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Johnson & Johnson's single-dose COVID-19 vaccine on track for March rollout: exec – CTV News

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Johnson & Johnson is on track to roll out its single-shot coronavirus vaccine in March, and plans to have clear data on how effective it is by the end of this month or early February, the U.S. healthcare company’s chief science officer said.

Dr. Paul Stoffels in an interview on Tuesday also said J&J expects to meet its stated target of delivering 1 billion doses of its vaccine by the end of this year as the company ramps up production.

The New York Times reported earlier on Wednesday that J&J was experiencing manufacturing delays that would reduce the number of doses initially available. Stoffels declined to say how many doses would be ready to go into people’s arms in March, presuming it receives emergency authorization from the U.S. Food and Drug Administration.

“We are aiming for 1 billion doses in 2021. If it is a single dose, that means 1 billion people. But it will be in a ramp-up throughout the year,” Stoffels said.

Initial launch capacity depends in part on validation of manufacturing plants, he added. The company is scaling up efforts to both produce the active vaccine and the means to package and ship it in large quantities.

Johnson & Johnson’s vaccine is being produced in the United States, Europe, South Africa and India with the help of contract manufacturers in order to build capacity.

“It’s a few weeks too early to be giving final numbers on what we can launch in the first couple months,” he said.

Although J&J’s clinical trial protocols allowed for an early look at the data after 20 people became infected by the novel coronavirus, the company intends to deliver data on at least 154 confirmed cases – the target needed to fully assess the vaccine’s efficacy – when it releases results. That should come in the last week of January or the first week of February, Stoffels said.

The U.S. Food and Drug Administration requires at least two months of safety data on half of the study participants to ensure no unexpected side effects crop up, as well as data on specific populations such as the elderly. The company crossed that two-month threshold earlier this month.

“That point came so close to the final analysis that we decided not to do an interim analysis,” Stoffels said.

A surge in COVID-19 cases in the fall that exceeded J&J’s initial projections allowed the company to reduce the number of study volunteers to 40,000 from the initially planned 60,000 participants. Data can be collected faster when community transmission is widespread during testing.

J&J plans to seek emergency use authorization from the FDA based on the study of the vaccine as a single shot, Stoffels said. If results of ongoing studies suggest people would fare better with a second booster shot, Stoffels said J&J would file separately for a booster dose authorization.

The company is closely monitoring changes or mutations in the virus that might affect the vaccine’s effectiveness.

Scientists are particularly concerned about a highly transmissible variant of the virus first discovered in South Africa that could affect how well vaccines protect against it.

Because part of J&J’s clinical trial is being conducted in South Africa, Stoffels said the company should have data on how its vaccine fares against this new variant.

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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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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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Nova Scotia Health advises of potential COVID-19 exposure at 7 locations, flight – HalifaxToday.ca

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NEWS RELEASE
NOVA SCOTIA HEALTH PUBLIC HEALTH
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Nova Scotia Health Public Health is advising of potential exposure to COVID-19 at 7 locations in the Central Zone as well as an Air Canada flight. In addition to media releases, all potential exposure notifications are listed here: http://www.nshealth.ca/covid-exposures.

Anyone who worked at or visited the following locations on the specified dates and times should immediately visit covid-self-assessment.novascotia.ca/ to book a COVID-19 test, regardless of whether or not they have COVID-19 symptoms. You can also call 811 if you don’t have online access or if you have other symptoms that concern you.

For the following locations, if you have symptoms of COVID-19 you are required to self-isolate while you wait for your test result. If you do not have any symptoms of COVID-19 you do not need to self-isolate while you wait for your test result.

  • Head Shoppe Mic Mac Mall (21 Micmac Blvd, Dartmouth) on Feb. 17 between 9:15 a.m. and 11:00 a.m. It is anticipated that anyone exposed to the virus at this location on the named date may develop symptoms up to, and including, March 3.
  • Lawton’s Drugs Westphal (90 Main St. Dartmouth) on Feb. 18 between 2:30 p.m. and 4:30 p.m. It is anticipated that anyone exposed to the virus at this location on the named date may develop symptoms up to, and including, March 4.
  • NSHA Blood Collection Clinic (5110 St. Margaret’s Bay Rd, Tantallon) on Feb. 18 between 12:00 p.m. and 8:00 p.m.; and Feb. 22 between 7:00 a.m. to 9:00 a.m. It is anticipated that anyone exposed to the virus at this location on the named date may develop symptoms up to, and including, March 8. (Testing recommended for anyone that visited the clinic on the above dates and times who have not already been contacted by Public Health).
  • Winners Mic Mac Mall (21 Micmac Blvd, Dartmouth) on Feb. 19 between 12:30 p.m. and 2:30 p.m. It is anticipated that anyone exposed to the virus at this location on the named date may develop symptoms up to, and including, March 5.
  • Chapters Mic Mac Mall (21 Micmac Blvd, Dartmouth) on Feb. 19 between 12:00 p.m. and 1:15 p.m. It is anticipated that anyone exposed to the virus at this location on the named date may develop symptoms up to, and including, March 5.
  • Walmart Bedford Commons (141 Damascus Road, Bedford) on Feb. 23 between 11:15 a.m. and 12:45 p.m. It is anticipated that anyone exposed to the virus at this location on the named date may develop symptoms up to, and including, March 9.
  • Dollarama Dartmouth Crossing (100 Gale Terrace, Dartmouth) on Feb. 24 between 9:30 a.m. and 10:45 a.m. It is anticipated that anyone exposed to the virus at this location on the named date may develop symptoms up to, and including, March 10.

Anyone who was on the following flight in the specified rows and seats should visit https://covid-self-assessment.novascotia.ca/en to book a COVID-19 test, regardless of whether or not they have COVID-19 symptoms. You can also call 811 if you don’t have online access or if you have other symptoms that concern you.

  • Air Canada flight 614 departing from Toronto on Feb. 24 (2:18 p.m.) and arriving in Halifax (5:05 p.m.). Passengers in rows 12-18, seats A, B, C and D are asked to immediately visit https://covid-self-assessment.novascotia.ca/en to book a COVID-19 test, regardless of whether or not they have COVID-19 symptoms. All other passengers on this flight should continue to self-isolate as required and monitor for signs and symptoms of COVID-19. It is anticipated that anyone exposed to the virus on this flight on the named date may develop symptoms up to, and including, March 10.

Please remember:

Do not go directly to a COVID-19 assessment centre without being directed to do so. Please book an appointment online and do not go to a pop-up rapid testing location.

Currently, anyone who traveled outside Nova Scotia or PEI is expected to self-isolate alone for 14 days after arriving. If a person returning from non-essential travel outside Nova Scotia or PEI is unable to isolate alone, then everyone in the home where they are self-isolating will have to self-isolate as well.

When Nova Scotia Health Public Health makes a public notification it is not in any way a reflection on the behaviour or activities of those named in the notification.

All Nova Scotians are advised to continue monitoring for COVID-19 symptoms and are urged to follow Public Health guidelines on how to access care. Up to date information about COVID-19 is available at novascotia.ca/coronavirus

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