FAQs on COVID-19 Vaccines and Vaccination Program-MoHFW Release on 01-09-2021
- VACCINE ATTRIBUTES
- EFFICACY & PROTECTION
- FOLLOW-UP & BOOSTER
- COVID-19 VACCINATION PROGRAM
- COVID-19 VACCINATION IN PREGNANT AND LACTATING WOMEN
1. Which COVID-19 vaccines are licenced and used in the country at present for COVID Vaccination?
Three vaccines that have been granted authorization for restricted use in emergency situation by the Central Drugs Standard Control Organization (CDSCO) in India are Covishield (AstraZeneca’s vaccine manufactured by Serum Institute of India), Covaxin® (manufactured by Bharat Biotech Limited) and Sputnik V (developed by Gamaleya Research Institute, Russia), which is the third vaccine to get approval from the Drugs Controller General of India (DCGI).
2. 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, there are rigorous assessments of laboratory and clinical trial data, including data on quality, safety, production of protective antibodies and efficacy. 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.
3. 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.
4. Have the vaccines undergone the needed clinical trials before EUA?
Both the Indian COVID-19 vaccines and the Russian vaccine Sputnik V have conducted their phase I, II & III trials. Covishield® has completed its Phase III trials in UK and the bridging trial in India.
5. What is Phase I, II and III of clinical trial for a vaccine?
The clinical trial phases include:
|Phases of vaccine development / trial||Purpose|
|Pre-clinical||Vaccine development in laboratory animals|
|Phase I Clinical trial (small number of participants)||Assess vaccine safety, immune response and determine right dosage (short duration)|
|Phase II Clinical trial (few hundred participants)||Assess safety and the ability of the vaccine to generate an immune response (short duration)|
|Phase III Clinical trial (thousands of participants)||Determine vaccine effectiveness against the disease and safety in a larger group of people (duration 1-2 years)|
6. Why vaccination is not provided to children who are usual target?
COVID-19 affects all age groups, however, the 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 in the country 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.
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|Title of PDF File||FAQs on COVID-19 Vaccines and Vaccination Program-MoHFW Release on 01-09-2021|
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