COVID-19 vaccination and assisted reproduction
Statement from the ESHRE COVID-19 Working Group
There are different types of COVID-19 vaccines under development (mRNA, protein subunit and vector) (1) and at different approval stages in the EU (2). At the time of publication only mRNA COVID-19 vaccines (Comirnaty from Pfizer/BioNTech and COVID-19 Vaccine Moderna) have been approved for use in the EU, following review by the European Medicines Agency (EMA) and authorisation from the European Commission (2). In the EU member states the first COVID-19 vaccines were administered from 27/12/2020 (3). In other countries, such as the UK and the US, vaccines have also been approved and vaccination programmes introduced.
The European Centre for Disease Control (ECDC) has recommended national vaccination strategies based on prioritisation of groups at risk of severe COVID-19 as well as those with an increased risk of exposure and onward transmission of SARS-CoV-2 (e.g. in professional settings) (4). A recent ECDC overview of EU vaccination plans indicates that men and women of reproductive age, of whom some may be pregnant or planning pregnancy with fertility treatment, will be included in these programmes based on their individual risk of severe COVID-19 disease and/or professional exposure (5).
Although as a general rule all inactivated and toxoid-based vaccines are considered safe for use during pregnancy (6), the access of reproductive-age people to a COVID-19 vaccination programme raises specific questions that have not yet been formally addressed:
- Should men and women receive the COVID-19 vaccine before attempting conception?
- Should couples who received COVID-19 vaccination postpone conception, and if so, for how long?
- Should pregnant women be vaccinated?
- Should men and women receive the COVID-19 vaccine before attempting conception?
There is a lack of information on the possible effect of COVID-19 vaccination on assisted reproduction treatment or future pregnancy. The product information for both Comirnaty and COVID-19 Vaccine Moderna states that animal studies “do not show any harmful effects in pregnancy”. However, data during pregnancy are reported as “very limited”, with no data on breast-feeding (7,8). As a result, ESHRE can make no recommendations on whether men and women attempting to conceive through assisted reproduction should receive the vaccine before starting treatment.
For women with co-morbidities putting them at higher risk of COVID-19 and/or pregnancy complications, consideration should be given to encouraging vaccination before attempting conception. The same applies to women in whom the risk of exposure to SARS-CoV-2 infection is high and cannot be avoided.
ESHRE recommends that men and women living in countries where the vaccine is not available or choosing not to be vaccinated should not be prevented from access to assisted reproduction treatments.
There are different viewpoints with regards to the need to postpone conception after vaccination. It seems prudent to postpone the start of assisted reproduction treatments (sperm collection, ovarian stimulation, embryo transfer) for at least a few days after the completion of vaccination (i.e. after the second dose) to allow time for the immune response to settle.
In the absence of information on the effect of the COVID-19 vaccine on oocytes and sperm, embryo implantation and early stages of pregnancy, and to allow time for antibody development, a more cautious approach could be considered (i.e. postpone the start of ART treatment for up to 2 months).
Assisted reproduction treatments should not be started in women who have had any significant side effects from COVID-19 vaccination (such as an allergic reaction) and until they are considered fit for pregnancy by their physician.
As stated in previous ESHRE guidance documents, pregnant patients with COVID-19 are at an greater risk of more severe illness than their non-pregnant peers (9). Vaccines against diseases such as tetanus, pertussis and influenza have been described as safe during pregnancy (6). However, the safety of COVID-19 vaccines in human pregnancy has not been evaluated to date.
For Comirnaty and COVID-19 Vaccine Moderna, the EMA states that the decision on whether to use the vaccine in pregnant women should be made in close consultation with a healthcare professional after considering the individual benefits and risks (3). Similar advice is provided on administration during pregnancy and breastfeeding for the Oxford/AstraZeneca vaccine (ChAdOx1-SARS-CoV-2) recently authorised in the UK (10).
Pregnant women should be informed about the lack of long-term human studies on Covid-19 vaccination but should not be excluded from vaccination programmes.
Vaccination of healthcare workers aims for their protection and to help reduce the risk of transmission. Fertility clinic staff are healthcare workers and as such should be given priority for vaccination based on individual risks and benefits.
Summary recommendations and considerations
• ESHRE reaffirms its earlier guidance for safe ART practices. Even after the start of large-scale vaccination programmes, ESHRE recommends continued observance of its previous guidance on modified services and risk mitigation measures in line with local epidemiological data (9).
