Which COVID-19 vaccines are licensed in India?
The vaccines that have been granted emergency use authorization by the Central Drugs Standard Control Organization (CDSCO) in India are
COVISHIELD and COVAXIN have been accorded approval for Manufacture for Sale or for Distribution in the country.
For more information and updates visit Ministry of Health and Family Welfare
What is Emergency Use Authorization (EUA)/ Permission for restricted use?
Emergency Use Authorization (EUA) is a regulatory mechanism to allow the use of vaccines and medicines to prevent and/or reduce the impact of life-threatening diseases or conditions as caused by COVID-19. However, before grant of the EUA, rigorous assessments of laboratory and clinical trial data, including data on quality, safety, production of protective antibodies and efficacy is conducted. Safety is particularly critical aspect of this scrutiny and a risk-versus- benefit evaluation is done in the context of a public health emergency. Full licensure is obtained when the manufacturer submits the complete data. EUA by Indian regulators is aligned with global guidelines.
Is the EUA a new process introduced for COVID-19 Vaccine?
Concept of EUA always existed to save the lives of people all over the world with vaccine and medicines for life threatening diseases while companies continue to obtain additional safety and effectiveness information to enable full licensure. Previously, EUAs have been granted to vaccines for outbreaks due to anthrax, Ebola, enterovirus, H7N9 influenza, and Middle East respiratory syndrome. As of January 2021, nine COVID-19 vaccines were in emergency use in numerous countries around the globe.
What is Phase I, II and III of clinical trial for a vaccine?
Vaccine trial phases includes:-
What technology has been used in development of the currently available vaccines in India?
Covishield® vaccine, manufactured by the Serum Institute of India, is a Viral Vector-based Technology which is also used to manufacture Ebola vaccine.
Covaxin® vaccine, manufactured by the Bharat Biotech, is a Whole-virion Inactivated Coronavirus Vaccine which is also used to manufacture vaccines like Influenza, Rabies and Hepatitis- A.
Sputnik V - M/s Dr. Reddy’s Laboratories Ltd. (M/s DRL) and M/s Gamaleya Institute, Russia Gam-COVID-Vac have developed the combined vector vaccine.
What are the compositions of the above vaccines?
Composition of Covishield® includes inactivated adenovirus with segments of Corona Virus, Aluminium Hydroxide Gel, L-Histidine, L-Histidine hydrochloride monohydrate, Magnesium chloride hexahydrate, Polysorbate 80, Ethanol, Sucrose, Sodium chloride, and Disodium edetate dihydrate (EDTA).
Composition of Covaxin® includes inactivated Corona Virus, Aluminium Hydroxide Gel, TLR 7/8 agonist, 2-Phenoxyethanol and Phosphate Buffered Saline
Composition of Sputnik V:
Does India have the capacity to store the COVID vaccine at temperature of +2 to +8 degree Celsius and transport them at required temperature?
The two vaccines (Covishield & Covaxin) need to be stored and transported at +20 to +8⁰ Celsius. The cold chain for the vaccines is maintained through active and passive cold chain equipment available at approximately 29,000 cold chain points across India. Sputnik V requires storage temperature of -180C (minus eighteen degrees centigrade) or below. The deep freezers are available under Universal Immunization Programme across the country for storage of this vaccine.
What is the dose schedule of the vaccines under the national vaccination program?
As per the permission granted by the Drugs Controller General (India), the dose schedule is as follows:
Do I have a choice of the vaccine that I will receive?
Yes, Co-WIN portal displays the availability of the different vaccines across the COVID Vaccination Centres, both government and private. The beneficiary can choose to get vaccinated with a particular vaccine at a particular CVC of his/her choice.
7. General Indications of COVID-19 vaccine:
Developing a vaccine takes years. But this time our scientists have developed a vaccine against the novel corona virus in such a short time. How was this possible?
