[ad_1]
transcript
transcript
E.U. Regulator Approves Pfizer-BioNTech Vaccine for Ages 12 to 15
The European Medicines Agency cleared the Pfizer-BioNTech coronavirus vaccine for children ages 12 to 15 on Friday. The opinion will be sent to the European Commission for final approval.
-
The vaccine, as you know, was already authorized in people from the age of 16 and above, and now we have data that would show that the vaccine is safe in also in the age of 12 to 15 years. And that has allowed the scientific committee indeed to conclude today. This opinion from the scientific committee now will be transmitted to the European Commission, which will issue the final approval. However, it will be then up to each individual member state to decide if and when to use this vaccine in adolescents in the future. Extending the protection of a safe and effective vaccine in this younger population is an important step forward in the fight against this pandemic. And so we recognize that this important achievement.
The European Medicines Agency approved on Friday the use of the Pfizer-BioNTech coronavirus vaccine for children aged 12 to 15, in what the drug regulator called “an important step forward in the fight against the pandemic” in a statement.
The U.S. Food and Drug Administration authorized the vaccine for that age group earlier this month after clinical trials showed it was safe.
The E.M.A.’s opinion will now be sent to the European Commission, the bloc’s administrative arm, for final approval, which it is expected to do swiftly. It will then be up to the national governments of the member countries to decide if and when to inoculate children, the regulator said.
Anticipating the vaccine’s approval, Germany announced on Thursday that it would open appointments to children in that age range starting June 7. Italy will start vaccinating people who are 16 and older next month, the commissioner in charge of vaccinations announced on Friday.
The European Union had a slow start to its vaccination campaign, with shortages of doses delaying the rollout in many member countries. The bloc’s efforts have gained pace in recent weeks, and now appear to be on track to get at least one dose to 70 percent of its adult population by the end of June.
The Pfizer vaccine has already been authorized in the bloc for those who are 16 and older. The doses for children will be the same as for adults, with two shots administered three weeks apart.
In Italy, all regions will broaden eligibility to those 16 and older starting June 3, Francesco Paolo Figliuolo, the army general in charge of Italy’s vaccination effort, told reporters on Friday.
General Figliuolo said that the country will make 20 million more doses available next month. He acknowledged that the amount isn’t enough to fully vaccinate Italy’s population of about 60 million, “but if we think about two or three months ago, we couldn’t have imagined it even in the rosiest predictions.”
For much of the year, Italy, which was severely hit by the pandemic in early 2020, has vaccinated only the elderly and the most vulnerable residents, both because of the scarcity of doses and for a number of logistical reasons. The country opened vaccinations to those 40 and older only in the last few weeks, with the exception being health care workers and teachers.
Public concern has grown about people starting to move around more, especially as summer approaches, while younger Italians have yet to receive their first shots. But not all regions have taken the same approach to vaccination: In Lazio, where Rome is situated, for example, the governor opened eligibility to all students about to take the test to receive their high school diplomas.
Italy’s Medicine Agency is also expected to authorize the use of the Pfizer-BioNTech vaccine for children 12 to 15 years old next Monday, a spokeswoman said, paving the way for students to return to in-person learning in September.
According to a database maintained by the Italian government, more than 19 percent of Italians are fully vaccinated, and 37 percent of the population have received a first dose, in line with the European average.
In the statement on the Pfizer vaccine for children 12 to 15, the E.M.A. said it would continue to track very rare cases of heart inflammation reported after vaccination, mostly in people younger than 30. The agency said the vaccine’s benefits outweighed the risks, and it remained unclear whether there was any possible link between the inflammation and vaccination.
