NEW YORK — Drugmaker Pfizer and German partner BioNTech have begun a nine-country study of their COVID-19 vaccine in pregnant women.
The companies said Thursday that the first volunteers have received shots in the study, which is to enroll about 4,000 healthy pregnant women aged 18 and older. Some will receive the two-dose vaccine and others dummy shots, three weeks apart and between 24 weeks and 34 weeks into their pregnancies.
The volunteers will be followed for seven months to 10 months, depending on whether they received vaccine or placebo, to see how effective and safe the vaccine is in pregnant women. Women in the U.S., Canada, Argentina, Brazil, Chile, Mozambique, South Africa, Spain and the UK will be included.
“Pregnant women have an increased risk of complications and developing severe COVID-19,” Dr. William Gruber, Pfizer’s head of vaccine clinical research and development, said in a statement. “It is critical that we develop a vaccine that is safe and effective” for them.
Women known to be pregnant were excluded from prior studies of the vaccine, which has emergency use authorization in the U.S., the European Union and other countries.
Once the babies are born, mothers who received dummy shots will be given the vaccine.
The study will assess effects on the infants for about six months, checking for safety and whether they received potentially protective antibodies from their mothers.
The companies plan later this year to begin vaccine testing in children, aged 5 to 11 and younger than five, and to test their vaccine in people with weakened immune systems. Results of their study in children aged 12 through 15 are currently being evaluated.
THE VIRUS OUTBREAK:
— U.S. life expectancy drops by a year in pandemic, the most since World War II
— Crippling winter weather in U.S. hampers vaccine deliveries, distribution
— New York’s governor faces mounting pressure over COVID deaths at nursing homes
— One Good Thing: When coronavirus lockdowns shut down classes in a youth prison, a Greek math teacher created a DIY TV channel that broadcasts lessons 24 hours a day
HERE’S WHAT ELSE IS HAPPENING:
NASHVILLE, Tennessee — Officials in Nashville made haste to administer about 500 does of the coronavirus vaccine that were set to expire, inoculating hundreds of people at two homeless shelters Wednesday.
More than 100 people receiving the doses were mostly older than 65, minorities and had underlying health conditions in a historically Black neighborhood. Others went to those on a standby list for extra doses, local health officials said.
“I think it’s pretty cool how quickly we in public health can mobilize for that,” Dr. Alex Jahangir, Nashville’s COVID-19 task force chairman, said.
CARSON CITY, Nevada — Nevada health officials have confirmed the first known case in the state of a coronavirus variant that was first identified in South Africa.
The Nevada State Public Health Laboratory said Thursday that the mutated version of the virus was confirmed a day earlier in a sample traced to a person who traveled from South Africa and began showing symptoms of COVID-19 when arriving in Reno.
The U.S. Centers for Disease Control and Prevention reports the variant has been detected in 10 states thus far, not including Nevada’s case.
Dr. Mark Pandori, the director of Nevada’s public health lab, says COVID-19 vaccines may be less effective on the new strain. He said it is not yet known if the strain causes a more severe illness and that it’s not believed to be more lethal than the original COVID-19 strain.
BRATISLAVA, Slovakia — Slovakia’s government has failed to agree on a plan to acquire Russia’s made Sputnik V coronavirus vaccine to speed up the vaccination program in one of the hardest-hit European Union nations.
Prime Minister Igor Matovic says one of the four partners in his coalition government, the center-right For People political party vetoed such a move on Thursday.
Matovic says the plan called for Slovakia to receive 160,000 dozes of Sputnik V next week, enough for 80,000 people.
Slovakia has become the country with most COVID-19 deaths by size of population in the world amid a surge of a highly contagious coronavirus variant originally found in Britain. The government wanted to turn to the Russian vaccine due to the EU’s slow vaccine rollout.
MADRID — Spanish health authorities say they expect the curve of coronavirus contagion to continue flattening after the 2-week incidence rate per 100,000 inhabitants dropped Thursday to 320 cases from a peak of nearly 900 at the end of January.
Spain has logged 3.1 million confirmed virus cases since infections began and over 66,000 deaths, including 14,515 new cases and 388 new fatalities in the previous 24 hours.
Fernando Simón, who heads Spain’s response to the pandemic, says that authorities estimate that the a new variant first detected in Britain makes up around 20 to 25% of all new cases, with variations region by region.
“That reflects the expected progression according to what we are seeing in other countries,” Simón said.
