Yesterday, Thursday, July 30, marked six months since the World Health Organization (WHO) declared COVID-19 a public health emergency of international concern. Dr. Tedros Adhanom Ghebreyesus, Director-General, WHO, noted that while this was the sixth time a global health emergency has been declared, it is “easily the most severe.”
On Tuesday, July 28, WHO described COVID-19 as “one big wave” and cautioned against viewing it as a seasonal problem. The need for a vaccine to protect against COVID-19 has been at the forefront of discussions about an effective response to the virus’s growing health and economic toll. Public health experts around the world have asserted that widespread availability of safe and effective vaccines is essential to control the pandemic.
This week’s edition of Rabin Martin’s COVID-19 Briefing explores the current state of the COVID-19 vaccine pipeline among five manufacturers, all part of the initial Operation Warp Speed investment. Others have since joined Operation Warp Speed – future editions of the Rabin Martin COVID-19 briefing will profile their efforts. Please find our earlier COVID-19 Briefings here.
In April, the U.S. government launched Operation Warp Speed – an initiative to fast-track the development of diagnostics, treatments, and vaccines to combat COVID-19. The U.S. government has invested over $5 billion in more than 30 research projects. One of the initiative’s key objectives is to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021. Operation Warp Speed is coordinated by the U.S. Department of Health and Human Services, with collaboration from the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA).
Below is a synthesis of the latest developments around the vaccine candidates from five companies selected for Operation Warp Speed and those that testified before the U.S. House Energy and Commerce Oversight and Investigations Subcommittee last week.
AstraZeneca – Phase 2/3
AstraZeneca received $1.2 billion in funding from BARDA to expedite development and trials of the non-replicating viral vector vaccine candidate the company is co-developing with the University of Oxford. The viral vector platform splices a SARS-CoV-2 gene into a modified, and harmless, chimpanzee adenovirus that is then delivered as a vaccine. On Monday, July 20, researchers reported results from their Phase 1/2 trial in The Lancet, showing that after two doses, the vaccine induced dual immune responses (antibodies and T-cell activity), without causing severe side effects. AstraZeneca has already begun large-scale Phase 3 trials in the U.K., Brazil, and South Africa and expects to begin trials in the U.S. soon. Results could come in early to late fall.
Johnson & Johnson – Phase 1/2
J&J received $456 million in funding from BARDA to support development of its experimental vaccine. The technology, a viral vector vaccine, combines an attenuated adenovirus with part of SARS-CoV-2 to induce immunity. Over the past week, human trials began in Belgium and the U.S.; plans to enroll additional participants in the Netherlands, Spain, Germany, and Japan are underway. The company aims to begin Phase 3 clinical studies in September.
Merck & Co., Inc. – Preclinical
Merck & Co., Inc. received $38 million in funding from BARDA to develop a recombinant COVID-19 vaccine, based on the same technology used in the company’s Ebola vaccine. The company is partnering with the International AIDS Vaccine Initiative (IAVI) to develop the candidate, with human trials expected later this year. Merck & Co., Inc. also acquired the Austrian biotech, Themis, for access to a potential COVID-19 vaccine being developed in conjunction with Institut Pasteur.
Moderna – Phase 3
Moderna received almost $1 billion in funding from BARDA to accelerate the development and assessment of its mRNA vaccine candidate. The mRNA technology introduces a snippet of RNA that encodes for a protein found on the outside of the SARS-CoV-2 virus. Preliminary clinical trial results demonstrated the vaccine prompts an immune response. In collaboration with the NIH, Moderna launched a Phase 3 trial of its vaccine candidate on Monday, July 27. The randomized control trial seeks to enroll up to 30,000 participants across the U.S.: half will receive two doses of the vaccine spaced 28 days apart, the other half will receive an inert placebo.
Pfizer – Phase 2/3
As part of Operation Warp Speed, Pfizer has entered a contract with the U.S. government to supply the mRNA vaccine candidate it is developing with BioNTech, should it prove safe and effective. One week after releasing preliminary Phase 1/2 data suggesting the vaccine candidate triggers an immune response, on Monday, July 27, the companies announced the launch of Phase 2/3 trials. Up to 30,000 participants in Argentina, Brazil, Germany, and the U.S. will participate in the trial to test the vaccine’s safety and efficacy. Pending positive results, Pfizer could seek FDA approval in October.
As of Friday, July 31, at 8:30 am ET, Johns Hopkins University has reported 17,325,093 confirmed cases and 673,868 deaths attributed to COVID-19, globally. There have been 4,495,375 confirmed cases and 152,075 deaths in the U.S. In the U.S., cases continue to rise, while testing capacity remains insufficient.
As the virus continues to traverse the world, decision-makers and public health authorities are taking measures to attempt to curb the spread. In a regional shift, Latin America’s COVID-19 epidemic has swelled. As of Thursday, July 30, it has an estimated 4.5 million cases. Infections are surging in Argentina, Brazil, Colombia, Mexico, and Peru, among other countries. Brazil alone now has more than 2.6 million cases, accounting for almost 28 percent of all cases in the Americas, and remains second to the U.S., globally, in total number of cases and related deaths, now exceeding 90,000.
