Allergy warning issued concerning covid vaccines

[rogue06]

None remotely relevant to your assertions in of the degree of fraud in this election the courts have rejected such incompetent claims as "without merit and no evidence," and ridiculed the Republicans for such claims that would compare to your examples. You know over fifty cases and the citizens of Wisconsin are stiffed with the bill for Trumps incompetent demands ridiculed by the courts. You have not responded when the level of problems in this election warranted redoing the election. In fact no national election in USA history has ever been rejected to be redone.

Still waiting . . .

Your continual clumsy attempts at moving goal posts are getting weary. Moreover this has absolutely nothing to do with this thread. If you continue to try to derail it then I'm asking you to leave.

[rogue06]

Some of what you cite here has some merit. We should be concerned about vaccines being developed in other countries without the standards of the US medical industry. Bottom line I am not addressing all the vaccines being developed, only at present the 2 or three vaccines being approved in the USA. They are not highly experimental.

That was largely the reason places like Britain started issuing the vaccinations before us. Pretty much ever since the thalidomide scandal of the 50s and 60s the FDA insists on running their own tests rather than simply relying on the results of those run in other countries.

[shunyadragon]

Your continual clumsy attempts at moving goal posts are getting weary. Moreover this has absolutely nothing to do with this thread. If you continue to try to derail it then I'm asking you to leave.

No coherent response.

[rogue06]

No coherent response.

You were warned. Now leave.

[Bill the Cat]

Moderated By: Bill the Cat

Shuny, please refrain from further posts in this thread per the OP request. Thanks

***If you wish to take issue with this notice DO NOT do so in this thread.***
Contact the forum moderator or an administrator in Private Message or email instead. If you feel you must publicly complain or whine, please take it to the Padded Room unless told otherwise.

[mikewhitney]

Some of what you cite here has some merit. We should be concerned about vaccines being developed in other countries without the standards of the US medical industry. Bottom line I am not addressing all the vaccines being developed, only at present the 2 or three vaccines being approved in the USA. They are not highly experimental.

you never look at the truth and evidence. It is okay if you, as an individual, do not comprehend these things.

[Chaotic Void]

This is interesting and returning to the OP and how it relates to where you live...

Source: Liberals announce a vaccine-harms compensation program

The federal Liberals have announced financial support for anyone who suffers an 'adverse reaction' from a COVID-19 vaccine approved by Health Canada

The federal Liberals have announced a compensation program for anyone who is harmed by the COVID-19 vaccine — or any other vaccine that’s approved by Health Canada.

"In the very unlikely event of an adverse reaction though, we want to make sure Canadians have fair access to support," said Prime Minister Justin Trudeau.

There have been two reports out of the United Kingdom regarding severe allergic reactions to the COVID-19 vaccine.

If Canada were to create such a program — requiring cooperation with the provinces and territories — we would join just 19 other countries around the world that have some variety of a vaccine compensation policy.

Dr. Lynora Saxinger, a University of Alberta professor and infectious disease specialist, said there’s a risk the messaging that the vaccine is super safe is undermined by the announcement.

"And so, it depends, I guess, on whether you think people’s main fear is an adverse reaction or their main fear is not getting support in the event of an adverse reaction," Saxinger said.

It’s unclear what the program might actually look like, but Trudeau told reporters it would be to support those who experience an “adverse reaction.” It’s unclear how he is defining that — or what form supports from the government might take.

Tim Caulfied, the Canada Research Chair in health law and policy at the University of Alberta who has spoken extensively about misinformation in medicine, said such a policy creates "challenging communications issues, even if the policy makes sense."

"On the one hand, they make sense because we’re asking Canadians to get vaccinated as a public health act, an act for their community and therefore, if there’s injury it makes sense to compensate them for it," he said.

"On the other hand, it does create this impression injuries happen and require compensation."

As the government points out, adverse reactions from vaccines are incredibly rare. For example, anaphylaxis or a severe allergic reaction, occur in one in 760,000 vaccinations, according to an article in the Canadian Medical Association Journal.

Mild reactions — such as swelling around the injection site — are common, as the body reacts to build immunity, says the Public Health Agency of Canada in the news release.

