Covaxin had much lower adverse effects and overall favourable short-term safety profile in adolescents: Study | India News

HYDERABAD: Bharat Biotech’s indigenously developed Covid-19 vaccine Covaxin was overall found to have “much lower” AEFI (adverse effects following immunisation) rates in adolescents with a favourable short-term safety profile as compared to those reported with mRNA vaccines but adolescent females and those with a history of allergy were at a 1.6 times and three times increased risk of AEFI after taking Covaxin.
These were the findings of a study conducted by researchers at Benaras Hindu University on adolescent (15-18 years) and adult (over 19 years) recipients of Covaxin that claims to be the first real-world safety analysis of Covaxin.
Titled ‘A prospective Observational Study on BBV152 Coronavirus Vaccine Use in Adolescents and Comparison with Adults: Interim Results of the first Real-World Safety Analysis’, the study tracked 698 adolescents and 326 adults at a tertiary hospital in North India from January 2022 and its findings were published in Springer Nature in August 2022.
Bharat Biotech said for such a study in safety to be effective, informative and to avoid investigator bias, various data points were also required to be taken into consideration.
These include the AESI (adverse effects of special interest) safety profile of the subjects prior to participation in the study, comparison of the safety profile of non-vaccinated subjects during the course of the study as well as comparison of safety profile of subjects who received other vaccines during the course of the study.
Bharat Biotech also pointed out that all the study participants should be followed during the course of the study, instead of only a subset. “Several studies have been executed on the safety of COVAXIN, and published in peer reviewed journals, demonstrating an excellent safety track record,” the Hyderabad-based vaccine maker said.
The BHU study’s results have surfaced at a time when pharma giant AstraZeneca has admitted to its Covishield causing rare but serious and fatal clotting side effect called Thrombosis with Thrombocytopenia Syndrome (TTS) and is now also being linked to another side effect called vaccine-induced immune thrombocytopenia and thrombosis (VITT).
The BHU researchers found that 243 out of 670 adolescents (36.3%) reported AEFIs after the first dose of Covaxin with 21% reporting only local AEFIs and 15.2% reporting systemic AEFIs. Of the 340 adolescents who received the second dose of Covaxin, 129 (37.9%) developed AEFIs with only local involvement in 20.3% and systemic involvement in 17.6%.
A majority of the AEFIs were mild to moderate and were resolved in one to two days with the most common AEFIs reported being injection site pain and fever. Other AEFIs were weakness, headache, general body pain, injection site swelling, abdominal distress, diarrhea, dizziness, itching.
However, AEFIs persisted in over 2% of adolescents at day 14 after the second dose and in 3.7% of the adults overall at follow-up, the study said. One recipient each reported burning sensation in lower limbs, hypothyroidism and heavy menstrual bleeding.
While nearly 91% of AEFIs in the adolescents and adults studied pertained to general disorders and administration site conditions, nervous system disorders were the second highest at 4.6% followed by gastrointestinal disorders at 1.6% and musculoskeletal and connective tissue disorders at 1%, about 0.7% pertained to skin and subcutaneous tissue disorders followed. Respiratory thoracic and mediastinal disorders, vascular disorders, endocrine disorders and reproductive system and breast disorders accounted for just 0.3% of AEFI each.
Despite terming Covaxin as having an overall favourable short-term safety profile in adolescents, the researchers called for the need to generate long-term safety data for the vaccine and watchfullness for severe and persistent adverse effects for females and those with history of allergy.