EpiVacCorona / State Research Center of Virology and Biotechnology Vector - LARVOL DELTA

Vaccination and Therapeutics. (PubMed, Adv Exp Med Biol) - "In the wake of the novel Coronavirus, it has become imperative to develop vaccines that can alert our immune system to the virus, hence reducing the severity of disease if exposed to it...Despite this, hesitancy toward taking these vaccines is still present among certain groups in society due to various factors. Special emphasis has been placed on studies concerning pregnant women, children, elderly people, and immunocompromised individuals where efficacy and safety were proven."

Journal • Review • Infectious Disease • Novel Coronavirus Disease

Study of the Safety, Reactogenicity and Immunogenicity of "EpiVacCorona" Vaccine for the Prevention of COVID-19 (clinicaltrials.gov) - P1/2 | N=100 | Completed | Sponsor: Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" | Active, not recruiting ➔ Completed | Trial completion date: May 2021 ➔ Dec 2021 | Trial primary completion date: May 2021 ➔ Dec 2021

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Study of the Tolerability, Safety, Immunogenicity and Preventive Efficacy of the EpiVacCorona Vaccine for the Prevention of COVID-19 (clinicaltrials.gov) - P3 | N=3000 | Completed | Sponsor: Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" | Active, not recruiting ➔ Completed | Trial completion date: Sep 2021 ➔ Dec 2021

Trial completion • Trial completion date • Infectious Disease • Novel Coronavirus Disease

Study of the EpiVacCorona Vaccine With the Involvement of Volunteers Aged 60 Years and Above (clinicaltrials.gov) - P3; N=150; Completed; Sponsor: Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"

Clinical • New P3 trial • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8 • IFNG • IL2

Study of the Tolerability, Safety, Immunogenicity and Preventive Efficacy of the EpiVacCorona Vaccine for the Prevention of COVID-19 (clinicaltrials.gov) - P3; N=3000; Active, not recruiting; Sponsor: Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"

Clinical • New P3 trial • Infectious Disease • Novel Coronavirus Disease

Study of the Safety, Reactogenicity and Immunogenicity of "EpiVacCorona" Vaccine for the Prevention of COVID-19 (clinicaltrials.gov) - P1/2; N=100; Active, not recruiting; Sponsor: Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"; Trial completion date: Oct 2020 ➔ May 2021; Trial primary completion date: Sep 2020 ➔ May 2021

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Russia’s second vaccine ’100% effective’, watchdog tells media (Reuters) - P1/2; N=100; NCT04527575; "A candidate COVID-19 vaccine known as EpiVacCorona, Russia’s second to be registered, proved '100% effective' in early-stage trials...The data, based on Phase I and II trials, were released before the start of a larger Phase III trial which would normally involve thousands of participants and a placebo group as a comparison....The Phase I and II studies tested the safety, side-effects and immunogenicity of the potential vaccine in 100 people aged 18-60...Moscow said its other approved vaccine, Sputnik V, was 92% effective...Russian President Vladimir Putin has ordered mass vaccinations to start this week. EpiVacCorona will be used in mass vaccinations from March..."

Commercial • P1/2 data • Infectious Disease • Novel Coronavirus Disease

Russia approves second Covid-19 vaccine, says Vladimir Putin (Deccan Herald) - "Russia has granted regulatory approval to a second Covid-19 vaccine, a delighted President Vladimir Putin announced at a government meeting....Putin congratulated scientists for approving the new jab, which was developed by Siberia's Vector Institute and completed early-stage human trials last month. 'We need to increase production of the first and second vaccine,' he said in comments broadcast on state TV."

Non-US regulatory • Infectious Disease • Novel Coronavirus Disease

30,000 volunteers to take part in Vector’s post-registration trials of COVID-19 vaccine (TASS) - "Nearly 30,000 volunteers will take part in post-registration trials of the coronavirus vaccine developed by Russia's Vector State Research Center....'After the vaccine’s registration the centers of carrying out post-registration trials will be selected, and 30,000 volunteers will take part in them'....Medical institutions will receive the vaccine once its mass production is launched....Post-registration trials of the vaccine would begin in November-December 2020 after the first series of the medication are received....The vaccine’s registration procedure is due to be over by October 15."

Enrollment status • Infectious Disease • Novel Coronavirus Disease

Russia to begin Phase III trials of second COVID-19 vaccine in Nov-Dec - TASS (Reuters) - "Russia will begin Phase III trials of a second potential vaccine against COVID-19, developed by Siberia’s Vector Institute, in November-December, the TASS news agency cited Russian consumer safety watchdog Rospotrebnadzor as saying on Friday."

New P3 trial • Infectious Disease • Novel Coronavirus Disease

Russia completes clinical trials of second potential COVID-19 vaccine - RIA (Reuters) - "Russia has completed clinical trials of a second potential vaccine against COVID-19, developed by Siberia’s Vector Institute, the RIA news agency cited Russian consumer safety watchdog Rospotrebnadzor as saying on Wednesday. The institute completed early-stage human trials, known as Phase II, earlier this month."

Trial completion • Infectious Disease • Novel Coronavirus Disease

Study of the Safety, Reactogenicity and Immunogenicity of “EpiVacCorona“ Vaccine for the Prevention of COVID-19 (clinicaltrials.gov) - P1/2; N=100; Active, not recruiting; Sponsor: Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"

New P1/2 trial • Infectious Disease • Novel Coronavirus Disease

Russia readies for approval of second COVID-19 vaccine: official (Reuters) - "Russia is preparing to approve a second vaccine against COVID-19 in late September or early October....Early-stage clinical trials on the vaccine, developed by the Vector virology institute in Siberia, would be completed by the end of September. 'As of today there have been no complications among those vaccinated in the first and second stages of testing...'"

Non-US regulatory • Trial completion date • Trial initiation date • Infectious Disease • Novel Coronavirus Disease

Russia to register second COVID-19 vaccine by Oct. 15 -TASS (The Economic Times) - "Russia expects to register a second potential vaccine against COVID-19 by Oct. 15....The vaccine has been developed by Siberia's Vector Institute, which completed early-stage human trials of the vaccine last week."

Non-US regulatory • Infectious Disease • Novel Coronavirus Disease

Russia Completes Early Trials Of Second Potential COVID-19 Vaccine - Ifax (National Post) - P2, N=100; "Siberia’s Vector virology institute on Tuesday completed early-stage human trials, known as Phase II, of a second potential Russian vaccine against COVID-19....'Today… the final group of 20 volunteers was released from hospital'....'All 100 volunteers were vaccinated with two doses and have completed a 23-day monitoring period in hospital. The volunteers are feeling good.'"

P2 data • Trial completion date • Infectious Disease • Novel Coronavirus Disease

Newly added product (Deccan Herald) - Preclinical, Novel Coronavirus Disease

Pipeline update