Why COVID vaccine safety needs scrutiny

Sub: Science and tech

Sec: Health

Context:

The Indian Council for Medical Research (ICMR) issued a letter to the researchers of Banaras Hindu University last week, countering their study on the side effects of India’s indigenous vaccine for COVID — Covaxin.

What did the BHU study conclude?

Adolescent girls and those with comorbidities were at a higher risk of adverse events after receiving Bharat Biotech’s BBV152 (Covaxin) vaccine against COVID-19.
A third of the participants reported adverse events of special interest (AESI).
Findings from a one-year prospective study in North India’, also said that serious adverse events occurred in 1% of BBV152 recipients, and that extended surveillance is warranted following the vaccine administration.
Viral upper respiratory tract infections were reported in 47.9% adolescents and 42.6% adults, as per the study.
Menstrual abnormalities were noticed in 4.6% of female participants.
Ocular abnormalities and hypothyroidism were observed in 2.7% and 0.6% of the participants, respectively.
Among the serious AESIs (1%), stroke and Guillain-Barre syndrome were identified in 0.3% and 0.1% of the participants, respectively.

What is the ICMR stance?

With reference to the study itself, ICMR claimed there were critical flaws:
the study had no control arm of unvaccinated individuals for comparison with the vaccinated group, and therefore,
the reported events in the study cannot be linked or attributed to COVID-19 vaccination;
it did not provide background rates of patterns observed in the general population, and
thereby made it impossible to study the observed events in the post vaccination period.

What was the fallout?

Multiple accounts of doctors and researchers on social media also pointed out that the ICMR developed the vaccine along with the company, and not declaring its vested interest was also a serious lapse in research terms.

About COVAXIN:

COVAXIN is an inactivated vaccine, created from a strain of the infectious SARS-CoV-2 virus, that has shown promise in preclinical studies, demonstrating extensive safety and effective immune responses.
COVAXIN has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech.
It is an inactivated vaccine that is made by using particles of the Covid-19 virus that were killed, making them unable to infect or replicate.
Injecting particular doses of these particles serves to build immunity by helping the body create antibodies against the dead virus.
Bharat Biotech’s track record in developing Vero cell culture platform technologies has been proven in several vaccines for polio, rabies, rotavirus, Japanese Encephalitis, Chikungunya and Zika.