COVID-19 vaccine | Bharat Biotech releases Covaxin fact sheet; here's all you need to know

Bharat Biotech's Covaxin was granted restricted emegency use approval in 'clinical trial mode' on January 2.

Bharat Biotech has released a fact sheet for Covaxin recipients in a bid to allay fears about the COVID-19 vaccine, which was granted emergency use authorisation by the DCGI even as the Phase-3 clinical trial is yet to be completed.

"The clinical efficacy 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," it said.

Here's all you need to know about Bharat Biotech's Covaxin:

What is Covaxin?

Covaxin is a vaccine granted approval for restricted use in emergency situation that may prevent COVID-19. 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, Covaxin has demonstrated the ability to produce antibodies against COVID-19. However, the clinical efficacy of Covaxin is yet to be established and it is still being studied in phase 3 clinical trial.

Who is eligible to receive Covaxin?

CDSCO has authorised the restricted use of Covaxin under Clinical Trial Mode. Individuals who are prioritized under the public health program of the Ministry of Health and Family Welfare, Government of India will be covered under this endeavor.

Informing the individuals about the offer for vaccination with COVAXIN will rest with the respective Government Program Officials. Those offered Covaxin at pre-specified booths will have the options to receive or reject administration of the vaccine.

What should you mention to the vaccination before getting Covaxin dose?

You must tell the supervisor about all of your medical conditions, including if you:
> Are you on regular medication for any illness? If yes, for how long and for which condition?
> Have any allergies
> Have fever
> Have a bleeding disorder or are on a blood thinner
> Are immunocompromised or are you on a medicine that affects your immune system
> Are pregnant/breastfeeding
> Have received another COVID-19 vaccine

Who should not get Covaxin?

You should not get the Covaxin if you:

> Have any history of allergies
> Have fever
> Have a bleeding disorder or are on a blood thinner
> Are immune-compromised or are on a medicine that affects your immune system
> Are pregnant/breastfeeding
> Have received another COVID-19 vaccine
> Any other serious health-related issues, as determined by the vaccinator/officer supervising vaccination.

How is it administered?

The vaccine will be given to you as an injection into the deltoid muscle of the upper arm.

Has the vaccine been used before?

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 the vaccine. Phase 3 clinical trial is ongoing in 25,800 participants, and all the participants have received the first dose, as on Jaunuary 6, 2021.

What are the benefits of Covaxin?

In an ongoing clinical trial, the Covaxin has shown to generate immunity following 2 doses given 4 weeks apart.

What are the risks?

Side effects that have been reported with the vaccine 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

Additionally, there is a remote chance that the Covaxin could cause a severe allergic reaction. 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.

What should I do if I experience side effects?

If you experience any side effect(s), please contact/visit your health provider/vaccinator/officer supervising your vaccination or immediately go to the nearest hospital.

Can I receive Covaxin in addition to other vaccines?

There is no scientific information yet available on the appropriateness of use of the Covaxin along with other vaccines.

How long will I have to participate in the vaccination programme?

All the vaccine recipients will be followed-up for a period of 3 months after the second dose of vaccination. In case of any serious adverse events, vaccine recipients will be provided with a medically recognised standard of care in the government designated and authorised centres/hospitals. The compensation for the 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.