AstraZeneca

Government Guidance to GPs on Vaccine Safety Omits Pfizer Trial Data Showing Twice as Many Cardiovascular Deaths in Vaccinated

When Daily Sceptic reader Ian Price experienced an alarming adverse reaction to his first AstraZeneca jab he decided that he did not want to risk a second dose. However, his GP had other ideas and told him he should have Pfizer for his second dose. Despite being presented with worrying safety data from Pfizer’s own trial results, the GP would not agree to an exemption. Ian writes:

I am pro-vaccine but anti-mandate. However, I have recently discovered via correspondence from my GP that the Department of Health is not ‘following the science’ in the guidance it gives to GPs on vaccine safety.

By way of background, I declined the second vaccine following an adverse reaction to the first AstraZeneca vaccine received in March 2021. I remain partially vaccinated which means that I fall into the category of citizens described by Sir Tony Blair as “idiots”. Resenting the increasing stigmatisation of the unvaccinated, I discovered via Google search that there was such a thing as a vaccine exemption. After all, even Blair acknowledges that it is possible to have a “health reason” for not being jabbed. So I called the NHS number and had a form posted to me. I filled it in and dropped it off at my GP’s surgery.

“I’m struggling a bit with the Covid exemption form,” wrote my GP to me in a text on December 1st. “I am not sure I am comfortable with precluding you from the option of a second injection.” He was about to go away but offered a phone consultation on his return. Puzzled by his framing of the issue as being about not limiting my options, I agreed to the follow-up call.

In our long discussion on December 29th, his advice remained that I should take the Pfizer vaccine. I explained that I felt my risk from Covid was negligible and I was not convinced that it was greater than the risk from a second vaccine. He remained reluctant to issue an exemption but agreed to look into it further and come back to me. His subsequent text message read as follows: “I have re-read the guidance extensively on issuing of vaccine exemptions and unfortunately it can only be issued if there is a medical contraindication to receiving an alternate vaccine.”

He was good enough to attach a link to the guidance document from the Department of Health and Social Care. I looked at this document and found a further link to the Green Book Chapter 14a. As outlined in my letter to him below, the paragraph on the safety of the Pfizer vaccine reads as if the scientific evidence is reassuring. The paragraph cites two published papers that describe safety studies of the Pfizer vaccine: Walsh et al, 2020 and Polack et al, 2020. Both studies demonstrated very limited evidence of systemic events – “generally mild and shortlived”. Reading this paragraph, as a layman, I would conclude that there is no cause for concern.

Study Links Pfizer and Astrazeneca Vaccines to Life Threatening Side Effects

The most comprehensive study into vaccine side effects so far has uncovered that the Pfizer and AstraZeneca vaccines are linked to serious and potentially life threatening side effects. Although rare, the Pfizer vaccine has been connected to the neurological condition Guillain-Barré syndrome, which carries symptoms of numbness and muscle weakness, while the AstraZeneca vaccine has been associated with bleeding on the brain and hemorrhagic stroke. The Times has the story.

Professor Aziz Sheikh, from the University of Edinburgh, said that it was possible to identify the adverse events only because they were able to look at so much data. The study, published in the journal Nature Medicine, looked at 20 million first doses of the Oxford-AstraZeneca vaccine, 12 million of Pfizer and two million infections.

“These are very rare adverse events. They’re so rare that we’re having to report them per million of the population,” Sheikh said. “It’s not what you’d normally see, where it’s per 1,000 people exposed.”

The work is the largest investigation into potential side effects so far, using data from the UK vaccine programme. It involved comparing occurrences of the conditions in the same people prior to vaccination with occurrences after. In this way it attempted to correct for the possibility that those getting the vaccines were different in other ways from those who did not.

