The Latest: FDA head expects vaccine emergency use soon
WASHINGTON — The head of the Food and Drug Administration says his agency has told Pfizer that it “will rapidly work” to grant emergency use of its COVID-19 vaccine following a positive recommendation by government advisers.
The FDA decision will kickstart an unprecedented vaccination campaign needed to eventually defeat the virus. The FDA’s greenlight of the vaccine, co-developed with BioNtech, was practically assured after the positive vote by agency advisers a day earlier.
The FDA’s brief statement came less than an hour after President Donald Trump tweeted directly at FDA Commissioner Stephen Hahn, complaining that FDA “is still a big, old, slow turtle.”
FDA staff have repeatedly said they expect to issue a decision within days of Thursday’s meeting. Many FDA observers predict action by Saturday ahead of a Sunday meeting by the Centers for Disease Control and Prevention.
The panel of CDC advisers will vote on who should get priority for the initial shots. Federal officials plan to allocate the first 6.4 million doses of the vaccine to states based on their population.
THE VIRUS OUTBREAK:
— US experts endorse wide use of the Pfizer-BioNTech vaccine. Shots could begin within days for U.S. health care workers and people in nursing homes.
— Germany sees record daily virus infections and deaths, calls grow louder for tougher lockdown.
— ICU workers struggle find a balance, acknowledging the vast amounts of deaths they have witnessed but trying to keep their own mental health intact
— U.S. daily coronavirus deaths top 3,000, more tha n 9/11 or Pearl Harbor
HERE’S WHAT ELSE IS HAPPENING:
LONDON — Britain is shortening the mandatory self-isolation period for people arriving from overseas and those who come into contact with confirmed coronavirus cases.
The government says starting Monday they will have to quarantine for 10 days rather than 14. The change was agreed by the chief medical officers of England, Scotland, Wales and Northern Ireland.
It comes amid concerns that many people are not following instructions to self-isolate.
England’s deputy chief medical officer, Jenny Harries says reducing the period to 10 days was a “reasonable balance between managing the risk to the public but allowing us not to intrude on their lives.”
The rule for passengers applies to arrivals from everywhere except a list of “safe” countries that have low levels of the virus.
ROME — Italy’s interior minister doesn’t have the coronavirus after all.
The interior ministry says Luciana Lamorgese received a false positive result after a molecular test Monday. That result had forced her to leave a Cabinet meeting as it was under way and raised concern about possible contagion within the government.
Subsequent tests Wednesday and Thursday were negative. The ministry says the original test, done as part of a periodic control, gave an erroneous result.
Italy has seen a strong resurgence of the coronavirus this fall that has spread throughout the country.
BERLIN — Switzerland’s government is ordering restaurants, bars, shops and leisure facilities in most regions to close early as it faces a resurgence in coronavirus infections.
President Simonetta Sommaruga says the requirement to close at 7 p.m. will take effect at midnight Friday and run though Jan. 22.
There will be exceptions for regions where the coronavirus reproduction rate is below 1 and the infection rate below the national average for seven days, where opening until 11 p.m. will be allowed.
Sommaruga says action is needed because infections are rising quickly in most Swiss regions, but “we want to prevent a lockdown.”
Lockdowns in one shape or another have been imposed in many other European countries. Health Minister Alain Berset says the Swiss restrictions are “very moderate” and residents must respect them to avoid tougher measures.
MANHATTAN BEACH, Calif. — California health officials are urging the state’s residents to stay home as much as possible because of a coronavirus surge taxing the state’s hospitals.
But the most recent stay-at-home order allows Californians to do many more activities than the March shutdown that made the state a model on how to respond to the virus. People have been buying Christmas trees, shopping for groceries and hitting the gym since the orders took effect Monday in Southern California and much of the Bay Area and Central Valley.
On Thursday, the state set a one-day record of 220 deaths. Los Angeles County Health Director Barbara Ferrer is warning of catastrophic consequences if more people don’t heed orders to stay home and within their own household members.
She says hospitals are becoming overwhelmed and may result in “severely ill patients not able to get the care they need.”
PARIS — Even for hospital staff for whom death is a constant, witnessing the loss of a fellow human being to COVID-19 is a churn of emotions.
At the Paris hospital that recorded the first virus death outside Asia, nurses and paramedics in the intensive care unit have their own coping mechanisms. Some use meditation. Others try to remain detached.
But in treating the critically sick, they also become involved emotionally. Some mourn the dead by performing the final washing of their bodies. They also have an in-house psychologist to turn to. They sometimes come to her in a rage or in tears, in need of her hot tea and understanding.
LONDON — Drugmakers GlaxoSmithKline and Sanofi say their potential COVID-19 vaccine won’t be ready until late next year as they seek to improve the shot’s effectiveness in older people.
The companies say early-stage trials showed the vaccine produced an “insufficient” immune response in older adults, demonstrating the need to refine the product so it protects people of all ages.
GSK and Sanofi, based in London and Paris, respectively, say they were confident of the vaccine’s ultimate success due to positive results from other tests.
