The Latest: Drug maker begins applying for vaccine approval

In this July 30, 2013, file photo, large banners hang in an atrium at the headquarters of Johnson & Johnson in New Brunswick, N.J. Johnson & Johnson is beginning a huge final-stage study Wednesday, Sept. 23, 2020, to try to prove if a single-dose COVID-19 vaccine can protect against the virus. (AP Photo/Mel Evans, File)

Orange County Fire Rescue workers give out Personal Protective Equipment (PPE), consisting of disposable masks and hand sanitizer, free to small businesses, Tuesday, Dec. 1, 2020, in Orlando, Fla. (AP Photo/John Raoux)

Alabama Health Officer Dr. Scott Harris speaks during a news conference update on COVID-19 restrictions at the Alabama State Capitol in Montgomery, Ala., on Thursday, Nov. 5, 2020. (Jake Crandall/The Montgomery Advertiser via AP)

Iowa Gov. Kim Reynolds updates the state's response to the coronavirus outbreak during a news conference, Thursday, Nov. 19, 2020, in Johnston, Iowa. (AP Photo/Charlie Neibergall)

In this March 16, 2020, file photo, vials used by pharmacists to prepare syringes used on the first day of a first clinical trial of the potential vaccine for COVID-19 rest on a lab table at the Kaiser Permanente Washington Health Research Institute in Seattle. An influential scientific panel on Tuesday, Dec. 1, is set to tackle one of the most pressing questions in the U.S. coronavirus epidemic: When the first doses of COVID-19 vaccine become available, who should be at the front of the line for shots? (AP Photo/Ted S. Warren, File)

Workers of the Federal Agency for Technical Relief (THW) are setting up a vaccination centre in the sports hall of a school in Eschwege, Germany, Tuesday, Dec. 1, 2020. The German government is preparing to roll out a nationwide coronavirus vaccination program. (Sven Pfoertner/dpa via AP)

One of around 200 health professionals protest at the entrance of the Nurse Isabel Zendal Hospital as officials entered the state-of-the-art facility, built in 100 days at a cost of 100 million euros (119 dolllars), twice the original budget in Madrid, Spain, Tuesday, Dec. 1, 2020. Authorities in Madrid held a ceremony to open part of a 1,000-bed hospital for emergencies that critics say is no more than a vanity project, a building with beds not ready to receive patients and unnecessary now that contagion and hospitalizations are waning. Spain has officially logged 1.6 million infections and over 45,000 deaths confirmed for COVID-19 since the beginning of the year. Message on mask reads ' Public heath service'. (AP Photo/Paul White)

Tokyo Gov. Yuriko Koike speaks during a news conference Wednesday, Nov. 25, 2020, in Tokyo. The board reads "infection control measures, Short and intensive." (Kyodo News via AP)

In this Saturday, Nov. 28, 2020 file photo Mercedes driver Lewis Hamilton of Britain gestures after taking the pole position after the qualifying session at the Formula One Bahrain International Circuit in Sakhir, Bahrain. World champion Lewis Hamilton tested positive for COVID-19 and will miss the Sakhir Grand Prix this weekend, his Mercedes-AMG Petronas F1 Team said Tuesday Dec. 1, 2020. (Hamad Mohammed, Pool via AP, File)

New wheelchairs sit in the empty Isabel Zendal new hospital during the official opening in Madrid, Spain, Tuesday, Dec. 1, 2020. Authorities in Madrid are holding a ceremony to open part of a 1,000-bed hospital for emergencies that critics say is no more than a vanity project, a building with beds not ready to receive patients and unnecessary now that contagion and hospitalizations are waning. Spain has officially logged 1.6 million infections and over 45,000 deaths confirmed for COVID-19 since the beginning of the year. (AP Photo/Paul White)

A desk with computer screens and new beds sit in the empty Isabel Zendal new hospital during the official opening in Madrid, Spain, Tuesday, Dec. 1, 2020. Authorities in Madrid are holding a ceremony to open part of a 1,000-bed hospital for emergencies that critics say is no more than a vanity project, a building with beds not ready to receive patients and unnecessary now that contagion and hospitalizations are waning. Spain has officially logged 1.6 million infections and over 45,000 deaths confirmed for COVID-19 since the beginning of the year. (AP Photo/Paul White)

