Drug controllers: AstraZeneca is safe and suitable for people of all ages



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This use of AstraZeneca is described in the Summary of Product Characteristics (SPC).

Data from 23,745 subjects were analyzed in clinical trials with this vaccine. Subjects belonged to all age groups older than 18 years. Subjects were followed for a mean of 62 days after the second dose.

So far, there are not enough results for the EEA to provide an accurate figure on the efficacy of the vaccine in the elderly population, according to the IWT report. However, given that an immune response is seen in the elderly and based on experience with other vaccines, the vaccine is expected to be effective in this population as well. There is also reliable information on the safety of the vaccine in this patient population, which is why the VAS experts have decided that the vaccine can be used in older people. More information is expected in the near future from ongoing clinical trials involving more older people.

The IUDC notes that patients can be vaccinated with a second dose of AstraZeneca 4 to 12 weeks after the first dose. However, a review of clinical trials indicates that the maximum efficacy of the vaccine is seen when the second dose of the vaccine is administered 9 to 12 weeks after the first dose.

The CHMP notes that the marketing authorization for AstraZeneca has been approved by the EEA Committee for Medicinal Products for Human Use (CHMP), after a comprehensive evaluation of all data on the quality, safety and efficacy of this vaccine. This means that the AstraZeneca vaccine is safe, effective and meets all the quality standards of the European Union, say IWT specialists.

Unlike other vaccines registered and already used against the COVID-19 disease in Lithuania, which use mRNA technology, AstraZeneca is manufactured using another virus from the adenovirus family, which is modified to contain the gene encoding the spike protein SARS-CoV-2. Adenovirus itself cannot reproduce and therefore does not cause disease. When the vaccine is given, the SARS-CoV-2 gene enters the cells of the body, causing the cells of the body to make the spine protein based on that gene. The human immune system recognizes this spine protein as foreign to the body, so it begins to produce antibodies and T cells against it, which are natural defense components of the immune system. Later, if a vaccinated person comes into contact with the SARS-CoV-2 virus, their immune system is able to recognize the virus and is ready to fight it: antibodies and T cells can work together to kill the virus, prevent that enter the body’s cells and destroy infected cells, thereby helping to protect against COVID-19 disease.

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