Indian National COVID Vaccination Program-Necessary Documentation

Revised Guidelines for implementation of National COVID Vaccination Program

Effect from 21st June 2021

India’s National COVID Vaccination Program is built on scientific and epidemiological evidence, WHO guidelines and global best practices. Anchored in systematic end-to-end planning, it is implemented through effective and
efficient participation of States/UTs and the people at large.

Government of India’s commitment to the vaccination program has been unwavering and proactive from the beginning, from strengthening Research and Development capacity, to encouraging and enabling manufacturing and vaccinating each and every adult Indian safely, as fast as possible.

For the COVID vaccination program, Government of India initiated early and proactive steps as far back as April 2020:

Task Force for Focused Research on Corona Vaccine” (constituted in April
2020), to encourage domestic R&D of Drugs, Diagnostics and Vaccines,
headed by Principal Scientific Advisor to the Government of India.

National Expert Group on Vaccine Administration for COVID-19
(NEGVAC), (constituted in August 2020), to formulate a comprehensive
action plan for vaccine administration, co-chaired by Member (Health)
NITI Aayog and Union Health Secretary.

Empowered Group on Vaccine Administration for COVID-19
(constituted in January 2021), to facilitate optimal utilization of
technology to make COVID vaccination all inclusive, transparent, simple
and scalable, headed by CEO, National Health Authority.

India’s COVID vaccination program incorporates recommendations of the
foremost experts in the field of immunization, public health, disease control and
information technology. Based on scientific and epidemiological evidence, the
programme gives priority to strengthening the country’s healthcare system by
protecting the professionals, health and frontline workers, manning it, as well
as protecting the most vulnerable population groups.

COVID vaccination in the country commenced with vaccination to all Health Care
Workers. The program was expanded with time to include vaccination of Front
Line Workers, citizens more than 60 years of age, citizens more than 45 years of
age and eventually citizens more than 18 years of age.

Under the National COVID Vaccination Program, from 16th January to 30th April
2021, 100% of vaccine doses were procured by Government of India and
provided free of cost to State Governments. State Governments were in turn to
administer vaccination free of cost to defined priority groups. To increase the
pace of vaccination, participation of private hospitals was also enlisted where
individuals could also chose to get vaccinated at a prescribed rate.

In response to the suggestions of many State Governments to be permitted the
flexibility to procure vaccine directly and administer them as per their own
prioritization based on local requirements, Government of India revised the
Guidelines. Under the revised Guidelines effective from 1st May, 2021,
Government of India was procuring 50% of the vaccine produced and was
continuing to provide them to States free of cost for administering to priority
groups. The State Government and private hospitals were now also empowered
to directly procure from the remaining 50% vaccine pool.

Many States have however now communicated that they are facing difficulties
in managing the funding, procurement and logistics of vaccines, impacting the
pace of the National COVID Vaccination Program. It has also been noted that
smaller and remoter private hospitals are also facing constraints.
Keeping in view the aforesaid aspects, the experiences gained from 1st May 2021
and the repeated requests received from States, the Guidelines for National
COVID Vaccination Program have been reviewed and revised.

The main elements of the Revised Guidelines are as follows –

Government of India will procure 75% of the vaccines being produced by
the manufacturers in the country. The vaccines procured will continue to
be provided free of cost to States/UTs as has been the case from the
commencement of the National Vaccination Programme. These doses will
be administered by the States/UTs free of cost to all citizens as per priority
through Government Vaccination Centres.

