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

  1. ↑ Pradhan R 'We Sent a Terrible Message': : Scientists Say Biden Jumped the Gun With Vaccine Booster Plan. Kaiser Health News. August 20, 2021 https://khn.org/news/article/covid-vaccine-boosters-science-biden-plan-jumped-gun/
  2. ↑ 2.0 2.1 Zimmer C Second Dose of J. & J. Vaccine Gives Strong Boost, Company Reports. New York Times. August 24, 2021 (via Doximity) https://www.doximity.com/articles/d5769040-5949-4336-9d7c-638c22702d27
  3. ↑ Armour S, Hopkins JS Biden Administration Likely to Approve Covid-19 Boosters at Six Months. Pfizer, BioNTech have requested clearance for Covid-19 vaccine boosters that an official said could be administered six months after previous dose. Wall Street Journal. August 26, 2021 https://www.wsj.com/articles/biden-administration-plans-covid-19-vaccine-boosters-at-six-months-instead-of-eight-11629919356
  4. ↑ 4.0 4.1 4.2 Nature Editorial. August 17, 2021 The WHO is right to call a temporary halt to COVID vaccine boosters. Nature 596, 317 (2021) https://www.nature.com/articles/d41586-021-02219-w
    Mishra M, Nadeem D WHO calls for halting COVID-19 vaccine boosters in favor of unvaccinated. Reuters. August 4, 2921 https://www.reuters.com/business/healthcare-pharmaceuticals/who-calls-moratorium-covid-19-vaccine-booster-doses-until-september-end-2021-08-04/
  5. ↑ 5.0 5.1 5.2 Vogel G Unethical? Unnecessary? The COVID-19 vaccine booster debate intensifies. Science. 2020. August 27. https://www.sciencemag.org/news/2021/08/unethical-unnecessary-covid-19-vaccine-booster-debate-intensifies
  6. ↑ 6.0 6.1 Fowlkes A, Gaglani M, Groover K, et al. Effectiveness of COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Frontline Workers Before and During B.1.617.2 (Delta) Variant Predominance - Eight U.S. Locations, December 2020-August 2021. MMWR Morb Mortal Wkly Rep. 2021 Aug 27;70(34):1167-1169 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34437521 Free article. https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e4.htm
  7. ↑ Prasad V Are We Jumping the Gun on COVID Boosters? Efficacy, safety, and ethical questions linger. MedPage Today. August 24, 2021 https://www.medpagetoday.com/opinion/vinay-prasad/94188
  8. ↑ 8.0 8.1 8.2 Sullivan P Pfizer to seek FDA authorization for booster of COVID-19 vaccine. The Hill. 2021. July 8 https://thehill.com/policy/healthcare/562169-pfizer-to-seek-fda-authorization-for-booster-of-covid-19-vaccine
    HHS.gov. July 8, 2021 Joint CDC and FDA Statement on Vaccine Boosters. https://www.hhs.gov/about/news/2021/07/08/joint-cdc-and-fda-statement-vaccine-boosters.html
    HHS.gov. August 18, 2021 Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots. https://www.hhs.gov/about/news/2021/08/18/joint-statement-hhs-public-health-and-medical-experts-covid-19-booster-shots.html
  9. ↑ 9.0 9.1 9.2 McNamara D Pfizer Vaccine Protection Wanes After 6 Months: Study. Medscape - Jul 28, 2021. https://www.medscape.com/viewarticle/955601
    Thomas SJ, Moreira ED Jr, Kitchin N et al Six Month Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine. medRxiv. July 18, 2021 Not indexed in PubMed https://www.medrxiv.org/content/10.1101/2021.07.28.21261159v1
  10. ↑ 10.0 10.1 Reuters Israel finds COVID-19 vaccine booster significantly lowers infection risk. Reuters. August 23, 2019 https://www.reuters.com/world/middle-east/israel-finds-covid-19-vaccine-booster-significantly-lowers-infection-risk-2021-08-22/