A man entering the national library in The Hague, Netherlands, Tuesday, Dec. 1, 2020, passes a sign informing visitors to wear mandatory face masks. Wearing face masks in publicly accessible indoor venues such as libraries, museums became obligatory in the Netherlands on Dec. 1, 2020, when a new temporary law underpinning existing government coronavirus restrictions came into force. (AP Photo/Peter Dejong)

People wearing face masks to protect against the spread of the coronavirus walk under the yellow leaves of ginko trees in Yokohama, Kanagawa prefecture, near Tokyo, Tuesday, Dec. 1, 2020. (AP Photo/Koji Sasahara)

People wearing face masks to prevent the spread of the coronavirus wait in a line to enter a shop in Liege, Belgium, Tuesday, Dec. 1, 2020. Non-essential shops in Belgium are reopening on Tuesday in the wake of encouraging figures about declining infection rates and hospital admissions because of the coronavirus. (AP Photo/Valentin Bianchi)

Minister of Health Patty Hajdu uses a translation headset as she listens to a speaker via video conference at a news conference Tuesday, Dec. 1, 2020, in Ottawa. (Adrian Wyld/The Canadian Press via AP)

In celebration of Giving Tuesday a giant Salvation Army Red Kettle is seen Tuesday, Dec. 1, 2020, in New York's Times Square. The kettle is in place in various New York City locations during the holiday season. (AP Photo/Mary Altaffer)

Cargo workers move a palette of cool boxes and other items into a pharma transport container during a demonstration on the handling and logistics of vaccines and medicines at the DHL cargo warehouse in Steenokkerzeel, Belgium, Tuesday, Dec. 1, 2020. European Commission President Ursula von der Leyen said Tuesday that member states have started working on their vaccination plans and on the logistics for the delivery of tens of millions of doses across the 27-nation bloc. Safely delivering COVID-19 vaccines, once approval has been made, will be the mission of the century for the global air cargo industry. (AP Photo/Virginia Mayo)

A hazardous goods worker shows how dry ice is used on specific vaccines and medicines to keep them cool during a demonstration of logistics and handling of vaccines and medicines at the DHL cargo warehouse in Steenokkerzeel, Belgium, Tuesday, Dec. 1, 2020. European Commission President Ursula von der Leyen said Tuesday that member states have started working on their vaccination plans and on the logistics for the delivery of tens of millions of doses across the 27-nation bloc. Safely delivering COVID-19 vaccines, once approval has been made, will be the mission of the century for the global air cargo industry. (AP Photo/Virginia Mayo)

In this Aug. 3, 2020, file photo, a member of the Nevada National Guard installs social distancing stickers while setting up a new temporary coronavirus testing site in Las Vegas. Nevada health officials have reported 1,642 new coronavirus cases and eight additional deaths on Monday, Nov. 30, 2020. Officials are warning that the statewide surge shows few signs of slowing as the deadliest month of the pandemic so far is ending. (AP Photo/John Locher, File)

NEW BRUNSWICK, N.J. — Johnson & Johnson, one of the largest drugmakers developing a vaccine against COVID-19, on Tuesday began the process of applying for emergency approval of its vaccine from the European Medicines Agency and Health Canada.

In what’s called a rolling submission, J&J’s Janssen Pharmaceutical business sent regulators in the EU and Canada early testing data from its experimental one-dose vaccine for preventing COVID-19. Rolling submissions are used to speed up evaluation of crucial drugs by giving regulators data as it becomes available, and while human testing is still ongoing, rather than submitting reams of data at once after testing ends.

Johnson & Johnson said in a statement that the European Medicines Agency allowed the rolling submission mainly due to positive results from laboratory testing, which showed the vaccine triggered a robust immune response, creating antibodies that could fight the virus.

The New Brunswick, New Jersey-based company also talking with regulators in other countries around the world about starting rolling reviews with them.

J&J is now in the final phase of testing its one-dose vaccine on human volunteers. Meanwhile, it recently began a second study looking at whether two vaccine doses work better than just one.

The company has said it will provide its vaccine on a not-for-profit basis throughout the pandemic emergency.

