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U.S. approves Johnson & Johnson's single-dose COVID-19 vaccine – CBC.ca

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The U.S. is getting a third vaccine to prevent COVID-19, as the Food and Drug Administration (FDA) 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 per cent 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 (NIH), 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.”

Shipments of a few million doses to be divided among 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.

A person is administered the Johnson & Johnson vaccine at a hospital in Cape Town, South Africa, on Feb. 17. (Nardus Engelbrecht/The Associated Press)

J&J also is seeking authorization for emergency use of its vaccine in Europe and from the World Health Organization. Worldwide, 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.

Health Canada is still reviewing the vaccine. Canada has ordered 10 million doses from Johnson & Johnson with options for up to 28 million more, if necessary. Most of those shots are expected to arrive by the end of September.

‘We’re champing at the bit to get more supply’

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 of vaccine 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.

WATCH | Will Canadians be able to choose which vaccine they get?:

Doctors answer questions about the latest COVID-19 vaccine news including whether Canadians will be able to choose which one they get. 5:48

In the U.S., the two-dose Pfizer and Moderna shots were 95 per cent protective against symptomatic COVID-19. J&J’s one-dose effectiveness of 85 per cent against severe COVID-19 dropped to 66 per cent 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.

Collins said the evidence of effectiveness shows no reason to favour 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.

WATCH | Canada’s procurement minister on Johnson & Johnson vaccine:

The CBC’s Tom Parry asks Procurement Minister Anita Anand how many doses of Johnson & Johnson’s COVID-19 vaccine Canada will receive after it’s approved by Health Canada. 4:56

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 champing 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.

The FDA said 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.

The vaccine has been authorized for emergency use in adults 18 and older for now. But like other vaccine makers, J&J is about to begin a study of its vaccine 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 spike protein that coats it. But they’re made in very different ways.

WATCH | Provinces offer different timelines for COVID-19 vaccine rollout:

When Canadians will be able to get a COVID-19 vaccine may depend on where they live. The provinces have started revealing their rollout plans, but the timing of who can get a shot varies across the country. 1:58

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 — which was approved for use in Canada on Friday and is already in use in 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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Coronavirus: What's happening in Canada and around the world on Monday – CBC.ca

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The latest:

Hospitals across much of Ontario will start ramping down elective surgeries and non-urgent procedures Monday to ensure they have the capacity to treat more COVID-19 patients. Health Minister Christine Elliott said Friday that could increase intensive-care unit capacity in Ontario by up to 1,000 patient beds.

The province reported on Sunday that there were 1,513 people in hospital with COVID-19, including 605 people in intensive care “due to COVID-related illness.”

Ontario also said that there were 4,456 new COVID-19 cases in the province on Sunday, marking a new single-day high for new infections.

Hospitals in northern Ontario are exempt from cancelling non-urgent procedures, but a memo from Ontario Health on Thursday night said they should prepare to ramp down quickly in the near future.

The memo also asked hospitals to identify staff who may be redeployed to other sites if necessary.

Meanwhile, more than 700 pharmacies are joining Ontario’s COVID-19 vaccine rollout as the province races to slow the spread of the virus. Government officials say the move will rapidly expand availability of the AstraZeneca vaccine to people aged 55 and over this week.

-From The Canadian Press, last updated at 7 a.m. ET


What’s happening elsewhere in Canada

WATCH | Many educators still waiting for access to COVID-19 vaccine:

Educators are eligible for COVID-19 vaccines in several provinces, but many are still waiting for access to the shots. 2:01

As of early Monday morning, Canada had reported 1,060,163 confirmed cases of COVID-19, with 73,446 considered active. A CBC News tally of deaths stood at 23,315.

Across Atlantic Canada, health officials reported 15 new cases of COVID-19 on Sunday, including:

  • 9 new cases in the Edmundston area of New Brunswick, which entered a lockdown on Sunday.
  • 5 new cases in Nova Scotia, which brought the number of active cases in the province to 40.
  • 1 new case in Newfoundland and Labrador, putting the number of active cases in the province at 10.

Prince Edward Island, which did not report any new cases on Sunday, is as of Monday allowing people aged 55 and up to get the AstraZeneca-Oxford vaccine at 12 pharmacies on the island.

In Central Canada, Quebec health officials on Sunday reported 1,535 new cases and five new deaths. Hospitalizations in the province, as reported on a provincial dashboard, stood at 608, with 139 people in intensive care.  The province, which has moved up its curfew in Montreal and Laval, on Sunday night saw hundreds of protesters gather in Old Montreal.

