Developing and distributing a safe and effective SARS-CoV-2 (COVID-19) vaccine has garnered immense global interest. Less than a year after COVID-19 was declared a pandemic, several vaccine candidates had received emergency use authorization across a range of countries. Despite this scientific breakthrough, the journey from vaccine discovery to global herd immunity against COVID-19 continues to present significant policy challenges that require a collaborative, global response. We offer a framework for understanding remaining and new policy challenges for successful global vaccine campaigns against COVID-19 as well as potential solutions to address them. Decision-makers must be aware of these challenges and strategize solutions that can be implemented at scale. These include challenges around maintaining R&D incentives, running clinical trials, authorizations, post-market surveillance, manufacturing and supply, global dissemination, allocation, uptake, and clinical system adaption. Alongside these challenges, financial and ethical concerns must also be addressed.

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Highlights Currently, unconditional investment is being made into COVID-19 vaccine R&D COVID-19 vaccine R&D investments should also ensure access and affordability. The options market for antibiotics, could be adapted for use with COVID-19 vaccines. This could help fund R&D, boost manufacturing capacity and secure fair prices. Further research on the OMV model in the current COVID-19 crisis is warranted.

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BackgroundSocial determinants of health (SDoH) affect congenital heart disease (CHD) mortality across all forms and age groups. We sought to evaluate risk of mortality from specific SDoH stratified across CHD to guide interventions to alleviate this risk.MethodsWe searched electronic databases between January 1980 and June 2019 and included studies that evaluated occurrence of CHD deaths and SDoH in English articles. Meta-analysis was performed if SDoH data were available in >3 studies. We included race/ethnicity, deprivation, insurance status, maternal age, maternal education, single/multiple pregnancy, hospital volume, and geographic location of patients as SDoH. Data were pooled using random-effects model and outcome was reported as odds ratio (OR) with 95% confidence interval (CI).ResultsOf 17,716 citations reviewed, 65 met inclusion criteria. Sixty-three were observational retrospective studies and two prospective. Of 546,981 patients, 34,080 died. Black patients with non-critical CHD in the first year of life (Odds Ratio 1.62 [95% confidence interval 1.47–1.79], I2 = 7.1%), with critical CHD as neonates (OR 1.27 [CI 1.05-1.55], I2 = 0%) and in the first year (OR 1.68, [1.45-1.95], I2 = 0.3%) had increased mortality. Deprived patients, multiple pregnancies, patients born to mothers <18 years and with education <12 years, and patients on public insurance with critical CHD have greater likelihood of death after the neonatal period.ConclusionThis systematic review and meta-analysis found that Black patients with CHD are particularly vulnerable for mortality. Numerous SDoH that affect mortality were identified for specific time points in CHD course that may guide interventions, future research and policy.Systematic Review Registration[https://www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42019139466&ID=CRD42019139466], identifier [CRD42019139466].