Mitch McConnell, top Republicans question Biden on getting ahead of FDA on Covid-19 boosters
Senate Minority Leader Mitch McConnell, Senate Health Committee ranking member Richard Burr and other top Republicans are questioning the Biden administration’s decision to get out in front of the FDA and announce that Covid-19 vaccine boosters would be ready for administration by this week.
While Burr praised the FDA’s EUA for the boosters Wednesday evening, the Republicans earlier in the day called on White House coronavirus response coordinator Jeffrey Zients to release an updated strategy on leveraging vaccines to end the pandemic and to clarify what exactly happened with the premature announcement on the boosters.
Last month, the Biden administration controversially planned for the boosters to be available for all beginning this week, before any of the follow-on shots had been authorized for use. Since then, his top Covid officials have attempted to downplay the certainty of the plan. Two top FDA vaccine officials also allegedly retired in part because of concerns with this political pressure to meet Biden’s timeline.
Surgeon General Vivek Murthy said in a press briefing last Friday: “The announcement in August, and certainly in the time since then, we have always said that this initial plan would be contingent on the FDA and the CDC’s independent evaluation.” That evaluation from the FDA led to a more restricted EUA than Pfizer initially sought.
The Republicans questioned Zients on this point in a letter Wednesday: “Why did the White House announce vaccine boosters would be available to all Americans prior to any scientific or regulatory work being done to approve or authorize such boosters?” They also asked which studies are being conducted and relied upon to determine that boosters are necessary for all Americans.
And the Republican senators questioned HHS’ new plan to control distribution to certain states seeking access to monoclonal antibody treatments for Covid-19.
Last week, HHS announced it would transition from a direct ordering process to a state/territory-coordinated distribution system, similar to what was used when mAbs were first distributed from November 2020 through February 2021.
Under the new system, HHS will determine the weekly amount of mAbs each state and territory receives based on Covid-19 case burden and mAb utilization. State and territorial health departments will then select sites to receive product as well as the amount each site receives. That places more of the burden on the federal government to figure out which states are in greatest need.
But the change comes amid a growing demand and recent increase in the prevalence of the Delta variant, and as HHS announced earlier in the month that it was looking into mAb shortages and orders.