According to a paper, from the Public Health Agency of Canada, they’re even rarer for some vaccines: the tetanus shot has adverse reactions in one in 10 million injections; the flu shot ranges between one in 500,000 and one in one million.

Caulfield also says that a review of the vaccination program in the United States suggests that some of the compensation are for things such as shoulder injuries at the vaccination puncture sites.

"We’re not talking about some serious, adverse, long-term injury," he said.

The program would likely be "no fault," meaning the vaccine maker wouldn’t be admitting liability for the harms caused.

Quebec is the only province in Canada that already has a vaccine compensation program. Between 1985 and 2018, the province disbursed $5.4 million in 43 cases; there had been 228 claims, 187 of which were deemed likely enough to be evaluated.

A survey of other vaccine compensations programs, and published in September by the Public Health Agency of Canada, says eligibility requirements vary; in some, compensation is available only for mandatory vaccines, in others, all vaccines recommended by public health or in cases where vaccines are known to have an associated risk.

Countries also opt for a variety of standards of proof and may have administrative boards to determine whether or not someone’s "injury" was actually caused by vaccination.


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And there is another story from Reuters that was linked to in this account

Source: One of the vaccines ordered by Canada fails to protect older adults from COVID-19

Canada has arranged to buy 72 million COVID-19 vaccines from Sanofi Pasteur

Sanofi and Britain’s GlaxoSmithKline said on Friday they will test their potential COVID-19 vaccine further after clinical trials showed an insufficient immune response in older people, delaying its potential launch until the end of next year.

The two companies said they planned to start another study next February, hoping to come up with a more effective vaccine by the end of 2021, in a blow to efforts to fight the pandemic.

Canada has arranged to buy 72 million COVID-19 vaccines from Sanofi Pasteur.

The news comes as a disappointment for one of a crop of vaccines under development that rely on more conventional proven designs as the shot developed by Pfizer and BioNTech using breakthrough technology gets rolled out across Britain.

It is also a blow for many governments, including Canada, the European Union, the United States and Britain, which have booked hundreds of millions of doses of the shot as they struggle to tame the virus that has killed more than 1.5 million people and crushed economies.

Delays and additional trials are not unusual but the setback highlights the challenges in developing vaccines at record speed. It also underscores why governments have booked lots of different shots so they are not replying on just one.

Friday’s results showed "an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in older adults likely due to an insufficient concentration of the antigen," France’s Sanofi said.

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"With this type of vaccine, the result is not a surprise, we know that more antigen is needed in older patients. But when in phase I and II, drugmakers test tolerance and one cannot test strong dosages," said Jean-Daniel Lelievre, head of clinic immunology and infectious diseases at Henri-Mondor hospital in Creteil, France.

"I would think Sanofi and GSK will be able to improve their vaccine."

Phase III studies were expected to start this month.

Sanofi said it would launch a phase 2b study in February of next year instead after a recent challenge study in non-human primates performed with an improved antigen formulation demonstrated better effects.

"The study will include a proposed comparison with an authorized COVID-19 vaccine," the company said.

"If data are positive, a global Phase III study could start in Q2 2021. Positive results from this study would lead to regulatory submissions in the second half of 2021, hence delaying the vaccine’s potential availability from mid-2021 to Q4 2021."

The two companies said they had "updated governments and the European Commission where a contractual commitment to purchase the vaccine has been made."

The Sanofi-GSK vaccine uses the same recombinant protein-based technology as one of Sanofi’s seasonal influenza vaccines. It will be coupled with an adjuvant, a substance that acts as a booster to the vaccine, made by GSK.

The Phase I/II study tested the safety, tolerability and immune response of the vaccine in 440 healthy adults across 11 investigational sites in the United States.

This week, Britain started deploying a vaccine that uses a breakthrough mRNA technology developed by Pfizer and BioNTech, jumping ahead of the rest of the world in the race. Canada gave the greenlight for the shot, too.

The data comes as a panel of outside advisers to the U.S. Food and Drug Administration on Thursday voted overwhelmingly to endorse emergency use of the Pfizer/BioNTech vaccine.

