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Our Take: Pfizer, BioNTech nab first FDA authorization of a COVID-19 vaccine

Dec 14, 2020

Late on Friday, the FDA issued its first emergency use authorization (EUA) for a vaccine to prevent COVID-19 to Pfizer and the company’s German partner, BioNTech, making the U.S. the sixth country to authorize this particular vaccine, according to The New York Times.

The EUA allows the vaccine to be administered on a widespread basis to individuals who are at least 16 years old. Two doses are required, administered three weeks apart.

Pfizer was prepared to begin shipping the first batch of about 3 million doses immediately, which means that many health care workers and seniors in skilled nursing facilities are likely to be vaccinated this week.

The FDA’s decision followed the overall favorable vote on Thursday by an advisory committee to recommend the vaccine’s authorization. The panel of outside experts voted 17-4 in favor of recommendation, with one abstention, The Associated Press reported.

The authorization was based on clinical trial results that included an analysis of 36,523 participants in an ongoing study. Roughly half of the participants received the vaccine and the remainder received placebo. The vaccine demonstrated 95% efficacy in preventing COVID-19, with eight participants in the vaccine group and 162 participants in the control group contracting the disease. Of those cases, one in the vaccine group and three in the control group were deemed severe.

“At this time, data are not available to make a determination about how long the vaccine will provide protection,” the FDA stated in its authorization notice.

As Pfizer mentioned in a press release, severe allergic reactions have been reported after mass vaccination began in other countries that authorized the vaccine, prompting the company to caution against administering it to those “with known history of severe allergic reaction (e.g., anaphylaxis) to any component” of the vaccine.

Pfizer and BioNTech will continue to clinically evaluate their vaccine, which is based on BioNTech’s proprietary mRNA technology, with an eye toward filing a Biologics License Application for full approval in 2021.

Pfizer’s agreement with the federal government is for the company to supply 100 million doses of the vaccine by March. That would be enough to vaccinate about one-fifth of the adult population. The company advised officials that it would not be able to supply a substantial amount more than that until late June or July, The Washington Post reported.

Separately, on Saturday, various news outlets reported that the U.S. government had purchased an additional 100 million doses of Moderna’s vaccine, doubling the amount it originally agreed to buy earlier in the year. The reported cost for all 200 million doses is $3.2 billion. The FDA’s vaccines advisory committee is scheduled to meet on Thursday to discuss Moderna’s EUA request.

Several other industry-relevant COVID-19 announcements were made recently, including the following:

  • UnitedHealth Group and Eli Lilly said they are collaborating on a study to assess at-home infusions of Lilly’s bamlanivimab in patients with mild to moderate symptoms of COVID-19 who are at high risk for progressing to severe symptoms and/or hospitalization. The FDA just recently issued an EUA for use of the drug in this patient population. UnitedHealth will enroll as many as 500,000 Medicare Advantage members with COVID-19 in the study, and at least 5,000 of them are expected to receive the drug.
  • CVS Health said the Department of Health and Human Services selected the company’s Coram infusion care business unit to participate in a pilot program in which Coram will administer bamlanivimab to patients at home or in long-term care facilities.
  • The U.S. government purchased another 650,000 doses of bamlanivimab for $812.5 million, which are to be delivered through the end of January. The government paid $375 million for 300,000 doses of the drug in October.
  • The FDA authorized the first direct-to-consumer COVID-19 test system. Adults can use LabCorp’s Pixel home collection kit to take a nasal swab sample and send it to LabCorp for testing. The kits can be bought online or at the store without a prescription.
  • The FDA also authorized the first at-home combination COVID-19 and flu test. The PCR test is made by Quest Diagnostics and requires a prescription.
Our Take: With COVID-19-related deaths approaching 300,000 in the U.S. and the daily death toll continuing to climb ever higher, the FDA’s authorization of Pfizer and BioNTech’s vaccine is certainly welcome news.
Now comes the hard work of distributing the vaccine and convincing people to be vaccinated.

The vaccine’s need for ultra-cold storage — it has to be stored at approximately -90 degrees Fahrenheit to avoid degradation of the mRNA — poses numerous logistical challenges.

But Pfizer seems confident that it can address these issues, stating that it “has vast experience and expertise in cold-chain shipping and has an established infrastructure to supply the vaccine worldwide.” The company said its distribution strategy “is built on a flexible just-in-time system that can ship the frozen vials quickly to designated points of vaccination at the time of need, minimizing the need for long-term storage.”

