Discussion
Increasing evidence of the safety of COVID-19 vaccines in pregnancy supports the conclusion that the benefits outweigh the risks whenever there is ongoing or anticipated community transmission. We documented and categorised pregnancy-specific COVID-19 vaccination policies issued by PHAs in 176 countries and by the WHO. We found marked changes in policies over time. Recommendations became substantially more permissive, with 32% permitting or recommending at least one COVID-19 vaccine in May, and 66% doing so as of 30 September. Among countries issuing pregnancy-specific policies, one-third noted the availability of observational safety data and almost half cited evidence of the risks of SARS-CoV-2 infection in pregnancy in their rationale for recommending or permitting use. Nevertheless, even at the end of the study period, 17% of national policies continued to recommend against the use of any COVID-19 vaccine during pregnancy. Importantly, gaps in policies appeared to exist regionally and in poorer countries, with policies available in only 40% of sub-Saharan African countries and 28% of low-income countries. These disparities are likely explained, at least in part, by delays in country-wide vaccine access but may also be related to an absence of pregnancy-specific data for some of the vaccines available in these countries. Further work is needed to delineate the range of reasons for these policy gaps.
Our findings raise concern about equitable access to COVID-19 vaccines during pregnancy. In many countries, pregnant people are less likely than other groups who are also at increased risk of serious disease, and even those groups not at increased risk, to have access to COVID-19 vaccines.
Globally, inequities also exist among pregnant people, as well as between pregnant people and other groups. As of 30 September, the Oxford-AstraZeneca vaccine was the most commonly administered COVID-19 vaccine in the world (172 countries),34 but far fewer countries/territories explicitly recommended or permitted its use in pregnant people without qualifications compared with the Moderna or Pfizer vaccines. Pregnant people living in largely low-income parts of the world, where mRNA vaccines are in limited supply, were less likely than pregnant people living in high-income countries, where mRNA vaccines are widely available, to have access to COVID-19 vaccines. Thus, the global inequity in access to vaccines in pregnancy does not merely reflect global injustices in vaccine supply, it is an inequity that is further compounded by disparities between higher-income and lower-income countries in the types of vaccines that are locally available.
Previously, we and others developed the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) Guidance for inclusion of the interests of pregnant individuals in development and deployment of vaccines against emerging pathogens.5 In the PREVENT Guidance, which was developed prior to the COVID-19 pandemic, we noted that standard approaches to determining whether pregnant people could be offered vaccines in the research context typically operated on a presumption of exclusion, in which the default position was to deny access. We described a cascade in which the presumption of exclusion of pregnant people from vaccine trials resulted in the absence of data specific to pregnancy, leading to exclusion of pregnant people from vaccine deployment activities. Unfortunately, the uniform exclusion of pregnant people from COVID-19 vaccine trials prior to authorisation has led to a predictable scenario in many countries, in which countries clearly articulate the absence of clinical trial data in their rationale for restricting access to COVID-19 vaccines for pregnant people. Another specific PREVENT recommendation, that DART studies be completed as early as possible and preferably before the onset of phase 3 trials, was also not heeded. The fact that no DART data were available for several COVID-19 vaccines until months after emergency use authorisation/listing was granted was noted by multiple countries as a reason for restrictive pregnancy policies. The subsequent availability of observational data for some vaccines has led some countries to modify their positions in favour of broadly permitting or recommending vaccination; however, the scarcity of data for many vaccines, and the absence of evidence from LMIC settings, have meant that the most permissive recommendations focus principally on Pfizer or Moderna vaccines, which, as of this writing, are available in only a few LMICs.34
Our study has a number of limitations. First, country policies regarding the use of COVID-19 vaccines are continuously evolving. Our data only provide a snapshot of dynamic global policymaking over a short time period. To continue tracking global variance in public health guidelines for COVID-19 vaccine use in pregnancy, we have developed an online tracker (www.comitglobal.org), in which data are updated at least every 3 weeks. Second, we were unable to find policies on COVID-19 vaccines and pregnancy for 48 countries/territories, many of them in Africa. This may initially have been related to limited vaccine access; however, most countries have introduced at least one COVID-19 vaccine but policies on administration in pregnancy continue to lag. It is also possible that countries with fewer resources may not regularly post their policies or recommendations on their online platforms, so that we may not have captured policies that were developed and disseminated through other channels. As we identify updates for these and other countries, they will be posted to the COMIT tracker (www.comitglobal.org).
Although the WHO Prioritization Roadmap recommends that pregnant people receive COVID-19 vaccines at the same time as other people who are at elevated risk of severe disease and death,26 17% of countries still recommended against any use of COVID-19 vaccines in pregnancy as of late September 2021. In many instances, these recommendations were product or platform specific and referred to adenovirus-vectored vaccines. The categorical exclusion of pregnant people from adenovirus-vectored vaccine rollout in settings with community transmission and where no alternative vaccines are available is ethically unjustifiable.5 Of note, the WHO specifically rejects this position. In its interim recommendations for both the Oxford/AstraZeneca and the Janssen/J&J vaccine,35 36 the WHO allows for the administration of these vaccines in pregnancy when the benefits of vaccination outweigh the risks, as they likely do in many high-transmission settings with no or insufficient vaccine alternatives. Because the epidemiology of the pandemic can change rapidly, as has recently occurred with the Omicron variant, it is our position that pregnant people should have access to vaccines wherever there is ongoing or anticipated community transmission.
In some countries, vaccines are in such short supply that pregnant people are only one among many higher-risk groups who have no access. But constrained national supply is only part of the story. In some countries, pregnant people are being denied access even when they are members of high priority groups, like health workers, who are being offered vaccines. In still other countries, immunisation programmes are offering vaccines to groups at elevated risk of severe disease and death, but not to pregnant people who, as a group, also fit this description. As evidence continues to mount regarding the harms of COVID-19 in pregnancy, including increasing rates of maternal mortality,27 37 national policymakers must include pregnant people in their prioritisation plans and work to increase demand and uptake in this group.
