Vaccinating the UK against covid-19
BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4654 (Published 30 November 2020) Cite this as: BMJ 2020;371:m4654Read our latest coverage of the coronavirus outbreak

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Dear Editor
Re: - Vaccinating the UK.
This series of comments on the many questions currently being raised about the vaccines being rolled out for protecting populations against Covid-19 related illness includes the query ‘Do we know anything about interactions with other drugs?’ [1] The response given is that ‘no interaction studies have been performed’, which is understandable in the light of the speed at which vaccine development and trials of their use has had to proceed, though such data will emerge in due course. However, one potentially useful interaction could, and should, be investigated rapidly.
Better vitamin D status has been associated with greater seroprotective responses to vaccination with some strains of Influenza. [2] Curtailing the current Covid-19 pandemic and reducing its mortality is likely to be highly dependent on effective vaccination but vitamin D deficiency continues to be common across the UK, especially in BAME people [continuing an avoidable inequality known for 50 years] as recently confirmed in the UK Biobank cohort. [3,4] Thus, the opportunity should be taken to examine responses to vaccination in that representative cohort. Better pre-pandemic vitamin D status is also associated with dose-wise reductions in Covid-19 risks in a prospective study of a large representative cohort of Americans. [5]
Furthermore, emerging data suggests that better vitamin D repletion and correcting deficiency with large doses of D3 or with its 25-hydroxylated metabolite calcifediol [the substrate determining target tissue activation to form calcitriol] can reduce covid-19 severity and mortality, information that has led to correction of vitamin D deficiency being included in protocols for treating Covid-19 patients. [6] A recent report using UK Biobank data found a strong inverse association of serum 25(OH)D values, prospectively, with Covid-19 severity, abolished by adjustment for obesity and ethnicity which both reduce serum 25(OH)D concentrations directly by well-understood mechanisms, meaning that mechanistically predictable protective effects of adequate vitamin D repletion were not excluded. [7-9]
If the suggestion in a current open letter that vitamin D intakes likely to reduce deficiency rates could provide a simple, safe and cheap aid to reducing UK covid-19 risks were to be actioned, or if protection by vaccination against Covid-19 proved to be increased by pre-existing vitamin D repletion, these effects would be useful adjunctive measures for reducing Covid-19 risks nationally, especially in high risk groups for Covid-19 which are well-known to coincide with groups at high risk of vitamin D deficiency.
References
1. Mahase E. Vaccinating the UK, ‘How was the first Covid vaccine approved? How will it be rolled out, and who will get it? (do we know anything about interactions with other drugs?) 2020 12th December;371:427
2. Lee MD, Lin CH, Lei WT, Chang HY, Lee HC, Yeung CY, Chiu NC, Chi H, Liu JM, Hsu RJ, Cheng YJ, Yeh TL, Lin CY. Does Vitamin D Deficiency Affect the Immunogenic Responses to Influenza Vaccination? A Systematic Review and Meta-Analysis. Nutrients. 2018 Mar 26;10(4):409. doi: 10.3390/nu10040409. PMID: 29587438;
3. Sutherland JP, Zhou A, Leach MJ, Hyppönen E. Differences and determinants of vitamin D deficiency among UK biobank participants: A cross-ethnic and socioeconomic study. Clin Nutr. 2020 Nov 25:S0261-5614(20)30639-7. doi: 10.1016/j.clnu.2020.11.019. Epub ahead of print.
4. Bivins R. "The English disease" or "Asian rickets"? Medical responses to postcolonial immigration. Bull Hist Med. 2007 Fall;81(3):533-68. doi: 10.1353/bhm.2007.0062.
5. Kaufman HW, Niles JK, Kroll MH, Bi C, Holick MF. SARS-CoV-2 positivity rates associated with circulating 25-hydroxyvitamin D levels. PLoS One. 2020 Sep 17;15(9):e0239252. doi: 10.1371/journal.pone.0239252. PMID
6. Kory P, Meduri GU, Inglesias J, Varon J, Marik P. Clinical and Scientific rationale for . the “MATH+” hospital treatment protocol for COVID-19. (Analytic Rev.) J Int Care Med. 2020;1-20. DOI: 10.1177/0885066620973585
7. Hastie CE, Mackay DF, Ho F, Celis-Morales CA, Katikireddi SV, Niedzwiedz CL, Jani BD, Welsh P, Mair FS, Gray SR, O'Donnell CA, Gill JM, Sattar N, Pell JP. Vitamin D concentrations and COVID-19 infection in UK Biobank. Diabetes Metab Syndr. 2020 Jul-Aug;14(4):561-565. doi: 10.1016/j.dsx.2020.04.050. Epub 2020 May 7. Erratum in: Diabetes Metab Syndr. 2020 Sep - Oct;14(5):1315-1316. PMID: 32413819; PMCID.