Getting the vaccine to the point of care could prove easier than getting people there. Much has been written over the last many months about growing skepticism of the first vaccines to become available. Some have feared that political pressure to expedite the testing process could compromise safety assessments. Even in the absence of any external pressure, there’s simply no way of knowing what the long-term effects might be until a sufficient amount of time has elapsed following administration of the vaccines.

Nevertheless, we have to start. We can still take steps to try to contain the spread of the coronavirus, but at this point a two-pronged approach is our best hope for returning to any semblance of “normal.”

What else you need to know
AstraZeneca will acquire Boston-based Alexion Pharmaceuticals in a cash and stock deal valued at $39 billion. According to a joint press release, the boards of directors of both companies have unanimously approved the acquisition. “Alexion has established itself as a leader in complement biology, bringing life-changing benefits to patients with rare diseases,” said AstraZeneca CEO Pascal Soriot. “We look forward to welcoming our new colleagues at Alexion so that we can together build on our combined expertise in immunology and precision medicines to drive innovation that delivers life-changing medicines for more patients.” The deal is subject to customary regulatory approvals and is expected to be completed in Q3 2021.

Xavier Becerra, Jeff Zients, and Dr. Rochelle Walensky have been selected to fill top roles in the fight against the pandemic when President-elect Joe Biden takes office next month. Becerra, who has served as California’s attorney general since 2017 and was a member of the U.S. House of Representatives before that for 24 years, is Biden’s choice to head the Department of Health and Human Services. Becerra must be confirmed by the Senate before taking office. Zients, an economic adviser and former health care consultant, will coordinate the new administration’s pandemic response, including vaccine distribution efforts, in his role as coronavirus “czar.” Dr. Walensky, currently chief of infectious diseases at Massachusetts General Hospital, will lead the Centers for Disease Control and Prevention.
CMS unveiled its Geographic Direct Contracting Model on Thursday. The voluntary payment model, which CMS is calling Geo, is designed to see if direct contracting entities (DCEs) — accountable care organizations, health systems, provider groups, and health plans — can improve the quality of care and lower costs for Medicare fee-for-service beneficiaries across an entire region through care coordination and clinical management. A region’s DCEs will be required to “take full risk with 100% shared savings/shared losses for Medicare Parts A and B services” for all beneficiaries in the region (not just those beneficiaries seeing certain providers), according to a CMS fact sheet. They will be able to offer additional benefits such as meal programs, home visits, and transportation. Providers can enter into value-based care payment arrangements with the DCEs, choosing either total or partial capitation, or they can continue to be reimbursed at the usual Medicare rates. DCE applications for the first three-year performance period, which begins Jan. 1, 2022, are due April 2; participants will be selected through a competitive bidding process. CMMI Director Brad Smith called the model “one of the Center’s largest bets to date on value-based care.”

The FTC’s attempt to block Jefferson Health’s acquisition of Albert Einstein Healthcare Network was dealt a blow last Tuesday when a federal judge refused to issue an injunction. The federal agency is fighting the merger on the grounds that insurers in the Philadelphia area would likely see price increases if the two organizations combined. The judge said the FTC failed to prove its argument, noting that the insurer market is much more consolidated in the region than the provider sector is. Becker’s Hospital Review reported on Friday that the FTC filed a motion for an emergency injunction to give it time to appeal the decision.

In separate news, the FTC will sue to stop Hackensack Meridian Health from acquiring Englewood Healthcare Foundation for the same reason — that insurers, and ultimately consumers, would pay more because of the resulting loss of competition. The agency said in a press release that the merger “would also remove the competitive pressures that have driven these hospitals to invest in quality improvements to the benefit of patients.”

Amazon rolled out a new service called Amazon HealthLake, describing it as a HIPAA-eligible service that aggregates an organization’s data across different silos and disparate formats into a centralized Amazon Web Services “data lake.” Health systems, pharmaceutical companies, researchers, insurers, and other businesses within the health care industry can use the data lake to “help spot trends and anomalies in health data,” Amazon said in its announcement. The intent is to help these various entities “make much more precise predictions about the progression of disease, the efficacy of clinical trials, the accuracy of insurance premiums, and many other applications.”

Tenet Healthcare will pay approximately $1.1 billion in cash to buy majority interests in up to 45 ambulatory surgical centers (ASCs) from Towson, Md.-based SurgCenter Development. Tenet subsidiary United Surgical Partners International will operate the ASCs, which are located in nine states. Tenet stated in a press release that it will fully acquire SurgCenter Development’s interests in the ASCs and partially acquire interests in the ASCs from physician partners. The Dallas-based health care services company has already completed most of the acquisitions and expects to complete the rest by the end of the year, pending state approvals.

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