Rival developers AstraZeneca Plc and Moderna have also reported late stage data that shows their shots are effective at preventing the virus.

The French group is also working on another vaccine candidate to prevent COVID-19 with U.S. company Translate Bio which will rely on a different technology called mRNA, similar to the developed by Pfizer and Moderna.

Phase I trials for this vaccine are expected to start this month.

Sanofi and GSK have scaled up manufacturing in order to be ready to produce up to one billion doses of their vaccine in 2021.

GSK is contributing adjuvants to two other COVID-19 vaccines projects, one with Medicago of Canada and the other with China’s Clover Biopharmaceuticals.

Australia on Friday canceled the production of a COVID-19 vaccine developed by the University of Queensland and using an adjuvant made by biotech firm CSL after trials showed it could interfere with HIV diagnosis.



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The Compensation Policy is probably just CYB Protocol after the reaction in the UK, but it really doesn't stoke any confidence from me that things are going smoothly behind the scenes.

And knowing how Compensation Boards work here, they probably won't pay out anything big unless you're employing a Lawyer so Ruthless and Vile that Satan himself petitioned that they be banned from Hell. Worker's Comp is especially nasty for finding excuses to not pay out what someone's owed, unless it's something dinky like a day's wages.

[rogue06]

The Compensation Policy is probably just CYB Protocol after the reaction in the UK, but it really doesn't stoke any confidence from me that things are going smoothly behind the scenes.

And knowing how Compensation Boards work here, they probably won't pay out anything big unless you're employing a Lawyer so Ruthless and Vile that Satan himself petitioned that they be banned from Hell. Worker's Comp is especially nasty for finding excuses to not pay out what someone's owed, unless it's something dinky like a day's wages.

Sooo, you're run of the mill ambulance chaser.

[Chaotic Void]

Sooo, you're run of the mill ambulance chaser.

But Competent!

[mossrose]

The Compensation Policy is probably just CYB Protocol after the reaction in the UK, but it really doesn't stoke any confidence from me that things are going smoothly behind the scenes.

And knowing how Compensation Boards work here, they probably won't pay out anything big unless you're employing a Lawyer so Ruthless and Vile that Satan himself petitioned that they be banned from Hell. Worker's Comp is especially nasty for finding excuses to not pay out what someone's owed, unless it's something dinky like a day's wages.

I don't know how much more money Trudeau can throw out for covid relief. We are already so much behind the 8 ball that we'll never see that debt paid off.

And compensation is a joke. Seniors got a one-time payment of $300. We didn't need it here, but seniors who are already struggling likely won't think that $300 is much of a help when The Libranos are pumping our billions for "covid relief" to individuals and businesses and landlords.

[Chaotic Void]

I don't know how much more money Trudeau can throw out for covid relief. We are already so much behind the 8 ball that we'll never see that debt paid off.

And compensation is a joke. Seniors got a one-time payment of $300. We didn't need it here, but seniors who are already struggling likely won't think that $300 is much of a help when The Libranos are pumping our billions for "covid relief" to individuals and businesses and landlords.

Not to mention that they didn't explicitly specify that Net Income (not Gross) was what determined eligibility for CERB so now a lot of people have to pay it back... Yeah, this is has been screwy from Day 1.

[rogue06]

British officials have advised those with a history of significant allergies not to get the Pfizer covid vaccine after two people reported adverse reactions. They weren't severe and it isn't unheard of for a small number of people to have an allergic reaction to a vaccine. Still, the type of reactions, anaphylaxis, have been known to produce life-threatening effects since it causes throat swelling, breathing trouble as well as difficulty swallowing, so this caution seems warranted.

Source: Covid-19 vaccine: Allergy warning over new jab

It came after two NHS workers had allergic reactions on Tuesday.

The advice applies to those who have had reactions to medicines, food or vaccines, the Medicines and Healthcare products Regulatory Agency said.

The two people had a reaction shortly after having the new jab, had treatment and are both fine now.

They are understood to have had an anaphylactoid reaction, which tends to involve a skin rash, breathlessness and sometimes a drop in blood pressure. This is not the same as anaphylaxis which can be fatal.

Both NHS workers have a history of serious allergies and carry adrenaline pens around with them.