8. Boucher BJ. Vitamin D status as a predictor of Covid-19 risk in Black, Asian and other ethnic minority groups in the UK. Diabetes Metab Res Rev. 2020 Nov;36(8):e3375. doi: 10.1002/dmrr.3375. Epub 2020 Jul 31. PMID: 32588937.
9. Bouillon R, Bikle D. Vitamin D Metabolism Revised: Fall of Dogmas. J Bone Miner Res. 2019 Nov;34(11):1985-1992. doi: 10.1002/jbmr.3884.
Competing interests: No competing interests
Dear Editor
I thank Judith Neaves for her response to the editorial from myself and Mariam Molokhia.
Dr Neaves questions whether suspending appraisals, revalidation and CQC inspections would have much impact on general practices. This was given as one example and would be needed to be supported by other measures, such as ensuring the NHS Hospital Contract is fully implemented, as I have argued in a previous article.[1]
Dr Neaves mentions workforce shortages. This is also an issue I have covered in a previous article.[2]
Finally, Dr Neaves questions whether I am in touch with grass roots GPs. I can confirm that I have been a GP Partner for over 20 years and I am fully familiar with the NHS GP (GMS) contract and with managing an NHS general practice, including lobbying on behalf of GPs with commissioners when other GPs have been unwilling to do this.[3, 4]
References
1. Price A, Majeed A. Improving how secondary care and general practice in England work together: requirements in the NHS Standard Contract. Journal of the Royal Society of Medicine. 2018;111(2):42-46.
2. Majeed A. Shortage of general practitioners in the NHS BMJ 2017; 358 :j3191
3. PMS cuts could force practice redundancies. https://www.pulsetoday.co.uk/news/contract/pms-cuts-could-force-practice...
4. GPs having to refer urgent cases for hubs due to ‘smart card’ problems. https://www.pulsetoday.co.uk/news/uncategorised/gps-having-to-refer-urge...
Competing interests: No competing interests
Dear Editor
General practice does need considerable support to deliver CVP, reasonable contracts with NHS to provide this, not ones that can be unilaterally changed with 1 hour notice, and crown indemnity. Additional staff needed, no point in NHS giving GP some additional funds when nurses and GP cannot be found. GP is already about 16% down in GP's before pandemic started.
Majeed and Molokhia are incorrect about suspending appraisals and revalidation and CQC inspections will make any significant different to work load to allow CVP to be delivered in primary care, this will make virtually no difference at all, and I wonder how in touch they are with grass roots GPs.
Ensuring secondary care stop off loading work to GP, refer to LMC conference motion, will help primary care. Fines are not much help , we just cant deal with any work from secondary care. There are emerging serious health problems , patients have delayed presenting to GP, and need immediate input to address this, including prompt appointments in secondary care for these patients. What about mobilizing GP and health care staff who volunteered to do additional work , coming out of retirement at the start of the pandemic?
Competing interests: No competing interests
Dear Editor
General practice does need considerable support to deliver CVP, reasonable contracts with NHS to provide this, not ones that can be unilaterally changed with 1 hour notice, and crown indemnity. Additional staff needed, no point in NHS giving GP some additional funds when nurses and GP cannot be found. GP is already about 16% down in GP's before pandemic started.
Majeed and Molokhia are incorrect about suspending appraisals and revalidation and CQC inspections will make any significant different to work load to allow CVP to be delivered in primary care, this will make virtually no difference at all, and I wonder how in touch they are with grass roots GPs.
Ensuring secondary care stop off loading work to GP, refer to LMC conference motion, will help primary care. Fines are not much help , we just cant deal with any work from secondary care. There are emerging serious health problems , patients have delayed presenting to GP, and need immediate input to address this, including prompt appointments in secondary care for these patients. What about mobilizing GP and health care staff who volunteered to do additional work , coming out of retirement at the start of the pandemic?
