Evidence does not justify mandatory vaccines - everyone should have the right to informed choice
Dear Editor,
As doctors and health professionals, many of whom work in the NHS, we would like to express our opposition to anti-SARS-CoV-2 vaccination being mandated for any group of people, including health and care workers. We agree with the House of Lords committee that the evidence is insufficient to justify this measure, but the government and Parliament do not appear to be listening and mandatory vaccines for NHS staff looks likely to be passed into law this week.
We do not dispute that covid-19 can be and has been a dangerous infection, and we agree that vaccines are effective in many situations. However, there is considerable uncertainty about the effectiveness of the covid vaccines, some serious short-term complications and a lack of data on long-term harms. In this situation, it is imperative that people are able to make a fully-informed choice about whether to have the vaccine or not.
It is widely accepted that randomised controlled trials are the only means of providing robust data on the efficacy of medical interventions because observational data is subject to uncontrolled biases. Yet the randomised trials of the covid vaccines lasted for a very short time and were only powered to provide definitive statistical evidence on preventing ‘symptomatic infections’, not on preventing infection per se, hospitalisation or death. The trials also provided no data on whether the vaccines reduce transmission or not—things we have had to learn the hard way, through real world evidence like the rapid spread of the Delta and now Omicron variants.
Results from the randomised vaccine trials published so far suggested the vaccines were effective in reducing symptomatic infections for a few weeks. The average duration of follow-up for people in the first report from the Pfizer trial, on which licensing was based, was only 46 days, for example. [1] The recent report on data from people who had been in the trial for up to 6 months revealed that the mean total duration of follow-up for the primary outcome of the double-blind trial was 3.6 months for those who received the vaccine and 3.5 months for those allocated to placebo. [2] Moreover, only 7% of participants actually remained in the double blind trial for 6 months. [3] Real-world data are not consistent with the trial results, with high case numbers in doubly vaccinated individuals reported from the UK [4] and Israel [5], for example. This suggests either that effects of vaccines wear off quickly, and/or that some bias crept into original trial procedures, possibly due to unblinding caused by vaccine reactions [6] or other procedural irregularities. [7] The same observational data suggests the vaccines may reduce hospital admission and death due to covid infection, but, in the absence of data from randomised trials it is difficult to be certain, since unknown factors may bias the data in either direction.
More alarmingly, third and fourth ‘booster’ shots have not been tested in any randomised trials, and other data on the efficacy and safety of administering further doses are scanty.
In other words, data on the only outcome properly tested in randomised trials, the prevention of cases by two vaccinations, appear unreliable, possibly due to rapidly waning effects or other factors, and other outcomes and procedures have not been investigated in randomised trials, meaning there is no secure evidence either way.
As far as the safety of the vaccines is concerned, it is clear that rare but serious, and potentially fatal adverse effects occur, such as thrombosis and myocarditis, [8] and that these took months to identify. Long-term harms will be difficult to detect due to the short duration of the randomised trials, and will only become apparent in coming years.
There are also no data on groups who might be particularly adversely affected by the vaccine, such as those with, or at risk of autoimmune disorders, and there is little data on adverse effects of booster shots, which is significant since there have long been safety concerns about repeated exposure to mRNA technology. [9] Repeated booster vaccines therefore represent cumulative risk for untested benefit.
For young age groups, in whom covid-related morbidity and mortality is low, and for those who have had covid 19 infection already, and appear to have longstanding immunological memory, [10] the harms of taking a vaccine are almost certain to outweigh the benefits to the individual, and the goal of reducing transmission to other people at higher risk has not been demonstrated securely. [11]
Respecting people’s autonomy and bodily integrity is at the heart of human rights and medical ethics and the data currently available on the vaccines by no means justify over-riding these important principles. More good quality research and access to existing data from the vaccine trials are required for people to make fully-informed decisions about whether to take these vaccines or not. [12] Coercing people to have a covid vaccine, either through the threat of legal sanctions or, in the case of mandates for occupational groups, by depriving people of their livelihoods and careers, is not justified due to the prevailing uncertainty about the overall benefits of the vaccines, the unfavourable risk-benefit ratio for many groups, and, not least, the lack of data on long-term harms.
1. Polack FP, Thomas SJ, Kitchin N, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med 2020;383(27):2603-15. doi: 10.1056/NEJMoa2034577 [published Online First: 2020/12/11]
2. Thomas SJ, Moreira ED, Jr., Kitchin N, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months. N Engl J Med 2021;385(19):1761-73. doi: 10.1056/NEJMoa2110345 [published Online First: 2021/09/16]
3. Doshi P. Does the FDA think these data justify the first full approval of a covid-19 vaccine? British Medical Journal 2021 23rd Aug 2021. https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justi....
