Our Take: Vaccine update: Pfizer, BioNTech get full FDA nod, Moderna completes its BLA submission
Chief among the spate of vaccine-related news last week was the FDA’s full approval of Pfizer and BioNTech’s COVID-19 vaccine, which Pfizer will now market in the U.S. as Comirnaty.
(If you’re wondering, the name is a combination of the terms COVID-19, mRNA, community, and immunity.)
The FDA noted that the messenger RNA-based vaccine has been available to people who are at least 16 years old since Dec. 11, 2020, under emergency use authorization, though the rollout strategy varied from state to state and older adults were often prioritized. The EUA was extended in May to include adolescents and teens aged 12 through 15.
“The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
Based on results from a clinical trial of 20,000 vaccine recipients and 20,000 placebo recipients age 16 or older, the vaccine was 91% effective in preventing COVID-19 disease, the FDA said.
In theory, this approval means that physicians could now administer the vaccine to younger children through “off-label” use, but the FDA said such use is “not appropriate” and the American Academy of Pediatricians (AAP) released a statement discouraging clinicians from giving the shots to children younger than 12.
“The clinical trials for the COVID-19 vaccine in children ages 11 years old and younger are underway, and we need to see the data from those studies before we give this vaccine to younger children,” said Dr. Lee Savio Beers, president of the AAP. “The dose may be different for younger ages. The AAP recommends against giving the vaccine to children under 12 until authorized by the FDA.”
Pfizer said it anticipates having trial data on the vaccine for children ages 5 through 11 by the end of September and for children ages 2 to 5 soon after.
The full approval was widely expected to lead to more vaccine mandates — which it did.
For example, CVS Health announced that it would require all corporate employees, including those at Aetna, and certain clinical workers who interact with patients to be vaccinated by Oct. 31. Pharmacists must be vaccinated by Nov. 30.
The Pentagon also said it would be sending guidelines to 1.4 million active-duty service members who will be required to get vaccinated.
Health systems including Geisinger, Northwestern Medicine, Ochsner Health, and CoxHealth issued or revised their mandates following the FDA approval. Fierce Healthcare reported last Tuesday that so far 151 health systems were requiring their workers to be vaccinated, with more expected to follow suit.
- Pfizer and BioNTech initiated the rolling submission of a supplemental biologics license application (sBLA) to the FDA for a booster shot in people age 16 or older. The companies said Phase III trial data showed that participants’ neutralizing titers after the third dose were 3.3 times higher than after the second dose.
- A U.K. study indicates that the effectiveness of the Pfizer-BioNTech vaccine tapers off within the first six months, CNBC reported. The analysis, which included more than 400,000 recipients, found the vaccine was 88% effective in protecting against COVID-19 a month after the second shot, but just 74% effective after five or six months. The AstraZeneca vaccine also appears to offer diminished protection. It was found to be 77% effective a month after the second shot but just 67% effective at four to five months.
- The Wall Street Journal reported that the U.S. will probably offer booster shots for fully vaccinated people six months after their second shot, rather than eight months, as previously announced — if the FDA approves the booster shots.
- J&J said interim data from two studies demonstrate that a booster dose of its COVID-19 vaccine, given six to eight months after the initial shot, “generated a rapid and robust increase in spike-binding antibodies, ninefold higher than 28 days after” the first dose.
- Moderna announced Wednesday that it had completed the rolling BLA submission to the FDA for full approval of its COVID-19 vaccine in individuals age 18 or older. The company requested priority review of the application.
- A study published last week in the CDC’s Morbidity and Mortality Weekly Report suggests that effectiveness of the mRNA vaccines — Pfizer-BioNTech’s and Moderna’s — in preventing COVID-19 among frontline workers decreased from 91% before the delta variant became the dominant strain to 66% afterward. The CDC noted that the results “should be interpreted with caution,” however, because vaccine effectiveness in general could be declining over time (as indicated in the U.K. study above) and because of certain study limitations.
