Never spoke of vaccinating entire country, says Centre; initial findings of Chennai case did not necessitate trial stoppage: ICMR

FP Staff
·8-min read

Amid ongoing discussion over India's COVID-19 vaccine strategy and vaccination plans, the Union Ministry of Health and Family Welfare clarified on Tuesday that the Central Government has "never spoken about vaccinating the entire country".

Health Secretary Rajesh Bhushan made the remark amidst a controversy over the Covieshield vaccine candidate, an Indian licensed version of the Oxford University-Astrazeneca vaccine that has allegedly caused some adverse reactions, including a virtual neurological breakdown and impairment of cognitive functions, in a Chennai-based volunteer.

The health ministry also laid the various processes that every drug manufacturer has to mandatorily follow in India and said that all vaccine volunteers are informed of the risks before the trials.

Meanwhile, the ICMR said that initial findings into the 'adverse event' allegedly suffered by the Covieshield volunteer in Chennai did not necessitate halting of the trials and the health ministry asserted that it would not affect vaccine timelines in any way

Complications not induced by Covieshield vaccine, says SII

On Tuesday, Pune-based vaccine manufacturer Serum Institute of India which is manufacturing the Covieshield vaccine candidate, said the complication suffered by the trial participant in Chennai while unfortunate, but was in "no way induced by the vaccine".

It also said that a legal notice was sent to the volunteer to protect the company's reputation.

"Taking into consideration the complexities and existing misnomers about vaccination and immunisation; the legal notice was sent (to the volunteer) therefore to safeguard the reputation of the company which is being unfairly maligned," Serum said.

In a blog, the company claimed that said all the requisite regulatory and ethical processes and guidelines were followed diligently and strictly.

"The concerned authorities were informed and the principal investigator, DSMB and the Ethics Committee independently cleared and reckoned it as a non-related issue to the vaccine trial. Post which, we submitted all the reports and data related to the incident to the DCGI (Drugs Controller General of India). It is only after we cleared all the required processes that we continued with the trials," it said.

The Chennai volunteer had sought Rs 5 crore compensation in a legal notice to SII, and others, as well sough a halt to the trial. SII, however, has rejected the charges as "malicious and misconceived" and earlier said it will seek damages in excess of Rs 100 crore.

The Pune-based vaccine manufacturer also sought to assure that the vaccine will not be released for mass usage unless it is proven to be immunogenic and safe.

India's cases reach 94.62 lakh

On Tuesday, India's coronavirus case count climbed to 94,62,809 with 31,118 new infections, while the toll mounted to 1,37,621 after 482 more fatalities were reported, the health ministry said in its morning update.

The number of people who have recuperated from the disease surged to 88,89,585, pushing the national recovery rate to 93.94 percent. The COVID-19 case fatality rate stands at 1.45 percent, the data updated at 8 am showed.

At 4,35,603, active cases remained below five lakh for the 21th consecutive day and at present comprise 4.60 percent of the total caseload. A net decline of 11,349 cases has been recorded in the total active cases in 24 hours, the ministry said.

Bhushan said that Maharashtra, Karnataka, Kerala, Andhra Pradesh and West Bengal ate the top five states which have shown a decline in active cases in between 1 November and 1 December while Punjab, Himachal Pradesh, Madhya Pradesh, Haryana and Rajasthan are the top five states which have recorded a rise in active cases in the same period.

Bhushan also said that in the last seven days, 211 cases per million population and two deaths per million population have been recorded in India.

"More than 14.13 crore COVID-19 tests have been conducted so far and the cumulative positivity rate has declined from 7.15 percent on 11 November to 6.69 percent on 1 December," he said.

"On an average 10,55,386 COVID-19 tests were conducted daily and on average 43,152 new cases were reported daily in the month of November," he added.

November reports 30% decline in deaths, new cases

According to PTI, November saw over 30 percent decline in both new deaths and cases as compared to October, as per news agency PTI.

A total 12,78,727 cases were reported in November, a decrease from October's 18,71,498, accounting for about 13.51 percent of the total instances of the viral infection reported in the country so far.

The past month also saw 15,510 lives lost due to the disease, which is around 11.27 percent of the total 1,37,621 deaths recorded so far.

Sputnik V trials get underway in India

In another development on the vaccine front, Dr Reddy's Laboratories Ltd and the Russian Direct Investment Fund (RDIF) announced the commencement of adaptive phase 2/3 clinical trials for COVID-19 vaccine Sputnik V in India after receiving necessary clearance from the Central Drugs Laboratory, Kasauli in Himachal Pradesh.

The Indian drugmaker, in a release, said this will be a multicentre and randomised controlled study, which will include a safety and immunogenicity study.

The clinical trials are being conducted by JSS Medical Research as a clinical research partner. Further, Dr Reddy's has partnered with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology for advisory support and to use BIRAC's clinical trial centres for the vaccine, it said.

In September 2020, Dr Reddy's and RDIF entered into a partnership to conduct clinical trials of the Sputnik V vaccine and the rights for distribution of the first 100 million doses in India.

Recently, RDIF announced the second interim analysis of clinical trial data, which showed 91.4 percent efficacy for the vaccine on Day 28 after the first dose and vaccine efficacy of over 95 percent 42 days after the first dose. Currently, 40,000 volunteers are taking part in Phase III of Sputnik V clinical trials, out of which over 22,000 have been vaccinated with the first dose and more than 19,000 with both the first and second doses of the vaccine.

Cabinet secretary reviews vaccine roll-out arrangements

Also on Tuesday, Cabinet Secretary Rajiv Gauba reviewed the arrangements for the roll-out of vaccines after these are available with top officials of states and asked them to prepare a database of people like health workers who will receive the vaccine in the initial stages, reported PTI quoting officials.

The meeting was attended by chief secretaries, health secretaries, and other senior officials of states and UTs.

The Central Government has been putting in place measures for quick and effective distribution of coronavirus vaccine when it becomes available.

An estimated one crore frontline health workers will receive the first dose of COVID-19 vaccine whenever it becomes available, with around 92 percent of government hospitals and 55 percent of private hospitals across all states and union territories providing data to identify the workers.

The government has also called an all-party meeting to discuss the COVID-19 pandemic situation on 4 December that will be chaired by Modi. The issue of vaccination is also expected to be discussed in the meeting.

Test kit prices state matter: health ministry

On Tuesday, health secretary Bhushan also said that the Central Government had issued written directions to states and Union Territories last week to form expert groups to study the market and determine the rates of COVID-19 tests.

Health Secretary Rajesh Bhushan also said that deciding the rates of the tests does not come under the purview of the Centre and is a state matter.

"However, the Centre gives recommendations to the states and UTs from time to time on deciding the rate of tests in a rational and transparent manner."

Meanwhile, ICMR Director-General Dr Balram Bhargava said that with the increase in the production of kits by indigenous manufacturers, the price of COVID-19 testing kits has come "dramatically down" and is Rs 75 for RT-PCR kits and Rs 37 for RNA kits.

"India has started exporting the kits and the demand is much less than the supply, so the price has come down," he said.

With inputs from PTI

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