Professor Stephen Powis, medical director for the NHS in England, said both individuals were recovering well.

He said this was "common with new vaccines", describing it as a precautionary measure.

Dr June Raine, head of the MHRA, said it was only right to take this step now that "we've had this experience".

Reactions like this are uncommon, but do happen with other vaccines, including the annual flu jab.

Several thousand people were vaccinated on Tuesday in hospital clinics on the first day of the UK rollout of the new Covid jab.

Prof Peter Openshaw, an expert in immunology at Imperial College London, said: "The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well."


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[*The story continues at the above link including analysis*]

Source: Allergy warning for Pfizer/BioNTech vaccine after UK health workers with allergy history suffer reaction

People with a "significant history of allergic reactions" should not be given the Pfizer/BioNTech coronavirus vaccine, UK health authorities said Wednesday, after two health care workers experienced symptoms after receiving a shot the day before.

The precautionary advice was given after the pair "responded adversely" following their shots on the first day of the mass vaccination rollout in the UK, National Health Service England said Wednesday.

The two staff members -- who both carried an adrenaline auto injector and had a history of allergic reactions -- developed symptoms of anaphylactoid reaction after receiving the vaccine on Tuesday. Thousands overall were vaccinated in the UK on Tuesday, NHS England told CNN on Wednesday.

"As is common with new vaccines the MHRA [Medicines and Healthcare products Regulatory Agency] have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination after two people with a history of significant allergic reactions responded adversely yesterday," said Stephen Powis, the national medical director for NHS England, in a statement. "Both are recovering well."

The MHRA issued new advice to health care professionals stating that any person with a significant allergic reaction to a vaccine, medicine or food -- such as previous history of anaphylactoid reaction, or those who have been advised to carry an adrenaline autoinjector -- should not receive the Pfizer/BioNtech vaccine.

"We are fully investigating the two reports that have been reported to us as a matter of priority," an MHRA spokesperson said.

"Once all the information has been reviewed we will communicate updated advice," the spokesperson added.

They advised anyone with a history of a significant allergic reaction due to receive the Pfizer/BioNTech vaccine to speak to the health care professional administering the vaccine.

Pfizer said in a statement that it had been advised by the UK regulator of "two yellow card reports that may be associated with allergic reaction" due to administration of the vaccine.
The advice also states that vaccines "should only be carried out in facilities where resuscitation measures are available."

"As a precautionary measure, the MHRA has issued temporary guidance to the NHS while it conducts an investigation in order to fully understand each case and its causes. Pfizer and BioNTech are supporting the MHRA in the investigation," the statement said.

"In the pivotal phase 3 clinical trial, this vaccine was generally well tolerated with no serious safety concerns reported by the independent Data Monitoring Committee. The trial has enrolled over 44,000 participants to date, over 42,000 of whom have received a second vaccination."

Documents released on Tuesday by the US Food and Drug Administration (FDA) said the Pfizer/BioNTech trial data indicated that there were potentially slightly more adverse responses thought to be allergic reactions among the vaccine group compared with the placebo group, at 0.63% compared with 0.51%.

Pfizer's trial protocol shows that people with a history of severe allergic reaction (e.g., anaphylaxis) "to any component of the study intervention" were not able to take part.

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, told the UK's Science Media Centre that the increase was only "small" but said there was "a lot of uncertainty around that estimate."

He said that "some people won't know if they have hypersensitivity to some constituents of the vaccine."

He backed the MHRA advice for people who carry an EpiPen to delay having a vaccination until the reason for the allergic reaction has been clarified. But he said the news did not mean the general public should be anxious.

Peter Openshaw, professor of experimental medicine at Imperial College London, said: "As with all food and medications, there is a very small chance of an allergic reaction to any vaccine.

"The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well."

Vaccine expert Dr. Paul Offit told CNN that allergic reactions to vaccines were not uncommon: "Certainly, vaccines can cause severe allergic reactions. In the United States, roughly one of every 1.4 million doses of vaccines is complicated by a severe allergic reaction."

He said that rather than a "blanket recommendation" for people with allergies, "the smarter thing to do would be to try and look at these two patients and see what specific component of the vaccine they were allergic to."

