AstraZeneca

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:

Does the AstraZeneca Vaccine Give 97% Protection Against the Indian Variant? This Science-by-Press-Release Tells Us Nothing

A new study from India has been reported claiming to show that the AstraZeneca vaccine offers 97% protection against Covid infection. The observational study involved healthcare workers who reported to Delhi’s Indraprastha Apollo Hospital with symptomatic COVID-19 after having been vaccinated using the Covishield (AstraZeneca) vaccine. 

According to the newspaper report, there were a total of 3,235 healthcare workers in the study, all of whom had received at least one dose of the vaccine. Eighty five of them experienced symptomatic Covid, of which 65 were fully vaccinated and 20 were partially vaccinated. 0.06% were hospitalised, which appears to be two people. No one was admitted to intensive care or died.

This seems good. However, by itself it tells us almost nothing about how effective the vaccines are. Most crucially, there is no control group of unvaccinated people for comparison. We also don’t know how many of those vaccinated had a previous infection or exposure which would have provided some immunity – these are healthcare workers after all. Also, although this is India we don’t know which variant anyone was infected with.

Unfortunately, we can’t look into this in more detail as the study does not appear to have been published anywhere. Instead all we have is a newspaper report based on a press release.

The figures provided in the newspaper report also don’t make sense. It says:

The study covered 3,235 healthcare workers (HCWs). A total of 85 of the 3,235 HCWs acquired the SARS-COV-2 infection during the study period. Out of these, 65 (2.62%) were fully vaccinated, and 20 (2.65%) were partially vaccinated. 

What does the 2.62% refer to? 65 is 2.62% of 2,480.9, but where does 2,480.9 come from? Again, 20 is 2.65% of 754.7, but what is that number?

Eighty five is 2.63% of the 3,235 healthcare workers, which is close to 2.62% and would (almost) correspond to the headline of 97.38% protection. But the percentages in the brackets have no obvious relationship to the figures they accompany.

This is yet another example of science-by-press-release and shows again why it is such a poor way to present findings. Yet the results have appeared in newspaper headlines around the world, despite no one being able to read the actual study and the shortcomings of the uncontrolled design and the confused and incomplete reporting of the data.

Nonetheless, it does seem likely that immunity from infection or vaccination will also work against the Indian variant. But science by newspaper report is no way to show it or reassure doubters.

Pfizer and Moderna Vaccines to Be Offered to Under-40s From Thursday

The Covid vaccine rollout is set to extend to those below the age of 40 from Thursday, with the Pfizer and Moderna vaccines being offered as alternatives to that made by AstraZeneca “where possible”. MailOnline has the story.

An NHS bulletin showed adults aged 38 and 39 will be invited to come forward for their jab from Thursday morning.

They will be offered either the Pfizer or Moderna vaccine on the back of guidance from medical regulators last week.

The Joint Committee on Vaccination and Immunisation (JCVI) said under-40s should be given an alternative to the AstraZeneca jab due to its link to rare blood clots.

The NHS Digital bulletin said 38 and 39 year-olds already booked in for a first dose of the British vaccine will have their appointment cancelled…

The vaccine rollout is currently in phase two – which includes people between 20 to 49 – and is moving down by age. 

The Government says it is on track to fully vaccinate every adult in Britain by the end of July.

Everyone in phase one of the scheme, which included elderly people and patients with underlying health conditions, has already been offered a vaccine.

Uptake is thought to be around 90% in the over-60s U.K.-wide, while coverage in the over-50s is above 50% and still climbing. Over-50s only started to be invited last month…

The JCVI – which advises the Government on how best to vaccinate the population – said younger people should be offered an alternative to the AZ jab because of its link to blood clots. 

So far regulators have spotted major blood clots in 242 people given the AZ vaccine, of whom 49 died. But they are occurring more in younger adults, with a rate of around one in 60,000 under-40s.

Experts said the infection rate in the U.K. is now so low that the risk of the rare clots outweighs that of Covid in younger adults, who often only suffer mild illness. 

They will be offered the Pfizer or Moderna vaccines instead, so long as there is enough supply and it won’t delay the rollout.

Given that the risk of blood clots after taking the AstraZeneca vaccine outweighs the risk of Covid in younger adults, it is strange that the JCVI has only advised for alternatives to be given “where possible and only where no substantial delay would arise“. Why not just restrict its use for those below the age of 40 altogether?

The MailOnline report is worth reading in full.

Majority of Covid Hospital Admissions Over Winter Were Vaccinated, PHE Study Shows

The Government announced results from two new vaccine studies from Public Health England (PHE) yesterday. One looks at how much protection the vaccines offer against death once a person is infected, the other at how much protection against hospitalisation with COVID-19 the vaccines offer.

