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


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

Situation report – 201
Coronavirus disease 2019 (COVID-19)
8 August 2020

Confirmed cases :: 19 187 943 [week ago: 17 396 943]
Confirmed deaths :: 716 075 [week ago: 635 173]

Highlights [selected]
:: WHO has published guidance on the public health surveillance of coronavirus disease 2019 (COVID-19) in humans caused by infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This document combines and supersedes the Global surveillance guidance for COVID-19 caused by human infection with COVID-19 virus: Interim guidance, and Surveillance strategies for COVID-19 human infection: Interim Guidance 10 May 2020.

:: A plane carrying 20 tonnes of trauma and surgical supplies from WHO has landed in Beirut, Lebanon to support the treatment of patients injured by the blast which occurred in the city on 4 August. This latest emergency has occurred at a time of recent civil unrest, economic crisis, the COVID-19 outbreak and heavy refugee burden. “We are in this together, and we are committed to supporting Lebanon in this very difficult time” said Dr Najat Rochdi, UN Resident Coordinator in Lebanon…


COVID-19 Vaccines – Access/Procurement/Supply

Up to 100 million COVID-19 vaccine doses to be made available for low- and middle-income countries as early as 2021
:: New landmark collaboration between the Serum Institute of India (SII), Gavi, the Vaccine Alliance and the Bill & Melinda Gates Foundation to accelerate manufacturing and delivery of up to 100 million doses of future safe and effective COVID-19 vaccines for low- and middle-income countries in 2021

:: Vaccines will be priced at maximum US$ 3 per dose and made available to up to 92 countries included in Gavi’s COVAX Advance Market Commitment (AMC)

:: Dr Seth Berkley: New collaboration will help “ensure we have additional manufacturing capacity to begin producing doses for every country, not just the wealthy few”

Geneva, 7 August 2020 – A new landmark collaboration between SII, the world’s largest vaccine manufacturer by volume, Gavi and the Bill & Melinda Gates Foundation will accelerate the manufacture and delivery of up to 100 million doses of COVID-19 vaccines for low- and middle-income countries (LMICs) as part of the Gavi COVAX AMC, a mechanism within the COVAX Facility.

The collaboration will provide upfront capital to SII to help them increase manufacturing capacity now so that, once a vaccine, or vaccines, gains regulatory approval and WHO Prequalification, doses can be produced at scale for distribution to LMIC countries as part of the Gavi COVAX AMC mechanism as early as the first half of 2021.

“Too many times we’ve seen the most vulnerable countries left at the back of the queue when it comes to new treatments, new diagnostics and new vaccines,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance. “With COVID-19 vaccines we want things to be different. If only the wealthiest countries in the world are protected, then international trade, commerce and society as a whole will continue to be hit hard as the pandemic continues to rage across the globe. This new collaboration is an important step in our efforts to prevent this from happening, helping to ensure we have additional manufacturing capacity to begin producing doses for every country, not just the wealthy few. We now need other vaccine manufacturers to step up and follow SII’s lead.”

The funding will help de-risk manufacturing by SII for candidate vaccines from AstraZeneca and Novavax, which will be available for procurement if they are successful in attaining full licensure and WHO Prequalification. SII has set a ceiling price of US$ 3 per dose, a price enabled by investments made by partners such as CEPI and the Bill & Melinda Gates Foundation. The arrangement also provides an option to secure additional doses if the vaccines pillar of the ACT Accelerator sees a need for it.

“In an attempt to make our fight against COVID-19 stronger and all-embracing; SII has partnered with Gavi and the Bill & Melinda Gates Foundation to advance the manufacturing and delivery of up to 100 million doses of future COVID vaccines for low and middle income countries in 2021,” said Adar Poonawalla, CEO of Serum Institute of India. “The rampant spread of the virus has rendered the entire world in an unimaginable halt of uncertainty. And to ensure maximum immunization coverage and contain the pandemic, it is important to make sure that the most remote and poorest countries of the world have access to affordable cure and preventive measures. Through this association, we seek to ramp up our constant efforts to save the lives of millions of people from this dreadful disease.”

The Gavi COVAX AMC, which is currently seeking at least US$ 2 billion in initial seed funding, will meet at least part of the cost of procurement for the vaccine doses. Last week the Gavi Board agreed upon the final list of 92 countries that will be supported by the AMC. Under the new collaboration, AstraZeneca’s candidate vaccine, if successful, will be available to 57 Gavi-eligible countries. Novavax’s candidate, if successful, will be available to all 92 countries supported by the AMC. These countries align with SII’s licensing agreements with the two partners.

