This week we’ve highlighted the White House’s strategy to address future pandemics, President Biden’s executive order on lowering prescription drug costs, the availability and reduced pricing of hearing aids, and the Food and Drug Administration’s updated authorization for Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines. We’ll also look at BioNTech’s aspirations for an mRNA cancer vaccine.
Each week we highlight five things affecting the life sciences industry. Here’s the latest.
This week, President Biden signed the National Security Memorandum-15 and launched the National Biodefense Strategy and Implementation Plan for Countering Biological Threats, Enhancing Pandemic Preparedness, and Achieving Global Health Security. The strategy will be funded by an $88 billion request to Congress over five years. The strategy sets out to:
- Detect pandemics and other biological threats
- Prevent outbreaks from becoming epidemics and prevent biological incidents before they happen
- Prepare for pandemics and other biological incidents
- Rapidly respond to outbreaks when they occur
- Recover from a pandemic or biological incident
Also of note to the life sciences industry, over the next five to 10 years, the strategy aims to enable diagnostic testing within 12 hours of an event, development of vaccines within 100 days, and the development of novel therapeutics within 180 days.
A recent executive order from President Biden directs the secretary of the Department of Health and Human Services to consider whether to select for testing by the Innovation Center new health care payment and delivery models that would lower drug costs and promote access to innovative drug therapies for beneficiaries enrolled in the Medicare and Medicaid programs. The secretary has 90 days to prepare a report summarizing any models selected.
Cheaper hearing aids are now available thanks to the Biden administration and the FDA’s collaboration to make hearing aids available over-the-counter without a prescription. Starting this week, retailers across the country are selling over-the-counter hearing aids. For example, Walgreens is selling a pair for $799 that cost $2,000 to $8,000 from a specialist. Walmart has pairs available from $199 to $999 with similar cost savings.
Last week, the FDA authorized the Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines for use as a booster dose in children 5 years and above. The boosters are authorized for administration at least two months following completion of primary or booster vaccination. According to the FDA release: “These bivalent COVID-19 vaccines include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant.”
BioNTech founders have said that mRNA vaccines targeting cancers could be available before 2030. The company was working on mRNA cancer vaccines prior to the pandemic; however, research slowed as COVID-19 became the global focus. BioNTech now has several cancer vaccines undergoing clinical trials.