What else you need to know
UPMC launched a drug discovery and development company called Novasenta. The company will focus on tumor microenvironments, the ecosystem that surrounds and interacts with tumors in the body, to develop new cancer treatments — specifically, immunotherapies. According to the health system’s announcement, Novasenta was founded in 2018 by Dr. Robert Ferris, Dario Vignali, and Greg Delgoffe, who are with the UPMC Hillman Cancer Center and the University of Pittsburgh. “We are building on decades of successful research from our founders in the fields of tumor biology, immunology, computational biology, and drug discovery,” said Mani Mohindru, Novasenta’s CEO. UPMC invested in Novasenta through UPMC Enterprises, the health system’s innovation and capital venture arm, in a $20 million seed round.
Geisinger partnered with PayZen on a new AI-backed billing system with zero-interest payment plans that allow patients to pay their medical bills “over a timeline of their choosing.” The health system said in a news release that patients who receive bills for out-of-pocket expenses totaling more than $250 (after insurance payments) will have the option to pay the balance in a lump sum or over the course of months. If they opt to spread out the payments, “they can choose from several customized payment plans, all without fees or interest.” Geisinger’s chief revenue officer, Robert Dewar, said, “[I]t’s our obligation to make sure our patients don’t avoid or put off necessary care for financial reasons.” Among patients enrolled so far, the average monthly payment is $52.
Mayo Clinic and Alphabet’s Verily are collaborating on an advanced clinical decision support tool. According to Dr. Bradley Leibovich, medical director of Mayo Clinic’s Center for Digital Health, the organizations hope the tool can be used as “a GPS for patient care.” The health system will provide curated clinical content, including deidentified health record data, to Verily, who will apply clinical analytics to provide clinicians with vetted knowledge on disease management, care guidelines, and treatment, Mayo Clinic said in a press release. Although it will be deployed at Mayo Clinic first, with an initial focus on cardiovascular and cardiometabolic conditions, Verily plans eventually to offer the tool to its other health system partners and customers.
On-demand teletherapy provider Ginger is merging with Headspace. The combined entity, to be called Headspace Health, “will address the systemic challenges of access and affordability in a fundamentally different way by creating the world’s most holistic, scalable, and effective mental health and well-being company,” CeCe Morken, CEO of Headspace, said in a press statement. Known for being one of the first meditation apps, Headspace offers an array of mindfulness products and services. Ginger provides behavioral health coaching, video-based therapy, and psychiatry support via smartphone. Together, they will reach almost 100 million lives in more than 190 countries through direct-to-consumer business and 2,700-plus employer clients and health plan partners. The transaction is expected to close in the fourth quarter. Financial terms were not disclosed, but the combined company will have an estimated value of $3 billion.
Illumina completed its $7.1 billion acquisition of Grail, despite an ongoing regulatory review by the European Commission (EC) and a legal challenge by the Federal Trade Commission (FTC) to block the transaction. Illumina said in a press release that it needed to finalize the transaction now, before the agreed-upon terms expired. It also said it believes the EC has no jurisdiction to review the acquisition because Grail “has no business” in the European Union. Further Illumina said there is “no legal impediment to acquiring Grail in the U.S.” Nonetheless, Illumina said that Grail would remain a separate and independent unit during the review and that it is prepared to abide by whatever legal and regulatory decisions are made. The FTC trial, the first litigated “vertical” merger at the FTC in decades, got underway last week. Grail relies on Illumina’s DNA sequencing technology for its early detection liquid biopsy test. The FTC is arguing that the merger would likely reduce innovation and make tests like Grail’s more expensive. The EC is now looking into whether Illumina violated a “standstill obligation” by completing the acquisition.
WebMD is partnering with symplr to allow consumers who search for information on WebMD to also find a local provider and make an appointment with a few additional clicks. WebMD said its research shows that 72% of consumers visit a health website for information just before and after they visit an online provider directory to schedule an appointment. Symplr has a provider data management search platform called Directory that is used by some of the nation’s largest health systems. In a news release, symplr said the solution it is developing with WebMD would “drive consumers to a health system’s digital front door for real-time provider search and appointment scheduling.” B.J. Schaknowski, symplr’s CEO, said, “[p]rovider organizations will realize increased patient flow and higher utilization using this new, end-to-end digital workflow.”
COVID-19: Implications for business. McKinsey & Company, 8.26.21
The Ethical Brain: The Science of Our Moral Dilemmas, by Michael S. Gazzaniga.
