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Interim Statement of the COVID-19 Subcommittee of the WHO World Advisory Committee on Vaccine Safety on AstraZeneca COVID-19
The COVID-19 subcommittee of the WHO Global Vaccine Safety Advisory Board (GACVS) has reviewed reports of rare cases of low-platelet blood clots following vaccination with AstraZeneca COVID-19 (including Covishield) since their inception a few weeks ago.
At its most recent meeting on April 7, 2021, the subcommittee reviewed the latest information from European Medicines Agency together with information from UK Medicines and Other Health Products Regulatory Agency (MHRA)and other Member States and noted the following:
- Based on current data, a cause-and-effect relationship between the vaccine and the occurrence of low-platelet blood clots is considered plausible but not confirmed. Specialized studies are needed to fully understand the potential relationship between vaccination and possible risk factors.
- The GACVS subcommittee will continue to collect and review further data, as it has done since the beginning of the COVID vaccine program.
- It is important to note that, although worrying, the events being estimated are very rare, and a small number have been reported among the nearly 200 million individuals who have received the AstraZeneca COVID-19 vaccine worldwide.
- Rare adverse events after immunization should be assessed based on the risk of death from COVID-19 disease and the potential of the vaccine to prevent infections and reduce disease mortality. In this context, it should be noted that as of today, at least 2.86 million people have died from COVID-19 disease worldwide.
- Side effects within two or three days after vaccination, most of which are mild and local in nature, are also expected to be frequent. However, people who have any serious symptoms – such as shortness of breath, chest pain, swelling of the legs, persistent abdominal pain, neurological symptoms such as severe and persistent headaches or blurred vision, tiny bloodstains under the skin outside the injection site – are about four to 20 days after vaccination, emergency medical attention should be sought. Clinicians should be familiar with relevant case definitions and clinical guidelines for patients with thrombosis and thrombocytopenia following COVID-19 vaccination.. To this end, the GACVS subcommittee also proposed that a committee of clinical experts, including hematologists and other experts, be convened for advice on clinical diagnosis and case management.
- Active surveillance, including guard / hospital case investigations, should be considered to further characterize these rare events. The WHO has developed a protocol template that countries could adapt to such studies. The GACVS will meet again next week to review additional information and issue further recommendations as needed
The WHO is closely monitoring the introduction of all vaccines against COVID-19 and will continue to work closely with countries in managing potential risks and using science and data to trigger responses and recommendations.
In extensive vaccination campaigns, it is normal for countries to identify potential adverse events after immunization. This does not necessarily mean that the events are related to the vaccination itself, but they must be investigated to ensure that any safety issues are resolved quickly. Vaccines, like all medications, can have side effects. The use of the vaccine is based on a risk-benefit analysis.
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