EMERGENCIES – Novel Coronavirus [COVID-19]

EMERGENCIES

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

Situation report – 194
Coronavirus disease 2019 (COVID-19)
1 August 2020

Confirmed cases :: 17 396 943 [week ago: 15 581 009]
Confirmed deaths :: 675 060 [week ago: 635 173]

Highlights [selected]
:: The fourth meeting of the International Health Regulations (2005) Emergency Committee regarding COVID-19 was convened by the WHO Director-General on 31 July 2020. The Director-General declared that the outbreak of COVID-19 continues to constitute a public health emergency of international concern (PHEIC). The recommendations from the Emergency Committee highlight the need for response efforts to continue over the long term.

:: WHO has updated the interim guidance on Water, sanitation, hygiene (WASH), and waste management for SARS-CoV-2. The document provides additional details on risks associated with excreta and untreated sewage, on hand hygiene, on protecting WASH workers and on supporting the continuation and strengthening of WASH services, especially in underserved areas.

:: WHO has published a draft for Target Product Profiles (TPP) for COVID-19 therapeutics. The three sets of TPPs describe the preferred and minimally acceptable profiles for therapeutic agents for the treatment of those with COVID-19, ranging from mild through critically ill patients. Comments on this document are welcomed by submitting a comment form. All forms should be completed with the details of the individual or organization providing the comment.

:: For World Breastfeeding Week, WHO and UNICEF are calling on governments to protect and promote women’s access to skilled breastfeeding counselling. This is a critical component of breastfeeding support and, amidst the COVID-19 pandemic, it is even more important to find innovative solutions to ensure that access to these essential services is not disrupted.

 

::::::
::::::

COVID-19 Vaccines – Access/Procurement/ Supply

92 low- and middle-income economies eligible to get access to COVID-19 vaccines through Gavi COVAX AMC
:: Gavi Board agrees scope of COVAX Advance Market Commitment (AMC), which aims to secure doses of COVID-19 vaccines for 92 low- and middle-income countries and economies at the same time as wealthier nations
:: The Gavi COVAX AMC forms part of the COVAX Facility, a mechanism hosted by Gavi, the Vaccine Alliance, designed to guarantee rapid, fair and equitable access to COVID-19 vaccines for every country in the world, rich and poor
:: Dr Ngozi Okonjo-Iweala: “We are facing the most severe contraction of the economy since World War Two, and this crisis will have a terrible impact on the poorest and emerging economies.”

Geneva, 31 July 2020 – A total of 92 low- and middle-income countries and economies will be able to access COVID-19 vaccines through Gavi’s COVAX Advance Market Commitment (AMC), the Gavi Board agreed yesterday. The Board also agreed that the Gavi secretariat will host and administer the COVAX Facility, the umbrella mechanism to which 78 countries have already submitted written expressions of interest.

“We are facing the most severe contraction of the economy since World War Two, and this crisis will have a terrible impact on the poorest and emerging economies,” said Dr Ngozi Okonjo-Iweala, Chair of the Gavi Board. “These countries will have limited resources to access future COVID-19 vaccines: it is our duty to support them. Without this support the majority of the world’s population will continue to suffer from this disease even after we’ve developed a tool to tackle it. We now can stop this from happening.”

The 92 low- and middle-income countries and economies approved by the Gavi Board will be able to access vaccines through the COVAX AMC, which will also cover at least part of the cost. The COVAX AMC launched the 4th of June at the Global Vaccine Summit draws from the lessons of the successful Pneumococcal AMC. It forms part of the COVAX Facility, a mechanism designed to guarantee rapid, fair and equitable access to COVID-19 vaccines worldwide. COVAX will enable countries to have access to the world’s largest and most diverse COVID-19 vaccine portfolio. This means that, even if separate bilateral deals with vaccine manufacturers exist, through the Facility countries stand a far better chance of getting access to the vaccine or vaccines that prove to be most effective.

The high- and middle-income economies that have already submitted expressions of interest in the COVAX Facility will need now to enter into a legally binding agreement to purchase doses through the Facility. This commitment will need to be confirmed in the next month by making upfront financial contributions, enabling the Facility to enter into manufacturer agreements for future vaccine supply.