___

THE VIRUS OUTBREAK:

— U.S. panel to decide who should get the first COVID-19 shots

— BioNTech and Pfizer ask European regulator for expedited approval of coronavirus vaccine

— Americans face new COVID-19 restrictions after Thanksgiving

— At tiny rural hospitals, exhausted medical workers t reat friends and family

— Formula 1 champion Lewis Hamilton tests positive for coronavirus

— A pop-up school has blossomed to teach reading, writing, math and art to Central American children living in a camp of asylum seekers stuck at America’s doorstep

___

Follow AP’s coverage at https://apnews.com/hub/coronavirus-pandemic and https://apnews.com/UnderstandingtheOutbreak

___

HERE’S WHAT ELSE IS HAPPENING:

MIAMI — Florida joined Texas and California in surpassing 1 million confirmed COVID-19 cases Tuesday as the governor has vowed not to adopt any further restrictions or impose closures like those enacted in the spring and summer.

Hospitalizations have also climbed in the state with 4,261 COVID-19 patients, up from 4,139 tallied on Monday.

The figure is still less than half what hospitals saw in late July, but it has steadily climbed since October after plateauing at about 2,000 hospitalizations daily for weeks following the summer surge of the virus.

The state’s health department on Tuesday reported 82 new virus deaths, raising the toll in the third-most populous state to at least 18,942 since the beginning of the pandemic.

While vaccines could arrive as early as this month, officials say it will be spring at the earliest before most people can receive the treatment.

Florida Gov. Ron DeSantis said Tuesday on Twitter that the priority for the allocation of the new vaccines should be to residents of long-term care facilities who are “by far the most likely demographic to die with COVID.”

___

SAN FRANCISCO — San Francisco officials said Tuesday that they are considering more stringent restrictions on businesses and private gatherings as cases continue to spike.

Mayor London Breed said the speed with which the city’s rate climbed showed “how fast (COVID-19) can move.”

She acknowledged the sacrifices people have already made to tamp down two spikes in the spring and summer.

“If I’m honest, as someone who basically lives alone, it’s been a tough year for me personally. ... I was so happy to tell everyone just a month ago that San Francisco has done such a good job with COVID that we were in the yellow” tier the state uses to measure case rates.

The city’s health director, Dr. Grant Colfax, said new orders could come as soon as Wednesday that may further limit outdoor dining, reduce capacity at local businesses and gyms and potentially impose a quarantine order like the one Santa Clara County adopted.

___

DENVER -- Colorado Gov. Jared Polis joined the nation’s top infectious disease expert and urged people to wear masks and socially distance to prevent stay-at-home orders and overwhelmed hospitals as cases of the coronavirus surge during the holidays.

Dr. Anthony Fauci warned Tuesday that Colorado isn’t alone in seeing a spike in cases. He pleaded with people not to travel or gather in large groups.

He said the country will likely see “a surge upon a surge” of cases, based on the number of people who traveled for Thanksgiving. About one in 41 Colorado residents is believed to be contagious with the virus.

___

RALEIGH, N.C. — North Carolina Gov. Roy Cooper said on Tuesday that North Carolina will soon receive nearly 85,000 doses of Pfizer’s coronavirus vaccine from the federal government.

Frontline healthcare workers at hospitals will be the first to get vaccinated, followed by other health workers and vulnerable populations, such as people with at least two comorbidities.

Mandy Cohen, secretary of the state’s Department of Health and Human Services, says North Carolina will receive a weekly allocation of vaccine doses from the federal government. Its first allotment of 84,800 doses could come as soon as Dec. 15.

Cooper said every resident in the state will be able to receive a free vaccine, regardless of whether they have health insurance.

___

BATON ROUGE, La. — The number of COVID-19 patients in Louisiana’s hospitals continues to grow, intensifying worries that coronavirus cases from Thanksgiving holiday gatherings will balloon the number further and could overwhelm hospitals.

Louisiana’s health department said 1,280 people in Louisiana were hospitalized Tuesday because of COVID-19. That’s an increase of more than 200 over the last week and more than double the 596 COVID-19 patients hospitalized a month ago.

