Causality assessment of COVID-19 vaccine deaths will be made public, says National AEFI Committee advisor

Vaccine as a biological cause is least likely to cause deaths. The adenovirus vector and the genetic material that helps in making the spike protein are unlikely to cause deaths. But other ingredients in the vaccine and the quality of the vaccine in the particular batches that were used in these situations should be investigated. Sometimes vaccines could act as a trigger.

The Advisor to the National Adverse Event Following Immunisation (AEFI) Committee for COVID-19, Dr. N.K. Arora, has said that data from the assessment of the deaths of health care and frontline workers would be placed in the public domain.

On January 31, when 11 deaths of health-care and frontline workers were reported from across the country following administration of Serum Institute’s Covishield vaccine nearly two-dozen scientists and others wrote to Health Minister Dr. Harsh Vardhan, DCGI Dr. V.G. Somani and others urging them to urgently investigate the deaths. They requested that the findings of the causality assessment by the National AEFI Committee be made public.

As on February 4, less than three weeks after the mass COVID-19 vaccination programme began on January 16, there have been 16 deaths. In all these cases, the district/State officials have stated that deaths are unrelated to the vaccine. But so far, no reports of the district, State and National AEFI Committees on the assessment of these deaths and other serious AEFIs have been released. “The National AEFI Committee has an obligation to investigate possible patterns in causative factors for these deaths,” the two-dozen people say.

“Please place complete information on all deaths, severe and serious AEFIs in the COVID-19 vaccine rollout, and their investigation, in the public domain. This information should include the numbers, date of vaccination, details of the AEFI, place, investigation status and results,” their letter states.

Most of the 16 deaths in people of 23 to 56 year age group so far have been ascribed to cardiovascular problems or stroke and the causal link of the deaths to the vaccine has been ruled out in each case.

Assuaging the concerns raised by the scientists and others, Dr. Arora said that the National AEFI Committee met on Monday and would again meet on February 5.

“In causality assessment, deaths are of highest importance. Once causality assessment is done, we will put out the information in the public domain. Even if causality assessment is completed in one case, we will make the information available in the public domain,” Dr. Arora said.

Dr. Arora also said, “The causality assessment by the National AEFI Committee will be on a rolling basis. This is because we want everyone to know if the vaccine caused the deaths.”

Vaccination, death time relationship 

“The sequence (death following vaccination) is not an evidence of consequence,” says virologist Dr. Jacob John, who is one of the signatories of the letter. “Causality association is through exclusion. The time relationship of the deaths with vaccination should be explained, for which alternative cause of death should be established through investigation in each case. Only then can the vaccine be exonerated. If you can’t find any cause of death in a young person, then you have to attribute the cause of death to the vaccine.”

Around 25,000 people die in India every day. About 28% deaths are due to cardiovascular diseases, as per a 2018 The Lancet report. We are vaccinating around two lakh people a day. So around four deaths per day and one death per day due to heart attack/stroke can be at random as well. No AEFI assessment is complete without knowledge of background rates of adverse effects, Dr. Anupam Singh from Santosh University, Ghaziabad, said in a tweet.

Responding to the background rate of deaths, Dr. John says: “Numerical frequency of deaths even if it tallies with background deaths in the specific age group does not automatically exonerate the vaccine. Would these people have died in the absence of the vaccine? The committee has to investigate this.”  

Norway investigates 23 deaths

For instance, in Norway, 23 elderly, frail patients died shortly after receiving the first jab of the Pfizer vaccine. The Norwegian Medicines Agency (NOMA) investigated 13 of the deaths in mid-January and found that deaths were caused by common adverse reactions such as fever, nausea, and diarrhoea. These common adverse events can lead to fatal outcomes in old people. NOMA had said that vaccination of old people had to be carried out with an extra evaluation of very sick people whose underlying condition might be aggravated by it. Around 400 deaths normally occur among care home residents every week.

Dr. John also says: “Vaccine as a biological cause is least likely to cause deaths. The adenovirus vector and the genetic material that helps in making the spike protein are unlikely to cause deaths. But other ingredients in the vaccine and the quality of the vaccine in the particular batches that were used in these situations should be investigated. Sometimes vaccines could act as a trigger.” He cites the case of a rotavirus vaccine (RotaShield) that was withdrawn in the U.S. in 1999. The vaccine was found to act as a trigger causing significantly increased frequency of intussusception one-two weeks after vaccination, leading to death in some vaccinated children.

Gaining trust through transparency

‘We are not blaming the vaccine for the deaths. We are not an anti-vaccine lobby. But the cause of deaths should be investigated. Once done, this can help gain trust in the vaccine and avoid vaccine hesitancy,” says Dr. S.P. Kalantri, a physician from Sevagram, Maharashtra who has signed the letter.

Ms. Malini Aisola, Public Health Researcher based in Delhi and one of the signatories of the letter complains that there is lack of transparency. She is also concerned about the clustering of cases where many deaths have been due to cardiovascular problems. “Vaccination is a public good. So the National AEFI Committee has to make public the findings of the investigation,” she says.

VAERS reporting in the U.S.

In the case of the U.S., 386 adverse events including deaths following COVID-19 vaccination have been reported so far. Almost all the details of each person including the name of the vaccine received, clinical symptoms and adverse events are reported in the Vaccine Adverse Event Reporting System (VAERS), a national vaccine safety surveillance program run by CDC and the FDA and made publicly available.

“VAERS is used to detect possible safety problems – called “signals” – that may be related to vaccination. If a vaccine safety signal is identified through VAERS, scientists may conduct further studies to find out if the signal represents an actual risk,” says the CDC.

“The doctor performing the post-mortem can only declare the cause of death. But he/she cannot decide if the death is related to the vaccine or not,” says Mr. Amar Jesani, Editor, Indian Journal of Medical Ethics, Mumbai and one of the signatories of the letter. “The State and National AEFI Committees have to meet regularly and investigate the deaths and decide whether the deaths are related or not.”

“Relatedness is judged on many factors. Determination of relatedness, who is determining it and how it is being done should be shared with everyone,” Mr. Jesani added. “Most deaths have been cardiovascular-related. The AEFI Committee needs to explain the clustering of such deaths.”

Published in The Hindu on February 4, 2021