In the Prairie provinces, Manitoba reported 112 new cases of COVID-19 on Sunday, while neighbouring Saskatchewan reported 321 new cases of COVID-19 and one additional death.

Health officials in Alberta, meanwhile, reported 1,183 new cases of COVID-19 and one additional death. The province’s chief medical health officer said 50.5 per cent of the active cases in the province are variants of concern.

In British Columbia, health officials have decided that all adults who live or work in Whistler are eligible as of Monday for a COVID-19 vaccine as the region struggles with increasing cases.

Across the North, there were no new cases of COVID-19 reported on Sunday in Nunavut, the Northwest Territories or Yukon.

-From CBC News and The Canadian Press, last updated at 7:05 a.m. ET


What’s happening around the world

Women take a selfie with their drinks on Monday at The Fox on the Hill pub after its reopening as coronavirus restrictions ease in London. (Hannah McKay/Reuters)

As of early Monday morning, more than 136.1 million cases of COVID-19 had been reported worldwide, according to a tracking site run by Johns Hopkins University in the United States. The reported global death toll stood at more than 2.9 million.

In Europe, British Prime Minister Boris Johnson has urged people to “behave responsibly” as shops, gyms, hairdressers, restaurant patios and beer gardens reopen after months of lockdown. Monday sees the easing of restrictions that have been in place in England since early January to suppress a surge in coronavirus infections linked to a more transmissible new variant of the virus.

Scotland, Wales and Northern Ireland are following their own, broadly similar plans to ease lockdown. Britain has had Europe’s worst coronavirus outbreak, with more than 127,000 confirmed deaths.

Meanwhile, in France, more than 10 million people have received a first shot of a COVID-19 vaccine, Prime Minister Jean Castex said.

In the Asia-Pacific region, the hard-hit Philippine capital and four nearby provinces have been placed under a lighter coronavirus lockdown to avoid further damage to an already battered economy despite a continuing surge in infections and deaths. The Philippines has long been a Southeast Asian coronavirus hot spot, with about 865,000 confirmed infections and nearly 15,000 deaths.

“Our emerging strategy is to increase our bed capacities instead of closing the economy,” said presidential spokesperson Harry Roque  who spoke in a televised news briefing from a Manila hospital after contracting COVID-19 like many cabinet members.

Hundreds of thousands of Hindu devotees flocked to take a holy bath in India’s Ganges river, even as the nation racked up the world’s highest tally of new daily coronavirus infections.

Thai workers prepare a field hospital for COVID-19 patients in Bangkok on Monday. Thailand’s Health Ministry warned Sunday that restrictions may need to be tightened to slow the spread of a fresh coronavirus wave as the country hit a daily record for new cases. (Somchai Chanjirakitti/The Associated Press)

In the Middle East, Iran imposed a 10-day lockdown across most of the country on Saturday.

In the Americas, the United States had administered 187,047,131 doses of COVID-19 vaccines and distributed 237,796,105 doses as of Sunday, the U.S. Centers for Disease Control and Prevention said.

Venezuela has secured the funds to fully pay for coronavirus vaccines via the COVAX system, President Nicolas Maduro said on Sunday, a day after a surprise announcement that the country had paid more than half the amount due.

In Africa, Tunisia approved Johnson & Johnson’s vaccine and will soon receive 1.5 million doses of the vaccine under an African Union plan.

-From The Associated Press and Reuters, last updated at 7:10 a.m. ET


Have questions about this story? We’re answering as many as we can in the comments.


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Myanmar military sentences 19 to death, says anti-coup protests dwindling

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(Reuters) – Nineteen people have been sentenced to death in Myanmar for killing an associate of an army captain, the military owned Myawaddy TV station said on Friday, the first such sentences announced in public since a Feb. 1 coup and crackdown on protesters.

The report said the killing took place on March 27 in the North Okkalapa district of Yangon, Myanmar’s biggest city. Martial law has been declared in the district, allowing courts martial to pronounce sentences.

The military rulers who overthrew an elected government said on Friday that a protest campaign against its rule was dwindling because people wanted peace, and that it would hold elections within two years, the first timeframe it has given for a return to democracy.

Troops fired rifle grenades at anti-coup protesters on Friday in the town of Bago, near Yangon, witnesses and news reports said. At least 10 people were killed and their bodies piled up inside a pagoda, they said.

Myanmar Now news and Mawkun, an online news magazine, said at least 20 people were killed and many wounded. It was not possible to get a precise toll because troops had cordoned off the area near the pagoda, they said.

