After Covishield, new study 'finds' side effects in Covaxin recipients

In observational study on Bharat Biotech's Covaxin recipients, about one-third of participants reported adverse events

People in India who took Bharat Biotech’s vaccine against Covid-19 have had adverse side effects, said a news report on Thursday, weeks after Anglo-Swedish drugmaker Astrazeneca admitted the same about its inoculation for the disease.

The Economic Times (ET) reported that nearly a third of the participants of an observational study on the side-effects of Bharat Biotech's Covaxin vaccine reported adverse events of special interest (AESI). The business newspaper cited a report on SpringerLink, an integrated platform for journals and other materials published by international publisher Springer.

Researchers found that female adolescents and those with a history of allergy are at a higher risk of AESI after receiving Covaxin, ET reported.

Covaxin ‘side effects’

Among the 1,024 individuals enrolled, 635 adolescents and 291 adults were reachable for the one-year follow-up. The study found that 304 adolescents (47.9 per cent) and 124 adults (42.6 per cent) reported viral upper respiratory tract infections.

In adolescents, common AESIs included new-onset skin and subcutaneous disorders (10.5 per cent), general disorders (10.2 per cent), and nervous system disorders (4.7 per cent). In adults, common AESIs were general disorders (8.9 per cent), musculoskeletal disorders (5.8 per cent), and nervous system disorders (5.5 per cent).

Menstrual abnormalities affected 4.6 per cent of female participants, while ocular abnormalities and hypothyroidism were observed in 2.7 per cent and 0.6 per cent of participants, respectively, ET said citing the study.

Serious AESIs (1 per cent) such as stroke and Guillain-Barre Syndrome were identified in 0.3 per cent and 0.1 per cent of participants, respectively. Adolescents, females, and those with a history of allergy and post-vaccination typhoid were at 1.6, 2.8, and 2.8 times higher risk of AESIs, respectively, the business-daily added.

The majority of AESIs persisted at the one-year follow-up, with females, adolescents with pre-vaccination Covid-19, those with comorbidities, and those with post-vaccination typhoid having 1.6, 2, 2.7, and 3.2 times higher odds of persistent AESIs, respectively, ET reported, citing the study.

Adults with comorbidities had more than two times higher odds of AESIs and persistent AESIs. The patterns of adverse events differed between Covaxin and other Covid-19 vaccines, as well as between adolescents and adults.

Given the prolonged persistence of adverse events, researchers recommended extended surveillance of Covid-19-vaccinated individuals to comprehend the course and outcomes of late-onset adverse events.

Focus on safety: Bharat Biotech

In a statement earlier this month, Bharat Biotech said Covaxin is safe and did not have any side effects. The company said Covaxin was developed with a “single-minded focus on safety first”, followed by efficacy.

The vaccine was evaluated in more than 27,000 subjects as part of its licensure process, Bharat Biotech stated. It was licensed under restricted use in clinical trial mode, where detailed safety reporting was carried out for several hundred thousand subjects, it noted, adding that the vaccine was also evaluated by the Union Ministry of Health.

The company’s statement came just days after AstraZeneca admitted in a UK court that its vaccine could in very rare cases cause thrombosis with thrombocytopenia syndrome.

The AstraZeneca vaccine, which was manufactured by the Serum Institute of India, was sold in the country under the name Covishield.