The Covid-19 Vaccine “Important Information” Leaflet
Authored by NHS Scotland, Healthier Scotland Scottish Government, Public Health Scotland
Date of this write up 11th May
There are 15 demonstrable and knowably incorrect items in this leaflet, which is the basis upon which patients are giving informed consent for this vaccine, required under Human Rights legislation etc. If there is misinformation in this leaflet. that denies receivers of the vaccine the possibility of giving informed consent.
Below, we have outlined our concerns about particular statements made in the leaflet, and omissions.
|Page 2 Section titled ‘What is COVID-19?’|
|1.||‘[COVID-19] is highly infectious and spreads through the air when people cough or sneeze, or when they touch surfaces where it has landed then touch their eyes, nose or mouth.’|
|a.||The first part of this statement is misleading: the virus is only as infectious as susceptibility to it is high, and only infected people spread through coughing and sneezing. It does only spread through the air, according to WHO (1).|
|b.||This virus has never been shown to spread through fomites. There have been many studies which have found the virus on surfaces, but there has never been culture grown from these samples, nor is there any evidence that any person has contracted the virus through touching an infected surface (2).|
|2.||‘It is possible to have COVID-19 without showing any symptoms’|
|This is nonsensical – COVID-19 is a disease and is a set of symptoms.|
|Page 3 Section titled ‘About the types of vaccine’
This section, despite its title gives no information about the types of vaccine – not that they are a new technology, nor how the different vaccines from different manufacturers vary. This is vitally important information to any patient’s attempt to give informed consent.
|3.||‘The vaccines will only be approved on the basis of large studies of safety and effectiveness’|
|The studies are in fact very small compared to the size of the population being vaccinated and therefore cannot determine likely outcomes in a much larger group, such as that being vaccinated. They are not, in fact, approved. They are authorised under emergency arrangements which, arguably, no longer apply.|
|4.||‘The UK vaccination programme has been very successful with tens of millions of people vaccinated and many thousands of lives already saved.’|
|This cannot be known. The decline in the cases and deaths in the UK as a whole have matched almost exactly the decline at the end of the epidemic last year. This was clearly a seasonal effect then, since there was no vaccine in the spring of 2020, and there is no way to distinguish that it is not a seasonal effect now (3).|
|5.||‘The vaccine will reduce your risk of getting seriously ill from COVID-19.’|
|This statement really should be quantified. The beneficial effect seen in the studies was minimal. And infection rates have risen in almost every country where the vaccine has been rolled out (4), so it is in fact very difficult to calculate to what extent the reduction in risk of serious illness exists (5).|
|6.||‘Being healthy does not reduce your risk of getting COVID-19 and passing it on.’|
|This is just untrue. Without co-morbidities, or with minor co-morbidities, you are much less likely to develop the disease COVID-19 following infection with SARS-CoV-2. If healthy, you are less likely to suffer severe symptoms and this reduces your risk of passing it on (6). This is all very clear from the UK Government and Scottish Government data. Healthy people are not spreaders of this disease (7).|
|7.||‘You can spread COVID-19 to family and those around you, even if you have very mild symptoms or no symptoms at all.’|
|It is extraordinarily unlikely you will pass on the disease if you have no symptoms. Specifically, you cannot have a disease with no symptoms. But the proportion of cases attributed to spread of SARS-CoV-2 from an asymptomatic person is 0.7% in the home in the research, without correcting for false positives, so this is a tiny risk (8).|
|8.||‘Rates of COVID-19 infection remain high.’|
|In the week 26th April to 2nd May, the ONS prevalence survey showed that the infection rate in the Scottish population was 1 in 760 (9). This is not ‘high’. The percentage of positive tests being returned has been hovering around or below 1% for weeks in Scotland at the time of writing (11th May) and the false positive rate is unknown. This is a very low rate of infection. As with all epidemics, this epidemic has to end some time, and if it had ended now, the apparent infection rates we see now would be what we expect. If the epidemic is over there would be no reason to vaccinate at all, because then the risk of the vaccine would become altogether unnecessary. There is no evidence of any widespread infection anywhere in Scotland now. These issues need to be addressed urgently.|
|Page 5 Section titled ‘What are the side effects?’|
|9.||‘Even if you do have symptoms after the first dose, you still need to have the second dose.’|
|If a patient has symptoms after the first dose, this implies that an immune response has been invoked. Why would a second dose be required? There is a risk of an over-reaction of the immune system if it is already primed after the first dose and there can be no benefit to the patient of risking a worse second reaction.
