Day: 19 May 2021

Vaccine Safety Update

We’re publishing a round-up of Covid vaccine safety reports and news compiled by a group of medical doctors who are monitoring developments but prefer to remain anonymous in the current climate. By no means is this part of an effort to generate alarm about the vaccines or dissuade anyone from having them. At Lockdown Sceptics we report all news about the vaccines whether positive or negative and give no one advice about whether they should or should not be received. Unlike with lockdowns, we are neither pro-vaccine nor anti-vaccine; we see our job as to report the facts, not advocate for or against vaccines. The vaccine technology is novel and the vaccines have not yet fully completed their trials, which is why they’re in use under temporary and not full market authorisation. This has been done on account of the emergency situation and the trial data was largely encouraging on both efficacy and safety. For a summary of that data, see this preamble to the Government’s page on the Yellow Card reporting system. We publish information and opinion to inform public debate and help readers come to their own conclusions about what is best for them, based on the available data.

News Round-Up

  • COVID-19 vaccines are to be investigated by the European Medicines Agency for side-effects including Guillain Barre Syndrome, face-swelling anaphylaxis and blood clots.
  • AstraZeneca faces further bans in Slovakia, Quebec and Brazil (for pregnant women).
  • 57 Scientists and Doctors have created a report that summarises key concerns on COVID-19 vaccines regarding long and short term health implications.
  • The Israeli People’s Committee have released a report on the adverse events related to the COVID-19 vaccine (Pfizer).
  • Concerns continue to arise around COVID-19 vaccination and pregnancy. The MHRA have announced that the vaccines are safe for pregnant women, following the results of a “preliminary study” in the New England Journal of Medicine which only included a small group of 827 women, 13.9% of whom suffered pregnancy loss. Cases of spontaneous abortion have been reported to Yellow Card, VAERS and Eudravigilance and countries like Brazil have currently banned certain vaccines. Hundreds of thousands of reports have been made of hormonal disruption, bleeding and miscarriage with Facebook groups being censored and removed, as also reported by the BBC. Fears could centre around the effect of the virus (as replicated by vaccination) as flagged up in this study in the Journal of Cells on the effects on the placenta of COVID-19.
  • The MHRA has given approval for the mixing of vaccines following the publication of the Com Cov Study by Oxford University in the Lancet. This is despite findings that there is some increase in adverse events with the mixing of vaccines.
  • A useful article in the Pharmaceutical Journal summarised all the current approved vaccines and treatments for COVID-19 and others currently in development.
  • Concerns about the connection between COVID-19 vaccines and blood clots are ongoing – this week in relation to the Johnson & Johnson vaccine.
  • In a study by Radboud University Medical Center and Erasmus MC in the Netherlands, and the Helmholtz-Centre for Infection Research (HZI), Hannover Medical School (MHH), and the University of Bonn, in Germany, researchers have found possible links between mRNA vaccines and the reprogramming of the innate immune system.
  • VAERS update: The U.S. vaccine adverse event reporting system has recorded 4,057 deaths relating to COVID-19 vaccines as of May 7th 2021. This is over twenty times the average annual number of all vaccine-related deaths usually reported to VAERS (under 200 per year) in a period of less than four months. Forty six per cent of these deaths occurred in people who fell ill within 48 hours of being vaccinated.

Summary of Adverse Events UK

Updated report published on May 6th 2021 from MHRA Yellow Card Reporting up to 28th April 2021. (NB: Reported adverse events are not necessarily caused by the vaccine.)

Cumulatively 20 weeks for Pfizer (approx 19.5 million doses) and 16 weeks for AstraZeneca (approx 28.5 million doses) and two weeks for Moderna (approx 0.1 million doses); 34 million unique people received one or two doses; 215,939 unique reports filed with Yellow Card.

Total Events 757,564; Total Reports 215,939; Total Fatalities 1,102.

Health Experts Express “Grave Concerns” over Proposals to Vaccinate Children Against Covid

Over 40 health experts have expressed their “grave concerns regarding all proposals to administer Covid vaccines to children” in an open letter sent to the Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA). The letter was organised by Dr Ros Jones, a member of the Health Advisory and Recovery Team (HART), and warns against a “repeat of any past tragedies which have occurred especially when vaccines are rushed to market”. The Telegraph has more.

In a joint letter, [the health experts] warned it is “irresponsible, unethical and unnecessary” to jab children and urged the medicines watchdog not to “repeat mistakes from history”.

Their intervention came as Matt Hancock announced that Britain had bought enough Pfizer vaccines to inoculate all children over the age of 12.

The Health Secretary said the Government would be “very, very careful and sensitive” about whether to roll out the vaccination programme to children, but stressed that research showed the jabs were safe. 

He told MPs on Monday that a decision was likely to be taken within the next two months while the rollout continued through younger age groups.

