Russia Announces WORLD’S FIRST COVID-19 Vaccine!
Posted by Warm Southern Breeze on Friday, September 4, 2020
Well… they did it!
Russian coronavirus vaccine – A coronavirus vaccine developed in Russia shows safety, nad causes an antibody response in small human trials, according to research published in Lancet Friday, September 4, 2020.
Sputnik V has won!
So much for Trump’s “Operation Warp Speed.”
Russia has just handed Trump’s hat to him.
Twice.
They have developed TWO different versions of the vaccine.
Here are pertinent excerpts from the research published in The Lancet, the world’s leading, and among the oldest, scientific and medical journal.
“We developed a heterologous COVID-19 vaccine consisting of two components, a recombinant adenovirus type 26 (rAd26) vector and a recombinant adenovirus type 5 (rAd5) vector, both carrying the gene for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike glycoprotein (rAd26-S and rAd5-S). We aimed to assess the safety and immunogenicity of two formulations (frozen and lyophilised) of this vaccine.”
Note the first two words – “We developed.”
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31866-3/fulltext#seccestitle10
“In conclusion, these data collectively show that the heterologous vaccine based on rAd26-S and rAd5-S is safe, well tolerated, and does not cause serious adverse events in healthy adult volunteers. The vaccine is highly immunogenic and induces strong humoral and cellular immune responses in 100% of healthy adult volunteers, with antibody titres in vaccinated participants higher than those in convalescent plasma. Unprecedented measures have been taken to develop a COVID-19 vaccine in Russia. Based on our own experience in developing vaccines against Ebola virus disease and MERS, the COVID-19 vaccine has been developed in a short time. Preclinical and clinical studies have been done, which has made it possible to provisionally approve the vaccine under the current Decree of the Government of the Russian Federation of April 3, 2020, no 441 on Aug 11, 2020 (registration no LP-006395 [Gam-COVID-Vac]) and on Aug 26, 2020 (registration no LP-006423 [Gam-COVID-Vac-Lyo]).”
Summary Background
We developed a heterologous COVID-19 vaccine consisting of two components, a recombinant adenovirus type 26 (rAd26) vector and a recombinant adenovirus type 5 (rAd5) vector, both carrying the gene for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike glycoprotein (rAd26-S and rAd5-S). We aimed to assess the safety and immunogenicity of two formulations (frozen and lyophilised) of this vaccine.Methods
We did two open, non-randomised phase 1/2 studies at two hospitals in Russia. We enrolled healthy adult volunteers (men and women) aged 18–60 years to both studies. In phase 1 of each study, we administered intramuscularly on day 0 either one dose of rAd26-S or one dose of rAd5-S and assessed the safety of the two components for 28 days. In phase 2 of the study, which began no earlier than 5 days after phase 1 vaccination, we administered intramuscularly a prime-boost vaccination, with rAd26-S given on day 0 and rAd5-S on day 21. Primary outcome measures were antigen-specific humoral immunity (SARS-CoV-2-specific antibodies measured by ELISA on days 0, 14, 21, 28, and 42) and safety (number of participants with adverse events monitored throughout the study). Secondary outcome measures were antigen-specific cellular immunity (T-cell responses and interferon-γ concentration) and change in neutralising antibodies (detected with a SARS-CoV-2 neutralisation assay). These trials are registered with ClinicalTrials.gov, NCT04436471 and NCT04437875.Findings
Between June 18 and Aug 3, 2020, we enrolled 76 participants to the two studies (38 in each study). In each study, nine volunteers received rAd26-S in phase 1, nine received rAd5-S in phase 1, and 20 received rAd26-S and rAd5-S in phase 2. Both vaccine formulations were safe and well tolerated. The most common adverse events were pain at injection site (44 [58%]), hyperthermia (38 [50%]), headache (32 [42%]), asthenia (21 [28%]), and muscle and joint pain (18 [24%]). Most adverse events were mild and no serious adverse events were detected. All participants produced antibodies to SARS-CoV-2 glycoprotein. At day 42, receptor binding domain-specific IgG titres were 14703 with the frozen formulation and 11143 with the lyophilised formulation, and neutralising antibodies were 49·25 with the frozen formulation and 45·95 with the lyophilised formulation, with a seroconversion rate of 100%. Cell-mediated responses were detected in all participants at day 28, with median cell proliferation of 2·5% CD4+ and 1·3% CD8+with the frozen formulation, and a median cell proliferation of 1·3% CD4+ and 1·1% CD8+ with the lyophilised formulation.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.
Russian vaccine trials show strong immune response: The Lancet
The two-part vaccine includes two adenovirus vectors – recombinant human adenovirus type 26 (rAd26-S) and recombinant human adenovirus type 5 (rAd5-S) – which have been modified to express the SARS-CoV-2 spike protein.
Results from two early-phase Russian non-randomised vaccine trials (Sputnik V) released on Friday show that two formulations of a two-part vaccine have a good safety profile with no serious adverse events over 42 days, and induce antibody responses within 21 days.
The two-part vaccine includes two adenovirus vectors – recombinant human adenovirus type 26 (rAd26-S) and recombinant human adenovirus type 5 (rAd5-S) – which have been modified to express the SARS-CoV-2 spike protein, medical journal The Lancet reported.
SARS-CoV-2 causes Covid-19.
These types of recombinant adenovirus vectors have been used for a long time, with safety confirmed in many clinical studies. Currently, several candidate Covid-19 vaccines using these vectors and targeting the SARS-CoV-2 spike protein have been tested in clinical trials.
These include an adenovirus type 5 vector-based vaccine (CanSino Biological/Beijing Institute of Biotechnology, China), an adenovirus type 26 vector-based vaccine (Johnson & Johnson, USA), and a vaccine containing a simian adenoviral vector (AstraZeneca/University of Oxford, UK).
In July, results from the Oxford vaccine trial showed no early safety concerns, inducing strong immune responses in both parts of the immune system.
The journal said secondary outcomes (planned outcome measures that are not as important as the primary outcome measure, but are still of interest in evaluating the effect of an intervention) from the trial suggest the vaccines also produce a T cell (antibody) response within 28 days.
The paper reported the findings from two small phase 1/2 trials lasting 42 days – one studying a frozen formulation of the vaccine, and another involving a lyophilised (freeze-dried) formulation of the vaccine.
The frozen formulation is envisaged for large-scale use using existing global supply chains for vaccines, while the freeze-dried formulation was developed for hard-to-reach regions as it is more stable and can be stored at 2-8 degrees centigrade.
Explaining why they used two adenovirus vectors, lead author Denis Logunov of the N F Gamaleya National Research Centre for Epidemiology and Microbiology, Russia, says: “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”.
“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”.
“However, booster vaccinations that use the same adenovirus vector might not produce an effective response, because the immune system may recognise and attack the vector. This would block the vaccine from entering people’s cells and teaching the body to recognise and attack SARS-CoV-2. For our vaccine, we use two different adenovirus vectors in a bid to avoid the immune system becoming immune to the vector.”
The trials took place in two hospitals in Russia, involving healthy adults aged 18-60 years, who self-isolated as soon as they were registered for the trial and remained in hospital for the first 28 days of the trial (from when they were first vaccinated).
The authors noted that more research is needed to evaluate the vaccine in different populations, including older age groups, individuals with underlying medical conditions, and people in at-risk groups.
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