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Which COVID-19 vaccines are licensed in India?

Two vaccines that have been granted emergency use authorization by the Central Drugs Standard Control Organization (CDSCO) in India are Covishield® (AstraZeneca's vaccine manufactured by Serum Institute of India) and Covaxin® (manufactured by Bharat Biotech Limited).

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.

Have the vaccines undergone the needed clinical trials before EUA?

Both the Indian COVID-19 vaccines have completed their Phase I & II trials. Covishield® has completed its Phase III trials in UK and the bridging trial in India.

What is Phase I, II and III of clinical trial for a vaccine?

Vaccine trial phases includes:-

  • Pre-clinical: Vaccine development in laboratory animals

  • Phase 1 Clinical trial (small number of participants): Assess vaccine safety, immune response and determine right dosage (short duration)

  • Phase 2 Clinical trial (few hundred participants): Assess safety and the ability of the vaccine to generate an immune response (short duration)

  • Phase 3 Clinical trial (thousands of participants): Determine vaccine effectiveness against the disease and safety in a larger group of people (duration 1-2 years)

Why vaccination is not provided to children who are usual target?

COVID-19 affects all age groups; however, morbidity & mortality is several times higher in adults particularly in those above the age of 50 years. Children have either asymptomatic or mild infection. The general practice is to first evaluate any new vaccine in older population and then age reduction is done to assess the safety and effectiveness in paediatric population. The currently available vaccines have not been evaluated in children so far. There are some clinical trials now underway to test the effectiveness and safety of the COVID-19 vaccines in children.

What technology has been used in development of the currently available two 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.

What is the composition of both the vaccines?

Composition of Covishield includes inactivated adenovirus with segments of Coronavirus, 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 Coronavirus, Aluminum Hydroxide Gel, TLR 7/8 Agonist, 2-Phenoxyethanol and Phosphate Buffered Saline [NKA1].

Both vaccines require cold chain temperature. How is the cold chain been maintained during storage and transportation of vaccine?

Both vaccines need to be stored and transported at +20 to +8⁰ Celsius. The cold chain for both vaccines is maintained through active and passive cold chain equipment available at approximately 29000 cold chain points across India.

If I have received vaccine as a health worker, how will my family members receive the vaccine (as they are exposed as well)?

The people at highest risk of exposure such as health care and frontline workers will receive the vaccine on priority. These personnel are also likely source of infection of their family members. Other family members will be vaccinated according to the age specific prioritization by the Government of India.

Is COVISHIELD® same as the vaccine been given in UK by Astrazeneca?

Yes, Covishield® vaccine, manufactured by the Serum Institute of India, is based on the same patent technology as the Astrazeneca vaccine.

What is the dose schedule of both the vaccines?

The time interval between two doses of the Covishield vaccine has been extended from four-six weeks to four-eight weeks. The second dose of Covaxin can be taken four to six weeks after the first.

Do I have a choice of vaccine I will receive?

The vaccine will be supplied to various parts of India as per availability and distribution plan, beneficiaries load and so at present the option of choice of vaccine is not available.

Developing a vaccine takes years. But this time our scientists have developed a vaccine against the novel coronavirus 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 pre-clinical 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.

Is a COVID-19 vaccine scheduled anytime soon for me?

The COVID-19 vaccine was launched on 16th January, 2021. The first group includes healthcare and frontline workers. The second group to receive COVID-19 vaccine are persons over 60 years of age as of January 1st, 2022 and persons between 45 and 59 years with comorbid conditions. This group started receiving vaccinations from March 1st, 2021. Those who are above 45 years of age will be able to take the vaccination from April 1st, 2021.

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 oneself against this disease and also to limit the spread of this disease to the close contacts including family members, friends, relatives and co-workers.

Will the vaccine be safe as it is being tested and introduced in a short span of time?

Vaccines will be introduced in the country only after the regulatory bodies clear it based on its safety and efficacy.

Out of the multiple vaccines available, how is one or more vaccine chosen for administration?

The safety and efficacy data from clinical trials of vaccine candidates are examined by Drug Regulator of our country before granting the license for the same. Hence, all the COVID-19 vaccines that receive license will have comparable safety and efficacy. However, it must be ensured that the entire schedule of vaccination is completed by only one type of vaccine as different COVID-19 vaccines are not interchangeable.

