Kolkata: Covaxin reaches vaccine sites but inoculation blueprint not yet ready

Kolkata: The first lot of Covaxin doses has reached three vaccination centres in Kolkata on Monday. But health officials said it would take a few more days to roll out this indigenously developed vaccine as it requires a different set of SOP and needs coordination between extended stakeholders as the inoculation will be on a ‘clinical trial mode’ unlike Covishield vaccination.

Bengal got 1,12,960 Covaxin doses on January 22 and the consignment was kept at the state’s Central Family Welfare Store in Bagbazar. On Monday, 1,000 doses were dispatched to Medical College Hospital, Kolkata, and RG Medical College while 2,000 were sent to IPGMER. The rest of the doses have been shifted to the District Vaccine Store in Ballygunge.

Health department officials said the Covaxin rollout will start only from three centres in the city — School of Tropical Medicine (STM), RG Kar Medical College and IPGMER. Since STM does not have ILR (ice-lined refrigerator) facilities, its share of vaccines has been stored at Medical College Hospital.

“Covaxin doses have been sent to three centres on Monday. But it will take a few days to introduce this vaccine due to the need for a separate SOP and elaborate planning,” said Ashim Das Malakar, state family welfare officer. In addition to the state health department machinery, the Covaxin rollout will need close coordination with officials of ICMR and Bharat Biotech, which has collaborated in developing the vaccine.

“Several critical issues have been identified that warrant careful consideration for successful implementation of Covaxin on a clinical trial mode. These issues include willingness to take Covaxin by written consent, eligibility of the recipients as decided by the inclusion-exclusion criterion, intense monitoring of all adverse events, medical management of adverse events, causality analysis of all reported serious and severe adverse events, assessment of serious adverse events (following the defined regulatory criteria) in order to recommend entitlement to financial compensation and reporting of such events to the DCGI,” said clinical trial specialist Santanu Tripathi, former head of clinical pharmacology at the School of Tropical Medicine.

Unlike Covishield, Covaxin will be administered only after obtaining a written consent. The guideline on Covaxin implementation issued by ICMR has an inclusion-and-exclusion criterion.“A potential recipient has to be explained about the vaccine before taking an informed consent and undergo a thorough screening. Who will take the responsibility of this explanation and screening process? Will it be the responsibility of one of the vaccination officers or someone else will be designated? There is need for more clarity before the vaccine is rolled out,” said a source at the state health department.

In Covishield rollout, AEFI (adverse event following vaccination) was being monitored by a team from the state health department. For Covaxin, designated persons from the ICMR and Bharat Biotech will be taking up active safety surveillance. ICMR has designated Suman Kanungo, a scientist at NICED Kolkata, as its nodal officer while Bharat Biotech has nominated its representative Jayanta Maity for the purpose.