Pfizer and the German company BioNTech have become the first companies to apply to the U.S. Food and Drug Administration for full approval of their Covid-19 vaccine for use in people 16 and older. The vaccine is currently being administered to adults in America under an emergency use authorization granted in December.
The approval process is likely to take months.
The companies said in a statement on Friday that they had submitted their clinical data, which includes six months of information on the vaccine’s safety and efficacy, to the F.D.A. They plan to submit additional material, including information about the manufacturing of the vaccine, in the coming weeks.
“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. government,” Dr. Albert Bourla, Pfizer’s chief executive, said in the statement. “We look forward to working with the F.D.A. to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”
As of Thursday, more than 134 million doses of the vaccine had been administered in the United States, according to the Centers for Disease Control and Prevention. Full approval would allow Pfizer and BioNTech to market the vaccine directly to customers.
It could also make it easier for companies, government agencies and schools to require vaccinations. The Equal Employment Opportunity Commission said in December that employers could mandate vaccination, and legal experts have generally agreed.
Many companies have been hesitant to require the vaccines, especially while they have only emergency authorization, which is designed to be temporary. Some institutions, like the University of California and California State University systems, have said that they would do so only after a vaccine has full approval.
Full approval could also prompt the U.S. military, which has had low uptake of Covid-19 vaccines, to mandate vaccinations for service members.
If the F.D.A. grants full approval, it could also help raise confidence in the vaccine. The pace of vaccination has slowed in the United States in recent weeks, and a recent national survey indicated that most people in the country who planned to get the shots had already done so.
The agency is also expected to issue an emergency authorization for use of the Pfizer-BioNTech vaccine in 12- to 15-year-olds next week. The companies have said that they plan to file for emergency authorization for 2- to 11-year-olds in September.
Moderna plans to apply for full approval for its Covid-19 vaccine this month, the company said during its quarterly earnings call on Thursday.
India’s worsening coronavirus outbreak has spread far outside its cities to rural areas with poor health care infrastructure and limited testing capacities, doctors and experts say.
One factor behind the surge of cases, they believe, is a series of recent campaign rallies held without social distancing.
The state of West Bengal, where Prime Minister Narendra Modi’s party lost an election last week after more than a month of campaigning to vast crowds, is recording the highest rate of positive coronavirus tests in India. More than 31 percent of tests in the state are now coming back positive.
“There is a clear pattern here: States that went through elections and where large rallies were held are witnessing a huge rise in cases,” said Dr. Thekkekara Jacob John, a senior virologist in the southern state of Tamil Nadu.
In Uttar Pradesh, India’s most populous state, 1,028 new coronavirus cases and four deaths were recorded on March 26. On April 29, after campaigns for local village council elections were held, there were 35,104 cases and 288 deaths. A teachers’ union in the state said that 577 teachers and support staff members who were on duty as election workers had died of Covid-19.
As the outbreak reaches new heights, India’s vaccination campaign has slowed down, marred by supply shortages and competition among states.
The official daily death in the country has stayed over 3,000 over the past 10 days, and experts say the numbers are much higher,.
The true scope of the outbreak remains hard to measure. Nationwide, India conducted about 1.9 million coronavirus tests on Thursday, an increase from about 1.2 million daily tests last month, but hardly enough to keep up with a daily caseload that has almost quadrupled in that time.
West Bengal, a state of 90 million people that has poor health care infrastructure and is under a partial lockdown, has carried out fewer than 60,000 coronavirus tests a day. That is one of the lowest rates in the country, according to data compiled by researchers at the University of Michigan.
Dr. Abhijeet Barua, a physician in Kolkata, the state’s capital, said that cases had exploded in every corner of the city and that infections were spreading quickly in the state’s rural areas. At his 10-bed clinic, two people have died every day over the past 15 days, Dr. Barua said.
“What is making things worse in Kolkata is that over 70 percent of the population lives in close contact,” he said, adding that he was receiving dozens of calls a day from patients seeking help. “You can’t isolate yourself, because it is so congested here.”
Mr. Modi has repeatedly refrained from imposing a nationwide lockdown. Instead nearly a dozen of India’s 28 states have imposed restrictions, though they are less stringent than the nationwide lockdown put in place last year.
TOKYO — Japan on Friday extended a state of emergency in Tokyo and other regions until the end of May to contain a surge of coronavirus cases, casting further doubt on the country’s ability to safely host the Summer Olympics, which are scheduled to begin in 11 weeks.
Prime Minister Yoshihide Suga made the announcement at a meeting of the government’s coronavirus task force, saying that the measures were necessary because infections remain at a “high level, mainly in large cities.”