“We now have the framework in place to ensure that every economy, particularly the poorest nations, don’t get left behind in the race for a COVID-19 vaccine,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance. “This disease has spread at lightning speed across the globe, which means nobody is safe until everybody is safe. That’s why we now need support and vital funding to ensure that, once a safe, effective vaccine is ready, we can work on protecting the world and not just the lucky few. Gavi will work with governments, international organisations, manufacturers and civil society organisations to ensure doses get to those who need them.”

The goal is by the end of 2021 to deliver two billion doses of safe, effective vaccines to all participating countries including the 92 AMC-eligible economies. Once a vaccine has been approved by regulatory agencies and/or prequalified by the WHO, the COVAX Facility will then purchase these vaccines with a goal to try and initially provide doses for an average of 20% of each country’s population, focusing on health care workers and the most vulnerable groups. Further doses will be made available based on financing, country need, vulnerability and potential threat, and a buffer of doses will also be maintained for emergency and humanitarian use.

The list of 92 AMC-eligible economies includes all economies with Gross National Income (GNI) per capita under US$ 4,000 plus other World Bank International Development Association (IDA)-eligible economies. While close to US$ 600 million has already been raised for the AMC, this innovative financing mechanism requires seed funding of US$ 2 billion before the end of the year to secure and guarantee doses for the 92 AMC-eligible economies. A minimum of an additional US$ 3.4 billion is estimated to be required to procure around one billion doses by the end of 2021.

The Gavi COVAX Facility forms a key part of the COVAX pillar (COVAX) of the Access to COVID-19 Tools (ACT) Accelerator, a ground-breaking global collaboration to accelerate the development, production, and equitable access to COVID-19 tests, treatments, and vaccines. COVAX is co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO, working in partnership with developed and developing country vaccine manufacturers.
According to the latest estimates published by WHO, over 16.5 million people have been infected with COVID-19 and over 655,000 people have died from the disease.

 

Notes to editors
List of 92 Gavi COVAX AMC-eligible countries and economies (based on 2018 and 2019 World Bank GNI data)
Low income: Afghanistan, Benin, Burkina Faso, Burundi, Central African Republic, Chad, Congo, Dem. Rep., Eritrea, Ethiopia, Gambia, The Guinea, Guinea-Bissau, Haiti, Korea, Dem. People’s Rep., Liberia, Madagascar, Malawi, Mali, Mozambique, Nepal, Niger, Rwanda, Sierra Leone, Somalia, South Sudan, Syrian Arab Republic, Tajikistan, Tanzania, Togo, Uganda, Yemen, Rep.,
Lower-middle income: Angola, Algeria, Bangladesh, Bhutan, Bolivia, Cabo Verde, Cambodia, Cameroon, Comoros, Congo, Rep. Côte d’Ivoire, Djibouti, Egypt, Arab Rep., El Salvador, Eswatini, Ghana, Honduras, India, Indonesia, Kenya, Kiribati, Kyrgyz Republic Lao PDR, Lesotho, Mauritania, Micronesia, Fed. Sts., Moldova, Mongolia, Morocco, Myanmar, Nicaragua, Nigeria, Pakistan, Papua New Guinea, Philippines, São Tomé and Principe, Senegal, Solomon Islands, Sri Lanka, Sudan, Timor-Leste, Tunisia, Ukraine, Uzbekistan, Vanuatu, Vietnam, West Bank and Gaza, Zambia, Zimbabwe
Additional IDA eligible: Dominica, Fiji, Grenada, Guyana, Kosovo, Maldives, Marshall Islands, Samoa, St. Lucia, St. Vincent and the Grenadines, Tonga, Tuvalu.

 

Of the 78 countries that have expressed written interest in the Gavi COVAX Facility, 39 have agreed to be named publicly:
Andorra, Argentina, Armenia, Botswana, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Estonia, Finland, Greece, Iceland, Ireland, Israel, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Mauritius, Mexico, Monaco, Montenegro, New Zealand, North Macedonia, Norway, Palau, Portugal, Qatar, Republic of Korea, San Marino, Saudi Arabia, Seychelles, Switzerland, United Arab Emirates, United Kingdom of Great Britain & Northern Ireland, Venezuela.

