COVID‐19 vaccination in pregnancy: Need for global pharmaco‐vigilance

Abstract

Wuhan in China was the first place to be affected by the SARS-CoV-2 infection, called COVID-19, in December 2019, quickly spreading to the rest of the world through international travelers. It was declared a pandemic by WHO on March 11, 2020. 1 Its three waves with different variants of the virus hit the world in 2020-2022 and took a huge toll on millions of lives globally. The first vaccine against COVID-19, an mRNA vaccine by Pfizer/ BioNTech, was launched in December 2020. Later, several other types of vaccines were manufactured and launched. Presently there are nine different vaccines against COVID-19 that have obtained WHO's Emergency Use Listing. 2 Two COVID-19 vaccines, Pfizer and Moderna, have received full approval from the United States Food and Drug Administration (US-FDA). 3 Vaccination against COVID-19 was initially reserved for the most vulnerable population, primarily the elderly, healthcare workers, other front-line workers, and persons with comorbidity. Pregnant and lactating women were specifically excluded from the vaccination drive due to lack of evidence on safety of the vaccine for the pregnant woman, her fetus and her breastfed baby. For ethical reasons, no clinical trials could be conducted to study the effect of

Knowledge, Propensity and Hesitancy among Pregnant Women in the Post-Pandemic Phase Regarding COVID-19 Vaccination: A Prevalence Survey in Southern Italy

“…Other studies claim the presence of several risk factors to the development of vaccine hesitancy, with the role of many determinants [34,35]. For this reason, adequate vaccine counseling can be an important building block for increasing trust in the healthcare system, which will be essential in countering disinformation and misinformation about the COVID-19 vaccine for pregnant women [36][37][38][39][40][41][42][43][44]. Further research is necessary to test our results and explore additional questions.…”

Editorial: Vaccinations and women's reproductive health

“…There is a paucity of COVID‐19 vaccine safety reporting in pregnancy from LMIC settings. Establishment and strengthening of vaccine pharmacovigilance systems 18 and electronic health records 19 are required globally to ensure that adequate data are accessible for vaccine safety and effectiveness surveillance.…”

“…17 There is a paucity of COVID-19 vaccine safety reporting in pregnancy from LMIC settings. Establishment and strengthening of vaccine pharmacovigilance systems 18 and electronic health records 19 are required globally to ensure that adequate data are accessible for vaccine safety and effectiveness surveillance. This special issue on 'Vaccinations and Women's reproductive health' highlights the importance of healthcare provider education, vaccination advisories and improvement of vaccination logistics to improve the accessibility and acceptance of vaccines by women.…”

COVID-19 vaccine adverse events: Evaluating the pathophysiology from an undersulfated and degraded glycocalyx perspective

“…More research is needed to test the immunogenicity, reactogenicity, and safety of COVID-19 vaccines during pregnancy 282 , especially since pregnant and lactating women were excluded from the initial COVID-19 vaccine trials 283 . In recipients of the Pfizer vaccine, a wide-ranging immune response was observed, including stimulation of neutralizing nAb responses, stimulation of CD4 + cells, and expansion of effector memory CD8+ T cells in men and non-pregnant women.…”