Milestones :: Perspectives :: Research
COVID-19 Vaccines – Development/Distribution
Johnson & Johnson and U.S. Department of Health & Human Services Expand Agreement to Support Next Phase of COVID-19 Vaccine Candidate Research and Development
NEW BRUNSWICK, N.J., Nov. 14, 2020 /PRNewswire/ — Johnson & Johnson (the Company) announced the expansion to the partnership between its Janssen Pharmaceutical Companies (Janssen) and the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services for the ongoing development of Janssen’s investigational COVID-19 vaccine candidate.
Under the amendment, Janssen will commit approximately $604 million and BARDA will commit approximately $454 million to support the ongoing Phase 3 ENSEMBLE trial evaluating Janssen’s investigational COVID-19 vaccine candidate as a single-dose in up to 60,000 volunteers worldwide…
Moderna Has Completed Case Accrual for First Planned Interim Analysis of its mRNA Vaccine Against COVID-19 (mRNA-1273)
Acceleration in rate of COVID-19 disease across trial sites; Company expects more than 53 cases will be submitted to Data Safety Monitoring Board for the first interim analysis
November 11, 2020
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that it has completed case accrual for the first interim analysis of the Phase 3 COVE study of mRNA-1273, its COVID-19 vaccine candidate.
Moderna has seen a significant increase in the rate of case identification across sites in the last week. As a result, the Company expects the first interim analysis will include substantially more than 53 cases, the targeted trigger point for the analysis. The data on these cases is being prepared for submission to the independent Data Safety Monitoring Board (DSMB) for analysis and recommendation. Moderna remains blinded to whether these participants received vaccine or placebo…
The First Interim Data Analysis of the Sputnik V Vaccine Against COVID-19 Phase III Clinical Trials in the Russian Federation Demonstrated 92% Efficacy
November 11, 2020
:: The Sputnik V vaccine efficacy amounted to 92% (calculation based on the 20 confirmed COVID-19 cases split between vaccinated individuals and those who received the placebo). Currently 40,000 volunteers are taking part in double-blind, randomized, placebo-controlled Phase III of Sputnik V clinical trials, out of which over 20,000 have been vaccinated with the first dose of the vaccine and more than 16,000 with both the first and second doses of the vaccine.
:: Efficacy was demonstrated on the basis of a first interim analysis obtained 21 days after the first injection.
:: There were no unexpected adverse events during the trials. Monitoring of the participants is ongoing.
:: The world’s first registration of COVID-19 vaccine, done in Russia on the 11th of August under the emergency use authorization mechanism, enables the Russian Federation to administer the vaccine outside of the clinical trials to volunteers such as medics and other high-risk groups. Trials conducted under the civil use of the vaccine in Russia (not being a part of clinical trials) based on the monitoring of additional 10,000 vaccinated confirmed vaccine efficacy at a rate of over 90%.
:: The interim research data will be published by the Gamaleya Center team in one of the leading international peer-reviewed medical journals. Following the completion of Phase III clinical trials of the Sputnik V vaccine, Gamaleya Center will provide access to the full clinical trial report.
:: Currently Sputnik V Phase III clinical trials are approved and are undergoing in Belarus, UAE, Venezuela and other countries, as well as Phase II-III – in India.
:: The Sputnik V vaccine is based on a well-studied human adenoviral vector platform that had proven safe and effective with no long-term side effects in more than 250 clinical trials globally conducted during the past two decades (while the history of use of human adenoviruses in vaccine development started in 1953). More than 100,000 people have received approved and registered drugs based on the human adenoviral vectors.
:: The uniqueness of the Russian vaccine is in using two different human adenoviral vectors that enable to provide strong and long-term immune response after the second injection.
Pfizer and BioNTech Reach an Agreement to Supply the EU With 200 Million Doses of Their BNT162b2 mRNA-Based Vaccine Candidate Against SARS-CoV-2
November 11, 2020
:: Agreement provides a supply of 200 million doses and an option to request additional 100 million doses, with deliveries anticipated to start by the end of 2020, subject to regulatory approval
:: The vaccine supply for the EU will be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium and based on current projections, the companies expect to produce globally up to 1.3 billion doses in 2021
:: Pfizer and BioNTech initiated a rolling submission to the European Medicines Agency (EMA) in October, and will continue regular and open dialogue with the EMA providing results from their ongoing Phase 3 study
Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study
November 09, 2020
:: Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
:: Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected
:: Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November
:: Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints