Authors Reply Section

Affiliations

1. Dr. Muhammad Ammar Bin Hamid, Department of Haematology and Oncology, Alabama Cancer Care Centre of Anniston, Alabama, USA

AUTHOR’S  REPLY

I appreciate the opportunity to address the points raised regarding my article on the potential adverse effects of the Johnson & Johnson (J&J) COVID-19 vaccine in pregnant women.

The J&J COVID-19 vaccine, also known as the Ad26.COV2.S vaccine, has not been recommended for pregnant women according to the latest guidelines of the Centres for Disease Control and Prevention (CDC) in the United States due to limited data on its safety during pregnancy.^1,2 This recommendation underscores the necessity for a cautious approach when considering vaccination options for such high-risk populations.

While clinical trials for the J&J vaccine did not specifically include pregnant women, data from animal studies have raised concerns about the potential risks of the vaccine during pregnancy. In particular, these studies have suggested that the vaccine may cause harm to the developing placenta, potentially leading to pregnancy complications.^3,4 This highlights the need for extensive human data to fully understand the implications of administering this vaccine to pregnant women.

It is crucial to consider that COVID-19 vaccines, when compared to influenza vaccines, are associated with a significant increase in adverse events with all proportional reporting ratios of >2.0. These adverse events include menstrual abnormalities, miscarriages, foetal chromosomal abnormalities, foetal malformations, foetal cystic hygromas, foetal cardiac disorders, foetal arrhythmias, foetal cardiac arrest, foetal vascular mal-perfusions, foetal growth abnormalities, foetal abnormal surveillance, foetal placental thrombosis, low amniotic fluid, and foetal death / stillbirth, all with p-values significantly lower than 0.05.⁵ This is not only statistically significant but also clinically alarming and has now been proven using correlating autopsy findings.⁶ These autopsy findings are crucial, revealing significant pathological changes that correlate with the adverse events reported. Such findings emphasise the need for careful consideration and further investigation into the vaccine's safety profile, especially for vulnerable populations such as pregnant women.

The response to my article seems to underestimate the gravity of the potential adverse effects and the lack of comprehensive data on the J&J vaccine's safety during pregnancy. Given the significant risks associated with pregnancy itself being a hypercoagulable state, it is imperative to follow the recommendations from authoritative bodies such as the CDC and the American College of Obstetricians and Gynaecologists (ACOG).^1,7

In my previous work, including the article "Challenges of COVID-19 Vaccination Delivery in Pakistan," I have consistently advocated for vaccination and have been pro-vaccine from the very first day.⁸ My advocacy is rooted in the understanding that vaccines are a critical tool in combating and even eradicating infectious diseases, provided they are backed by robust safety and efficacy data.

Furthermore, it is essential to acknowledge the emerging evidence suggesting that genetic predispositions can significantly impact individual responses to vaccines. Comprehensive research that includes genetic, environmental, and other risk factors is essential to developing a holistic understanding of vaccine safety in pregnant women.

In conclusion, the safety of the J&J COVID-19 vaccine in pregnant women remains an area requiring significant research. Until more robust data is available, it is critical to follow established guidelines that prioritise the safety of this vulnerable population. Rigorous research and years of testing are essential to establish comprehensive safety data before implementing widespread use of any vaccine.

REFERENCES

1. Centers for disease control and prevention. Vaccination considerations for people who are pregnant or breast-feeding. Available from: https://www.cdc.gov/coronavirus/2019- ncov/vaccines/ recommendations/pregnancy.html.
2. Centers for disease control and prevention. Johnson & Johnson's Janssen COVID-19 vaccine overview and safety. Available from: https://www.cdc.gov/coronavirus/2019- ncov/vaccines/different-vaccines/janssen.html.
3. Shimabukuro TT, Kim SY, Myers TR, Moro PL, Oduyebo T, Panagiotakopoulos L, et al. Preliminary findings of mRNA Covid-19 vaccine safety in pregnant persons. N Engl J Med 2021; 384(24):2273-82. doi: 10.1056/NEJMoa2104983.
4. Salvatore CM, Han JY, Acker KP, Tiwari P, Jin J, Brandler M, et al. Neonatal outcomes in pregnant women with COVID-19: A systematic review. Am J Obstet Gynecol MFM 2021; 3(3):100293. doi: 10.1016/j.ajogmf.2021.100293.
5. Thorp JA, Rogers C, Deskevich MP, Tankersley S, Benavides A, Redshaw MD, et al. COVID-19 vaccines: The impact on pregnancy outcomes and menstrual function. Preprints 2022:2022090430. doi: 10.20944/preprints202209. 0430.v1.
6. Hulscher N, Alexander PE, Amerling R, Gessling H, Hodkinson R, Makis W, et al. A systematic review of autopsy findings in deaths after COVID-19 vaccination. Forensic Sci Int 2024:112115. doi: 10.2139/ssrn.4496137.
7. American college of obstetrics and gynecology. COVID-19 vaccination considerations for obstetric–gynecologic care. Available from: https://www.acog.org/clinical/clinical- guidance/practice-advisory/articles/2020/12/covid-19-vaccination-considerations-for-obstetric-gynecologic-care.
8. Tariq S, Hamid MAB. Challenges of COVID-19 vaccination delivery in Pakistan. Pak J Med Sci 2021; 37(7):2036. doi: 10.12669/pjms.37.7.4489.