To check the findings, the scientists looked first at English data then checked it with that from Scotland. In doing so, they could not find strong enough evidence to be certain the strokes really were associated with the Pfizer vaccine, but they again found the link between the AstraZeneca jab and Guillan-Barré [sic] syndrome. Eighty per cent of people recover completely from Guillain-Barré syndrome, but some can experience long-term ill health.

Sheikh said that it was up to individuals to weigh up the risks, but that in his view the benefits of the vaccines still easily outweighed any potential side effects.

Worth reading in full.

Australia to Stop Manufacturing AstraZeneca Covid Vaccine, Blaming “Negative Press” for Lower Uptake

Australia is set to stop manufacturing the AstraZeneca Covid vaccine because fears over side effects mean the jab is “not going to be utilised” as much as others. Health officials have pinned the blame for these fears on “negative press”. The Mail Australia has the story.

The federal Government in November last year contracted Australia biomedical firm CSL to produce 50 million doses of the vaccine at its manufacturing hub in Melbourne.

At the time worldwide vaccine development for the coronavirus was in its fledgling stages and policymakers prioritised domestic production as a necessity during the crisis.

But just one month after its launch in March 2021, the Australian Technical Advisory Group on Immunisation (ATAGI) pulled the pin on younger Australians receiving the dose due to the extremely rare risk of fatal blood clots – about one in 1.6 million. …

ATAGI flip-flopped on their health advice recommending the AstraZeneca jab only to over-50s, before ratcheting up the warning to over 60s – with the age bracket less susceptible to developing blood clots.

Then as the Delta outbreak started ravaging NSW and Victorian in the winter months the medical body suggested it should be considered for over-18s living in a hot spot area.

But by that stage the reputation of the safe and effective vaccine was tarnished and many Australians decided to wait for Pfizer and Moderna supplies to filter into the country from abroad.

“Obviously we don’t want to manufacture something that is not going to be utalised and we will have a number of other options moving into the future,” Associate Professor Paul Griffin from the University of Queensland told 9News.

“It obviously has received a lot of negative press although it’s a vaccine that has proven highly effective and very safe.”

Some of that ‘bad press’ came from a very unlucky source back in June with Queensland Chief Health Officer Jeannette Young adding to the disinformation and later being accused of “fear mongering”.

“I don’t want an 18 year-old in Queensland dying from a clotting illness who, if they got Covid, probably wouldn’t die,” she said after the Prime Minister urged younger people to consider taking the AstraZeneca jab.

Worth reading in full.

All U.K. Children Could Be Offered Covid Vaccines by the End of the Year

The Government will announce its plans for the vaccination of children against Covid later today and is expected to say that only clinically vulnerable children and those living with vulnerable adults will be included in the national roll-out – for now. It hasn’t taken long for reports to emerge suggesting that all children could be offered a vaccine by the end of the year. The argument is that it will be difficult to reach herd immunity if children remain unvaccinated. The Telegraph has the story.

The Joint Committee on Vaccination and Immunisation (JCVI) is expected to announce that only vulnerable youngsters between the ages of 12 and 15, and 17 year-olds within three months of their 18th birthday, will be offered a jab amid concerns there is too little data on safety and efficacy in young people.

But the JCVI is expected to leave the door open for more children to be vaccinated once trials conclude later this year, the Telegraph understands.

In June, the Medicines and Healthcare products Regulatory Agency approved the Pfizer jab for 12 to 15 year-olds in Britain following early trial results in teenagers, but there is still no data for younger children. 

Pfizer is expected to release results on trials for five to 11 year-olds in September and two to five year-olds by November, with the company expecting regulator approval within a month of releasing positive data. AstraZeneca is also conducting trials in children aged six to 17, with the British team likely to release results before the end of the year.

On Sunday, experts warned that it may be difficult to reach herd immunity in Britain if children are not vaccinated. Nearly one in five people in the U.K. are under 16 and, despite everyone being offered a vaccine, around 12% of adults have not had a first jab.