Though hospitalizations of COVID-19 patients remain below Louisiana’s peak of nearly 2,000 in April during the first of the state’s three coronavirus surges, they have been steadily and sharply increasing since mid-October.

This prompted Gov. John Bel Edwards to toughen Louisiana’s coronavirus restrictions on businesses and gatherings ahead of Thanksgiving.

His chief public health adviser Dr. Joe Kanter warned that the strong uptick in Louisiana’s COVID-19 hospitalizations was happening at a rate “that our hospitals simply cannot stand” without running out of the staff needed to treat patients.

___

DENVER — Colorado’s Democrat-led Legislature is plowing ahead on special session legislation to provide limited state relief to businesses, students and others affected by the coronavirus pandemic.

Democrats have overcome Republican objections to the scope of the aid and GOP attempts to limit the Democratic governor’s ability to decree public health orders.

The Senate on Tuesday unanimously passed bills to direct $5 million to help residents to pay utility bills; $50 million to assist landlords and tenants; and $100 million to the governor’s office for use in the public health emergency. The bills were immediately taken up by the House.

___

BISMARCK, N.D. — North Dakota lawmakers decided to require masks at the state Capitol. for the three-day organizational session.

The vote Tuesday is supported by legislative leaders but opposed by far-right members of the Republican-controlled Legislature.

House Majority Leader Chet Pollert and Senate Majority Leader Rich Wardner told reporters Tuesday they support a mask mandate at Capitol legislative spaces to help protect lawmakers and the public.

Lawmakers are expected to finalize the rules Thursday for the upcoming session it convenes Jan. 5.

___

BIRMINGHAM, Ala. — A health official says Alabama hospitals treating a record number of COVID-19 patients are bracing for a “tidal wave” of additional cases linked to holiday gatherings.

Dr. Jeanne Marrazzo of the University of Alabama at Birmingham says health care systems could be overwhelmed within two or three weeks. The Alabama Hospital Association says only 11% of the state’s intensive care beds were available Monday. The remaining spaces could be filled as more patients are admitted than leave hospitals.

A statewide order requiring face masks in public expires Dec. 11, but it could be extended by Gov. Kay Ivey for additional weeks as in the past.

Nearly 253,000 people have contracted the coronavirus and more than 3,600 have died in Alabama.

___

JOHNSTON, Iowa — Public health data in Iowa shows the coronavirus infection rate is slowing, but the number of people hospitalized with COVID-19 remains high.

Iowa’s positivity rate declined in the past two weeks but remains third in the nation at 41%, according to Johns Hopkins University.

Some of the ease in case positivity could be from reduced testing around the Thanksgiving holiday. Hospital officials were bracing for another surge in positive tests and illness because of Thanksgiving family gatherings.

Iowa posted 24 deaths and 1,906 new confirmed cases on Tuesday. Hospitals reported 1,172 patients with COVID-19, up 10 from the previous day.

___

HELENA, Mont. — A new counseling hotline is available to help Montana residents struggling with their mental health during the coronavirus crisis.

Gov. Steve Bullock announced the new hotline will be available for at least the next nine months. It’s funded by a $1.6 million federal grant.

The governor’s office says the new service is meant to aid health care workers, first responders, school officials, veterans, the elderly, Native Americans, and farmers and ranchers but is available to all residents.

More than 1,000 new coronavirus cases were reported Tuesday in Montana, bringing the confirmed total to more than 63,000.

___

CARSON CITY, Nev. — Nevada Gov. Steve Sisolak has returned to his office after he was diagnosed with the coronavirus in mid-November.

He announced his return on Twitter. Sisolak, a Democrat, was isolating at the Governor’s Mansion in Carson City.

He announced on Nov. 13 that he had tested positive for the coronavirus. Three days later, he said he was only experiencing mild head congestion.

___

NEW YORK — An influential scientific panel is set to tackle one of the most pressing questions in the U.S. coronavirus epidemic: Who should get the first vaccines when they become available?

The Advisory Committee on Immunization Practices will meet in an open-to-the-public, virtual meeting to vote on a proposal that would give priority to health care workers and patients in nursing homes and other long-term care facilities. The two groups together represent around 23 million Americans out of a population of about 330 million.

