WASHINGTON — The Food and Drug Administration said Monday that it won’t require huge, months-long studies if COVID-19 vaccines eventually need tweaking to better match a mutating virus -- small, short studies will suffice.
The vaccines now being rolled out do still protect against different variants of the virus, the FDA stressed. But viruses mutate constantly, and some new versions are starting to raise concerns. So FDA issued new guidelines for vaccines -- as well as for virus tests and treatments -- on steps that companies can start taking to get ready.
“We’re trying to be prepared in advance,” said Dr. Peter Marks, the FDA’s vaccines chief.
Already major manufacturers have started updating their vaccine recipes if regulators eventually decide that’s necessary.
Marks said the needed tests would include a few hundred people rather than thousands, and could take just two or three months. Volunteers would receive experimental doses of the tweaked vaccine and then have their blood checked to see if it revved up the immune system about as well as the original vaccines do.
Marks said the hope is that if vaccines have to be updated, they would work broadly enough to cover both the original virus and a new mutant version -- rather than requiring a combination shot like flu vaccines. Having to make multiple kinds of vaccine and then combine them would put a greater strain on already stretched production capabilities.
Any decision on changing the vaccines’ recipe would be made with global health officials.
THE VIRUS OUTBREAK:
— Researchers in Scotland say its COVID-19 vaccination program has caused hospitalizations to plummet
— British Prime Minister Boris Johnson to lay out plan to ease coronavirus restrictions but pubs, gyms and hairdressers to stay closed for weeks
— Russia’s vaccine rollout picks up speed but experts say the campaign is still moving slowly
— Elementary schools and kindergartens reopen in over half of Germany's 16 states
— Every Democratic vote is needed on $1.9 trillion COVID-19 relief bill, but minimum wage and other issues will force choices
— Follow all of AP’s pandemic coverage at https://apnews.com/hub/coronavirus-pandemic, https://apnews.com/hub/coronavirus-vaccine and https://apnews.com/UnderstandingtheOutbreak
HERE’S WHAT ELSE IS HAPPENING:
WASHINGTON — The White House now says it expects to catch up by mid-week on deliveries of coronavirus vaccine doses that were delayed by severe weather.
Officials had said on Friday that they anticipated catching up by the end of this week. Some 6 million doses were delayed by snow and icy conditions.
But White House coronavirus response coordinator Andy Slavitt is attributing the improved timeline to an “all-out, round-the-clock” effort.
Slavitt says pharmaceutical distributor McKesson ran extended shifts over the weekend to pack vaccines with employees volunteering to work in the middle of the night to prepare shipments. UPS also participated.
Slavitt says 7 million doses -- a combination of those delayed by weather and the regular distribution -- were being delivered Monday as a result of those and other efforts.
BISMARCK, N.D. — North Dakota’s Republican-led House endorsed a measure Monday that would prohibit state or local governments from mandating face coverings.
Representatives approved the measure 50-44. The bill also prohibits “making use of a face mask, shield, or covering a condition for entry for education, employment, or services.”
The bill now goes to the Senate.
Bill sponsor GOP Rep. Jeff Hoverson and others argued there was no proof that masks work to slow the spread of the coronavirus and they questioned the government’s role in mandating them.
The state health officer, backed by Gov. Doug Burgum, imposed a mask mandate in November after months of refraining from such an order, hoping to stem a coronavirus surge that had been among the worst in the U.S. and threatened to overwhelm the state’s hospitals.
HARTFORD, Conn. - A major change to Connecticut’s vaccination schedule was announced Monday, with the state continuing with a mostly age-based system to make the rollout less complicated after seeing the challenges other states have faced in vaccinating essential workers and people with underlying health conditions.
“The lesson learned here from all these other states is, complexity is the enemy of equity and speed, which makes it the enemy of public health,” Max Reiss, spokesman for Gov. Ned Lamont, told The Associated Press.
Beginning March 1, anyone aged 55 to 64 will be allowed to get a COVID-19 vaccine. That group will be followed by people 45-54 on March 22; 35-44 years on April 12; and everyone else 34 years and younger on May 3.
Lamont previously said he would release details this week about which essential workers and people with underlying medical conditions could soon begin signing up for vaccinations.
Currently, only people ages 65 and older and medical workers are eligible. The previous group eligible for the vaccine included people 75 years and older.
Lamont said Friday he would release a list on Monday of the particular medical conditions that would make people eligible.
OKLAHOMA CITY — Oklahoma opened its second phase of coronavirus vaccinations on Monday, providing inoculations to public school teachers and staff and to adults of any age with illnesses that make them susceptible to the virus.
“Our goal is to make sure that every Oklahoma teacher and staff member who wants the COVID-19 vaccine can get it by spring break” in mid-March, said health commissioner Dr. Lance Frye at a vaccination clinic in Norman.
More than 681,000 Oklahomans had been vaccinated as of Friday, according to the state health department, and an estimated 60,000 more vaccinations were administered during the weekend, said deputy health commissioner Keith Reed.
State schools superintendent Joy Hofmeister said she expects a high percentage of public school staff to accept the vaccine.
