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Johnson and Johnson vaccine: tell me this is not true.
- Thread starter tobelightlight
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by the way,
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Johnson & Johnson's one-dose COVID-19 vaccine won't be coming to Australia
Posted 59m
Vials of vaccines sit on top of a medical form
Because patients only require one dose of the Johnson & Johnson shot, full vaccination of a population can be achieved relatively quickly. ( Johnson&Johnson/AP: Cheryl Gerber )
Share
Johnson & Johnson's one-dose vaccine will not be part of Australia's vaccine rollout, at least for now, after the federal government confirmed it would not purchased any doses from the company.
Key points:
The federal government had been in talks with Johnson & Johnson about potentially acquiring its vaccine
The vaccine is similar to the AstraZeneca vaccine
Australia has deals in place with Pfizer, AstraZeneca and Novavax
The vaccine is being widely used in the United States and has the advantage of only requiring one dose, unlike the Pfizer, AstraZeneca and Moderna alternatives which all require two doses.
The federal government had been in talks with the global pharmaceutical giant about potentially acquiring its vaccine, and the company had previously submitted an application to the Therapeutic Goods Administration for provisional registration.
The Johnson & Johnson vaccine is based on similar technology to the AstraZeneca vaccine.
A spokesperson for Health Minister Greg Hunt said those similarities were the reason the federal government had decided against pursuing the option any further.
Pharmacists prepares to give a vaccine.
Australia has deals in place with Pfizer, AstraZeneca and Novavax.( Johnson & Johnson Via AP )
"The [Johnson & Johnson] vaccine is an adenovirus vaccine, the same type of vaccine as the AstraZeneca vaccine," they said in a statement.
The news comes despite the fact the federal government has been considering how to increase Australia's vaccine orders in response to changing advice around the AstraZeneca vaccine.
Under new advice, Pfizer's coronavirus vaccine is the preferred option for Australians under 50 due to concerns over an extremely small number of cases of a rare blood clotting condition recorded in recipients of the AstraZeneca vaccine.
Late last week it was confirmed an order for a further 20 million doses of the Pfizer vaccine had been lodged.
Australia has deals in place with Pfizer, AstraZeneca and Novavax, but the Novavax vaccine is yet to be approved.
Millions vaccinated abroad with a single dose
As of April 11, nearly 6.5 million doses of the Johnson & Johnson vaccine had been administered in the United States, according to the US Centers for Disease Control and Prevention.
Because patients only require one dose, full vaccination of a population can be achieved relatively quickly.
The vaccine is approved for use in the European Union, and shipments to Europe reportedly began this week.
At a press conference with the Prime Minister last Friday, Health Department Secretary Brendan Murphy confirmed the government was "still exploring with Johnson & Johnson".
But he also noted that it was a similar type of vaccine to that produced by AstraZeneca.
Last week the European Medicines Agency said it was looking into four blood-clotting cases in the US associated with the Johnson & Johnson vaccine.
However, Johnson &Johnson said "no clear causal relationship has been established" between the cases and the vaccine.
Posted 59m
Vials of vaccines sit on top of a medical form
Because patients only require one dose of the Johnson & Johnson shot, full vaccination of a population can be achieved relatively quickly. ( Johnson&Johnson/AP: Cheryl Gerber )
Share
Johnson & Johnson's one-dose vaccine will not be part of Australia's vaccine rollout, at least for now, after the federal government confirmed it would not purchased any doses from the company.
Key points:
The federal government had been in talks with Johnson & Johnson about potentially acquiring its vaccine
The vaccine is similar to the AstraZeneca vaccine
Australia has deals in place with Pfizer, AstraZeneca and Novavax
The vaccine is being widely used in the United States and has the advantage of only requiring one dose, unlike the Pfizer, AstraZeneca and Moderna alternatives which all require two doses.
The federal government had been in talks with the global pharmaceutical giant about potentially acquiring its vaccine, and the company had previously submitted an application to the Therapeutic Goods Administration for provisional registration.
The Johnson & Johnson vaccine is based on similar technology to the AstraZeneca vaccine.
