Vaccine Safety International Monitoring

Дармостукова, М. А.; Снегирева, И. И.; Вельц, Н. Ю.; Казаков, А. С.; Аляутдин, Р. Н.

doi:10.30895/2312-7821-2019-7-1-6-14

Cited by 3 publications

(1 citation statement)

References 23 publications

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“…Инвагинация тонкого кишечника в крайне редких случаях была отмечена после совместной иммунизации живыми оральными полиомиелитными вакцинами и ротавирусными вакцинами разных производителей [48,49]. Ротавирусные вакцины RotaTeq ™ и Rotarix ™ могут повышать риск инвагинации в течение первых 7 сут после вакцинации [50,51]. В США и Австралии было выявлено от 1 до 6 дополнительных случаев инвагинации на 100 тысяч вакцинированных [52].…”

Section: безопасность и реактогенность живых ротавирусных вакцинunclassified

Vaccine Safety and Efficacy in Preventing Rotavirus Infection

Шевцов¹,

Евреинова²,

Indikova³

et al. 2019

Biopreparaty. Profilaktika, diagnostika, lechenie

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The rotavirus infection causes acute gastroenteritis and is a major cause of lethal severe dehydrating diarrhoea in children under 5 years of age worldwide. Live attenuated rotavirus vaccines are the only means of preventing severe forms of the disease. The aim of the study was to analyse the twenty-year international experience of prophylactic immunisation against rotavirus infection. The paper summarises safety and efficacy data on the long-term use of Rotarix® (Belgium) and RotaTeq® (USA) for the prevention of rotavirus infection in the WHO European Region, the European Union and other countries. It addresses the development of correlates of immune protection for vaccines as well as evaluation of efficacy and safety of the new vaccines Rotavac® and Rotasiil® (India) in clinical trials. The authors analysed international experience of using the vaccines in countries that do not keep records of infant mortality from diarrhoea. The study summarises the results of clinical studies on the use of new vaccines prequalified by WHO in 2018 in regions with high rates of infant mortality from diarrhoea. It was demonstrated that vaccination not only reduces the rates of hospital admission of immunised children, but also contributes to the development of herd immunity. Rotarix® and RotaTeq® vaccines are authorised or included in the national immunisation schedules of many countries, but this type of vaccination is not mandatory in most of these countries. Vaccination coverage in the EU countries is about 24 %. Alternative vaccination schemes using live attenuated vaccines based on strains derived from newborn children, and parenteral rotavirus vaccines which do not replicate in the intestine may help reduce existing risks. It was concluded that the introduction of live rotavirus vaccines in immunisation schedules should be accompanied by the analysis of incidence of intussusception of the small intestine before and after the introduction of mass immunisation, and by active pharmacovigilance.

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Section: безопасность и реактогенность живых ротавирусных вакцинunclassified

Vaccine Safety and Efficacy in Preventing Rotavirus Infection

Шевцов¹,

Евреинова²,

Indikova³

et al. 2019

Biopreparaty. Profilaktika, diagnostika, lechenie

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A Clinical Case of Adverse Events After Immunization Against a New Coronavirus Infection

Gabbasova,

Mamchik,

Yatsenko

et al. 2023

Bulletin of the Central Chernozem Region

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A 20-year-old girl was immunized against COVID-19 with Sputnik V. 6 hours after vaccination, symptoms of intoxication, body aches, weakness appeared, body temperature increased to 40.3С during the day, pain was noted at the injection site. The post-vaccination reaction lasted 2 days. The patient did not seek medical attention. The girl received the second dose of the vaccine on the 21st day after the first vaccination. 6 hours after immunization, symptoms of intoxication, body aches, weakness appeared, body temperature increased to 40.6C, pain was noted at the injection site. The next day she asked for medical help at the clinic, diagnosed with: Post-vaccination reaction to the Sputnik-V vaccine; symptomatic therapy was prescribed. The body temperature was 37.0-38.0C for 2 weeks. Despite the superstrong general post-vaccination reaction, revaccination was carried out six months later. After the introduction of the vaccine, the body temperature increased to 41.6C, there were pronounced symptoms of intoxication, body aches, weakness, at the injection site - hyperemia, soreness, swelling of more than 8 cm in diameter. The next day, the student asked for medical help, an infectious disease doctor diagnosed her with an allergic reaction to the Sputnik V, Sputnik Light vaccine, and symptomatic treatment was prescribed. Body temperature remained febrile for 6 days, general symptoms persisted for 2 weeks, and local reactions persisted for 3 weeks.

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Current regulatory requirements for clinical trials of viral vaccines

Soldatov,

Gorenkov,

Avdeeva

et al. 2023

Biological Products. Prevention, Diagnosis, Treatment

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Scientific relevance. In recent years, the development of various vaccines based on novel platforms has underscored the significance of updating regulatory requirements for vaccines. Consequently, clinical trials of viral vaccines need harmonised approaches within national guidelines and the Eurasian Economic Union (EAEU) regulatory framework.Aim. This study aimed to analyse national and international requirements for clinical trials of the efficacy and safety of preventive viral vaccines.Discussion. This article presents an analysis of the guidelines issued by the WHO and leading regulatory authorities on different aspects of clinical trials of viral vaccines. These guidelines place particular emphasis on the immunogenicity of vaccines. The lack of well-established immune correlates of protection for most infections presents a significant problem for assessing the effectiveness of vaccines. Immunobridging studies may be conducted to expand vaccine indications to different populations (such as a new age group). The size of the prelicensure safety database should include data on at least 3,000 vaccinated study participants. For some vaccines, safety studies must assess the risk of disease onset or enhancement due to vaccination.Conclusions. The clinical trial requirements for viral vaccines have been substantially aligned by the WHO and major international regulatory authorities, thereby facilitating the development of harmonised national or EAEU guidelines.

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Vaccine Safety International Monitoring

Cited by 3 publications

References 23 publications

Vaccine Safety and Efficacy in Preventing Rotavirus Infection

Vaccine Safety and Efficacy in Preventing Rotavirus Infection

A Clinical Case of Adverse Events After Immunization Against a New Coronavirus Infection

Current regulatory requirements for clinical trials of viral vaccines

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