This collaboration underscores India’s proven-track record in developing safe and quality vaccines. There is a long history of Gavi and pharmaceutical companies successfully partnering with Indian manufactures, particularly the Serum Institute of India, to manufacture vaccines that protect against meningitis, severe diarrhoea, pneumonia and measles.

“It is encouraging to see an Indian vaccine manufacturer, SII, work collaboratively with global partners with a view to making available affordable Covid-19 vaccine supplies for India and the world,” said Professor K VijayRaghavan, Principal Scientific Adviser to the Government of India. “Normally it would take more than a decade to develop such a vaccine but with the efforts of our researchers, academia and private sector, working closely with global collaborators we are hopeful of accelerating the availability of a successful vaccine, at reasonable cost and in sufficient quantities, to fight the pandemic.”

“Researchers are making good progress on developing safe and effective vaccines for COVID-19,” said Bill Gates, co-chair of the Bill & Melinda Gates Foundation. “But making sure everyone has access to them, as soon as possible, will require tremendous manufacturing capacity and a global distribution network. This collaboration gives the world some of both: the power of India’s manufacturing sector and Gavi’s supply chain. It’s just a start. Organizations like Gavi and CEPI need much more support to facilitate development and delivery of hundreds of millions – maybe billions – of vaccine doses by next year.”

The collaboration between Gavi, SII, and the Gates Foundation supports the efforts of the ACT Accelerator’s vaccines pillar, also known as COVAX, co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization (WHO), to accelerate the development of COVID-19 vaccines and ensure rapid, global access to them. Decisions around investment in manufacturing are taken in close collaboration between these three lead organisations of the COVAX pillar.

Under the COVAX umbrella, Gavi is leading the COVAX Facility, which provides governments with the opportunity to benefit from a large portfolio of COVID-19 candidate vaccines using a range of technology platforms, produced by more manufacturers across the world, with a bigger market to provide security of demand. The Facility, which is available to any country or economy, includes the AMC which specifically provides funding for vaccines for 92 low- and middle-income countries.

The COVAX pillar is working to accelerate R&D for promising vaccine candidates, manufacture doses at scale and deliver 2 billion doses globally by the end of 2021. CEPI, as a co-lead for the ACT Accelerator’s Vaccines pillar, has agreements to support R&D for nine candidate vaccines, including the AstraZeneca and Novavax vaccine candidates.

The Bill & Melinda Gates Foundation, via its Strategic Investment Fund, will provide at-risk funding of US$150 million to Gavi, which will be used to support the Serum Institute of India to manufacture potential vaccine candidates, and for future procurement of vaccines for low- and middle-income countries via Gavi’s COVAX AMC.

The deal is additional to a Memorandum of Understanding between AstraZeneca and Gavi, announced in June, which will guarantee an additional 300 million doses of AstraZeneca’s candidate vaccine to the wider COVAX Facility, to be supplied upon licensure or prequalification. These two deals can help guarantee access to early doses for the most vulnerable on a truly global scale.


Johnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 Vaccine
Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators
NEW BRUNSWICK, N.J., Aug. 5, 2020 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) (the Company) today announced its Janssen Pharmaceutical Companies have entered into an agreement with the U.S. government for the large scale domestic manufacturing and delivery in the U.S. of 100 million doses of Janssen’s SARS-CoV-2 investigational vaccine, Ad26.COV2.S, for use in the United States following approval or Emergency Use Authorization by the U.S. Food and Drug Administration (FDA).
The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, in collaboration with the U.S. Department of Defense, is committing over $1 billion for this agreement. The vaccine will be provided at a global not-for-profit basis for emergency pandemic use. The U.S. government may also purchase an additional 200 million doses of Ad26.COV2.S under a subsequent agreement…


COVID-19 Vaccines – Discovery

Novavax and Takeda Announce Collaboration for Novavax’ COVID-19 Vaccine Candidate in Japan
August 07, 2020

See NIH below in Announcements


COVID-19 Vaccines – Manufacturing

CEPI survey assesses potential COVID-19 vaccine manufacturing capacity
05 Aug 2020 By The CEPI Sustainable Manufacturing Team
One of the many challenges we are presented with by the COVID-19 pandemic is finding a way to meet the sheer scale of demand for a vaccine when it has been demonstrated to be safe and effective. We have to take a global view on what manufacturing capacity is available and to ensure we are investing in reserving such capacity now to avoid any delays in the manufacture and distribution of vaccines.

