Gam-COVID-19 is claiming to the first COVID-19 Vaccine even having no scientific data about its safety or efficacy by Russia. Russia had recently published the clinical trials data in medical journal The Lancet. The publication gives details of Gam-COVID-19 as follows
- It is developed by Moscow’s Gamaleya Institute
- It is an adenovirus based vaccine
- Trials of Gam-COVID-19 NCTO4436471 and NCTO4437875 were conducted in June of this year
- Sample size was 76 healthy individuals of 18-60 years
- Both trials were non randomized of 42 days
The results of the trial were successful in
- Producing humoral and cellular immune response to SARS-COV-2
- Significantly higher antibody titres
- 100% development of antibodies in all the samples.
Since the trials were done on healthy individuals, the scientific community raised concerns about the trials.
Oxford university vaccine ChAdOx1 is currently in phase-I / II and III trials and also demonstrated that adenovirus based vaccines do not produce any major side effects in humans.
The potential flaws in Russian data are
- The trial design with 76 subjects upto 60 years age is a critical aspect as clinically very elderly people have worse condition when infected.
- Phase-I/II trials tests lack safety and efficacy of the vaccine on this very elderly age group which is an important and required concern for a vaccine.
- For regulatory approval, the Phase-I/II study is not even near to the widely recognized standard approval.
- Rare safety issues cannot be detected as the study was not randomized.
