WASHINGTON (AP) — The U.S. is getting a third vaccine to prevent COVID-19, as the Food and Drug Administration on Saturday cleared a Johnson & Johnson shot that works with just one dose instead of two.
Health experts are anxiously awaiting a one-and-done option to help speed vaccinations, as they race against a virus that already has killed more than 510,000 people in the U.S. and is mutating in increasingly worrisome ways.
The FDA said J&J’s vaccine offers strong protection against what matters most: serious illness, hospitalizations and death. One dose was 85% protective against the most severe COVID-19 illness, in a massive study that spanned three continents — protection that remained strong even in countries such as South Africa, where the variants of most concern are spreading.
“This is really good news,” Dr. Francis Collins, director of the National Institutes of Health, told The Associated Press Saturday. “The most important thing we can do right now is to get as many shots in as many arms as we can.”
J&J initially is providing a few million doses and shipments to states could begin as early as Monday. By the end of March, J&J has said it expects to deliver 20 million doses to the U.S., and 100 million by summer.
J&J also is seeking authorization for emergency use of its vaccine in Europe and from the World Health Organization. The company aims to produce about 1 billion doses globally by the end of the year. On Thursday, the island nation of Bahrain became the first to clear its use.
“This is exciting news for all Americans, and an encouraging development in our efforts to bring an end to the crisis,” President Joe Biden said in a statement. “But I want to be clear: this fight is far from over,” he added, encouraging people to stick with masks and other public health measures.
On Sunday, a U.S. advisory committee will meet to recommend how to prioritize use of the single-dose vaccine. And one big challenge is what the public wants to know: Which kind is better?
“In this environment, whatever you can get — get,” said Dr. Arnold Monto of the University of Michigan, who chaired an FDA advisory panel that unanimously voted Friday that the vaccine’s benefits outweigh its risks.
Data is mixed on how well all the vaccines being used around the world work, prompting reports in some countries of people refusing one kind to wait for another.
In the U.S., the two-dose Pfizer and Moderna shots were 95% protective against symptomatic COVID-19. J&J’s one-dose effectiveness of 85% against severe COVID-19 dropped to 66% when moderate cases were rolled in. But there’s no apples-to-apples comparison because of differences in when and where each company conducted its studies, with the Pfizer and Moderna research finished before concerning variants began spreading.
NIH’s Collins said the evidence shows no reason to favor one vaccine over another.
“What people I think are mostly interested in is, is it going to keep me from getting really sick?” Collins said. “Will it keep me from dying from this terrible disease? The good news is all of these say yes to that.”
Also, J&J is testing two doses of its vaccine in a separate large study. Collins said if a second dose eventually is deemed better, people who got one earlier would be offered another.
The FDA cautioned that it’s too early to tell if someone who gets a mild or asymptomatic infection despite vaccination still could spread the virus.
There are clear advantages aside from the convenience of one shot. Local health officials are looking to use the J&J option in mobile vaccination clinics, homeless shelters, even with sailors who are spending months on fishing vessels — communities where it’s hard to be sure someone will come back in three to four weeks for a second vaccination.
The J&J vaccine also is easier to handle, lasting three months in the refrigerator compared to the Pfizer and Moderna options, which must be frozen.
“We’re chomping at the bit to get more supply. That’s the limiting factor for us right now,” said Dr. Matt Anderson of UW Health in Madison, Wisconsin, where staffers were readying electronic health records, staffing and vaccine storage in anticipation of offering J&J shots soon.
The FDA said studies detected no serious side effects. Like other COVID-19 vaccines, the main side effects of the J&J shot are pain at the injection site and flu-like fever, fatigue and headache.
An FDA fact sheet for vaccine recipients says there is “a remote chance” that people may experience a severe allergic reaction to the shot, a rare risk seen with the Pfizer and Moderna vaccines. Such reactions are treatable, and vaccine recipients are supposed to be briefly monitored after the injection.
The vaccine has been authorized for emergency use in adults 18 and older for now. But like other manufacturers, J&J is about to study how it works in teens before moving to younger children later in the year, and also plans a study in pregnant women.
All COVID-19 vaccines train the body to recognize the new coronavirus, usually by spotting the spikey protein that coats it. But they’re made in very different ways.
J&J’s shot uses a cold virus like a Trojan horse to carry the spike gene into the body, where cells make harmless copies of the protein to prime the immune system in case the real virus comes along. It’s the same technology the company used in making an Ebola vaccine, and similar to COVID-19 vaccines made by AstraZeneca and China’s CanSino Biologics.