Junta spokesman Brigadier General Zaw Min Tun told a news conference in the capital, Naypyitaw, that the country was returning to normal and government ministries and banks would resume full operations soon.

More than 600 people have been killed by security forces cracking down on protests against the coup, according to an activist group. The country has ground to a standstill because of the protests and widespread strikes against military rule.

“The reason of reducing protests is due to cooperation of people who want peace, which we value,” Zaw Min Tun said. “We request people to cooperate with security forces and help them.”

He said the military had recorded 248 deaths and he denied that automatic weapons had been used. Sixteen policemen had also been killed, he said.

The Assistance Association for Political Prisoners (AAPP) activist group has said 614 people, including 48 children, had been killed by security forces since the coup, as of Thursday evening. More than 2,800 were in detention, it said.

“We are humbled by their courage and dignity,” a group of 18 ambassadors in Myanmar said of the protesters in a joint statement.

“We stand together to support the hopes and aspirations of all those who believe in a free, just, peaceful and democratic Myanmar. Violence has to stop, all political detainees must be released and democracy must be restored.”

The statement was signed by the ambassadors of the United States, Britain, the EU, Canada, Australia, New Zealand, South Korea, Switzerland and several other European nations.

“The suggestions from neighbouring countries and big countries and powerful people in politics, we respect them,” Zaw Min Tun said. He also accused members of deposed leader Aung San Suu Kyi’s National League for Democracy of arson and said the protest campaign was being financed by foreign money, but gave no details.

Suu Kyi and many of her party colleagues have been in custody since the coup.

Zaw Min Tun said reports that some members of the international community did not recognise the military government were “fake news”.

“We are cooperating with foreign countries and working together with neighbouring countries,” the spokesman said.

Ousted Myanmar lawmakers urged the United Nations Security Council on Friday to take action against the military.

“Our people are ready to pay any cost to get back their rights and freedom,” said Zin Mar Aung, who has been appointed acting foreign minister for a group of ousted lawmakers. She urged Council members to apply both direct and indirect pressure on the junta.

“Myanmar stands at the brink of state failure, of state collapse,” Richard Horsey, a senior adviser on Myanmar with the International Crisis Group, told the informal U.N. meeting, the first public discussion of Myanmar by council members.

The U.N. special envoy for Myanmar, Christine Schraner Burgener, had wanted to visit the country but said she has been rebuffed by the generals.

She said on Friday she had arrived in Bangkok, the capital of neighbouring Thailand.

“I regret that Tatmadaw answered me yesterday that they are not ready to receive me,” Schraner Burgener said on Twitter, referring to the Myanmar military. “I am ready for dialogue. Violence never leads to peaceful sustainable solutions.”

 

(Reporting by Reuters Staff; Writing by Raju Gopalakrishnan and Grant McCool; Editing by Nick Macfie and Daniel Wallis)

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Australia abandons COVID-19 vaccination targets after new advice on AstraZeneca shots

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By Paulina Duran

SYDNEY (Reuters) – Australia has abandoned a goal to vaccinate nearly all of its 26 million population by the end of 2021 following advice that people under the age of 50 take Pfizer’s COVID-19 vaccine rather than AstraZeneca’s shot.

Australia, which had banked on the AstraZeneca vaccine for the majority of its shots, had no plans to set any new targets for completing its vaccination programme, Prime Minister Scott Morrison said in a Facebook post on Sunday afternoon.

“While we would like to see these doses completed before the end of the year, it is not possible to set such targets given the many uncertainties involved,” Morrison said.

Authorities in Canberra changed their recommendation on Pfizer shots for under-50s on Thursday, after European regulators reiterated the possibility of links between the AstraZeneca shot and reports of rare cases of blood clots.

Australia, which raced to double its order of the Pfizer vaccine last week, had originally planned to have its entire population vaccinated by the end of October.

Australia’s hardline response to the virus largely stopped community transmissions but the vaccination rollout has become a hot political topic – and a source of friction between Morrison and state and territory leaders – after the country vaccinated only a fraction of its four million target by the end of March.

About 1.16 million COVID-19 doses have now been administered, Morrison added, noting the speed of Australia’s vaccination programme was in line with other peer nations, including Germany and France, and ahead of Canada and Japan.

Australia began vaccinations much later than some other nations, partly because of its low number of infections, which stand at just under 29,400, with 909 deaths, since the pandemic began.

(GRAPHIC – Global COVID tracker: https://graphics.reuters.com/world-coronavirus-tracker-and-maps/)

 

(Reporting by Paulina Duran; Editing by Lincoln Feast.)

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