The recent announcement that other Western States will be joining California’s review workgroup on COVID-19 adds to the serious questions and concerns that have yet to be addressed by Governor Gavin Newsom.
Will Governor Newsom establishment of a panel to review the Food and Drug Administration’s approval process for COVID-19 vaccines, thus delaying access to vaccines by several weeks or even months for those Californians who want them?
Will expanding the review panel to include experts appointed by the Governors of Washington, Oregon and Nevada make Californians wait even longer for FDA approved vaccines?
The FDA is broadly regarded as the global Gold Standard in pharmaceutical safety and efficacy. It’s not clear what this review plan includes – will it repeat all of the FDA’s required document submissions and clinical trials?
Governor Newsom’s process would potentially only add layers of unnecessary bureaucracy and delays to delivering vaccines to Californians without substantively reviewing the safety or efficacy of the COVID-19 vaccines, let alone improving them.
California would be better served by making sure it had the necessary infrastructure in place, including sufficient cold storage and effective data management systems, to be able to safely store and track inventories, and deliver patient doses safely and effectively. Californians at risk for acquiring COVID-19 can’t afford for Gov. Newsom to turn this vital program into the next failed High Speed Rail, Employment Development Department unemployment insurance debacle, or the Department of Motor Vehicles Real ID fiasco.
Questions for Governor Gavin Newsom:
- How long will Californians have to wait on Gov. Newsom’s review before they can get the vaccine?
- Will Gov. Newsom’s review stop California Medicare and VA patients from getting the vaccine?
- Will Gov. Newsom’s review stop members of sovereign tribes in California from getting vaccines until his panel signs off on the FDA’s work?
- Will Gov. Newsom’s review stop military personnel and their dependents in California from getting COVID-19 vaccines from military clinics and hospitals?
- Has Gov. Newsom assessed how long this review will take, how many people might get sick with COVID-19, and how many of those might die, because they had to wait for Gov. Newsom’s review process to finish?
- Has Gov. Newsom thought of the inequalities that will result from this misguided order? The wealthy, and the well-connected will go out of state for COVID-19 vaccines, while lower- income Californians with fewer choices will be waiting on Newsom’s review to finish. Does Newsom’s modeling show how many of those people prevented from getting the FDA approved vaccines when first available will get sick?
- How does Gov. Newsom think this group is going to add value to the FDA’s vaccine approval process?
- Have any independent, respected scientific bodies recommended states perform independent reviews of the FDA’s vaccine approval process? If so, who? And, on what basis? Have any of these bodies shared their concerns with the FDA?
- What exactly does Newsom believe the FDA is ignoring, overlooking, or discounting that his vaccine review panel is going to catch?
- Did Gov. Newsom share those concerns with the FDA? If not, why not? If so, what did the FDA say?
- How exactly is Newsom’s review panel going to review the FDA’s vaccine approval process?
- Have the FDA, or the vaccine manufacturers, indicated they will cooperate with Newsom’s review panel, or comply with any requests for information by Newsom’s review panel?
- Does Newsom believe his review panel will have access to all the necessary background research, documents, and clinical trial results to confirm, or disprove, the FDA’s approval?
- How much does Newsom anticipate the state will spend to independently verify the FDA’s approval process for COVID-19 vaccines?
- Is this just more grandstanding?