ABSTRACT
Objectives: Systemic lupus erythematosus (SLE) is an autoimmune disease which presents infections as one of the most frequent complications, including more severe outcomes of Coronavirus disease 2019 (COVID-19). Immunization of these patients has been strongly recommended, however, data on safety are still scarce. In this study we evaluate the safety after vaccination against SARS-CoV2 in patients with SLE. Method(s): Safety and Efficacy on COVID-19 Vaccine in Rheumatic Disease - the 'SAFER' study, is a longitudinal Brazilian multicenter phase IV study. In this study patients with SLE (according to the 2019 ACR/EULAR criteria), older than 18 years who received vaccination against SARS-CoV-2 CoronaVac (Inactivated SARS-CoV-2 Vaccine), ChadOx-1 (AstraZeneca) and BNT162b2 (Pfizer-BioNTech) were included. The evaluation of adverse events (AEs) was done by telephone contact, symptom diaries and a face-to-face visit on the 28th day after each dose. Patients were followed up also by disease activity, assessed using SLEDAI-2 K score. Result(s): A total of 367 individuals with SLE were included, 207 received CoronaVac, 128 received ChadOx-1 and 32 received BNT162b2. Ninety percent of the subjects were female with a mean age of 37 years. About 50% (182) of patients were using oral glucocorticoids and azathioprine was the most frequent immunosuppressive therapy. Regarding disease activity parameters, 38%(140) of patients had zero SLEDAI-2Kat baseline and 41%(147) had zero SLEDAI-2 K 28 days after the 2nd dose. After the first and second dose the most frequent AEs were pain at injection site (58%/44%), headache (48%/33%) and pruritus (42%/37%). Comparing the three vaccines, after the first dose, local symptoms, myalgia, and fever were less frequent in patients who received CoronaVac (p alpha 0.001) as well as headache, tiredness (p = 0.001) and arthralgia (p = 0.003). After the second dose, only local symptoms such as pain at the application site and thickening of the skin around the application site were less frequent in the CoronaVac group (p alpha 0.05). Headache, tiredness, musculoskeletal symptoms and fever were more common in patients receiving AstraZeneca. No serious adverse events were reported regardless of the vaccination schedule used. Conclusion(s): This study suggests that vaccines against SARS-COV-2 are safe in SLE patients. Neither severe AEs were reported nor worsening of disease activity were reported. Comparing the different vaccines, CoronaVac had fewer adverse events.
ABSTRACT
In the early seventeenth century, smallpox was one of the most fearsome communicable diseases in the world. Lady Mary Montagu noted that the disease could be prevented by introducing liquid extracted from smallpox scabs from an infected patient into the skin of healthy individuals. This process, known as “variolation” was used in England and in USA until the first investigations by the English physician Edward Jenner appeared. Jenner created the vaccine for an animal poxvirus from the pustule formed by the vaccinia virus in the teats of cows, where the technique was essentially based on the idea that a virulent agent for animals could be attenuated in humans. In 1885, Louis Pasteur, through a fixed virus which was obtained by successive passages in the nervous tissue of rabbits with the dissecting action of potassium hydroxide, developed the vaccine against rabies, in which similar procedures were adopted in the development of several vaccines of live attenuated viruses. Already in the 1940s, a revolution occurred with the discovery that cells could be cultured in vitro and used as substrates for viral growth. Oral polio vaccine and vaccines against measles, rubella, mumps and chickenpox were made possible by selecting clones by passage in in vitro cell culture. Some RNA virus have segmented genomes that can be manipulated. Co-cultivation of two virus in cell culture with clone selection by plaque formation allows the isolation of virus with segments from both. This regrouping planned to create three main vaccines: live and inactivated influenza as well as one of two rotavirus vaccines. Another discovery in the late nineteenth century was that immunogenicity could be maintained as the substance contained in those killed by heat or chemical treatment. This type of inactivation was first applied to pathogens of typhoid fever, plague and cholera bacilli. In the twentieth century, chemical inactivation was also applied to a virus. The influenza vaccine was the first successful inactivated virus vaccine, developed against Polio and Hepatitis A. Besides, several vaccines consist of partially or fully purified proteins. Most of the inactivated flu vaccines used are created by growing the virus in embryonated eggs and then breaking down the entire virus with detergents. The viral hemagglutinin protein is purified to serve as the vaccine antigen, although other influenza virus components may be part of the final product. Early in the history of bacteriology, morphological studies and chemical analyzes showed that many pathogens were surrounded by a polysaccharide capsule and that antibodies against the capsule could promote phagocytosis. The first use of this information to create a vaccine was the development of the meningococcal polysaccharide vaccine. After years of study and development in bacterology, the scientific community faced the Covid-19 pandemic in 2020, marked by the race against time in the invention of effective vaccines against the SARS-CoV-2 virus. After all, most of vaccines take more than a decade to be formulated and, in the case of the vaccine against the new coronavirus, in less than a year, at least 34 candidate vaccines appeared in clinical analysis. New vaccine production techniques using DNA and RNA recombination techniques are being implemented in this race. In Brazil, the most widely distributed vaccines approved by Anvisa are AstraZeneca, CoronaVac and Pfizer-BioNTech. The AstraZeneca/Oxford vaccine is composed of a non-replicating viral vector, which consists of a defective chipamzee virus (adenovirus), with a segment of the SARS-CoV-2 genome, responsible for producing the structure present on the viral surface (protein S), being recognized by human cells, triggering an immune response against Coronavirus. The CoronaVac vaccine is composed by the inactivated SARS-CoV-2 virus, along with its complete structure. It is unable to multiply, although it can stimulate the response to produce antibodies. The Pfizer-BioNTech vaccine, on the other hand, consists of a formulated lipid nanoparticle of nucleoside-modified mRNA that encodes the pre-fusion peak glycoprotein of SARS-CoV-2. Despite the small amount of dose applications in Brazil, the Janssen vaccine has recently started its distribution in the country. This is the only vaccine, so far, with a single dose application. It is an adenovirus 26 (Ad26) vector vaccine that contains in its interior genetic material of the S protein contained in the surface spikes of SARS-CoV-2, and that stimulates, after application, the cellular responses of T CD4 + and T CD8 + antibodies. Here, we propose a detailed review of the entire history of vaccination, from Smallpox to Covid-19. © 2022, The Author(s), under exclusive license to Springer Nature Switzerland AG.
ABSTRACT
The article presents the Gender and Sexuality Project of the Escola de Aplicação da FEUSP, created in the early 1990s under the title Adolescent Sexual Orientation. Based on interviews with two teachers involved in the project, as well as the analysis of school documents, the article discusses the challenges, transformations and advances of this discussion at school along almost 30 years of debate with adolescents and young people on topics such as gender identity, sexuality, teenage pregnancy and health. Through the memory of two teachers at the school, we reconstruct some transformations and challenges faced by the project since its creation, in the 1990s, until 2020, already in the COVID-19 pandemic context. © 2021 Federal University of Fronteira Sul. All rights reserved.