 

::::::

Pfizer and BioNTech to Supply Japan with 120 Million Doses of their BNT162 mRNA-based Vaccine Candidate
:: Supply of 120 million doses to be provided in the first half of 2021, subject to regulatory approval
:: Agreement is part of Pfizer’s and BioNTech’s global commitment to help address the pandemic
:: Pfizer and BioNTech began a Phase 2b/3 safety and efficacy trial and remain on track to seek regulatory review as early as October 2020, and manufacture globally up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021
July 31, 2020
NEW YORK & MAINZ, Germany–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced an agreement with the Ministry of Health, Labour and Welfare (MHLW) in Japan to supply 120 million doses of BNT162 mRNA-based vaccine candidate against SARS-CoV2, subject to clinical success and regulatory approval, beginning in 2021.
Financial details of the agreement were not disclosed, but the terms were based on the timing of delivery and the volume of doses. As requested by the Government of Japan, deliveries of the vaccine candidate are planned for the first half of 2021…

 

::::::

HHS, DOD Partner With Sanofi and GSK on Commercial-Scale Manufacturing Demonstration Project to Produce Millions of COVID-19 Investigational Vaccine Doses
BARDA News, July 31 2020
The U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD) today announced agreements with Sanofi and GlaxoSmithKline (GSK) to support advanced development including clinical trials and large-scale manufacturing of 100 million doses of a COVID-19 investigational adjuvanted vaccine.

By funding the manufacturing effort, the federal government will own the doses that result from the demonstration project. The adjuvanted vaccine doses could be used in clinical trials or, if the U.S. Food and Drug Administration (FDA) authorizes use, as outlined in agency guidance, the doses would be distributed as part of a COVID-19 vaccination campaign.

“The portfolio of vaccines being assembled for Operation Warp Speed increases the odds that we will have at least one safe, effective vaccine as soon as the end of this year,” said HHS Secretary Alex Azar. “Today’s investment supports our latest vaccine candidate, an adjuvanted product being developed by Sanofi and GSK, all the way through clinical trials and manufacturing, with the potential to bring hundreds of millions of safe and effective doses to the American people.”

The manufacturing demonstration project will take place while clinical trials are underway. Working in parallel this way expedites the traditional vaccine development timeline. This step builds toward the U.S. government’s Operation Warp Speed goal to begin delivering millions of doses of safe and effective vaccines to the American people by the end of the year.

The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, collaborated with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and the Army Contracting Command to provide approximately $2 billion to support late-stage development, clinical trials including a large-scale phase 3 efficacy clinical trial, and the manufacturing demonstration project. The U.S. government also has the ability to acquire up to 500 million additional doses.

The project also includes fill-finish manufacturing in the United States so that vaccine doses are packaged and ready to ship immediately if clinical trials are successful and FDA authorizes use. If these doses are used in a COVID-19 vaccination campaign, the vaccine would be available to the American people at no cost. As is customary with government-purchased vaccines, healthcare professionals could charge for the cost of administering the vaccine.

Both companies have long-standing relationships with BARDA. Today’s effort with Sanofi builds on initial vaccine development work undertaken through a flexible agreement between BARDA and Protein Sciences, part of Sanofi, and work with GSK on adjuvant for pandemic influenza vaccines.

The vaccine candidate uses an antigen from Sanofi, which stimulates the body’s immune response against the virus, based on recombinant DNA technology and is being developed using an adjuvant from GSK to enhance the immune response, reduce the amount of antigen required per dose, and improve the chances of delivering an effective vaccine that can be manufactured at scale. GSK’s manufacturing scale is supported through U.S.-based reactivation efforts funded by BARDA since 2018.