4. UK Health Security Agemcy. COVID-19 vaccine surveillance report: Week 48. 2021
5. Goldberg Y, Mandel M, Bar-On YM, et al. Waning Immunity after the BNT162b2 Vaccine in Israel. New England Journal of Medicine 2021;385:e85. doi: DOI: 10.1056/NEJMoa2114228
6. Doshi P. Pfizer and Moderna’s “95% effective” vaccines—we need more details and the raw data. British Medical Journal 2021 4th Jan 2021. https://blogs.bmj.com/bmj/2021/01/04/peter-doshi-pfizer-and-modernas-95-... (accessed 10th Dec 2021).
7. Thacker PD. Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial. British Medical Journal 2021;375:n2635. doi: doi.org/10.1136/bmj.n2635
8. Mevorach D, Anis E, Cedar N, et al. Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel. New England Journal of Medicine 2021;385:2140-49. doi: 10.1056/NEJMoa2109730
9. Garde D. Lavishly funded Moderna hits safety problems in bold bid to revolutionize medicine. STAT News 2017 10th Jan 2017. https://www.statnews.com/2017/01/10/moderna-trouble-mrna/ (accessed 12th Dec 2021).
10. Dan JM, Mateus J, Cato Y, et al. Immunological memory to SARS-CoV-2 assessed for up to 8 months after infection. Science 2021;371:(6529):eabf4063. doi: 10.1126/science.abf4063
11. Singanayagam A, Hakki S, Dunning J, et al. Community transmission and viral load kinetics of the SARS-CoV-2 delta (B.1.617.2) variant in vaccinated and unvaccinated individuals in the UK: a prospective, longitudinal, cohort study. Lancet Infect Dis 2021 doi: 10.1016/S1473-3099(21)00648-4 [published Online First: 2021/11/11]
12. Tanveer S, Rowhani-Farid A, Hong K, et al. Transparency of COVID-19 vaccine trials: decisions without data. BMJ Evid Based Med 2021 doi: 10.1136/bmjebm-2021-111735 [published Online First: 2021/08/11]
Competing interests:
No competing interests
13 December 2021
Joanna Moncrieff
Professor of Critical and Social Psychiatry
Professor Peter C. Gøtzsche, Dr Rufus May, Dr Giovanni Dalla-Valle, Dr Rachel Brown, Dr Lili Dawson, Dr Andrew Docherty, Professor Gabor Keleman, Dr Brian Martindale, Dr John Mason, Dr Gad Meyer, Dr. Livia Hronska, Dr Tomasz Pierscionek, Dr Pino Pini, Dr Jessica Robinson, Dr Clive Sherlock, Dr Marianne Siapera, Dr Federico Soldani, Dr Maria Tsvetkova, Dr Cathy Wield, Dr Sami Timimi, Dr Kasha Siubka-Wood
Rapid Response:
Evidence does not justify mandatory vaccines - everyone should have the right to informed choice
Dear Editor,
As doctors and health professionals, many of whom work in the NHS, we would like to express our opposition to anti-SARS-CoV-2 vaccination being mandated for any group of people, including health and care workers. We agree with the House of Lords committee that the evidence is insufficient to justify this measure, but the government and Parliament do not appear to be listening and mandatory vaccines for NHS staff looks likely to be passed into law this week.
We do not dispute that covid-19 can be and has been a dangerous infection, and we agree that vaccines are effective in many situations. However, there is considerable uncertainty about the effectiveness of the covid vaccines, some serious short-term complications and a lack of data on long-term harms. In this situation, it is imperative that people are able to make a fully-informed choice about whether to have the vaccine or not.
It is widely accepted that randomised controlled trials are the only means of providing robust data on the efficacy of medical interventions because observational data is subject to uncontrolled biases. Yet the randomised trials of the covid vaccines lasted for a very short time and were only powered to provide definitive statistical evidence on preventing ‘symptomatic infections’, not on preventing infection per se, hospitalisation or death. The trials also provided no data on whether the vaccines reduce transmission or not—things we have had to learn the hard way, through real world evidence like the rapid spread of the Delta and now Omicron variants.
Results from the randomised vaccine trials published so far suggested the vaccines were effective in reducing symptomatic infections for a few weeks. The average duration of follow-up for people in the first report from the Pfizer trial, on which licensing was based, was only 46 days, for example. [1] The recent report on data from people who had been in the trial for up to 6 months revealed that the mean total duration of follow-up for the primary outcome of the double-blind trial was 3.6 months for those who received the vaccine and 3.5 months for those allocated to placebo. [2] Moreover, only 7% of participants actually remained in the double blind trial for 6 months. [3] Real-world data are not consistent with the trial results, with high case numbers in doubly vaccinated individuals reported from the UK [4] and Israel [5], for example. This suggests either that effects of vaccines wear off quickly, and/or that some bias crept into original trial procedures, possibly due to unblinding caused by vaccine reactions [6] or other procedural irregularities. [7] The same observational data suggests the vaccines may reduce hospital admission and death due to covid infection, but, in the absence of data from randomised trials it is difficult to be certain, since unknown factors may bias the data in either direction.