Developing a vaccine generally involves years of research. First, we need a vaccine candidate that is evaluated in animals for its safety and efficacy. After a vaccine candidate passes a pre-clinical trial, it enters the clinical trial phase. While scientists have worked round the clock in the laboratory, even regulatory approvals which used to take several months have been fast-tracked. It helped eliminate all the time lapses between the preclinical and clinical trial stages. Earlier, the vaccine development involved a series of steps, but in the case of the coronavirus vaccine, the scientists and regulators worked in tandem, accelerating the whole process without compromises on any protocols and any step.
What is the safety and efficacy of the vaccines used in the country?
To ensure that a vaccine is safe, we need to try it on a large number of people. The vaccine developers have not reduced the sample size at any stage of clinical trials rather it was bigger than what usually a vaccine is tested on.
When a vaccine is tested, most of the adverse events or unwanted effects, if any, occur in the first four to six weeks of its administration. So, in order to ensure that it is safe, a close watch is kept on the people it has been given to for the first two-three months. This data helps to decide if a vaccine is safe. All concerned in the line of vaccine development, testing and evaluation have followed these procedures. The vaccines being used are considered safe on this yardstick.
As for the efficacy of the vaccine, we need time to tell how effective a vaccine is. All the global agencies have set the benchmark that only those vaccine candidates which show an efficacy of at least 50-60% will be considered. Most of the vaccines have shown an efficacy of 70-90% within the short period of two or three months of observation. Besides when a vaccine is given as emergency use authorization/permission for restricted use, as in the case of the COVID-19 vaccine, the trial follow-up continues for one to two years to assess the total duration of protection the vaccine will provide.
Do I need to use the mask/other COVID-19 appropriate precautions after receiving the vaccine?
Yes, it is absolutely necessary that everyone who has received the COVID-19 vaccine should continue to follow the COVID-19 appropriate behaviour i.e., mask, do gaj ki doori and hand sanitization to protect themselves and those around from spreading the infection.
How long I will remain protected after vaccination?
The duration of protection is yet to be established.
Does vaccination protect me against newer strains / mutated virus of SARS-CoV 2?
The body responds to vaccination by making more than one type of antibodies to virus parts including spike protein. Therefore, all vaccines are expected to provide reasonable amount of protection against the mutated virus also. Based on the available data, the mutations as reported are unlikely to make the vaccine ineffective.
In how many days will the vaccination create an adequate immune response and protection?
Adequate immune response takes 2-3 weeks after completion of entire vaccination schedule i.e., after the second dose of COVISHIELD® and COVAXIN®.
Is it important for me to receive the same vaccine during second dose?
As the vaccines available are not interchangeable, it is important to receive the second dose of same vaccine as the first one. The Co-WIN portal is also going to help to ensure that everyone receives the same vaccine.
What are expected immediate and delayed side effects of this vaccine?
Covishield®: Some mild symptoms may occur like injection site tenderness, injection site pain, headache, fatigue, myalgia, malaise, pyrexia, chills and arthralgia, nausea. Very rare events of demyelinating disorders have been reported following vaccination with this vaccine but without the causal relationship establishment.
Covaxin®: Some mild symptoms AEFIs may occur like injection site pain, headache, fatigue, fever, body ache, abdominal pain, nausea and vomiting, dizziness-giddiness, tremor, sweating, cold, cough and injection site swelling. No other vaccine-related serious adverse effects have been reported.
Short term general: Chills, fever, arthralgia, myalgia, asthenia, general discomfort, headache
What are the contraindications to COVID-19 vaccines?
Which drug should be taken to minimize the adverse effects of this vaccine?
In case of minor adverse effects such as injection site pain, , tenderness, malaise, pyrexia, etc., paracetamol tablet may be used to alleviate the symptoms
Should you avoid alcohol after receiving the COVID-19 vaccine?
As per experts, there is no evidence of alcohol impairing the effectiveness of the vaccine.