  11. ↑ 11.0 11.1 11.2 Reuters Staff Antibodies Fade Faster After Vaccine vs Actual Infection. Medscape. August 24, 2021 https://www.medscape.com/viewarticle/957089
    Israel A, Shenhar Y, Green I et al Large-scale study of antibody titer decay following BNT162b2 mRNA vaccine or SARS-CoV-2 infection. medRxiv. August 22, 2021 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34462761 Free PMC article. https://www.medrxiv.org/content/10.1101/2021.08.19.21262111v1
  12. ↑ Leonhart D The Morning. The booster-industrial complex. New York Times. August 30, 2021
  13. ↑ 13.0 13.1 Goodman B Politics or Protection? What's Behind the Push for Boosters? Medscape. September 1, 2021 https://www.medscape.com/viewarticle/958013
    Brennan Z In a major blow to vaccine efforts, senior FDA leaders stepping down Endpoints News. August 31, 2021 https://endpts.com/breaking-in-a-major-blow-to-vaccine-efforts-senior-fda-leaders-stepping-down-report/
  14. ↑ 14.0 14.1 Erman M, Maddipatla M Moderna Seeks US Authorization for COVID-19 Vaccine Booster. Medscape. September 2 2021 https://www.medscape.com/viewarticle/958068
  15. ↑ 15.0 15.1 15.2 Bar-On Y, Goldberg Y, Mandel M et al BNT162b2 vaccine booster dose protection: A nationwide study from Israel. MedRxiv. 2021. August 31. https://www.medrxiv.org/content/10.1101/2021.08.27.21262679v1
    Bar-On YM, Goldberg Y, Mandel M Protection of BNT162b2 Vaccine Booster against Covid-19 in Israel. N Engl J Med. 2021 Sep 15. PMID: https://www.ncbi.nlm.nih.gov/pubmed/34525275
  16. ↑ 16.0 16.1 Mendez R WHO says Covid will mutate like the flu and is likely here to stay. CNBC Health and Science. September 7, 2021. https://www.cnbc.com/2021/09/07/who-says-covid-is-here-to-stay-as-hopes-for-eradicating-the-virus-diminish.html
  17. ↑ 17.0 17.1 Crist C. Biden Administration Scaling Back Sept. 20 Booster Plan. Medscape - Sep 08, 2021. https://www.medscape.com/viewarticle/958365
  18. ↑ 18.0 18.1 Keaten J WHO chief urges halt to booster shots for rest of the year. AP News. September 8, 2021 https://apnews.com/article/business-health-coronavirus-pandemic-united-nations-world-health-organization-6384ff91c399679824311ac26e3c768a
  19. ↑ 19.0 19.1 19.2 Steenhuysen J FDA Vaccine Advisers Face Thorny Question: Are COVID-19 Boosters Needed? Medscape. September 7, 2021 https://www.medscape.com/viewarticle/958117
    Goodman B FDA Analysis Chills the Rush to Approve Boosters. Medscape. 2021 Sept 16. https://www.medscape.com/viewarticle/958906
  20. ↑ Khoury DS, Cromer D, Reynaldi A et al. Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection. Nat Med. 2021. PMID: https://www.ncbi.nlm.nih.gov/pubmed/34002089
  21. ↑ Mandavilli A In a new review, some F.D.A. scientists and others say boosters aren't needed for the general population. New York Times. Sept. 13, 2021 https://www.nytimes.com/2021/09/13/health/covid-vaccine-booster-lancet.html Krause PR, Fleming TR, Peto R et al Considerations in boosting COVID-19 vaccine immune responses. Lancet. 2021 Sept 13 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34534516 Free PMC article https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02046-8/fulltext
  22. ↑ 22.0 22.1 Strohbehn GW, Parker WF, Tabarrok A. What's the Right Dose for COVID Boosters? FDA must demand dosing data before giving full approval. https://www.medpagetoday.com/opinion/second-opinions/94500
