FDA reportedly aims to fully approve Pfizer-BioNTech COVID-19 vaccine by early next month; Biogen’s Alzheimer drug sees little uptake; majority of Americans over 65 have received at least 1 dose of a COVID-19 vaccine.
The FDA has accelerated its timeline in order to fully approve the Pfizer-BioNTech COVID-19 by early September, according to The New York Times. Last week, President Joe Biden stated he expected a fully approved vaccine in early fall, but the FDA’s unofficial deadline is Labor Day or sooner, according to sources in the report, who hope that full approval, rather than just emergency use authorization, might inspire higher vaccination rates. Multiple universities and hospitals plan to mandate vaccination after its approval. Recent polls conducted by the Kaiser Family Foundation found that 3 of 10 unvaccinated Americans said they would be more likely to get a vaccine with full approval.
Few patients have received the controversial Alzheimer drug aducanumab (Aduhelm) yet, STAT News reported, as hospitals, health systems, and payers conduct their own reviews of the drug. Biogen, the drug’s manufacturer, has not released the number of patients treated since its FDA approval in early June, but analysts estimated in July that fewer than 100 patients have received it. The drug’s $56,000 annual cost, unknown benefit, limited availability, and delivery requirements are factors playing a role in the limited uptake.
The majority of older Americans 65 years and older are at least partially vaccinated against COVID-19, Kaiser Health News reported, with 90% partially vaccinated; some states have higher rates than others. Pennsylvania, Hawaii, and Vermont have vaccinated more than 99% of their seniors and Connecticut has vaccinated 96%, whereas West Virginia ranks last among the states with 78%. Nearly 80% of COVID-19–related deaths in the United States have been among this age group.