Washington Monthly, March 26, 2021: Not since the polio vaccine became available in April 1955 have Americans been so excited about getting a shot. But behind the scenes, there’s a lot we don’t know because of a decision made back in December by the FDA. The agency allowed manufacturers to effectively stop their clinical trials as soon as they were authorized to market their vaccines, making it impossible to learn how long the vaccines work and for whom.
Read More »Tag: Covid-19
The Differences Between the Vaccines Matter
The Atlantic, March 7, 2021: Public-health officials are enthusiastic about all 3 COVID-19 vaccines available in the U.S. For example, Virginia’s vaccine coordinator stated, “A hundred percent efficacy against deaths and hospitalizations? That’s all I need to hear.” But experts, including NCHR, point out that there were too few people with severe COVID in the vaccine studies to draw conclusions.
Read More »Drug Industry Pushes FDA to Solve Growing Inspection Backlog
Politico, March 2, 2021: The FDA is under pressure from the pharmaceutical industry to address the growing backlog of drug inspections — nearly a year after Covid-19 prompted the agency to halt most plant visits. From March through September, FDA inspected just three plants outside the U.S. and 52 within the U.S., well below the 600 and 400, respectively in each of the prior two years. NCHR president reports device inspections have also dropped dramatically
Read More »J&J COVID-19 Vaccine Wins Unanimous Backing of FDA Panel
Medscape Medical News: February 26, 2021. An FDA advisory panel lent their support today to a rapid clearance for Janssen/Johnson & Johnson’s COVID-19 vaccine, but several researchers expressed concerns to the panel about the lower standards of EUAs, including NCHR’s president Dr. Diana Zuckerman.
Read More »Testimony of Dr. Diana Zuckerman at the FDA Advisory Committee on Johnson & Johnson COVID Vaccine
February 26, 2021: The Johnson & Johnson vaccine seems to be effective, but not proven to be more effective for moderate or severe COVID than the Pfizer or Moderna vaccines. We asked FDA to stop the hype and require studies to continue.
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