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Our Take: Late-stage trials of COVID-19 vaccine candidates get underway as BARDA agrees to additional funding for vaccine development, production

Aug 03, 2020
Early last week, Moderna, a front-runner in the race to develop an effective vaccine against COVID-19, announced that the company’s contract with the Biomedical Advanced Research and Development Authority (BARDA) had been modified to include up to $472 million in additional funding to support late-stage clinical development of Moderna’s messenger RNA (mRNA) vaccine candidate.

BARDA, which operates within the Department of Health and Human Services (HHS), awarded up to $483 million to Moderna in April. Initially, the planned Phase III clinical trial of the vaccine candidate included a smaller number of participants, but after discussions with federal officials, Moderna decided to conduct “a significantly larger” Phase III trial with an estimated 89 sites in the U.S. and 30,000 adult participants.

The Phase III COVE study, which started last Monday in Savannah, Ga., is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Half of the participants will receive two doses of the experimental vaccine, administered 28 days apart, and the other half will receive a placebo.

Study investigators will evaluate the vaccine’s safety, as well as its ability to prevent symptomatic COVID-19 after both doses have been received, NIH said in a news release. Secondary endpoints include whether the vaccine can prevent death caused by COVID-19 and if one dose might be enough to prevent symptomatic COVID-19.

Trial results could be available by November, according to Dr. Anthony Fauci, the director of NIAID.

Midweek, Fujifilm Diosynth Biotechnologies (FDB) announced that it would receive $265 million from BARDA to manufacture vaccines at a facility in College Station, Texas. One of those vaccines is expected to be Novavax’s. FDB recently signed an agreement with Novavax to manufacture bulk drug substance for the company’s vaccine at a North Carolina facility.

The federal government awarded Novavax $1.6 billion in early July to complete late-stage development of its vaccine. The Gaithersburg, Md.-based biotech firm is preparing to launch a Phase III trial with approximately 30,000 participants, possibly later this quarter.

And at the end of the week, Sanofi and GSK announced that they had signed an agreement to supply the U.S. with 100 million doses of the recombinant protein-based vaccine they are working on together. Worth up to $2.1 billion, that contract is the U.S. government’s largest one yet for a coronavirus vaccine, according to the Washington Post. The agreement includes an option for the U.S. to buy an additional 500 million doses. Human studies of the vaccine are planned to begin in September, followed by larger efficacy trials before the end of the year.

Our Take:
More than 150 potential COVID-19 vaccines are in development globally; Moderna’s and Pfizer/BioNTech’s are among those that are furthest along in the process.

Pfizer also started a Phase II/III clinical trial of a vaccine candidate early last week — an investigational nucleoside-modified messenger RNA (modRNA) vaccine the company is developing in partnership with Germany’s BioNTech. Like the COVE study, Pfizer’s trial is expected to have about 30,000 adult participants, but it will be conducted at an estimated 120 sites in the U.S. and other countries, including Argentina, Brazil, and Germany. The endpoints are similar to those in the COVE study.

Pfizer CEO Albert Bourla said the company hopes that most of the participants will have concluded dosing by the end of August, and the firm plans to submit an application to the FDA for the vaccine’s approval in October, Barron’s reported.

Moderna took some heat last week when the Financial Times reported that the company suggested in discussions with government entities that it might charge $50 to $60 per course, or $25 to $35 per injection, for its vaccine in the U.S. and other high-income countries.
Pfizer and BioNTech, on the other hand, agreed to a per-dose price of $19.50 for the first 100 million doses in a pre-order agreement with the U.S. government, and Bourla told Barron’s that other developed countries would pay about the same price if they commit to buying a similar volume.

“During the pandemic, we just went with the price that is at the very low end of whatever exists,” Bourla said. “It’s fractions of what vaccines of this high technology are sold [for] in the U.S.”

During an earnings call on Tuesday, Pfizer executives said the company would likely use a two-phase pricing strategy for its vaccine. The first, or “pandemic,” phase would run through the end of 2021 or early 2022, when “high volumes of doses will need to be provided for mass vaccinations.” The price during this phase would be set at a level “for broad access.” In the subsequent, or “seasonal,” phase, the company would probably “return to … a more value-based pricing approach.”

Executives from AstraZeneca and Johnson & Johnson (J&J) told lawmakers during a congressional hearing a couple of weeks ago that they would produce hundreds of millions of doses of their vaccines at no profit to their companies. But executives from Moderna, Pfizer, and Merck said at the hearing that they intended to profit from their vaccines if they were eventually approved.

Of note, Pfizer is the only one of the leading companies working on a potential COVID-19 vaccine that hasn’t accepted government funding for its research.

AstraZeneca recently reiterated its promise not to profit from a COVID-19 vaccine during the pandemic and reportedly has signed agreements with countries in Europe to provide the vaccine at $3 to $4 per dose.
AstraZeneca’s CEO, Pascal Soriot, said, “We felt, there [is] a time in life when companies need to step up and make a contribution,” adding that a vaccine needed to be accessible to as many people as possible, the Associated Press reported Thursday.

The British drugmaker licensed an experimental vaccine developed at the University of Oxford, and large-scale clinical studies of the vaccine are underway in the U.K., South Africa, and Brazil.