More alarmingly, third and fourth ‘booster’ shots have not been tested in any randomised trials, and other data on the efficacy and safety of administering further doses are scanty.
In other words, data on the only outcome properly tested in randomised trials, the prevention of cases by two vaccinations, appear unreliable, possibly due to rapidly waning effects or other factors, and other outcomes and procedures have not been investigated in randomised trials, meaning there is no secure evidence either way.
As far as the safety of the vaccines is concerned, it is clear that rare but serious, and potentially fatal adverse effects occur, such as thrombosis and myocarditis, [8] and that these took months to identify. Long-term harms will be difficult to detect due to the short duration of the randomised trials, and will only become apparent in coming years.
There are also no data on groups who might be particularly adversely affected by the vaccine, such as those with, or at risk of autoimmune disorders, and there is little data on adverse effects of booster shots, which is significant since there have long been safety concerns about repeated exposure to mRNA technology. [9] Repeated booster vaccines therefore represent cumulative risk for untested benefit.
For young age groups, in whom covid-related morbidity and mortality is low, and for those who have had covid 19 infection already, and appear to have longstanding immunological memory, [10] the harms of taking a vaccine are almost certain to outweigh the benefits to the individual, and the goal of reducing transmission to other people at higher risk has not been demonstrated securely. [11]
Respecting people’s autonomy and bodily integrity is at the heart of human rights and medical ethics and the data currently available on the vaccines by no means justify over-riding these important principles. More good quality research and access to existing data from the vaccine trials are required for people to make fully-informed decisions about whether to take these vaccines or not. [12] Coercing people to have a covid vaccine, either through the threat of legal sanctions or, in the case of mandates for occupational groups, by depriving people of their livelihoods and careers, is not justified due to the prevailing uncertainty about the overall benefits of the vaccines, the unfavourable risk-benefit ratio for many groups, and, not least, the lack of data on long-term harms.
1. Polack FP, Thomas SJ, Kitchin N, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med 2020;383(27):2603-15. doi: 10.1056/NEJMoa2034577 [published Online First: 2020/12/11]
2. Thomas SJ, Moreira ED, Jr., Kitchin N, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months. N Engl J Med 2021;385(19):1761-73. doi: 10.1056/NEJMoa2110345 [published Online First: 2021/09/16]
3. Doshi P. Does the FDA think these data justify the first full approval of a covid-19 vaccine? British Medical Journal 2021 23rd Aug 2021. https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justi....
4. UK Health Security Agemcy. COVID-19 vaccine surveillance report: Week 48. 2021
5. Goldberg Y, Mandel M, Bar-On YM, et al. Waning Immunity after the BNT162b2 Vaccine in Israel. New England Journal of Medicine 2021;385:e85. doi: DOI: 10.1056/NEJMoa2114228
6. Doshi P. Pfizer and Moderna’s “95% effective” vaccines—we need more details and the raw data. British Medical Journal 2021 4th Jan 2021. https://blogs.bmj.com/bmj/2021/01/04/peter-doshi-pfizer-and-modernas-95-... (accessed 10th Dec 2021).
7. Thacker PD. Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial. British Medical Journal 2021;375:n2635. doi: doi.org/10.1136/bmj.n2635
8. Mevorach D, Anis E, Cedar N, et al. Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel. New England Journal of Medicine 2021;385:2140-49. doi: 10.1056/NEJMoa2109730
9. Garde D. Lavishly funded Moderna hits safety problems in bold bid to revolutionize medicine. STAT News 2017 10th Jan 2017. https://www.statnews.com/2017/01/10/moderna-trouble-mrna/ (accessed 12th Dec 2021).
10. Dan JM, Mateus J, Cato Y, et al. Immunological memory to SARS-CoV-2 assessed for up to 8 months after infection. Science 2021;371:(6529):eabf4063. doi: 10.1126/science.abf4063
11. Singanayagam A, Hakki S, Dunning J, et al. Community transmission and viral load kinetics of the SARS-CoV-2 delta (B.1.617.2) variant in vaccinated and unvaccinated individuals in the UK: a prospective, longitudinal, cohort study. Lancet Infect Dis 2021 doi: 10.1016/S1473-3099(21)00648-4 [published Online First: 2021/11/11]
12. Tanveer S, Rowhani-Farid A, Hong K, et al. Transparency of COVID-19 vaccine trials: decisions without data. BMJ Evid Based Med 2021 doi: 10.1136/bmjebm-2021-111735 [published Online First: 2021/08/11]
Competing interests: No competing interests