BackgroundAlthough COVID-19 vaccines are currently under use in pregnant and postpartum women, there is still lack of evidence regarding safety and effectiveness in these populations. This study aims to describe the safety profile of COVID-19 vaccines in pregnant and postpartum women in the early stage of vaccination campaign in Brazil.MethodsThis is an observational cross-sectional study using data from the Brazilian surveillance information system for adverse events (SI-EAPV) to characterize the safety of COVID-19 vaccines available (Sinovac/Butantan, Pfizer/BioNTech, AstraZeneca and Janssen) in Brazilian pregnant and postpartum women after receiving it from April to August 2021. A descriptive analysis was performed to assess the frequency and incidence rate of the adverse events (AE) for COVID-19 vaccines.ResultsA total of 3,333 adverse events following COVID-19 immunization were reported for the study population in the SIEAPV. The incidence of AE found was 309.4/100,000 doses (95% CI 297.23, 321.51). Regarding the four vaccines available in the country, Sinovac/Butantan had the lowest incidence (74.08/100,000 doses; 95% CI 63.47, 84.69). Systemic events were the most frequent notified for the group (82.07%), followed by local (11.93%) and maternal (4.74%), being most of them classified as non-severe (90.65%).ConclusionA similar pattern of AE as stated in other studies was found, with even better results for non-viral vector vaccines, corroborating to the recommendation of vaccination for these groups. Even though, further studies appraising a longer observation time are still needed to provide a broader safety aspect for the vaccines currently under use for this population.

Greece has a public universal health system, the National Health System (ESY) – with mandatory insurance coverage (IKA) for all working people (either employees or self-employed). On top of that, people can voluntarily have private insurance. EOPYY (National Organisation for Healthcare Provision) is the only responsible party for purchasing health services funded by public resources based on the National Social Security Fund (EFKA) contributions and state budget. There is only a limited number of drugs being exclusively provided by the public health care system, for free (EOPYY pharmacies) like the high-cost medications. Other than these, patients can buy any drug they want. National Organization for Medicines (EOF) is the regulatory authority and also responsible for pharmacovigilance of medicines, medical products, of beauty and veterinary drugs. In 2011, the pricing and reimbursement processes were separated, with pricing taking place after marketing authorization; subsequently, analysis for reimbursement by the social health insurance is allowed with inclusion in a positive list. New pharmaceutical products follow an external reference pricing system, in which the maximum ex-factory price for medicines under patent is defined by the mean of the three lowest prices for the same drug in European Union (EU) countries, this same rule being applied to biological and biosimilar medicines. Generic drugs are priced either by the mean of the three lowest prices charged in the EU or by a 50% price reduction in relation to the period in which the medication was under patent; thus, the maximum prices of the generic drugs are set at 65% of the price of the respective reference product. In 2018, the Health Technology Assessment (HTA) was introduced in the country to evaluate medications and to issue recommendations to the Ministry of Health on the inclusion or removal of products from the Positive List. As the HTA process is still being reformed in Greece, it is believed that, in the coming years, the country will have the opportunity to improve the implementation, having the linking of the HTA results with the clinical guidelines as one of the major challenges.