Which COVID-19 vaccines are licensed in India?What

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 the grant of the EUA, rigorous assessments of laboratory and clinical trial data, including data on quality, safety, production of protective antibodies, and efficacy are conducted. Safety is a 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 the COVID-19 Vaccine?

The concept of EUA always existed to save the lives of people all over the world with vaccines 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 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 The UK and the bridging trial in India.

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

Vaccine trial phases include:-

1. Pre-clinical: Vaccine development in laboratory animals

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

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

4. 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 the 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 an either asymptomatic or mild infection. The general practice is to first evaluate any new vaccine in the older population and then age reduction is done to assess the safety and effectiveness in the pediatric 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 the development of the currently available two vaccines in India?

Covishield® vaccine, manufactured by the Serum Institute of India, is a Viral Vector-based Technology that is also used to manufacture the 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? 

The 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). The 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 the storage and transportation of vaccines?

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

The people at the highest risk of exposure such as health care and frontline workers will receive the vaccine on priority. This personnel is also likely a 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® the same as the vaccine been given in the UK by AstraZeneca?

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

What is the dosing schedule of both 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 the 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 the 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 on 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 the COVID-19 vaccine for protecting oneself against this disease and also limiting the spread of this disease to 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 them based on their safety and efficacy.

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

The safety and efficacy data from clinical trials of vaccine candidates are examined by the Drug Regulator of our country before granting the license for the same. Hence, all the COVID-19 vaccines that receive licenses 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 the COVID-19 pandemic. COVID-19 has caused social disruption, an economic downturn, and a significant number of deaths. To control this pandemic, the society, as well as the system, may have to take steps that 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 has 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.