidelined with the virus; almost 3,000 of them are doctors. Most are catching the virus not at work, but on the streets, or from friends or relatives, Kubek believes.

The numbers are so high that Czech hospitals are limping along with vital help from volunteers -- who get bonus points for having medical experience -- but beggars can't be choosers.

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Maine reported its highest single day increase of new cases on Thursday, making it the 30th US state to do so in October.

The other states include nearby New Hampshire and Rhode Island, as well as Alabama, Alaska, Colorado, Idaho, Illinois, Indiana, Kansas, Kentucky, Michigan, Minnesota, Missouri, Montana, Nebraska, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Utah, Washington, West Virginia, Wisconsin and Wyoming. 

Last week Maine reported an outbreak of 49 cases which were linked to a fellowship event at a church in the small town of Brooks.

Daily cases nationally also reached a record high on Thursday, with 88,521 reported according to Johns Hopkins University (JHU).

In total, there have been 8,944,934 cases and at least 228,656 deaths in the US, according to JHU.

As Covid-19 cases surge in the US, one Texas veterinarian has been quietly tracking the spread of the disease — not in people, but in their pets.

Since June, Sarah Hamer and her team at Texas A&M University have tested hundreds of animals from area households where humans contracted Covid-19. They've swabbed dogs and cats, but also pet hamsters and guinea pigs, looking for signs of infection.

"We're open to all of it," said Hamer, a professor of epidemiology, who has found at least 19 cases of infection.

One pet that tested positive was Phoenix, a 7-year-old part-Siamese cat owned by Kaitlyn Romoser, who works in a university lab. Romoser, 23, was confirmed to have Covid-19 twice, once in March and again in September. The second time she was much sicker, she said, and Phoenix was her constant companion.

"He sleeps in my bed with me. There was absolutely no social distancing."

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Authorities in Paris estimate there were traffic jams with a combined total length of 730 kilometres (454 miles) on Thursday evening, ahead of new Covid-19 travel restrictions.

“Even though this is not the highest traffic jam recorded, this is still a very important data,” the press office for the Paris region traffic authority told CNN. 

Thursday was the last day before the whole country went into a national lockdown, and also one of the last few days for people to return to their homes after France’s school half-term, which ends after the All Saints’ holiday this weekend.

More information is expected to be known later on Friday once the data has been analyzed.

Despite the heavy restrictions on travel that came into place at midnight on Thursday, French President Emmanuel Macron assured French citizens that people will be allowed by the authorities to return to their homes by Sunday evening.