Covishield and Covaxin are safe vaccines, assures ICMR

A day after hue and cry over the controversy for granting Emergency Use Authorisation (EUA) approval to Bharat Biotech's Covaxin, Dr Balram Bhargava, Director General of Indian Council of Medical Research (ICMR) reiterated that both the vaccines are safe.

New Delhi:The central government on Tuesday clarified that nationwide COVID-19 vaccination process will start by January 13 asserting that both Covishield and Covaxin are safe vaccines.

A day after hue and cry over the controversy for granting Emergency Use Authorisation (EUA) approval to Bharat Biotech's Covaxin, Dr Balram Bhargava, Director General of Indian Council of Medical Research (ICMR) reiterated that both the vaccines are safe.

Quoting to the interim analysis of the Covishield trial, Dr Bhargava said that the vaccine to be produced and manufactured by Serum Institute of India (SII) is safe and immunogenic.

"There is no safety concern for Covaxin too. For this vaccine DCGI has granted restricted use in clinical trial mode with the proper consent of all sides and constant follow up," said Dr Bhargava in a press conference in New Delhi.

Referring to the New Drugs and Clinical Trial Rules, Dr Bhargava further clarified, "If the remarkable efficacy is observed with a defined dose in Phase II clinical trial of an investigational new drug for the unmet medical needs of serious and life-threatening disease in the country, it may be considered for grant of marketing approval by the central licensing authority based on phase II clinical trial data."

Union Health Secretary Rajesh Bhusan who was also present in the programme said that Health Ministry is ready to introduce COVID-19 vaccines as soon as possible.

"Based on the feedback of dry run, the Health Ministry is ready to introduce COVID-19 vaccine within 10 days from date of emergency use authorisation (EUA)," said Bhushan.

"India's apex drug regulator, DCGI, has approved both Covishield and Covaxin on January 3, so by January end, we may start the vaccination. However, the final call will be taken by the government of India, he said."

Bhushan said that in spite of giving opportunities, Pfizer has not appeared before the Subject Expert Committee (SEC) for required clarification of their vaccines.

He reiterated that proper blueprint had been prepared for a well-coordinated vaccination process with the help of Co-WIN vaccine delivery management system.

Starting from dispatch of vaccines from the manufacturing sites, Co-WIN will keep monitoring over the vaccination, proper distribution and adverse effect following immunisation process on a real-time basis.

He said that India is ready to help other countries with Co-WIN digital system which has been prepared on support with the Ministry of Information and Communication Technology.

Referring to the two back to back dry run before the COVID-19 vaccination process, Bhushan said that no major issues observed in operational aspects.

"Minor issues noted in Co-WIN for further enhancement which have been addressed," said Bhushan.

He informed that the health care and frontline workers need not register to Co-WIN for getting vaccinated as their database has already been prepared.

"When the vaccination will start for the general population, they need to register themselves," said Bhushan.

He said that with its features like SMS in 12 languages to guide beneficiaries, Aadhar authentication to prevent malpractice, automated session allocation, Co-WIN is made in India "for the world."

The health secretary informed that there is no ban on the export of COVID-19 vaccines from India.

When asked about vaccination to school children, ICMR DG Dr Bhargava said that teachers should be vaccinated first and adults at home.

"UK burnt its finger by opening schools. Here teachers and adults will be vaccinated first. In fact, in India children's between 12-18 years of age has already been vaccinated in phase II trial," said Dr Bhargava.

Talking on the availability of vaccines, Dr VK Paul, member, Niti Aayog said that by July India will have enough vaccine supply available.

He said that an expert committee is looking into the matter of "conditioning vaccination" for people above 50 years of age with co-morbidities. The committee will submit its report shortly, he said.

Dr Renu Swarup, secretary in the department of biotechnology informed that Cadila Healthcare Limited's DNA vaccine candidate, Biological E. Limited's protein subunit vaccine, Gennova Biopharmaceuticals Limited's self-amplifying mRNA platform, Dr Reddy's SputnikV are other vaccines candidates which are in the pipelines as COVID-19 vaccines in India.

"All these vaccines can be stored at 2-8°C. The attempt is on to make the storage of Dr Reddy's human adenoviral vector-based vaccine in similar temperature," said Dr Swarup.

She reiterated that the new virus strain that has been detected in the UK will not have any effect on Indian vaccines.

"Our scientists across India are also getting the genome sequencing. As of now we have detected 71 UK virus strain which is under close observation," said Dr Swarup and added, "there is no scientific data yet to support its higher infectivity."

Meanwhile, Secretary Bhushan said that COVID-19 active cases in India has registered less than 2.5 lakhs after 6 months and declining.

"Daily number of deaths is less than 300 for 11 consecutive days where cumulative positivity rate is 5.87 per cent," said Bhushan.

The positivity rate during last week is 1.97 per cent. He said that 43.96 per cent of the active patients are currently at health care facilities whereas 56.04 per cent people are in home isolation.

He said that India with 7,504 cases per million population is amongst the lowest in the world.