9:45am 13 June 2021: This article was updated to reflect a clearer picture of findings from the PHE study on the effectiveness of Pfizer and AstraZeneca vaccines against the Delta variant of the coronavirus.
It’s now certain that the easing of coronavirus (Covid-19) restrictions will not commence on 21 June as anticipated. It will instead be delayed by some weeks. Moreover, scientists have identified a shortcoming in the vaccine programme. Despite the delay in easing of restrictions, unless this shortcoming is addressed, we’ll likely see a third wave of cases emerge.
And in a double whammy, one of the world’s leading medicines regulators has said the testing device widely used in the UK is worthless.
Shortcomings in vaccination programme
At the beginning of June, 25 scientists published a paper in the prestigious medical journal Lancet. The paper identified a significant flaw in the government’s strategy to ease coronavirus restrictions.
The paper examined the effects of the Pfizer-BioNTech vaccine against the five coronavirus variants. Other vaccines available in the UK were not studied in this paper. Although similar research into the AstraZeneca vaccine applied to the same variants is currently underway.
Significantly, the paper found:
After a first dose, Pfizer jab recipients had 79 per cent antibody protection against the original [Wuhan] strain, 50 per cent against the Alpha (Kent) variant, and only 32 per cent against the Delta (India) variant.
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It further found:
that in people who had been fully vaccinated with two doses of the Pfizer-BioNTech vaccine, levels of neutralising antibodies were more than five times lower against the B.1.617.2 [Delta or India] variant when compared to the original strain, upon which current vaccines are based.
Meanwhile an earlier Public Health England (PHE) report examined the effects of both the Pfizer and AstraZeneca vaccines. It found that three weeks after the first dose, both vaccines were 33% effective against symptomatic disease from the Delta variant, compared to 50% effectiveness against the Alpha (Kent) coronavirus strain. However, it also found that there was little reduction in efficacy after two doses of the Pfizer or AstraZeneca vaccines.
The findings of both reports appear to indicate one thing with regard to the Delta variant. That relying mostly on the vaccine, which has been the government’s strategy, will not be enough.
The Lancet paper also found another problem. Namely that those who’ve had the second dose will need a booster jab, sooner rather than later. The second dose provides protection, but the booster should be designed to combat the more recent variants.
Separately a BBC article claims that:
Out of 33,000 cases analysed by PHE and confirmed to be the Delta variant since February, 223 have been admitted to hospital – most were unvaccinated or had only had only dose, and 20 people were fully vaccinated.
Earlier in June, Independent SAGE made a number of recommendations to the government. These were on how the government should proceed if restrictions are eased. Independent SAGE also issued an emergency statement saying it “strongly advises” the government not to proceed with further easing of restrictions from 21 June.
According to Independent SAGE’s latest video report, the Delta variant now makes up a massive 90% of coronavirus cases in the UK.
Covid testing device worthless
Meanwhile the US Food and Drugs Agency (FDA) has announced that the Antigen Rapid Qualitative Test – known in the UK as the Lateral Flow Test (LFT) – is virtually useless. In fact, the regulatory body has gone as far to say that these test devices should be binned.
The FDA announcement goes on to explain how:
- False-negative results may lead to delayed diagnosis or inappropriate treatment of [coronavirus], which may cause patient harm including serious illness and death. False-negative results can also lead to further spread of [coronavirus]
It went on to add:
- False-positive results could lead to a delay in both the correct diagnosis and the initiation of an appropriate treatment for the actual cause of patient illness, which could be another life-threatening disease that is not [coronavirus]. False-positive results could also lead to further spread of [coronavirus] when presumed positive patients are grouped into cohorts based on false test results
The FDA also stated that on 23 April pharmaceutical company Innova recalled its Antigen Rapid Qualitative Test.
But concern over LFT isn’t new. In November 2020, The Canary reported on comments from expert Jon Deeks. Deeks is professor of biostatistics at the University of Birmingham and leader of Cochrane Collaboration’s coronavirus test evaluation activities. In a BMJ article on mass testing, specifically in Liverpool, Deeks remarked:
if 100 000 people are tested in a city where the prevalence of covid is 400 per 100 000, assuming the Innova test has a sensitivity of 58% and specificity of 99.6% (as per the testing centre performance), these figures predict the test will give 630 test positives. However, only 230 of these will have covid; 400 of them will be false positives.
The poor detection rate of the test makes it entirely unsuitable for the government’s claim that it will allow the safe ‘test and release’ of people from lockdown and students from university.
Also in November 2020, The Canary reported how leaked emails showed that PHE first raised the problem of antibody testing inaccuracies in September 2020. But the government blocked the report.
Moreover, experts described delivery of the government’s Test and Trace programme as a “lethal mistake”. Former associate specialist in haematology Bing Jones, former GP Jack Czauderna, and former director of public health, Sheffield Paul Redgrave suggested that:
the media and our profession appear complicit in allowing systematic misinformation, egregious miscalculation, delay, and diversion of public funds, to benefit private companies.
In January 2021, The Canary further reported on research on university students who used LFT. It showed that LFT for students at the University of Birmingham and universities in Scotland resulted in 58% false-positives. Also, a separate study found that the lateral flow method “failed to detect three in 10 cases with the highest viral loads”.
Clearly, there is a risk of giving false reassurance to people who get a negative result. You also have to question whether mass screening using a test that performs so poorly is the best use of our limited resources.
Separately, a Cochrane diagnostic review of 64 studies into LFTs confirmed that only 58% of people without symptoms, whether or not they have the virus, were correctly identified.
But the government ignored all these warnings. Instead it added the testing programme to ‘Operation Moonshot’, promoted by Dominic Cummings and headed by Dido Harding.
Over time, Test and Trace, which includes Lateral Flow Testing, would be allocated an eye-watering £37bn.
Avoiding a third wave
A revised, effective testing programme is sorely needed. Moreover, the Lancet study, together with observations from Independent SAGE, makes it clear that the government must delay easing of restrictions.
And a booster vaccine, that’s as least as effective as the current vaccines are against earlier variants, needs to be fast-tracked.
Otherwise, the alternative may be a third wave of cases – and thousands more deaths.
Featured image via Wikimedia – US Secretary of Defence
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