• ESHRE recommends that men and women should have access to fertility services, and such access should not depend on the availability of COVID-19 vaccines or on the decision of individual patients about vaccination.
• In men and women who receive the vaccine, it seems prudent to postpone assisted reproduction treatments for at least a few days after the completion of vaccination.
• A decision on whether to use the vaccine in pregnant women should be made in close consultation with a healthcare professional after considering the benefits and risks.
• There is currently no information on the role of vaccination in patients and staff who have had COVID-19 disease and could have developed immunity.
• ESHRE recommends monitoring the outcomes of assisted reproduction treatments and to compare them in vaccinated versus non-vaccinated patients.
• ESHRE urges COVID-19 vaccine manufacturers to share any relevant information and advice on vaccination in pregnant women and couples contemplating pregnancy.
• At this stage, there is no information on the safety of different vaccine types during assisted reproduction treatment or pregnancy, and no recommendation can be made on which is the safer for men and women aiming to attempt pregnancy.
1. Dong Y, Dai T, Wei Y, Zhang L, Zheng M, Zhou F. A systematic review of SARS-CoV-2 vaccine candidates. Signal Transduct Target Ther. 2020 Oct 13;5(1):237. doi: 10.1038/s41392-020-00352-y.2.-
3. European Medicines Agency, Human medicine European public assessment report (EPAR): Comirnaty (last updated
29/12/2020). Available through https://www.ema.europa.eu/en/medicines/human/summaries-opinion/comirnaty
4. European Centre for Disease Prevention and Control. Key aspects regarding the introduction and prioritisation of COVID-19 vaccination in the EU/EEA and the UK. 26 October 2020. ECDC: Stockholm; 2020. Available through https://www.ecdc.europa.eu/en/publications-data/key-aspects-regarding-introduction-and-prioritisation-covid-19vaccination
5. European Centre for Disease Prevention and Control. Overview of COVID-19 vaccination strategies and vaccine deployment plans in the EU/EEA and the UK – 2 December 2020b. ECDC: Stockholm; 2020a. Available through https://www.ecdc.europa.eu/en/publications-data/overview-current-eu-eea-uk-plans-covid-19-vaccines
6. Maertens K, Orije MRP, Van Damme P, Leuridan E. Vaccination during pregnancy: current and possible future recommendations. Eur J Pediatr 2020 Feb; 179(2): 235-242. doi:10.1007/s00431-019-03563-w
7. Comirnaty: EPAR – Product Information (pdf) (last update 29/12/2020) available through the EMA information on Comirnaty – product information section https://www.ema.europa.eu/en/medicines/human/summariesopinion/comirnaty
8. COVID-19 Vaccine Moderna: Product Information (pdf) (as approved by the CHMP on 6 January 2021, pending endorsement by the European Commission) available through the EMA information on COVID-19 Vaccine Moderna– product information section https://www.ema.europa.eu/en/medicines/human/summaries-opinion/covid-19-vaccinemoderna
9. ESHRE. ART and COVID-19 A Statement from ESHRE. Phase 3: Safe ART services during the third phase of the COVID-19 pandemic. (publication date: 14 October 2020) (https://www.eshre.eu/Press-Room/ESHRE-News#guidoct20)
10. Information for Healthcare Professionals on COVID-19 Vaccine AstraZeneca (pdf) (last updated 29/12/2020). available through https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca
This guidance represents the views of ESHRE, which were achieved after careful consideration of the scientific evidence available at the time of preparation. In the absence of scientific evidence on certain aspects, a consensus between the relevant ESHRE stakeholders has been obtained. ESHRE makes no warranty, express or implied, regarding the guidance and specifically excludes any warranties of merchantability and fitness for a particular use or purpose. ESHRE shall not be liable for direct, indirect, special, incidental, or consequential damages related to the use of the information contained herein. While ESHRE makes every effort to compile accurate information and to keep it up-to-date, it cannot, however, guarantee the correctness, completeness, and accuracy of the guidance in every respect. The advice expressed herein is not binding on professionals working in the field of human reproduction and embryology. Hence, this advice will never lead to the liability of ESHRE in case a professional is willing to implement it. Notwithstanding the foregoing, ESHRE will not be liable for indirect damages or consequential damage.