Should one avoid taking vaccine during and around menstruation?
The time period around menstruation is no contraindication to taking vaccines and like other vaccines, COVID-19 vaccine can be taken at any time of the monthly period.
Is vaccination free at all vaccination centres?
COVID-19 vaccination is available free of cost to all citizens aged 15 years and above at government CVCs. Those who have the capacity to pay may approach COVID Vaccination Centres at private hospitals. The price of different vaccine products at private CVC may differ and will be dynamic as per vaccine pricing offered by the manufacturers, which will be declared by each vaccine manufacturer. The private hospitals may chargeas per existing costing norms set by government as service charge. The price of vaccination would also be displayed on CoWIN portal and would be visible to citizens at the time of seeking online appointment.
Can a person presently having COVID-19 (confirmed or suspected) infection be vaccinated?
Person with confirmed or suspected COVID-19 infection may increase the risk of spreading the same to others at vaccination site. For this reason, infected individuals should defer vaccination for three months after recovery.
How will I know if I am eligible for vaccination?
In the initial phase, COVID-19 vaccine was provided to the priority group - Health Care and Front-line workers. The second phase vaccinations, which started on March 1, 2021 allowed for all Indians above the age of 60 and Indians between the age of 45 and 59 with comorbidities to be vaccinated.
From April 1st, 2021, People above the age of 45 years (born before 1st Jan, 1977) are eligible to get the COVID-19 vaccine.
From May 1, 2021, all eligible citizens above the age of 18 years can get the COVID-19 vaccine.
From January 01, 2022, all eligible citizens above the age of 15 years can get the COVID-19 vaccine.
From March 16, 2022, all eligible citizens above the age of 12 years can get the COVID-19 vaccine.
Is it necessary for a COVID-19 recovered person to take the vaccine? And if I had COVID-19 infection and was treated, why should I receive the vaccine?
Development of immunity or duration of protection after COVID-19 exposure is not established therefore it is recommended to receive vaccine even after COVID-19 infection.
What are the contraindications for this vaccine?
Is it necessary for a COVID recovered person to take the vaccine?
Yes, it is advisable to receive complete schedule of COVID vaccine irrespective of past history of infection with COVID-19. This will help in developing a strong immune response against the disease.
If one is taking medicines for illnesses like Cancer, Diabetes, Hypertension etc, can s/he take the COVID- 19 vaccine?
Yes. Persons with one or more of these comorbid conditions are considered high risk category. They need to get COVID -19 vaccination
Is it mandatory to take the vaccine?
Vaccination for COVID-19 is voluntary. However, it is advisable to receive the complete schedule of COVID-19 vaccine for protecting one-self against this disease and also to limit the spread of this disease to the close contacts including family members, friends, relatives and co-workers.
Out of the multiple vaccines available, Which vaccine is better?
There is no head-to-head comparison done between the vaccines being used in India, so one cannot choose one over another. All vaccines would work well in preventing the infection as well as prevent a person from going into severe state of the disease. As a longterm effect, it would be preventing death for elderly people or those who have comorbidities
Can a person get the COVID-19 vaccine without online registration?
Yes. Vaccination Centres provide for a limited number of on-spot registration slots every day. Beneficiaries can schedule appointments online or walk-in to vaccination Centres. In general, all beneficiaries are recommended to register online and schedule vaccination in advance for a hassle-free vaccination experience.
What documents are required for registration of eligible beneficiary?
Any of the below mentioned ID with Photo may be produced at the time of registration:
For children born in the year 2010 or earlier, registration can be done using AADHAAR, PAN card, Unique Disability ID, Ration card with Photo and School photo ID card.
Will a Photo / ID be required at the time of registration?
The Photo ID produced at the time of registration must be produced and verified at the time of vaccination.
If a person is not able to produce Photo ID at the session site, whether s/he be vaccinated or not?