In adults 18 to 49, the vaccine produced an immune response comparable to patients who had recovered from COVID-19, the companies say.
NEW DEHLI — Serum Institute of India, the world’s largest manufacturer of vaccines, is increasing its production capacity by the end of 2021 to over 2.5 billion doses a year to cope with future disease outbreaks.
Serum Institute CEO Adar Poonawalla told The Associated Press in an interview that the coronavirus pandemic is a “wake up call” for governments to invest more in health care.
Poonawalla’s company has an annual capacity of 1.5 billion doses. That is more than the billion doses that China, home to the most vaccine makers in the world, says it manufactures in a year.
The Serum Institute has a vital role as the largest company licensed to manufacture the Oxford University-AstraZeneca coronavirus vaccines. Poonawalla says he anticipates more frequent outbreaks and increasing spread of animal-related diseases to humans
ATHENS, Greece — Greek authorities say bookshops and hairdressers will be allowed to reopen beginning Monday but all other retail stores, entertainment venues, restaurants, bars and cafes will remain shut throughout the Christmas period as part of the country’s second lockdown.
A mandatory quarantine for travelers arriving in Greece will be cut on Dec. 18 to three days from the previously announced 10 but a 10 p.m.-5 a.m. curfew will be in place throughout the holiday season.
Government spokesman Stelios Petsas said that despite five weeks of lockdown measures, coronavirus infections remain high, putting pressure on the country’s health system. Intensive care units were at 83% of their capacity nationwide, and at 91% of capacity in the hard-hit northern city of Thessaloniki, Greece’s second largest urban center.
Churches will be allowed to open to the faithful only on Christmas Day and Epiphany on Jan. 6, with limits on the number allowed inside according to church size.
Greece has registered more than 121,000 confirmed cases and 3,370 deaths.
GAZA CITY, Gaza Strip — The Hamas militant group has imposed a second lockdown in the Gaza Strip to contain a worsening coronavirus outbreak in the isolated and impoverished territory, home to more than 2 million Palestinians.
Residents have been ordered to remain at home on Friday and Saturday, a brief period that appears unlikely to significantly alter the outbreak’s trajectory. A nighttime curfew has been in place since August.
Authorities are reluctant to impose more sweeping measures because the economy is already suffering from an Israeli and Egyptian blockade imposed when Hamas seized power from rival Palestinian forces in 2007. Israel says the blockade is needed to keep Hamas from importing arms.
The blockade, and strict quarantine measures, delayed the arrival of the coronavirus, but the first cases of local transmission were detected in August. Some 27,000 infections have been reported since then, including 175 deaths.
Gaza’s health system has been hollowed out by the blockade and years of conflict, and experts have warned that a major outbreak could overwhelm hospitals.
WASHINGTON — A U.S. government advisory panel has endorsed widespread use of Pfizer’s coronavirus vaccine, putting the country just one step away from launching an epic vaccination campaign against the outbreak that has killed close to 300,000 Americans.
Shots could begin within days, depending on how quickly the Food and Drug Administration signs off, as expected, on the expert committee’s recommendation. First in line for the vaccinations would be health care workers and nursing home residents. Widespread access to the general public is not expected until the spring.
“This is a light at the end of the long tunnel of this pandemic,” declared Dr. Sally Goza, president of the American Academy of Pediatrics.
In a 17-4 vote with one abstention, the government advisers concluded that the vaccine from Pfizer and its German partner BioNTech appears safe and effective for emergency use in adults and teenagers 16 and over.
BERLIN — Calls were growing Friday for tougher lockdown measures in Germany as officials report record daily coronavirus cases and deaths.
The Robert Koch Institute said the country’s 16 states reported 29,875 new cases of COVID-19, breaking the previous daily record of 23,679 cases reported the day before.
The number of deaths from the virus rose by 598, to a total of 20,970. The previous daily record of deaths was 590, set on Wednesday.
Germany’s states are responsible for imposing and lifting restrictions, and Chancellor Angela Merkel earlier this week urged action, saying “we are in a decisive, perhaps the decisive, phase of fighting the pandemic.”
Restaurants, bars, leisure and sports facilities are currently closed in Germany and hotels are closed to tourists, but schools and nonessential shops remain open.
Merkel has called on state governments to consider closing schools early before Christmas and is expected to meet with governors soon to discuss possible new measures. Several states have already announced new restrictions on their own.
SEOUL, South Korea — South Korea is expanding the use of rapid tests and deploying hundreds of police officers and soldiers to help with contact tracing.
Senior Health Ministry official Yoon Taeho says rapid antigen tests at emergency rooms, intensive-care units and remote-area hospitals will be covered by the national health insurance starting Monday, which would cost recipients about 8,000 won ($7) for each test.
Antigen tests and another form of rapid testing based on saliva samples will also be available at designated coronavirus testing sites in the Seoul metropolitan area, where officials are temporarily providing free tests to anyone, regardless of whether they have symptoms or clear reasons to suspect infection.