  23. ↑ Schaefer GO, Leland RJ, Emanuel EJ. Making Vaccines Available to Other Countries Before Offering Domestic Booster Vaccinations. JAMA. 2021;326(10):903-904 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34382999 https://jamanetwork.com/journals/jama/fullarticle/2783234
  24. ↑ New Pfizer data makes case for booster shots 6 months after primary doses ABC News. 2021. September 15 https://www.msn.com/en-us/health/medical/new-pfizer-data-makes-case-for-booster-shots-6-months-after-primary-doses/ar-AAOtkxI?li=BBnb7Kz
  25. ↑ McNamara D New Moderna Vaccine Data 'Support' Booster Shot After 8 Months. Medscape. 2021. September 15. https://www.medscape.com/viewarticle/958808
  26. ↑ 26.0 26.1 26.2 Goodman B FDA Panel Backs Pfizer's COVID Booster for 65 and Older, Those at High Risk. Medscape. September 17, 2021 https://www.medscape.com/viewarticle/958997
    Walker M FDA Panel Backs Pfizer Booster for Select Groups. Advisors overwhelmingly support authorization, but shot down full approval bid. MedPage Today September 17, 2021 https://www.medpagetoday.com/infectiousdisease/covid19vaccine/94579
  27. ↑ Centers for Disease Control & Prevention (CDC) COVID-19 Vaccine Booster Shot. CDC Vaccines August 20, 2021 https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html
  28. ↑ 28.0 28.1 Goodman B CDC Panel Backs Boosters for Seniors, but Not Healthcare Workers. Medscape. September 23, 2021 https://www.medscape.com/viewarticle/959389
  29. ↑ Wingrove J, Jacobs J FDA Leans Toward Authorizing Moderna Booster at a Half Dose. Bloomberg News. 2021, September 28. https://www.bloomberg.com/news/articles/2021-09-29/fda-leans-toward-authorizing-moderna-booster-at-a-half-dose
    Crist C FDA May Authorize Half-Dose Moderna Booster. Medscape. Spetember 30, 2021 https://www.medscape.com/viewarticle/960044
  30. ↑ Scott J, Richterman A, Cevik M. Covid-19 vaccination: evidence of waning immunity is overstated. BMJ 2021;374:n2320. September 23 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34556464 https://www.bmj.com/content/374/bmj.n2320
  31. ↑ 31.0 31.1 Goodman B FDA Neutral on Moderna Bid for COVID Booster Ahead of Decisive Meeting. Medscape. October 12, 2021 https://www.medscape.com/viewarticle/960750
    Walker M Moderna Booster for Certain Populations Sails Through FDA Panel. All thumbs up, despite small sample size, data quality issues. MedPage Today October 14, 2021 https://www.medpagetoday.com/infectiousdisease/covid19vaccine/95050
    Goodman B FDA Advisors Vote to Recommend Moderna Boosters. Medscape. October 14, 2021 https://www.medscape.com/viewarticle/960915
  32. ↑ 32.0 32.1 Walker M FDA Panel Endorses Booster for All J&J Recipients. Committee advises booster at least 2 months following initial Johnson & Johnson shot. MedPage Today October 15, 2021 https://www.medpagetoday.com/infectiousdisease/covid19vaccine/95080
    Gooodman B FDA Panel Backs Second Shot for Those Who Got J&J Vaccine. Medscape. October 15, 2021 https://www.medscape.com/viewarticle/961003
  33. ↑ 33.0 33.1 Goodman B Mixing COVID Vaccine Boosters May Be Better Option: Study. Medscape. October 14, 2021 https://www.medscape.com/viewarticle/960932
    Atmar RL, Lyke KE, Deming ME et al Heterologous SARS-CoV-2 Booster Vaccinations - Preliminary Report medRxiv. Octeober 13, 2021 https://www.medrxiv.org/content/10.1101/2021.10.10.21264827v1.full.pdf
  34. ↑ 34.0 34.1 34.2 Goodman B FDA Authorizes Boosters for Moderna, J&J, Allows Mix-and-Match. Medscape. October 20, 2021 https://www.medscape.com/viewarticle/961291
