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Our Take: AstraZeneca ramps up COVID-19 vaccine manufacturing, distribution capacity with two more deals

Jun 15, 2020
In the race to develop, produce, and supply an effective vaccine against the novel coronavirus, AstraZeneca is staking out its position as a front-runner.

To further extend its supply chain network, the British drugmaker recently signed “landmark” agreements with the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi the Vaccine Alliance, and the Serum Institute of India (SII). The $750 million agreement with CEPI and Gavi is the first commitment to materialize from an accelerator program co-chaired by the World Health Organization and the Bill and Melinda Gates Foundation. That agreement pertains to the manufacture, procurement, and distribution of 300 million doses of AZD1222, the COVID-19 vaccine that AstraZeneca is collaborating on with Oxford University, whereas the licensing agreement with SII is for a billion doses of the vaccine for low- and middle-income countries. Both agreements call for hundreds of thousands of doses to be available by the end of this year.

Last month, AstraZeneca signed agreements with the U.S. and the U.K. to supply at least 400 million doses, starting in September. At the same time, the company announced that it would receive up to $1.2 billion from the Biomedical Advanced Research and Development Authority (BARDA), an agency within the Department of Health and Human Services (HHS), to advance the vaccine. Subsequently, as we reported last week, AstraZeneca was selected as one of the finalists in the federal government’s “Operation Warp Speed” project, which means the firm will be eligible to receive additional resources.

Collectively, the agreements that AstraZeneca has signed so far represent a global supply capacity exceeding 2 billion doses per year. FiercePharma said this is “the single largest effort so far to pump hundreds of millions of doses of a COVID-19 vaccine hopeful onto the market before the end of 2020.”

Oxford University has started a Phase IIb/III clinical trial of AZD1222 that could eventually include more than 10,000 people. AstraZeneca is expected to base its decisions regarding the timing of the first vaccine shipments on the results of that trial.

Our Take:
Currently, there are more than 125 vaccines in the preclinical stages of development and 10 in clinical trials. At this point, there’s no telling whether any of them will work.

Nonetheless, governments, drug companies, and health organizations around the world, along with philanthropic institutions like the Gates Foundation, are spending billions of dollars to ensure that when an effective vaccine is found, it can be produced and distributed quickly (and, at least in theory, equitably).

Collapsing the average 10-year vaccine development timeline entails taking a different approach than normal. Instead of going through the usual process that starts with exploratory development and proceeds through preclinical and clinical testing, followed by several additional steps before distribution is possible, the efforts to bring a COVID-19 vaccine to market involve working on some of those steps — namely, combined-phase testing and manufacturing — in parallel.

Pfizer’s strategy is a prime example. In mid-March, CEO Albert Bourla challenged his vaccine research and manufacturing teams to make millions of doses of a vaccine available by the time flu season rolls around in the fall. According to a Forbes article, he told the teams to “build manufacturing of a [potential] vaccine before you know what’s working. If it doesn’t … we will write it off and throw it out.”

By early May, dosing of an investigational messenger RNA (mRNA) vaccine that Pfizer had developed in partnership with Germany’s Bio-NTech was underway in healthy volunteers. The company is evaluating three additional mRNA vaccine candidates to see which holds the most promise and hopes to receive emergency use authorization for at least one of them by October, Forbes reported.

Incidentally, Moderna, another “Warp Speed” finalist, is also testing an mRNA vaccine in collaboration with the National Institute of Allergy and Infectious Disease. Moderna anticipates starting Phase III trials in a couple of weeks and hopes the vaccine will be available for distribution early next year.

We keep reading in the news that millions of vaccine doses could be ready by year-end. Yet, public health experts and even top executives at certain drug companies have cautioned that this timing may be — or flat out is — unrealistic. Even if testing yields a viable candidate (or if we’re really lucky, a few), scaling up to produce such vast quantities could prove difficult. The Gates Foundation and other entities are focusing on building out manufacturing facilities and equipment, but a lack of raw materials for the vaccines and an insufficient number of qualified people to oversee production could be problematic.

AstraZeneca is playing it smart. Along with AZD1222, the firm is simultaneously developing COVID-19 antibodies as a potential alternative to a vaccine. Bloomberg Law reported last Tuesday that the firm licensed two immune proteins from Vanderbilt University and signed an agreement with BARDA and another HHS agency to develop and test the antibodies in an early-stage clinical trial.

Pfizer is likewise hedging its bets by exploring potential COVID-19 treatments, including a protease inhibitor originally developed to combat SARS and a couple of rheumatoid arthritis drugs.