What else you need to know
A new bipartisan bill introduced in the House on July 24 proposes changes to Medicare’s alternative payment models (APMs), with the goal of accelerating the shift to value-based payment by encouraging more accountable care organizations (ACOs) to participate in the Medicare Shared Savings Program. Clif Gaus, CEO of the National Association of ACOs, said in a press release that there has been “a dramatic decline in the formation of new ACOs and a flattening of ACO participation” since 2018, when CMS made numerous changes through the Pathways to Success program in an attempt to get ACOs to take on risk sooner.

Specifically, the new bill, called the Value in Health Care Act, would reinstate the original shared savings rate of 50% for newer ACOs; the Pathways to Success program lowered the rate to 40%. The bill would also raise shared savings for ACOs that take on more financial risk in the basic track from the current rate of 50% to 55% and 60%. Additionally, the proposed legislation would extend the annual 5% bonus for physicians in Advanced APMs for six more years and lower the threshold for qualifying participants. It would also modify performance metrics and eliminate the distinction created in the Pathways to Success program between high- and low-revenue ACOs.

Eastman Kodak, best known for making film and cameras, will get a $765 million loan from the federal government to make active pharmaceutical ingredients (APIs) for generic drugs under the Defense Production Act. When the new Kodak Pharmaceuticals business unit is fully operational, it will be able to produce up to 25% of the APIs used in non-biologic and non-antibacterial generic drugs in the U.S. market, according to a press release issued by the U.S. International Development Finance Corp., the federal agency that will be providing the loan. Kodak facilities in New York and Minnesota will be repurposed, and Kodak will coordinate with the government and pharmaceutical companies to identify and prioritize the APIs that will be manufactured there. Components for hydroxychloroquine, which has been promoted as a potential treatment for COVID-19 but has shown less-than-promising results in recent clinical trials, are among the possibilities, The Wall Street Journal reported. Kodak’s stock was up more than 1,100% after the news broke.

XPrize launched its $5 million Rapid Covid Testing competition last week in collaboration with the nonprofit organization OpenCovidScreen. The purpose of the competition, XPrize said in the announcement, is to accelerate the development of “high-quality COVID-19 testing that is low cost, easy to use, and fast-turnaround, enabling frequent testing” for the “safe return to school, work, and everyday life.” The Anthem Foundation and Anthem are the competition’s founding anchor partners, and Blue Shield of California, Cambia Health Solutions, Health Care Service Corp., GuideWell Mutual Holding Corp., Horizon Healthcare Services (NJ), and Blue Cross Blue Shield of South Carolina are founding partners. Amazon, Google, and Thermo Fisher Scientific are among the competition’s supporting partners. The competition has four categories: At Home, Point-of-Care, Distributed Lab, and High-Throughput Lab.

Hackensack Meridian Health System and Maimonides Medical Center are teaming up with startup Nanowear on a clinical trial collaboration that will involve remote diagnostic monitoring through the use of clinical-grade wearable technology. Patients with a confirmed or suspected case of COVID-19 will wear an adjustable undershirt embedded with Nanowear’s patented, cloth-based nanosensors. Physicians will be able to remotely assess physiological signals — including electrocardiogram, blood pressure, blood flow hemodynamics, respiration, lung volume and fluid, and temperature trends — for signs of clinical deterioration that might warrant further intervention, the company explained in a news release.

Walgreens Boots Alliance announced last Monday that Stefano Pessina has decided to step down as the company’s CEO. The board of directors will conduct a search for a new CEO “to drive further progress on [the company’s] key strategic priorities and to transform the business for the future to address the rapidly evolving health care sector.” When the new CEO is appointed, Pessina will become the executive chairman, a role that James Skinner now holds. Skinner will continue to serve as a board member.

A federal appeals court ruled on Friday that HHS’ 28.5% reduction in the reimbursement rate for covered drugs in the 340B Drug Pricing Program is legal, reversing the decision a district court judge made in December 2018 and reiterated in May 2019. U.S. District Judge Rudolph Contreras ruled that HHS had overstepped its statutory authority when it implemented the change. Nonetheless, HHS included cuts to the 340B program in its hospital payment rule for 2019 and 2020. The American Hospital Association, one of the plaintiffs in the lawsuit against HHS, issued a statement in response to Friday’s ruling in which it said, “Hospitals that rely on the savings from the 340B drug pricing program are also on the front lines of the COVID-19 pandemic, and today’s decision will result in the continued loss of resources at the worst possible time. … We call on CMS to reverse this harmful policy to ensure hospitals can continue to provide the services people need the most.”

SOC Telemed and Healthcare Merger Corp. signed a definitive agreement Wednesday for a “business combination.” SOC Telemed, based in Reston, Va., and previously known as Specialists on Call, is an acute care telemedicine company used mostly inside hospitals. Healthcare Merger Corp. is a “special purpose acquisition’ or so-called “blank check” company that businesses can use to go public instead of doing an initial public offering. The agreement values SOC Telemed at approximately $720 million. The new company will retain the name SOC Telemed and will be listed in the Nasdaq when the deal closes, probably in the fourth quarter. Warburg Pincus, currently the majority equity holder in SOC Telemed, will be the largest shareholder of the new company.

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