@pete The current FDA Emergency Use Authorization (EUA) vaccines are all “active,” like a lot of childhood vaccines and the first one for shingles they hijack cells. Almost all flu vaccines in the US, and all the injected one are “passive,” protein like Novavax and Sanofi/GSK, only one in the US with an adjuvant like those COVID-19 vaccines being tested now.
But this has nothing to do with the “rush” to dispense them with EUAs, the tests were as large as any FDA strength ones are. If this were a matter of small numbers, nothing but Phase IV “post-marketing” would have detected it.
But swollen lymph nodes, lymphadenopathy, while technically a side effect since they’re undesired but you are poking the immune system with a stick, are as @drgo says entirely expected after a vaccination, and are in the list of “solicited” local side effects, ones that are specifically asked about.
And incidents of this short term adverse effect, thus covered by the “rushed” EUA process were of course observed. From the published EUA submission documents, Pfizer/BioNTech 64 vaccine, 6 placebo. Moderna lists more than a thousand, but “Grade 3” a bit more vaccine and significantly more for placebo, and that’s with less test subjects. Janssen doesn’t even bother to break them out. The Pfizer document says most showed up 2-4 days after an injection, 15 >= 8 days, one 98 days after, and average duration was 10 days.
@pete The current FDA Emergency Use Authorization (EUA) vaccines are all “active,” like a lot of childhood vaccines and the first one for shingles they hijack cells. Almost all flu vaccines in the US, and all the injected one are “passive,” protein like Novavax and Sanofi/GSK, only one in the US with an adjuvant like those COVID-19 vaccines being tested now.
But this has nothing to do with the “rush” to dispense them with EUAs, the tests were as large as any FDA strength ones are. If this were a matter of small numbers, nothing but Phase IV “post-marketing” would have detected it.
But swollen lymph nodes, lymphadenopathy, while technically a side effect since they’re undesired but you are poking the immune system with a stick, are as @drgo says entirely expected after a vaccination, and are in the list of “solicited” local side effects, ones that are specifically asked about.
And incidents of this short term adverse effect, thus covered by the “rushed” EUA process were of course observed. From the published EUA submission documents, Pfizer/BioNTech 64 vaccine, 6 placebo. Moderna lists more than a thousand, but “Grade 3” a bit more vaccine and significantly more for placebo, and that’s with less test subjects. Janssen doesn’t even bother to break them out. The Pfizer document says most showed up 2-4 days after an injection, 15 >= 8 days, one 98 days after, and average duration was 10 days.