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Rapid responses are electronic comments to the editor. They enable our users to debate issues raised in articles published on bmj.com. A rapid response is first posted online. If you need the URL (web address) of an individual response, simply click on the response headline and copy the URL from the browser window. A proportion of responses will, after editing, be published online and in the print journal as letters, which are indexed in PubMed. Rapid responses are not indexed in PubMed and they are not journal articles. The BMJ reserves the right to remove responses which are being wilfully misrepresented as published articles or when it is brought to our attention that a response spreads misinformation.

From March 2022, the word limit for rapid responses will be 600 words not including references and author details. We will no longer post responses that exceed this limit.

The word limit for letters selected from posted responses remains 300 words.

Re: Acute vertigo: getting the diagnosis right Diego Kaski, et al. 378:doi 10.1136/bmj-2021-069850

Dear Editor,

Assessment of vertigo consumes clinical time that is a precious resource. The DIx-Hallpike test takes time to set up and administer. In General Practice, a short, chair based test(1) (2) can identify laterality in BPPV and so leave time for an Epley Manoeuvre.

1.https://bjgp.org/content/bow-and-rise-test-leaves-time-epley-10-minute-c...
2. https://youtu.be/8FpxLPu_JCU

Competing interests: No competing interests

13 August 2022
Andrew j Ashworth
GP and Occupational Physician
Bonhard Medical Ltd
Bonhard House, Bo'ness, EH51 9RR
Re: Long covid: Hair loss and sexual dysfunction are among wider symptoms, study finds Jacqui Wise. 378:doi 10.1136/bmj.o1887

At the outset, the ‘COVID-19’ was described as a ‘Novel Disease’ and very rapidly became an ‘Unprecedented Devastating Ravaging 21st Century Scourge’ subsequently declared as the ‘COVID-19 Pandemic’ by the 11th March 2020! It was initially largely thought to be a ‘Respiratory System Disease’ manifesting mostly with Fever, Cough and Catarrh. Some ‘COVID-19 Cases’ also presented with ‘Loss of the Sense of Smell’ and ‘Loss of the Sense of Taste’! The ‘COVID-19 Presentation’ was further compounded by some being ‘Asymptomatic’! All these compromised the capacity to mount ‘Effective Global COVID-19 Control Interventions’!!
As the ‘COVID-19 Pandemic’ progressed, it became clear that the ‘COVID-19’ had other ‘Systemic Manifestations’ including but not restricted to the ‘Gastrointestinal System’, the ‘Neurological System’ and the ‘Haematological and Coagulation Systems’! Thus, there were ‘Reports’ of ‘COVID-19 Cases’ presenting with Diarrhoea, Abdominal Disturbances, Headaches, Altered Behaviour, Convulsions, Abnormal Bleeding Disorders, Widespread ‘Massive Clots’ in various ‘Body Systems’, ‘Immune System Disorders’ (Including ‘Cytokine Storm Syndrome (CSS)’) and peculiar ‘Multi-System Inflammatory Syndromes in Children’ (e.g. ‘Multi-System Inflammatory Syndrome in Children (MIS-C)’) 1-8!
With the emergence of the ‘SARS-CoV-2 Delta Variant’, the ‘COVID-19 Manifestations’ were reported to include ‘Some Hearing Loss’, more ‘Involvement of Children’ and ‘Very High Transmissibility’ than was observed with previous ‘SARS-CoV-2 Variants and Sub-variants’! Subsequently, the ‘COVID-19 Manifestations’ persisted for more than 4 weeks9 and lingered on to a different ‘Recognized Clinical Condition’ which is the ‘Long Covid’!!
A recent ‘Communication’ reports new ‘Long Covid Manifestations’ which include ‘Hair Loss’ and ‘Sexual Dysfunction’10! A critical review of Electronic Health Records of ‘Confirmed COVID-19 Cases’ from January 2020 to April 2021 in the United Kingdom revealed the commonest ‘COVID-19 Symptoms’ to be ‘Anosmia’ (6.49%), ‘Hair Loss’ (3.99%), ‘Sneezing’ (2.77%), ‘Ejaculatory Dysfunction’ (2.63%), ‘Reduced Libido’ (2.36%) and ‘Shortness of Breath’ (2.20%) while others were ‘Chest Pain’, ‘Hoarseness of Voice’ and ‘Fever’11! The ‘Communication’ also reported possible ‘Risk Factors’ for ‘Long Covid’ and include, among others: Blacks/ Minority, Poor Background, Obesity/ Overweight, Chronic Obstructive Pulmonary Disorder, Benign Prostatic Hyperplasia, Fibromyalgia, Anxiety, Depression etc11!!
From the narratives, thus far, it is obvious that increasingly more information is unearthed by the day concerning ‘COVID-19’ and ‘COVID-19 Pandemic Specifics’ and increasingly much less information is disposed with certainty and confidence because of the increasing ‘COVID-19 Chameleonic Manifestations’: Changing ‘Systems of Affliction’ to ‘Long Covid’ with ‘Transmuting Features’ all making ‘Global COVID-19 Pandemic Control’ a ‘Difficult Mission’! In spite of the ‘COVID-19 Chameleonic Manifestations’ and ‘Long Covid Uncertainties and Changing Picture’, it is reportedly suggested that ‘Long-term COVID-19 and ‘Long Covid’ Monitoring’ will be rewarding and beneficial re: Support for Research, Improved Service Delivery and Better Patient Involvement/ Engagement12! The ‘England Long Covid Registry’ is a ‘Case-in-Point’ in this regard13!!
This ‘Communication’ highlights the need for ‘High Alert’ to the emerging ‘COVID-19 Chameleonic Manifestations’ and the ‘Long Covid Changing Picture’ so as to bolster the ‘Global COVID-19 Pandemic Control Interventions/ Strategies’ to assure success with the ‘Global Fight’ against the ‘COVID-19 Pandemic’.