-
Seaside Heights, N.J., 2020 Bryan Anselm for The New York Times
-
Seville, Ohio, 2020 Aaron Josefczyk/Reuters
-
Las Vegas, 2020 Mario Tama/Getty Images
-
Austin, Texas, 2020 Nuri Vallbona/Reuters
-
Ventura, Calif., 2020 Brent Stirton/Getty Images
-
San Antonio, 2021 Tamir Kalifa for The New York Times
-
Manhattan, 2021 Hiroko Masuike/The New York Times
-
Colombia, Mo., 2021 Jacob Moscovitch for The New York Times
-
Los Angeles, 2021 Marcio Jose Sanchez/Associated Press
Ahead of Memorial Day a year ago, many officials in the United States had canceled parades and banned crowded gatherings. The country was on the cusp of recording 100,000 deaths from the coronavirus.
This year, parades and barbecues are set to take place across the country and vaccinated people are being urged to get outside and enjoy the holiday. As the national economy roars back, concerns over soaring gas prices, sold-out hotels and lifeguard shortages may be eclipsing virus fears.
“A year ago, we were at the end of the beginning of the pandemic in the U.S., and now we’re kind of at the beginning of the end,” said Dr. Dan Diekema, an epidemiologist at the University of Iowa.
Hundreds of people are still dying each day, pushing the death count in the United States past 592,000 — an enormous toll that few envisioned a year ago. But the vaccinations over the past six months have proved a game-changer in the fight against Covid-19, even as challenges remain in reaching those without shots and the nation may never reach herd immunity.
About 62 percent of people 18 and older have received at least one shot; President Biden has set a goal of reaching 70 percent of adults by July 4. New cases have plunged 40 percent or more in many states around the country. The daily death rate is at its lowest level since last summer.
“If you are vaccinated, you are protected, and you can enjoy your Memorial Day,” the director of the Centers for Disease Control and Prevention, Dr. Rochelle P. Walensky, said at a White House news conference this week. “If you are not vaccinated, our guidance has not changed for you. You remain at risk of infection. You still need to mask and take other precautions.”
After the C.D.C. shifted its guidance this month by saying fully vaccinated people could take off their masks in most situations, one state after another moved to ease restrictions or eliminate them altogether.
California, the most populous U.S. state, announced plans to lift capacity limits and social-distancing restrictions while still requiring masks in indoor settings for now. At the same time, other states are barreling ahead with reopening plans.
Missouri’s governor, a Republican, reopened all remaining businesses this month and directed all state workers to return to offices for in-person work. Texas went even further, banning public schools and local governments from requiring masks.
Gov. Pete Ricketts of Nebraska, also a Republican, similarly prohibited mask mandates in state office buildings.
“If somebody wants to wear a mask, that is their personal choice,” he said.
As political leaders embrace policies aimed at returning to normalcy, the vaccines are accentuating a chasm between the United States — where the shots are widely available and where doses are being offered to children — and other nations, such as Brazil and India, where the virus is still raging and vaccines are in short supply.
There are also reminders around the United States that the pandemic, and the partisan positioning around the crisis, remain far from over. The pace of vaccinations has declined sharply since mid-April, with providers administering about 1.7 million doses per day on average, about a 50 percent decrease from the peak of 3.38 million reported on April 13. As the Biden administration has shifted its vaccine strategy to more local and personalized efforts, states are trying different tactics, including offering $1 million vaccine lottery prizes and other incentives.
Gov. Andrew M. Cuomo of New York ordered flags to be flown at half-staff in remembrance of the frontline workers who died during the pandemic, only to have a top Republican leader in the State Senate demand an apology from the governor for such a move during a holiday honoring soldiers.
A year ago, President Donald J. Trump mocked Mr. Biden for appearing in public with a face mask. Some states that moved early to reopen, such as Arizona, Florida and Texas, were slammed with a surge in cases weeks later.
Dr. Diekema, the Iowa epidemiologist, said he hoped that the resurgence of the virus last summer would serve as a reminder of the risks to unvaccinated people.
He said he couldn’t imagine a year ago that more than half a million people in the United States would die because of the virus. And the toll continues to grow: Over the holiday weekend, Dr. Diekema said that he planned to be working.
“I’ll be in the hospital seeing patients with infectious diseases like Covid-19,” he said.