“Teachers have been clamoring for the prioritization of having the vaccine,” Hofmeister said.
There have been 419,853 coronavirus cases and 4,203 deaths due to COVID-19 in Oklahoma since the pandemic began, the state health department reported.
LONG BEACH, Calif. — More than 7.3 million Californians have received at least one dose of COVID-19 vaccine but supplies are well below the amount that the state has the capacity to administer, Gov. Gavin Newsom said Monday.
“There’s not enough vaccines to accommodate the need and demand,” Newsom said during a stop in Long Beach on a tour of vaccination efforts around the state. “Sites all across the state of California are toggling back based up on limited supply. That’s a manufacturing issue.”
California anticipates receiving 1.4 million doses this week and 1.5 million next week, he said.
“It’s simply not what we’re capable of administering, we could do exponentially more, but nonetheless we are seeing modest improvement week to week,” he said.
Overall, there is a “bright light” at the end of the tunnel, the governor said.
The state’s seven-day test positivity rate was 3% as of Monday compared to 8.9% a month earlier, he said. Daily deaths totaled 233, well below the high of 764 a month earlier. Hospitalization and ICU counts were also significantly improved.
WASHINGTON — President Joe Biden plans to order all U.S. flags lowered at federal buildings for the next five days in order to memorialize the deaths from the coronavirus.
White House press secretary Jen Psaki says the president will also make remarks later Monday to commemorate the grim milestone of roughly 500,000 people dying from COVID-19.
Psaki says Biden will be speaking from the White House and will ask all Americans to observe a moment of silence during a candlelight service at sundown.
MADRID — Coronavirus infections, hospitalizations and deaths continue receding in Spain, but the top official guiding the country’s response to the pandemic is warning against relaxation of restrictions.
“We continue to have a high incidence that doesn’t allow us to relax measures of control,” says Fernando Simón, head of Spain’s health emergency coordination center.
Despite the warning, some regional governments on Monday joined others that have already reopened bars and restaurants, reduced the nighttime curfew or allow small gatherings of people who are not living together.
The two-week rate of infection continued dropping to 252 cases per 100,000 on Monday from a high of nearly 900 cases at the end of January.
The Health Ministry recorded 20,849 new infections and 535 deaths since Friday, bringing the pandemic’s confirmed totals to 3.1 million infections and 67,636 fatalities.
Spain has administered over 3 million vaccine doses, with nearly 1.2 million fully vaccinated, mostly residents in nursing homes, their caretakers and health workers.
JUNEAU, Alaska — Alaska Gov. Mike Dunleavy is in quarantine at his home near Wasilla after learning he was in close contact with someone later found to be positive for COVID-19, his office said Monday.
Dunleavy learned of the close contact Sunday and went into quarantine after receiving a COVID-19 test, which came back negative on Monday, his office said.
Dunleavy shows no symptoms and will teleworking from home and receive additional tests “until it is certain he is free of the virus,” his office said. He will follow health guidelines and remain at home for at least seven days, the release states.
The U.S. Centers for Disease Control and Prevention says it endorses 14-day quarantines but says local public health authorities make the final decision for how long quarantine should last and lists as options possibly ending quarantine after the seventh day after a negative test result from a test taken on the fifth day or later.
BATON ROUGE, La. — Louisiana's health department said Monday that the delayed Pfizer vaccine doses were received Friday and the state will continue to get the final doses from last week’s shipments by Tuesday.
The state’s Moderna doses from last week were expected to arrive Monday through Wednesday.
Louisiana’s network of hospitals, clinics, community vaccine sites and pharmacies will be getting double allocations of doses in some instances this week.
And those delayed doses come right as Gov. John Bel Edwards has expanded access to the shots for teachers, daycare workers, pregnant women and people age 55 to 64 who have certain preexisting conditions.
Kanter said he expects it could take the state a week or two to catch up on distributing its vaccine doses, after the disruptions caused by the icy weather last week.
SALT LAKE CITY — The Southwest Utah Public Health Department has announced plans to reschedule appointments for coronavirus vaccinations delayed by a winter storm last week.
The severe weather impacted shipments of vaccine to area clinics from outside the state.
The state health department says its Feb. 18 appointments have been rescheduled for Feb. 22, 25 and 27. The Weber-Morgan Health Department also rescheduled Feb. 18 appointments for Feb. 22.
Utah residents age 65 and older are now eligible to receive vaccines and should check with local health departments for appointment availability. Utah so far has distributed more than 607,000 vaccines.
ATLANTIC CITY — Fans will be allowed to attend sports and entertainment events at New Jersey’s largest facilities in limited numbers starting next week, Gov. Phil Murphy said Monday.
New Jersey venues with an indoor seating capacity of 5,000 or more will be allowed to have 10% of those seats occupied by fans starting on March 1, the Democratic governor said on the WFAN sports radio station.
For outdoor venues over 5,000 seats, the number will be 15% of capacity.
Murphy said he decided to allow the limited in-person attendance after reviewing a vast array of coronavirus-related statistics including hospitalizations, the number of hospital admissions versus discharges, overall positivity rate for COVID-19, and the rate of transmission, and determining that small crowds can be permitted safely.
