This new study provides the first real-world safety data on the BBV152 COVID-19 vaccine also known as COVAXIN recently approved for adolescents.

Since January 2022, prospective observational research has been underway. After 14 days after receiving the BBV152 coronavirus vaccine, recruited adolescents and adults were contacted by phone.

The primary outcome was vaccine safety, which was measured by the number of adverse events following immunization (AEFI) or the side effects of the vaccine.

The FDA scale was used to grade the severity of side effects post-vaccination.

There were a total of 698 teenagers and 326 adults that took part in the study. Side effects were seen in 36.3 percent of teenagers after the first dosage and 37.9 percent after the second.

What are the side effects of COVAXIN?

The study found that 15-17 percent of teenagers had systemic involvement. The most common AEFIs were injection site pain and fever. The majority of AEFIs were mild to moderate in severity.

Adolescents with severe and atypical AEFIs were detected in 0.9 percent and 0.6 percent, respectively.

The majority of AEFIs returned to normal after 1-2 days. At 14 days after the second shot, AEFIs were still present in over 2 percent of adolescents.

There were no differences in AEFI incidence or patterns between adolescents and adults.

Females and those with a history of allergy were found to have a 1.5-times and 3-times greater risk of side effects among teenagers, according to regression analysis.

In adolescents, COVAXIN has a generally positive short-term safety profile. Adolescent AEFI rates are significantly lower than those reported with mRNA vaccinations.

Women in their adolescent years, as well as those with a history of allergies, should be cautious.

With some side effects of COVAXIN lasting 14 days, a lengthier follow-up is advised to bolster vaccine safety data.

The findings of the study were published on the preprint server medrixv.org.

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*Important Note: Since medRxiv publishes preliminary scientific studies that have not been peer-reviewed, they should not be regarded as conclusive, should not be used to direct clinical practice/health-related behavior, and should not be seen as established information.