The announcement extends emergency measures imposed last month to two more prefectures, covering a total of six prefectures, including Tokyo and Osaka, that are together home to over a third of Japan’s 126 million people. Another eight prefectures will be under slightly looser restrictions.
The existing state of emergency, which were imposed to curb travel during the just-ended Golden Week holiday period and had been set to expire next week, have not slowed Japan’s fourth wave of coronavirus infections. In early March, the country recorded about 1,000 daily new. It is now recording nearly 6,000, according to a New York Times database.
Health officials say that they are seeing a growing number of cases of coronavirus variants spreading in the population, including at least 26 cases of the strain first detected in India. The authorities in Tokyo say that in four out of five cases found in the city, the infected person neither traveled abroad nor had close contact with someone who had.
The outbreak is stretching health care systems even in Japan’s biggest cities. On Thursday, there were 370 people being treated for serious cases of Covid-19 in Osaka, a prefecture of nine million people, more than the number of hospital beds available for seriously ill patients.
Japan, which has recorded more than 620,000 infections and 10,000 deaths since the start of the pandemic, has controlled the virus better than many countries. But the government has faced criticism for the sluggish pace of vaccinations, and for pledging to go ahead with the Tokyo Olympics, scheduled to begin on July 23, despite widespread public opposition.
Toru Hashimoto, a lawyer and a former governor of Osaka prefecture, said on a television show on Friday that Olympic organizers were ignoring the severity of Japan’s outbreak, and that it was inappropriate to continue holding pre-Olympic “test events” during the state of emergency, even though they are taking place without spectators.
“If the government wants to reduce the number of people in the city, it’s not a time when test events can be held,” Mr. Hashimoto said.
The government has imposed two previous states of emergency during the pandemic, although they are looser than the total lockdowns seen in many nations. The measures allow the prefectures to ask businesses to close or to restrict their hours, and to fine those that do not.
Under the extended state of emergency, people are asked not to go out for nonessential matters, especially after 8 p.m., and to refrain from traveling outside their prefectures. Karaoke parlors are asked to close, and restaurants requested not to serve alcohol, with fines of up to 300,000 yen, or $2,750, for noncompliance.
A global debate is heating up over how to get Covid-19 vaccines to the nations most in need.
The United States is supporting an effort to suspend intellectual property protections on Covid-19 vaccines, and European countries say that richer nations should begin exporting more of their vaccine supply to poorer ones.
The European Union — whose approval is needed for any waiver of vaccine patents — said on Thursday that it would consider the Biden administration’s proposal. But Germany, the bloc’s largest economy, said that pushing pharmaceutical companies to share vaccine patents could have “significant implications” for the production of vaccines.
“The limiting factor in vaccine manufacturing is production capacity and high-quality standards, not patents,” a spokeswoman for Chancellor Angela Merkel of Germany said in a statement.
On Friday, Canada shared similar concerns. “Our government firmly believes in the importance of protecting intellectual property and recognizes the integral role that industry has played in innovating to develop and deliver lifesaving Covid-19 vaccines,” the minister of small businesses, Mary Ng, said in a statement.
She added many barriers to vaccine access, like supply shortages, were unrelated to intellectual property.
The European Commission president, Ursula von der Leyen, said the bloc was “ready to discuss any proposals that address the crisis in an effective and pragmatic manner.”
She also suggested, however, that the focus should be on getting more vaccines to countries that needed them by following the bloc’s example in allowing significant exports of doses. The United States has balked at that approach, keeping most doses produced domestically for use at home.
“We call upon all vaccine-producing countries to allow export and to avoid measures that disrupt the supply chains,” Ms. von der Leyen said.
The European statements emphasized the challenges of winning E.U. support for the waivers at the World Trade Organization, where the bloc wields significant influence, and where unanimous approval would be needed for any measure to suspend patents.
Many experts believe that the waivers are needed to expand the manufacturing of vaccines and get them to poorer parts of the world where inoculations have far lagged behind those of richer countries.
Until the Biden administration’s announcement this week, the United States had been a major holdout at the W.T.O. over a proposal by India and South Africa to suspend some intellectual property protections. The move could give drugmakers access to the trade secrets of how the vaccines are made.
The pharmaceutical industry has argued that suspending patent protections would undermine risk-taking and innovation.
“Who will make the vaccine next time?” Brent Saunders, the former chief executive of Allergan, which is now part of AbbVie, wrote on Twitter.
But Stephane Bancel, the chief executive of Moderna, told investors on Thursday, “We saw the news last night, and I didn’t lose a minute of sleep.”