About Operation Warp Speed (OWS):
OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

 

::::::
::::::

COVID-19 Vaccines – Discovery

Pfizer and BioNTech Choose Lead mRNA Vaccine Candidate Against COVID-19 and Commence Pivotal Phase 2/3 Global Study
:: Companies advance nucleoside-modified messenger RNA (modRNA) candidate BNT162b2, which encodes an optimized SARS-CoV-2 full-length spike glycoprotein, at a 30 µg dose level in a 2 dose regimen into Phase 2/3 Study
:: Candidate and dose level selection informed by preclinical and clinical data obtained in Phase 1/2 studies conducted in the U.S. (C4591001) and Germany (BNT162-01) 
:: The Phase 2/3 study protocol follows all the U.S. Food and Drug Administration (FDA) guidance on clinical trial design for COVID-19 vaccine studies.
:: Phase 2/3 study of up to 30,000 participants aged 18 – 85 years started in the U.S. and expected to include approximately 120 sites globally  
:: Trial regions to include areas with significant expected SARS-CoV-2 transmission to assess whether investigational vaccine candidate, BNT162b2, is effective in preventing COVID-19
:: Assuming clinical success, Pfizer and BioNTech on track to seek regulatory review as early as October 2020 and, if regulatory authorization or approval is obtained, plan to supply up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021

July 27, 2020 05:15 PM Eastern Daylight Time
NEW YORK & MAINZ, Germany–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the start of a global (except for China) Phase 2/3 safety and efficacy clinical study to evaluate a single nucleoside-modified messenger RNA (modRNA) candidate from their BNT162 mRNA-based vaccine program against SARS-CoV-2.

After extensive review of preclinical and clinical data from Phase 1/2 clinical trials, and in consultation with the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) and other global regulators, Pfizer and BioNTech have chosen to advance their BNT162b2 vaccine candidate into the Phase 2/3 study, at a 30 µg dose level in a 2 dose regimen. BNT162b2, which recently received U.S. Food and Drug Administration (FDA) Fast Track designation, encodes an optimized SARS-CoV-2 full length spike glycoprotein (S), which is the target of virus neutralizing antibodies.

“Our selection of the BNT162b2 vaccine candidate and its advancement into a Phase 2/3 study are the culmination of an extensive, collaborative and unprecedented R&D program involving Pfizer, BioNTech, clinical investigators, and study participants with a singular focus of developing a safe and effective COVID-19 RNA vaccine. The Phase 2/3 study protocol follows all the U.S. Food and Drug Administration (FDA) guidance on clinical trial design for COVID-19 vaccine studies,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “The initiation of the Phase 2/3 trial is a major step forward in our progress toward providing a potential vaccine to help fight the ongoing COVID-19 pandemic, and we look forward to generating additional data as the program progresses.”…

 

::::::

Moderna Announces Phase 3 COVE Study of mRNA Vaccine Against COVID-19 (mRNA-1273) Begins
July 27, 2020
Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the Phase 3 study of its mRNA vaccine candidate (mRNA-1273) against COVID-19 has begun dosing participants. The Phase 3 study, called the COVE (Coronavirus Efficacy) study, is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

Moderna Announces Expansion of BARDA Agreement to Support Larger Phase 3 Program for Vaccine (mRNA-1273) Against COVID-19
July 26, 2020
Moderna, Inc. (Nasdaq: MRNA), a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced a modification to its contract with the Biomedical Advanced Research and Development Authority (BARDA) for an additional commitment of up to $472 million to support late stage clinical development including the expanded Phase 3 study of the Company’s mRNA vaccine candidate (mRNA-1273) against COVID-19…

 

::::::

Single Dose of Johnson & Johnson COVID-19 Vaccine Candidate Demonstrates Robust Protection in Pre-clinical Studies
Jul 30, 2020
:: Study published in Nature shows J&J’s investigational SARS-CoV-2 vaccine elicits a strong immune response that protects against subsequent infection
:: First-in-human Phase 1/2a clinical trial now underway in United States and Belgium; Phase 3 clinical trial expected to commence in September

 

::::::
::::::

COVID-19 Vaccines Logistics/Delivery – Opinion/Analysis

What the government must do to successfully administer a covid-19 vaccine
Opinion by Ezekiel J. Emanuel and Topher Spiro
Washington Post July 31, 2020 at 1:48 p.m. EDT
Ezekiel J. Emanuel is vice provost of the University of Pennsylvania and a member of Joe Biden’s public health advisory committee. Topher Spiro is the vice president for health policy at the Center for American Progress.

