AstraZeneca

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.

Those Who Have Had AstraZeneca Vaccine – or No Vaccine at All – Banned From Upcoming Bruce Springsteen Show

Broadway is reopening in New York, but you’ll need to have received a vaccine approved by the country’s Food and Drug Administration (FDA) in order to go to a show. Bruce Springsteen will shortly be opening in a one-man show on Broadway, but audience members will be forced to show proof of vaccination to attend – and the AstraZeneca vaccine won’t count! The Telegraph has the story.

The show, billed as “an intimate night with Bruce, his guitar, a piano, and his stories” will run five nights a week at the St James theatre.

“At the direction of New York State, Springsteen on Broadway and the St James Theatre will only be accepting proof of FDA-approved Covid vaccines,” the website says.

Anyone who has received another jab, or is unwilling or unable to have a vaccine will not be allowed to attend.

The news has been met with disappointment just hours north, across the Canadian border, where more than 1.7 million people have had the AstraZeneca vaccine.

Only those who have had a Moderna, Pfizer or Johnson & Johnson vaccine will be allowed to go to the theatre.

Worth reading in full.

The nyc.com website says young children will be exempt from the vaccine rule, but no one else.

The only exception to the above will be for children under the age of 16, who must be accompanied by a vaccinated adult and also must provide proof of at least one of the following:

~ negative antigen Covid test taken within six hours of the performance start time, or

~ negative PCR Covid test taken within 72 hours of the performance start time.

AstraZeneca Covid Vaccine Recommended Only for Australians Aged 60 and Over

The Australian medicines regulator has recommended that the AstraZeneca Covid vaccine is only used in those aged 60 years and over amid further reports of blood clotting following vaccination, as well as reports of a link between the AZ vaccine and an illness that can leave patients paralysed.

Five out of the 12 confirmed and probable new cases of blood clotting following vaccination are actually in people over the age of 60, according to the Australian Therapeutic Goods Administration (TGA). A further four cases are in people less than five years away from turning 60. All remaining cases are in people above the age of 50.

The Guardian has more.

Pfizer will be the preferred vaccine for eligible people under 60 following a recommendation from the Australian Technical Advisory Group on Immunisation (ATAGI). However, people who have had their first shot of AstraZeneca will be advised to have their second shot of the same vaccine.

The Health Minister, Greg Hunt, said the opening of Pfizer to people aged 50 to 59 would mean that the 2.1 million people in this cohort who have yet to have the AstraZeneca shot will receive the Pfizer vaccine instead.

The TGA reported on Thursday there were a further 12 reports of blood clots and low blood platelets assessed to be confirmed or probable cases of thrombosis with thrombocytopenia syndrome (TTS) linked to the AstraZeneca vaccine in the past week.

The new cases include three confirmed in 55 and 65 year-old women from Victoria and a 53 year-old woman from NSW. The nine new probable cases include: a 54 year-old man from the Northern Territory, a 65 year-old woman from Tasmania, 50 and 56 year old men and a 69 year-old woman from Victoria, a 58 year-old woman from South Australia, 59 and 80 year-old men from Queensland, and a 67 year-old woman from NSW.

It takes the total of Australian reports of TTS following the AstraZeneca vaccine to 37 confirmed and 23 probable.

The estimated risk of TTS following the first dose is 3.1 per 100,000 for people under 50, 2.7 for people between 50 and 59, 1.4 for people between 60 and 69, 1.8 for people 70 to 79, and 1.9 for people over 80 years of age.

The Chief Medical Officer, Professor Paul Kelly, said the new cases had “changed the rate” for those between 50 and 59, changing the risk profile more in line with those under 50. There have been two deaths in Australia linked to TTS, and Kelly stressed it remains a very rare condition.

“Remember this remains a very rare but sometimes serious event; we’re picking it up much more commonly than other countries because we’re looking more fully,” he said. 

“For most people, they’ve been diagnosed early, there was a large proportion of those with a less severe form of this rare syndrome, and most of those have been discharged from hospital already.”

Last week, the Italian Government also restricted the use of the AZ vaccine to people over the age of 60 after the death of a teenager with blood clots following vaccination.

The Guardian report is worth reading in full.

PHE Quietly Revises Down Effectiveness of AstraZeneca Vaccine

The latest Public Health England (PHE) weekly vaccine surveillance report appeared on Thursday (another one is due tomorrow).

I wasn’t holding out high hopes for this instalment, after digging down into the method used the previous week and finding it didn’t control adequately for background incidence (so confounded vaccine effectiveness with natural decline) and applied such brutal adjustments it could turn a 4% effectiveness into a 73% one. It lived down to expectations.