A spokesperson for Health Minister Greg Hunt said those similarities were the reason the federal government had decided against pursuing the option any further.
Pharmacists prepares to give a vaccine.
Australia has deals in place with Pfizer, AstraZeneca and Novavax.( Johnson & Johnson Via AP )
"The [Johnson & Johnson] vaccine is an adenovirus vaccine, the same type of vaccine as the AstraZeneca vaccine," they said in a statement.
The news comes despite the fact the federal government has been considering how to increase Australia's vaccine orders in response to changing advice around the AstraZeneca vaccine.
Under new advice, Pfizer's coronavirus vaccine is the preferred option for Australians under 50 due to concerns over an extremely small number of cases of a rare blood clotting condition recorded in recipients of the AstraZeneca vaccine.
Late last week it was confirmed an order for a further 20 million doses of the Pfizer vaccine had been lodged.
Australia has deals in place with Pfizer, AstraZeneca and Novavax, but the Novavax vaccine is yet to be approved.
Millions vaccinated abroad with a single dose
As of April 11, nearly 6.5 million doses of the Johnson & Johnson vaccine had been administered in the United States, according to the US Centers for Disease Control and Prevention.
Because patients only require one dose, full vaccination of a population can be achieved relatively quickly.
The vaccine is approved for use in the European Union, and shipments to Europe reportedly began this week.
At a press conference with the Prime Minister last Friday, Health Department Secretary Brendan Murphy confirmed the government was "still exploring with Johnson & Johnson".
But he also noted that it was a similar type of vaccine to that produced by AstraZeneca.
Last week the European Medicines Agency said it was looking into four blood-clotting cases in the US associated with the Johnson & Johnson vaccine.
However, Johnson &Johnson said "no clear causal relationship has been established" between the cases and the vaccine.
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- Jun 27, 2018
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What is an adenovirus vaccine? The reason Australia isn't asking for the Johnson & Johnson jab
Posted 4h
ago
Why isn't Australia ordering the Johnson & Johnson vaccine?
Despite significant delays in the government's vaccination timetable, Australia has no plans to buy the single-dose Johnson & Johnson vaccine that has helped the US fully vaccinate millions of people.
But despite those delays, the government is pointing to a key similarity between the vaccines as a reason not to purchase Johnson & Johnson's product — they're both built with adenoviruses.
That means they use a modified and harmless virus — in this case an adenovirus — as a delivery system for genetic instructions.
Those genetic instructions teach your body to produce spike proteins like those that adorn the outer shell of SARS-CoV-2, the virus that causes COVID-19.
A health worker loads syringes with the vaccine on the first day of the Johnson & Johnson vaccine being made available.
Millions of people have been vaccinated with the Johnson & Johnson vaccine in the US.
When your body begins producing the harmless spike protein, your immune system reacts and learns how to fight the real thing.
Both AstraZeneca and Johnson & Johnson use adenoviruses in their vaccines, which have some key benefits over other types of COVID vaccines.
They are easier to manufacture than mRNA-based formulas like the Pfizer and Moderna vaccines.
They can also be kept at regular refrigerated temperatures, as opposed to the freezing temperatures needed to preserve mRNA vaccines for long periods.
Why isn't Australia purchasing Johnson & Johnson?
Currently, AstraZeneca (an adenovirus vaccine) and Pfizer (an mRNA vaccine) are approved for use in Australia.
The AstraZeneca vaccine is also produced locally, at CSL's plant in Melbourne.
CSL is able to produce the AstraZeneca vaccine locally.(Supplied: CSL)
Health Minister Greg Hunt said the government's vaccine advisory body had not provided advice that the Johnson & Johnson vaccine should be purchased.
The Theraputic Goods Administration (TGA) confirmed it has recieved an application from Johnson & Johnson for the "provisional registration" of its vaccine in Australia.
The TGA said the application is being assessed, adding that it "will approve any therapeutic or vaccine for use when the benefits outweigh the risks".
The vaccine could be accessed with a prescription if approved and if Johnson & Johnson decide to make the vaccine available privatley, the TGA said in a statement.
