Explore chapters and articles related to this topic
COVID-19 and MIS-C
Published in Jason Liebowitz, Philip Seo, David Hellmann, Michael Zeide, Clinical Innovation in Rheumatology, 2023
Jordan E. Roberts, Mary Beth Son
While the approval of several highly efficacious and safe vaccines for COVID-19 provided new hope in the depths of the 2020 winter spike in cases, these advances brought new questions for people with rheumatologic diseases. The BNT162B2 mRNA (Pfizer-BioNTech) and mRNA-1273 (Moderna) vaccines demonstrated excellent protection against SARS-CoV-2 but also had higher levels of reactogenicity than most other vaccines, raising concerns that the robust immune response generated by mRNA vaccines might put patients with autoimmune and autoinflammatory disease at risk of flares of their underlying diseases. Fortunately, data thus far has been reassuring, with one large study showing that less than 1% of autoimmune disease patients experienced a flare requiring medical attention after receiving the COVID-19 vaccine (Connolly).
Development of m-RNA Vaccines in Covid-19 Pandemic Scenario
Published in Yashwant Pathak, Gene Delivery, 2022
The analysis at the primary endpoint reveals that the efficacy of mRNA1273 is 30% or less. The findings from secondary analyses displayed a higher level of efficacy of 95.2% (95% CI). The efficacy endpoints were consistent across all the subgroups and indicated that the magnitude of vaccine efficacy is higher than other vaccines for respiratory diseases, such as influenza vaccine, for symptomatic, confirmed disease in adults. Similarly, the studies suggested that efficacy rate of mRNA-1273 is like BNT162b2 (95% effective). Systematic reactogenicity was observed as mild or moderate in older adults as compared to younger adults (Polack et al., 2020). With these changes in some severity in few vaccine trials, it also presents us with some limitations.
Clinical Trials of COVID-19 Therapeutics and Vaccines
Published in Debmalya Barh, Kenneth Lundstrom, COVID-19, 2022
Candan Hizel Perry, Havva Ö. Kılgöz, Şükrü Tüzmen
The mRNA-1273 vaccine, encoding the full-length SARS-CoV-2 S protein encapsulated in lipid nanoparticles (LNPs) [22], was developed by Moderna. It has shown 94.1% efficacy at preventing COVID-19 after two intra-muscular (IM) injections 28 days apart in Phase III clinical evaluation. No safety issues have been reported except for minor transient reactogenicity. Furthermore, the BNT162b2 mRNA vaccine developed by Pfizer/BioNTech has been evaluated in Phase III trials. BNT162b2 is an LNP-encapsulated mRNA vaccine encoding the nucleoside-modified full-length S protein of SARS-CoV-2. In placebo-controlled clinical trials, the test subjects received prime and booster IM injections of the vaccine 21 days apart. The interim results from Phase II/III have shown good tolerability of the BNT162b2 vaccine candidate with 95% efficacy in people 16 years of age and older [30].
Single administration vaccines: delivery challenges, in vivo performance, and translational considerations
Published in Expert Review of Vaccines, 2023
Kyprianos Michaelides, Maruthi Prasanna, Raj Badhan, Afzal-Ur-Rahman Mohammed, Adam Walters, M. Keith Howard, Pawan Dulal, Ali Al-Khattawi
Vaccines are typically provided to healthy populations where there is a reasonable expectation for a high benefit-risk ratio. Reactogenicity is a term used to describe the adverse effects after vaccination and a high immunogenicity-reactogenicity ratio is desired. The development of adverse effects from vaccination varies between individuals and different types of vaccines, but it can be divided into two categories: local and systemic effects. Local effects may include swelling, pain, redness or localized hardening of soft tissues, whereas systemic effects may involve fever, fatigue, headache, and muscle pain. Reactogenicity arises from vaccines being recognized as potential pathogens by the body and inducing innate immune responses. Maintaining the balance between immunogenicity and reactogenicity is fundamental for a successful vaccine candidate [86]. Reactogenicity assessment is a long and dynamic process that spans through all the stages of vaccine development, from animal models to pharmacovigilance post-licensing [87].
Reactogenicity and immunogenicity of BNT162b2 or mRNA-1273 COVID-19 booster vaccinations after two doses of BNT162b2 among healthcare workers in Japan: a prospective observational study
Published in Expert Review of Vaccines, 2022
Toshio Naito, Nao Tsuchida, Susumu Kusunoki, Yoshihiro Kaneko, Morikuni Tobita, Satoshi Hori, Suminobu Ito
The reactogenicity parameters recorded daily in the questionnaire included injection-site reactions (pain, burning sensation, redness, swelling, itching, induration), systemic reactions (fatigue, headache, fever ≥37.5°C, nasal discharge), and sick-leaves. Serum anti-Spike and anti-nucleocapsid protein (anti-N) antibody titers were measured in all blood samples; subjects who tested positive for anti-N IgG, indicating a history of SARS-CoV-2 infection were excluded from the analysis for antibody titers. Adverse reaction and serious adverse events including anaphylaxis, thrombosis, myocarditis/pericarditis, convulsions, Guillain-Barré syndrome, acute disseminated encephalomyelitis, thrombocytopenic purpura, vasculitis, aseptic meningitis, encephalitis or encephalopathy, meningitis, arthritis, facial nerve paralysis, and vasovagal reflex were noted and reported to the COVID-19 Vaccine Secretariat. All personal identifiable information was removed prior to the data analysis of the present study.
Update on CVD 103-HgR single-dose, live oral cholera vaccine
Published in Expert Review of Vaccines, 2022
James McCarty, Lisa Bedell, Paul-Andre De Lame, David Cassie, Michael Lock, Sean Bennett, Douglas Haney
To demonstrate the consistency of the manufacturing process, the immunologic equivalence of different production lots of Vaxchora vaccine was tested in a large, randomized, placebo-controlled, double-blind, Phase 3 study conducted at multiple sites in the United States and Australia [70]. Safety and immunogenicity were assessed in more than 3000 healthy adults with a mean age of 29.9 years, randomized 8:1 to vaccine or placebo [70]. A robust and consistent SVA response after vaccination was demonstrated across multiple production lots, with overall seroconversion rates of 94% and 4% in Vaxchora vaccine and placebo recipients, respectively. The safety analysis showed that the vaccine was well-tolerated and that there were no meaningful differences in the frequency and severity of solicited reactogenicity signs and symptoms (tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite, diarrhea, and fever) between vaccine production lots. Reactogenicity signs and symptoms that were significantly more frequent in the vaccine group than in the placebo arm were headache (28.9% vs 23.3%; P = 0.0419) and diarrhea (3.9% vs 1.2%; P = 0.0079), of which most cases were mild. Severe diarrhea (≥6 stools per 24 hours) was reported by 22/2789 (0.8%) vaccine recipients, but no symptoms lasted longer than 2 days. Unsolicited adverse events recorded up to 28 days after vaccination were similar in the two groups, with 23.0% of Vaxchora vaccine recipients and 24.0% of placebo recipients reporting at least one event [70]. There were no study-related serious adverse events.