The authors appear still to be working out what exactly their reports are for as each of the three to date presents different information in a slightly different way. While the first was largely a summary of evidence published elsewhere, the second served more as a showcase for PHE’s latest study and focused on effectiveness against symptomatic disease in the over-65s (90%, supposedly). This week, the over-65s are gone and the focus is on effectiveness against the Indian variant. This makes reading the reports quite confusing, as each doesn’t feel so much like an update to the previous one as a stand-alone report on a separate topic.

In between Report 2 (for week 20) and Report 3, a separate PHE study was published on the Indian Delta variant which found the effectiveness of full vaccination against symptomatic Covid reduced from 93% to 88% with Pfizer and 66% to 60% with AstraZeneca when the Indian Delta variant was involved versus the British Alpha variant.

As I noted last week, this 66% effectiveness of AstraZeneca (against the British Alpha variant) was a long way below the 90% in the over-65s claimed in Report 2. It’s probably a sign of how low my opinion is of PHE vaccine studies that I was pleasantly surprised to see this discrepancy actually make an impact on the data presented in Report 3, and you can see below in the AstraZeneca two-doses box (top right) week 20’s “85-90%” has become “65% to 90%” in week 21. There is still no explanation from PHE, however, as to why one of their studies finds AstraZeneca 90% effective against symptomatic infection in the over-65s while another finds it is just 66% effective in all ages. Is this not the kind of discrepancy that should occasion comment from the authors?

Scottish Government Covid Adviser U-Turns on Efficacy of AstraZeneca Vaccine against Variants

Professor Devi Sridhar, the Chair of Global Public Health at the University of Edinburgh and a member of the Scottish Government Covid Advisory Group, said two months ago (in a tweet that has since been deleted) that the AstraZeneca Covid vaccine does not work against the South African variant. She now claims that the vaccine does work against variants, and that “we have to move away from harsh restrictions and lockdowns”. “Steerpike” has the details on this U-turn in the Spectator.

Eight weeks ago… the good professor was spreading inaccurate information about the effectiveness of the AstraZeneca jab against new variants after she tweeted on March 26th: “Huge risk: watching a slow-moving car crash as U.K. Government stays open to France and other European countries, which have a South African variant our main vaccine (AZ) doesn’t work against. The red list approach doesn’t work. We need blanket international quarantine to avoid future lockdowns.”

Two months later, such a blanket international quarantine has not been introduced. Case numbers continue to fall in Scotland with just 313 cases reported yesterday and zero new reported deaths of those who tested positive. The red list approach is still in place and AstraZeneca is still being administered daily to thousands across the U.K.. You might have thought an academic who had been so outspoken on this might be somewhat embarrassed by this extremely positive data.

Apparently not, given Sridhar’s recent tweets. The professor has now done a complete 180 and switched to being bullish about the resilience of Britain’s vaccines (including the much-maligned AstraZeneca). She tweeted on May 23rd: “My take on current situation: variants will continue to cause issues but our vaccines (both doses!) are effective as an additional layer of protection. We have to move away from harsh restrictions and lockdowns to data-driven, precise outbreak management using science and logistics.” Quite the turn around.

Of course, you cannot point this volte-face out to Sridhar as she has a disconcerting habit of blocking her critics online. Her tweet of March 26th has now been deleted – not surprising given how inaccurate her AstraZeneca claims proved to be. Other claims are harder for Sridhar to remove, such as her apocalyptic warning on Sky News at the end of February that “there is a huge risk of bringing back all kids at the same time and then having to shut schools again” – another prediction that failed to transpire.

Sridhar herself has shown no qualms about demanding greater accountability and transparency for others, writing online that “secrecy goes against public good esp in crisis when decisions have implications for 66 million people”. Mr S wonders whether Sridhar’s preference for expunging her inaccurate predictions is conducive to good policymaking.

Worth reading in full.

15 Brits Have Suffered from Blood Clotting Disorders after Their Second AstraZeneca Covid Vaccine

15 cases of blood clotting have be found in Brits recently given their second dose of the AstraZeneca Covid vaccine up until May 12th, according to the U.K.’s medicines regulator. The occurrence rate is around one in 600,000 (nine million have been given two doses of the AZ vaccine to date) – though this could increase as younger people are given their second doses of the vaccine, given that people below the age of 40 are more likely to suffer from clotting after the first dose. The MailOnline has the story.

Scientists told MailOnline it was “disappointing” the extremely rare complication was becoming more frequent in double-jabbed patients. The clots – which can occur in the brain – are happening alongside abnormally low platelet levels, known as thrombocytopenia. 

But the Medicines and Healthcare products Regulatory Agency (MHRA) said symptoms were “milder” and less frequent than after the first dose. 

As of May 12th, the MHRA had spotted 294 cases of the clots in Britons given an initial injection, affecting about one in 80,000. The conditions were found to be occurring more frequently in young people, which has led to the British jab being restricted for use in under-40s. 

Scientists believe in some people, the immune system sees the vaccine as a threat and over-produces antibodies to fight it. These lead to the formation of clumps in the bloodstream, which can become deadly if the clots move towards vital organs and cut off supply.

