The Centre on Saturday informed the Supreme Court that Zydus Cadila, which is developing DNA vaccine, has concluded its clinical trials for the 12 to 18 age group, and the vaccine may be available in near future, subject to the statutory permissions.
The Centre had filed an affidavit in response to the SC’s questions about the vaccination policy in the country that underwent an overhaul earlier this month. The Centre also briefed the court about the status of vaccine availability in the country, and its overall plan to vaccinate all adults by December end.
On the status of vaccine availability for children, the Central government said that the Drugs Controller General of India on May 12 gave permission to Bharat Biotech to conduct clinical trials of its Covid-19 vaccine, Covaxin, on volunteers between 2 to 18 years of age. The affidavit added that the enrolment process for the clinical trials has also begun.
"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.
ON VACCINATION DRIVE AND VACCINE AVAILABILITY
The Centre told the Supreme Court that the "biggest vaccination drive in the history" is going on with full swing.
The Centre provided a break-up of vaccines till June 26, the date of filing of the affidavit. According to the affidavit, 35.6 crore vaccine doses were made available across the country. Of these, 26.6 crore were Covishield vaccines, 8 crore were Covaxin, and an additional on1 crore doses were made available as commodity assistance under COVAX facility.
Moreover, the Centre told the Supreme Court that a total of 51.6 crore Covid vaccine doses would be made available by July 31. Of these, 35.6 crore doses have already been provided.
CENTRE TO INCREASE VACCINE AVAILABILITY
Apart from the three Covid-19 vaccines-- Covaxin, Covishield, and Sputnik V-- that are currently being administered across the country, the Centre also apprised the Supreme Court about other vaccines that are currently in the pipeline.
The Centre 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 Central government in its 380-page affidavit stated that in order to further increase vaccine availability in the country and to incentivise foreign manufacturers, the regulatory process for the use of foreign vaccines within India has been accelerated and simplified.
ON VACCINE PRICING
On pricing mechanism of the Covid-19 vaccine, the government clarified that due to the initial assistance provided for developing Covaxin, it has ensured a price of Rs 150 per dose for Covaxin and it is not possible to reduce it any further.
"This price is the lowest procurement price in the world,” the Centre said.
VACCINE REQUIREMENT FOR COMPLETE COVERAGE
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. As such an estimated 186 to 188 crore doses of Covid-19 vaccine would be required to administer two doses to each beneficiary.
"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," the Centre said.
The government further provided a breakup of vaccines that may be procured from all sources. The Centre said that a total of 135 crore doses will be procured—50 crore doses of Covishield, 40 crore doses of Covaxin, 30 crore doses of Bio E Subunit vaccine, 5 crore doses of Zydus Cadila DNA vaccine, and 10 crore doses of Sputnik V.
Notably, 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 added that for the purpose of procurement of these Covid-19 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.
(With inputs from PTI)