The Japanese government on Friday extended a state of emergency in Tokyo and eight other prefectures until at least June 20, barely one month before the city is scheduled to host the Olympic Games.
Although new coronavirus infections are declining, Japan is still recording more than 4,000 cases a day during a prolonged fourth wave that has strained medical systems in many cities. Officials said that it was necessary to continue restrictions on businesses that were enacted in April until the caseload drops further.
“The newly reported cases are on a downward trend, but they are still at a high level,” Yasutoshi Nishimura, a government minister who leads Japan’s Covid-19 response, said on Friday.
Under the emergency measures, restaurants, department stores and other major commercial businesses have been ordered to curtail their operating hours, and dining establishments are forbidden from serving alcohol.
Japan’s vaccine rollout has been among the slowest in the industrialized world, with only 2.4 percent of the population fully vaccinated, according to a New York Times database. This week, the country opened its first mass vaccination sites in an effort to jump-start inoculations. But the government’s current goals call for only those over 65 to be fully vaccinated by the end of July, when the Summer Games would have begun.
Amid frustration over the government’s response to the pandemic, public opposition to hosting the Olympics, which were postponed from last year, has grown. In a recent survey, 83 percent of Japanese people said that they did not want Tokyo to hold the Games. The daily Asahi Shimbun, an official Olympic partner, published an editorial this week calling on Japan’s prime minister, Yoshihide Suga, to cancel the Games.
But organizers and Japanese officials have insisted that the Games will go on. On Thursday, Toshiro Muto, chief executive of the Tokyo Olympics, said, “No one on the executive board has explicitly mentioned a view that we should cancel or postpone the Games,” adding that as coronavirus cases decline, public opinion “will improve.”
President Biden’s call for a 90-day sprint to understand the origins of the coronavirus pandemic came after intelligence officials told the White House that they had a raft of still-unexamined evidence requiring additional computer analysis to shed more light on the mystery, according to senior administration officials.
The officials declined to describe the new evidence. But the revelation that they are hoping to apply an extraordinary amount of computer power to the question of whether the virus accidentally leaked from a Chinese laboratory suggests that the U.S. government may not have exhausted its databases of Chinese communications, the movement of lab workers and the pattern of the outbreak of the disease around the city of Wuhan.
In addition to marshaling scientific resources, Mr. Biden’s push is intended to prod American allies and intelligence agencies to mine existing information — like intercepts, witnesses or biological evidence — as well as hunt for new intelligence to determine whether Beijing covered up an accidental leak.
Mr. Biden committed on Thursday to making the results of the review public, but added a caveat: “unless there’s something I’m unaware of.”
His call for the study has both domestic and international political ramifications. It prompted his critics to argue that the president had dismissed the possibility that the lab was the origin until the Chinese government this week rejected allowing further investigation by the World Health Organization. And, administration officials said, the White House hopes American allies will contribute more vigorously to a serious exploration of a theory that, until now, they considered at best unlikely, and at worst a conspiracy theory.
So far, the effort to glean evidence from intercepted communications within China, a notoriously hard target to penetrate, has yielded little. Current and former intelligence officials say they strongly doubt that anyone will find an email or a text message or a document that shows evidence of a lab accident.
Idaho’s governor, Brad Little, said on Friday that he had repealed a ban on mask mandates that a political rival, Lt. Gov. Janice McGeachin, had issued while he was traveling out of state for a conference of the Republican Governors Association.
“Let me offer some advice as Idaho’s duly elected Governor — governing in a silo is NOT governing,” Mr. Little said in a statement announcing the reversal. “The action that took place was an irresponsible, self-serving political stunt.”
In the government equivalent of throwing a party while your parents are out of town, Ms. McGeachin, who is also a Republican and recently announced a bid to challenge Mr. Little for governor, had issued an executive order on Thursday banning mask mandates while Mr. Little had traveled briefly to Nashville.
