The BHARAT BIOTECH COVID-19 VACCINE (COVAXIN ) includes the following ingredients: COVAXIN
contains 6µg of whole-virion inactivated SARS-CoV-2 antigen (Strain: NIV-2020-770), and the other inactive
ingredients such as aluminum hydroxide gel (250 µg), TLR 7/8 agonist (imidazoquinolinone) 15 µg,
TM 2-phenoxyethanol 2.5 mg, and phosphate buffer saline up to 0.5 ml. The vaccine (COVAXIN ) thus has been
developed by using inactivated/killed virus along with the aforementioned chemicals.
TM HOWIST
HEBHARATBIOTECHCOVID-19VACCINE(COVAXIN )GIVEN?
The BHARAT BIOTECH COVID-19 VACCINE will be given to you as an injection into the deltoid muscle of the
TM
upper arm. The BHARAT BIOTECH COVID-19 VACCINE (COVAXIN ) vaccination series is 2 doses given 4 weeks
apart.
TM HAS BHARAT BIOTECH COVID-19 VACCINE (COVAXIN ) BEEN USED BEFORE?
TM The Central Licensing Authority has granted permission for the sale or distribution of COVAXIN for restricted
use in emergency situation in public interest as an abundant precaution, in clinical trial mode. In phase 1 and
Phase 2 clinical trials, about 680 (300 in Phase 1, and 380 in Phase 2) were administered with 2-doses of
TM COVAXIN . Phase 3 clinical trial is ongoing in 25,800 participants, and all the participants have received the
rst dose, as on 06th Jan 2021.
TM WHAT ARE THE BENEFITS OF BHARAT BIOTECH COVID-19 VACCINE (COVAXIN )?
TM In an ongoing clinical trial, the BHARAT BIOTECH COVID-19 VACCINE (COVAXIN ) has been shown to
generate immunity following 2 doses given 4 weeks apart.
TM However, the clinical efcacy of COVAXIN is yet to be established and it is still being studied in phase
3 clinical trial. Hence, it is important to appreciate that receiving the vaccine does not mean that other
precautions related to Covid-19 need not be followed.
TM WHAT ARE THE RISKS OF BHARAT BIOTECH COVID-19 VACCINE (COVAXIN )?
TM Side effects that have been reported with the BHARAT BIOTECH COVID-19 VACCINE (COVAXIN ) include:
• Injection site pain
• Injection site swelling
• Injection site redness
• Injection site itching
• Stiffness in the upper arm
• Weakness in injection arm
• Body ache
• Headache
• Fever
• Malaise
• Weakness
• Rashes
• Nausea
• Vomiting
TM There is a remote chance that the BHARAT BIOTECH COVID-19 VACCINE (COVAXIN ) could cause a severe
allergic reaction. A severe allergic reaction may very rarely occur after getting a dose of the BHARAT BIOTECH
TM COVID-19 VACCINE (COVAXIN ). For this reason, your vaccination provider will ask you to stay for 30 minutes
after each dose of vaccination at the place where you received your vaccine for monitoring after vaccination.
Signs of a severe allergic reaction can include:
• Difculty in breathing
• Swelling of your face and throat
• A fast heart beat
• Rash all over your body
• Dizziness and weakness
TM These may not be all the possible side effects of the BHARAT BIOTECH COVID-19 VACCINE (COVAXIN ).
TM Serious and unexpected side effects may occur. BHARAT BIOTECH COVID-19 VACCINE (COVAXIN ) is still
being studied in clinical trials.
WHAT SHOULD I DO ABOUT SIDE EFFECTS?
If you experience any side effect(s), please contact/visit your health provider/Vaccinator/ Ofcer supervising
your vaccination or immediately go to the nearest hospital.
TM WHAT IF I DECIDE NOT TO GET THE BHARAT BIOTECH COVID-19 VACCINE (COVAXIN )?
TM It is your choice to receive or not to receive the BHARAT BIOTECH COVID-19 VACCINE (COVAXIN ).
TM CAN I RECEIVE THE BHARAT BIOTECH COVID-19 VACCINE (COVAXIN ) WITH OTHER VACCINES?
