Russian researchers have published first report on their Covid-19 vaccine in the medical journal The Lancet.
The report says that early tests were found to show signs of an immune response. None of the Covid patients showed any serious side effects, the report, published in the journal, said.
NEW—Preliminary results from Russian trials find that #COVID19 vaccine candidates led to no serious adverse events and elicit antibody response https://t.co/jGUwQa8oNd
Thread (1/8) pic.twitter.com/NWBpWDvUK3
— The Lancet (@TheLancet) September 4, 2020
In August, Russia became the first country to license the coronavirus vaccine for public use. The move to approve Sputnik V for public use by the Russian authority was criticised by the health experts because Russia had gone ahead with its Covid vaccine plan without publishing any data about the safety and effectiveness of its vaccine.
Results from early-phase non-randomised vaccine trials in a total of 76 people show that two formulations of the vaccine have a good safety profile detected over 42 days, and induce antibody responses in all participants within 21 days.
The new paper reports the findings of two open-label, non-randomised phase 1/2 trials looking at a frozen formulation and a freeze-dried formulation of a two-part #COVID19 vaccine (2/8) pic.twitter.com/fcYqgpjfsl
— The Lancet (@TheLancet) September 4, 2020
The scientists designed a COVID-19 vaccine with two different adenoviral vectors (recombinant Ad26 [rAd26] and recombinant Ad5 [rAd5]), both carrying the gene for SARS-CoV-2 spike glycoprotein (rAd26-S and rAd5-S), and implemented a prime-boost regimen.
The trials were open label and not randomised. No placebo was involved in the trial. All volunteers who participate in the trial knew that they were receiving the vaccine shot.
“Large, long-term trials including a placebo comparison, and further monitoring are needed to establish the long-term safety and effectiveness of the vaccine for preventing Covid-19 infection,” the report said.
“When adenovirus vaccines enter people’s cells, they deliver the SARS-CoV-2 spike protein genetic code, which causes cells to produce the spike protein,” said study lead author Denis Logunov, from Gamaleya National Research Centre for Epidemiology and Microbiology, Russia.
“This helps teach the immune system to recognise and attack the SARS-CoV-2 virus. To form a powerful immune response against SARS-CoV-2, it is important that a booster vaccination is provided,” Logunov said.
Interpretation
The heterologous rAd26 and rAd5 vector-based COVID-19 vaccine has a good safety profile and induced strong humoral and cellular immune responses in participants. Further investigation is needed of the effectiveness of this vaccine for prevention of COVID-19.
Meanwhil, Kirill Dmitriev, CEO, Russian Direct Investment Fund said yesterday, “We are having close dialogue with corresponding ministries and Indian government and its leading manufactures regarding localisation of production of Sputnik V vaccine”.