He said face coverings and social distancing will be required at these venues.
NEW YORK — New York City officials expect to catch up on their vaccination efforts after being forced to put off scheduling tens of thousands of appointments last week, Mayor Bill de Blasio said Monday.
“The supply that we expected last week is arriving today,” de Blasio said. “That means we’ve basically lost a full week in our vaccination efforts. But it will not stop us from reaching our goal of 5 million New Yorkers vaccinated by June because we still have the ability and the capacity to do it.”
ATLANTA — A new study finds that teachers may be more important drivers of COVID-19 transmission in schools than students.
The paper released Monday by the U.S. Centers for Disease Control and Prevention studies nine COVID-19 transmission clusters in elementary schools in the Atlanta suburb of Marietta in December and January.
In only one cluster was a student clearly the first documented case. The CDC again advises that schools need to pursue “multifacted” strategies to prevent the spread of the virus, including cutting down on teacher-to-teacher meetings, making sure masks are worn correctly, and increasing physical distancing.
In addition, the CDC says it might be desirable to vaccinate teachers although the CDC restates teacher vaccination isn’t required to reopen.
HONOLULU — The Hawaii Senate is reconsidering allowing county emergency departments to charge out-of-bounds hikers for rescue costs as government spending remains under pressure because of the coronavirus pandemic.
A Senate bill would allow counties to issue criminal fines in addition to seeking reimbursement from hikers requiring rescue after leaving marked trails or ignoring signs saying areas are closed to hikers. The bill also would add new petty misdemeanor penalties for hiking illegally.
A revised version of a different Senate bill would only give counties the option of seeking reimbursement. The Honolulu Fire Department opposes seeking rescue reimbursement.
HILO, Hawaii — Coronavirus testing of travelers arriving on Hawaii island is expected to continue after the end of February, but officials have not yet determined the duration of the extension.
Partnerships between Hawaii County and private philanthropists allowing the county to test trans-Pacific arrivals are set to continue.
Hawaii County mayor spokesman Cyrus Johnasen says the terms of the continued testing are dependent on the level of funding the Big Island receives from the $1.9 trillion congressional relief bill under consideration.
Johnasen says the county will follow the state’s lead regarding exceptions for travelers who have been vaccinated.
BERLIN — Prosecutors have searched the mayor‘s office in the German city of Halle in an investigation triggered by the mayor and other politicians getting vaccinated against COVID-19 although they apparently weren’t yet entitled to be.
Germany has a several-tier priority list for vaccinations, starting with the most vulnerable and elderly. Its vaccination campaign is still at an early stage. Government leaders and other administrative officials don’t feature in the top tiers.
Halle Mayor Bernd Wiegand and several local politicians did get vaccinated, drawing strong criticism. Wiegand has advanced various defenses, including that the local disaster unit and council must remain functional in the pandemic.
Halle prosecutors said Monday that they are investigating Wiegand on suspicion of misappropriation of vaccines.
They said searches were carried out at the mayor’s office, at the local health office and vaccination center.
PARIS — Sanofi is going to produce as many as 12 million coronavirus vaccine doses per month for rival Johnson & Johnson, the second time the French drug maker is turning over production facilities to speed up supplies of a rival company’s vaccine, while its own candidate faces delays.
Sanofi’s announcement on Monday was quickly trumpeted by French President Emmanuel Macron, who relayed the development on his Twitter account. “We must together accelerate the production of vaccines with industrial partnerships,” Macron tweeted.
Sanofi said its vaccine manufacturing plant in Marcy l’Etoile, France, will formulate and fill vials of Johnson & Johnson’s vaccine candidate, developed by its Janssen companies. Sanofi said its French plant is expected to produce about 12 million doses per month of the single-dose vaccine.
Sanofi’s CEO, Paul Hudson, said the company remains committed to its own two COVID-19 vaccine programs but is also “stepping forward to show solidarity.” Sanofi has already previously announced that it will help bottle and package 125 million vaccine doses for the rival partnership of Pfizer-BioNTech.
PHNOM PENH, Cambodia — Cambodia’s Health Ministry on Monday reported 35 new confirmed cases of the coronavirus, 31 of them coming from community transmission. The new cases are part of a recent surge that includes 17 cases reported Sunday, 15 of them local.
Prime Minister Hun Sen posted an audio message on social media telling people to keep up their measures against infection by wearing face masks, using hand sanitizers and practicing social distancing.
“I plead with people living in the capital Phnom Penh to please not go out from their homes if there is nothing urgent to do outside,” he said.
As of Monday, a total of 568 people throughout the country have tested positive for the coronavirus, with 93 still receiving treatment. Cambodia has reported no deaths from the disease.
The Health Ministry said at least 23 locations in capital Phnom Penh and nearby provinces, including schools, night clubs, beer gardens and other entertainment sites, appear to be prime locations for the transmission of the virus. The Tourism Ministry ordered the temporary closing of all such entertainment venues, and seven schools have been shut as well.