Covid-19 vaccine booster

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Indications

  • immunocompromised individuals
  • adults, adolescents 12 & up (5 months after 2nd dose) (Pfizer or Moderna)[40]
    • mix & match equally safe & effective[46]
  • during Omicron predominance, COVID-19 hospitalization rates in Los Angeles County among unvaccinated persons were 23.0 times those of fully vaccinated persons with a booster, & 5.3 times those among fully vaccinated persons without a booster[45]
  • previously unvaccinated individuals will be eligible for a single dose of bivalent Moderna or Pfizer Covid-19 vaccine[82]
    • they will then be considered fully vaccinated (after 2 weeks) & not eligible for a Covid-19 vaccine booster[82]

Adverse effects

Notes

WHO did not support booster vaccinations early in the pandemic

  • richer countries should focus on ramping up vaccine supply to billions who are still waiting for their first dose[4][5]
  • solely for the purpose of managing a pandemic (independent of alleviating death & suffering in low & lower-middle income countries where < 15% of people are vaccinated), preventing the emergence of variants is far better managed by vaccinating the underserved unvaccinated than to vaccinate the vaccinated[4][22]
  • Covid-19 is likely here to stay as SARS-CoV2 continues to mutate in unvaccinated countries across the world & previous hopes of eradicating it diminish (WHO)[16]

* see pandemic management

2 dose mRNA vaccines produce strong protection

  • multiple studies show that 2 dose mRNA vaccines provide strong protection against severe disease (95% against hospitalization)[5]
  • data from the Israeli Ministry of Health suggests protection against severe disease is nearly 92% for people < 50 years & 85% for those > 50 years (without booster)
  • overall effectiveness of Pfizer vaccine decreases from 96% to 84% after 6 months[9]
  • antibody titer decline faster in cipients of the Pfzer vaccine than in COVID-19 survivors[11]
    • antibody titers decline by up to 40% per month in vaccinated persons, vs < 5% per month in Covid-19 convalescents
    • at 6 months, ~84% of vaccine recipients still have detectable antibody titers, whereas ~90% of Covid-19 convalescents still have detectable antibodies titers after 9 months[11]
    • a 3rd dose of Pfizer vaccine increases immune response 11 times higher than after the 2nd dose in older patients 65-85 years of age[9] (12 people studied)
    • a 3rd dose of Pfizer vaccine increases protection against Covid-19 infection 4-fold after 10 days in adults > 60 years according to Israeli Health Ministry[10]
  • early supporting evidence for booster largely from Israel for Pfizer vaccine
  • 4th Pfizer vaccine of marginal benefit to Israeli healthcare workers[47]
  • vaccine effectiveness generally decreases over time against SARS-CoV-2 infections, hospitalizations, & mortality[79]

breakthrough infections likely due to Delta variant, not waning immunity

in immunocompromised patients

Covid-19 vaccine booster marketing

  • Pfizer vaccine booster does substantially increase serum anti-spike protein antibody levels[35]
  • Moderna seeks FDA-approval for Covid-19 vaccine booster September 2021[14]
  • a Pfizer BNT162b2 vaccine booster among fully vaccinated Israeli citizens >= 60 years at least 5 months after 2nd dose had 11 fold decrease in risk of confirmed Covid-19 infection & > 19-fold decrease in risk of severe disease[15]
    • methods include 1,144,690 individuals >= 60 years followed between July 30 & August 22, 2021 & adjusting for possible confounding factors
    • reported follow-up period for that trial only went to 25 days post vaccination[15]
  • a 2nd dose of J&J Ad26.COV2.S vaccine induces high antibody levels[2]
  • Covid-19 vaccine makers plan for annual boosters[37]
  • Omicron variant could make it more likely that people will need a 4th Covid-19 vaccine earlier than expected[39]

boosters & Omicron

Federal Agencies on Covid-19 vaccine booster

  • FDA & CDC joint statements: (historical)
    • Covid-19 vaccine booster not needed (July 8, 2021)[8]
    • Covid-19 vaccine booster would be offered Sept 20, 2021 (August 18, 2021)[8]
      • 2 high-level officials in the FDA's Office of Vaccines Research & Review resigned reportedly because they were angry that the Biden administration was making decisions that should be left up to that agency[13]
  • FDA advisory panel voted unanimously on Sept 17, 2021 to recommend a 3rd dose of Pfizer's mRNA COVID-19 vaccine for elderly >=65 & those at high risk for severe outcomes[19][26]
    • the FDA advisory panel voted 16-2 against a 3rd dose of Pfizer vaccine for Americans >= 16 years[26]
    • CDC confirms recommendation of a 3rd dose of Pfizer's mRNA COVID-19 vaccine for elderly >=65 & those at high risk for severe outcomes, but not for healthcare or other frontline workers[28]
  • FDA advisory panel VRBPAC[31] & CDC[34] recommends approval of Moderna booster
    • dose 50 ug
    • adults ages >= 65 years
    • younger adults with high-risk medical conditions
    • high risk of occupational or institutional exposure
  • FDA advisory panel VRBPAC recommends a booster dose of Johnson & Johnson's COVID-19 vaccine for all individuals who received the single-dose vaccine[32]
  • FDA approves Johnson & Johnson's vaccine booster[34]
    • to be given >= 2 months after the initial dose
    • safe for people who got the Johnson & Johnson vaccine follow up with a dose of an mRNA vaccine from Pfizer or Moderna[33]
  • FDA approves 2nd booster dose of Pfizer or Moderna's mRNA COVID-19 vaccine for adults ages >= 50 years, & immunocompromised persons[48]*
  • FDA approves 2nd booster dose of Pfizer or Moderna's mRNA COVID-19 vaccine for adults >= 65 years or immunocompromised persons[81]
  • large study supports the recommendation for a second Pfizer booster in long-term care residents June 2022[59]
    • senior author with signficant financial ties to Pfizer
  • study in Isreal among healthcare workers Jan 2-Jan 31, 2022 reports 4th dose of Pfizer vaccine (given on Jan 2) reduced infection from 19.8% to 6.9%[60]

* immunocompromised people will receive 5 doses of Covid-19 mRNA vaccine in total: a 3-dose primary series, & 2 boosters[48]

Pfizer Covid-19 vaccine booster in Israel

  • Pfizer Covid-19 vaccine booster decreased risk of severe disease by a factor of 18 in persons > 60 years and 22 in younger persons
  • a 4th dose of Pfizer BNT162b2 vaccine effectiveness against infection peaked at 65% during week 3 after vaccination but declined to 22% by week 10
    • 72% effective in preventing severe disease for >= 10 weeks[56]

More general terms

References

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