BMJ, August 20, 2021: The FDA is being criticized for not holding an advisory committee meeting to discuss Pfizer’s application for full approval of its covid-19 vaccine. Will it undermine public confidence?
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NCHR’s Testimony to FDA on Pediatric Covid Vaccines
June 10, 2021: We agree with the FDA’s assessment that the lower burden of disease for COVID-19 in pediatric populations warrants more stringent criteria for safety and efficacy of vaccines than for adults.
Read More »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 »What you need to know about J&J’s newly authorized one-shot COVID-19 vaccine
ScienceNews: February 27, 2021. On February 27, the FDA authorized Johnson & Johnson’s COVID-19 vaccine for use in the U.S. The other two authorized vaccines are made by Pfizer and Moderna. None are FDA approved. All show effectiveness, but there are too few serious COVID-19 cases in any of the studies to conclude how well it prevents hospitalizations or deaths.
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