[The letter reads:] “Extreme caution has been exercised over many aspects of the pandemic, but surely now is the most important time to exercise true caution.

“We must not be the generation of adults that, through unnecessary haste and fear, risks the health of children.”

The letter has been signed by over 40 medics, scientists and doctors including Professor Karol Sikora, Dean of Medicine at Buckingham University, and Lord Moonie, a former consultant in Public Health Medicine.

It argues that while there are clear benefits of a vaccine for the elderly and vulnerable, the balance of benefit and risk for youngsters is “quite different” since healthy children are at “almost no risk” from Covid.

The letter goes on to say that children do not need the vaccination to support herd immunity, adding that recent modelling suggests the U.K. has now achieved the herd immunity threshold.

“All medical interventions carry a risk of harm, so we have a duty to act with caution and proportionality,” it says.

“This is particularly the case when considering mass intervention in a healthy population, in which situation there must be firm evidence of benefits far greater than harms”.

A new petition, flagged up in today’s News Round Up, says that children should not be given Covid vaccines until Phase Three trials are complete.

The Telegraph report is worth reading in full.

“Danger of Unrest” in Bolton If Local Lockdown Imposed Because of Indian Covid Variant, Council Leader Warns

Ministers met on Tuesday to discuss emergency plans that could see local lockdown restrictions being imposed in Indian Covid variant “hotspots”, with Boris Johnson saying that things will be clearer in “days“. But the Leader of Bolton Council has warned that there is a “danger of unrest” if local restrictions are used in the area. Sky News has the story.

David Greenhalgh, a Conservative and head of the local authority, said that previous implementations of the coronavirus measures were ineffective in the region.

Speaking to the BBC’s Today programme, Mr Greenhalgh was asked if it was true he had warned Health Secretary Matt Hancock about civil unrest in the event of local Covid restrictions.

The councillor said: “I do think there is a danger of unrest.

“There was a great deal of resentment. Bolton was… disproportionately affected, really since July last year, and even when our rates were coming down, we still remained in lockdown when other areas rates were higher than ours.”

Bolton is currently one of the hotspots of the Indian variant of the coronavirus.

Cases have doubled in the last week, and 19 people are in hospital, according to Mr Hancock.

Mr Greenhalgh added: “We are putting all the measures in that we can at the moment. We have community spread, there’s no doubt about that, and we’re holding back a variant that would appear – although the evidence is still being gathered – to be a little bit more transmissible, easily transmissible.

“The majority of our cases are in very much our younger age groups – primary school, secondary school and in their 20s.

“We still haven’t got an increase in hospitalisation and severe illness, which is hugely welcome, those figures still remain low.”

As Will Jones highlighted in an earlier post, the number of Covid cases in Bolton – as well as in Blackburn with Darwen, another Indian variant hotspot – already seems to be flattening.

The Sky News report is worth reading in full.

Professor Neil Ferguson: Indian Variant Outbreaks are “Flattening”

Professor Neil Ferguson of Imperial College’s modelling team appeared on the BBC Radio 4 Today programme this morning where he took a surprisingly sanguine attitude to emerging data on the Indian variant in the UK. The Spectator has the transcript.

Presenter Nick Robinson asked him: “Transmissibility is this key thing that you’re looking to get the answer to. When do you think you will have that answer and is it really a case as we were hearing earlier on the programme which is if it is 50% more transmissible this variant, that’s little short of a disaster, but 20% we could kind of live with?”

Ferguson said:

So first of all it’s never all or nothing with science, you gain evidence as the data is collected. Certainly it is much easier to deal with 20 and 30 per cent than it would be 50% or more. The challenge we have – and just to explain to people why this is difficult, I mean we’re tracking this virus you could say “Well, why can’t we immediately see how it outcompetes the existing Kent variant?” – is because of how it was introduced into the country. 

It was introduced from overseas, principally into people with Indian ethnicity, a higher chance in living in multigenerational households and often in quite deprived areas with high density housing so we’re trying to work out whether the rapid growth we’ve seen in areas such as Bolton is going to be typical of what we could expect elsewhere or is really what is called a “founder effect” which is often seen in these circumstances. 

There’s a little bit of – I would say – a glimmer of hope from the recent data that while this variant does still appear to have a significant growth advantage, the magnitude of that advantage seems to have dropped a little bit with the most recent data so the curves are flattening a little but it will take more time for us to be definitive about it.

It certainly does seem to be flattening. Here’s the latest data from the hotspots.

New daily infections have also been dropping fast in India for some days now, having peaked in Delhi almost a month ago.

