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Statement of the WHO Global Advisory Committee on Vaccine Safety (GACVS) COVID-19 subcommittee on safety signals related to the AstraZeneca COVID-19 vaccine

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Statement of the WHO Global Advisory Committee on Vaccine Safety (GACVS) COVID-19 subcommittee on safety signals related to the AstraZeneca COVID-19 vaccine

As of 17 March 2021, more than 120 million cases of COVID-19 infections, with more than 2 million deaths, had been reported globally.  Vaccination remains a indispensable tool to abet stop further illness and death and to control the pandemic.

To this point, more than 20 million doses of the AstraZeneca vaccine had been administered in Europe and more than 27 million doses of the Covishield vaccine (AstraZeneca vaccine by Serum Institute of India) had been administered in India. 

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The GACVS COVID-19 subcommittee met as regards to on 16 and 19 March 2021 to review on hand information and information on thromboembolic occasions (blood clots) and thrombocytopenia (low platelets) after vaccination with the AstraZeneca COVID-19 vaccine.

The subcommittee reviewed clinical trial information and reports primarily primarily based on safety information from Europe, the United Kingdom, India, and Vigibase, the WHO world database of particular person case safety reports.

Essentially primarily based on a cautious scientific review of the on hand information, the subcommittee came to the following conclusions and recommendations: 

  • The AstraZeneca COVID-19 vaccine (including Covishield) continues to own a sure serve-threat profile, with colossal possible to stop infections and nick deaths all the scheme by means of the world.
  • The on hand information conclude now not suggest any total develop in clotting conditions equivalent to deep venous thrombosis or pulmonary embolism following administration of COVID-19 vaccines. Reported rates of thromboembolic occasions after COVID-19 vaccines are in accordance with the anticipated number of diagnoses of these conditions. Each and each conditions occur naturally and are now not uncommon. They also occur because of this of COVID-19.  The noticed rates had been fewer than anticipated for such occasions.
  • While very uncommon and habitual thromboembolic occasions in combination with thrombocytopenia, equivalent to cerebral venous sinus thrombosis (CVST), own also been reported following vaccination with the AstraZeneca COVID-19 vaccine in Europe, it is a long way now not particular that they had been precipitated by vaccination. The European Medicines Company’s Pharmacovigilance and Possibility Evaluation Committee has reviewed 18 cases of CVST out of a total of more than 20 million vaccinations with the AstraZeneca COVID-19 vaccine in Europe. A causal relationship between these uncommon occasions has now not been established right this moment (1)
  • Satisfactory education wants to be equipped to health-care professionals and persons being vaccinated to acknowledge the signs and symptoms of all extreme harmful occasions after vaccinations with all COVID-19 vaccines, in negate that participants would possibly additionally search and get prompt and relevant clinical care and treatment. 
  • The GACVS subcommittee recommends that nations continue to monitor the safety of all COVID-19 vaccines and promote reporting of suspected harmful occasions.
  • The GACVS subcommittee also is of the same opinion with the European Medicines Company’s plans to further investigate and monitor for these occasions. 

The GACVS COVID-19 subcommittee will continue to review the safety information from all COVID-19 vaccines and replace any recommendation as major. The WHO COVID-19 vaccine safety surveillance handbook supplies steerage to nations on the safety monitoring and harmful occasions information sharing for the new COVID-19 vaccines, and would possibly additionally be accessed right here.

(1) EMA Statement: https://www.ema.europa.ecu/en/news/covid-19-vaccine-astrazeneca-advantages-restful-outweigh-risks-regardless of-conceivable-link-uncommon-blood-clots

UK MHRA whine: https://www.gov.uk/authorities/news/uk-regulator-confirms-that-folk-would possibly additionally restful-continue-to-get-the-covid-19-vaccine-astrazeneca

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Statement of the WHO Global Advisory Committee on Vaccine Safety (GACVS) COVID-19 subcommittee on safety signals related to the AstraZeneca COVID-19 vaccine