Scary revelations developed by the European Medicines Agency (EMA) – a body responsible for evaluating medical products – regarding the safety profile of AstraZeneca’s Covishield vaccine, has deep lessons for India. Lesson on how India should proceed to investigate Adverse Vaccine Events (AEFI). The EMA studied the side effects on a case-by-case basis and disclosed the results to the public. So, the world has now become aware of the rare side effects of coagulation – some of them even fatal – which are linked to Covishield’s jab. India, on the other hand, has put stories of suspected deaths under the rug.
As of March, India was investigating at least 71 autopsies Related deaths from vaccination, but there has not been much clarity on how these investigations were conducted. In at least three of the eight Covishield-related deaths that have been probed, India has said Covishield could have triggered the death. Read the central government report here.
There was worries about the safety of Covishield even in November 2020, after a Chennai resident sued the company for developing neurological complications after the coup. This was when the vaccine was in clinical trials.
In January there was palpable reluctance among healthcare workers to take the vaccines, because while Covishield had anecdotal safety concerns, the scientific data on Covaxin from Bharat Biotech had not yet been released.
But government factions have pushed forward with arm-twisting methods. To Odisha, for example, the civil surgeon of the city of Koderma, in an office order dated Jan. 15, said those who do not take the hit will not receive their pay.
On January 17, news of one of the first deaths after vaccination began to flow. It was a ward boy from the city of Moradabad, Uttar Pradesh, who had taken the first dose of Covishield the day before, and later deceased sepsis shock. Around the same time, another health worker in Sandur, Bellary also deceased of similar causes.
Although the government maintains that these events are “unrelated” to the vaccine, the European EMA finding sets a precedent. “The committee conducted an in-depth review of 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis reported in the EU Medicines Safety Database (EudraVigilance) as of 22 March 2021 , including 18 fatalities, ”he says.
This is the first time that a government agency has admitted that Covishield causes fatal side effects in rare cases, which the Indian government has been too timid to admit.
Questions also arise as to whether beneficiaries have been screened fully for morbidities and unsuitable conditions for taking the vaccines.
On January 20, two more deaths had occurred in patients who had taken Covishield, but the government was quick to fire them.
Two days later, a 56-year-old health worker in Gurgaon deceased—Six days after taking Covishield – and his family filed a complaint with the police. Yet another health worker in Guntur deceased of a stroke on January 24, four days after the Covishield stroke.
Requests to disclose the results of the investigation fell on deaf years. Consecutive reports of deaths from vaccination are too much of a coincidence.
As of February 25, up to 45 deaths were reported after vaccination, after which the Indian government stopped sharing data.
On March 1, Prime Minister Narendra Modi took the safer Covaxin counterpart manufactured by Bharat Biotech. He has, so far, managed to maintain a reputation free, with no reports of death following his vaccination. While people were hesitant about Covaxin earlier due to lack of data, Release data from phase III trials enhanced confidence.
But while Covaxin has always been available in lesser quantities – with the majority of centers administering Covidshield – the shortcoming supply has now come.
Even after revelations regarding the EMA, which conclude that 1 in 100,000 people may suffer from the side effects of Covishield, investigations into these deaths have not been transparent in India. And we can only hope that things will change for the better, after the upheavals caused by the EMA.