 In respect of the vaccine doses provided free of cost by Government of India to the States, vaccination will be prioritized as the following:

o Health Care Workers
o Front Line Workers
o Citizens more than 45 years of age
o Citizens whose second dose has become due
o Citizens 18 years & above

 Within the population group of citizens more than 18 years of age,
States/UTs may decide their own prioritization factoring in the vaccine
supply schedule.
 Vaccine doses provided free of cost by Government of India will be
allocated to States/UTs based on criteria such as population, disease
burden and the progress of vaccination. Wastage of vaccine will affect
the allocation negatively.
 Government of India will provide States/UTs advance information of
vaccine doses to be supplied to them. States/UTs should similarly, further
allocate doses well in advance to districts and vaccination centers. They
should also put in the public domain the information about the above
availability at district and vaccination center level, and widely disseminate
it among the local population, maximizing the visibility and convenience
of citizens.
 In order to incentivize production by vaccine manufacturers and
encourage new vaccines, domestic vaccine manufacturers are given the
option to also provide vaccines directly to private hospitals. This would be
restricted to 25% of their monthly production. States/UTs would
aggregate the demand of private hospitals keeping in view equitable
distribution between large and small private hospitals and regional
balance. Based on this aggregated demand, Government of India will
facilitate supply of these vaccines to the private hospitals and their
payment through the National Health Authority’s electronic platform.
This would enable the smaller and remoter private hospitals to obtain
timely supply of vaccines, and further equitable access and regional
balance.
 The price of vaccine doses for private hospitals would be declared by each
vaccine manufacturer, and any subsequent changes would be notified in
advance. The private hospitals may charge up to a maximum of Rupees
150 per dose as service charges. State Governments may monitor the
price being so charged.

All citizens irrespective of their income status are entitled to free
vaccination. Those who have the ability to pay are encouraged to use
private hospital’s vaccination centres.

 To promote the spirit of “Lok Kalyan”, use of non-transferable Electronic
Vouchers which can be redeemed at private vaccination centers, will be
encouraged. This would enable people to financially support vaccination
of Economically Weaker Sections at private vaccination centres.

The CoWIN platform provides every citizen the facility of conveniently and
safely pre-booking vaccination appointments. All government and private
vaccination centers would also provide onsite registration facility,
available both for individuals as well as groups of individuals, for which
detailed procedure is to be finalized and published by States/UTs, in order
to minimize any inconvenience to citizens. States may also optimally utilize the Common Service Centres and Call
Centres to facilitate prior booking by citizens.

The above revised program provides States/UTs with additional central
government support across funding, procurement and logistics. It also facilitates
scientific prioritization, wider access, harnessing of private sector capacity and
flexibility at the state and local level.

The revised guidelines will come into effect from 21st June 2021 and will be reviewed from time to time. [Ministry of Helth nd Fmily Welfre-  https://www.mohfw.gov.in/pdf/RevisedVaccinationGuidelines.pdf%5D


Guidelines for COVID-19 Vaccination of Children between 15 to 18 years and Precaution Dose to HCWs, FLWs & 60+ population with co-morbidities-27.12.2021

Effective from: 3rd January 2022

India’s National COVID Vaccination Program is built on scientific and epidemiological evidence, WHO guidelines and global best practices. Anchored in systematic end-toend planning, it is implemented through effective and efficient participation of States/UTs and the people at large.

Government of India’s commitment to the vaccination program has been unwavering
and proactive from the beginning, from strengthening Research and Development
capacity, to encouraging and enabling manufacturing and vaccinating each and every
adult Indian safely, as fast as possible.

As a consequence of reliance on scientific & epidemiological evidence and pro-active
implementation, India’s COVID-19 vaccination programme has achieved historical
milestone of administering more than 141 crore doses so far. 90% of the adult
population of the country has been covered with at least one dose and 62% of the
adult population has been covered with both the doses.

For the COVID vaccination program, Government of India initiated early and proactive steps as far back as April 2020:

• “Task Force for Focused Research on Corona Vaccine” (constituted in April
2020), to encourage domestic R&D of Drugs, Diagnostics and Vaccines, headed
by Principal Scientific Advisor to the Government of India.
• “National Expert Group on Vaccine Administration for COVID-19” (NEGVAC),
(constituted in August 2020), to formulate a comprehensive action plan for
vaccine administration, co-chaired by Member (Health) NITI Aayog and Union
Health Secretary.
• “Empowered Group on Vaccine Administration for COVID-19” (constituted in
January 2021), to facilitate optimal utilization of technology to make COVID
vaccination all inclusive, transparent, simple and scalable, headed by CEO,
National Health Authority.