REFERENCES
1. Tian L, Li X, Qi F, Tang Q-Y. Presymptomatic Transmission in the Evolution of the COVID-19 Pandemic. https://www.researchgate.net/publication/339972752
2. Jin X, Lian J-S, Hu J-H et al. Epidemiological, Clinical and Virological Characteristics of 74 Cases of Coronavirus-infected disease 2019 (COVID-19) with gastrointestinal symptoms. Gut Epub ahead of print doi:10.1136/gutjnl-2020-320926 of 17th March 2020
3. Talan J. COVID-19: Neurologists in Italy to Colleagues in US: Look for Poorly-Defined Neurological Conditions in Patients with the Coronavirus. https://journals.lww.com/neurotodayonline/blog/breakingnews/pages/post.a... of 27th March 2020
4. Rettner R. Mysterious blood clots in COVID-19 patients have doctors alarmed. https://www.livescience.com/amp/coronavirus-blood-clots.html of 23rd April 2020
5. Willyard C. Coronavirus blood-clot mystery intensifies. https://www.nature.com/articles/d41586-020-01403-8 of 13th May 2020
6. Smith M. What Parents should know about Multi-System Inflammatory Syndrome in Children (MIS-C). https://www.chla.org/blog/health-and-safety-tips/what-parents-should-kno...
7. American Academy of Pediatrics. COVID-19 and Multi-System Inflammatory Syndrome in Children. https://www.healthychildren.org/English/health-issues/conditions/COVID-1... inflammatory condition.aspx of 25th June 2020
8. Levy HR, Suarez CI. COVID-19 and Cytokine Storm Syndrome. https://www.mlo-online.com/continuing-education/article/21138224/covid19... of 20th May 2020
9. Office for National Statistics. Prevalence of ongoing symptoms following coronavirus (covid-19) infection in the UK. 7 Jul 2022. https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/...
10. Wise J. Long covid: Hair loss and sexual dysfunction are among wider symptoms of , study finds. BMJ 2022; 378:o1887
11. Subramanian A, Nirantharakumar K, Hughes S, et al. Symptoms and risk factors for long covid in non-hospitalized adults. Nat Med 2022 (published online 25 Jul). doi:10.1038/s41591-022-01909-w
12. Davies F, Finlay I, Howson H, Rich N. Recommendations for a voluntary long covid registry. J Royal Soc Med 2022 (published online 27 Jul). doi:10.1177/01410768221114964https://journals.sagepub.com/doi/full/10.1177/01410768221114964
13. NHS England. Long covid: the NHS plan for 2021-22. Jun 2021. https://www.england.nhs.uk/coronavirus/documents/long-covid-the-nhs-plan...

Professor Charles Osayande Eregie,
MBBS, FWACP, FMCPaed, FRCPCH (UK), Cert. ORT (Oxford), MSc (Religious Education),
Professor of Child Health and Neonatology, University of Benin, Benin City, Nigeria.
Consultant Paediatrician and Neonatologist, University of Benin Teaching Hospital, Benin City, Nigeria.
UNICEF-Trained BFHI Master Trainer,
ICDC-Trained in Code Implementation,
*Technical Expert/ Consultant on the FMOH-UNICEF-NAFDAC Code Implementation Project in Nigeria,
*No Competing Interests.

