Coronavirus [COVID-19] – PHEIC


Coronavirus [COVID-19]
Public Health Emergency of International Concern (PHEIC)

Editor’s Note:
The most recent COVID-19 Situation Report posted is dated 16 August 2020. These daily reports seem to have been replaced with Weekly Epidemiological Updates, the first issue of which is dated 17 August 2020 as just below.

Weekly Epidemiological Update – 1
Coronavirus disease 2019 (COVID-19)
17 August 2020

Confirmed cases :: 22 812 491 [week ago: 21 026 758]
Confirmed deaths :: 795 132 [week ago: 755 786]

Key weekly updates
:: “There are two essential elements to addressing the pandemic effectively: leaders must step up to take action and citizens need to embrace new measures…My message is crystal clear: suppress, suppress, suppress the virus.”
WHO Director-General Dr Tedros, at his regular media briefing on Monday, 10 August

:: The Access to COVID-19 Tools (ACT) Accelerator, is a global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. Nine vaccine candidates are currently in the portfolio of the vaccines pillar (called COVAX) and going through phase two or phase three trials. This portfolio, already the broadest in the world, is constantly expanding. The ACT-Accelerator is the only up-and-running global initiative that brings together all the global research and development, manufacturing, regulatory, purchasing and procurement needed for all the tools required to end the pandemic.

:: Access to basic handwashing facilities is a key condition for schools to be able to operate safely in the midst of the COVID-19 pandemic. Yet the latest data from the WHO/UNICEF Joint Monitoring Programme (JMP) found that 43% of schools worldwide lacked access to basic handwashing with soap and water in 2019. UNICEF and partners have published a Framework for Reopening schools and guidance on hand hygiene, which compliments Key Messages and Actions for COVID-19 Prevention and Control in Schools and Considerations for school-related public health measures in the context of COVID-19.

:: WHO has published updated guidance on home care for patients with suspected or confirmed COVID-19 and the management of their contacts. The document provides guidance on the issues to be considered when deciding whether or not to provide care for COVID-19 patients at home and offers advice for health workers and caregivers providing that care.

:: WHO has published the Emergency Global Supply Chain System (COVID-19) catalogue, which lists all medical devices, including personal protective equipment, medical equipment, medical consumables, single use devices, laboratory and test-related devices that may be requested through the COVID-19 Supply Portal.


COVID-19 Vaccines – Discovery/Trials

Pfizer and BioNTech Share Positive Early Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19
August 20, 2020
:: In a Phase 1 study in the U.S., at 7 days after a second dose of 30μg, BNT162b2 elicited SARS-CoV-2–neutralizing geometric mean titers (GMTs) in younger adults (18-55 years of age) that were 3.8 times the GMT of a panel of 38 sera of SARS-CoV-2 convalescent patients, and in older adults (65-85 years of age) the vaccine candidate elicited a neutralizing GMT 1.6 times the GMT of the same panel, demonstrating strong immunogenicity in younger and older adults.

:: The companies previously announced that BNT162b2-vaccinated human participants displayed a favorable breadth of epitopes recognized in T cell responses specific to the SARS-CoV-2 spike antigen, and that BNT162b2 demonstrated concurrent induction of high magnitude CD4+ and CD8+ T cell responses against the receptor binding domain (RBD) and against the remainder of the spike glycoprotein

:: Across all populations, BNT162b2 administration was well tolerated with mild to moderate fever in fewer than 20% of the participants

:: These results informed the selection of the BNT162b2 candidate for the pivotal Phase 2/3 global study in up to 30,000 participants that started in July 2020, which has to date enrolled more than 11,000 participants, including in areas with significant SARS-CoV-2 transmission

:: Assuming clinical success, 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

…The totality of the clinical and preclinical data informed Pfizer and BioNTech’s decision to select BNT162b2 as the lead candidate to advance into pivotal trials. We are proud to share our findings with the scientific community as we continue our work to deliver a safe and effective vaccine to combat this devastating virus,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We are especially pleased to offer these early data showing our vaccine candidate’s promising safety and immunogenicity profile from the U.S. trial and we look forward to sharing T cell immune response data from the German trial in the near future.”

“It is important to us to continue sharing data and related information on our COVID-19 vaccine lead candidate,” said Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “The favorable safety profile of BNT162b2 and the breadth of T cell responses we previously announced have supported our decision to select this candidate for the pivotal Phase 2/3 study. As of today, we have already dosed more than 11,000 participants with BNT162b2 in that study.”…