NEW YORK — Drugmaker Pfizer has again modified the protocol for its late-stage study of its vaccine against the new coronavirus, this time to include more young participants.
The company said Monday that it’s received permission from the Food and Drug Administration to include adolescents aged 12 through 15 in its global COVID-19 vaccine study.
New York-based Pfizer originally planned for 30,000 participants, but in September expanded that to 44,000 people. That increase was made to boost diversity in the trial population, specifically by including 16- and 17-year-old teens, as well as stable patients with some common chronic infections: hepatitis B, hepatitis C and HIV.
Pfizer’s trial also includes significant numbers of Hispanic, Black, Asian and Native American participants, plus many people aged 56 through 85. The diversity is aimed at providing information on how safe and effective the experimental vaccine is in people of different ages and backgrounds.
HERE’S WHAT YOU NEED TO KNOW ABOUT THE VIRUS OUTBREAK:
— Supreme Court nominee Amy Coney Barrett faces Senate despite virus
— Trump insists he’s free of virus, ready for campaign trail
— Britain expected to tighten restrictions on hard-hit northern cities like Liverpool
— EU nations gear up to adopt traffic-light system to identify outbreaks
— Four Swiss guards who protect 83-year-old Pope Francis have the virus
— Follow AP's pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak
HERE’S WHAT ELSE IS HAPPENING:
WASHINGTON — President Donald Trump’s White House doctor says Trump has tested negative for COVID-19 on consecutive days using a newer rapid test from Abbott laboratories.
The assessment from Navy Cmdr. Sean Conley comes as Trump is traveling to Sanford, Florida, to headline his first campaign rally Monday since becoming infected with the coronavirus. Conley had said in a written memo released over the weekend that Trump is no longer at risk of spreading the virus to others.
Conley says in a fresh update released Monday that Trump tested negative for COVID-19 on consecutive days using a newer 15-minute test. He did not say when Trump was tested.
Trump announced Oct. 2 that he had tested positive for the disease caused by the coronavirus. He was admitted to Walter Reed military hospital that night and released on Oct. 5.
Over the weekend, Trump addressed scores of supporters who crowded onto the White House lawn from a balcony.
PITTSFIELD, Maine — The Maine company that makes specialized swabs for coronavirus testing is ready to open a third manufacturing plant.
Guilford-based Puritan had already opened one factory in Pittsfield to expand production, and on Monday announced it’s now taking over the former San Antonio Shoemakers factory in Pittsfield for a third manufacturing location.
The project will produce 50 million swabs per month and is funded by a $51.2 million coronavirus relief grant announced by U.S. Sen. Susan Collins in August. Construction company Cianbro is partnering on the project.
Puritan is one of only two companies that produce the specialized swabs that are needed as testing ramps up during the coronavirus pandemic. The other manufacturing facility is in Italy.
The Trump administration already provided $75.5 million through the Defense Production Act for the first Pittsfield facility that opened this summer. It’s expected to be producing 90 million swabs by mid-November.
Together the two Pittsfield sites will account for hundreds of jobs.
DES MOINES, Iowa — As Iowa surpassed 100,000 confirmed coronavirus cases Monday and remained the fourth-highest state for rate of infection, the mayor of Des Moines expressed concern that President Donald Trump’s rally this week at the city’s airport could become a super-spreader event.
The state averaged 1,300 new cases per day over the past four days, and during that time there were an additional 46 deaths. As of Monday morning, Iowa had reported 100,052 confirmed cases of COVID-19 and 1,464 deaths from the disease since the pandemic started.
Trump plans a Wednesday rally at the Iowa Air National Guard hangar at the Des Moines International Airport. He acknowledged Oct. 2 that he had tested positive for COVID-19, and he now plans to resume campaigning despite skepticism about whether he could spread the virus.
Des Moines Mayor Frank Cownie told The Des Moines Register on Sunday that he’s worried that Trump’s visit could become a super-spreader event.
Iowa Democratic Party Chair Mark Smith said the state should not be hosting the event.
“In no way, shape or form should Governor Reynolds or any of our Republican leaders allow for this event to happen. Iowans need a President who will put the health and safety of the country above their own ego,” he said in a statement.
Trump campaign spokesman Tim Murtaugh said the event will be in an open door airplane hangar with temperature checks and masks.
