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Coronavirus: Interim statement by the COVID-19 subcommittee of the WHO Global Advisory Committee on Vaccine Safety

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The COVID-19 subcommittee of the WHO Global Advisory Committee on Vaccine Safety (GACVS) reviewed reports of rare cases of low-platelet blood clots following vaccination with the AstraZeneca COVID-19 vaccine (including Covishield) since their appearance a few weeks ago.

At its last meeting on April 7, 2021, the subcommittee reviewed the latest information from the European Medicines Agency (https://bit.ly/3mDu1Wx) as well as information from the UK Medicines Regulatory Agency and Other Health Products (MHRA) (https://bit.ly/2OxQ8ku) and other Member States and noted the following:

  • Based on current information, a cause and effect relationship between the vaccine and the occurrence of low platelet count 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 other data, as it has done since the start of the COVID vaccination program.
  • It is important to note that although of concern, events under evaluation are very rare, with low numbers reported among the nearly 200 million people who have received the AstraZeneca COVID-19 vaccine worldwide.
  • Rare adverse events following vaccination should be weighed against the risk of death from COVID-19 disease and the potential of vaccines to prevent infections and reduce disease deaths. In this context, it should be noted that to date, at least 2.6 million people have died from the COVID-19 disease worldwide.
  • Side effects within two to three days of vaccination, the majority of which are mild and local in nature, are expected and common. However, people who have severe symptoms – such as shortness of breath, chest pain, swelling in the legs, persistent abdominal pain, neurological symptoms, such as severe and persistent headaches or blurred vision, tiny blood spots under the skin beyond the injection site – approximately four to twenty days after vaccination, urgent medical attention is required. Clinicians should be aware of relevant case definitions and clinical advice for patients with thrombosis and thrombocytopenia after COVID-19 vaccination (https://bit.ly/3moTjra). To this end, the GACVS subcommittee also suggested that a clinical expert committee comprising hematologists and other specialists be convened, for advice on clinical diagnosis and case management.
  • Active surveillance, including case-based sentinel site / hospital investigations, should be considered to further characterize these rare events. WHO has developed model protocols that countries could adapt for such studies. GACVS will meet again next week to review additional data and make further recommendations as appropriate.

WHO is closely monitoring the deployment of all COVID-19 vaccines and will continue to work closely with countries to manage potential risks and use science and data to elicit responses and recommendations.

In extensive vaccination campaigns, it is normal for countries to identify potential side effects after vaccination. This does not necessarily mean that the events are related to the vaccination itself, but they should be investigated to ensure that any safety concerns are resolved quickly. Vaccines, like all medicines, can have side effects. Administration of vaccines is based on a risk-benefit analysis.

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