Mr. Bancel said his company never planned to enforce the patent because few, if any, other drug makers can easily manufacture mRNA, the genetic script that carries DNA instructions to each cell’s protein-making machinery.
The debate arises amid a growing divide between wealthy nations that are slowly regaining normal life, and poorer countries that are confronting new and devastating outbreaks.
In India, which is suffering the world’s worst outbreak since the start of the pandemic, only 2.2 percent of the population is fully vaccinated, according to a New York Times database. South Africa has fully vaccinated less than 1 percent of its people. By contrast, vaccinations are slowing down in the United States — where one-third of people are fully inoculated — as they begin to pick up in Europe.
If the European Union agrees to support patent waivers, it would take months for developing nations to see the impact. Ngozi Okonjo-Iweala, the head of the W.T.O., told The Washington Post that she would press member countries to reach an agreement by Dec. 3.
Even if a waiver receives support from the trade body, it alone would not increase the world’s vaccine supply. Large drug manufacturers in India and elsewhere would need extensive technological and other support to produce doses, experts say.
Lifting intellectual property protections “is only one element,” said Anant Bhan, a health researcher at Melaka Manipal Medical College in southern India. Because of the additional steps required to begin making a vaccine on a huge scale, he said, “it is not going to mean increased access to vaccines in the near future.”
Britain’s vaccines regulator advised on Friday that all adults under 40 in the country should be offered alternatives to AstraZeneca’s Covid-19 vaccine. It factored in concerns over very rare blood clots, the dwindling risk of severe coronavirus infection in younger adults and the availability of alternatives.
The guidance extends earlier advice that people under 30 would be offered alternative doses.
The use of the AstraZeneca vaccine has been marred by uncertainty after reports of a possible link between the doses and very rare blood clots, but public health experts around the world say that the vaccine’s benefits far outweigh the risks for most people.
Britain’s Joint Committee on Vaccination and Immunization stressed that the chances of younger people becoming seriously ill with the coronavirus had grown smaller as infection rates decrease across the country. It said that this new reality paired with the availability of alternative vaccines had factored into the decision.
But the country is also closely monitoring new variants of the coronavirus, and on Friday public health officials in England noted that a variant first detected in India was now considered a “variant of concern” — meaning that it is at least as transmissible as the dominant variant in Britain. The cases identified in the country more than doubled from 202 to 520 in the week, but still account for just a fraction of the cases there.
While there is still not enough evidence to indicate whether any of the variants recently detected in India cause more severe illness or render vaccines any less effective, Britain is proceeding with caution. Most of the identified cases of the variant are in London and in the town of Bolton in the northwestern England.
Regarding the AstraZeneca vaccine, the regulator advised that where available, an alternative should be offered to healthy adults under 40, though it stressed that potentially severe side effects from the doses were “extremely rare.” It noted that “for the vast majority of people, the benefits of preventing serious illness and death far outweigh any risks.”
The vaccination committee advised that anyone who received a first dose of the AstraZeneca vaccine should still receive a second, except those who experienced clotting.
Britain’s medicines regulatory agency had received reports of 242 cases of blood clots accompanied by low platelet counts in people who received the AstraZeneca vaccine through April 28. As of that date, about 22.6 million AstraZeneca doses had been administered in Britain, including about 5.9 million second doses.
Over all, about 35 million people in the country have received at least one dose of a coronavirus vaccine.
One returning pilot lost control of an aircraft during landing and skidded off the runway into a ditch. Another just returning from furlough forgot to activate a critical anti-icing system designed to prevent hazards in cold weather. Several others flew at the wrong altitudes, which they attributed to distractions and lapses in communication.
In all of these incidents, which were recorded on NASA’s Aviation Safety Reporting System, a database of commercial aviation mistakes that are anonymously reported by pilots and other airline crew, the pilots involved blamed the same thing for their mistakes: a lack of practice flying during the pandemic.
In 2020, global air passenger traffic experienced the largest year-on-year decline in aviation history, falling 65.9 percent compared with 2019, according to the International Air Transport Association. Flights were grounded, schedules reduced and thousands of pilots were laid off or put on furlough for up to 12 months.
As vaccination programs pick up speed across some parts of the world and travel starts to rebound, airlines are beginning to reactivate their fleets and summoning pilots back as they prepare to expand their schedules for the summer. But returning pilots can’t just pick up where they left off.
“It’s not quite like riding a bike,” said Joe Townshend, a former pilot for Titan Airways, a British charter airline, who was laid off when the pandemic hit in March last year.
