Press release from the Standing Committee on Vaccination (STIKO) dated March 30, 2021: “The task of the STIKO is to continuously evaluate all scientific data on the efficacy and safety of vaccines and to derive recommendations from them. This naturally also applies when new findings on the safety of a vaccine are obtained that were not previously available because the number of vaccinated individuals in the approval studies was insufficient to detect them.
After several consultations, and also with the involvement of external experts, the STIKO has decided by majority vote, based on the currently available data on the occurrence of rare but very serious thromboembolic side effects, to recommend the AstraZeneca COVID-19 vaccine only for individuals aged 60 and over, as this side effect occurred 4 to 16 days after vaccination, predominantly in individuals under 60 years of age.”
Regarding the question of administering the second vaccine dose to younger individuals who have already received a first dose of the AstraZeneca COVID-19 vaccine, the STIKO (Standing Committee on Vaccination) will issue a supplementary recommendation by the end of April. Since vaccination with the AstraZeneca vaccine began at the beginning of February, the first second doses are scheduled for the beginning of May, assuming a recommended interval of 12 weeks between doses.
The agreed-upon draft resolution and the scientific rationale are currently undergoing a consultation process with the federal states and relevant experts. The resolution will be adopted on Thursday, April 1, 2021, after reviewing the feedback and further deliberation by the STIKO (Standing Committee on Vaccination). It is possible that changes to the draft recommendation may still occur after the consultation process
The European Medicines Agency (EMA) reviewed the situation and recommended on March 18, 2021, that vaccinations with the AstraZeneca vaccine continue. The federal and state health ministers decided on March 18, 2021, to resume vaccinations with the AstraZeneca vaccine starting March 19, 2021. This decision was based on the fact that the benefits of the vaccine in combating the still widespread threat of COVID-19 continue to outweigh the risk of side effects. A warning was added to the product information.
A Dear Healthcare Professional Letter dated March 24, 2021, explains: “Vaccinated individuals should be advised to seek immediate medical attention if they develop symptoms such as shortness of breath, chest pain, leg swelling, or persistent abdominal pain after vaccination. Furthermore, anyone experiencing neurological symptoms after vaccination, such as severe or persistent headaches or blurred vision, or who develops bruising (petechiae) on the skin outside the injection site a few days later, should seek immediate medical attention.”
Download: Dear Doctor Letter COVID-19 Vaccine AstraZeneca: Risk of thrombocytopenia and coagulation disorders
In this context, the question arises as to why, in Germany, vaccination with the AstraZeneca vaccine was restricted to people under 65, contrary to its approval by the EMA (European Medicines Agency), citing insufficient efficacy data in older people. that young women in the healthcare system , such as nurses and doctors, have been given priority for treatment with this vaccine. The benefit of an additional warning about complications in the package insert, when no alternatives are offered, remains unclear. This would be understandable if no other options existed. However, such options were available, including vaccines from BioNTech/Pfizer. According to current findings, young women belong to the high-risk group for the described complications. Consequently, on March 29, 2021, the Euskirchen district decided with immediate effect to no longer vaccinate women under 55 with the AstraZeneca vaccine. Following the death of a 49-year-old nurse, Rostock University Hospital announced on March 26, 2021, that it is suspending AstraZeneca vaccinations for people with high blood pressure, obesity, and women taking birth control pills. Similarly, the Canadian expert panel for the COVID-19 vaccination campaign currently recommends suspending the AstraZeneca vaccine for people under 55. According to a report from March 30, 2021, the state-owned Charité and Vivantes hospitals in Berlin are also suspending AstraZeneca vaccinations for women under 55. Following Berlin's announcement, the city of Munich also announced on August 30, 2021, that it will no longer administer AstraZeneca to anyone under 60 until further notice. On March 30, 2021, the directors of five university hospitals in North Rhine-Westphalia also advocated for a temporary halt to vaccinations of younger women with the AstraZeneca vaccine. And also on March 30, 2021, the Standing Committee on Vaccination (STIKO) announced: “Based on the currently available, albeit still limited, evidence and taking into account the current pandemic situation, STIKO recommends using the AstraZeneca COVID-19 vaccine for people over 60 years of age. Its use below this age remains possible at the discretion of a physician and with individual risk acceptance after careful consultation. STIKO will issue a statement regarding the second vaccine dose for younger people who have already received a first dose of the AstraZeneca COVID-19 vaccine by the end of April.”
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