  35. ↑ 35.0 35.1 Eliakim-Raz N, Leibovici-Weisman Y, Stemmer A et al Antibody Titers Before and After a Third Dose of the SARS-CoV-2 BNT162b2 Vaccine in Adults Aged >= 60 Years. JAMA. Published online November 5, 2021. PMID: https://www.ncbi.nlm.nih.gov/pubmed/34739043 https://jamanetwork.com/journals/jama/fullarticle/2786096
  36. ↑ 36.0 36.1 Rottenberg Y, Grinshpun A, Ben-Dov IZ et al Assessment of Response to a Third Dose of the SARS-CoV-2 BNT162b2 mRNA Vaccine in Patients With Solid Tumors Undergoing Active Treatment. JAMA Oncol. Published online November 23, 2021 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34812840 https://jamanetwork.com/journals/jamaoncology/fullarticle/2786532
  37. ↑ 37.0 37.1 Rubin R COVID-19 Vaccine Makers Plan for Annual Boosters, but It's Not Clear They'll Be Needed. JAMA. Published online November 24, 2021 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34817538 https://jamanetwork.com/journals/jama/fullarticle/2786818
  38. ↑ 38.0 38.1 Frellick M Risk for Severe COVID-19 and Death Plummets With Pfizer Booster. Medscape. December 8, 2021 https://www.medscape.com/viewarticle/964420
    Bar-On YM, Goldberg Y, Mandel M et al Protection against Covid-19 by BNT162b2 Booster across Age Groups. N Engl J Med. 2021, Dec 8 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34879188 https://www.nejm.org/doi/10.1056/NEJMoa2115926
    Arbel R, Hammerman A, Sergienko R et al BNT162b2 Vaccine Booster and Mortality Due to Covid-19 N Engl J Med. 2021, Dec 8 PMID: https://www.ncbi.nlm.nih.gov/pubmed/34879190 https://www.nejm.org/doi/full/10.1056/NEJMoa2115624
  39. ↑ 39.0 39.1 Crist C Omicron May Require Fourth Vaccine Dose, Pfizer Says. Medscape. December 9, 2021 https://www.medscape.com/viewarticle/964505
  40. ↑ 40.0 40.1 40.2 Walker M FDA Lowers Age Range for Pfizer Booster Shot. Agency also shortens interval between primary series and boosters for ages 12 and up. MedPage Today January 3, 2022 https://www.medpagetoday.com/infectiousdisease/covid19vaccine/96470
    AMA Morning Rounds. Jan 10, 2022 American Medical Association
  41. ↑ 41.0 41.1 Garcia-Beltran WF, St. Denis KJ, Hoelzemer A et al. mRNA-based COVID-19 vaccine boosters induce neutralizing immunity against SARS-CoV-2 Omicron variant. Cell 2021 Dec 23; [e-pub]. PMID: https://www.ncbi.nlm.nih.gov/pubmed/34995482 PMCID: PMC8733787 Free PMC article https://www.cell.com/cell/fulltext/S0092-8674(21)01496-3
  42. ↑ 42.0 42.1 Crist C At-Risk Americans Become Eligible for Fourth COVID Shot This Week. Medscape. Jan 10, 2022 https://www.medscape.com/viewarticle/966335
  43. ↑ 43.0 43.1 Accorsi EK, Britton A, Fleming-Dutra KE et al Association Between 3 Doses of mRNA COVID-19 Vaccine and Symptomatic Infection Caused by the SARS-CoV-2 Omicron and Delta Variants. JAMA. Published online January 21, 2022. PMID: https://www.ncbi.nlm.nih.gov/pubmed/3506099 https://jamanetwork.com/journals/jama/fullarticle/2788485
  44. ↑ 44.0 44.1 Federman J Israel study: 4th vaccine shows limited results with omicron. Associated Press (AP). Jan 17, 2022 https://apnews.com/article/coronavirus-pandemic-health-middle-east-israel-5da0bbef16209e9c55e48af40248af11
  45. ↑ 45.0 45.1 Danza P, Koo TH, Haddix M et al SARS-CoV-2 Infection and Hospitalization Among Adults Aged >= 18 Years, by Vaccination Status, Before and During SARS-CoV-2 B.1.1.529 (Omicron) Variant Predominance - Los Angeles County, California, November 7, 2021=January 8, 2022. MMWR Morb Mortal Wkly Rep. ePub: 1 February 2022 PMID: https://www.ncbi.nlm.nih.gov/pubmed/35113851 https://www.cdc.gov/mmwr/volumes/71/wr/mm7105e1.htm