Around 15 million people are still waiting on their second AstraZeneca vaccine, with millions of eligible under-40s yet to be fully inoculated.

The current guidance says younger people who had their first dose before the jab was restricted should come forward for their second. 

Department of Health bosses do not provide data on vaccine take-up by age, making it impossible to say how many younger adults are booked in for their top-up.  

Professor Paul Hunter, an expert in medicine at the University of East Anglia, said it was “disappointing” there had been more clotting cases after the second dose.

But he highlighted that they were even less common than a first dose and less severe, urging people to continue to come for their second.

Worth reading in full.

New PHE Study Says AstraZeneca Vaccine is Just 66% Effective. What Happened to “90% in the Over-65s”?

On Thursday, Public Health England (PHE) released a surveillance report (criticised here) claiming that both Pfizer and AstraZeneca Covid vaccines are up to 90% effective in preventing symptomatic infection in the over-65s.

Two days later, on Saturday, PHE released a new study, the headline for which is the reassuring news that the vaccines appear to work almost as well against the Indian variant. Included in the report, however, are quite different effectiveness figures for the AstraZeneca vaccine. It states: “Two doses of the AstraZeneca vaccine were 60% effective against symptomatic disease from the B.1.617.2 [Indian] variant compared to 66% effectiveness against the B.1.1.7 [British] variant.”

This 66% effectiveness against the British variant is much closer to the vaccine effectiveness reported in the AstraZeneca trial (70%) and is likely to be much closer to truth. The vaccine will be less effective still in the over-65s, and so the new figures are well below the 90% effectiveness in the over-65s claimed by Thursday’s PHE study. Much of the data from Thursday’s study also came from a period when the British variant was dominant.

Where, though, are the science journalists jumping on this blatant inconsistency in key data coming out of Government and asking probing questions? On Thursday, many outlets cheerfully reported a Government study showing 90% effectiveness in the over-65s for the AstraZeneca vaccine. On Saturday, the same outlets dutifully reported the next study from the same Government body showing the same vaccine is only 66% effective across all ages.

What has happened to journalism in this country, that this passes without question? What, for that matter, has happened to science? Does anyone care about getting to the truth, or is it just about conforming to the narrative? Is the country too invested in the vaccine-saviour narrative to be able to ask awkward questions about the inconsistent claims coming out of Government?

Stop Press: Ross Clark in the Spectator notes the disappointing effectiveness figures for the AstraZeneca jab and the worrying reports of severe side-effects and deaths and asks, is it time to retire the AstraZeneca vaccine?

PHE Study Showing Vaccines “90% Effective” is Plagued With Problems – and the Post-Vaccination Infection Spike is There Again

New data from Public Health England (PHE) suggests that the vaccines (both AstraZeneca and Pfizer) are up to 90% effective in preventing symptomatic infection in the over-65s when fully vaccinated.

This is a remarkable result and was widely reported in the media. It is notably much better than the trial data for AstraZeneca, which suggested only 70% efficacy for all ages.

So much better, in fact, that one wonders if something has gone wrong with one or the other study. How can a vaccine be 70% effective for all ages in a controlled trial then 90% effective in the over-65s in the real world? The authors of the PHE study did not compare their results to the AstraZeneca trial or attempt an explanation so we are none the wiser.

The new findings come from the second instalment of a weekly vaccine surveillance report from PHE. The first coincided last week with a peer-reviewed article in the BMJ which set out the study design and method in full. I’ve gone through this study and discussed it at length with others who are medically qualified and we’ve identified a number of issues that are worth flagging up as they call into question the reliability of the results.

What have the authors done? They’ve looked at all the Pillar 2 testing data for England (in the community, so not hospitals) and narrowed it down to “156,930 adults aged 70 years and older who reported symptoms of COVID-19 between December 8th 2020 and February 19th 2021 and were successfully linked to vaccination data in the National Immunisation Management System”. They excluded various test results, including when there are more than three negative follow-ups for the same person and anyone who had tested positive prior to the study.

They have then used this data to compare symptomatic infection rates between those who are vaccinated and unvaccinated, breaking it down by age, vaccine type, and days since vaccination.

Here’s the table of the people in their study.

The first thing to note is the huge difference in the positivity rate between vaccinated and unvaccinated groups. It is 24% in the vaccinated (32,832/(32,832+106,037)) and 65% in the unvaccinated (11,758/(11,758+6,303)). This wide disparity and very high positivity rate (the high rate presumably being due in part to everyone in the study, including those who test negative, having symptoms) cast doubt on the extent to which these can be considered representative groups that can fairly be compared or the results generalised to the population.

The next strange thing about the study is the authors split it into two, giving results separately for people vaccinated before January 4th and after January 4th. They explain this stratification as follows: