The World Health Organization (WHO) has cleared the AstraZeneca COVID-19 vaccine as safe for use. This was the conclusion reached by the WHO’s Global Advisory Committee on Vaccine Safety (GACVS) that had met earlier in the week to review the data on blood clots and low platelets among some people who received the Oxford AstraZeneca vaccine.
Speaking to media persons, WHO Director-General Tedros Adhanom Ghebreyesus, said, “The Committee has concluded that the available data do not suggest any overall increase in clotting conditions following administration of the Oxford-AstraZeneca vaccine. As a result, the Committee has recommended that the AstraZeneca vaccine’s benefits outweigh its risks.”
According to WHO, more than 20 million doses of the AstraZeneca vaccine have been administered in Europe and more than 27 million doses of the Covishield vaccine (AstraZeneca vaccine by Serum Institute of India) have been administered in India so far.
WHO issued a detailed statement saying, “The GACVS COVID-19 subcommittee met virtually on 16 and 19 March 2021 to review available information and data on thromboembolic events (blood clots) and thrombocytopenia (low platelets) after vaccination with the AstraZeneca COVID-19 vaccine. The subcommittee reviewed clinical trial data and reports based on safety data from Europe, the United Kingdom, India, and Vigibase, the WHO global database of individual case safety reports.”
The committee concluded, “The AstraZeneca COVID-19 vaccine (including Covishield) continues to have a positive benefit-risk profile, with tremendous potential to prevent infections and reduce deaths across the world.” Elaborating on the findings related to blood clotting, GACVS said, “The available data do not suggest any overall increase in clotting conditions such as deep venous thrombosis or pulmonary embolism following administration of COVID-19 vaccines. Reported rates of thromboembolic events after COVID-19 vaccines are in line with the expected number of diagnoses of these conditions. Both conditions occur naturally and are not uncommon. They also occur as a result of COVID-19. The observed rates have been fewer than expected for such events.”
The entire WHO statement may be read here.
The European Medicines Agency (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded its preliminary review of a signal of blood clots in people vaccinated with COVID-19 Vaccine AstraZeneca at its extraordinary meeting of March 18, 2021. The Committee confirmed that:
- the benefits of the vaccine in combating the still widespread threat of COVID-19 (which itself results in clotting problems and may be fatal) continue to outweigh the risk of side effects;
- the vaccine is not associated with an increase in the overall risk of blood clots (thromboembolic events) in those who receive it;
- there is no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites;
- however, the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e. low levels of blood platelets (elements in the blood that help it to clot) with or without bleeding, including rare cases of clots in the vessels draining blood from the brain (CVST).
The EMA said, “A causal link with the vaccine is not proven, but is possible and deserves further analysis.” The entire statement may be read here. Concerns began being raised after one person developed blood clots and died in Denmark last week. Subsequently several countries had decided to halt administering the AstraZeneca vaccine. These include: Denmark, Iceland, Norway, Austria, Bulgaria and many others, but they are now expected to resume using the vaccine to inoculate their citizens.
*Feature image courtesy AstraZeneca COVID-19 Visual Resources.