  46. ↑ 46.0 46.1 Atmar RL, Lyke KE, Deming ME et al. Homologous and heterologous Covid-19 booster vaccinations. N Engl J Med 2022 Jan 26; [e-pub]. PMID: https://www.ncbi.nlm.nih.gov/pubmed/35081293 https://www.nejm.org/doi/10.1056/NEJMoa2116414
  47. ↑ 47.0 47.1 Walker M 4th COVID Shot Offered 'Marginal' Benefit for Israeli Health Workers. Real-world data find higher antibody levels, subpar vaccine efficacy with extra dose. MedPage Today March 16, 2022 https://www.medpagetoday.com/infectiousdisease/covid19vaccine/97706
  48. ↑ 48.0 48.1 48.2 Walker M FDA Greenlights Second COVID Booster for Select Groups. Another round of Pfizer or Moderna shots authorized for older or immunocompromised Americans. MedPage Today March 29, 2022 https://www.medpagetoday.com/infectiousdisease/covid19vaccine/97920
  49. ↑ 49.0 49.1 49.2 Walker M Mixed Bag for Fourth Dose of Pfizer Vaccine vs Omicron. Real-world data show less infection and severity, but long-term benefit less clear. MedPage Today April 5, 2022 https://www.medpagetoday.com/infectiousdisease/covid19vaccine/98061
    Bar-On YM, Goldberg Y, Mandel M et al Protection by a Fourth Dose of BNT162b2 against Omicron in Israel. N Engl J Med. 2022. April 5 PMID: https://www.ncbi.nlm.nih.gov/pubmed/35381126 https://www.nejm.org/doi/full/10.1056/NEJMoa2201570
  50. ↑ 50.0 50.1 Wolfson AR, Freeman EE, Blumenthal KG Urticaria 12 Days After COVID-19 mRNA Booster Vaccination. JAMA. Published online April 14, 2022 PMID: https://www.ncbi.nlm.nih.gov/pubmed/35420647 https://jamanetwork.com/journals/jama/fullarticle/2791317
  51. ↑ 51.0 51.1 51.2 Walker M Moderna: Bivalent COVID Booster Passes Muster. Superior immune response to authorized booster, company says. MedPage Today April 19, 2022 https://www.medpagetoday.com/infectiousdisease/covid19vaccine/98278
    McNamara D Moderna: Data Show COVID Booster 'Potent' vs Newer Omicron Variants. Medscape. June 22, 2022 https://www.medscape.com/viewarticle/976034
  52. ↑ 52.0 52.1 Magen O, Waxman JG, Makov-Assif M et al Fourth Dose of BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting. N Engl J Med. 2022. April 13 PMID: https://www.ncbi.nlm.nih.gov/pubmed/35417631 https://www.nejm.org/doi/full/10.1056/NEJMoa2201688
    Offit PA. Covid-19 boosters - Where from here? N Engl J Med 2022 Apr 28; 386:1661; [e-pub] PMID: https://www.ncbi.nlm.nih.gov/pubmed/35417633
  53. ↑ 53.0 53.1 Walker M NIH Probes Palovid Relapses; Pandemic of the Unvaxxed No More? Musk Disses Wellbutrin. A daily roundup of news on Covid-19 and the rest of medicine. MedPage Today May 2, 2022 https://www.medpagetoday.com/infectiousdisease/covid19/98500
  54. ↑ 54.0 54.1 Ellis R Omicron Breakthrough Cases Boost Protection, Studies Say, Medscape. May 18, 2022 https://www.medscape.com/viewarticle/974194
  55. ↑ 55.0 55.1 Chappell B, Stein R Moderna says its new vaccine booster shows 'superior' response to omicron. NPR. June 8, 2022 https://www.npr.org/2022/06/08/1103659340/moderna-vaccine-booster-omicron
  56. ↑ 56.0 56.1 Gazit S et al. Short term, relative effectiveness of four doses versus three doses of BNT162b2 vaccine in people aged 60 years and older in Israel: Retrospective, test negative, case-control study. BMJ 2022 May 24; 377:e071113 PMID: https://www.ncbi.nlm.nih.gov/pubmed/35609888 PMCID: PMC9127435 Free PMC article https://www.bmj.com/content/377/bmj-2022-071113
