Russia to Release COVID-19 Vaccine for Civilian Use
The preliminary trials have shown that the coronavirus vaccine developed by Russia appears to be safe and able to induce an immune response against SARS-CoV-2.
Despite the serious international concern, the vaccine named Sputnik V would enter mass production this month. The vaccine caused no major adverse effects on the volunteers so far and induced an immune response in them. The journal Lancet published the results on Friday.
The findings are encouraging not big enough to prove the vaccine is safe and effective, said the experts involved in the study.
The vaccine received regulatory approval in August, making it the world’s first COVID-19 vaccine to be cleared for use. Since the vaccine has not yet been tested in Phase 3 clinical trials, experts condemned Russia’s move as reckless, unethical, and foolish.
The Phase 3 clinical trials of the vaccine developed at the Moscow’s Gamaleya Research Institute started this week, participating 40,000 volunteers. Meanwhile, Russia’s top officials announced that the COVID-19 vaccine would be available for civilian use early this week.
The preliminary study that says the vaccine safe and effective involved phase 1 and phase 2 trials, where 76 volunteers were tested with a frozen formulation and freeze-dried version. Within 21 days, the vaccine-induced an immune response in the participants and showed no adverse effects over 42 days. The vaccine also seems to trigger T-cell response, which could provide long term protection against the virus.
Researchers are hoping to begin the next level examination and to obtain permission for civilian use in a few days. The vaccine must pass the medical watchdog Roszdravnadzor’s quality check to be ready for civilian use. They are hoping to release the first batch of vaccine for civilian use between September 10 and 13. The Russian Health Ministry will critically observe the distribution of the vaccine.
Several vaccines are being developed around the world against COVID-19. The one developed by Oxford University researchers is at the forefront of the race. It had shown strong immune responses in phase 1 and 2 trials, according to the study published in July.
The clinical trials of the Russian vaccine were not randomized and were open-label, meaning participants were aware that they were receiving vaccines. Volunteers aged between 18 and 60 isolated themselves in the hospital after they registered for the trial and remained there for 28 days post-vaccination. The design and size of phase 1 and 2 trials were not enough as per the widely recognized standards of approval.
However, since Russia is planning to release the COVID-19 vaccine for civilian use soon, it will be prioritized for high-risk groups to protect the people fighting the COVID-19 outbreak battle severely.