No vaccination site redness among ZyCoV-D trial participants in Pune

PUNE: Some of the common side-effects of the Covid vaccine — redness or soreness at the site of

vaccination

and low-grade fever/fatigue within 24 to 48 hours post-immunization — were not observed in the advanced trials of ZyCoV-D vaccine among adolescents in Pune.

None of the 47 adolescents receiving the three-dose needle-free intra-dermal vaccine at

Dr D Y Patil Medical College and Hospital

as a part of the countrywide trials complained of these commonly seen side-effects, trial researchers told TOI ahead of the ZyCoV-D’s nationwide rollout this month.

Dr D Y Patil Medical College and Hospital, and Bharati Medical College and Hospital in Pune were among the 50 trial sites in India where a total of 1,600 adolescents in the 12-17 years age bracket had participated.

While Bharati Medical College and Hospital carried out the trial in eight adolescents from Pune, Dr D Y Patil Medical College and Hospital carried it out in 47 adolescents mainly residing in Baner, Balewadi, Vimannagar, Wadgaonsheri, Pimpri, Chinchwad, Nigadi and rural parts of Pune.

The ZyCoV-D vaccine, manufactured by Ahmedabad-based Zydus Cadila, is the first vaccine in the country that has received emergency use authorization (EUA) for being administered to people aged 12 years and above.

Zydus Cadila, in association with the Nashik-based HCG Manavata Cancer Centre, also performed clinical trials of the vaccine on 300 adolescents in the 12-17 years age group in Nashik city. A company official said the trials were successful and there had been no reports of adverse effects.

D Y Patil Medical College and Hospital’s trial research consultant Shalaka Agarkhedkar said, “Typically, a small amount of pain or redness is expected with an intramuscular (IM) vaccine having a needle. But this common vaccination site complaint was not at all reported even by a single adolescent trial participant at our trial site in Pune. ZyCoV-D is a needle-free vaccine given just below the skin and not deep into the muscles with a specially designed jet injector. Few adolescents reported only a slight pinching sensation while receiving the shot.”

A subcutaneous shot is one into the fatty tissues just beneath the skin. These injections are shallower than those injected into muscle tissues.

As for ZyCoV-D, the needle-free intradermal vaccine is a shallow or superficial injection into the dermis, located between the epidermis and the hypodermis. This route was relatively rare compared to injections into the subcutaneous tissue or muscle, resulting in zero pain or redness/soreness at the site of the injection, Agarkhedkar said.

Besides, none of the adolescents in Pune complained of fever, fatigue or any other flu-like symptoms hours or days after receiving the ZyCoV-D shot.

“Some of the commonly seen side-effects post-vaccination like fever, fatigue and other flu-like symptoms were not at all observed in the trial adolescents who received three doses of ZyCoV-D 28 days apart,” Agarkhedkar said.

The trial enrolment of adolescents began in early March and the last trial participant received the last (third) dose on September 23 this year. The adolescents are from different socio-economic strata. Some of the families have an annual income of Rs2 lakh and a few have an annual income of Rs 70 lakh. The trial researchers reached out to these families through the trial participants and hospital’s patients’ database.


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