Does this have anything to do with blood clots?
Archie Clements, a professor of infectious disease epidemiology at Curtin University, said the government may have been stung by recent links between the AstraZeneca vaccine and a very rare blood clotting disorder.
The rollout of that vaccine was knocked off course last week after its association with the condition became clearer.
"The government is probably feeling a certain amount of political discomfort around the promotion of AstraZeneca earlier on and the reliance on AstraZeneca," Professor Clements said.
Last week, Chief Medical Officer Paul Kelly said the rare clotting condition was "most likely" brought on by an immune response to the adenovirus in the AstraZeneca vaccine.
But he could not be definitive.
Europe's drug regulator is reviewing rare blood clots in four people who received the Johnson & Johnson vaccine, but the company says at this stage there is no causal link.
Australia was initially meant to rely on the AstraZeneca jab for most vaccinations.(AAP Image: James Ross)
Dr Khai Lin Huang, an infectious diseases physician at the Burnet Institute, said it was too early to tell whether those instances had anything to do with the Johnson & Johnson vaccine.
"They are adenovirus-based. But whether or not that is the pure reason [behind the clots] … We don't know, it's too early. It’s too early to be drawing conclusions," he said.
"I'm not too concerned and can understand the rationale behind the decision. It doesn't seem unreasonable, with what information is available to us currently."
The AstraZeneca-linked condition is exceptionally rare, affecting between four and six people per million vaccinated.
Out of the millions of people vaccinated with the Johnson & Johnson vaccine, just four are being investigated as potential blood clotting cases.
This morning, a second case of the clotting disorder was reported in Australia, out of 700,000 doses of the AstraZeneca vaccine administered.
Posted 4h
ago
Why isn't Australia ordering the Johnson & Johnson vaccine?
Despite significant delays in the government's vaccination timetable, Australia has no plans to buy the single-dose Johnson & Johnson vaccine that has helped the US fully vaccinate millions of people.
But despite those delays, the government is pointing to a key similarity between the vaccines as a reason not to purchase Johnson & Johnson's product — they're both built with adenoviruses.
That means they use a modified and harmless virus — in this case an adenovirus — as a delivery system for genetic instructions.
Those genetic instructions teach your body to produce spike proteins like those that adorn the outer shell of SARS-CoV-2, the virus that causes COVID-19.
A health worker loads syringes with the vaccine on the first day of the Johnson & Johnson vaccine being made available.
Millions of people have been vaccinated with the Johnson & Johnson vaccine in the US.
When your body begins producing the harmless spike protein, your immune system reacts and learns how to fight the real thing.
Both AstraZeneca and Johnson & Johnson use adenoviruses in their vaccines, which have some key benefits over other types of COVID vaccines.
They are easier to manufacture than mRNA-based formulas like the Pfizer and Moderna vaccines.
They can also be kept at regular refrigerated temperatures, as opposed to the freezing temperatures needed to preserve mRNA vaccines for long periods.
Why isn't Australia purchasing Johnson & Johnson?
Currently, AstraZeneca (an adenovirus vaccine) and Pfizer (an mRNA vaccine) are approved for use in Australia.
The AstraZeneca vaccine is also produced locally, at CSL's plant in Melbourne.
CSL is able to produce the AstraZeneca vaccine locally.(Supplied: CSL)
Health Minister Greg Hunt said the government's vaccine advisory body had not provided advice that the Johnson & Johnson vaccine should be purchased.
The Theraputic Goods Administration (TGA) confirmed it has recieved an application from Johnson & Johnson for the "provisional registration" of its vaccine in Australia.
The TGA said the application is being assessed, adding that it "will approve any therapeutic or vaccine for use when the benefits outweigh the risks".
The vaccine could be accessed with a prescription if approved and if Johnson & Johnson decide to make the vaccine available privatley, the TGA said in a statement.
Does this have anything to do with blood clots?
Archie Clements, a professor of infectious disease epidemiology at Curtin University, said the government may have been stung by recent links between the AstraZeneca vaccine and a very rare blood clotting disorder.