Yoon said the country will also deploy more than 800 police officers, soldiers and civil servants to support contact tracing efforts in the capital area.
The Korea Disease Control and Prevention Agency on Friday reported another 689 new coronavirus cases.
NEW DELHI — India has recorded 29,398 new coronavirus cases in the past 24 hours, a continuing downward trend. It had reported 31,521 new cases a day earlier.
Single-day cases have remained below the 50,000 mark for more than a month now.
India reported another 414 deaths in the past 24 hours, raising the overall death toll to 142,186, according to the Health Ministry. India’s coronavirus tally since the pandemic began is 9.7 million cases, second behind the U.S.
CANBERRA, Australia — Australia’s prime minister says his government will not rush approval of Pfizer’s coronavirus vaccine because he wants Australians to have confidence in the product.
Prime Minister Scott Morrison said Friday that Australia is in a different position to Britain, which has given emergency approval to the roll out, and to the United States, which is near final approval for the vaccine’s use.
Morrison says he wants Australians to have “absolute full confidence that when it gets the tick, they can get the jab.”
The government expects the Australian regulator to approve the vaccine produced jointly by Pfizer and BioNTech by late January. The Australian roll out is expected to be underway by March.
Meanwhile, Australian researchers say they have abandoned development of the University of Queensland vaccine because it produced false positive results on HIV tests. It's one of five potential vaccines the Australian government had signed contracts with developers.
SANTA FE, N.M. — New Mexico health officials have issued orders that could limit nonessential surgeries and prepare for rationing of other medial services as the coronavirus pandemic strains resources and personnel at hospitals and intensive care centers.
One of the orders from the state Department of Health allows hospitals and acute-care facilities to limit surgeries. The second changes liability standards for emergency medical providers as the state prepares for possible triage procedures that might limit care to some individuals.
Gov. Michelle Lujan Grisham said the orders go into Friday and will last until at least Jan. 4.
OKLAHOMA CITY -- Some Oklahomans who lost wages due to the coronavirus pandemic will receive $400 from the state starting next week.
Oklahoma Employment Security Commission Director Shelley Zumwalt said Thursday the one-time payments will be going to to over 120,000 Oklahomans.
Zumwalt says the agency received permission from the Federal Emergency Management Agency to distribute Lost Wage Assistance funds to anyone who received $100 in benefits from any claim type and certify their employment was affected by the coronavirus pandemic during the week of Sept. 6-12.
TOPEKA, Kan. — Kansas does not plan to send personal information to the federal government about residents who receive coronavirus vaccines, though it has signed a data-use agreement with the CDC.
A spokeswoman for the Kansas Department of Health and Environment said Thursday in a text to The Associated Press that it signed a data-use agreement with the CDC “a while ago” but it “won’t be providing any identifying information.”
The CDC’s standard agreement calls for collection of data about vaccine recipients, including a person’s name, address and birthday. The CDC says the information will help determine how vaccines are distributed, monitor their safety and effectiveness, and identify places that are under-vaccinated.
The chief of the state health department said earlier this week that Kansas officials worry that sending personal information could discourage people from getting vaccinated.
CAIRO — Egypt has received its first shipment of a Chinese coronavirus vaccine, which was tested in the United Arab Emirates and is said to be 86% effective.
The shipment by Chinese state-owned pharmaceutical giant Sinopharm landed at Cairo’s international airport from the UAE on Thursday.
A health ministry statement says the government will first vaccinate health care workers, particularly those who deal with COVID-19 cases.
Egypt is the Arab world’s most populous country and it has seen an increase in confirmed coronavirus infections in recent weeks amid warnings by the government about a second wave of the pandemic. Egypt reported 445 newly confirmed coronavirus infections Thursday and 22 deaths from COVID-19, bringing the country’s overall tally to 120,147 cases, with 6,854 deaths.
HARRISBURG, Pa. — Pennsylvania is halting school sports and other extracurricular activities, ordering gyms, theaters and casinos to close and banning indoor dining at restaurants in response to the worsening pandemic.
A day after telling Pennsylvanians of his own COVID-19 diagnosis, Gov. Tom Wolf announced the widely expected clampdown Thursday. He said it aims to slow the accelerating spread of the coronavirus and prevent hospitals from becoming overrun.
“We all hoped it would not come to this,” Wolf said at a virtual news conference, but “we need to slow the spread to save lives.”
The restrictions include a 10-person cap on indoor gatherings, a 50-person limit for outdoor gatherings and capacity restrictions at retail stores. They take effect Saturday and run through until Jan. 4.
TORONTO — Canada’s most populous province will begin administering COVID-19 vaccinations at hospitals in Toronto and Ottawa on Tuesday.
Ontario Premier Doug Ford says a small number of doses are expected to arrive in the province in the coming days.
Canada’s health regulator approved the vaccine by U.S. drugmaker Pfizer and Germany’s BioNTech vaccine on Wednesday.
Ford says health care workers in long-term care homes and other high-risk settings will be the first to receive the vaccines.