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Our Take: Drug execs, public health officials try to shore up confidence in safety of future COVID-19 vaccine

Sep 14, 2020

Dr. Stephen Hahn, head of the FDA, said in an interview with the Financial Times late last month that the FDA would consider authorizing a COVID-19 vaccine based on preliminary Phase III trial results, before trials were concluded — if the data were strong enough to convince health officials that the vaccine’s benefits outweigh its risks, Reuters reported.

Dr. Hahn insisted that such a decision would be based on science, and not because of political pressure.

Nonetheless, Dr. Hahn’s comments were met with skepticism, leading the CEO of the Biotechnology Innovation Organization and seven CEOs of biotech companies — Acorda, Alkermes, Alnylam, Global Blood, GlycoMimetics, Nkarta, and Ovid — to write “an open letter to the biopharmaceutical industry” dated Sept. 3, in which they delineated the principles they believe are essential for COVID-19 vaccine clinical trials and data. Among those principals was the following:

“FDA should maintain its historic independence as the gold-standard international regulatory body, free from external influence. This will assure that the FDA review process will adhere to the highest standards of scientific and medical integrity, and that any approved products therefore will meet the required standards of safety and efficacy.”

Also on Sept. 3, Moncef Siaoui, head of the White House’s COVID-19 vaccine task force, said in an interview with ScienceInsider that any emergency use authorization of a vaccine “needs to be absolutely shielded from politics,” adding that he would “immediately resign if there is undue interference in the [vaccine approval] process.”

Additionally, the CEOs of nine major drug companies published a pledge last Tuesday promising that they would continue to prioritize “the safety and well-being of vaccinated individuals” while developing the first COVID-19 vaccines. The CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi all signed the pledge.

And the FDA itself took steps to allay concerns, with Dr. Hahn tweeting this last Tuesday: “While FDA is committed to expediting this work, we will not cut corners. We have not lost sight of our responsibility to ensure our decisions related to all medical products, including #COVID-19 vaccines, are based on science and data.”

During a congressional hearing on Wednesday, Dr. Francis Collins, director of the National Institutes of Health, and U.S. Surgeon General Jerome Adams told the Senate Health, Education, Labor and Pensions Committee that any vaccine approval would be based on science, with no shortcuts. “Otherwise, I will have no part of it,” Dr. Collins said.

Also last week, AstraZeneca paused global Phase III trials of the COVID-19 vaccine candidate it is developing with the University of Oxford after a participant in the U.K. displayed neurological symptoms consistent with transverse myelitis, a condition involving inflammation of the spinal cord.

AstraZeneca issued a press release on Saturday stating that trials have resumed in the U.K. after Britain’s Medicines Health Regulatory Authority confirmed that it was safe to do so. The company said it could not disclose medical information about the participant’s adverse event.

Our Take: A recent Gallup poll showed that roughly a third of Americans would be unwilling to get a COVID-19 vaccine — even if one was approved by the FDA and it was free. That was before Dr. Hahn potentially further eroded the public’s confidence by suggesting that the FDA would be willing to authorize a vaccine before late-stage trials are completed.

Were Dr. Hahn’s subsequent attempts, or those by other public health officials and pharma executives, enough to assure the public that any vaccine approved for use will be safe and effective? Time will tell.

What else you need to know

Lifespan and Care New England Health System signed a letter of intent to merge and create a nonprofit academic medical center with Brown University. The combined entity would include seven hospitals with more than 23,500 employees. The boards of both Providence, R.I.-based systems voted in favor of the merger last Monday and the move toward a merger was announced on Wednesday. It still must be approved by the state’s health department and attorney general’s office, as well as the Federal Trade Commission (FTC).

Mylan and Biocon Biologics launched a biosimilar insulin called Semglee, which will compete with Sanofi’s Lantus (insulin glargine). According to a press statement, Semglee is available in 10 mL vials at a wholesale acquisition cost (WAC) of $98.65 each and in packages of five pre-filled 3 mL pens at a WAC of $147.98 per package. Mylan said these prices are 65% lower than comparable insulins and are the lowest of any long-acting insulin glargine on the market. Semglee is approved to help control high blood sugar in adult and pediatric patients with type 1 diabetes and in adults with type 2 diabetes. STAT reported that most U.S. patients with diabetes won’t benefit from the low-priced biosimilar, though, as patient-assistance and copay programs already help those who pay cash and several states have implemented caps on insulin copays.

CMS extended the deadline for finalizing a rule that creates new exceptions to the Stark Law. Proposed last October, the rule was to be finalized on Aug. 31, but a notice published late last month in the Federal Register indicated that the deadline has been pushed back to Aug. 31, 2021. The Stark Law prohibits physician self-referrals; hospital groups and other provider organizations have asked the federal government to revise the law, saying it interferes with care coordination and value-based payment arrangements. CMS said it needed more time to work through “the complexity of the issues raised by comments received on the proposed rule,” Healthcare Dive reported.

California could become the first state to develop its own generic drugs. The state legislature approved a bill that directs the California Health and Human Services Agency to partner with one or more drug companies by January to produce or distribute generic prescription drugs and at least one form of insulin. The bill, SB-852, also paves the way for the state to make its own generic drugs, Kaiser Health News reported. Gov. Gavin Newsom must sign or veto the bill by the end of the month.

Aetna and parent company CVS Health launched a new health plan in the Kansas City market for the 2021 plan year that combines CVS Health services with one of Aetna’s networks. Although the PPO plan — called the Aetna Connected Plan with CVS Health— will offer access to a range of regional providers, it predominantly features the HealthHUBs and MinuteClinics found in CVS stores along with CVS services, such as free prescription delivery and discounts on health-related items at CVS pharmacies. The plan design has renewed concerns among some who opposed the merger between Aetna and CVS Health on the grounds that it would lead to anticompetitive practices.

Amazon jumped into the health wearables market with its Halo, a digital health and wellness service intended to compete with Fitbit and Apple Watch. Along with tracking activity and sleep, Amazon Halo can measure the wearer’s body fat and tone of voice. Another Halo feature is “Labs,” a collection of “science-backed challenges, experiments, and workouts” that allow the wearer to “build healthier habits,” Amazon said in a press release. Early access pricing includes the screenless Amazon Halo Band, a smartphone app, and a six-month subscription for $64.99. San Diego-based Sharp Healthcare is the first health system to collaborate with Amazon and electronic health record company Cerner on the product in the clinical setting; Sharp Health Plan will distribute a limited number of Amazon Halo Bands to members next month.

Universal Health Services (UHS) founder Alan Miller will step down as CEO of the company in January. He will stay on as executive chairman, and his son, Marc Miller, who currently serves as UHS’ president, will assume the role of CEO. Alan Miller, who founded the King of Prussia, Pa.-based company in 1979, was recently recognized by Fox Business as the second longest-serving CEO in the U.S., according to a news release announcing the transition.


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