If you’re interested in reading more about the COVID-19 vaccine pipeline, we recommend this article published in The Lancet on June 6.

What else you need to know
Twenty-six manufacturers of generic drugs and 10 executives are accused of price fixing in a federal antitrust lawsuit filed Wednesday by the attorneys general of 46 states, Washington, D.C., and four U.S. territories. The complaint, filed in Connecticut, claims the drug companies and executives collectively conspired to “stifle price competition and maintain artificially high prices” for at least 80 products, between 2009 and early 2016. Among the companies named in the complaint are Teva Pharmaceuticals’ Actavis unit, Amneal, Bausch Health, Mallinckrodt, Mylan, Novartis’ Sandoz unit, Pfizer, and Sun Pharmaceutical Industries. Two similar lawsuits filed in 2016 and 2019 are still pending. In March, Novartis and the Department of Justice reached a $195 million settlement resolving allegations that Novartis colluded in an industry-wide price-fixing scheme between 2013 and 2015.

Separately, Cigna also filed a lawsuit last week in a district court in Pennsylvania accusing dozens of generic drug manufacturers — including many of the same defendants named in the federal complaint mentioned above — of fixing prices. Cigna is seeking damages resulting from the overcharges it paid for the drugs.

Intermountain Healthcare has begun providing in-home, hospital-level services in partnership with Castell, the system’s value-based care spinoff. The services are for eligible patients with conditions such as congestive heart failure, some kidney-related conditions, some intestinal and vein conditions, some infections, and certain cancer diagnoses, Intermountain stated in a press release.  After an orientation session in the hospital, patients are provided with a remote monitoring kit and other necessary equipment. They receive regular in-person and virtual check-ins from a care team, and on-call services are available 24/7. The goal is to improve outcomes and lower costs by preventing unnecessary emergency department visits and by shortening the duration of hospital stays or avoiding them altogether.

Boston-based telehealth giant Amwell has filed to go public later this year — possibly in September, according to CNBC, citing “people familiar with the matter.” CNBC reported that Amwell, previously known as American Well, said it has seen a 1,000% increase in virtual visits during the COVID-19 outbreak, though in some places the increase has been closer to 3,000% to 4,000%. The company raised $194 million in a Series C financing round last month. Anthem, Takeda, and Jefferson Health are among Amwell’s investors. Amwell’s roster of clients includes 240 health systems and 55 health plans.

Henry Ford Health System and Michigan State University signed a letter of intent to expand their long-standing partnership. The LOI is for a primary affiliation to share research and clinical care, create more education opportunities for health care professionals, and develop a plan to build a joint research institute in Detroit. They also intend to establish a fully integrated cancer program with the goal of achieving National Cancer Institute designation. In a news release, the organizations said their enhanced collaboration “will focus on improving access, affordability, and outcomes, especially for Detroit and Michigan’s most vulnerable populations.” A series of definitive agreements is in the works and could be finalized later this year.

The Trump administration on Friday finalized a regulation to revoke policies issued under the Obama administration that were designed to protect transgender people, as well as women seeking abortions, against sex discrimination in health care, NPR reported. The protections were provided under a nondiscrimination clause in the Affordable Care Act, but many conservatives felt that the Obama administration overstepped its legal authority. Roger Severino, director of HHS’ Office for Civil Rights, said the new rules “will eliminate mass confusion that was unleashed by the Obama-era decision to redefine sex to cover a wide array of gender identities.” The new rules also reverse policies implemented by the Obama administration requiring health care providers to post multilingual nondiscrimination notices and make translation services readily available for patients who are not fluent in English. Numerous activist and advocacy groups said they intend to challenge the new rules in court.

Geisinger signed a 10-year agreement with Siemens Healthineers, expanding a long-term relationship between the two. Siemens Healthineers, a medical technology firm headquartered in Germany, will give Geisinger access to its latest digital health innovations, diagnostic imaging equipment (along with AI-enabled and cloud-based management technologies), and onsite staff to support improvements for the duration of the agreement. Financial terms were not disclosed.

Dr. Patrick Conway is the new CEO of Optum’s Care Solutions unit, he announced on Twitter. He said his work will center on home care, mental health care, and acute and post-acute care, with an emphasis on value-based models. Dr. Conway previously served as CEO of Blue Cross Blue Shield of North Carolina, and before that he was the director of CMS’ Center for Medicare and Medicaid Innovation.

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