The US Food and Drug Organization’s (FDA’s) Office of Surveillance and Epidemiology issued its first-ever annual report summing up the office’s work.
 
The scope of the office’s charge meant that during the pandemic, staff effort was largely directed toward addressing the global public health emergency of the COVID-19 pandemic, noted Gerald Dal Pan, director of FDA’s Office of Surveillance and Epidemiology (OSE).
 

Family physician Mitchell A. Kaminski, MD, MBA, was still awash in feelings of joy and relief at recently being vaccinated against COVID-19 when a patient's comments stopped him cold. The patient, a middle-aged man with several comorbidities, had just declined the pneumonia vaccine – and he added, without prompting, that he wouldn't be getting the COVID vaccine either. This patient had heard getting vaccinated could kill him.

Moderna emerged as an early leader in the race for a vaccine to stop Covid-19 in its tracks. The Cambridge, Massachusetts-based biotech bounded through development of one of the world’s first mRNA vaccines, but in September — when the pandemic was claiming upwards of 700 lives a day in the US — they took a step back.

The company did something not many (if any) biotechs have ever done: At the urging of the US government, they slowed Phase III enrollment to recruit more participants from minority groups.

Susan Winckler, CEO of the Reagan-Udall Foundation for the Food and Drug Administration, is the American Pharmacists Association Foundation’s 2021 recipient of the Jacob W. Miller Award. The award recognizes individuals who help to advance the Foundation’s mission through their involvement and leadership in longstanding programs and new initiatives. 

Established in 2000, the award honors Jacob W. Miller who held positions in state and national pharmacy organizations and was APhA Foundation president from 1990-2000.

The global COVID-19 diagnostics market size is projected to reach USD 8.04 billion by 2027, exhibiting a CAGR of 2.7% during the forecast period.

Across every facet of life, 2020 tested our resolve and resilience. COVID-19 stretched our systems to the breaking point, exposing inexcusable gaps and limitations in our systems. As a force of creative destruction and reinvention, however, it also prompted new conversations, broke through barriers and accelerated the pace of innovation. This has been as much the case in the realm of real-world data (RWD) as it has anywhere.

Scientists at the Food and Drug Administration (FDA) have devoted countless hours to ensuring that the COVID-19 vaccines being deployed and those in the development pipeline are safe and effective. But it’s another task being done outside of the lab that’s growing in importance—helping to ensure public confidence in vaccines.

“Ultimately, all of what we do is for naught if people aren't willing to take the vaccines that come through the development process,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.