India's COVID-19 vaccine candidate Covaxin, which was recently approved for emergency use, is facing complications as several people reported adverse effects after receiving the vaccine shot. The lack of data from the phase 3 clinical trials in terms of the vaccine's efficacy has led to scepticism among people regarding the vaccine's safety.

Covaxin's manufacturing company Bharat Biotech International Ltd released a fact sheet detailing the risks of its vaccine for Covid-19. The company has mentioned that it is *not* advisable to take Covaxin in case the recipients suffered from any of the following conditions.

• Have any allergies

• Have fever

• Have a bleeding disorder or are on a blood thinner

• Are immunocompromised or are on a medicine that affects your immune system

• Are pregnant

• Are breastfeeding

• Have received another Covid-19 vaccine

• Any other serious health related issues, as determined by the vaccinator

The effects of the coronavirus vaccine have not yet been studied on pregnant/breastfeeding women and hence women who fall under the category have specifically been advised to not take the vaccine. The company also mentioned that there is no scientific information yet available of the appropriateness of use of Covaxin along with other vaccines.

Bharat Biotech stated that the CDSCO has authorised the restricted use of its vaccine under clinical trial mode and individuals who are prioritised under the public health program of the ministry of health and family welfare, will be covered under this endeavour. 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.

So far, some of the recipients of Covaxin have faced the following side-effects.

• Injection site pain

• Injection site swelling

• Injection site redness

• Injection site itching

• Headache

• Fatigue

• Fever

• Body ache

• Stiffness in the upper arm

• Abdominal pain

• Dizziness

• Sweating

• Nausea

• Vomiting

The company noted that Paracetamol may be used to provide symptomatic relief from post-vaccination adverse reactions. On January 3, two vaccines - Bharat Biotech's Covaxin and Oxford-AstraZeneca's Covishield manufactured by Serum Institute of India - were approved by India for restricted emergency use.