The Centre told the Supreme Court that a total of 51.6 crore Covid vaccine doses would be made available by July 31 of which 35.6 crore have already been provided.
Giving the status of vaccine availability for children, the Centre said in an affidavit that the Drugs Controller General of India on May 12 permitted Bharat Biotech to conduct clinical trials of its vaccine Covaxin on volunteers between 2 to 18 years of age, and the enrolment process for this trial has also begun.
It informed the court that Zydus Cadila which is developing DNA vaccines has concluded its clinical trial for between the age group of 12 to 18 years of age and, subject to the statutory permissions, it may be available in near future for children of the age group of 12 to 18 years of age.
"It is humbly submitted that as of now, the companies’ manufacturing COVID-19 vaccination in India have only been given ‘Emergency Use Authorization’ for vaccinating people of 18 years age and above. Therefore, COVID-19 vaccines are not recommended for persons/children less than 18 years of age and is due to the fact that the clinical trial cohort during Phase 1, 2 and 3 did not cover the children below 18 years of age," it said.
The government said that there would be availability of vaccine to vaccinate the entire eligible population.
It said the "biggest vaccination drive in the history" is going on with full swing, reaching even remotest areas of the country by constructive and cooperative collaboration of the Central government, State/UT governments, local authorities, human resources in medical sectors and the citizens of the country.
Giving the break-up of vaccines till the date of filing of the affidavit i.e. June 26, the Centre said a total of 35.6 crore doses were made available -- 26.6 crore Covishield, 8 crore Covaxin, and additional 1 crore doses as commodity assistance under COVAX facility.
It also said that apart from these supplies, it is expected that around 16 crore doses will also be available during the period of May and July across the country.
The Centre further said that 31.5 lakh doses of first component and 60,000 doses of second component of Sputnik V has been received.
It said that two vaccines (Covishield and Covaxin) have been a part of the vaccination program since January 2021 and Sputnik V has received Emergency Use Authoridation by the DCGI in April 2021 and is now being administered in the country.
The government said, "In addition, some other domestic vaccines such as those from Biological E and Zydus Cadila are in the late stages of clinical trials and subject to the regulatory approvals, will further increase the availability of vaccines."
The government in its 380-page affidavit filed in the suo motu matter on COVID-19 management said that in order to further increase vaccine availability and incentivising foreign manufacturers, the regulatory process for the use of foreign vaccines within India has been accelerated and simplified.
It clarified that due to the initial assistance provided for developing Covaxin, it has ensured a price of Rs.150 per dose of Covaxin and it is not possible to reduce it any further. "This price is the lowest procurement price in the world."
The government said that as per the projected mid-year population for 2020, the total population of the country aged 18 years and above is approximately 93-94 crore and as such, administering two doses to these beneficiaries would require an estimated 186 to 188 crore vaccine doses.
"Out of this requirement, 51.6 crore doses will be made available for administration by July 31, 2021, leaving a requirement of approximately 135 crore vaccine doses for complete vaccination to the eligible population," it said.
Giving the breakup for vaccines quantity that may be receivable from all sources the Centre said that a total of 135 crore doses will be procured: Covishield (50 crore), Covaxin (40 crore), Bio E Subunit vaccine (30 crore), Zydus Cadila DNA vaccine (5 crore) and Sputnik V (10 crore).
It said that the procurement of Bio E Subunit vaccine and Zydus Cadila DNA vaccine will be subject to approval which will come in the near future.
"It is submitted that the vaccination drive would obviously get a boost if the Government of India succeeds in its attempts to procure vaccines available outside India such as vaccines of Pfizer, Johnson & Johnson, Moderna etc," the affidavit said.
The Centre said that for the purpose of procurement of these vaccines from abroad, efforts are ongoing at the level of the highest political executive in the country and also at the highest diplomatic level.
"It is submitted that since these efforts are at a very advanced stage, it is neither desirable nor possible to give comprehensive details of these facts. As and when these efforts materialise, the speed of vaccination will be further augmented and enhanced," it said.