To deliver on its mission CEPI has undertaken a survey of vaccine manufacturers to assess what capacity might be available to meet demand for a COVID-19 vaccine.

CEPI’s Sustainable Manufacturing Project

In 2019, before the COVID-19 pandemic emerged, CEPI established a Sustainable Manufacturing Project to support the supply of CEPI’s investigational vaccines to tackle epidemic events. The Sustainable Manufacturing Project, led by James Robinson, consisted of modelling the supply of vaccines (supply side), modelling the epidemiology of CEPI’s priority diseases (demand side), evaluating potential manufacturing networks to secure capacity for manufacturing and stockpiling to ensure flexibility, affordability, and reliable supply. When COVID-19 emerged in early 2020, CEPI quickly pivoted this effort to focus on the pandemic response, so that we could quickly build a reliable evidence base for what facilities were potentially available for COVID-19 vaccine manufacture.

Survey of global COVID-19 vaccine manufacturing capacity
CEPI – in collaboration with the Bill & Melinda Gates Foundation, The Clinton Health Access Initiative, and PATH – undertook a broad, worldwide, survey of vaccine manufacturers to understand capabilities, capacities and interest in responding to the pandemic. We aimed to assess potential bottlenecks in the vaccine manufacturing and to work out what global capacity might be available to produce billions of doses of vaccine.

Between April 3, and June 19, 2020, CEPI invited vaccine manufactures from around the world to take part in an anonymised survey to assess what manufacturing capacity was available to produce drug substance (ie, the unformulated active [immunogenic] substance) and drug product (ie, the finished dosage form of the product including final container) in the coming months, specifically between Oct 1, 2020, and Dec 31, 2021.

A key objective of this survey was to understand how COVID-19 vaccine manufacturing could be scaled up without affecting the manufacture of other important vaccines and to identify additional capacity in the global manufacturing system for both drug substance and drug product.

There is a risk that a few countries could monopolise global vaccine supply, limiting the supply of vaccines to those who need them most, as was the case with the 2009 flu pandemic. To truly end COVID-19 pandemic, it’s crucial that the world works together to enable fair, global distribution of any vaccine.

In gathering these survey data, CEPI aims build a picture of the availability and global distribution of manufacturing capacity, which would inform how and where it could make strategic investments in vaccine manufacturing to ensure equitable access to any successful vaccine candidate.

Key findings
113 manufacturers, from over 30 countries, responded to our survey. 43 respondents were both drug-substance and drug-product manufacturers. 56 were drug-substance manufacturers only. 100 were drug-product manufacturers only.
:: 2 to 4 billion doses :: Global capacity to produce COVID-19 vaccines through to end of year 2021

:: 113 :: Number of manufacturers who responded to the survey

:: 20% :: Proportion of the population who will be vaccinated in countries that participate in COVAX

As reflected by the number of manufacturers with regulatory approvals for their operations, mature manufacturing capacity is available for both drug-substance and drug-product manufacturing in multiple locations around the world.

India has the largest production capacity for drug substance (specifically for microbial or yeast expression systems; recombinant protein from suspension cells; recombinant protein from insect cells; viruses; and DNA), followed by Europe and North America. Europe has the largest production capacity for RNA-based drug substance.

For drug product, the base-case estimates showed that China has the largest production capacity, followed by North America, and the rest of Asia and Oceania.

Crucially, the survey data show that there is potential global capacity to produce at least 2-4 billion doses of COVID-19 vaccine through end of year 2021. This finding is important for CEPI’s wider COVID-19 response because – in collaboration with Gavi and WHO – we aim to distribute 2 billion doses of COVID-19 vaccine by the end of 2021 through a programme called COVAX. Vaccines manufactured and procured through COVAX will be delivered equally to all countries who participate in the initiative, proportional to their populations (initially prioritising healthcare workers then expanding to cover 20% of their population). Our survey confirm that this 2 billion manufacturing target can not only be achieved but can be delivered without displacing other critical vaccine manufacturing activities.

This analysis represents a snapshot in time from our survey responders and will have changed dramatically since the data was collected between May and June, 2020. To the best of our knowledge, this is the only publicly available data on global drug-substance and drug-product manufacturing capacity for vaccines gathered specifically during the early days of the pandemic.

CEPI has been and will continue to use this information in its COVID-19 pandemic response including matchmaking between vaccine developers and available capacity to maximise global capacity for COVID-19 vaccine manufacturing.

See survey results here.