COVID-19: latest safety data provide reassurance about use of mRNA vaccines during pregnancy

News 18/01/2022

Vaccination remains a major pillar of the response to COVID-19, particularly as variants of the virus continue to spread in EU/EEA countries. EMA’s COVID-19 task force (ETF) highlights the growing evidence indicating that mRNA COVID-19 vaccines do not cause pregnancy complications for expectant mothers and their babies. 

The task force undertook a detailed review of several studies involving around 65,000 pregnancies at different stages. The review did not find any sign of an increased risk of pregnancy complications, miscarriages, preterm births or adverse effects in the unborn babies following mRNA COVID-19 vaccination. Despite some limitations in the data, the results appear consistent across studies looking at these outcomes.

Studies also showed that COVID-19 vaccines are as effective at reducing the risk of hospitalisation and deaths in pregnant people as they are in non-pregnant people. The most common side effects of the vaccines in pregnant people also match those in the overall vaccinated population. They include pain at the injection site, tiredness, headache, redness and swelling at the site of injection, muscle pain and chills. These effects are usually mild or moderate and improve within a few days of vaccination.

Given that so far pregnancy has been associated with a higher risk of severe COVID-19 particularly in the second and third trimesters, people who are pregnant or might become pregnant in the near future are encouraged to get vaccinated in line with national recommendations.

Most of the information so far has come from mRNA vaccines (Comirnaty and Spikevax). EMA will also review data for other authorised COVID-19 vaccines as they become available.

Initial clinical trials do not generally include pregnant people. As a result, data on the use of vaccines as any other medicines during pregnancy, are not usually available at the time of the authorisation but are obtained afterwards. Animal studies with the COVID-19 vaccines did not show any harmful effects in pregnancy or post-natal development. The review of real world evidence suggests that the benefits of receiving mRNA COVID-19 vaccines during pregnancy outweighs any possible risks for expectant mothers and unborn babies.

EMA’s human medicines committee (CHMP) will consider the latest data from the manufacturers of mRNA COVID-19 vaccines during pregnancy with a view to updating the recommendations in the product information for the vaccines where applicable.

Monitoring the safety of vaccines

In line with the EU’s safety monitoring plan for COVID-19 vaccines, those vaccines are closely monitored, and relevant new information emerging is continuously collected and promptly reviewed. Although very large numbers of people have already received COVID-19 vaccines, certain side effects may still emerge as more and more people are included in vaccination programmes. EMA’s safety committee, PRAC will continue to monitor safety in pregnancy.

The companies are required to provide regular updates and conduct studies to monitor the safety and effectiveness of their vaccines as used by the public. Authorities also conduct additional studies to monitor safety and effectiveness of the vaccines, including their use in pregnancy.

These measures allow regulators to swiftly assess data emerging from a range of different sources and take appropriate regulatory action to protect public health if needed.


References

Vaccination during pregnancy

Kachikis A, Englund JA, Singleton M, Covelli I, Drake AL, Eckert LO. Short-term Reactions Among Pregnant and Lactating Individuals in the First Wave of the COVID-19 Vaccine Rollout. JAMA Network Open. 2021;4(8):e2121310.

Zauche LH, Wallace B, Smoots AN, et al. Receipt of mRNA Covid-19 vaccines and risk of spontaneous abortion. N Engl J Med 2021;385:1533-1535.

Magnus MC, Gjessing HK, Eide HN, Wilcox AJ, Fell DB, Håberg SE. Covid-19 Vaccination during Pregnancy and First-Trimester Miscarriage. N Engl J Med. 2021 Nov 18;385(21):2008-2010.

Kharbanda EO, Haapala J, DeSilva M, et al. Spontaneous Abortion Following COVID-19 Vaccination During Pregnancy. JAMA. 2021 Oct 26;326(16):1629-1631.

Pregnancy outcomes

Wainstock T, Yoles I, Sergienko R, Sheiner E. Prenatal maternal COVID-19 vaccination and pregnancy outcomes. Vaccine. 2021;39(41):6037-6040.

Bookstein Peretz S, Regev N, Novick L, et al. Short-term outcome of pregnant women vaccinated with BNT162b2 mRNA COVID-19 vaccine. Ultrasound Obstet Gynecol. 2021 Sep;58(3):450-456.

Rottenstreich M, Sela HY, Rotem R, Kadish E, Wiener-Well Y, Grisaru-Granovsky S. Covid-19 vaccination during the third trimester of pregnancy: rate of vaccination and maternal and neonatal outcomes, a multicentre retrospective cohort study. BJOG. 2022 Jan;129(2):248-255.

Blakeway H, Prasad S, Kalafat E, et al. COVID-19 vaccination during pregnancy: coverage and safety. Am J Obstet Gynecol. 2021 Aug 10:S0002-9378(21)00873-5. 
UK Health Security Agency. COVID-19 vaccine surveillance report. Week 47. 25 November 2021.

Theiler RN, Wick M, Mehta R, Weaver AL, Virk A, Swift M. Pregnancy and birth outcomes after SARS-CoV-2 vaccination in pregnancy. Am J Obstet Gynecol MFM. 2021;3(6):100467.

Trostle ME, Limaye MA, Avtushka V, Lighter JL, Penfield CA, Roman AS. COVID-19 vaccination in pregnancy: early experience from a single institution. Am J Obstet Gynecol MFM. 2021;3(6):100464.

Shimabukuro TT, Kim SY, Myers TR, et al. CDC v-safe COVID-19 Pregnancy Registry Team. Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. N Engl J Med. 2021 Jun 17;384(24):2273-2282.

Lipkind HS, Vazquez-Benitez G, DeSilva M, et al. Receipt of COVID-19 Vaccine During Pregnancy and Preterm or Small-for-Gestational-Age at Birth - Eight Integrated Health Care Organizations, United States, December 15, 2020-July 22, 2021. MMWR Morb Mortal Wkly Rep. 2022 Jan 7;71(1):26-30.

ACIP Presentation Slides: Sept 22-23, 2021 Meeting. COVID-19 vaccine safety in pregnancy: Updates from the v-safe COVID-19 vaccine. Sept 22, 2021. 

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