There is no scientic information yet available on the appropriateness of use of the BHARAT BIOTECH COVID-19
TM VACCINE (COVAXIN ) along with other vaccines.
WHAT IF I AM PREGNANT OR BREASTFEEDING?
If you are pregnant or breastfeeding, you should not get the vaccine as the effect of the vaccine has not been
studied in pregnant women and nursing mothers.
TM WILLTHEBHARATBIOTECHCOVID-19VACCINE(COVAXIN )GIVEMECOVID-19?
TM No. BHARAT BIOTECH COVID-19 VACCINE (COVAXIN ) is an inactivated (killed) vaccine, and hence, there is
TM
no chance of getting COVID-19 because of COVAXIN vaccination.
HOW LONG WILL I HAVE TO PARTICPATE IN THIS PROGRAM?
All the Vaccine recipients will be followed-up for a period of 3 months after the 2nd dose of vaccination.
In case of any serious adverse events, Vaccine recipients will be provided medically recognized
standard of care in the government designated and authorized centers/hospitals. The compensation
for serious adverse event will be paid by sponsor (BBIL) if the SAE is proven to be causally related to
the vaccine. The compensation will be determined by the ICMR Central Ethics Committee, as
appropriate.
All the recipients need to report to the health care provider/site/sponsor, if they are having signs and symptoms
of COVID-19 or diagnosed with COVID-19. If any Vaccine recipient develops symptoms of COVID-19, Vaccine
recipient will be provided medically recognized standard of care in the government designated and authorized
centers/hospitals. COVID-19 Positive outcomes must be documented in Adverse Event Form. Proof of positive
RT-PCR (tests conducted under the existing government program and from approved laboratories) should be
provided to establish the diagnosis of COVID-19. Vaccine recipient's verbal recall will not conrm the diagnosis.
It is advisable not to
take the vaccine in any
of these conditions
The BHARAT BIOTECH COVID-19 VACCINE (COVAXIN ) includes the following ingredients: COVAXIN
contains 6µg of whole-virion inactivated SARS-CoV-2 antigen (Strain: NIV-2020-770), and the other inactive
ingredients such as aluminum hydroxide gel (250 µg), TLR 7/8 agonist (imidazoquinolinone) 15 µg,
TM 2-phenoxyethanol 2.5 mg, and phosphate buffer saline up to 0.5 ml. The vaccine (COVAXIN ) thus has been
developed by using inactivated/killed virus along with the aforementioned chemicals.
TM HOWISTHEBHARATBIOTECHCOVID-19VACCINE(COVAXIN )GIVEN?
The BHARAT BIOTECH COVID-19 VACCINE will be given to you as an injection into the deltoid muscle of the
TM
upper arm. The BHARAT BIOTECH COVID-19 VACCINE (COVAXIN ) vaccination series is 2 doses given 4 weeks
apart.
TM HAS BHARAT BIOTECH COVID-19 VACCINE (COVAXIN ) BEEN USED BEFORE?
TM The Central Licensing Authority has granted permission for the sale or distribution of COVAXIN for restricted
use in emergency situation in public interest as an abundant precaution, in clinical trial mode. In phase 1 and
Phase 2 clinical trials, about 680 (300 in Phase 1, and 380 in Phase 2) were administered with 2-doses of
TM COVAXIN . Phase 3 clinical trial is ongoing in 25,800 participants, and all the participants have received the
rst dose, as on 06th Jan 2021.
TM WHAT ARE THE BENEFITS OF BHARAT BIOTECH COVID-19 VACCINE (COVAXIN )?
TM In an ongoing clinical trial, the BHARAT BIOTECH COVID-19 VACCINE (COVAXIN ) has been shown to
generate immunity following 2 doses given 4 weeks apart.
TM However, the clinical efcacy of COVAXIN is yet to be established and it is still being studied in phase
3 clinical trial. Hence, it is important to appreciate that receiving the vaccine does not mean that other
precautions related to Covid-19 need not be followed.
TM WHAT ARE THE RISKS OF BHARAT BIOTECH COVID-19 VACCINE (COVAXIN )?
