Public Health Emergency of International Concern (PHEIC)
WHO – Situation report – 166
Coronavirus disease 2019 (COVID-19)
4 July 2020
Confirmed cases :: 10 922 324
Confirmed deaths :: 523 011
Countries, areas or territories with cases :: 216
:: WHO is providing support to bridge a shortfall in oxygen supplies in Iraq. To counter severe shortages, WHO has airlifted 300 oxygen concentrators from WHO’s warehouses in the United Arab Emirates.
:: As African countries begin to reopen borders and air spaces, it is crucial that governments take effective measures to mitigate the risk of a surge in infections.
:: The UN Secretary-General, Mr António Guterres in his remarks to the Security Council on the Maintenance of International Peace and Security warned that the COVID-19 pandemic has been affecting peace and security around the world. He stated that “Collective security and our shared well-being are under assault on many fronts led by a relentless disease and abetted by global fragilities.”
:: In Yemen, healthcare workers face a double battle – COVID-19 in a conflict zone. WHO chronicles the work of Dr Sami Al Hajj, a young doctor working at the Science and Technology Hospital in Sana.
Pfizer and BioNTech Announce Early Positive Data from an Ongoing Phase 1/2 study of mRNA-based Vaccine Candidate Against SARS-CoV-2
In an ongoing U.S. Phase 1/2 placebo-controlled, observer-blinded clinical trial, nucleoside-modified messenger RNA vaccine candidate (BNT162b1) expressing the SARS-CoV-2 receptor binding domain (RBD) is being evaluated in 45 subjects
At day 28 (7 days after dose 2), all subjects who received 10 or 30 mg of BNT162b1 had significantly elevated RBD-binding IgG antibodies with geometric mean concentrations (GMCs) of 4,813 and 27,872 units/ml which are 8- and 46.3-times, respectively, the GMC of 602 units/ml in a panel of 38 sera of convalescent patients who had contracted SARS-CoV-2
At day 28 (7 days after dose 2), all subjects who received 10 or 30 mg of BNT162b1 had SARS-CoV-2 neutralizing antibodies with geometric mean titers (GMTs) of 168 and 267, which are 1.8- and 2.8-times, respectively, the GMT of the convalescent serum panel
Local reactions and systemic events after immunization with 10 µg and 30 µg of BNT162b1 were dose-dependent, generally mild to moderate, and transient. No serious adverse events were reported
Further data from the ongoing Phase 1/2 clinical trial of four vaccine candidates will enable selection of a lead candidate and dose level for a large, global Phase 2b/3 safety and efficacy study that may begin as early as July 2020
Efforts to manufacture the leading candidates, at risk, are gearing up. In case the safety and efficacy study is successful, and the vaccine receives regulatory approval, the companies are expecting to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021
July 01, 2020 08:59 AM Eastern Daylight Time
NEW YORK & MAINZ, Germany–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced preliminary data from the most advanced of four investigational vaccine candidates from their BNT162 mRNA-based vaccine program, Project Lightspeed, against SARS-CoV-2, the virus causing the current global pandemic. The BNT162 program is evaluating at least four experimental vaccines, each of which represents a unique combination of mRNA format and target antigen. The manuscript describing the preliminary clinical data for the nucleoside-modified messenger RNA (modRNA) candidate, BNT162b1, which encodes an optimized SARS-CoV-2 receptor binding domain (RBD) antigen, is available on an online preprint server at https://www.medrxiv.org/content/10.1101/2020.06.30.20142570v1 and is concurrently undergoing scientific peer-review for potential publication. Overall, the preliminary data demonstrated that BNT162b1 could be administered in a dose that was well tolerated and generated dose dependent immunogenicity, as measured by RBD-binding IgG concentrations and SARS-CoV-2 neutralizing antibody titers.
“We are encouraged by the clinical data of BNT162b1, one of four mRNA constructs we are evaluating clinically, and for which we have positive, preliminary, topline findings”
“We are encouraged by the clinical data of BNT162b1, one of four mRNA constructs we are evaluating clinically, and for which we have positive, preliminary, topline findings,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We are dedicated to develop potentially groundbreaking vaccines and medicines, and in the face of this global health crisis, we approach this goal with the utmost urgency. We look forward to publishing our clinical data in a peer-reviewed journal as quickly as possible.”…