Photo ID is a must for both registration and verification of beneficiary at session site to ensure that the intended person is vaccinated.
How will the beneficiary receive information about due date of vaccination?
Following online registration, beneficiary will receive SMS on their registered mobile number on the due date, place and time of vaccination.
Will vaccinated beneficiaries receive information on the status of their vaccination after completion?
Yes. On getting due dose of COVID 19 vaccine, the beneficiary will receive SMS on their registered mobile number. After all doses of vaccine are administered, a QR code based certificate will also be sent to the registered mobile number of the beneficiary.
Are there any preventive measures and precautions that one needs to follow at the session site?
We request you to rest at the vaccination centre for atleast half an hour after taking the COVID-19 vaccine. Inform the nearest health authorities / ANM / ASHA in case you feel any discomfort or uneasiness subsequently. Remember to continue following key COVID Appropriate Behaviours like wearing of mask, maintaining hand sanitization and physical distance (or 6 feet or Do Gaj).
If I suffer from HTN/DM/CKD/heart disease/lipid disorders etc., can I safely take this vaccine?
Overall, the vaccine is safe and efficacious in adults with co-morbidity. The maximum benefit of getting the COVID vaccine is for those who have such co-morbidities. However, if you are concerned for any specific reason, please consult your doctor
What medications should be avoided before taking COVID-19 vaccine and for how long?
A person receiving aspirin, clopidogrel (both of these are anti-platelet agents) or other anticoagulants: The dose of that day should be taken after the vaccination. Patients on Vitamin K antagonist (VKA) should have an International Normalized Ratio (INR) less than 3 before administration of the vaccine. In all cases, application of firm pressure at the injection site for at least 5 minutes after the injection may be done to reduce the risk of haematoma formation.
The Health Ministry has advised caution in vaccinating persons with a history of bleeding or coagulation disorder. How does a person know if he/she has a coagulation disorder? What tests can be conducted?
There are a few bleeding disorders like 'haemophilia'. These persons should take the vaccine under the supervision of their treating physician. Patients who are admitted in hospital or ICU and have bleeding problems should delay the vaccination till they are discharged. However, several people with heart and brain disorders are on blood thinners like aspirin and anti-platelet drugs. They can continue with their medicines and have the vaccines. For them, vaccines are absolutely safe.
Vaccine should be administered with caution in persons with history of any bleeding or coagulation disorder (e.g., clotting factor deficiency, coagulopathy or platelet disorder). In such persons, there is a slightly increased risk of bleeding through the intra-muscular route of administration.
Individuals with these disorders are to be treated as those with any co-morbidity, they are an at-risk population and hence should be encouraged to get COVID 19 vaccines. COVID-19 vaccine should be administered with caution in individuals with Thalassemia and hemoglobinopathies, those who have a history of any bleeding or coagulation disorders (e.g., clotting factor deficiency, coagulopathy or platelet disorders). The vaccinator/health worker should ask these individuals and or their care providers if they have blue spots (ecchymosis), bleeding spots on the skin or prolonged oozing of blood after any injury.
The health advisory also states that those with immunity issues should be cautious about taking the vaccine. What are the markers of 'Immunity issues'?
Immune issues are of two types: first, immunosuppression due to any disease such as AIDS, and people on immunosuppressant drugs such as anti-cancer drugs, steroids, etc. Second, immunodeficiency in people who suffers from some defect in the body's protective system such as congenital immunodeficiency.
Currently, available COVID vaccines do not have any live virus and therefore individuals with immune issues can have the vaccine safely. But the vaccine may not be as effective in them.
One should inform the vaccinator about the medicines they consume and if they are suffering from any known immune issues. The vaccinator should have a record of one’s medical condition.
Immuno-deficiency, HIV, patients having immune-suppression due to any condition (persons on stable immunosuppression for 12 weeks or more) should be able to safely receive the vaccine although the response to the COVID-19 vaccines may be less in these individuals
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