She signed an executive order forbidding the state, municipalities and public schools from requiring masks. It said that wearing masks had done “significant physical, mental, social and economic harm,” that they failed to serve a health or safety purpose and that they “unnecessarily restrict the rights and liberties of individuals and business.”
Mr. Little said in an executive order, which was effective immediately, that the repeal would be applied retroactively to include Thursday, when Ms. McGeachin issued the ban.
Ms. McGeachin did not tell Mr. Little that she would be issuing the order ahead of time, his office said in a statement to KTVB, a television station in Boise, Idaho, on Thursday.
A spokeswoman for Mr. Little said he would not comment beyond the statement he issued on Friday. Ms. McGeachin’s office did not respond immediately to a request for comment on Friday.
The two officials, who were elected separately, recently went three weeks without speaking, according to The Idaho Statesman. Ms. McGeachin has consistently criticized Mr. Little’s measures to contain the virus, decrying restrictions as government overreach.
“The effects of the executive branch’s unilateral decisions will impact us for years,” Ms. McGeachin wrote in a guest essay in The Idaho Statesman this month.
Idaho did not have a statewide mask mandate, but an executive order effective May 21 required masks at long-term care facilities and said they were “strongly recommended” for others.
Mr. Little used an executive action to require social distancing and implement a brief stay-at-home order in March 2020, among other measures.
Mr. Little, who is in his first term, has not announced if he is running for re-election next year, but observers in the state believe he is likely to enter the race. It would set up a Republican race with the same contours as many others across the United States: Ms. McGeachin would be angling for President Trump’s base, while Mr. Little would represent a more moderate wing of the Republican Party.
Idaho has recorded around 192,000 coronavirus cases and at least 2,000 deaths, according to a New York Times database.
A new poll suggests that the United States could be on track to vaccinate at least 70 percent of the adult population against Covid-19 by this summer.
In the latest survey by the Kaiser Family Foundation, 62 percent of respondents said that they had received at least one dose of a vaccine, up from 56 percent in April. At the same time, about a third of those categorized as “wait and see” reported that they had already made vaccine appointments or planned to do so imminently.
Dr. William Schaffner, medical director of the National Foundation for Infectious Diseases and a vaccine expert, found the results encouraging.
“I think there are many people who were on the fence who were worried about things moving too rapidly and about possible side effects, but those concerns are being allayed as they see more of their friends and acquaintances celebrating getting vaccinated,” said Dr. Schaffner, who was not involved in the monthly survey.
“They’re getting that growing sense of comfort and reassurance that ‘people like me’ are getting vaccinated,” which, he said, was essential to instilling confidence in the vaccines.
The two demographic groups reporting the greatest increase in vaccination rates from April to May were Latino adults (from 47 percent to 57 percent) and adults without college degrees (from 48 percent to 55 percent).
The survey found that 40 percent of parents said that their child had either gotten at least one dose or would be getting one soon. But parents of younger children were more guarded, with only about a quarter expressing a willingness to get their children vaccinated as soon as the shots are authorized for them.
The finding suggests that efforts to protect as many young students as possible from Covid-19 by the start of the school year could face barriers.
While public health experts welcomed the continuing improvement in vaccination rates, they noted that it meant the pool of the most willing adults was shrinking.
President Biden set a goal of 70 percent vaccine coverage for adults by July 4. Dr. Schaffner said he thought the goal was possible. “We have to work harder,” he said.
Gov. Gavin Newsom of California on Thursday announced a $116.5 million giveaway to residents who receive a coronavirus vaccination, the latest and largest such effort among U.S. states seeking to motivate people to get a shot.
Under California’s incentive program, called Vax for the Win, 10 Californians who have had at least one dose of a vaccine will receive $1.5 million each. In addition, 30 people will be awarded $50,000 each, and two million people will receive $50 gift cards.
“Getting every eligible Californian vaccinated is how we bring our state roaring back from this pandemic,” Mr. Newsom said.
Fifty-six percent of California’s population has received at least one dose of a vaccine, and 42 percent has been fully vaccinated. Both percentages are above the national average, according to data from the Centers for Disease Control and Prevention.