PARIS — The virus variant dominant in Britain accounts for about 36% of infections in France and a majority of cases in some areas, and other variants account for 5% of new cases, the French health minister said Thursday.
As a result, the French government will extend its recommended quarantine period for people who test positive from seven days to 10 days, Health Minister Olivier Veran told reporters.
He said the growing proportion of more contagious variants may be why France’s 12-hour-a-day curfew and other restrictions aren’t bringing overall infections and hospitalizations down.
“We need to hang on together. We need to get out of the danger zone,” he said. “It’s not the time to relax our efforts, it’s not over.”
NEW YORK — Carnegie Hall will miss an entire season for the first time for the first time in its 130-year history.
Carnegie canceled performances from April 6 through July at its three venues, extending a closure that started last March 13 due to the novel coronavirus pandemic.
Carnegie hopes to reopen in October for its 2021-22 season.
The pandemic also caused the Metropolitan Opera to miss a season for the first time. Broadway theaters have been closed since March, and the arts shutdowns have contributed to major contraction to New York City’s economy.
PRAGUE — The lower house of the Czech Republic’s Parliament has approved new legislation that defines the state’s responsibilities and rights in fighting the pandemic in a hard-hit European Union country.
It’s a step to end a political crisis that started last week after the lower house refused the minority government’s request to extend the state of emergency, a powerful tool that gives the Cabinet the extra powers needed to impose nationwide restrictions and limit people’s rights.
In defiance, the government re-declared the state of emergency at the request of the leaders of all 14 Czech regions, who said they do have not enough powers to fight the pandemic.
Some legal experts and politicians argued it violated the Constitution.
But without the state of emergency, some key restrictive measures would have to be cancelled at a time the country has been facing a surge of a fast-spreading coronavirus variant first found in Britain.
ROME — Officials have postponed one of the main events this weekend commemorating the first anniversary of the start of Italy’s coronavirus outbreak after clusters of new infections traced to the British variant forced localized lockdowns in hardest-hit Lombardy and around the country.
Brescia’s public hospital, which was overwhelmed during the initial outbreak, had planned a daylong conference Saturday on lessons learned from the pandemic. It was to feature the intensive care doctor who diagnosed Italy’s first locally transmitted case, as well as the opening of a commemorative art exhibit dedicated to health care workers worldwide.
But the hospital announced Thursday that it was postponing the event out of a sense of responsibility “considering the rapid evolution of the epidemiological situation.”
BOSTON — With delivery being disrupted by winter storms, Massachusetts Gov. Charlie Baker said he’d consider sending the National Guard to southern states to collect shipments of COVID-19 vaccines earmarked for the state.
“We may have some real issues with supply delivery this week,” the Republican governor said in a remote address to the Greater Boston Chamber of Commerce. “We have been told it would be a few days late, based on some of the issues around weather in other parts of the country.” He said approval from the federal government may be needed.
Baker said he needs to make sure the federal government would allow the National Guard to be used this way.
LONDON — A major study suggests coronavirus infection rates in London have plunged by 80% in the past month as lockdown measures curb the spread of the virus.
Imperial College London researchers tested 85,000 people across England between Feb 4 and Feb 13 as part of the monthly study. It found that about 1 in 200 people were infected, a fall of two thirds from the month before.
The decline varied across the country and was steepest in London, where a new and more contagious strain of the virus was identified late last year. In January an estimated 1 in 30 people in London had the virus. That has now fallen to about 1 in 185.
Health Secretary Matt Hancock said the decline in cases was “encouraging … but we must not drop our guard.”
Britain has experienced Europe’s worst coronavirus outbreak, with more than 118,000 deaths, and is in lockdown as a mass vaccination program pushes ahead at the continent’s fastest rate. So far some 16 million people have had a first dose, about a quarter of the population.
ROME — The Vatican is taking Pope Francis’ pro-vaccine stance very seriously: Any Vatican employee who refuses to get a coronavirus shot without valid medical reason risks being fired.
A Feb. 8 decree signed by the governor of the Vatican City State sparked heated debate Thursday, since its provisions go well beyond the generally voluntary nature of COVID-19 vaccinations in Italy and much of the rest of the world.
The decree cited the need to protect Vatican employees in the workplace, as well as guidelines issued by Francis’ own COVID-19 commission of advisers who said there was a moral responsibility to vaccinate yourself “given that refusing a vaccine can constitute a risk for others.”
