SARS-CoV-2 seropositivity and HIV viral load among Mozambican pregnant women.

INTRODUCTION: Prevalence estimates of SARS-CoV-2 infection in Africa are limited, particularly among pregnant women and in those living with HIV. This study assessed the seroprevalence of SARS-CoV-2 antibodies among Mozambican HIV-infected pregnant women during the first year of the pandemic, before COVID-19 vaccines were deployed in the country. SETTING: The study was conducted in Manhiça district, a semi-rural area in southern Mozambique. METHODS: A prospective cohort study including pregnant women living with HIV was carried out from November 2019 to June 2021. Women were enrolled at the first antenatal care (ANC) clinic visit and followed until post-partum. HIV viral load (HIV-VL) and IgM/IgG antibodies against SARS-CoV-2 were determined in blood samples at first ANC clinic visit and at delivery. Associations between SARS-CoV-2 serostatus and maternal characteristics at enrolment were analysed. RESULTS: A total of 397 women were enrolled. SARS-CoV-2 IgG/IgM antibodies were detected in 7.1% of women at enrolment and in 8.5% of women at delivery. Overall, SARS-CoV-2 antibodies were detected in 45 (11.3%; 95%CI 8.4-14.9%) women during the study period; the first seropositive sample was identified in September 2020. Having undetectable HIV-VL was associated with seropositivity of SARS-CoV-2 IgG/IgM (OR 3.35 [1.10-11.29]; p=0.039). CONCLUSION: Seroprevalence of SARS-CoV-2 antibodies in this cohort of Mozambican unvaccinated pregnant women was similar to reported global estimates of approximately 10% in pregnancy for 2021. Findings also suggest that pregnant women with high HIV- viral load may have an impaired immune response against SARS-CoV-2 and might need to be carefully managed in case of COVID-19.

Preparing for Disease X: Ensuring Vaccine Equity for Pregnant Women in Future Pandemics.

Disease X represents a yet unknown human pathogen which has potential to cause a serious international epidemic or pandemic. The COVID-19 pandemic has illustrated that despite being at increased risk of severe disease compared with the general population, pregnant women were left behind in the development and implementation of vaccination, resulting in conflicting communications and changing guidance about vaccine receipt in pregnancy. Based on the COVID-19 experience, the COVAX Maternal Immunization Working Group have identified three key factors and five broad focus topics for consideration when proactively planning for a disease X pandemic, including 10 criteria for evaluating pandemic vaccines for potential use in pregnant women. Prior to any disease X pandemic, collaboration and coordination are needed to close the pregnancy data gap which is currently a barrier to gender equity in health innovation, which will aid in allowing timely access to life-saving interventions including vaccines for pregnant women and their infants.

Using maternal and neonatal data collection systems for coronavirus disease 2019 (COVID-19) vaccines active safety surveillance in low- and middle-income countries: an international modified Delphi study: [version 1;peer review: 1 approved with reservations]

Background: Given that pregnant women are now included among those for receipt coronavirus disease 2019 (COVID-19) vaccines, it is important to ensure that information systems can be used (or available) for active safety surveillance, especially in low- and middle-income countries (LMICs). The aim of this study was to build consensus about the use of existing maternal and neonatal data collection systems in LMICs for COVID-19 vaccines active safety surveillance, a basic set of variables, and the suitability and feasibility of including pregnant women and LMIC research networks in COVID-19 vaccines pre-licensure activities. Methods: A three-stage modified Delphi study was conducted over three months in 2020. An international multidisciplinary panel of 16 experts participated. Ratings distributions and consensus were assessed, and ratings’ rationale was analyzed. Results: The panel recommended using maternal and neonatal data collection systems for active safety surveillance in LMICs (median 9;disagreement index [DI] -0.92), but there was no consensus (median 6;DI 1.79) on the feasibility of adapting these systems. A basic set of 14 maternal, neonatal, and vaccination-related variables. Out of 16 experts, 11 supported a basic set of 14 maternal, neonatal, and vaccination-related variables for active safety surveillance. Seven experts agreed on a broader set of 26 variables.The inclusion of pregnant women for COVID-19 vaccines research (median 8;DI -0.61) was found appropriate, although there was uncertainty on its feasibility in terms of decision-makers’ acceptability (median 7;DI 10.00) and regulatory requirements (median 6;DI 0.51). There was no consensus (median 6;DI 2.35) on the feasibility of including research networks in LMICs for conducting clinical trials amongst pregnant women. Conclusions: Although there was some uncertainty regarding feasibility, experts recommended using maternal and neonatal data collection systems and agreed on a common set of variables for COVID-19 vaccines active safety surveillance in LMICs.

Ongoing and future COVID-19 vaccine clinical trials: challenges and opportunities.

Large-scale deployment of COVID-19 vaccines will seriously affect the ongoing phases 2 and 3 randomised placebo-controlled trials assessing SARS-CoV-2 vaccine candidates. The effect will be particularly acute in high-income countries where the entire adult or older population could be vaccinated by late 2021. Regrettably, only a small proportion of the population in many low-income and middle-income countries will have access to available vaccines. Sponsors of COVID-19 vaccine candidates currently in phase 2 or initiating phase 3 trials in 2021 should consider continuing the research in countries with limited affordability and availability of COVID-19 vaccines. Several ethical principles must be implemented to ensure the equitable, non-exploitative, and respectful conduct of trials in resource-poor settings. Once sufficient knowledge on the immunogenicity response to COVID-19 vaccines is acquired, non-inferiority immunogenicity trials-comparing the immune response of a vaccine candidate to that of an authorised vaccine-would probably be the most common trial design. Until then, placebo-controlled, double-blind, crossover trials will continue to play a role in the development of new vaccine candidates. WHO or the Council for International Organizations of Medical Sciences should define an ethical framework for the requirements and benefits for trial participants and host communities in resource-poor settings that should require commitment from all vaccine candidate sponsors from high-income countries.

SARS-CoV-2 Infection in Pregnant Women and Their Newborns.

There remain a number of uncertainties globally about the risks posed to women who are infected with SARS-CoV-2 during pregnancy. Furthermore, our understanding of the spread of COVID-19 in Sub-Saharan Africa is limited, owing to low testing rates in many parts of the continent. PeriCOVID Africa, in conjunction with the WHO/HRP Alliance, plans to address these knowledge gaps by harnessing research infrastructures in place in five sub-Saharan African countries in order to screen more than 50,000 pregnant women and their infants for SARS-CoV-2, while monitoring pregnancy and neonatal outcomes. We anticipate that the results of this study will provide much needed information about the risks that SARS-CoV-2 poses to pregnant women and their babies, as well as establishing potential routes of mother-to-child transmission.