Large Events with No Masks and No Social Distancing Are Just as Safe as Going Shopping, Data Shows

Large events with no face masks and no social distancing are just as safe as dining at a restaurant or going shopping, new data shows – so long as measures such as pre-entry Covid tests are in place. The bad news is that these findings could, according to some reports, persuade the Government to introduce vaccine passports for such events. The Times has the story.

Preliminary data from the events research programme is understood to have found that with screening, improved ventilation and other mitigating factors the risk of virus transmission can be significantly reduced, reducing fears that sports matches and concerts could cause big outbreaks.

The results will boost hopes that the end of restrictions can go ahead as planned on June 21st despite the spread of the Indian variant.

They are likely to strengthen the case for requiring “Covid-status certification” for such events to prove that those attending are at lower risk of being infectious.

The results will be forwarded to ministers in the coming days before a decision on further easing of lockdown measures due next month.

While the research programme took place before concerns over the spread of the Indian variant, it is likely to form a key plank of the Government’s plans for the reopening of society.

A Government source said the results from the trials had been encouraging and further test events were planned for the coming weeks. “We are still waiting for the final bits of data but the results so far have been very encouraging,” the source said.

“It will help make the case that these large events are not inherently more risky than other parts of the hospitality sector. It shows that there are things that you can do to make these settings as safe as other daily activities.

“It is true that they are not going to be 100% safe but you can lower the risk to a reasonable level.”

It doesn’t appear, however, that this study had any control – at least, there have been no reports of events going ahead with no mitigating measures including pre-entry testing against which to compare the results. So how can they know that the measures have “reduced transmission”? A study without a control group can’t tell us anything about how effective and necessary the intervention is. There were no outbreaks with the testing. But maybe there wouldn’t be any without as well. And even if there are, why is that a problem if hospitals can cope? These questions don’t seem to be being answered.

The Government is said to have already told football’s UEFA that crowd sizes at upcoming events will be limited to 45,000. A review is expected to report on the settings in which domestic vaccine passports will be required later this month.

The Times report is worth reading in full.

Member of Independent SAGE Who Warned Against Reopening is Race Adviser with No Medical Qualification

One of Independent SAGE’s “experts”, who on Tuesday criticised the Government for not delaying the latest easing of lockdown restrictions, is a social scientist-cum-race adviser with no medical qualifications. Dr Zubaida Haque, a founding member of the group, told Good Morning Britain that the third step of the Government’s roadmap out of lockdown should have been stalled because of the Indian Covid variant – not only to protect the unvaccinated but also to protect the vaccinated, who she claimed could still be vulnerable to this strain of the virus.

Vaccines will certainly help to reduce severe disease [from the variant]… but at the moment there are some things that we still don’t know about this variant and one of the main things we don’t know is, to what extent it can still escape the vaccines. We need to find that out.

What the Government should have done was to stall this stage of the roadmap, particularly because we didn’t pass test four… [which says] if we think that there’s any further risk from new variants of concern, we should stall. They have completely ignored that and gone ahead.

The Telegraph has more on Dr Haque’s medical expertise – or lack thereof!

Dr Zubaida Haque… specialises in racial equality and has been involved with various Government-commissioned reports on welfare issues. 

In an interview with Good Morning Britain, she said the Government should have stalled the latest stage of the roadmap out of lockdown…

She went on to criticise Matt Hancock for his recent comments indicating vaccine hesitancy may be behind the rise in Covid hospitalisations in Bolton, one of the Indian variant hotspots. 

“This whole notion that, that at the moment, everyone’s freedom is threatened because of vaccine hesitancy groups is absolute nonsense,” Dr Haque said.

It was one of Dr Haque’s many TV interviews and newspaper columns since the pandemic began, ranging in scope from vaccine passports and the reopening of schools to financial support for low-paid workers needing to self-isolate.

However, she has no medical, clinical, virological or epidemiological qualifications.

Instead, her PhD thesis was titled: Exploring the validity and possible causes of the apparently poor performances of Bangladeshi students in British secondary schools. 

She now works for the Hamilton Commission, an organisation set up by Formula 1 star Lewis Hamilton to improve the representation of Black people in U.K. motorsport.

Dr Haque was not the only member of the historically overly cautious Independent SAGE group to take to the airwaves criticising the latest step towards freedom. 

Dr Kit Yates and Prof Gabriel Scally both appeared on Sky News, on Monday and Tuesday, respectively, talking about the new variant. 

Dr Yates is an expert in using mathematical techniques to predict biological models at the University of Bath, while Prof Scally is president of the Epidemiology and Public Health section of the Royal Society of Medicine.

Sir David King, chairman of Independent Sage said: “When we set up Independent SAGE we wanted to ensure that it was truly multi-disciplinary and fit for purpose when it comes to giving the best possible evidence-based advice in relation to the pandemic.

“We are proud to have such a wealth of experience to call upon as [we] require.”

Worth reading in full.

News Round Up