The study on deaths is the more straightforward of the two. It looks at PCR positive cases in England between December 8th and April 6th. It finds among 80+ year-olds: 16.1% (1,462/9,105) of unvaccinated cases died versus 9.2% (99/1,072) of cases at least 21 days after their first Pfizer dose, 11.3% (33/293) of cases at least 21 days after their first AstraZeneca dose and 4.7% (6/128) of cases at least seven days after their second Pfizer dose. These correspond to unadjusted relative risk reductions of 43% (Pfizer 1), 30% (AZ 1) and 71% (Pfizer 2) respectively.

Among 70-79 year-olds it finds 4.0% (1,147/28,875) of unvaccinated cases died versus 2.7% (15/549) for Pfizer 1, 2.1% (10/484) for AZ 1 and 0% (0/7) for Pfizer 2. This corresponds to unadjusted relative risk reductions of 33% (Pfizer 1), 47% (AZ 1) and 100% (Pfizer 2).

Once adjusted for sex, clinical risk factors, age and being a care home resident, these become relative risk reductions of 44% (Pfizer 1), 55% (AZ 1) and 69% (Pfizer 2). This level of reduction in the mortality rate among the vaccinated over-70s once infected is encouraging. The lack of data on deaths within 21 days of the first jab and seven days of the second jab is disappointing. Why do we have yet another study on vaccine efficacy with no accompanying analysis of safety?

The second study looks at whether vaccination protects against hospitalisation. Unlike the first study, it doesn’t look at those already infected (testing positive) to see whether they are hospitalised, but at those who are hospitalised to see whether they’ve been vaccinated. It analyses 13,907 admissions in trusts participating in a surveillance programme between December 8th and April 18th. It excludes those who caught the virus in hospital. It also excludes those whose positive PCR test was more than five days before admission (1,230 cases), the reason for which is not explained. The breakdown of admissions by sex, age and vaccination status is shown in the table below.

Notice that a majority of admissions in this period – 57% – had received at least one vaccine dose. An earlier study that I noted before, from the ISARIC4C consortium, had found just 7.3% of hospital admissions over a similar period had received at least one vaccine dose. The reasons for this huge discrepancy are unclear, but given that the earlier figure made headlines for showing how effective the vaccines are, and for the sake of clarity in data, it should be cleared up.

Vaccine Booking System Hasn’t Allowed Pregnant Women to Book the Specific Vaccines Recommended to Them by the JCVI and the NHS

The NHS’s vaccine booking site hasn’t just failed to keep people’s vaccine status private but has also failed to allow pregnant women to book the vaccines they have been advised – both by the Joint Committee on Vaccination and Immunisation (JCVI) and by NHS England – to receive.

The JCVI says that it is “preferable” for pregnant women to be “offered” the Pfizer or Moderna vaccines “where available” due to there being more “real-world data” from the U.S. on these vaccines and because “more research is needed” on the AstraZeneca vaccine when given to pregnant women. “Where available” is not strong enough for NHS England. GPs at sites that are only administering the AstraZeneca Covid vaccine were told last month to cancel all appointments for pregnant women and to direct them to sites where alternative vaccines are available.

Regardless of the advice given, it has not been possible, for this whole time, for pregnant women to book specific vaccines through the NHS vaccine booking system – an issue which is, at long last, being amended (though how long this might take is anyone’s guess). The Guardian has more.

After the Government announced that people under 40 would be offered an alternative to the AstraZeneca vaccine where possible, the Royal College of Obstetricians and Gynaecologists (RCOG) warned the system for pregnant women – who are advised to have the Pfizer or Moderna vaccines – was not working.

Charities said pregnant women had faced confusion, delays and wasted trips, with the online booking system giving no option to pregnant women to specify what vaccine they wanted…

Professor Wei Shen Lim, the JCVI chair, said he hoped NHS England would be able to overcome difficulties in pregnant women accessing the Pfizer or Moderna jabs. “I understand there have been some reports of difficulties in accessing the vaccines,” he told a televised briefing. “I certainly hope that operationally NHS England will be able to overcome those difficulties in access.”

A letter to health providers from senior bosses, including the National Medical Director for England, Professor Stephen Powis, published on Friday, said: “NHS Digital will be amending the national booking service in the coming days to allow pregnant women to book into specific vaccine appointments in line with JCVI guidance.”

Before news of the letter, Dr Pat O’Brien, the RCOG Vice-President, had said: “The latest Government guidance for pregnant women is to contact their GP for advice on how to receive the appropriate vaccine. However, GP practices are reporting that they don’t have the ability to do this, leaving pregnant women feeling frustrated and helpless as they are passed from pillar to post.” 

Joeli Brearley, of the campaign group Pregnant Then Screwed, said pregnant women had faced “insurmountable challenges” when trying to access the vaccine, including medical professionals giving sometimes inaccurate information.

“Pregnant women are telling us that this is affecting their mental health,” she said. “The Government has had a baby blind spot throughout this pandemic.”

Worth reading in full.