The Pfizer and Moderna vaccines are made with a different technology, a piece of genetic code called messenger RNA that spurs cells to make those harmless spike copies.
The AstraZeneca vaccine, already used in Britain and numerous other countries, is finishing a large U.S. study needed for FDA clearance. Also in the pipeline, Novavax uses a still different technology, made with lab-grown copies of the spike protein, and has reported preliminary findings from a British study suggesting strong protection.
Still other countries are using “inactivated vaccines,” made with killed coronavirus by Chinese companies Sinovac and Sinopharm.
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Associated Press journalists Ricardo Alonso-Zaldivar and Marion Renault contributed to this report.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
doses shipping Sunday night
WASHINGTON — Nearly 4 million doses of the newest COVID-19 vaccine will be shipped Sunday night, and will begin to be delivered to states for injections starting on Tuesday.
The White House said the entire stockpile of the newly approved single-dose Johnson & Johnson vaccine will go out immediately. J&J will deliver about 16 million more doses by the end of March and 100 million total by the end of June, but the distribution would be backloaded.
Though the new shot is easier to administer and requires only one dose, the administration is not altering its distribution plans.
The White House is encouraging Americans to take the first dose available to them, regardless of manufacturer.
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THE VIRUS OUTBREAK:
— Fraud is overwhelming pandemic-related unemployment programs. J&J’s one-dose shot cleared, giving U.S. a 3rd COVID-19 vaccine to use. Health experts are urging Pope Francis to rethink his March trip to Iraq, saying that could become a huge superspreading event for the virus. Plunging demand for COVID-19 tests may leave US exposed. Biden team readies a broader economic measure after virus relief.
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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
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HERE’S WHAT ELSE IS HAPPENING:
WASHINGTON — A U.S. advisory panel has endorsed the new one-dose COVID-19 vaccine from Johnson & Johnson as a third option to bolster the national effort against the coronavirus pandemic.
Advisers to the Centers for Disease Control and Prevention voted overwhelmingly to recommend the vaccine for adults 18 years old and up. The ruling followed emergency clearance of the vaccine by U.S. regulators a day earlier.
Members of the group emphasized that all three vaccines now available in the U.S. are highly protective against the worst effects of the virus, including hospitalization and death.
J&J plans to ship several million vaccine doses to states in the coming week, delivering a total of 20 million shots by the end of March. Health officials are eager to have an easier-to-use vaccine against COVID-19, which has killed more than 511,000 Americans and continues to mutate in troubling ways.
CDC recommendations are not binding on state governments or doctors, but are widely heeded by the medical community. The same CDC panel previously recommended use of the two vaccines from Pfizer and Moderna authorized in December.
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SALT LAKE CITY — Utah is canceling about 7,200 coronavirus vaccine appointments after an error in the state health department’s registration website allowed people without qualifying conditions to register for the shots.
Department spokesman Tom Hudachko said in a statement that the error allowed residents who are not 65 or older or who don’t have an underlying medical condition to sign up.
The Salt Lake Tribune reported Sunday those appointments are being canceled.
People who meet the state’s conditions can keep their vaccine appointments scheduled through Vaccinate.utah.gov. Public school teachers and first responders also are eligible for vaccines.
Utah so far has administered more than 680,000 vaccine doses and estimates that 10% of its 3.2 million population has been fully vaccinated.
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ATHENS, Greece — Greek health authorities have announced that 70 specialized intensive care units will be added to Athens hospitals as high hospitalization rates have nearly filled the available ones.
The Athens area along with several others across the country are under lockdown until March 8, with most shops closed, schools operating on distance learning and a 9 p.m. curfew, but many experts talk of extending this for at least another week.
On Sunday, authorities announced 1,269 new COVID-19 cases, along with 36 deaths. This brings the number of confirmed cases since the start of the pandemic to 191,100, with 6,504 deaths. There are 391 patients on ventilators in ICUs, close to a record high.
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RIO DE JANEIRO — Brazil’s capital has entered a two-week lockdown, joining several states in adopting measures to reduce the spread of COVID-19 as intensive care beds begin to fill in some important cities.
At least eight Brazilian states adopted curfews over the past week due to the rise in cases and deaths from COVID-19. Thursday was Brazil’s deadliest day since the beginning of the pandemic, with 1,541 deaths confirmed from the virus. So far 254,000 people have died overall.
Brasilia Gov. Ibaneis Rocha decreed the total closure of bars, restaurants, shopping malls and schools until March 15 and prohibited gatherings of people. Sale of alcoholic beverages was prohibited after 8 p.m.
In the federal district, 85% of hospital beds were occupied on Sunday, according to the local health ministry.
President Jair Bolsonaro again criticized such measures, saying on his Twitter account: “The people want to work.” He threatened on Friday to cut off federal emergency pandemic assistance to states resorting to lockdowns.
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ROME — While new COVID-19 cases surge in Italy’s north, the island of Sardinia has earned coveted ‘’white zone’’ status, allowing for evening dining and drinking at restaurants and cafes and the reopening after months of closure of gyms, cinemas and theaters.
Earlier this year, the Italian government added ‘’white zone’’ status to its color-coded system of restrictions on businesses and schools, with “red zone” designation carrying the strictest measures.
Starting on Monday, the region of Sardinia, with an incidence of fewer than 50 cases per 100,000 residents, will be able to allow the most liberties since a second wave of coronavirus infections last fall prompted the government to tighten restrictions nationwide after easing them during summer.
The Health Ministry report covering the third week of February shows nationwide incidence was 145 cases per 100,000 inhabitants, and several regions had far higher incidence.
The Mediterranean island of Sardinia is a popular vacation destination. Last summer, crowds at seaside discos and clubs there were cited as a factor in the climb in an explosion of cases in Italy in the last months of 2020.
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TEHRAN, Iran — Iran has surpassed 60,000 known coronavirus-related deaths, the latest grim milestone for the hardest-hit country in the Middle East.
The Health Ministry reported 93 new deaths from COVID-19 on Sunday and more than 8,000 new infections, pushing the total infection count over 1.63 million.
After more than a year of the pandemic, deaths from COVID-19 recently have declined in Iran as movement restrictions in the capital have set in, including inter-city travel bans, mask mandates and school closures.
The government on Sunday banned incoming travelers from a list of 32 countries, including Britain and other states in Africa and Latin America, due to fears of new virus variants.
Over the year, Iran has struggled with surges that at times overwhelmed its health system as authorities resisted a total lockdown to salvage an economy crippled by U.S. sanctions.
Iran’s vaccine drive recently has gotten underway, with Russia’s Sputnik V vaccine administered to health workers this month. An additional 250,000 doses by the Chinese state-backed pharmaceutical Sinopharm arrived in Iran over the weekend.
The country is also accelerating efforts to produce a domestic vaccine, beginning human trials for its second vaccine on Sunday.
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BERLIN — The German disease control agency is adding France’s Moselle region to its list of areas with a high rate of variant coronavirus cases, meaning travelers from there will face additional hurdles when crossing the border into neighboring Germany.
The Robert Koch Institute said Sunday that the restrictions would come into force at midnight on March 2, putting Moselle on a par with countries such as the Czech Republic, Portugal and the United Kingdom.
Travelers from those areas must produce a recent negative coronavirus test before crossing the German border. The measure is likely to affect many people who live on one side of the frontier and work on the other.
The Moselle region in northeastern France includes the city of Metz and borders with the German states of Saarland and Rhineland-Palatinate.
Clement Beaune, the French minister for European affairs, said France regrets the decision and is in negotiations with Germany to try to lighten the measures for 16,000 inhabitants of Moselle who work across the border.
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LONDON — Britain’s government says families with children in school will be provided with free coronavirus home test kits as part of plans for schools to reopen beginning on March 8.
Free, twice-weekly tests will be provided to children’s households regardless of whether anyone has symptoms, officials said Sunday. The tests will also be offered to adults working with schools, including bus drivers.
Education Secretary Gavin Williamson said testing family members will provide “another layer of reassurance to parents and education staff that schools are as safe as possible.” Schools in England have been closed except to children of key workers since January.
Britain is also racing ahead with its vaccination program, with almost 20 million in the U.K. who have now had a first jab. Some 2 million people aged 60 to 63 in England will start getting invitations to book their shots beginning on Monday. The government aims to offer a first jab to all adults by the end of July.
Britain has Europe’s worst virus death toll at nearly 123,000 dead.
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BUDAPEST — Hungary’s prime minister on Sunday received a COVID-19 vaccine developed in China as his country aims to boost vaccination rates using jabs developed in eastern countries.
Prime Minister Viktor Orban posted photos on Facebook of himself being inoculated with the Sinopharm vaccine. Hungary last week became the first country in the European Union to begin using the Chinese jab.
