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Centre Says Covishield Clot Risk Minuscule, but Is the Monitoring System Robust?

Centre Says Covishield Clot Risk Minuscule, but Is the Monitoring System Robust?

A health worker holds the Covishield vaccine candidate in Ahmedabad, January 12, 2021. Photo: PTI

New Delhi: Though a Central panel investigating adverse events after immunisation has found that there is only a minuscule risk of bleeding and clotting after the Covishield vaccines is administered – identifying 26 potential cases so far, questions remain about how robust the monitoring process is.

The Union health ministry said in a statement on Monday that over 23,000 adverse events have been reported since the vaccination drive involving the Covishield and Covaxin vaccine candidates started in the country and of these, 700 cases were reported to be serious.

The National Adverse Event Following Immunisation (AEFI) Committee has completed an in-depth case review of 498 serious and severe events, of which 26 cases have been reported to be potential thromboembolic (formation of a clot in a blood vessel that might also break loose and carried by the blood stream to plug another vessel) events following administration of Covishield vaccine “with a reporting rate of 0.61 cases/ million doses”.

“There were no potential thromboembolic events reported following administration of Covaxin vaccine,” the ministry said.

As alerts were raised in some countries on post-vaccination embolic and thrombotic events on March 11, particularly with AstraZeneca-Oxford vaccine (which is sold in India by the Serum Institute as Covishield), a decision was taken to conduct an urgent in-depth analysis of the adverse events (AE) in India in the light of global concerns, the ministry said.

The death of Snehal Lunawat, a lecturer in Nasik who was administerd Covishield in January and died on March 1 due to cerebral venous thrombosis, bleeding in the brain and thrombocytopenia, shows that potential incidents could be slipping through the monitoring framework.

In a letter to the All India Drug Action Network (AIDAN), Snehal’s brother Shubham said his sister’s illness had all the signs of thromboembolic events, like bleeding and clot formation with low platelets.

“Doctors detected venous sinus thrombosis which was followed by intracranial brain hemorrhage. They performed craniotomy and clot removal surgery,” he said. The letter also said that Snehal was tested for COVID-19 thrice, with the results returning negative all three times.

However, Snehal’s death was not reported appropriately within the AEFI monitoring system despite the family’s efforts to report the serious adverse event and death to various authorities and Serum Institute of India.

The family informed SII of the development by February 9, when Snehal was in a critical condition. The company claimed that her condition was not linked to the vaccine.

Shubham also contacted the Haryana Food and Drugs Administration (FDA), as Snehal was hospitalised and received treatment in Gurugram. On 13 April, he received a letter from the Haryana FDA which indicated that Snehal’s death was not reported to the AEFI surveillance system because reporting it is the responsibility of the district where the vaccination was conducted.

In a letter that AIDAN sent to top government officials such as NITI Aayog member V.K. Paul and health secretary Rajesh Bhushan, the group said the family had already contacted the vaccination drive in-charge at the SMBT institute in Nasik in March, but he was “neither inclined to report the AEFI nor sought further details”.

“No responses were received to the letters sent to other relevant authorities such as the DCGI. No official has been in touch till date with the family regarding the medical records or case details of Dr. Snehal,” AIDAN’s letter added.

With Indian authorities either disinclined or uninterested in investigating Snehal’s case, the family approached the World Health Organisation. According to an Economic Times report, the UN agency had agreed to look into the death of the doctor.

‘Miniscule but definitive risk’

The press release issued by the National AEFI committee on Monday also noted that as of April 3, 75,435,381 vaccine doses had been administered (Covishield 68,650,819; Covaxin 6,784,562).

“Of these, 65,944,106 were first doses and 9,491,275 second dose. Since the COVID-19 vaccination drive was initiated more than 23,000 adverse events were reported through the CO-WIN platform reported from 684 of the 753 districts of the country.

“Of these, only 700 cases (@ 9.3 cases /million doses administered) were reported to be serious and severe in nature,” the statement said.

“The AEFI data in India showed that there is a very minuscule but definitive risk of thromboembolic events. The reporting rate of these events in India is around 0.61/million doses, which is much lower than the 4 cases/million reported by the UK’s regulator Medical and Health Regulatory Authority (MHRA). Germany has reported 10 events per million doses,” the statement stated.

Thromboembolic events keep occurring in the general population as background and scientific literature suggests that this risk is almost 70% less in persons of South and South East Asian descent in comparison to those of European descent.

The ministry is separately issuing advisories to healthcare workers and vaccine beneficiaries to encourage people to be aware of suspected thromboembolic symptoms occurring within 20 days after receiving any COVID-19 vaccine (particularly Covishield) and report preferably to the health facility where the vaccine was administered.

The symptoms listed are breathlessness, pain in chest, pain in limbs/pain on pressing limbs or swelling in limbs (arm or calf), multiple, pinhead size red spots or bruising of skin in an area beyond the injection site, persistent abdominal pain with or without vomiting, seizures in the absence of previous history of seizures with or without vomiting, severe and persistent headache with or without vomiting (in the absence of previous history of migraine or chronic headache).

The symptoms also include weakness or paralysis of limbs or any particular side or part of the body (including face), persistent vomiting without any obvious reason, blurred vision or pain in eyes or having double vision, change in mental status or having confusion or depressed level of consciousness or any other symptom or health condition which is of concern to the recipient or the family.

The ministry said that Covishield continues to have a definite positive benefit risk profile with tremendous potential to prevent infections and reduce deaths due to COVID-19 across the world and in India.

Over 13.4 crore doses of Covishield vaccine have been administered as of 27 April in India.

The National AEFI Committee was informed on March 31 that the government was aware of at least 617 severe AEFIs, including 180 deaths. Three-quarters of these deaths occurred within three days of vaccination, the presentation said.

Note: This article was first published at 6 pm on May 17, 2021, and updated at 7:30 pm on May 18, 2021, to include details of Snehal Lunawat’s death.

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