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Results from four clinical trials in the United Kingdom (United Kingdom), Brazil and South Africa showed that the AstraZeneca vaccine safely and effectively prevented the spread of COVID-19 in people over 18 years of age.
“The safety of the vaccine has been proven in four clinical trials. The VAS based its calculations on the effectiveness of the vaccine with data from two studies, one in the UK and one in Brazil. In the other two studies, fewer than 6 cases of COVID-19 were identified, so this number was too small to calculate the efficacy of the vaccine, ”said Simona Stankevičiūtė, member of the EEA Committee for Medicinal Products for Human Use ( CHMP). ).
According to S. Stankevičiūtė, most of the participants in the four clinical trials mentioned were between 18 and 55 years old. As of yet, there is insufficient data for the VAS to provide an accurate figure on the effectiveness of the vaccine among the elderly. However, since an immune response is seen in the elderly and based on experience with other vaccines, the vaccine is expected to be effective in this age group as well.
Ms. Stankevičiūtė also recalled that AstraZeneca’s overall safety assessment is based on pooled data from the 4 clinical trials in the UK, Brazil, and South Africa. Data from 23,745 subjects (aged 18 years and over) were analyzed. Subjects were followed for a mean of 62 days after the second dose.
The most frequently reported adverse reactions to the vaccine were injection site pain, fatigue, headache, muscle aches, malaise, and others. Most of these side effects generally resolve within a few days of the vaccine. Adverse reactions were milder and less frequent after the second dose than after the first. The reactogenicity of the elderly (65 years and older) was weaker and less frequently recorded.
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