California’s move comes after Ohio awarded the first $1 million lottery prize in its own vaccine incentive program this week, to Abbigail Bugenske, a 22-year-old from Cincinnati.
“I would encourage anyone to get the vaccine,” Ms. Bugenske said. “If winning a million dollars isn’t incentive enough, I don’t really know what would be.”
Among other states offering big prizes to those who have been vaccinated, Colorado announced its own $1 million lottery this week, and Oregon is offering a $1 million jackpot, in addition to $10,000 prizes.
Global Roundup
Britain’s drug regulator on Friday approved the use of the single-dose shots manufactured by Johnson & Johnson, the fourth coronavirus vaccine to be authorized in the country.
The authorization comes amid growing concerns about the spread in Britain of a coronavirus variant first detected in India. The number of cases of the variant, known as B.1.617.2, has doubled in a week, according to public data, and as of Thursday, nearly 7,000 cases had been detected.
“This fourth approved vaccine adds to our armory,” the British health secretary, Matt Hancock, said on Twitter. “When you’re eligible, get your jab.” Britain has also authorized the use of the vaccines manufactured by Moderna, Oxford-AstraZeneca and Pfizer-BioNTech.
More than 58 percent of Britain’s population has received at least one dose of a coronavirus vaccine, and 36 percent has been fully vaccinated. Britain opened vaccination to adults 30 and older this week, but most of the vaccination campaign’s efforts have in recent weeks focused on second injections.
Johnson & Johnson’s vaccine is 85 percent effective against severe illness from Covid-19, according to the British regulator.
The approval in Britain comes a day after Mexico gave emergency authorization to the same vaccine.
The Mexican government has previously authorized the vaccines from AstraZeneca and Pfizer, as well as Russia’s Sputnik V and China’s Sinovac and CanSino.
In other news around the world:
-
Hong Kong on Thursday recorded no new coronavirus cases for the first time in seven months, a promising sign in the Chinese territory’s efforts to quash a wave of infections that began in November. The city has gone more than a month without recording more than 15 daily cases, increasing calls for the authorities to relax social-distancing measures.
-
Vietnam ordered religious establishments to suspend large gatherings after a cluster of infections was linked to a Protestant congregation in Ho Chi Minh City, part of a nationwide surge in cases. Of more than 6,300 total cases recorded in the Southeast Asian nation since the start of the pandemic, half have come in the past month, the state-run Vietnam News Agency reported.
-
South America’s largest soccer tournament is scheduled to start in just over two weeks, but with one of the planned host countries, Colombia, removed because of political protests, and the remaining host, Argentina, mired in its worst coronavirus surge to date, it is unclear where the competition will take place.
A small but menacing rally this month in Poland followed a decision a few days earlier by the elected council in Walbrzych, a former mining town in the southwestern part of the country, to declare that vaccination against the coronavirus was mandatory for all adult residents.
That decision, the mayor, Dr. Roman Szelemej, said in an interview, reflected “the simple medical fact that vaccination is the only thing that can prevent this disease.” But instead of calming nerves, he lamented, “it made this small point on the map of Poland a place for all the skeptics of science and reality to focus on.”
Wariness of coronavirus vaccines runs deep in Poland, particularly among younger people, with a survey by the University of Warsaw indicating that around 40 percent of the population is averse to getting inoculated. That is a lower level of skepticism than in France but still enough to make vaccines a rallying cause for a diverse and, Dr. Szelemej fears, growing minority who “live in a different reality” based on distrust of all scientific, moral and political authority.
“There are no rules, no laws, no facts, no scientific achievements, no proven data. Everything is questioned, everything is fragile,” he said. “This is dangerous, very dangerous.”
The mandatory vaccine order, endorsed by 20 out of 25 town councilors, carried no real legal force. And it was declared invalid last week by the regional government, which is controlled by members of Poland’s deeply conservative governing party, Law and Justice, the political foes of Dr. Szelemej, who is a centrist liberal.
