New Delhi: A total of 165 lakh doses of COVID-19 vaccines — Covishield and Covaxin — have been procured so far at a cost of Rs 350.25 crore, Minister of State for Health Ashwini Choubey told Lok Sabha on Friday.

Giving out the details of the number of vaccines already procured by the government, Choubey, in a written reply, said only two vaccines namely Covishield manufactured by the Serum Institute of India and Covaxin manufactured by Bharat Biotech International Limited have so far been granted permission for restricted use in emergency situation by the Drugs Controller General of India.

“Therefore, only these two vaccines have been procured for COVID-19 vaccination drive in the country. A total of 165 lakh doses of COVID-19 vaccine have been procured so far, of which 110 lakh doses are of Covishield and 55 lakh doses are of Covaxin vaccine.

“The total cost of procurement of above mentioned doses of vaccines is Rs 350.25 crore,” he said. No pre-procurement agreements have been entered into, Choubey clarified.

In response to a question on the logistical hurdles in deployment of these vaccines, including storage and transportation, the minister said there are no logistical hurdles in the deployment of these vaccines, including storage and transportation.

The existing infrastructure under Universal Immunization Programme is being used and simultaneously strengthened for deployment of vaccines, including storage and transportation.

A National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) has been established, which provides guidance on all aspects of COVID-19 vaccination, including prioritisation of population groups, procurement and inventory management, vaccine selection, vaccine delivery and tracking mechanism.

Responding to a separate question in the Lok Sabha, Choubey also explained that fewer than planned beneficiaries attended the coronavirus vaccination sessions at the start due to transient technical issues in CoWIN portal and vaccine hesitancy, among others.

A total of 7,580 adverse events following immunisation have been reported till 31 January under the rollout. None of the 12 deaths of vaccinated persons have been causally attributed to the vaccination as per the current evidence, Minister of State for Health Ashwini Choubey told the Lok Sabha.

Responding to a question on the urgency on part of the government to go ahead with the vaccination when the cases are declining, Choubey said a second or third peak was experienced in other countries during the later part of the pandemic.

“Therefore, a declining trend of cases in the country does not necessarily promise a continued and steady decrease in cases,” he said. “Hence, it is necessary to provide prompt protection to the vulnerable and at risk population and maintain low case count through COVID-19 vaccination.”

As per the fact sheet of the vaccine manufactured by Bharat Biotech, one should not get Covaxin if the person has any allergies, fever, bleeding disorder or are on blood thinner, immune-compromised individuals or on medicines that affect immune system, pregnant, breastfeeding, received another coronavirus vaccine or any serious health-related issues, Choubey said in a written reply.

As per the fact sheet of Serum Institute, one should not get Covishield if a person had a severe allergic reaction after a previous dose of this vaccine and had a severe allergic reaction to any ingredient of this vaccine, he said.

The healthcare provider needs to be consulted about medical conditions, including severe allergic reaction after any drug, food, any vaccine or any ingredients of Covishield; fever; bleeding disorder; immunocompromised; pregnant; breastfeeding or received another COVID-19 vaccine, the minister said.

The introduction of the vaccine is being taken up in a phased manner starting with priority groups of healthcare workers and frontline workers, subsequent to this, NEGVAC recommends covering prioritised groups of persons aged 50 years and above and those aged less than 50 years with comorbidities.

A ‘Task Force on Focused Research on Corona Vaccine and other Science and Technology Issues’ chaired by Principal Scientific Advisor (PSA) is facilitating research and development of vaccines, drugs, diagnostics and other related issues.

The Central Drugs Standards Control Organization (CDSCO) has granted permission to manufacture both Covishield and Covaxin as per the New Drugs and Clinical Trials Rules, 2019 under the Drugs and Cosmetics Act, 1940.

As far as Covaxin is concerned, Bharat Biotech had submitted interim safety and immunogenicity data of phase I and II clinical trials carried out in the country along with safety data, including Serious Adverse Event (SAE) data, of the ongoing phase III clinical trial in the country.

The data was reviewed by the Central Drugs Standard Control Organisation (CDSCO) in consultation with Subject Expert Committee (SEC) comprising domain knowledge experts.

The committee noted that this vaccine is inactivated whole virion coronavirus vaccine having potential to target mutated coronavirus strains.
The data demonstrated a strong immune response (both antibody as well as T cell) and in-vitro viral neutralisation.

The ongoing clinical trial is a large trial on 25,800 Indian subjects in which all the subjects have already been enrolled. Moreover, the firm presented the safety and efficacy data from non-human primate challenge study also to CDSCO, where the vaccine has been found to be safe and effective.

“After detailed deliberations, SEC recommended grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains,” Choubey said in response to another question.

Based on the recommendations of SEC, CDSCO has granted permission to Bharat Biotech International Limited, Hyderabad to manufacture Covaxin vaccine for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode with various conditions/restrictions.

The Serum Institute of India, Pune has submitted safety immunogenicity and efficacy data of phase II/III 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 II/III clinical trial in the country.

The Subject Expert Committee (SEC) of CDSCO reviewed the proposal of restricted emergency use along with above details and the data received.

The Medicines and Healthcare products Regulatory Agency (MHRA) approval for AstraZeneca vaccine on December 30 last year along with its conditions/restrictions was also reviewed by the committee.

The committee noted that the safety and immunogenicity data presented by the firm from the Indian study is comparable with that of the overseas clinical trial data.

Based on the recommendations of SEC, CDSCO granted permission to Serum Institute of India to manufacture Covisheild vaccine for restricted use in emergency situation with various conditions/restrictions.

Furthermore, CDSCO has granted permission to conduct clinical trials of COVID-19 vaccines either manufactured in the country or outside the country.

So far, as Serious Adverse Events (SAE) are concerned, 51 SAEs have been received by CDSCO from various clinical trials of COVID-19 vaccine.