Hungary’s government has been critical of the speed of the EU’s vaccination program, and has purchased vaccines from Russia and China to boost procurements.
“The vaccines reserved by the EU are simply not arriving, and they are arriving more slowly than predicted. If we didn’t have the Russian and Chinese vaccines, we would be in big trouble,” Orban said during a radio interview on Friday.
He earlier said he would choose to receive the Sinopharm vaccine because he trusted it the most.
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ROME — Infectious disease experts are expressing concern about Pope Francis’ upcoming trip to Iraq, given a sharp rise in coronavirus infections there, a fragile health care system and the unavoidable likelihood that Iraqis will crowd to see him.
No one wants to tell Francis to call it off, and the Iraqi government has every interest in showing off its relative stability by welcoming the first pope to the birthplace of Abraham. The March 5-8 trip is expected to provide a sorely-needed spiritual boost to Iraq’s beleaguered Christians.
But from a purely epidemiological standpoint, a papal trip to Iraq amid a global pandemic is not advisable, health experts say.
“I just don’t think it’s a good idea,” said Dr. Navid Madani of Harvard Medical School’s Dana-Farber Cancer Institute. “This could potentially lead to unsafe or superspreading risks.”
Their concerns were reinforced with the news Sunday that the Vatican ambassador to Iraq, the main point person for the trip, tested positive for COVID-19 and was self-isolating. The embassy said Archbishop Mitja Leskovar’s symptoms were mild and that he was continuing to prepare for Francis’ visit.
Beyond his case, experts note that wars, economic crises and an exodus of Iraqi professionals have devastated the country’s hospital system, while studies show most of Iraq’s new COVID-19 infections are the highly-contagious variant first identified in Britain.
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ANKARA, Turkey — Traveling across roads covered with ice and snow, vaccination teams have been going to Turkey’s isolated mountain villages as the government seeks to inoculate 60% of the country’s people against coronavirus over the next three months.
After much effort, medical workers arrived Friday to vaccinate older villagers in Gumuslu, a small settlement of 350 in the central province of Sivas that lies 140 miles (230 kilometers) from the provincial capital.
“It’s a difficult challenge to come here,” said Dr Rustem Hasbek, head of Sivas Health Services. “The geography is tough, the climate is tough, as you can see.”
Turkey rolled out the Chinese Sinovac vaccine on Jan. 14 and has so far given out 8.2 million doses. Ankara has also ordered 4.5 million doses of the Pfizer-BioNTech vaccine.
Health Minister Fahrettin Koca said Turkey aims to vaccinate 52.5 million people by the end of May.
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HELSINKI — Police in Denmark said eight people were arrested following in an anti-lockdown demonstration with 1,200 participants in the center of Copenhagen, the Danish capital.
The demonstration proceeded largely peacefully Saturday but those detained are suspected of behaving violently against police or violating fireworks regulations, police said. Participants gathered in a square in front of Copenhagen’s town hall.
The rally was organised by a group identifying as “Men in Black Denmark.” It was the first demonstration in Copenhagen since the Danish government last week that it was extending several anti-coronavirus restrictions.
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BANGKOK — Thailand started its first vaccinations Sunday with 200 public health officials receiving the Sinovac vaccine from China.
Health Minister and Deputy Prime Minister Anutin Charnvirakul was given the first shot at a hospital near Bangkok, followed by the deputy health minister and other senior officials.
Prime Minister Prayuth Chan-ocha, who attended the vaccination ceremony, said the public should have confidence in the safety and effectiveness of the vaccine, as it has been approved by authorities in Thailand and other countries.
Prayuth did not receive the vaccine on Sunday because he is older than Sinovac’s recommended age, which is 18-59. Prayuth is 66.
Thailand received the first 200,000 doses of the Sinovac vaccine on Wednesday. They are part of the government’s plan that has so far secured 2 million doses from Sinovac and 61 million doses from AstraZeneca.
Thailand has had more than 25,000 confirmed cases and 83 deaths from COVID-19.
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WASHINGTON — The U.S. now has a third vaccine to prevent COVID-19.
The Food and Drug Administration on Saturday cleared a Johnson & Johnson shot that works with just one dose instead of two.
Health experts have anxiously awaited a one-and-done option to help speed vaccinations. The virus has already killed more than 510,000 people in the U.S. and is mutating in increasingly worrisome ways.
The FDA said J&J’s vaccine offers strong protection against what matters most: serious illness, hospitalizations and death. One dose was 85% protective against the most severe COVID-19 illness, in a massive study that spanned three continents.