Featured Journal Content
COVID-19 Vaccines – Development Status/Scorecard
IVI [to 12 Sep 2020]
Selected IVI News & Announcements
IVI to ready clinical trial sites for COVID-19 vaccine efficacy trials in 4 countries
September 9, 2020 – SEOUL, South Korea – The International Vaccine Institute (IVI) announced today that the Bill & Melinda Gates Foundation awarded close to 1.5 million USD to IVI to support clinical trial site preparedness in four African and Asian countries to potentially support future COVID-19 Phase III efficacy vaccine trials.
Following successful completion of early-stage clinical trials of COVID-19 vaccine candidates, it will be essential to transition to efficacy trials at different sites around the world with high disease burden, including those in resource-limited settings. To ensure these sites are prepared for efficacy trials with the necessary technical capability, trained staff, sufficient trial participants, and a thorough assessment of prevailing COVID-19 burden, IVI aims to bolster in-country capacity at select sites by 4Q2020.
Dr Florian Marks, Deputy Director General of Epidemiology, Public Health, Impact, and Clinical Development at IVI, said: “The COVID-19 threat is worldwide, which means preparations for the development and delivery of safe and effective vaccines must also be a global project. It is imperative that lack of resources does not equate to exclusion, that COVID-19 vaccines be regarded as global public goods from the outset, and that equal access is ensured. We look forward to working with our long-time partners in Africa and Asia to accelerate the global push toward a COVID-19 vaccine solution.”
IVI currently conducts active projects in Africa and Asia, including disease prevention and surveillance for cholera and typhoid in Mozambique and Ghana, respectively, as well as a Phase III clinical trial for a novel typhoid conjugate vaccine in thePhilippines. IVI also received funding from the Swedish International Development Cooperation Agency (Sida) this May to strengthen COVID-19 surveillance in Madagascar and Burkina Faso.
Selected Developer Announcements
COVID-19 vaccine AZD1222 clinical trials resumed in the UK
12 September 2020 14:20 BST
Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so.
On 6 September, the standard review process triggered a voluntary pause to vaccination across all global trials to allow review of safety data by independent committees, and international regulators. The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume.
AstraZeneca and the University of Oxford, as the trial sponsor, cannot disclose further medical information. All trial investigators and participants will be updated with the relevant information and this will be disclosed on global clinical registries, according to the clinical trial and regulatory standards…
Pfizer and BioNTech Propose Expansion of Pivotal COVID-19 Vaccine Trial
September 12, 2020
NEW YORK & MAINZ, Germany–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) announced today that they have submitted an amended protocol to the U.S. Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations…
Pfizer and BioNTech to Potentially Supply the EU with 200 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2
:: The proposed agreement is intended to provide a supply of 200 million doses and an option to purchase additional 100 million doses, with deliveries starting by the end of 2020, subject to regulatory approval
:: The vaccine supply for the EU would be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium
:: Pfizer and BioNTech are on track to seek regulatory review of BNT162b2 as early as October 2020 and, if regulatory authorization or approval is obtained, currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021
September 09, 2020
Sinovac Reports Preliminary Phase I/II Results of COVID-19 Vaccine in Elderly Volunteers
September 09, 2020
BEIJING–(BUSINESS WIRE)–Sinovac Biotech Ltd. (NASDAQ: SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, announced that the inactivated COVID-19 vaccine candidate developed by Sinovac Life Sciences (Sinovac LS), or “CoronaVac,” shows good safety and immunogenicity on healthy adults aged 60 and above from its phase I/II clinical studies conducted in China, which is comparable to the result in healthy adults aged from 18 to 59 in the earlier studies.
The phase I/II clinical trial on elderly volunteers were randomized, double-blinded and placebo controlled trials with two-dose immunization scheduled at 28 day intervals…