BOSTON — Massachusetts Gov. Charlie Baker has unveiled a new $171 million initiative that he said will help tenants and landlords cope with the fiscal challenges of the ongoing coronavirus pandemic.
The Republican governor said in a statement Monday that the goal of the initiative is to keep tenants in their homes and ease the ongoing expenses of landlords once the state’s pause on evictions and foreclosures expires on Saturday.
About $100 million will go to expand the capacity of the Residential Assistance for Families in Transition program to provide relief to renters and landlords struggling because of the pandemic. Another $49 million will go to rapid rehousing programs for tenants who are evicted and at risk of homelessness.
Other funds will help provide tenants and landlords with legal services during the eviction process and support mediation programs to help tenants and landlords resolve cases outside of court.
Landlords have called the pandemic eviction ban unconstitutional, arguing that it restricted their free speech and their ability to acquire compensation for unlawful land taking. Meanwhile, housing advocates have called for passage of a comprehensive eviction prevention measure intended to help stabilize renters, homeowners and small landlords for a year.
When the state moratorium expires Saturday, a moratorium established by the federal Centers for Disease Control and Prevention will take effect in Massachusetts and prevent evictions through December for qualified tenants.
CARSON CITY, Nev. — Nevada COVID-19 response director Caleb Cage said Monday that he had tested positive for the virus on October 6 after developing symptoms over the prior weekend.
Staff working in the governor’s office began working from home following his diagnosis.
Those who had come into contact with Cage were also tested, including Gov. Steve Sisolak, who tested negative.
Officials also reported 569 new confirmed cases and 3 new deaths on Monday. The number of new cases and positivity rate remain higher than they were in early September, before Sisolak relaxed restrictions on gatherings and before a state task force loosened thresholds for “high risk” counties.
HUNTINGTON, W.Va. — Officials at a West Virginia health system have said the network is again banning visitors from its hospitals as community spread of the coronavirus increases in the region.
News outlets reported that Mountain Health Network announced Monday that most visitors will not be allowed in its medical centers, including at St. Mary’s in Huntington, one of the largest hospitals in the state.
Officials say essential caregivers will be allowed for patients in labor and delivery, in the pediatrics unit and in the neonatal units. A statement from the system also said patients nearing the end of their life also will be allowed limited visitors.
At urgent care centers and emergency rooms, only one patient will be allowed in an exam room, though a parent or guardian can accompany minors.
The policy was first enacted in March as the virus began to spread, but it was lifted in June with Mountain Health medical centers allowing restricted visitation.
As of Monday, at least 385 people had died from COVID-19 in West Virginia, with the state reporting more than 4,500 current active cases. State data said Cabell County, the site of several of Mountain Health hospitals, had among the highest total case counts with 1,020.
PRAGUE — The Czech Republic is imposing a new series of restrictive measures in response to a record surge in coronavirus infections.
Amid the spike, the number of deaths has surpassed 1,000 people.
Prime Minister Andrej Babis says all bars, restaurants and clubs will be closed starting on Wednesday, while drinking alcohol is banned at public places.
Babis also says all schools will be closed at least until Nov. 2, with the exception of schools remaining open for the children of doctors, nurses and rescue workers.
The government has also limited the number of people who can gather to six and made it mandatory to wear face masks at outdoor public transport stops.
There was a new record high of 8,618 confirmed COVID-19 cases on Friday, marking the fourth straight day last week of a new record for single-day coronavirus infections.
As a result, new restrictive measures have been implemented since Monday, including closures of all theaters, cinemas, zoos, museums, art galleries, fitness centers and public swimming pools.
Also, all sports indoor activities are banned. Outdoors, only up to 20 people are allowed to participate in sport activities.
Government data shows the Czech Republic has had 119,007 confirmed cases with 1,045 deaths, on Monday. Of them, 256 people died last week.
NEW LONDON, Conn. — State and local officials on Monday urged southeastern Connecticut residents to get tested for COVID-19, noting a continued spike in cases in New London and elsewhere. They also called on people to be careful around friends, family members and co-workers.
Dr. Deidre Gifford is the acting commissioner of the Department of Public Health. She said contract tracers have found that people have become infected after taking off their masks in the car while carpooling, spending time with family members or in workplace lunch rooms. She urged anyone who tests positive or thinks they’ve been in contact with someone who has tested positive to quarantine for 14 days.
Stephen Mansfield is the director of health at the Ledge Light Health District. He said more than 700 tests were conducted in New London over the weekend. Free testing also began Monday in neighboring Groton.
JEFFERSON CITY, Mo. — A state official in Missouri said Monday, two days after a “database extract error” incorrectly showed a massive one-day increase in coronavirus cases in Missouri, the problem remains unresolved.
On Saturday, the Missouri Department of Health and Senior Services reported more than 5,000 new COVID-19 cases, which would be nearly 3,000 more than the previous record for a single day. But on Sunday, the health department said that number was wrong, blaming the process of migrating data into a new system.
“The team is continuing to work through the issues today. We’re still working to pinpoint the cause as it’s a new issue related to the automated (rather than manual) entry of data,” agency spokeswoman Lisa Cox said in an email.
Because the system is being fixed, the state had not updated any data on Monday, including the number of new cases, deaths and hospitalizations.
In late September, the state began using a new dashboard for tracking COVID-19 that provides additional data, including per capita cases by jurisdiction, rankings of counties by infection rates, and comparing Missouri to other states on several metrics.
NASHVILLE, Tenn. — Nashville officials are investigating a worship event outside the historic courthouse Sunday that packed together a big, largely unmasked crowd, despite rising new case counts of COVID-19 in Tennessee.
Nashville Health Department spokesperson Brian Todd says “appropriate penalties” will be pursued against the organizer, saying that person didn’t submit an application to health officials or permit application to any Nashville department.
“We have worked very hard to slow the spread of COVID by taking a measured approach to protect the community,” Todd said in a statement Monday. “The Health Department is very concerned by the actions that took place at the event and we are investigating and will pursue appropriate penalties against the organizer.”
Event leader Sean Feucht posted videos of the gathering on social media, calling it a protest. Feucht has been associated with similar gatherings elsewhere, including in California, Washington and Georgia.
“We had THREE venue changes and so much resistance BUT THE CHURCH WILL NOT BE SILENCED!” Feucht tweeted Sunday about the Nashville event.
Nashville is limiting gatherings without city approval to 25 people. Approved events can occur at 30% capacity, with 500 people maximum and masks required.
BOISE, Idaho — People who had their coronavirus relief checks wrongly denied or seized because they were behind bars now have a few more days to apply to receive the money.
The Internal Revenue Service has extended the application deadline 15 days to Oct. 30 in response to a ruling by a federal judge who said the payments couldn’t be denied based solely on someone’s incarceration status. That has prison officials scrambling to make sure incarcerated people know they can qualify for the funds.
In Idaho, prison officials followed IRS guidance earlier this year and seized the payments from 48 inmates.
Now the prison officials are working to tell those and other inmates they can get the money after all.
MANCHESTER, Tenn. — The mayor of a Tennessee city died early Monday after being hospitalized for 11 days with COVID-19.
The city of Manchester said in a Facebook post that Mayor Lonnie Norman died after putting up “a valiant fight against COVID-19."
News outlets report Norman was reelected to his third term, which was set to expire in 2024, in August.
Manchester, Tennessee is home to the Bonnaroo Music and Arts Festival. The organization posted Saturday about Norman’s hospitalization on Twitter and expressed well wishes for the “incredible” mayor.
WPLN-FM reports he was the city’s first Black Mayor.
BERLIN — Germany’s health minister says he expects a vaccination for the coronavirus to be ready to start rolling out in the first quarter next year.
Health Minister Jens Spahn and Research Minister Anja Karliczek had said in September that they hoped to be able to start vaccinating the most at-risk group of Germans in the first months of 2021, and Spahn said Monday that prognosis is on track.
“As things stand today, Oct. 12, I assume that we’ll be able to begin in the first quarter of next year,” Spahn said during a video conference with the Ifo Institute research think-tank.
Vaccinations would be voluntary, and go first to people with preexisting medical conditions, the elderly and people working in health care and nursing homes.
Germany is supporting several efforts to develop a vaccine, and Spahn said eventually there should be more than enough to go around.
“If all the horses reach the finish line, we will have far too much vaccine,” he said.