The decree says that Vatican employees who opt out without a proven medical need risk sanctions up to and including “the interruption of the relationship of employment.” The Vatican is an absolute monarchy in the heart of Rome that operates independently of Italian law and Italian labor protections.
The Vatican has around 5,000 employees. Francis has received both vaccinations.
RALEIGH, N.C. — North Carolina vaccine providers have yet to receive tens of thousands of COVID-19 vaccines the federal government was set to deliver this week, state health officials announced Thursday morning.
The Department of Health and Human Services is now asking clinics to plan to postpone appointments because of the delays fueled by severe winter weather.
None of the more than 163,000 first and second doses of the Moderna vaccine scheduled to arrive this week have been delivered by President Joe Biden’s administration, the state health department said. The state also noted that only a limited number of the nearly 127,000 expected Pfizer vaccines have been shipped.
North Carolina health officials are working with the Centers for Disease Control and Prevention to reduce the consequences of the delay.
PHOENIX — Arizona on Thursday reported 1,143 additional COVID-19 cases and 213 deaths while health officials in some areas said bad weather delayed vaccination deliveries, causing cancellations and rescheduling of some appointments.
The latest figures released by the Department of Health Services increased Arizona’s pandemic totals to 802,198 cases and 15,276 deaths.
Arizona continued to see declines in COVID-19 hospitalizations and seven-day rolling averages of confirmed cases and deaths, according to data from the state’s coronavirus dashboard and The COVID Tracking Project.
WASHINGTON — The number of Americans applying for unemployment aid rose last week to 861,000, evidence that layoffs remain painfully high despite a steady drop in the number of confirmed viral infections.
Applications from laid-off workers rose 13,000 from the previous week, which was revised sharply higher, the Labor Department said Thursday. Before the virus erupted in the United States last March, weekly applications for unemployment benefits had never topped 700,000, even during the Great Recession of 2008-2009.
BOSTON — Massachusetts’ coronavirus vaccine appointment portal crashed Thursday morning as more than one million additional state residents became eligible to schedule a shot.
Many residents who went to vaxfinder.mass.gov received the message “This application crashed” with a drawing of an octopus, and were urged to try again later. The site appeared to be working again by about 10 a.m.
Gov. Charlie Baker said Wednesday that more than 70,000 appointments would be made available at 8 a.m. Thursday, including for those age 65 and older, for people with two or more certain medical conditions, and for residents and staff of low income and affordable senior housing. But it came with a warning that it could take up to a month to book an appointment.
GENEVA — The head of WHO’s international team to China said the idea that coronavirus might have been imported to China via frozen food that ultimately sparked the pandemic is “not something that we are looking at.”
After the conclusion of the WHO-led team’s mission in Wuhan earlier this month, WHO’s Peter Ben Embarek said the team had identified frozen animal products in the market where dozens of early coronavirus cases were identified last January, saying there was “potential to continue to follow this lead.”
But at a Thursday press briefing, Ben Embarek said that because there were no large coronavirus outbreaks at any food factories worldwide before the virus was detected in Wuhan, “the hypothesis or idea of importing the virus to China through that route is not something we are looking at.”
GENEVA — The Prime Minister of Trinidad and Tobago called on the World Health Organization to convene an “international convention of the world’s people’s representatives” to commit to the fair sharing of coronavirus vaccines.
At a press briefing on Thursday, Prime Minister Keith Rowley said small states in the Caribbean and elsewhere have made “huge sacrifices in an endeavor to protect our populations from the worst ravages of the virus” and said global leaders should agree to make vaccines available to people everywhere, “not just the privileged, well-heeled few.”
To date, 75% of COVID-19 vaccines have been administered in just 10 countries and nearly 130 countries haven’t received a single dose.
BERLIN — Germany’s top security official says that about a fifth of the people checked at the Czech and Austrian borders since strict controls were introduced on Sunday have been turned back.
Germany implemented checks on its borders with the Czech Republic and Austria’s Tyrol province in a bid to reduce the spread of more contagious coronavirus variants that have taken hold there.
It is restricting entry to German citizens and residents, truck drivers, transport and health service workers and a few others including cross-border commuters working in “systemically relevant sectors.” All have to show a negative coronavirus test.
Interior Minister Horst Seehofer said during a visit to the Czech border Thursday that 50,000 checks have been conducted so far and 10,000 of them resulted in people being turned back.