Welcome TO BSIT-COVID19 HELP PORTAL COVID-19 Vaccine
Know About Vaccination
About Vaccine
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).
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.
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.
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.
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)
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.
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.
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 need to be stored and transported at +20 to +8° 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.
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.
Yes, Covishield® vaccine, manufactured by the Serum Institute of India, is based on the same patent technology as the Astrazeneca vaccine.
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.
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 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.
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 were persons over 60 years of age as of January 1st, 2021 and persons between 45 and 59 years with comorbid conditions. This group started receiving vaccinations from March 1st, 2021. 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.
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.
Vaccines will be introduced in the country only after the regulatory bodies clear it based on its safety and efficacy.
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.
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.
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.