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Sunday, 27 June 2021

In affidavit filed in SC, Centre lays out plan to vaccinate adult population against COVID-19 by year-end

The Centre has told the Supreme Court in an affidavit that it expects to get 188 crore vaccine doses by the end of this year, enough to cover the entire adult population of 94 crore.

The top court's 31 May order had criticised the Centre's liberalised vaccination policy, differential pricing of vaccines for Centre, states and private hospitals, basis of such a norm and mandatory registration on Co-WIN app in view of huge digital divide between rural and urban India, and sought the government's response on its queries in two weeks.

The Centre's affidavit also touched on issues such as vaccination for senior citizens and persons with disabilities unable to reach vaccination centres, on-site registration to bridge digital divide and vaccine trials for children.

51.6 crore vaccine doses by July-end

In an affidavit filed on Saturday, the Centre 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 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 31 July, 2021, leaving a requirement of approximately 135 crore vaccine doses for complete vaccination to the eligible population," it said.

Giving the break-up of vaccines till the date of filing of the affidavit i.e. 26 June, the Centre said a total of 35.6 crore doses were made available— 26.6 crore Covishield doses, 8 crore doses of Bharat Biotech's Covaxin, and additional 1 crore doses as commodity assistance under the COVAX facility.

The Centre further said that 31.5 lakh doses of the first component and 60,000 doses of the second component of Sputnik V have been received.

Giving the breakup for vaccines quantity that may be receivable from all sources, it 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).

As per affidavit submitted by the Govt of India in Supreme Court, the projected availability of COVID19 vaccines from August'21 to Dec'21: Covishield-50 crore, Covaxin-40 crore, Bio E sub unit vaccine-30 crore, Zydus Cadila DNA vaccine-5 crore, Sputnik V-10 crore; total 135 crore pic.twitter.com/mpDVizjefM

It said that domestic vaccines such as Bio E Subunit vaccine and Zydus Cadila DNA, which are in the late stages of clinical trials, will further boost the vaccine availability, subject to regulatory approval.

As regards the price of Covaxin, the Centre clarified that due to the initial assistance provided for developing the vaccine, it has ensured a price of Rs.150 per dose and it is not possible to reduce it any further. "This price is the lowest procurement price in the world," it claimed.

Efforts on to procure vaccines from abroad

In its 375-page affidavit filed in the suo motu matter on COVID-19 management, the government said that in order to further increase vaccine availability and incentivise foreign manufacturers, the regulatory process for the use of foreign vaccines within India has been accelerated and simplified.

"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.

For procuring 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 stated.

"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.

Vaccine trials for children

On the status of vaccine availability for children, the Centre said that as of now, the companies' manufacturing COVID-19 vaccines 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 affidavit also gave details of vaccine trials for children:

  • The Drugs Controller General of India (DCGI) on 12 May 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.
  • Zydus Cadila, which is developing DNA vaccines, has concluded its clinical trial for 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 in this age group.

The affidavit highlighted that there is no global scientific evidence of viruses selecting to affect a particular age group and added that the Centre has ensured that all state governments are geared-up to deal with any such potential threat to children.

Centre puts on record revised vaccination guidelines

The government also brought the revised "COVID-19 Vaccine Operational Guidelines" stating that under this, the Union government will procure vaccine and supply free of cost to the states/ UTs for all above 18 years of age from 21 June and this will ensure that 18-44 years persons will also receive free vaccine from government Covid vaccination centres.

"To put the same position differently, a person below poverty line and a multi-millionaire are equally entitled for the very same vaccine in the age group of 18 years and above free of cost," the affidavit said.

Only those who have the ability to pay and voluntarily chose to pay are encouraged to use private hospitals' vaccination centres so that the stress on public utilities can be reduced to the extent possible, it said.

An SC bench headed by Justice DY Chandrachud had slammed the Centre's COVID-19 vaccination policy as "prima facie arbitrary and irrational"  for allowing states and private hospitals to charge those in the 18-44 age group while the jabs were offered free for groups in the first two phases, and ordered its review.

The top court had also asked the Centre to provide information including as to how Rs 35,000 crore, earmarked for vaccines, has been spent so far, and to place on record all relevant documents and file notings reflecting its thinking culminating in the policy.

The bench had observed that a vaccination policy exclusively relying on the digital portal Co-WIN for inoculating those in the 18 to 44 years would be unable to meet its target of universal immunisation due to "digital divide" and marginalised sections of society would bear the brunt of "accessibility barrier".

In the affidavit filed on Saturday, the Centre said more than 31 crore vaccine doses have been administered across the country and the government has allowed on-site registration for vaccination to bridge the digital divide and solve the issue pointed out by the top court.

Over 1.73 crore doses have been administered to Health Care Workers (HCWs), over 2.66 crore doses to Frontline Workers (FLWs), more than 9.93 crores doses to those between 45 to 59 years of age and over 8.96 crore doses to persons above the age of 60 years, it said.

The government said besides these, over 7.84 crore doses have been administered to persons between 18 to 44 years of age.

On 'digital divide' and accessibility of Co-WIN

There is no question of anyone being left out in the COVID-19 vaccination drive due to "digital divide" and the Co-WIN system is designed to provide required flexibilities to states and Union Territories to overcome barriers to access, the Centre said.

The affidavit said that on-site registrations, also known as walk-in registration, and vaccinations have been permitted for all beneficiaries through a 23 May circular. As on 23 June, 19.13 crore (59 percent) of the 32.22 crore beneficiaries registered on Co-WIN have been registered in the onsite mode, it submitted.

Mmulti-lingual citizen and user interfaces are now available in 12 languages on Co-WIN, including Hindi, Marathi, Malayalam, Telugu, Oriya, Gurumukhi, Bengali and English and several measures have already been taken to improve the access for those who are visually challenged, the affidavit stated.

Directions have also been issued to facilitate vaccination for differently-abled persons and senior citizens, it added.

On vaccination for senior citizens

The Central government also told the SC that it has devised a strategy to inoculate the elderly and the differently-abled, who may have been left behind because of the inability to travel to vaccination centres.

It said that the Union health ministry constituted a committee consisting of domain knowledge experts and it recommended the strategy of Near to Home COVID Vaccination Centres (NHCVCs), which was also endorsed by the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC).

The affidavit listed details of the NHCVCs which included the following:

  • sessions can be conducted in non-health facility based settings and are nearer to home, like in a community centre or residents welfare association, office, panchayat ghar, school buildings, old age homes, sub-health centres and health and wellness centres with availability of adequate space.
  • or management of any adverse event following immunization (AEFI), an advanced life support/basic life support/transport vehicle must be stationed at the NHCVCs for transport to nearby AEFI Management Centre

The Centre said that guidelines on NHCVC was shared with all states and Union Territories on 27 May and is also available on the health ministry's website.

The Centre also listed measures to deal with a potential resurgence of the virus and said it is "continuously preparing" the states and UTs, and their infrastructure to deal with it. The possibility of a resurgence would necessarily be "speculative" at this stage but would depend on the behaviour pattern of the virus, behaviour of citizens as to whether they are following COVID-appropriate behaviour or not, the affidavit said.

The affidavit said that recent media reports regarding incidents of unauthorised or fake vaccination drives have come to the Centre's notice and it has directed states and UTs to promptly investigate any alleged irregularities and take suitable action as required. "It is submitted that any valid vaccination can only be through Co-WIN platform," it said.

The affidavit also dealt with the issue of shortage of medicines like Amphotericin to deal with Mucormycosis and Remdesivir.

With inputs from agencies



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