Will the vaccine introduced in India be as effective as the ones introduced in other countries?

Yes, the COVID-19 vaccine introduced in India will be as effective as any vaccine developed by other countries. Various phases of vaccine trials are undertaken to ensure its safety and efficacy.

Indian regulators have given authorization to Covaxin even before its Phase 3 trial results were out. How do we explain this?

We are passing through COVID-19 pandemic. COVID-19 has caused social disruption, economic downturn and significant number of deaths. To control this pandemic, the society as well as the system may have to take steps which may also be termed as drastic. Both pre-clinical and clinical data (complete data for Phase I and II, and partial data for Phase III) of Covaxin have been thoroughly scrutinized by the regulators. This data shows that the vaccine is safe and induces a robust antibody response. However, to what extent the vaccine will protect the recipients from getting the disease is not fully known yet. Therefore, the regulators have allowed its use in trial mode.

Out of the multiple vaccines available, how is one or more vaccine chosen for administration?

The safety and efficacy data from clinical trials of vaccine candidates are examined by Drug regulator of our country before granting the license for the same. Hence, all the COVID-19 vaccines that receive license will have comparable safety and efficacy. However, it must be ensured that the entire schedule of vaccination is completed by only one type of vaccine as different COVID-19 vaccines are not interchangeable.

Does India have the capacity to store the COVID-19 vaccine at temperature of +2 to +8 degree Celsius and transport them at required temperature?

India runs one of the largest Immunization programme in the world, catering to the vaccination needs of more than 26 million newborns and 29 million pregnant women. The programme mechanisms are being strengthened/geared up to effectively cater to the country’s large and diverse population.

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-19 Appropriate Behaviours like wearing of mask, maintaining hand sanitization and physical distance (or 6 feet or Do Gaj).

What does trial mode mean for a vaccine recipient?

The way we do in a clinical trial phase: first, the recipient will be asked to give a written consent. Additionally, the recipient will be followed up actively to see if the vaccine has led to any side effects. In short, it will be an extension of the Phase 3 trial. But in this, the person would know that he or she has received the vaccine, and not the placebo. It is completely voluntary.

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 we usually test a vaccine 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, we keep a close watch, for the first two-three months, on the people it has been given to. This data help us decide if a vaccine is safe. All concerned in the line of vaccine development, testing and evaluation have followed these procedures to the T. Both Indian vaccines 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 to three months of observation. Besides when a vaccine is given an emergency use authorizations/permission for restricted use, as in the case of the COVID-19 vaccine, the trial follow-up continues for one-two years to assess the total duration of protection the vaccine will provide.

Which vaccine is better between Covisheild and Covaxin?

There is no head-to-head comparison done between the two vaccines being used in India so one cannot choose one over the other. Both would work fine in preventing the infection as well as prevent a person from going into severe state of the disease. As a long-term effect, it would be preventing death for elderly people or those who have comorbidities.

What medications should be avoided before taking COVID-19 vaccine and for how long?

Currently, there is no such instruction. One can take one’s regular medication uninterruptedly. Just inform the vaccinator about the medicines you consume.

Is the vaccine contraindicated in person with chronic diseases?

Chronic diseases and morbidities like the cardiac, neurological, pulmonary, metabolic, renal and malignancies etc. are not contraindicated. In fact, the benefit of COVID-19 vaccines to reduce the risk of severe COVID-19 disease and death is for those who have these comorbidities.

If one is taking medicines for illnesses like Cancer, Diabetes, Hypertension etc, can s/he take the COVID-19 vaccine and/or If I suffer from HTN/DM/CKD/heart disease/lipid disorders etc., can I safely take this vaccine?

Yes, persons with one or more of these comorbid conditions are considered among the high risk category. They need to get COVID-19 vaccination. Overall, the vaccine is safe and efficacious in adults with comorbidity. The maximum benefit of getting the COVID-19 vaccine is for those who have such co-morbidities. However, if you are concerned for any specific reason, please consult your doctor.

 


 

 

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