Professor Neil Ferguson, of Imperial College, a member of SAGE, told the BBC: “In the absence of vaccinating it’s inevitable that we’re going to have very high numbers of cases in teenagers, and we will not be able to reach herd immunity without significant immunity in people under 18.”

The JCVI is expected to keep the situation under review and will be watching the results from trials closely. 

Scientists are particularly concerned that vaccination may damage the developing immune system of younger children. Different age groups may require different doses, further complicating the roll-out, and companies must show it will not make children who get Covid more ill – which has happened with other vaccines in the past. 

Experts are also worried that the benefits to children may not outweigh the risks, making vaccination ethically dubious and leaving the Government vulnerable to legal challenges.

A Department of Health spokesman said: “The Government will continue to be guided by the advice of the JCVI, and no decisions have been made by ministers on whether people aged 12 to 17 should be routinely offered Covid vaccines.”

Worth reading in full.

Health Secretary Sajid Javid Tests Positive for Covid

Health Secretary Sajid Javid, who has had two doses of the AstraZeneca Covid vaccine, is self-isolating with his family after he tested positive for the virus. Javid says his symptoms are “very mild” and has urged unvaccinated Brits to get ‘jabbed’ “as soon as you can”.

BBC News has the story.

Mr Javid, who became Health Secretary in June, said he had taken a lateral flow test after feeling a “bit groggy” on Friday night and it was positive. 

He said he was now self-isolating until he got the results of a PCR test. …

In a video posted on his Twitter feed, Mr Javid said: “I was feeling a bit groggy last night, so I took a lateral flow test this morning and it’s come out positive, so I’m now self-isolating at home with my family until I get the results of a PCR test.” 

“I’m grateful that I’ve had two jabs of the vaccine and so far my symptoms are very mild.” 

He urged people who had not been vaccinated yet to “get out there and get them as soon as you can”.

Mr Javid also said people who feel groggy or come into contact with someone who is positive should take a lateral flow test.

“If everyone plays their part, you’re not only protecting yourself and your loved ones but you’re also safeguarding the NHS and helping to preserve our way of life,” the Health Secretary added.

Worth reading in full.

Stop Press: Half the Cabinet could be pinged within a few days, according to MailOnline, including Boris.

Australia Agrees Plan to Abandon Zero Covid Strategy

As infections surge during winter and with half the country now under restrictions in the ‘Zero Covid’ state, the national Government in Australia has finally accepted that trying to keep Covid out forever is no way to run a country. The cabinet has agreed plans to end restrictions and reopen borders as the country shifts to a vaccine strategy that treats Covid “like the flu”. ABC reports.

National Cabinet has agreed to a four-stage plan that would see Australia transform into a vaccinated nation that manages COVID-19 with few restrictions.

The goal, as Prime Minister Scott Morrison said, is for Australia to begin treating COVID-19 “like the flu”.

It would mean governments shift from focusing on case numbers to focusing on rates of hospitalisation and death as Australians learn to live with low rates of mild illness in the community.

To get to a point beyond lockdowns and border closures, Australians will need to roll up their sleeves and get vaccinated, but leaders are yet to agree how many jabs it will take to open up.

However, as the Swiss Doctor notes, the country’s vaccine programme has not exactly got off to a good start.

Australia still has a very low, single-digit vaccination rate; moreover, the country currently relies on AstraZeneca, which achieves only a 60% protection rate against symptomatic infection with the ‘Indian variant’, and which will be phased out due to several fatal and severe reactions in young adults. Thus, Australia is likely to face a fierce uphill battle against the coronavirus during the ongoing winter season

The media hysteria is in full swing down under, with the Australian Associated Press telling readers that the Delta variant is “twice as contagious as the original virus and can be spread through fleeting contact that lasts just seconds”. Oh dear, where’s a fact checker when you need one? Glad not to be in Australia right now.