India’s COVID vaccination program incorporates recommendations of the foremost
experts in the field of immunization, public health, disease control and information
technology. Based on scientific and epidemiological evidence, the programme gives
priority to strengthening the country’s healthcare system by protecting the
professionals, health and frontline workers, manning it, as well as protecting the most
vulnerable population groups.

COVID vaccination in the country commenced with vaccination to all Health Care
Workers. The program was expanded with time to include vaccination of Front Line
Workers, citizens more than 60 years of age, citizens more than 45 years of age, and
eventually citizens more than 18 years of age.

Under the National COVID Vaccination Program, from 16th January to 30th April 2021,
100% of vaccine doses were procured by Government of India and provided free of
cost to State Governments. State Governments were in turn to administer vaccination
free of cost to defined priority groups. To increase the pace of vaccination,
participation of private hospitals was also enlisted where individuals could also choose
to get vaccinated at a prescribed rate.

In response to the suggestions of many State Governments to be permitted the
flexibility to procure vaccine directly and administer them as per their own
prioritization based on local requirements, Government of India revised the
Guidelines. Under the revised Guidelines effective from 1st May, 2021, Government of
India was procuring 50% of the vaccine produced and was continuing to provide them
to States free of cost for administering to priority groups. The State Government and
private hospitals were also empowered to directly procure from the remaining 50%
vaccine pool.

Many States subsequently communicated that they were facing difficulties in
managing the funding, procurement and logistics of vaccines, impacting the pace of
the National COVID Vaccination Program. It was also noted that smaller and remoter
private hospitals also faced constraints.

Keeping in view the aforesaid aspects, the experiences gained from 1st May 2021 and
the repeated requests received from States, the Guidelines for National COVID
Vaccination Program were reviewed and revised. These Revised Guidelines became
effective from 21st June 2021.

Under the Revised Guidelines, Government of India procured 75% of the vaccines
being produced by the manufacturers in the country and provided it free of cost to
States/UTs as has been the case from the commencement of the National Vaccination
Programme. These doses were administered by the States/UTs free of cost to all
citizens as per priority through Government Vaccination Centres.

Vaccine doses provided free of cost by Government of India have been allocated to
States/UTs based on criteria such as population, disease burden and the progress of
vaccination. Wastage of vaccine has affected the allocation negatively.

Government of India has also provided States/UTs advance information of vaccine
doses to be supplied to them. States/UTs were expected similarly, to further allocate
doses well in advance to districts and vaccination centers. They were also expected to
put in the public domain the information about the above availability at district and
vaccination center level, and widely disseminate it among the local population,
maximizing the visibility and convenience of citizens.

In order to incentivize production by vaccine manufacturers and encourage new
vaccines, domestic vaccine manufacturers were given the option to also provide
vaccines directly to private hospitals. This was restricted to 25% of their monthly
production. Later on, it emerged that the off take of private hospitals was much below
the aforesaid 25%. Therefore, the Govt. of India procured more than 75% of vaccines
being produced by the manufacturers in the country. These vaccines were provided
free of cost to the States/UTs.

All citizens irrespective of their income status have all along been entitled to free
vaccination. Those who have the ability to pay are encouraged to use private hospital’s
vaccination centres.

The CoWIN platform provides every citizen the facility of conveniently and safely prebooking vaccination appointments. All government and private vaccination centers also provide onsite registration facility, available both for individuals as well as groups of individuals, for which detailed procedure have been finalized and published by States/UTs, in order to minimize any inconvenience to citizens.