The rollout of that vaccine was knocked off course last week after its association with the condition became clearer.
"The government is probably feeling a certain amount of political discomfort around the promotion of AstraZeneca earlier on and the reliance on AstraZeneca," Professor Clements said.
Last week, Chief Medical Officer Paul Kelly said the rare clotting condition was "most likely" brought on by an immune response to the adenovirus in the AstraZeneca vaccine.
But he could not be definitive.
Europe's drug regulator is reviewing rare blood clots in four people who received the Johnson & Johnson vaccine, but the company says at this stage there is no causal link.
Australia was initially meant to rely on the AstraZeneca jab for most vaccinations.(AAP Image: James Ross)
Dr Khai Lin Huang, an infectious diseases physician at the Burnet Institute, said it was too early to tell whether those instances had anything to do with the Johnson & Johnson vaccine.
"They are adenovirus-based. But whether or not that is the pure reason [behind the clots] … We don't know, it's too early. It’s too early to be drawing conclusions," he said.
"I'm not too concerned and can understand the rationale behind the decision. It doesn't seem unreasonable, with what information is available to us currently."
The AstraZeneca-linked condition is exceptionally rare, affecting between four and six people per million vaccinated.
Out of the millions of people vaccinated with the Johnson & Johnson vaccine, just four are being investigated as potential blood clotting cases.
This morning, a second case of the clotting disorder was reported in Australia, out of 700,000 doses of the AstraZeneca vaccine administered.
- Joined
- Jun 27, 2018
- Messages
- 29,431
- Points
- 113
US regulators recommend pausing use of Johnson & Johnson COVID-19 vaccine over blood clot fears
FILE PHOTO: Vials and medical syringe are seen in front of J&J logo in this illustration
FILE PHOTO: Vials with a sticker reading "COVID-19/Coronavirus vaccine/Injection only" and a medical syringe are seen in front of a displayed Johnson & Johnson logo in this illustration taken on Oct 31, 2020. (Reuters/Dado Ruvic)
13 Apr 2021 08:15PM
(Updated: 13 Apr 2021 10:55PM)
Bookmark
WASHINGTON: US federal health agencies on Tuesday (Apr 13) recommended pausing the use of Johnson & Johnson's COVID-19 vaccine after six women under 50 given the shot developed rare blood clots, dealing a fresh setback to efforts to tackle the pandemic.
Following the news, Johnson & Johnson (J&J) said it was delaying the roll-out of the vaccine to Europe, a week after regulators there said they were reviewing rare blood clots in four recipients of the shot in the United States.
The moves come after European regulators said earlier this month they had found a possible link between AstraZeneca's COVID-19 vaccine and a similar rare blood clotting problem that led to a small number of deaths.
J&J's single dose vaccine - most COVID-19 shots are delivered over two doses - and AstraZeneca's low-cost vaccine are seen as vital tools in the fight against a pandemic that has claimed more than 3 million lives.
The White House said the pause would not have a "significant" impact on its plan to administer about 3 million shots per day and a total of 200 million shots before President Joe Biden's 100th day in office.
The US Food and Drug Administration (FDA) said one person had died from the rare blood clotting condition after taking the J&J vaccine and another was in a critical condition.
Immunology experts stressed the risk posed by the J&J vaccine appeared extremely low, and that the shot remained a valuable tool against the risks of COVID-19. However, they acknowledged the need for health officials to proceed with caution to understand the best ways to mitigate any risk.
"Even if causally linked to the vaccine: 6 cases with about 7 million doses (lower than the risk of clots with oral contraceptives) is not something to panic about," Dr Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security in Baltimore, said in an email.
"People are asking me if they should cancel their J&J vaccine appointments and I have told them not to but I know many will and this will stall progress in controlling the pandemic."
FDA acting commissioner Janet Woodcock said it expected the pause to be a matter of days, and it was aimed at providing information to healthcare providers so that they can diagnose, treat and report such blood clots.
FDA official Peter Marks said that part of the reason for the pause was to warn doctors that administering the standard treatments for clots can cause tremendous harm, or be fatal.