Millions of Brits Excluded from New E.U. Vaccine Passport Scheme

The European Union’s new vaccine passport scheme – the “E.U. digital Covid Certificate” – has been launched following recent trials, and it’s not just the unvaccinated who don’t qualify. Up to five million vaccinated Brits, and many others across the world, could be denied European holidays because their vaccines are not recognised by the scheme. The Telegraph has the story.

Millions of vaccines administered here do not qualify for the European Union’s vaccine passport scheme, because the shots were manufactured in India and are not yet authorised by the European Medicines Agency (EMA).

The hitch could leave thousands of Britons turned away at E.U. border crossings when the batch numbers on their vaccines are checked digitally.

The E.U. Digital Covid Certificate… is designed to allow Covid-secure travel across the continent but does not recognise a version of the AstraZeneca vaccine called Covishield, produced by the Serum Institute of India (SII), because it is yet to receive approval in Europe.

Up to five million doses of this version of the vaccine have been administered in the U.K. and are identifiable by the vaccine batch numbers (4120Z001, 4120Z002, 4120Z003) included on recipients’ vaccine cards and in the Covid travel pass available via the NHS app.

The E.U. ruling has already sparked outrage in Asia and Africa, where the Indian manufactured shot – which forms the backbone of the Covax distribution scheme – has been widely used. Now, some British holidaymakers may find themselves similarly excluded.

The Telegraph has traced three Britons affected, none of whom were told in advance they were to receive the Indian version of the AstraZeneca vaccine. All received their shots of the SII vaccine in March. …

The E.U. Digital Covid Certificate allows those who are fully vaccinated, recently tested or recovered from Covid to move across borders within the E.U. without having to quarantine or undergo extra coronavirus tests upon arrival.

But only vaccines approved by the EMA are included, though individual member states are free to accept other vaccines if they choose.

The EMA approved vaccines are Pfizer, Moderna, Johnson & Johnson, and the version of the AstraZeneca vaccine manufactured in the U.K. or Europe, which is sold under the brand name Vaxzevria. …

The E.U. vaccine passport will soon integrate with the Covid travel pass on the NHS app. By scanning a QR code, the E.U. system pulls up information including the traveller’s name, date of birth and vaccine details, including batch numbers.

Worth reading in full.

Stop Press: Professor Adam Finn from the Joint Committee on Vaccination and Immunisation says this is merely an “administrative hurdle” that needs to be “straightened out”. He was quoted by Sky News in its coverage of the story:

We’re in the early days of this new world of needed vaccine passports and there are lots of aspects of this that are still being sorted out for the first time.

But it’s clearly, ultimately not in anyone’s interest, including the E.U., to create hurdles that don’t need to be there. …

I would anticipate that this will get straightened out in due course.

Worth reading in full.

Australia to Phase Out the Use of the AstraZeneca Covid Vaccine Due to Safety Concerns

Australia will gradually phase out the use of the AstraZeneca Covid vaccine in its national vaccine roll-out, with doses only to be given if requested from October onwards. The decision has been spurred by safety concerns and follows the development of a condition that can cause paralysis and can even be life-threatening shortly after taking the AZ vaccine in at least eight Australians. The Guardian has more.

The Government released a revised planning document on Wednesday outlining how it intended to direct supplies over the rest of the year…

The vaccination document, titled National Vaccination Allocation Horizons, suggests in July and August AstraZeneca will continue to dominate the vaccination program, with up to 2.6 million doses being administered each week, predominantly to those over the age of 60, through state and territory clinics and the primary care network.

But as the vaccination of this age group nears completion, it is anticipated AstraZeneca will be used only “subject to request” from October.

The commonwealth last week announced changed health advice for the AstraZeneca shot restricting it to over-60s because it has been linked to an extremely rare blood clotting condition.

In the “Horizon Two” phase in September, supplies of the Moderna vaccine come on stream, with up to 125,000 doses per week to be made available to the primary care network, the document foreshadows.

