India reports 447 cases of vaccine side effects

India has reported 447 adverse reactions to COVID-19 vaccines as 224,301 people received the first dose of vaccines in the country, the Health Ministry confirmed on Sunday.

“Of the 447 Adverse Event Following Immunization (AEFIs), three had to be hospitalized, while two of them have now been discharged after 24 hours, one continues to be under observation,” said Manohar Agnani, joint secretary at the Health Ministry.

Following the reports of adverse events, Anadolu Agency spoke with Anant Bhan, a global health and bioethics researcher, who recently co-drafted the World Health Organization's policy brief on “ethical considerations for current and future COVID-19 vaccine trials”.

“Given the large number of individuals receiving the vaccination, it is not unexpected to see adverse events. However, for indigenously produced Bharat Biotech’s Covaxin, they [authorities] could have waited for the efficacy data prior to including it in the response,” said Bhan.

The Pune-based Serum Institute of India is manufacturing the Covishield vaccine developed by Oxford University and AstraZeneca, and Covaxin is the country's indigenous vaccine and is made by Bharat Biotech in collaboration with the Indian Council of Medical Research.

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While both the vaccines are being administered, experts have strongly reacted to the haste with which the Indian drug regulator approved the vaccines, especially in the case of “Covaxin” which does not have efficacy data available from a large phase III study.

“[It is] Important for everyone to remember that the government through the Indian Council of Medical Research (ICMR) is a co-sponsor for the clinical trials for both vaccines and hence has stake also in the vaccine research process and the data produced thereof,” Bhan underlined.​

Distrust

In a recent similar large-scale vaccine rollout in Norway, 29 beneficiaries above 75 years succumbed to serious underlying health conditions after getting Pfizer/BioNTech jab.

This and the absence of data has also led to distrust among the health care workers in India.

“There is no confidence in the way the approvals were done and in a language that seems to be more creative writing than based on any law. More transparency, clear rationale, and fact-based communication would perhaps have built more confidence. This should happen urgently even now,” Bhan said.

He further stressed that “Covaxin” has been released for usage “in clinical trial mode”. While exact details of this trial mode are still awaited in the public domain, those who receive this vaccine will still be certainly part of a trial.

“Since the vaccines are new, we will need close monitoring to understand risk profile and adverse events, especially in special populations such as the elderly. Hence it is important for us to also focus on proper adverse event monitoring here in India,” he stressed.

Meanwhile, the Indian National Congress, the main opposition party, said vaccine development and mass immunization are neither "Events" nor "Publicity Stunts", but important milestones in the “service of the people”.


“While the country stands united in providing immunization against coronavirus to our frontline ‘Corona Warriors’ […] let us remember that vaccinations are an important ‘Public Service’ and not a ‘Political or Business Opportunity’,” said Randeep S Surjewala, the party’s general secretary said on Sunday.