Covid-19 vaccination in pregnancy
BMJ 2022; 378 doi: https://doi.org/10.1136/bmj-2021-069741 (Published 10 August 2022) Cite this as: BMJ 2022;378:e069741
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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 In 1961 the drug was withdrawn and the medical profession vowed to never again test new treatments on pregnant women.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
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
Re: Covid-19 vaccination in pregnancy
Dear Editor
The green book which is the authority used for UK vaccination has the following statement re Covid vaccines in pregnancy
Surveillance of the inadvertent administration of COVID-19 vaccines in early pregnancy is
being conducted for the UK by the UK Health Security Agency Immunisation and Vaccine
Preventable Diseases Division, to whom such cases should be reported.1 This surveillance is
being undertaken to document safety in women who unknowingly receive a vaccine in
early pregnancy to provide better information to inform women and health professionals.
As above, any women who are inadvertently vaccinated in early pregnancy should
complete vaccination at the recommended interval.
I know we ask if pregnant when jabbing. Can we assume if the answer is yes the 'system' then reports and follows them up or is some other mechanism meant to happen?
The wording of this has not changed (though the green books has additions to each chapter it rarely has whole chapters re written and updated)
If one also reads the latest NHSE advice i re vaccine in pregnancy (as commented in a rapid response last week) we are told only to vaccinate if we think the benefit outweighs the risk
We can assume that many women of child bearing age will have ben exposed to covid infection and many will have had a primary course of vaccination.. If giving informed consent for the autumn covid programme to pregnant women we are in a bit of a data vacuum as to their own and their child to be risk benefit
Competing interests: No competing interests