By this stage, Pfizer supplies will also be ramping up, with up to 1.3 million doses a week available, up from the 750,000 a week available in July and August.

The Pfizer supplies are expected to increase again by the end of the year to between 1.7 million and 2.3 million doses a week, as the Government races to meet its pledge to allow every Australian access to a vaccine by the end of 2021.

Worth reading in full.

Four Brits Develop Condition That Can Cause Paralysis After Taking AstraZeneca Covid Vaccine

Four Nottinghamshire men aged between 20 and 57 have developed a condition that can cause paralysis and can even be life-threatening shortly after taking the AstraZeneca Covid vaccine. The condition, called Guillain-Barré Syndrome, has also been found in people who have had the AZ vaccine in Australia and India. The MailOnline has more.

All four cases were spotted in the Nottingham area, where around 700,000 people have had the AZ coronavirus jab. 

British health chiefs have yet to offer a public breakdown of how many cases of the syndrome have been spotted in vaccine recipients across the entire country…

Cases of Guillain-Barré syndrome after AstraZeneca’s vaccine were described in two separate studies in the journal Annals of Neurology.

The complication – normally triggered by an infection – usually occurs in around one in 100,000 people in the U.K. and U.S..

But doctors in India who also uncovered the link say it was occurring up to 10 times more than expected.

One of the articles published in the journal broke down the cases spotted in Nottingham, which all occurred within ten days of each other. 

Symptoms began 11 to 22 days after the first jab and all of the four men were aged between 20 and 57.

One had no relevant medical history. The three others had ulcerative colitis, asthma and high blood pressure.

None had been infected with Covid. They were treated with antibodies and steroid pills.

Dr Christopher Allen, a Clinical Neuroscientist at Nottingham University, who wrote the article, admitted they cannot be certain the jab caused the neurological illness and it could have happened by chance.

But it demonstrates the need for “robust post-vaccination surveillance”, he said…

The second paper by neurologists at the Aster Medcity hospital in Kochi, Kerala, identified seven cases of severe Guillain-Barré syndrome.

They were struck down within a fortnight of receiving the first AstraZeneca vaccine.

Lead author Dr Boby Varkey Maramattom said rates of the condition were between 1.4 and 10-fold higher than would normally be expected. 

Worth reading in full.

E.U. Fails in Court Ruling to Secure 120 Million Doses of AstraZeneca Vaccine – But Bloc Still Claims Victory

The European Union has failed in a legal attempt to obtain 120 million doses of the AstraZeneca Covid vaccine by the end of this month. Despite this, the President of the European Commission has claimed victory for the bloc, saying that the ruling demonstrates the drug maker’s failure to meet its commitments. Sky News has the story.

The two sides have had a rocky relationship over the past few months, with the E.U. accusing the vaccine maker of not producing supplies fast enough.

AstraZeneca was contracted to do its best to deliver 300 million doses to the bloc by the end of June, but it had to revise down its target to 100 million doses due to production problems.

A Brussels court rejected an E.U. request for at least 120 million vaccine doses by the end of this month – something the company has claimed as a win.

Instead, the drug maker said the judge ruled it should deliver only 80.2 million doses by September 27th.

AstraZeneca said it would “substantially exceed” that amount by the end of this month and that the court backed its assertion that the European Commission “has no exclusivity or right of priority over all other contracting parties”.

However, European Commission President Ursula von der Leyen said the ruling supported the E.U.’s view that AstraZeneca had failed to meet its commitments.

“It is good to see that an independent judge confirms this,” she said.

“This shows that our European vaccination campaign not only delivers for our citizens day by day. It also demonstrates that it was founded on a sound legal basis.” …

AstraZeneca has now been told by the court to deliver 15 million doses by July 26th, another 20 million by August 23rd, and a further 15 million by September 27th.

If the company misses these deadlines it will face a penalty of €10 (£8.57) per dose not delivered, the European Commission said.

Worth reading in full.