The Indian government advertises its policy to contain COVID-19 as the world’s largest vaccination drive. However, it keeps the data on adverse events and deaths after vaccination a top secret. Moreover, there is no online registry to report post-vaccination deaths or adverse effects in India.
The Indian government on Monday released its “advisory” outlining the signs to recognize Adverse Events Following Immunization (AEFIs) that occurred “within 20 days” and directs to report it to vaccination centres.
This advisory has been released 4 months after India began its national vaccination drive against COVID-19 pandemic. Questions are being raised as to why this advisory was not released before the vaccination trials began.
Government has also shared partial data and admitted “minuscule cases” of clotting occurred post-Covershield shots. But, the government did not disclose any figures on deaths.
Meanwhile, a former member of the National Technical Advisory Group on Immunisation has filed a petition in the Supreme Court of India to make public the clinical trials data and post vaccination adverse events data which is being kept secret by the government.
The petition states that in other countries, this type of observation has helped identify the occurrence of blood clots and strokes in vaccine recipients.
Indian doctors feel that the advisory is incomplete and unclear and it does not serve any purpose. Other nations like US and UK had established extensive and robust online mechanism which is missing in India.
Dr. Jaiprakash Pednekar, a senior physician told The Dialogue, “It is too little too late. They should have released it in January itself when the national vaccination drive began. Several cases of clotting have occurred post-vaccination and the government and vaccine makers both know it. They remained unreported.”
While the Ministry of Health and Family Welfare (MoHFW) asked to report adverse events within 20 days after getting jab, experts think that 20 days are not sufficient for figuring out AEFIs.
“It should be lengthened, the idea being reporting should be over-inclusive so that we don’t miss any. The wheat can be separated from the chaff later,” Dr. Harish Shetty says.
“There is no time limit to report such cases in the UK. We have an online system, which is an extension of a pre-existing system to capture side effects of drugs,” says Dr Aviral Vatsa, a physician associated with NHS-Scotland.
Dr. Lalit Anande, Medical Superintendent of TB Hospital in Mumbai, says:
“The government must track recipients at least two years post-vaccination as all vaccines have got “emergency use” approval. Every AEFI should be documented and discussed as per the rules of any clinical trials. Not documenting them means a mockery of the AEFI system.”
Dr. Anande stresses that the post-mortem of every death post-vaccination should be carried out.
“You can’t just say that that person died post-vaccination due to his comorbidities without even doing an autopsy. This is all more important since all approved vaccines in India have been developed on fast-track mode and received ’emergency use authorization’ only.”
The MoHFW says, AEFIs must be reported “preferably” to centre where the vaccine was administered. But experts think this is not feasible. These health facilities lack infrastructure or facilities to manage severe post vaccination cases.
The EU (EMA) and US (VAERS) have registry platforms online to report such cases. These platforms encourage doctors and patients to register side effects of jab online. There is no such online registry to report post-vaccination deaths or adverse effects in India.
“The government should establish a national helpline for reporting adverse events and a follow-up mechanism,” says Dr Able Lawrence, professor of clinical immunology.
A portal or helpline will be better option than reporting adverse effects at vaccination centers, he added.
In the absence of such mechanism, India is now facing a Black Fungus epidemic in the state of Rajasthan.
It was only a year and a half later that top Indian health chief came forward with daily press briefings warning that the Black Fungus is caused by the use of steroids during Covid-19 infection
If we had a robust reporting system, this mutation could have been stopped in this tracks from becoming an epidemic.
Sensing the dire need of such a mechanism, our team at GreatGameIndia is now working on a citizen’s Registry of Adverse Events Following Vaccination (RAEFV).
Those who wish to support us and volunteer in our initiative are welcome to contact us.