Offit said people should realize that there are immediate treatments for allergic reaction. "That's why you're hanging out in the doctor's office," he said, before warning that the reports of allergic reactions "will only serve as yet another way to scare people."

Saffron Cordery, deputy chief executive of NHS Providers, told Sky News on Sunday that the authorization and approval process for the Pfizer/BioNTech vaccine "has been incredibly robust." The head of Britain's medicines regulator also put out assurances on Sunday, saying the Pfizer/BioNTech shot was "as safe as any general vaccine."

US drug giant Pfizer and German company BioNTech have said there are "no serious safety concerns" over the vaccine

The US Centers for Disease Control and Prevention typically advises telling a provider if you have "any severe, life-threatening allergies" before taking any vaccine.

Allergies are also a consideration with other Covid-19 vaccines that have not yet been approved.

During Chinese company Sinovac's Phase 2 trial, one volunteer in the high dose group had a severe allergic reaction within 48 hours of the first dose, which researchers said may be related to the vaccine. The volunteer was treated for the reaction and recovered within three days. The same volunteer did not have a similar allergic reaction to the second shot.


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From the NYT through MSN it appears that up in Alaska we have a serious allergic reaction

Source: Health Care Worker Had Serious Allergic Reaction After Pfizer's Covid Vaccine

A health worker in Alaska had a serious allergic reaction after getting Pfizer’s coronavirus vaccine on Tuesday and was hospitalized, according to three people familiar with official reports of the person’s health. The person was still in the hospital on Wednesday morning, under observation.

Government officials were scrambling on Wednesday to learn more about the case. The worker had no history of drug allergies but it was unclear whether he or she suffered from other types of allergies, according to one person familiar with the case.

With millions of Americans expected to be vaccinated by the end of the year, the incident is likely to prompt federal officials to be even more watchful for any sign of serious side effects. The Alaska recipient’s reaction was believed to be similar to the anaphylactic reactions two health workers in Britain experienced after receiving the Pfizer-BioNTech vaccine last week. Both of them recovered.

Pfizer’s trial in the United States involving more than 40,000 people did not find any serious adverse events caused by the vaccine, although many participants did experience aches, fevers and other side effects. Severe allergic reactions to vaccines are typically linked to the vaccine because of their timing.

A Pfizer representative did not immediately comment on the case.

After the workers in Britain fell ill, authorities there initially warned against giving the vaccines to anyone with a history of severe allergic reactions. They later clarified their concerns, changing the wording from "severe allergic reactions" to specify that the vaccine should not be given to anyone who has ever had an anaphylactic reaction to a food, medicine or vaccine. That type of reaction to a vaccine is "very rare," they said.

Pfizer officials have said the two British people who had the reaction had a history of severe allergies. One, a 49-year-old woman, had a history of egg allergies. The other, a 40-year-old woman, had a history of allergies to several different medications. Both carried EpiPen-like devices to inject themselves with epinephrine in case of such a reaction.

Pfizer has said that its vaccine does not contain egg ingredients.

The British update also said that a third patient had a "possible allergic reaction," but did not describe it.

In the United States, federal regulators issued a broad authorization for the vaccine on Friday to adults 16 years and older. Health care providers were warned not to give the vaccine to anyone with a “known history of a severe allergic reaction” to any component of the vaccine, which they said was a standard warning for vaccines.

But because of the British cases, F.D.A. officials have said they would require Pfizer to increase its monitoring for anaphylaxis and submit data on it once the vaccine comes into use. Pfizer also said that the vaccine is recommended to be administered in settings that have access to equipment to manage anaphylaxis. Last weekend, the Centers for Disease Control and Prevention said that people with serious allergies can be safely vaccinated, with close monitoring for 30 minutes after receiving the shot.

Anaphylaxis can be life-threatening, with impaired breathing and drops in blood pressure that usually occur within minutes or even seconds after exposure to a food or medicine, or even a substance like latex to which the person is allergic.


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As noted these sort of reactions have been very rare but they're still saying that "the vaccine should not be given to anyone who has ever had an anaphylactic reaction to a food, medicine or vaccine."