In the all-important search for a covid-19 vaccine, the news seems promising. Several candidates have been found that increase antibodies with tolerable side effects. Worldwide, six have reached the final stage of testing and are now being administered to thousands of subjects to assess the vaccines’ effectiveness and safety.

But once a vaccine is found, the process of packaging, distributing and administering it to achieve herd immunity also presents significant challenges. Many months will pass between proving a vaccine is effective and being able to offer injections to 300 million Americans. Given the country’s covid-19 response so far, it’s not surprising that we are already behind.

Projections are that we will need to administer two vaccine doses, one month apart. And if the vaccine’s effectiveness is temporary, which seems likely, we may have to repeat this every 12 months. What does our government have to do to make that happen? In a report for the Center for American Progress, “A Comprehensive COVID-19 Vaccine Plan,” we identify four major potential bottlenecks — and solutions.

First, “fill and finish.” Vaccines must be put into specialized glass vials, and so far, the government has only contracted for 164 million glass vials, with the timing unknown. Corning, the major U.S. manufacturer, is expanding capacity, but it is likely to be able to produce only an additional 14 million or so vials a month with current funding.

The plants necessary to put vaccine into the vials are also highly specialized; they must be 100 times more sterile than a hospital operating room. Worldwide, these fill-finish plants are collectively operating at near-capacity. It is unclear precisely how much capacity there is in the United States, but in October 2018, a government assessment concluded “operational capability has not been adequately developed.”

It takes up to five years to build one fill-finish plant from scratch, but we can expand existing plants by installing new lines faster. Pfizer is retrofitting existing facilities for about $40 million per facility, and other companies are expanding or could expand their facilities.

We recommend that the government invest in retrofitting existing facilities, at an estimated cost of $400 million, and expanding the production of glass vials, as well as building new fill-finish facilities for 100 million doses, for $1.4 billion. Critically, the Defense Production Act must be invoked to free up and coordinate the nation’s existing manufacturing capabilities.

Second, syringes and needles. Once the vaccine is made and shipped, it has to be injected, requiring 650 million to 850 million syringes and needles. These are also in short supply. The five existing manufacturers produce 663 million injection devices per year, but most are already earmarked for many other medical purposes. The government has entered into contracts with BD, the largest manufacturer, to build production lines for an additional 320 million units. But this will take 12 months — and further production capacity is needed. The government needs to quickly invest at least $70 million to build two new manufacturing lines. It should also look into alternative delivery devices.

Third, payment. Paying for vaccines is a complex system involving physicians, pharmacies, insurers, Medicare and Medicaid, with lots of Americans falling through the cracks. In the early 1990s, Congress established the Centers for Disease Control and Prevention’s Vaccines for Children program for uninsured and low-income families. In 2009, the federal government provided free H1N1 vaccines.

The same has to occur for covid-19, and it will be comparatively cheap. The government should pay a maximum of $20 per dose — well within the range of existing CDC vaccine prices — meaning it would cost less than $20 billion to vaccinate the whole country.

Fourth, delivery. Traditionally, we administer vaccines through a patchwork of physician offices, pharmacies and public health clinics, with mixed success. Only about 45 percent of adults get an annual flu shot. To quell covid-19, we need to get 70 percent immunity, which probably means about 90 percent of Americans need to be vaccinated. To reach this goal, we calculate that we will need at least 7,300 community vaccination clinics, each providing nearly 30,000 doses per month. Some could be run by community health centers, CVS, Walmart and other existing vaccination or testing sites. But many new sites would also be needed. Collectively, we estimate these clinics would cost about $10 billion.

We all hope that by early 2021, pharmaceutical companies will be manufacturing an effective covid-19 vaccine. But it will do us no good unless we can package, ship and administer it to 300 million Americans — twice. We estimate that altogether it will cost less than $45 billion — an insignificant amount for a disease that has cost trillions of dollars in economic losses. More of a challenge is the need for a well-coordinated federal government effort to do the job. We need stronger leadership to ensure all Americans can get a vaccine and we can return to normalcy by fall 2021.

 

::::::
::::::