Competing interests: No competing interests
Dear Editor
We thank Paul Burnett for his comments on our editorial. Any drug or vaccine can generate an allergic reaction in a susceptible individual. We don’t yet know the full clinical details of the two people who were reported as having developed an allergic reaction to the Covid-19 vaccine they received. More details are likely to emerge in due course, such as the severity and nature of the allergic reactions. The MHRA did act quickly in response to these two reports and have recommended that people with a history of severe allergies should not undergo Covid-19 vaccination for now.
The number of people receiving a Covid-19 vaccination globally will soon far exceed the number of people who received the vaccines in clinical trials. Careful review of the medical records and subsequent health histories of these vaccine recipients will provide valuable information that can help guide professionals and patients about the merits and potential side effects of Covid-19 vaccination.
Competing interests: No competing interests
Dear Editor
The day after the roll out of the Pfizer vaccine commenced the MHRA were forced to issue a belated warning about the risk of anaphylaxis with particular suspicion surrounding the ingredient Polyetheline Glycol (PEG). MHRA Chief Executive June Raine said in a statement:
“Any person with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer BioNTech vaccine”
It was indicated that the issue may not come to light because people susceptible to allergic reactions had been excluded from Pfizer’s trials in the first place [1].
It is troubling this issue should have been revealed only after the product was offered to the public since it is apparent from the Reuter’s report that it was a known risk. In particular, I would point out that Children’s Health Defense, an organisation with which I am associated, including its chairman Robert F Kennedy Jr, wrote to the US government alerting it to the issue of PEG in relation to the rival Moderna product in August [2,3].
[1] Alistair Smout, ‘ UK issues anaphylaxis warning on Pfizer vaccine after adverse reactions’, Reuters 9 December 2020, https://uk.reuters.com/article/health-coronavirus-britain-vaccine/vaccin...
[2] Lyn Redwood, ‘ Breaking: CHD Responds to News of Life-Threatening Reaction to Pfizer COVID Vaccine. Will Regulators Take Action?’, Children’s Health Defense 9 December 2020, https://childrenshealthdefense.org/defender/pfizer-covid-vaccine-allergi...
[3] Robert F Kennedy Jr, Lyn Redwood, Harold Gielow, Letter to Dr Jerry Menikoff (Director, Office for Human Research Protections, Department of Health and Human Services), 26 August 2020, https://childrenshealthdefense.org/wp-content/uploads/Letter-to-OHRP-8-2...
Competing interests: AgeofAutism.com, an on-line daily journal, concerns itself with the potential environmental sources for the proliferation of autism, neurological impairment, immune dysfunction and chronic disease. I receive no payment as UK Editor. I also moderate comments for the on-line journal ‘The Defender’ for which I am paid. I am also a member of the UK Medical Freedom Alliance
Dear Editor,
MHRA’s ‘Information for Healthcare Professionals on Pfizer/BioNTech COVID-19 vaccine [1], updated yesterday (8th Dec 2020), makes no mention of possible allergic reactions. A number of other possible adverse events are listed; most frequently ‘pain at the injection site (> 80%), fatigue (> 60%), headache (> 50%), myalgia (> 30%), chills (> 30%), arthralgia (> 20%) and pyrexia/fever (> 10%)’. These symptoms have been reported as ‘usually mild or moderate in intensity and resolved within a few days after vaccination’ – usually, but evidently not always?
Vaccines are normally developed over 8 – 10 years: that is the timespan required to establish a true risk/benefit ratio, and to be able to fulfil legal requirements to warn recipients of all possible adverse events. That ‘serious allergic reactions’ should occur within a few hours of the ‘vaccine rollout’ start prompts serious concerns on what other hidden dangers lie in store.
This is surely a good time to remind MHRA and all politicians of top vaccinologist Paul Offit’s warning, as quoted in the BMJ by associate editor Professor Doshi [2]: ‘“If we don’t have adequate data in the greater than 65 year old group, then the greater than 65 year old person shouldn’t get this vaccine, which would be a shame because they’re the ones who are most likely to die from this infection. ….. I can’t see how anybody—the Data and Safety Monitoring Board or the FDA Vaccine Advisory Committee, or FDA decision-makers—would ever allow a vaccine to be recommended for that group without having adequate data.” [3]
Professor Doshi also notes: ‘None of the [Covid-19] trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus’. [3] And the 90 – 95% efficacy claims are now exposed as being calculated on the back of misleading use of PCR tests (nothing misleading about PCRs per se – it’s that those tests are neither licensed, nor even designed, to diagnose Covid).
