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AstraZeneca Admits of Blood Clots but in “Very Rare Cases”

AstraZeneca Admits of Blood Clots but in “Very Rare Cases”

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NEW DELHI, Apr 30: Global pharmaceutical giant AstraZeneca has said its AZD1222 vaccine against Covid-19, which was made under licence in India as Covishield, could cause low platelet counts and formation of blood clots in “very rare” cases.

AstraZeneca has accepted a link between the vaccine and Thrombosis with Thrombocytopenia Syndrome (TTS), a medical condition characterised by abnormally low levels of platelets and the formation of blood clots.

AstraZeneca’s vaccine formula was licensed to Pune-based vaccine maker Serum Institute of India (SII) during the Covid pandemic for the manufacture of Covishield. More than 175 crore doses of Covishield have been administered in India.

AstraZeneca spoke about TTS in court documents following a suit brought against the company in the United Kingdom. The pharmaceutical giant is being sued over health claims related to the vaccine that it developed in collaboration with the University of Oxford amid the Covid-19 pandemic in 2020.

The UK-based media reported recently that a “case was lodged last year by Jamie Scott, a father of two, who was left with a permanent brain injury after developing a blood clot and a bleed on the brain that has prevented him from working after he received the vaccine in April 2021.”

The report said in all, “fifty-one cases have been lodged in the High Court (in the UK), with victims and grieving relatives seeking damages estimated to be worth up to £100 million.”

In court documents from February, AstraZeneca denied that “TTS is caused by the vaccine at a generic level.” However, it admitted to the possibility of TTS as a result of its vaccination in “very rare cases.”

A range of symptoms are associated with TTS, including breathlessness, pain in the chest or limbs, pinhead-size red spots or bruising of the skin in an area beyond the injection site, headaches, numbness in body parts, etc. TTS could mean a restriction in the flow of blood due to clotting.

Before the Covid-19 vaccines were rolled out in India, the Indian government had issued a fact-sheet in January, 2021 in which it specifically said Covishield (the Indian variant of AstraZeneca’s vaccine) should be given with “caution” to individuals with thrombocytopenia, that is, a condition of low platelet counts. Covishield and Covaxin were the two Covid vaccines given to Indians.

Then, in March 2021, the European countries France, Germany, Italy, Netherlands, Denmark, Norway, Iceland, Austria, Estonia, Bulgaria, Romania, Estonia, Lithuania, Luxembourg, and Latvia had temporarily paused the use of AstraZeneca vaccine after a few cases of blood clotting were reported.

The following month, the World Health Organisation (WHO) said TTS was being reported in some cases after vaccinations with Covishield and Vaxzevria (which was the other trade name for AstraZeneca’s vaccine).

However, the WHO had added, “Based on latest available data, the risk of TTS with Vaxzevria and Covishield vaccines appears to be very low. Data from the UK suggest the risk was approximately four cases per million adults (1 case per 250,000) who receive the vaccine, while the rate is estimated to be approximately 1 per 100,000 in the European Union (EU).”

According to more recent data, the government’s committee on Adverse Events Following Immunization (AEFI) said at least 36 cases of TTS have been vetted and confirmed to have been caused due to Covishield. The committee’s last report, which was made public in June last year, showed that of these cases 18 deaths were reported. Almost all of these TTS cases pertain to 2021 which was the first year of Covid-19 vaccination in the country.

The Union Health Ministry had termed this possibility as “minuscule” and said Covishield “continues to have a definite positive benefit-risk profile” with “tremendous potential to prevent infections and reduce deaths” due to Covid-19. In the case of Covaxin, which was India’s indigenous vaccine manufactured by Bharat Biotech, it said “no potential thromboembolic events” had been reported.

(Manas Dasgupta)


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