Competing interests: No competing interests

13 August 2022
CHARLES OSAYANDE EREGIE
MEDICAL DOCTOR
Professor of Child Health and Neonatology, University of Benin, Benin City, Nigeria and Consultant Paediatrician and Neonatologist, University of Benin Teaching Hospital, Benin City, Nigeria
Institute of Child Health, University of Benin, PMB 1154, Benin City, Nigeria.
Re: Gestational diabetes mellitus and adverse pregnancy outcomes: systematic review and meta-analysis Zhixiong Liu, Fangkun Liu, et al. 377:doi 10.1136/bmj-2021-067946

Dear Editor,
We followed with interest the study by Ye et al. on the association of gestational diabetes mellitus (GDM) with adverse pregnancy outcomes; its findings could be useful in predicting risk and taking preventive measures to reduce adverse pregnancy outcomes. However, we consider that the study suffers from some methodological issues in the design and assessment, which may distort the true effects.
For the study design, the authors considered that insulin use can indicate poor glycaemic control, and therefore divided the studies into three categories: no insulin use, insulin use (different proportions of patients receiving insulin), and insulin use not reported. We have doubts about such a design: we believe that patients receiving insulin are more likely to have good glycaemic control, rather than poor control. Our argument can be supported by the results of meta-regression in the systematic review (Table S9), which showed that the proportion of patients receiving insulin was negatively associated with the incidence of preterm birth (β = -0.0069), namely, insulin was a protective factor of preterm birth (Here the authors were incorrect in their judgment that the proportion of patients receiving insulin was positively associated with the incidence of preterm birth). This evidence can shake all the conclusions regarding the association between insulin use and adverse pregnancy outcomes. We consider that only direct blood glucose indicators (e.g., fasting blood glucose, and glycated hemoglobin levels) can reflect glycaemic control, rather than using the proportion of patients receiving insulin as a replacement.
We also have some questions about the screening and assessment of this systematic review. First, the review excluded studies that identified GDM by the International Classification of Diseases (ICD) codes, for which the authors did not give a reasonable explanation. We believe that the diagnosis of GDM by the ICD codes is reliable and the exclusion of these studies would lead to selection bias. Second, we are concerned about the reliability of the selection process in Figure 1. Empirically, there should be more than 50% (22,310) duplicate records among the 44,620 records the systematic review screened, because a large proportion of bibliographies indexed in the four databases searched (Web of Science, PubMed, Medline, and Cochrane Database of Systematic Reviews) are identical. However, the authors only identified 1192 duplicates and 23,920 records were excluded as "irrelevant (rather than duplicate)" in the title and abstract screening. Third, although the authors gave definitions of high, medium, and low risk of bias for a single study, these definitions do not cover all scenarios; for example, it is unclear to which level of risk of bias "a study with a score of four for selection, one for comparability, and one for the outcome" can be assigned. Fourth, the authors did not include all subgroup categories in the subgroup analysis. For example, the subgroup analysis stratified by the risk of bias only included 50 studies with a low or medium risk of bias, and 106 studies with a high risk of bias studies were not included, without explanation. We believe that it is more important to evaluate the impact of studies with a high risk of bias on the effects estimates. Omitting the studies with a high risk of bias in the subgroup analysis may seriously underestimate the effect of the risk of bias on heterogeneity.
In summary, we believe that this systematic review and meta-analysis provided comprehensive evidence regarding the association between GDM and adverse pregnancy outcomes, but methodological limitations may affect the reliability of some key findings.

Competing interests: No competing interests

13 August 2022
Liu XiaoWu
Physician
Zhou Xu
School of Clinical Medicine, Jiangxi University of Chinese Medicine, Nanchang, China
Jiangxi University of Chinese Medicine, Mei Ling Da Dao No.1688, Nanchang 330004, Jiangxi, China
Re: Covid-19: Study provides further evidence that mRNA vaccines are safe in pregnancy Jacqui Wise. 378:doi 10.1136/bmj.o2013

Dear Editor
May I gently take Jacqui Wise to task for her reporting of the Canadian study providing “further evidence that mRNA vaccines are safe in pregnancy”?

This seems to be a follow-on article to a January BMJ news item that she references “Covid-19: Vaccination during pregnancy is safe, finds large US study”.

