Russian President Vladimir Putin on Tuesday, 11 August, said the country has registered the world's first COVID-19 vaccine manufactured by Moscow's Gamaleya Institute, even as its final stage trials continue.
The candidate vaccine is reportedly named ‘Sputnik V’ after the Soviet-era satellite.
"As far as I know, this morning for the first time in the world, a vaccine against the novel coronavirus infection was registered," Putin was quoted as saying as he opened a meeting with the state officials, reported news agency TASS.
"One of my daughters had this vaccine. I think in this sense she took part in the experiment," he said.
Russia, which is facing international scepticism due to its approach to developing the vaccine, is planning mass vaccination against COVID-19 in October, with the process starting for healthcare workers in August, according to IANS.
Doubts Cast Over Russia’s COVID-19 Vaccine: All You Need to Know
1. Has the Vaccine Completed Testing?
The registration of the world’s first vaccine comes after less than two months of human testing. Even though Putin claimed that the vaccine underwent the ‘necessary tests’ and was safe, the final stage of clinical trials to assess its safety and efficacy haven’t been completed, reported Reuters.
“I know that it works quite effectively, it forms a stable immunity,” he said.
For a vaccine to get approved for use, it is usually tested on thousands of volunteers for its safety and efficacy – a step that spans over months.
The Russian vaccine is yet to undergo these phase 3 trials, which involve following up on the participants to check how many of them get infected over a period of time.
Phase 3 tests are considered important precursors for administering a vaccine to the masses, considering their large sample size and long-term implications for safety and efficiency. FIT had earlier explained the risks associated with skipping this stage here.
On Monday, 10 August, the Association of Clinical Trials Organisations (ACTO) industry body that represents organisations conducting multi-national clinical trials, had urged for more tests before its registration, The Moscow Times reported.
Expand2. Results from Early Clinical Trials
Russia has not published any findings from its vaccine trials.
Clinical trials of the vaccine began on 18 June with 38 volunteers who developed immunity. Another trial was started on 20 July. The trials were conducted at 7 sites across the country.
Both females and males aged between 18 and 65 years were part of the trial, some of whom experienced headaches and an ‘elevated body temperature’ after getting the vaccine. However, these symptoms were resolved within 24 hours and they are all now in ‘good health’, the researchers said.
These initial trials are conducted to test the safety and the optimum dosage of the vaccine, and are followed by large-scale final trials to ascertain effectivity as well as any long-term adverse effects.
Expand3. International Skepticism
The World Health Organisation (WHO) still lists this candidate as being in Phase 1. WHO Spokesperson Christian Linmeier told reporters that any vaccine should go through ‘all the various trials and tests before being licensed for rollout’, Bloomberg reported.
At a congressional hearing last week, Anthony Fauci, the top US infectious disease specialist, expressed doubts over this approach. “I do hope that the Chinese and the Russians are actually testing a vaccine before they are administering the vaccine to anyone, because claims of having a vaccine ready to distribute before you do testing, I think, is problematic at best,” he was quoted as saying.
Expand4. Vaccine Candidate Type
The Gamaleya vaccine is a viral vector vaccine. These vaccines use a virus to transfer the genes from COVID-19 into healthy cells to provoke an immune response. The Russian one is based on the adenovirus, the common cold.
Oxford University’s much-touted vaccine falls into this category.
It must be noted that vaccine development is a long process involving multiple stages, and a candidate vaccine can fail at any step. Fast-tracking a vaccine and prioritising speed over safety can have enormous consequences on public health and a society’s trust in vaccination.
(The story was first published in FIT and has been republished with permission.)
(At The Quint, we are answerable only to our audience. Play an active role in shaping our journalism by becoming a member. Because the truth is worth it.)
Expand
Has the Vaccine Completed Testing?
The registration of the world’s first vaccine comes after less than two months of human testing. Even though Putin claimed that the vaccine underwent the ‘necessary tests’ and was safe, the final stage of clinical trials to assess its safety and efficacy haven’t been completed, reported Reuters.
“I know that it works quite effectively, it forms a stable immunity,” he said.
For a vaccine to get approved for use, it is usually tested on thousands of volunteers for its safety and efficacy – a step that spans over months.
The Russian vaccine is yet to undergo these phase 3 trials, which involve following up on the participants to check how many of them get infected over a period of time.
Phase 3 tests are considered important precursors for administering a vaccine to the masses, considering their large sample size and long-term implications for safety and efficiency. FIT had earlier explained the risks associated with skipping this stage here.
On Monday, 10 August, the Association of Clinical Trials Organisations (ACTO) industry body that represents organisations conducting multi-national clinical trials, had urged for more tests before its registration, The Moscow Times reported.
Results from Early Clinical Trials
Russia has not published any findings from its vaccine trials.
Clinical trials of the vaccine began on 18 June with 38 volunteers who developed immunity. Another trial was started on 20 July. The trials were conducted at 7 sites across the country.
Both females and males aged between 18 and 65 years were part of the trial, some of whom experienced headaches and an ‘elevated body temperature’ after getting the vaccine. However, these symptoms were resolved within 24 hours and they are all now in ‘good health’, the researchers said.
These initial trials are conducted to test the safety and the optimum dosage of the vaccine, and are followed by large-scale final trials to ascertain effectivity as well as any long-term adverse effects.
International Skepticism
The World Health Organisation (WHO) still lists this candidate as being in Phase 1. WHO Spokesperson Christian Linmeier told reporters that any vaccine should go through ‘all the various trials and tests before being licensed for rollout’, Bloomberg reported.
At a congressional hearing last week, Anthony Fauci, the top US infectious disease specialist, expressed doubts over this approach. “I do hope that the Chinese and the Russians are actually testing a vaccine before they are administering the vaccine to anyone, because claims of having a vaccine ready to distribute before you do testing, I think, is problematic at best,” he was quoted as saying.
Vaccine Candidate Type
The Gamaleya vaccine is a viral vector vaccine. These vaccines use a virus to transfer the genes from COVID-19 into healthy cells to provoke an immune response. The Russian one is based on the adenovirus, the common cold.
Oxford University’s much-touted vaccine falls into this category.
It must be noted that vaccine development is a long process involving multiple stages, and a candidate vaccine can fail at any step. Fast-tracking a vaccine and prioritising speed over safety can have enormous consequences on public health and a society’s trust in vaccination.
(The story was first published in FIT and has been republished with permission.)
(At The Quint, we are answerable only to our audience. Play an active role in shaping our journalism by becoming a member. Because the truth is worth it.)