'LESS THAN ONE IN A MILLION'
Most of the available J&J vaccine has been used in the United States due to production issues that have limited the company's supply. As of Apr 12, more than 6.8 million doses of the J&J vaccine had been administered in the United States, compared with more than 180 million shots combined of the Moderna and Pfizer-BioNTech shots.
US health officials said during a press briefing there had been no similar blood clot cases reported among recipients of the Pfizer-BioNTech or Moderna vaccines.
An advisory committee to the US Centers for Disease Control and Prevention (CDC) will meet on Wednesday to review the cases, and the FDA will review the analysis, the agencies said in a joint statement.
All six cases involved women between the ages of 18 and 48, and the symptoms occurred six to 13 days after vaccination.
In the cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).
J&J said it was working closely with regulators and noted no clear causal relationship had been established between the cases and the COVID-19 vaccine made by its Janssen unit.
"Even if all of the cases were caused by the vaccine, the risk of less than one in a million would have to be set against the benefits of protection from COVID-19 disease; a disease which, in itself, causes clotting in many cases," said Peter English, a retired consultant in communicable disease control and a vaccine expert.
'ABUNDANCE OF CAUTION'
"The FDA recommendation to pause the administration of the Johnson and Johnson vaccine out of an abundance of caution makes sense in terms of the nature of the unusual and serious side effect not seen with the other vaccines," said Dr Robert Klugman at the UMass Memorial Medical Center in Massachusetts in an email.
J&J's shares were down 2.6 per cent in early New York trade.
The J&J and AstraZeneca vaccines both use an adenovirus vector - a harmless cold virus that instructs human cells to produce a protein found on the surface of the coronavirus, thereby spurring the immune system to prepare an arsenal against the COVID-19-causing virus.
Among leading global COVID-19 vaccine developers, China's CanSino Biological and Russia's Gamaleya Institute with its Sputnik V vaccine are also relying on this approach. The Pfizer-BioNtech and Moderna vaccines use mRNA technology.
The roll-out of J&J's vaccine has been slowed by issues at production plants.
The company has supplied the United States with at least 20 million doses but is behind schedule on its deliveries. Problems at a Baltimore, Maryland plant run by outside contractor Emergent BioSolutions forced the companies to trash a batch of vaccine substance.
J&J only began delivering its COVID-19 vaccine to European Union countries this week. It has committed to delivering 55 million doses to the bloc by the end of June and another 120 million in the third quarter.
J&J has been doing vaccinations in South Africa to study the effects on health workers, and had vaccinated just under 300,000 people there as of Monday, according to data from the country's health department. J&J recently struck a deal with the African Union for up to 400 million doses.
Europe's drugs regulator continues to recommend the use of AstraZeneca's COVID-19 vaccine, saying the benefits outweigh the risks. Several EU countries, however, have limited its use to certain age groups.
FILE PHOTO: Vials and medical syringe are seen in front of J&J logo in this illustration
FILE PHOTO: Vials with a sticker reading "COVID-19/Coronavirus vaccine/Injection only" and a medical syringe are seen in front of a displayed Johnson & Johnson logo in this illustration taken on Oct 31, 2020. (Reuters/Dado Ruvic)
13 Apr 2021 08:15PM
(Updated: 13 Apr 2021 10:55PM)
Bookmark
WASHINGTON: US federal health agencies on Tuesday (Apr 13) recommended pausing the use of Johnson & Johnson's COVID-19 vaccine after six women under 50 given the shot developed rare blood clots, dealing a fresh setback to efforts to tackle the pandemic.
Following the news, Johnson & Johnson (J&J) said it was delaying the roll-out of the vaccine to Europe, a week after regulators there said they were reviewing rare blood clots in four recipients of the shot in the United States.
The moves come after European regulators said earlier this month they had found a possible link between AstraZeneca's COVID-19 vaccine and a similar rare blood clotting problem that led to a small number of deaths.
J&J's single dose vaccine - most COVID-19 shots are delivered over two doses - and AstraZeneca's low-cost vaccine are seen as vital tools in the fight against a pandemic that has claimed more than 3 million lives.