Had she read the response to that article from GP Dr Ayiesha Malik (1), she might have chosen her words differently. Neither of these studies shows that mRNA vaccines are safe in pregnancy. They may, as Dr Malik pointed out, suggest that they are not known to be harmful.

To put the Canadian study in perspective, it looked at adverse events occurring in the seven days after immunisation, i.e. 2.5% of the duration of a pregnancy.

Ref
1) https://www.bmj.com/content/376/bmj.o27/rapid-responses

Competing interests: No competing interests

12 August 2022
Peter Selley
Retired GP
Crediton, Devon
Re: Why the monkeypox outbreak constitutes a public health emergency of international concern Tedros Adhanom Ghebreyesus, World Health Organization. 378:doi 10.1136/bmj.o1978

Dear Editor,
A recent article confirms that Monkeypox (MPX) sometimes manifested ocular involvement as the first symptomatology, with the risk of not being correctly identified [1], so we might think that even the ophthalmologists could find themselves facing a case of MPX, having in the eye the first onset symptoms [2].
Disseminating awareness of atypical presentations is of vital clinical importance as failure to recognize MPX infection as a possible differential could pose a major risk to healthcare professionals and other contacts [3].
If to these factors, which make it difficult to think in non-endemic geographic areas to the disease caused by MPX virus, we also add the possibility that there are transmissions of the MPX virus conducted from some animals to humans or from humans to animals [4-6], the problem could really become serious. Above all, in a period of holidays with large movements of people.
References:
[1] Thornhill JP, Barkati S, Walmsley S. et al.; SHARE-net Clinical Group. Monkeypox Virus Infection in Humans across 16 Countries - April-June 2022. N Engl J Med. 2022 Jul 21. doi: 10.1056/NEJMoa2207323. Epub ahead of print. PMID: 35866746.
[2] Gianni Zuccheri, Minniti Davide; 08 August 2022 Rapid Response: Monkeypox and Ophthalmology https://www.bmj.com/content/378/bmj.o1845/rr
[3] Patel A, Bilinska J, Tam JCH, et al.. Clinical features and novel presentations of human monkeypox in a central London centre during the 2022 outbreak: descriptive case series. BMJ. 2022 Jul 28;378:e072410. doi: 10.1136/bmj-2022-072410. PMID: 35902115.
[4] Reynolds MG, McCollum AM, Nguete B, Shongo Lushima R, Petersen BW. Improving the Care and Treatment of Monkeypox Patients in Low-Resource Settings: Applying Evidence from Contemporary Biomedical and Smallpox Biodefense Research. Viruses. 2017 Dec 12;9(12):380. doi: 10.3390/v9120380. PMID: 29231870; PMCID: PMC5744154.
[5] McCollum AM, Damon IK. Human monkeypox. Clin Infect Dis. 2014 Jan;58(2):260-7. doi: 10.1093/cid/cit703. Epub 2013 Oct 24. Erratum in: Clin Infect Dis. 2014 Jun;58(12):1792. PMID: 24158414.
[6] Sophie Seang, Sonia Burrel, Eve Todesco, Valentin Leducq et al., Evidence of human-to-dog transmission of monkeypox virus The Lancet August 10, 2022

Competing interests: No competing interests

12 August 2022
Gianni Zuccheri
Ophthalmologist
ASL TO 3
ITALY
Re: Doctor who misdiagnosed girl’s fatal appendicitis as stomach bug receives warning Clare Dyer. 378:doi 10.1136/bmj.o1995

Dear Editor

Twice since 2020, I have written on behalf of the Doctors Association U.K. to the GMC pointing out that a doctor who is facing a fitness to practice proceeding that the GMC is not following the guidance that itself has signed up to for Just Culture as a partner (1), it took the GMC over a year in each instance to come to the same conclusion and find no case to answer.

If the regulator is unable to follow its own guidance is it actually fit for purpose?

I’ve seen nothing in this case to suggest that the GMC is in fact acting to improve patient care which actually is its remit. Perhaps if the GMC spent more time following its own guidance on Just Culture it would spend less time targeting doctors unfairly in fitness to practice hearings and actually improving patient care.

1. https://www.england.nhs.uk/wp-content/uploads/2021/02/NHS_0932_JC_Poster...

Competing interests: No competing interests

12 August 2022
David J Nicholl
Consultant Neurologist
Doctors Association U.K.
Dept of Neurology, City Hospital, Birmingham
Re: Covid-19 vaccination in pregnancy Martina L Badell, Carolynn M Dude, Sonja A Rasmussen, Denise J Jamieson. 378:doi 10.1136/bmj-2021-069741

Dear Editor,

Never again…

The study concludes “Covid-19 vaccination is the safest and most effective way for people who are pregnant to protect themselves and their babies against severe covid-19 disease”.