The Indian government is in talks with Pfizer to obtain 50 million doses of the company’s coronavirus vaccine starting this summer, but is still considering the drug manufacturer’s demand for indemnity from costs related to severe side effects, officials have said.
India has not given indemnity, or protection from legal liability, to any manufacturer of coronavirus vaccines, but government officials indicated that they were likely to grant Pfizer’s request. The drug company has obtained indemnity in several countries where its vaccine is already in use, including the United States.
“We are examining this request, and we will take decisions in the larger interest of people and on merits,” Vinod Paul, who heads the Indian government’s vaccination program, told reporters on Thursday.
Officials said that Pfizer was prepared to supply India with 50 million vaccine doses from July to October and that the company had shared information related to the drug’s efficacy with the Indian health authorities.
India is struggling to inoculate its population as a second wave of the coronavirus ravages the country, killing thousands a day and overwhelming medical facilities. More than 315,000 people in India have died of the virus, the third-highest toll in the world, after the United States and Brazil, but experts believe the official data is a significant undercount.
Only 3 percent of India’s 1.3 billion people have been fully vaccinated, according to a New York Times database, and experts say that vaccines are slow to reach rural India, where the outbreak is growing. The pace of vaccinations nationwide has slipped to two million shots a day from three million a few months ago, with health centers saying that they are running out of doses and many in the country saying that they cannot find a place to be inoculated.
Indian officials now say that expanding vaccinations is the only way out of the outbreak, but, unlike many other countries, the government of Prime Minister Narendra Modi declined to sign advance purchase agreements with vaccine manufacturers, believing this year that it had defeated the virus. Experts say that as Indians lowered their guard, they were left defenseless against coronavirus variants that are believed to be more transmissible.
India’s large vaccine manufacturing industry has failed to keep up with demand, leaving the country reliant on imported doses that are in short supply globally. On Thursday, Indian officials said that they would work with Pfizer to make its doses available as soon as possible.
Despite the vaccine shortage, some places are beginning to ease restrictions. India’s capital, New Delhi, will begin a phased end to its monthlong lockdown next week, the chief minister of Delhi, Arvind Kejriwal, said.
The government in Spain ended the Covid-19 state of emergency on May 9. The country’s inoculation campaign is accelerating. And Prime Minister Pedro Sánchez recently predicted that 70 percent of the population of 47 million would be vaccinated by mid-August.
But amid the good news, some medical experts in Spain have urged the authorities to bolster access to testing, which they say remains essential in limiting the spread of the coronavirus.
There has been a debate in Spain over whether pharmacists, in addition to doctors, should be able to conduct tests. According to the Spanish General Council of Pharmacists, only 790 of the country’s 22,100 pharmacies can conduct tests.
Jesús Aguilar, the president of the council, said that in the few regions where pharmacists had been allowed to test, the outcome had been excellent.
“It is a shame that the administrations have not sped up this collaboration, which has been a unanimous request from citizens,” he noted.
The Spanish government has justified limiting access to testing in pharmacies by portraying them as places where the virus could spread if infected patients mingle with other customers.
Other Spanish medical associations have also called for tests to be limited to health centers. Some doctors have warned that in-home testing could make it harder to trace the disease and could give people a false sense of security if they test negative, because test kits can be misused.
Javier Segura del Pozo, an epidemiologist who is also the deputy president of the public health association of Madrid, compared the Spanish debate about coronavirus testing to that which followed the introduction of the morning-after contraceptive pill.
“In general, I believe that the population should have access to diagnostics without always having to go through the medical profession, but it is also important to have people understand that a Covid-19 test is not in itself a prevention measure, which is how many people seem to view it,” he said.
Many private clinics have been conducting coronavirus tests, independent of their normal field of expertise.
Clinicas Pronatal, a Madrid clinic that normally focuses on fertility treatments, said that it had hired 14 more workers, doubling its staff, since the start of the pandemic to cope with the demand for Covid-19 tests.
[ad_2]
Source link