Everyone is entitled to choose to receive a Covid-19 vaccine, but the law requires all risks first to be disclosed: including Professor Doshi’s and Paul Offit’s warnings.
[1] https://www.gov.uk/government/publications/regulatory-approval-of-pfizer...
[2] https://www.bmj.com/about-bmj/editorial-staff/peter-doshi
[3] https://www.bmj.com/content/371/bmj.m4037
Competing interests: Practising homeopath. Not ‘anti-vax’, but pro-health, pro safety, and pro-informed choice.
Dear Editor
I am sure all the correspondents here would wish to thank Azeem Majeed and Mariam Molokhia for their noble aspirations [1] (and I thank them particularly for their personal reply). If one has qualms it is because the science at this stage seems somewhat incomplete, speculative and even premature [2, 3]. Might we have made even more progress at combatting the epidemic if early on we had focussed on what was known [4,5,6]. It is not only in the Prime Minister’s terms that have we been waiting for “the cavalry” all this time, it is that battles usually have casualties.
[1] Responses to Majeed and Molokhia, ‘ Vaccinating the UK against covid-19’, https://www.bmj.com/content/371/bmj.m4654/rapid-responses
[2] ‘Peter Doshi: Pfizer and Moderna’s “95% effective” vaccines—let’s be cautious and first see the full data’, https://blogs.bmj.com/bmj/2020/11/26/peter-doshi-pfizer-and-modernas-95-...
[3] Pete Doshi, ‘ Will covid-19 vaccines save lives? Current trials aren’t designed to tell us’, BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4037 (Published 21 October 2020)
[4] Ellen CG Grant, ‘ Life saving high dose Vitamin D and Vitamin C Re: Covid-19’s known unknowns’, 22 October 2020, https://www.bmj.com/content/371/bmj.m3979/rr-7
[5] Ellen CG Grant, ‘ Vitamin D and Vitamin C missing Re: Covid-19: politicisation, “corruption,” and suppression of science’, 17 November 2020, https://www.bmj.com/content/371/bmj.m4425/rr-28
[6] Ellen CG Grant, ‘ Vitamin D and Pandemics Re: Malnutrition: the silent pandemic’, 2 December 2020, https://www.bmj.com/content/371/bmj.m4593/rr
Competing interests: AgeofAutism.com, an on-line daily journal, concerns itself with the potential environmental sources for the proliferation of autism, neurological impairment, immune dysfunction and chronic disease. I receive no payment as UK Editor. I also moderate comments for the on-line journal ‘The Defender’ for which I am paid. I am also a member of the UK Medical Freedom Alliance
Dear Editor
We thank Mitzi Blennerhassett for her response to our editorial. We agree with Mitzi Blennerhassett that the public need to have easy access to full information about Covid-19 vaccines. This is also the case for health professionals, who will be responsible for counselling patients and administering vaccines. Much of the information about the new vaccines for both health professionals and patients has come via the media rather than through official channels from government bodies. It is also the case that detailed documents have been sent to health professionals with very limited time for them to read and respond to the information in the documents. We hope that NHS England can improve its performance in this regard and give NHS staff (and patients) enough time to review the information they send before they make very important decisions about their participation in the Covid-19 vaccine programme.
Competing interests: No competing interests
Vaccinating the UK against covid-19: response to Barbara J Boucher
We thank Barbara Boucher for her response to our editorial. Dr Boucher suggests that Vitamin D supplements may help protect people from the risks from a Covid-19 infection. The National Institute of Health Care Excellence (NICE) recently reviewed this question and concluded that there was currently insufficient evidence to support taking vitamin D solely to prevent or treat covid-19.[1]
Further research is ongoing about the use of Vitamin D in Covid-19 that will provide new data on this question and whether this conclusion needs to change.[2] While we await further data, people should follow UK government advice and take a Vitamin D supplement during the Autumn and Winter to maintain bone and muscle health, in line with guidance from the National Institute of Health Care Excellence, Public Health England, and the Scientific Advisory Committee on Nutrition.[3]
References:
1. NICE. Covid-19 rapid guideline: vitamin D. 17 December 2020. www.nice.org.uk/guidance/ng187.
2. Wise J. Covid-19: Evidence is lacking to support vitamin D’s role in treatment and prevention BMJ 2020; 371 :m4912
3. Statement from PHE and NICE on vitamin D supplementation during winter. 28 November 2020. www.gov.uk/government/publications/vitamin-d-supplementation-during-wint...
Competing interests: No competing interests