Has the medial profession forgotten the tragedy of falsely reassuring pregnant women about safe therapeutics in pregnancy?

In the 1950s thalidomide (1) was presented as a safe and effective drug to pregnant women for hyperemesis. Sadly, over 10 000 babies were born with congenital deformities and many died. In 1961 the drug was withdrawn and the medical profession vowed to never again test new treatments on pregnant women. The BNF (2) repeatedly reminds us, even when prescribing the most commonly used drugs such as paracetamol to consider the drug as not “safe” but “not known to be harmful”.

The article states: “Once mRNA from the vaccine has been read, it is destroyed” suggesting this is a quick process. However, studies demonstrate this can take weeks as opposed to minutes (3).

The article also states “COVID-19 vaccines are strongly recommended in pregnancy”. For a new injection using mRNA technology that has been licensed under emergency usage to be deemed “safe for pregnant women” with limited data is concerning. This is not the medicine and caution I was taught at medical school, but the chants of profiting medical pharmaceutical companies with a history of criminal fines (4), many of which are due to making false claims about their pharmaceutical products and suppressing trial results (5).

I remind doctors of our principles, “Do no harm”. It takes years and even decades to establish the safety of medication in pregnancy, even in a pandemic.

The number of pregnant women who have acquired immunity through prior infection, has not been acknowledged in the study, particularly in view of the evidence that natural immunity is on par with vaccine induced immunity (6)(7)(8). The waning and even negative efficacy data of the vaccine has also not been discussed. (9)

The term “vaccine hesitancy” refers to women who decline the intervention and “need educating”. Whatever happened to informed consent and autonomy? Declining a procedure does not make a woman hesitant and anxious. A pregnant woman’s decision to refuse an injection with no long term safety data, is a decision to be respected.

Dr Ayiesha Malik
Locum GP

1)https://pubmed.ncbi.nlm.nih.gov/21507989/
2) https://bnf.nice.org.uk/medicines-guidance/prescribing-in-pregnancy/
3) https://doi.org/10.1016/j.cell.2022.01.018
4) https://www.theguardian.com/business/2009/sep/02/pfizer-drugs-us-crimina...
5) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2875889/
6) https://www.medrxiv.org/content/10.1101/2022.03.17.22272529v1.full.pdf
7)  https://www.medrxiv.org/content/10.1101/2021.06.01.21258176v3
8)  https://www.medrxiv.org/content/10.1101/2022.07.06.22277306v1 
9) https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00089-7/fulltext

Competing interests: No competing interests

12 August 2022
Ayiesha Malik
Locum GP
Member of the Hart Group - but writing in a personal capacity.
ayiesha.malik@nhs.net
Re: An ethicist’s view on the Archie Battersbee case: a bad situation made worse Daniel Sokol. 378:doi 10.1136/bmj.o1980

Dear Editor,

I was only [loosely] following Archie's case through the media, and then Twitter. Just before I read Sokol's BMJ paper, I had read a piece by Dr Rachel Clarke (The Guardian {online}, Sunday 7 August 2022, 16.06 BST). Dr Clarke told readers 'Yet Archie's parents fundamentally disagreed with his medical team that recovery was impossible because Archie was brain dead'. That isn't the 'feeling neither joy nor pain' of Sokol's paper: it amounts to 'Archie was not thinking and feeling at all' - Archie was, using my phrase here, 'in a very-real sense already dead'.

Discussing this case with a friend, and starting by pointing out that 'I do adults - to me 'best interests' means section 4(6) of the Mental Capacity Act', I mentioned something which had struck me. Section 4(6) of the MCA, says that if it is known, what I shall term 'the patient's individuality' must be considered when coming to a best-interests determination. Logically, that leads to 'If the patient's individuality could never affect the determination, then the decision being made is NOT a best-interests decision'. It would be a very silly law, that required a decision-maker to consider something which could not affect the decision (and 4(6) says 'must consider'). I haven't read the court ruling, but my impression is that had Archie been any other 12 years old boy in the same clinical situation, the judge would [always] have arrived at the same ruling. So - and again admitting that the MCA does not apply to children, so my 'argument from 4(6)' is stretching things - if Archie had been an adult, then 'that cannot have been a best-interests decision' which the judge was expressing. At which point, I get stuck: I'm wondering if we are 'lacking a legal term' for the type of ruling which the judge made? Do judges, despite best interests for adults being defined within the MCA, fall back on 'best interests' as a term, in the way that unclear types of fossil were frequently classified as 'worms'?