There is simply not enough known about these vaccines to make the statement made in the leaflet.
|10.||‘… having the full recommended course will give you the best protection against the virus.’|
|Referring to point 9, this seems unclear. It may give ‘better’ protection, but possibly at an unacceptable risk to the patient.|
|11.||‘These common side effects are much less serious than developing COVID-19 or complications associated with COVID-19.’|
|This needs to be put in context of age. Looking at the yellow card reports (and even without correcting for under-reporting in them) the risks to most age groups from the vaccine are greater than the risks of COVID-19. Most people in most age groups suffer no serious complications from COVID-19 and avoid developing the disease at all after infection, but the side effects seem rather more difficult to avoid for the vaccinated.|
|Page 7 Section titled ‘COVID-19 AstraZeneca vaccine and rare blood clots’|
|12.||‘Because of the high risk of complications and death from COVID-19…’|
|For the vast majority, even the most at risk, the risk of complications and death from COVID-19 is extremely low, by any calculation.|
|Page 10 Section titled ‘Fertility’|
|13.||‘There is no evidence to suggest that the COVID-19 vaccine will affect fertility.’|
|There is only ‘no evidence’ for this because there have been no studies into it, but early yellow card reports are alarming as they refer to menstrual difficulties and fertility issues following vaccination. The studies themselves recommended mitigations for those sharing a house with vaccinated persons because viral shedding was clearly a concern. This continuing concern is not being addressed currently.|
|Page 11 Section titled ‘How does the vaccine work?’|
|14.||‘The vaccine is suitable for people with disorders of the immune system.’|
|This cannot be known because the trials excluded people with immune system disorders. Those with immune system disorders or on medication to suppress antibody production are unlikely to be able to generate an antibody response and therefore would be unlikely to benefit from vaccination.|
|Page 13 Section titled ‘I’ve had COVID-19 before, should I still get the vaccine?’|
|15.||‘Yes. Even if you’ve already had COVID-19, you could still get it again.’|
|There is no evidence for this. Re-infections were extraordinarily rare (10). Those known to have had a prior infection were excluded in the trials, therefore it cannot be known what the risks to them from vaccination would be.|
|Omissions and obfuscation|
|Page 3 Section titled ‘About the types of vaccine’
This gives the patient no information about the vaccine, the novel nature of the technology or the differences in the technologies of the various manufacturers.
Page 7 Section titled ‘Reporting side effects’
This section does not explain to the patient the importance of reporting all side effects because these vaccines have not been fully trialled – trials finish 2023. This should have been stressed very strongly – and it is fairly mild advice in the way it is communicated in this leaflet.
Page 8 Section titled ‘Are there any reasons you should not get the vaccine?’
This section is woefully inadequate – the trials have not identified those who should not get the vaccine because they excluded any people who had health conditions.
Page 9 Section titled ‘People with bleeding disorders or taking medication to thin their blood’
Given the lack of trial data on people with these disorders, and the risks of blood clots seen due to the spike protein the vaccines instruct the cells to make, this seems like very unwise advice.
It is stated those with bleeding disorders should consult their specialist for vaccine advice, but this vaccine is novel so it is unclear how their specialist could advise them.
Page 14 Section titled ‘After the vaccine’
‘It is not yet known whether having the vaccine completely stops you spreading the virus to others’
This makes all the advice in this leaflet even more confusing, and it also makes a proper risk/benefit analysis impossible. But it is honest. We do not know to any extent at all how this vaccine prevents spread. In fact, it looks like there is reason to believe vaccinated people do spread the virus, since in almost every country where the vaccine is rolled out, there is a rise in COVID-19 infections immediately, and this phenomenon does not diminish as a larger proportion of the population is vaccinated.
Due to testing differences, the infections for the first wave have been scaled up by a factor of 7 so they can be compared to the second wave. This shows if anything there has been a slower rate of decline in the second wave, after vaccinations commenced.
(1) JAMA Network Open. 2020;3(12):e2031756. doi:10.1001/jamanetworkopen.2020.31756
(3) See Graph at end of this document
(5) Amit S, Beni SA, Biber A, Grinberg A, Leshem E, Regev-Yochay G. Post-vaccination COVID-19 among healthcare workers, Israel. Emerg Infect Dis. 2021 Apr [date cited]. https://doi.org/10.3201/eid2704.210016
(7) See Footnote 1
(8) See Footnote 1
(10) Assessment of protection against reinfection with SARS-CoV-2 among 4 million PCR-tested individuals in Denmark in 2020: a population-level observational study, The Lancet, Volume 397, Issue 10280, 27 March–2 April 2021, Pages 1204-1212