Richard H. Hughes, IV, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, authored an article in MedPage Today, titled “An Uncertain Vaccines Market Keeps Getting Dicier.”
Following is an excerpt:
It's going to become unnecessarily harder to develop and make new vaccines. I've witnessed firsthand the dynamic nature of the vaccine industry, especially during my tenure at Moderna. It's a rocky business that is dealing with a rapidly occurring negative shift.
During the COVID pandemic, companies navigated market uncertainty while rushing to develop, test, and manufacture vaccines. A big difference maker was a national demand and collective understanding of the public health need for vaccines -- we all wanted to get out of our homes and back to our daily lives. The corresponding purchase commitments those companies secured with unprecedented government partnership made it viable for them to step forward and produce vaccines in an otherwise uncertain marketplace.
That all feels like ancient history now as our nation's health officials impose new obstacles in the form of increased regulatory hurdles and misrepresentation of what exactly constitutes science. It starts with the very tropes these officials deploy, insisting on "gold-standard science" and parents "doing their own research."
But we have moved beyond mere words. Now, several developments are coalescing to create a significant degree of unpredictability in the vaccine marketplace. Recent administration actions signal increasing trouble and significant obstacles in getting vaccines onto the market.
In recent months, the foundation of America's vaccine enterprise -- development, regulation, and access -- has begun to erode. A series of quiet but seismic changes at the FDA and CDC should concern anyone who cares about public health. …
