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okay, moving on from my contention that poverty, job loss, business loss, loneliness, food/housing insecurity, harm reduction should all figure in our public health recommendations from now on, the CDC’s Advisory Committee on Immunization Practices (ACIP) released guidelines
yesterday so wanted to summarize. Nice slide set summary here (pdf) and here are main points (necessarily focused on Pfizer/BioNTech vaccine as only one approved!).
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-12/slides-12-12/COVID-03-Mbaeyi.pdf
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-12/slides-12-12/COVID-03-Mbaeyi.pdf
Vaccine given intramuscularly as a 2-dose series 3 weeks apart. If >21 days since the 1st dose, the 2nd dose should be given at the earliest opportunity (but doses do not need repeating). There is some protective efficacy after the first dose (52%)
so health centers will decide (for their health care workers) if their first supply should be given to as many as possible as 1st dose while awaiting 2nd dose or reserve supplies for 2-dose administration for fewer. I would favor former but not in charge of administration
As discussed before, natural immunity is "real" so I would favor those who have had COVID to step back in line to allow those nonimmune to get vaccinated first; ACIP agrees but says "you can wait until 90 days after COVID, if desired". I haven't had COVID but would be happy to
give my dose to a public school teacher! IF you are quarantining, ACIP says wait until end of quarantine after exposure to get your dose (to avoid coming in after exposure) until you are in care facility. Wait 90 days post getting convalescent plasma or monoclonal antibody
for COVID. Low rate adverse events among the >20,000 individuals who got vaccinated in the phase III trial of the Pfizer/BioNTech mRNA vaccine, mainly injection site reactions (see Tables 18, 19 for exact amounts here). Little fever, headache, myalgias too https://www.fda.gov/media/144245/
In post-vaccine distribution phase in the UK, 2 individuals with a history of severe allergic reactions had an allergic reaction to the Pfizer vaccine, so ACIP recommends that anyone with a history of anaphylactoid reactions to a vaccine or injectable defer vaccination.
But for those with a history of allergies in general, even severe, don't worry - just recommend that monitoring after vaccination should occur for ~30 minutes (instead of the usual 15 minutes).
And if you HIV or are pregnant/lactating? 196 people with HIV were enrolled into the Pfizer/BioNtech trial but the NEJM article said safety and efficacy data for this population will be presented separately - should happen right away, we have asked. NEJM: https://www.nejm.org/doi/10.1056/NEJMoa2034577we
Since not live vaccine and no biological reason to be concerned about HIV, would recommend those with HIV be vaccinated. In terms of pregnancy/breastfeeding, many of those who work on women health (i have interest in HIV&women) are disappointed this was an exclusion criterion
Despite stronger FDA industry draft guidance that you need to justify why leave pregnant/breastfeeding women OUT rather than IN. See here from FDA: https://www.fda.gov/media/90160/download
However, again, no animal model data why concerning in preg/lactation; not live vaccine; so would encourage
However, again, no animal model data why concerning in preg/lactation; not live vaccine; so would encourage
this population of pregnancy/breastfeeding women to get vaccinated (ACIP agrees). Moderna mRNA-1273 vaccine FDA hearing is December 17, 2020 (next week) so this 2nd vaccine shouldn't be too far behind in getting shipped. Certainly makes holidays bright.