Keeping in view the recent global surge of COVID-19 cases, detection of Omicron variant which has been categorized as a Variant of Concern (VOC), scientific evidence, global practices and the inputs/suggestions of ‘COVID-19 Working Group of National Technical Advisory Group on Immunization (NTAGI)’ as well as of ‘Standing Technical Scientific Committee (STSC)’ of National Technical Advisory Group on Immunization [NTAGI] it has now been decided to further refine the scientific prioritization & coverage of COVID-19 vaccination as follows:

1. COVID-19 Vaccination of children in the age-group of 15-18 years to be started
from 3rd January 2022. For such beneficiaries, vaccination option would be “Covaxin” only.

2. As a matter of abundant precaution, for those Health Care Workers (HCWs) &
Front Line Workers (FLWs) who have received two doses, another dose of
COVID-19 vaccine would be provided from 10th January 2022. The prioritization
and sequencing of this precaution dose would be based on the completion of 9
months i.e. 39 weeks from the date of administration of 2nd dose.

3. All persons aged 60 years and above with comorbidities who have received two
doses of COVID-19 vaccine, will on Doctor’s advice be provided with a precaution dose from 10th January 2022. The prioritization and sequencing of this precaution dose would be based on the completion of 9 months i.e. 39
weeks from the date of administration of second dose.

All citizens irrespective of their income status are entitled to free COVID-19
vaccination at Govt. Vaccination Centres. Those who have the ability to pay are
encouraged to use Private Hospitals’ Vaccination Centres.

Co-WIN features and provisions:

1. HCWs, FLWs and Citizens 60+ with co-morbidities:
a. All HCWs, FLWs and citizens aged 60 years or above with comorbidities will
be able to access the vaccination for precaution dose through their existing
Co-WIN account.
b. Eligibility of such beneficiaries for the precaution dose will be based on the
date of administration of 2nd dose as recorded in the Co-WIN system.
c. Co-WIN system will send SMS to such beneficiaries for availing the
precaution dose when the dose becomes due.
d. Registration and appointment services can be accessed through both, the
online and the onsite modes.
e. The details of administration of the precaution dose will be suitably reflected
in the vaccination certificates.
2. New beneficiaries aged 15-18 years:
a. All those aged 15 years or more will be able to register on Co-WIN. In other
worlds, all those whose birth year is 2007 or before, shall be eligible.
b. Beneficiaries can self-register, online through an existing account on Co-WIN
or can also register by creating a new account through a unique mobile
number, this facility is available for all eligible citizens presently.
c. Such beneficiaries can also be registered onsite by the verifier/vaccinator in
facilitated registration mode.
d. Appointments can be booked online or onsite (walk-in).
e. For such beneficiaries, option for vaccination would only be available for
Covaxin as this is the only vaccine with EUL for the age-group 15-18.

These Guidelines will come into effect from 3rd January 2022 & will be reviewed from time to time.

Note: National immunization technical advisory groups (NITAGs) is sponsored by WHO

FAQs on SARS-CoV-2 Variant-Omicron Govt of India


National Technical Advisory Group on Immunization- India

Press Information Bureau
Government of India
Ministry of Health and Family Welfare
08-February-2017 16:59 IST
Press Note

The Universal Immunization Programme of the Ministry of Health & Family Welfare (MoHFW) provides immunization services free of cost to all children across the country as per its Immunization schedule.

There have been reports in a section of media which have highlighted concerns regarding the National Technical Advisory Group on Immunization (NTAGI) and the transitioning of the NTAGI Secretariat to the National Institute of Health & Family Welfare (NIHFW) from Immunization Technical Support Unit (ITSU).

NTAGI is the highest advisory body on immunization in the country which consists of independent experts who provide recommendations on vaccines after reviewing data on disease burden, efficacy and cost-effectiveness of vaccines.

The Immunization Technical Support Unit (ITSU) was established to support MoHFW for evidence based planning, program operations, monitoring and evaluation, strategic communication, cold chain and vaccine logistics management and support for Adverse Event Following Immunization. One of the functions of ITSU was to host the NTAGI Secretariat to facilitate the secretarial work of NTAGI which includes coordination of its regular meetings.

