According to a presentation made to the National AEFI Committee during a meeting held on March 31, there have been 617 severe and serious (including deaths) adverse events following immunisation (AEFI). As on March 29, a total of 180 deaths (29.2%) have been reported following vaccination across the country . Complete documentation is available only for 236 (38.3%) cases.
- Total number of severe and serious AEFI (including death) reported: 617
- Total number of cases with complete documents: 236 (38.3%)
- Total number of deaths reported: 180 (29.2%)
- Total number of cases where NACM approved: 13/180 (10 deaths and 3 hospitalised)
- Number of dates to be presented today: 180/180
- Causality deferred after discussion: 9 cases/180
- Total number of deaths with complete documents awaiting causality: 35 (19.4%)
In all, 492 severe and serious AEFI have been classified by the AEFI Secretariat of the Immunisation Technical Support Unit (ITSU) at the Health Ministry. Classification has been completed for 124 deaths, 305 serious events that required hospitalisation, and 63 severe events that did not require hospitalisation.
The classification by the AEFI Secretariat was on the basis of case reporting forms (CRF) and case investigation forms (CIF) submitted at the district level. In the meeting, individual AEFI cases were presented and brought up for discussion by experts in the AEFI causality assessment committee.
Of the 124 deaths, more than 63 deaths (nearly 51%) have been categorised as being caused due to acute coronary syndrome (a range of conditions associated with sudden, reduced blood flow to the heart) or heart attack. Another 11 deaths (12%) of deaths are due to stroke.
As on March 17, the details of the causality assessment of only 13 AEFI including 10 deaths have already been made public by the national AEFI committee. The vaccine was not found to have caused death in any of the 10 vaccinated people.
However, in many cases post mortems have not been conducted. For example, in at least six out of 10 cases where the National AEFI Committee has completed causality assessment, no post mortem has been done, says Malini Aisola, a Public Health Researcher based in Delhi.
Virologist Dr. Jacob John, formerly of CMC Vellore, says that if deaths are not associated with vaccination, then they would be nearly evenly distributed across weeks post vaccination. However, there are 93 deaths in the first three days (31 deaths per day) and 18 deaths in four-seven days (4.5 deaths per day) after vaccination. There have been 11 deaths in 8-28 days (0.5 deaths per day) post-vaccination. “Deaths are not evenly distributed,” he says. There is hence a compulsion to investigate the deaths more thoroughly for any association.
If deaths are seen on a weekly basis, there have been 111 deaths in the first week (nearly 16 deaths per day) but in the next three weeks, there have been only 11 deaths (0.5 deaths per day). “If the deaths are unrelated to vaccination, then deaths should be evenly distributed across weeks after vaccination. There are an extraordinary number of deaths in the first week but in the next two-four weeks there are only about four deaths per week,” says Dr. John.
There have been 59 deaths due to sudden, reduced blood flow to the heart (acute coronary syndrome) or heart attack in the first week but only four in the second-four weeks after vaccination. Similarly, deaths due to stroke are 13 in the first week but only one death in two-four weeks after vaccination. There have been nine “sudden deaths” during the first week but only one death in two-four weeks after vaccination.
In the case of AEFI requiring hospitalisation, there have been 291 AEFI needing hospitalisation in the first week compared with only 13 in two-four weeks after vaccination. “The number of hospitalisations in the first week stands out strikingly different,” Dr. John says. Again, 18 cases of reduced blood flow to the heart (acute coronary syndrome) or heart attack, 10 cases of stroke, and 46 cases of severe allergic reaction (anaphylaxis) in the first week require thorough investigation.
Weakness in one, two or all four limbs (mono/para/quadriparesis) seen in 17 people hospitalised is similar to transverse myelitis seen during the trial in the U.K., says Dr. John. About 15 cases of seizure in the first week and no such cases in the two-four weeks after vaccination is abnormal, he says. “There is something going on in the central nervous system. Also, 17 cases of mono/para/quadriparesis in four weeks needs thorough investigation,” he says.
According to him, 59 cases of severe AEFI not requiring hospitalisation in the first week and four such cases in two-four weeks may be a signal.
“Since Covishield is the same vaccine as AstraZeneca, updated warnings related to these rare conditions, information for vaccine recipients and the public about when to seek medical attention, and information for health providers about how to identify and treat such occurrences needs to be done for the vaccine,” says Ms. Aisola.
The European Medicines Agency (EMA) has included only six deaths from India after vaccination with Covishield for its analysis. “Due to a massive backlog in processing assessments in India, we have reported the data internationally for just a tiny fraction of the actual cases that have occurred,” she says. “Timely assessment is important to formulate recommendations for vaccination for particular groups and guidance for any groups that may be identified as more susceptible to serious AEFIs. It is also important for revising and updating screening procedures and to ensure that arrangements for treatment are put in place.”
“The National Committee is depending on evidence and investigations conducted at the local level. However, we observed a strong tendency by local authorities to immediately rule out any links to vaccination, even before investigation has been conducted,” says Ms. Aisola. “There is an urgent need to strengthen AEFI investigation at the local level where protocols may not be adhered to and the quality of evidence being collected is often weak and inadequate.”