Cases of adverse vaccine effect less than 0.01%: Centre in SC

Seeking to put to rest apprehensions about Covid-19 vaccines, the Centre has told the Supreme Court that the percentage of Adverse Event Following Immunisation (AEFI) having serious or severe consequences, including deaths, in the case of both Covaxin and Covishield is less than 0.01% and sought dismissal of a PIL that sought release of segregated trial data for each of the phases of clinical trials of these vaccines saying that entertaining it will not be in public interest as any misgivings can led to vaccine hesitancy.

In an affidavit filed in the SC, the Union Ministry of Health and Family Welfare said India has a robust statutory regime in place for regulating vaccine trials and that the procedure prescribed under it was “strictly followed” while granting permission to the two vaccines.

It said that the “entire concentration of the Central Government and the state governments should be and is on vaccination drive and encouraging people to get them vaccinated. It is, therefore, not desirable at this juncture to invest time finding out motives behind few elements attempting to act against the interest of nation at the cost of violating the right of crores of citizens to be protected from pandemic”.

The government said that “all cases of serious and severe AEFI…including reported death cases are subjected to scientific and technical review process. This process consists of rapid reviews, analysis and causality assessment done by a team of subject experts who have been trained for doing so. Only after the causality assessment has been done that the AEFI can be attributed to the vaccine. AEFI surveillance is a tool to identify and record all the possible adverse events following vaccination so that causality assessment can be done and adverse events actually caused by the vaccine could be identified. Therefore, mere reporting of AEFI case should not be attributed to be caused by the vaccine unless proved by the causality assessment analysis”.

It said that these AEFI “is being monitored and reviewed. The percentage of such effect having serious / severe [including deaths] in case of both Covaxin and Covishield is less than 0.01%. This again is in the caveat that any such severe / serious effect including death cannot be attributed to vaccination. In all cases, it is respectfully submitted that the Central Government is conducting Rapid Review and Causality Assessment Of Serious And Severe AEFIS continuously”.

Detailing this, the affidavit said, “2,116 serious and severe AEFI cases have been reported from 1,19,38,44,741 doses of Covid-19 vaccine administered till 24th Nov 2021. A report of rapid review and analysis completed for 495 (463 Covishield & 32 Covaxin) cases has been submitted. Another report of 1,356 cases (1,236 Covishield, 118 Covaxin & 2 Sputnik) serious and severe AEFI cases (including 495 cases already analysed) has been presented to NEGVAC. The rapid review and analysis of balance cases is underway and will be completed soon.”

The government pointed out that all clinical trial data, except where the confidentiality of the subject is required to be maintained as per the Drugs and Cosmetics Rules, 2019, is already available in the public domain. Additionally it said, that the guidelines of the Indian Council of Medical Research as well as the Declaration of Helsinki “clearly mention to maintain privacy of the potential participant; her/his identity and records are kept confidential subject to certain exceptions as stated therein”.

It said that the approval to Covaxin and Covishield vaccines “has been granted for restricted emergency use after following the procedure prescribed under Rules of 2019 and the Drugs and Cosmetics Act, 1940 and after detailed deliberations among eminent scientific experts, taking all precautions necessary, considering the Covid-19 pandemic”.

The court had, on August 8, issued notice to the Centre on the plea filed by Jacob Puliyel, a paediatrician who has been advising Centre on vaccines, as a member of National Technical Advisory Group on Immunisation (NTAGI).

The Health Ministry said that once it is submitted that there is a statutory regime in place and the same is followed, the court “may not undertake the exercise any further as it would enable the petitioner and handful of others like him to create serious misgivings and misconceived doubts against the vaccination in the process of this petition itself…Any misgivings and misconceived doubts and motivated propaganda against vaccination can only result into a potential threat of setting vaccine hesitancy again”.

The government also denied that Covid-19 vaccine has been made mandatory and said it is still voluntary. “However, it is emphasised and encouraged that all individuals take vaccination for public health and in his / her interest as well as public interest since in case of pandemic, an individual’s ill health has a direct effect on the society. Covid-19 vaccination is also not linked to any benefits or services”.

The Ministry added that “no indemnity has been granted (to the vaccine manufacturers) and the current legal regime under the New Drugs and Clinical Trials Rules, 2019 and Drugs and Cosmetics Act, 1940 does not contain any such provisions”.