The White House said the pause would not have a "significant" impact on its plan to administer about 3 million shots per day and a total of 200 million shots before President Joe Biden's 100th day in office.
The US Food and Drug Administration (FDA) said one person had died from the rare blood clotting condition after taking the J&J vaccine and another was in a critical condition.
Immunology experts stressed the risk posed by the J&J vaccine appeared extremely low, and that the shot remained a valuable tool against the risks of COVID-19. However, they acknowledged the need for health officials to proceed with caution to understand the best ways to mitigate any risk.
"Even if causally linked to the vaccine: 6 cases with about 7 million doses (lower than the risk of clots with oral contraceptives) is not something to panic about," Dr Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security in Baltimore, said in an email.
"People are asking me if they should cancel their J&J vaccine appointments and I have told them not to but I know many will and this will stall progress in controlling the pandemic."
FDA acting commissioner Janet Woodcock said it expected the pause to be a matter of days, and it was aimed at providing information to healthcare providers so that they can diagnose, treat and report such blood clots.
FDA official Peter Marks said that part of the reason for the pause was to warn doctors that administering the standard treatments for clots can cause tremendous harm, or be fatal.
'LESS THAN ONE IN A MILLION'
Most of the available J&J vaccine has been used in the United States due to production issues that have limited the company's supply. As of Apr 12, more than 6.8 million doses of the J&J vaccine had been administered in the United States, compared with more than 180 million shots combined of the Moderna and Pfizer-BioNTech shots.
US health officials said during a press briefing there had been no similar blood clot cases reported among recipients of the Pfizer-BioNTech or Moderna vaccines.
An advisory committee to the US Centers for Disease Control and Prevention (CDC) will meet on Wednesday to review the cases, and the FDA will review the analysis, the agencies said in a joint statement.
All six cases involved women between the ages of 18 and 48, and the symptoms occurred six to 13 days after vaccination.
In the cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).
J&J said it was working closely with regulators and noted no clear causal relationship had been established between the cases and the COVID-19 vaccine made by its Janssen unit.
"Even if all of the cases were caused by the vaccine, the risk of less than one in a million would have to be set against the benefits of protection from COVID-19 disease; a disease which, in itself, causes clotting in many cases," said Peter English, a retired consultant in communicable disease control and a vaccine expert.
'ABUNDANCE OF CAUTION'
"The FDA recommendation to pause the administration of the Johnson and Johnson vaccine out of an abundance of caution makes sense in terms of the nature of the unusual and serious side effect not seen with the other vaccines," said Dr Robert Klugman at the UMass Memorial Medical Center in Massachusetts in an email.
J&J's shares were down 2.6 per cent in early New York trade.
The J&J and AstraZeneca vaccines both use an adenovirus vector - a harmless cold virus that instructs human cells to produce a protein found on the surface of the coronavirus, thereby spurring the immune system to prepare an arsenal against the COVID-19-causing virus.
Among leading global COVID-19 vaccine developers, China's CanSino Biological and Russia's Gamaleya Institute with its Sputnik V vaccine are also relying on this approach. The Pfizer-BioNtech and Moderna vaccines use mRNA technology.
The roll-out of J&J's vaccine has been slowed by issues at production plants.
The company has supplied the United States with at least 20 million doses but is behind schedule on its deliveries. Problems at a Baltimore, Maryland plant run by outside contractor Emergent BioSolutions forced the companies to trash a batch of vaccine substance.
J&J only began delivering its COVID-19 vaccine to European Union countries this week. It has committed to delivering 55 million doses to the bloc by the end of June and another 120 million in the third quarter.
J&J has been doing vaccinations in South Africa to study the effects on health workers, and had vaccinated just under 300,000 people there as of Monday, according to data from the country's health department. J&J recently struck a deal with the African Union for up to 400 million doses.
Europe's drugs regulator continues to recommend the use of AstraZeneca's COVID-19 vaccine, saying the benefits outweigh the risks. Several EU countries, however, have limited its use to certain age groups.
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