Table 1

Recommended actions for integrating sex and gender considerations in COVID-19 vaccine development and deployment

Data collectionMember statesCollect, analyse and report data disaggregated by sex and age, at a minimum on:
  • Symptomatic and asymptomatic infection

  • Testing

  • Hospitalisation

  • Post-COVID-19 condition

  • Death

Disaggregated data should be collected to enable analysis for different occupation groups.
  • Encourage and support member states to strengthen collection of disaggregated data.

  • Make disaggregated data publicly available.

  • Conduct regular intersectional gender analysis to inform policy and guideline development.

Research and developmentResearchers (academia and pharmaceutical companies)
  • Design preclinical and clinical studies that allow sex and gender analyses and examine the rationale for alternative vaccine dosage, frequency and interval for women and men.

  • Plan DART studies at an early stage and appropriately design trials for inclusion of pregnant and lactating women.

  • Consider intersectional gender dimensions in clinical trials to facilitate balanced representation and trial participation.

  • Collect data by sex and age, at a minimum, and other gender-related variables.

  • Ensure follow-up and collection of data on participants who inadvertently become pregnant during trials.

  • Ensure meaningful sex- and gender-based analysis.

  • Make raw disaggregated data publicly available (such as supplementary material in peer-reviewed journals).

  • Report data by sex and age, including data on discontinuation and dropouts, adverse events and primary and secondary outcomes.

Research ethics committees and data and safety monitoring boards
  • Review the gendered risk and benefit of studies.

  • Ensure that studies adequately consider sex and gender dimensions in the study protocol, and monitor adherence to protocols.

  • Ensure protocols include mandatory follow-up on the outcome of participants who become pregnant during study.

  • Review by data and safety monitoring board to consider sex and gender implications.

Editors, peer reviewers and publishers
  • Evaluate whether sex and gender dimensions are adequately addressed in the reporting of the study and its findings (see SAGER guidelines37).

  • Require that all baseline and outcome data, including data on discontinuation and adverse events, be provided by sex, at a minimum.

  • Request subgroup analysis, if appropriate.

Regulatory agencies and WHO prequalification mechanism
  • Require that all data, including data on discontinuation and adverse events, be provided by sex, at a minimum.

  • Request subgroup analysis, if appropriate.

  • Evaluate sex and gender dimensions.

  • Require complete data by sex, and sex- and gender-based analysis.

  • Conduct a thorough review of equal safety and efficacy in women and men and whether different dosing strategies may be justified.

WHO, ministries of health and other international, regional or national technical bodies
  • Adequately incorporate gender considerations in policy recommendations and technical guidelines, and be transparent about the underlying evidence.

Deployment and deliveryWHO (SAGE)
  • Ensure that intersectional gender dimensions are considered in guidance on prioritisations, allocation and deployment.

Member states
  • Be mindful about gender gaps and biases in data when developing prioritisation strategies and deployment plans.

  • Conduct baseline gender assessment to identify needs and barriers to immunisation.

  • Be transparent about the rationale and the evidence on which groups are prioritised.

  • Invest to improve data collection capacity and monitoring to ensure reliable gender data.

  • Develop gender transformative national polices to minimise gender and other inequities.

  • Ensure vaccine campaigns and information are gender sensitive and do not stereotype certain groups.

  • Provide training to health workers to sensitise them about gender dimensions and minimise discriminatory provider attitudes.

  • Invest in the well-being and resilience of the health workforce by ensuring a respectful and enabling working environment, zero tolerance for sexual harassment and gender-based discrimination, measures to prevent burnout, provision of psychosocial support, sick leave, insurance and prompt payment of salaries, guarantee of equal pay, access to suitable personal protective equipment, essential hygiene and sanitation products, as well as essential sexual and reproductive health services.

Civil society
  • Advocate for transparent decision-making about prioritisation and deployment plans.

  • Involve community-based organisations in vaccine delivery to collect and analyse disaggregated data and monitor and address gender and other inequities in access to vaccines.

Monitoring and surveillanceMember states
  • Ensure that postmarketing surveillance and pharmacovigilance systems adequately collect data by sex and other important variables.

  • Monitor potential gender differences in access and uptake.

  • Invest in qualitative research to understand gender differences in vaccine hesitancy, acceptability, accessibility and uptake.

Inclusive decision-makingWHOEnsure that international COVID-19 vaccine governance structures and policymaking are inclusive, gender balanced, transparent and evidence based.
Member states
  • Ensure that national and subnational decision-making processes on distribution of resources, equipment, policies and practices meaningfully involve women.

  • DART, development and reproductive toxicology; SAGE, Strategic Advisory Group of Experts on Immunization; SAGER, Sex and Gender Equity in Research.