Data and safety monitoring boards work under a cloak of secrecy meant to prevent undue influence by stakeholders, such as companies or the government. In the Trump era, some worry the anonymity could actually invite it.
President Donald Trump has the legal power to authorize a COVID vaccine over the objections of the Food and Drug Administration and vaccine manufacturers. Such a move could further erode public trust in a vaccine and foist an unsafe shot on Americans.
The National Institutes of Health has suggested minorities should be overrepresented in COVID-19 vaccine trials — perhaps at rates that are double their percentage of the U.S. population. But efforts to recruit patients from racial minority groups are just beginning, while some trials have already advanced to phase 3.
The AstraZeneca trial is on hold in the U.S. as scientists try to unravel whether a rare neurological condition is linked to the vaccine. But regulators are frustrated by a lack of information from the drugmaker.
Republicans have all but abandoned the Affordable Care Act as a campaign cudgel, judging from their national convention, at least. Meanwhile, career scientists at the federal government’s preeminent health agencies — the Food and Drug Administration, the Centers for Disease Control and Prevention and the National Institutes of Health — are all coming under increasing political pressure as the pandemic drags on. Joanne Kenen of Politico, Mary Ellen McIntire of CQ Roll Call and Sarah Karlin-Smith of the Pink Sheet join KHN’s Julie Rovner to discuss this and more. Plus, Rovner interviews KHN’s Elizabeth Lawrence about the latest KHN-NPR “Bill of the Month” installment.
About 60% of poll respondents are worried that federal regulators will rush to allow a vaccine because of political pressure. Opposition to getting a vaccine that might be authorized before the November election is strongest among Republicans.
Traditionally, requirements that kids undergo certain immunizations before attending school have been a critical public health tool. Health officials are scrambling to make sure children don’t fall through the cracks.
Efforts are underway to bring to market a vaccine for valley fever, a fungal infection with COVID-like symptoms that occurs in the deserts of the Southwest. The illness is getting more attention as cases rise and a warming climate threatens to spread it through the West.
As the nation awaits a vaccine to end the pandemic, local health departments say they lack the staff, money, tools ― and a unified plan ― to distribute, administer and track millions of vaccines, most of which will require two doses. Dozens of doctors, nurses and health officials interviewed by KHN and The Associated Press expressed their concern and frustration over federal shortcomings.
The nation’s top infectious disease official is confident that an independent panel will base vaccine approval on science, not politics.