With a growing pandemic across Africa, on Friday, July 24, the African Development Bank approved $27.4 million in funding to boost the African Union’s COVID-19 response. The majority of funding will be directed towards implementing the Africa CDC’s COVID-19 pandemic response plan. “With this financing package, we are reaffirming our strong commitment to a coordinated African response in the face of COVID-19… which is straining health systems and causing unprecedented socio-economic impacts,” said Akinwumi Adesina, President, African Development Bank. Dr. John Nkengasong, Director, Africa CDC, echoed that sentiment, saying, “We need to come together as a continent of 1.3 billion people to not be left behind.” To date, 754,390 infections have been reported on the continent, and 12,838 deaths.
Global COVID-19 Cases (Johns Hopkins University Center for Systems Science and Engineering)
From the Experts
“Now, along comes the pandemic, and it’s more important now than ever that we have minorities included [in research trials]. We should be jumping over mountains to try and make this work.”
Dr. Consuelo Wilkins, Vice President for Health Equity Research,
Vanderbilt University Medical Center
Sunday, July 26
“The bottom line is that one of the most fundamental ingredients for stopping this virus is determination, and the willingness to make hard choices to keep ourselves and each other safe.”
Dr. Tedros Adhanom Ghebreyesus, Director-General, WHO
Monday, July 27
“We’re trying to do everything we can…to have a global approach [to vaccine distribution], because we think it’s the right thing to do from a science point of view and from an equity point of view.”
Dr. Seth Berkley, CEO, Gavi
Tuesday, July 28
“The Americas are at risk of losing years of health gains in a matter of months. This is tragic.”
Dr. Carissa Etienne, Director,
Pan American Health Organization (PAHO)
Thursday, July 30
Reports from International Governments and Bodies
- WHO COVID-19 Information and Guidance
- WHO Situation Reports, July 28, July 29, July 30
- CDC Coronavirus Resource Page
- COVID-19 Health Systems Response Monitor
- NCD Alliance COVID resources relevant to NCDs
Funding and Policy Trackers
- International Monetary Fund Policy Tracker
- Kaiser Family Foundation Coronavirus Policy Tracker
- U.S. Chamber of Commerce Foundation Corporate Aid Tracker
- Devex Interactive Funding Tracker
Resource Pages and Market Research Literature
- JAMA Resource Center
- The Lancet COVID-19 Resource Centre
- 2019 Novel Coronavirus Research Compendium (NCRC)
- National Academy of Medicine COVID-19 News and Resources
- WIPO COVID-19 IP Policy Tracker
- The COVID Tracking Project
- PharmaIntelligence: Coronavirus – What will the Impact Be?
- Health Affairs Resource Center
- STAT News COVID-19 Tracker
- Global Health NOW’s COVID-19 Expert Reality Check
- International Association of National Public Health Institutes COVID-19 Resources
- Center for Strategic and International Studies The Reopening and Take as Directed Coronavirus Crisis Update Podcast
- Primary Health Care Performance Initiative Forum
- U.S. Global Leadership Coalition COVID-19 Issue Briefs
- Prevent Epidemics Weekly Science Review
- COVID-19 Watch Weekly Updates
What We’re Reading
- ‘Vaccine Nationalism’ Threatens Global Plan To Distribute COVID-19 Shots Fairly – Kai Kupferschmidt, Science Magazine
- Public Health Decision Making during Covid-19 — Fulfilling the CDC Pledge to the American People – Sonja a. Rasmussen and Denis J. Jamieson, New England Journal of Medicine
- 150,000 Americans Have Died From Covid-19. Here’s Why That Staggering Loss Of Life Can’t Be Ignored – Holly Yan, CNN
- A Vaccine Reality Check – Sarah Zhang, The Atlantic
- Who Gets the Covid-19 Vaccine First? Here’s One Idea – Gina Kolata, New York Times
- ‘A Huge Experiment’: How The World Made So Much Progress On A COVID-19 Vaccine So Fast – Andrew Joseph, STAT News
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About Rabin Martin
Rabin Martin is a global health strategy firm working at the intersection of private sector capabilities and unmet public health needs. Rooted in our mission to improve health for underserved populations, we design strategies, programs and partnerships that both deliver public health impact and drive business results. We leverage our deep knowledge and networks across a wide range of geographies and health areas to develop tailored solutions for every client engagement. We have helped many clients create bold global health initiatives and innovative multi-sector partnerships. Our specific areas of expertise include infectious disease and vaccines, non-communicable diseases, rare diseases, maternal and child health, and universal health coverage. Our clients and partners include multinational health care companies, multilateral institutions, government agencies, large foundations and leading NGOs. Rabin Martin is part of the Omnicom Public Relations Group.
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