In the last few years, many steps have been taken to strengthen NTAGI by providing a Secretariat, establishing a code of practice and now institutionalizing it at the NIHFW. The transitioning of the NTAGI Secretariat from ITSU to NIHFW was a planned activity and is part of the health system strengthening efforts by the Government. This will have no adverse impact on its functioning. There is no financial link of NTAGI with Bill and Melinda Gates Foundation (BMGF) or any other organization as the body consists of independent experts.

As far as technical support by ITSU is concerned, it is functioning till 28th February 2017 and the project will continue to support the immunization program in techno-managerial capacity beyond this date. The contours of this support are being finalized with Public Health Foundation of India (PHFI) and BMGF.

Some media reports have suggested that all health related collaboration with the Gates Foundation with National Health Mission (NHM) has been stopped. This is inaccurate and misleading. BMGF continues to collaborate and support the Ministry of Health and Family Welfare.

Read More

Minutes of the National Technical Advisory Group on Immunization (NTAGI India) held on 28th May 2021

Extrct-

The 16th NTAGI meeting was held virtually on Friday, May 28, 2021 at MoHFW, New Delhi, under the Chairpersonship of Shri Rajesh Bhushan, Secretary Health & Family Welfare (H&FW), Dr Renu Swarup, Secretary, Department of Biotechnology (DBT) and Dr Balram Bhargava, Secretary, Department of Health Research & Director General, Indian Council of Medical Research (ICMR). All participating NTAGI members and invited attendees had duly filled and signed the confidentiality agreement, and declared conflict of interests (if any), and shared them with the NTAGI Secretariat. No conflict of interest was noted. The list of attendees is Annexed as Annexure-1 and agenda as Annexure-2. It was informed that the minutes of the NTAGI meeting held on December 10, 2020 were shared with the members and no comments were received. The minutes were formally confirmed by the NTAGI.

COVID-19 Vaccines: Members were apprised that a preliminary guidance document on use of COVID-19 vaccines was prepared and shared with the MoHFW and NEGVAC. Further, it was informed that a preliminary modeling exercise on seroprevalence based COVID-19 vaccination strategies was conducted with the help of Dr. Sarang’s group. It has been suggested to refine the model using ICMR, NCDC and Delhi Government’s data. In addition, as recommended, a document on contraindications and precautions associated with COVID19 vaccines was shared with MoHFW in January, 2021. An updated version of the document will be presented in the meeting.

It has been strongly recommended to establish a National Vaccine tracking platform to determine the impact of COVID-19 vaccines and track breakthrough infections. Breakthrough infections are those infections, which occurred two weeks after getting the second dose or full schedule of the vaccine. ICMR is currently doing the harmonization works for different administrative data, including RT PCR data, the disease data and genomic surveillance data. If these are all harmonized, that would give a very close look at what is happening on the ground in real time basis.

It is recommended that a randomized trial of varying dose interval of Covishield and other vaccine as they come in should also be planned and immediately embedded in the proposed study, and the manufacture should be asked to do the study.

There is this evidence that if somebody has a proven infection, probably for next six months, there is reasonable protection from reinfection. It has been recommended that the vaccination for individuals may be deferred for three months after recovery. Similarly, who have received the first dose and before completion of the dosing schedule get infected with COVID-19, they may take next dose 3 months after complete recovery. Same deferral duration has been recommended for patients who are given plasma or convalescent or monoclonal antibodies. In addition, people who may be hospitalized for other serious illnesses, may take covid-19 vaccine 4-8 weeks after discharge from hospital. 

Note: Aproving Covid Vccine

The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control. Major functions of CDSCO is regulatory control over the import of drugs, approval of new drugs and clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), approval of certain licenses as Central License Approving Authority is exercised by the CDSCO headquarters.


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