“You can probably go 10 years without flying a plane and still get it off the ground,” he said, “but what fades is the operational side of things.”
Although Covid-19 is primarily a respiratory disease, research conducted early in the pandemic revealed that people infected with the coronavirus often shed it in their stool. This finding, combined with the scale and urgency of the crisis, spurred immediate interest in tracking the virus by sampling wastewater.
In the past year, many scientists have been drawn into the once niche field of wastewater epidemiology. Researchers in 54 countries are tracking the coronavirus in sewage, according to the Covid19Poops Dashboard, a global directory of the projects.
These teams have found that the wastewater data seemed to accurately indicate what was happening in society. When the number of diagnosed Covid-19 cases in an area increased, more coronavirus appeared in the wastewater. Levels of the virus fell when areas instituted lockdowns and surged when they reopened.
Several teams have also confirmed that sewage can serve as an early warning system: Wastewater viral levels often peaked days before doctors saw a peak in official Covid-19 cases.
And wastewater analysis has allowed scientists to detect the arrival of certain variants in a region weeks before they are found in people — and to identify mutations that have not yet been detected in people anywhere.
The surveillance is not a replacement for clinical testing, experts said, but can be an efficient and cost-effective complement. The approach is likely to be especially valuable in low- and middle-income countries, where testing resources are more limited.
“Not every population gets tested, not everyone has access to health care,” said Dr. Marc Johnson, a virologist at the University of Missouri. “If there’s groups of people that are asymptomatic, they probably aren’t getting tested either. So you aren’t really getting the full big picture. Whereas for our testing, everyone poops.”
A series of vaccine developments and the loosening of restrictions amid an improving virus trajectory may foreshadow a welcome return to normalcy for many young Americans, just as summer vacation nears.
By early next week, the Food and Drug Administration is expected to issue an emergency use authorization allowing the Pfizer-BioNTech coronavirus vaccine to be used in children 12 to 15 years old, a major step ahead in the United States’ efforts to tackle Covid-19. Pfizer also expects to seek federal clearance in September to administer the vaccine to children age 2 to 11, the company said on Tuesday.
Vaccinating children is key to raising the level of immunity in the population, experts say, and to bringing down the numbers of hospitalizations and deaths. It could also put school administrators, teachers and parents at ease if millions of adolescent students become eligible for vaccination before the next academic year begins.
The move would be a major leap forward, experts say, and comes as the director of the Centers for Disease Control and Prevention, Dr. Rochelle Walensky, said that vaccinated adolescents would be able to remove their masks outdoors at summer camps.
Yet the eagerness of parents to let their children be vaccinated is limited, according to a new national poll, which found that three in 10 parents surveyed said they would get their children vaccinated right away and 26 percent said they wanted to wait to see how the vaccine was working. About 23 percent said they would definitely not get their children vaccinated, and 18 percent said they would do so only if a child’s school required it. The survey also noted that only 9 percent of respondents said they had not yet gotten a shot but still intended to do so, one more indication that achieving widespread immunity in the United States is becoming increasingly challenging.
As health experts focus on the future of vaccinating children, a growing number of students have returned to in-person learning this school year. In March, 54 percent of K-8 schools were open for full-time in-person learning, and 88 percent were open for either full-time in-person and/or hybrid learning, according to data from a federal government survey released on Thursday. But Black, Hispanic and Asian students are enrolled in full-time in-person learning at much lower rates than white students.
The Biden administration has made an aggressive push for reopening schools in recent months, including an effort to prioritize vaccinations for teachers and employees.
global roundup
Australia will resume repatriation flights for Australian nationals in India after May 15, Prime Minister Scott Morrison said on Friday.
The resumption will end a travel ban that made it a criminal offense for citizens and residents of Australia to enter the country from India. No other democratic nation has issued a similar ban on all arrivals.
Australians who test positive for the coronavirus will not be allowed to travel, officials said, and the government has introduced a pre-departure testing regime in India in an effort to catch infections before they reach Australia.
Critics of the travel ban have accused the government of racism and insensitivity, but officials have said that the restrictions are necessary to prevent transmission from the devastating outbreak in India.
Australian officials initially said that anyone trying to return from India faced up to five years in prison and nearly 60,000 Australian dollars ($46,300). But as the measure came under withering criticism this week, Mr. Morrison said it was “highly unlikely” that those seeking to return home would actually face jail.
In other news from around the world:
Tunisia will enter a weeklong nationwide lockdown starting on Sunday, Prime Minister Hichem Mechichi said on Friday. The country of nearly 12 million people has reported 11,122 deaths and 315,000 cases, according a New York Times database.