New Delhi: The Central government on Saturday told the Supreme Court that Zydus Cadila, which is developing DNA vaccines, has concluded its clinical trial for beneficiaries in the age group of 12 to 18 years and, subject to the statutory permissions, it may be available in near future.


Besides this, 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, the union government stated.


Providing the details on availability of COVID vaccines for children, the Centre told the top court in an affidavit that the Drugs Controller General of India on May 12 permitted Bharat Biotech to conduct clinical trials of Covaxin on volunteers between 2 to 18 years of age, and the enrolment process for this trial has also begun.


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"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 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 informed.


The government assured the top court that enough vaccine doses would be available to inoculate the entire eligible population.


It said the "biggest vaccination drive in history" is going on in full swing, reaching even remotest areas of the country by a 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 various COVID vaccines being administered till the date of filing of the affidavit i.e. June 26, the Centre stated that 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.


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, it said.


31.5 lakh doses of the first component and 60,000 doses of the second component of Sputnik V has been received, the centre informed.


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."


As per the projected mid-year population for 2020, an estimated 186 to 188 crore vaccine doses would be required for giving both shots to the total population of the country aged 18 years and above which is approximately 93-94 crore.


"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.


Elaborating on the vaccines quantity that is likely to be received from all sources, the Centre informed that a total of 135 crore doses will be procured: Covishield (50 crores), Covaxin (40 crores), Bio E Subunit vaccine (30 crores), Zydus Cadila DNA vaccine (5 crores) and Sputnik V (10 crores).


It said that the procurement of the Bio E Subunit vaccine and Zydus Cadila DNA vaccine will be subject to approval that will be decided on 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," affidavit read.


The Centre stressed that to be able to procure vaccines from abroad, efforts are undertaken 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.


The government revealed these details in a 380-page affidavit filed in the suo motu matter on COVID-19 management in Supreme Court.


(With Agency Inputs)