TM Side effects that have been reported with the BHARAT BIOTECH COVID-19 VACCINE (COVAXIN ) include:
• Injection site pain
• Injection site swelling
• Injection site redness
• Injection site itching
• Stiffness in the upper arm
• Weakness in injection arm
• Body ache
• Headache
• Fever
• Malaise
• Weakness
• Rashes
• Nausea
• Vomiting
TM There is a remote chance that the BHARAT BIOTECH COVID-19 VACCINE (COVAXIN ) could cause a severe
allergic reaction. A severe allergic reaction may very rarely occur after getting a dose of the BHARAT BIOTECH
TM COVID-19 VACCINE (COVAXIN ). For this reason, your vaccination provider will ask you to stay for 30 minutes
after each dose of vaccination at the place where you received your vaccine for monitoring after vaccination.
Signs of a severe allergic reaction can include:
• Difculty in breathing
• Swelling of your face and throat
• A fast heart beat
• Rash all over your body
• Dizziness and weakness
TM These may not be all the possible side effects of the BHARAT BIOTECH COVID-19 VACCINE (COVAXIN ).
TM Serious and unexpected side effects may occur. BHARAT BIOTECH COVID-19 VACCINE (COVAXIN ) is still
being studied in clinical trials.
WHAT SHOULD I DO ABOUT SIDE EFFECTS?
If you experience any side effect(s), please contact/visit your health provider/Vaccinator/ Ofcer supervising
your vaccination or immediately go to the nearest hospital.
TM WHAT IF I DECIDE NOT TO GET THE BHARAT BIOTECH COVID-19 VACCINE (COVAXIN )?
TM It is your choice to receive or not to receive the BHARAT BIOTECH COVID-19 VACCINE (COVAXIN ).
TM CAN I RECEIVE THE BHARAT BIOTECH COVID-19 VACCINE (COVAXIN ) WITH OTHER VACCINES?
There is no scientic information yet available on the appropriateness of use of the BHARAT BIOTECH COVID-19
TM VACCINE (COVAXIN ) along with other vaccines.
WHAT IF I AM PREGNANT OR BREASTFEEDING?
If you are pregnant or breastfeeding, you should not get the vaccine as the effect of the vaccine has not been
studied in pregnant women and nursing mothers.
TM WILLTHEBHARATBIOTECHCOVID-19VACCINE(COVAXIN )GIVEMECOVID-19?
TM No. BHARAT BIOTECH COVID-19 VACCINE (COVAXIN ) is an inactivated (killed) vaccine, and hence, there is
TM
no chance of getting COVID-19 because of COVAXIN vaccination.
HOW LONG WILL I HAVE TO PARTICPATE IN THIS PROGRAM?
All the Vaccine recipients will be followed-up for a period of 3 months after the 2nd dose of vaccination.
In case of any serious adverse events, Vaccine recipients will be provided medically recognized
standard of care in the government designated and authorized centers/hospitals. The compensation
for serious adverse event will be paid by sponsor (BBIL) if the SAE is proven to be causally related to
the vaccine. The compensation will be determined by the ICMR Central Ethics Committee, as
appropriate.
All the recipients need to report to the health care provider/site/sponsor, if they are having signs and symptoms
of COVID-19 or diagnosed with COVID-19. If any Vaccine recipient develops symptoms of COVID-19, Vaccine
recipient will be provided medically recognized standard of care in the government designated and authorized
centers/hospitals. COVID-19 Positive outcomes must be documented in Adverse Event Form. Proof of positive
RT-PCR (tests conducted under the existing government program and from approved laboratories) should be
provided to establish the diagnosis of COVID-19. Vaccine recipient's verbal recall will not conrm the diagnosis.
It is advisable not to
take the vaccine in any
of these conditions
https://www.google.com/imgres?imgurl=https%3A%2F%2Fimages.cnbctv18.com%2Fwp-content%2Fuploads%2F2021%2F01%2Fvaccine_covaxin-768x432.jpg&imgrefurl=https%3A%2F%2Fwww.cnbctv18.com%2Fhealthcare%2Fcovaxin-and-covishield-know-open-market-price-efficacy-and-other-details-of-covid-19-vaccines-9064281.htm&tbnid=u-2-0WFgUf40oM&vet=1&docid=ZID_TN4m_6e7TM&w=768&h=432&hl=en-IN&gl=in&source=sh%2Fx%2Fim