About 2 million people live in nursing homes and other U.S. long-term care facilities. Those patients and the staff members who care for them have accounted for 6% of the nation’s coronavirus cases and a staggering 39% of the deaths, CDC officials say.

Later this month, the Food and Drug Administration will consider approval of two vaccines made by Pfizer and Moderna.

Experts say the vaccines will probably not become widely available in the U.S. until the spring. There’s been more than 13.6 million confirmed cases and nearly 270,000 deaths in the U.S., the highest tallies in the world.

___

PARIS — French President Emmanuel Macron says France’s coronavirus vaccination program will likely start in early January on a focused population.

A French public health watchdog recommended the first vaccines go to nursing home residents. No vaccines have been approved yet.

Macron says the larger population is expected to get a potential vaccine between April and June.

France has 2.2 million cases, fifth highest in the world, and more than 52,000 deaths.

___

PHOENIX — Arizona reported a record 10,000 new coronavirus cases on Tuesday, which included delayed reporting because of the holiday weekend.

The state’s coronavirus dashboard reported 10,322 coronavirus cases and 48 deaths. Arizona’s previous single-day high was 4,878 on July 1.

Arizona’s latest seven-day rolling average of daily new cases was 3,499 on Monday.

Hospitalizations related to COVID-19 continued to increase, reaching 2,594 on Monday, with 597 patients in intensive care unit beds.

___

TORONTO — Canadian Prime Minister Justin Trudeau says Canada won’t lift restrictions at the U.S.--Canada border until the coronavirus is significantly under control throughout the world.

Canada has limited border crossings to essential travel since March. Trudeau told the Canadian Broadcasting Corporation that Canada is fortunate that trade in essential goods like agriculture products and pharmaceuticals is still flowing back and forth.

Trudeau says it’s critical that people not travel. He says while President-elect Joe Biden has an “obvious” different approach on the pandemic than President Donald Trump, the situation in the U.S. remains serious. The United States leads the world with 13.6 million coronavirus cases and nearly 270,000 deaths.

About 400,000 people crossed the world’s longest international border each day before the pandemic closed it to nonessential travel nine months ago.

___

BERLIN — Germany’s health minister toured a new vaccination center in Duesseldorf on Tuesday, preparing for possible mass vaccinations against the coronavirus in the coming weeks.

Vaccinations in Germany will be free, voluntary and people will receive letters about when it’s their turn for the shot, Health Minister Jens Spahn says.

The first shots will be given either in vaccination centers around the country or by mobile medical teams who will go to nursing homes to vaccinate the most vulnerable people. Later next year, doctors will vaccinate people at their local practices, the health minister says.

Spahn expects Germany to receive five to eight million doses of vaccine developed by Pfizer and BioNTech as well as by Moderna.

There will be 53 centers opened in Germany’s most populous state of North Rhine-Westphalia, with 18 million people, where Duesseldorf is based. In Berlin, home to 3.6 million people, six centers are being prepared.

In Germany, there were 13,604 confirmed cases and 388 deaths in the last 24 hours.

___

PROVIDENCE, R.I. — Rhode Island has opened two field hospitals with a combined 900 beds to deal with an expected increase of COVID-19 patients.

Care New England opened a field hospital with more than 300 beds in Cranston on Monday, the same day the state sent an emergency alert saying conventional hospitals had reached their coronavirus capacity.

A facility with nearly 600 beds opened Tuesday at the Rhode Island Convention Center in Providence. It is run by Lifespan, the state’s largest hospital group.

There were 365 COVID-19 patients in the state’s hospitals on Saturday, according to the state Department of Health. That’s down from a high of 381 on Nov. 23.

___

ISLAMABAD — A top Pakistani health official says Islamabad plans to procure a COVID-19 vaccine in the first quarter of next year.

The announcement Tuesday by Faisal Sultan came hours after Pakistan registered 67 more deaths and 2,458 new coronavirus cases.

Pakistan has allocated $150 million to acquire vaccine, which first will be administered to frontline health workers and elderly people.

The government has imposed a partial lockdown in many areas across Pakistan. Authorities have asked people to adhere to social distancing rules to avoid stricter measures.

Pakistan’s death toll stands at 8,091 and more than 400,000 confirmed cases.

deaths.