Days before the meeting Friday, FDA scientists published an analysis on J&J’s application for a booster, questioning the strength of the data. The FDA said people may benefit from a second dose, but added the information provided by the company was limited and the agency hadn’t verified all of it yet. It acknowledged a single J&J dose was consistently less effective than the mRNA vaccines in clinical trials and in real-world studies.P. S. Massachusetts cases were up a fifth of a percentage point today.
Before the vote, some committee members asked the FDA whether they could postpone a decision on boosters, saying it may be too early as there are still a number of outstanding questions. Other members wondered why the agency brought J&J’s application before the committee before it was able to verify all of the data.
Friday, October 15, 2021
Day 623: Johnson & Johnson & Johnson
Yesterday's rubber-stamp-happy FDA committee are still in session; today they approved boosters for Johnson & Johnson's COVID vaccine, for all the unfortunates previously vaccinated with their one-shot non-mRNA regimen. The recommended delay after an initial dose is two months; most people are well past that by now. The doubts about Moderna PlagueBlogged earlier this week also apply to this decision:
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