Apologies if my chain-of-thought is indecipherable - I'm hoping it might be of some interest. And apologies for any proof-reading errors I've made.

TWITTER @MikeStone2_EoL

Competing interests: No competing interests

12 August 2022
Michael H Stone
Retired Non Clinical
None Private Individual
Coventry, West Midlands, England
Re: Mary Gillies John Gillies. 378:doi 10.1136/bmj.o1988

Dear Editors

In response to a sudden glut of obituaries on the BMJ at the same time, I was curious about the lives and deaths of those mentioned, in case they were somehow connected in the timeline to their deaths.

I am surprised to find that the BMJ obituaries are still not open access, being subscriber only.

Being of several institutions and organisations, I can get access to subscription-only areas of BMJ through their portals (the BMJ certainly being the basic requirement for clinical libraries/resources) so I am not whingeing about not getting access.

However, I would have thought in this day and age, where transparency and accessibility is touted as the new norm for the greater public, that obituaries of healthcare professionals, written by those who know them well and care to remember/remind others of their legacies, should be openly accessible to all, particularly to those who worked with them as colleagues/mentors, or were looked after by them as patients, or long lost friends/classmates/peers.

Several newspapers I know of have free access to obituaries, although some require registration (but not subscription) for access. I seriously doubt that the BMJ is going to lose big money by letting these writings become subscription-free access. After all, surely no monies should be generated from writings about those who were respected, and are honoured in memory after their passing.

Competing interests: No competing interests

12 August 2022
Shyan Goh
Orthopaedic Surgeon
Sydney, Australia
Re: Covid-19 vaccination in pregnancy Martina L Badell, Carolynn M Dude, Sonja A Rasmussen, Denise J Jamieson. 378:doi 10.1136/bmj-2021-069741

Dear Editor

Badell and colleagues’ review of Covid19 vaccination in pregnancy concludes that observational data confirm that the benefits of vaccination outweigh the potential risks. They suggest that there are still many avenues left open for research.

Little attention has been given to adverse effects on the babies born to mothers vaccinated during pregnancy; this is perhaps surprising in view of the concerns expressed in the “patient involvement” section where two pregnant women “both expressed concern about unknown fetal risks with receiving a novel vaccine in pregnancy.”

Several fundamentally different covid-19 vaccine types are available - Viral vector, Genetic (e.g. RNA), Inactivated, Attenuated and Protein.

It is not clear which of these have been tested on pregnant animals (including non-human primates), and what outcomes have been analysed.

Most of the reports of pregnancy outcomes in vaccinated mothers examine predictable events – miscarriage, premature labour, congenital abnormalities, etc. Vaccination during pregnancy is not straightforward. There is a need to look out for the unexpected.

For example, a recent report of an ongoing clinical trial of RSVpreF in pregnant women to prevent bronchiolitis in their offspring (1) showed more than twice as many babies of vaccinated mothers developing neonatal jaundice, or being born premature, compared with placebo controls.

In February this year an Independent Data Monitoring Committee recommended that another large trial of a different RSV vaccine given during pregnancy should be stopped, based on an observation from a routine safety assessment (2,3). That vaccine contained a recombinant subunit pre-fusion RSV antigen (RSVPreF3). The safety concerns have not been disclosed.

In addition, there are theoretical concerns that the presence of maternal antibodies in the baby has a potential for harm - vaccine-associated enhanced disease (4), a problem recognised with dengue vaccination of children.

Covid vaccination during pregnancy must be prioritized in vaccine research, but with particular emphasis on the outcome in the baby during its first few years of life.

References
1) Simões EAF et al. Prefusion F Protein–Based Respiratory Syncytial Virus Immunization in Pregnancy. Supplementary Appendix. N Engl J Med 2022; 386:1615-1626 DOI: 10.1056/NEJMoa2106062
2) https://www.clinicaltrials.gov/ct2/show/NCT04605159
3) https://www.gsk.com/en-gb/media/press-releases/gsk-provides-update-on-ph...
4) Gartlan C et al. Vaccine-Associated Enhanced Disease and Pathogenic Human Coronaviruses. Front. Immunol., 04 April 2022 Sec. Vaccines and Molecular Therapeutics https://doi.org/10.3389/fimmu.2022.882972

Competing interests: No competing interests

11 August 2022
Peter Selley
Retired GP
Crediton, Devon

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