New Delhi: A total of 2,116 serious and severe AEFI (adverse event following immunisation) cases have been reported from 1,19,38,44,741 — or over 119.38 crore — doses of Covid-19 vaccines administered till 24 November, the Government of India has told the Supreme Court in an affidavit.
The percentage of such serious or severe AEFIs — including death — continues to be less than 0.01 per cent in case of both Covaxin and Covishield, the government said in the affidavit, which was filed Monday.
The affidavit was filed in response to a petition seeking details of the scientific process followed for the clearance of the two vaccines. The petition also seeks the entire segregated trial data for each of the phases of trials to be made public.
“It is humbly submitted that 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,” the health ministry said in the affidavit.
“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 ministry added.
NEGVAC or National Expert Group on Vaccine Administration for Covid-19 acts as the final vetting authority on decisions related to the rollout of the Covid vaccination programme.
The last public AEFI report, dated 5 November, gave out the analysis of the national AEFI committee meeting held on 18 October. AEFI monitoring is important for all vaccines but more importantly for Covid vaccines since they have been developed and approved in unprecedented time.
According to health ministry guidelines, an AEFI will be considered serious if it results in death, requires hospitalisation, results in persistent or significant disability/incapacity, or a cluster (two or more cases) of AEFIs occur in a geographical area.
‘Not possible to release additional trial data’
In the affidavit, the government submitted details of the scientific data that was available when the vaccines were licensed in January this year.
In the case of Bharat Biotech’s Covaxin, the data was the result of phase 1 and 2 clinical trials as the recruitment was still on at that point for phase 3. For Covishield, safety, immunogenicity & efficacy data of Phase 2/3 clinical trials of AstraZeneca vaccine carried out in the UK, Brazil and South Africa, along with the safety and immunogenicity data from the ongoing Phase 2/3 clinical trial in the country, were available.
The government said that, according to law, there is no provision under which the government can ask companies to release full clinical trial data.
“The clinical data generated in a clinical trial resides with the sponsor of the clinical trial and the data is submitted to the regulatory authorities for obtaining various permissions/licences etc,” the government said in the affidavit.
“The regulatory authority may verify the veracity of the data submitted. However, there are no regulatory provisions under which the regulatory authorities can direct the sponsor to place the full clinical trial data in public domain,” it added.
The government also told the court that the drug controller was working within the legal framework of approving new drugs when it approved the two vaccines. The New Drugs and Clinical Trial Rules, it said, provide for an accelerated approval process especially if the new drug is “intended for the treatment of a serious or life-threatening condition or disease of special relevance to the country, and addresses unmet medical needs”.
(Edited by Neha Mahajan)