  57. ↑ 57.0 57.1 Rubin R COVID-19 Boosters This Fall to Include Omicron Antigen, but Questions Remain About Its Value. JAMA. Published online July 8, 2022 PMID: https://www.ncbi.nlm.nih.gov/pubmed/35802386 https://jamanetwork.com/journals/jama/fullarticle/2794259
  58. ↑ 58.0 58.1 58.2 Twenter P Moderna's omicron-targeted vaccine nearly twice as effective against BA.4, BA.5. Becker's Hospital Review. July 11, 2022 https://www.beckershospitalreview.com/pharmacy/moderna-s-omicron-targeted-vaccine-nearly-twice-as-effective-against-ba-4-ba-5.html
  59. ↑ 59.0 59.1 Muhsen K et al. Association of receipt of the fourth BNT162b2 dose with Omicron infection and COVID-19 hospitalizations among residents of long-term care facilities. JAMA Intern Med 2022 Jun 23; [e-pub]. PMID: https://www.ncbi.nlm.nih.gov/pubmed/35737368 https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2793699
  60. ↑ 60.0 60.1 Cohen MJ, Oster Y, Moses AE et al Association of Receiving a Fourth Dose of the BNT162b Vaccine With SARS-CoV-2 Infection Among Health Care Workers in Israel. JAMA Netw Open. 2022;5(8):e2224657. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2794864
  61. ↑ 61.0 61.1 Cennimo DJ, Brusch JL COVID-19 Vaccines. Booster Vaccine Candidates Medscape. July 14, 2022 https://emedicine.medscape.com/article/2500139-overview
  62. ↑ 62.0 62.1 Havers FP, Patel K, Whitaker M, et al. Laboratory-Confirmed COVID-19-Associated Hospitalizations Among Adults During SARS-CoV-2 Omicron BA.2 Variant Predominance - COVID-19-Associated Hospitalization Surveillance Network, 14 States, June 20, 2021-May 31, 2022. MMWR Morb Mortal Wkly Rep 2022;71:1085-1091 PMID: https://www.ncbi.nlm.nih.gov/pubmed/36006841 https://www.cdc.gov/mmwr/volumes/71/wr/mm7134a3.htm
  63. ↑ 63.0 63.1 McNamara D FDA Authorizes Updated COVID Boosters to Target Newest Variants. Medscape. August 31, 2022 https://www.medscape.com/viewarticle/980027
  64. ↑ 64.0 64.1 Chalkias S et al. A bivalent Omicron-containing booster vaccine against Covid-19. N Engl J Med 2022 Sep 16; [e-pub]. PMID: https://www.ncbi.nlm.nih.gov/pubmed/36112399 https://www.nejm.org/doi/10.1056/NEJMoa2208343
  65. ↑ 65.0 65.1 Tseng HF, Ackerson BK, Bruxvoort KJ et el Effectiveness of mRNA-1273 against infection and COVID-19 hospitalization with SARS-CoV-2 Omicron subvariants: BA.1, BA.2, BA.2.12.1, BA.4, and BA.5. MedRxiv. Oct 1, 2022 https://www.medrxiv.org/content/10.1101/2022.09.30.22280573v1.full.pdf
  66. ↑ 66.0 66.1 Stulpin C Early data show Pfizer's omicron booster 'substantially' boosted antibodies against BA.5. Helio. Infectious Diseases. Oct 13, 2022 https://www.healio.com/news/infectious-disease/20221013/early-data-show-pfizers-omicron-booster-substantially-boosted-antibodies-against-ba5
  67. ↑ 67.0 67.1 AMA Morning Rounds. Oct 20, 2022 American Medical Association
  68. ↑ 68.0 68.1 Chin ET, Leidner D, Lamson L et al Protection against Omicron from Vaccination and Previous Infection in a Prison System. N Engl J Med 2022. Oct 26 PMID: https://www.ncbi.nlm.nih.gov/pubmed/36286260 https://www.nejm.org/doi/full/10.1056/NEJMoa2207082
  69. ↑ 69.0 69.1 Ellis R Pfizer: Bivalent Booster Protects Against BQ.1.1 Subvariant. Medscape. Nov 22, 2022 https://www.medscape.com/viewarticle/984471
  70. ↑ 70.0 70.1 Chalkias S et al Neutralization of Omicron Subvariant BA.2.75 after Bivalent Vaccination. N Engl J Med. 2022. Nov 23 PMID: https://www.ncbi.nlm.nih.gov/pubmed/36416761 https://www.nejm.org/doi/full/10.1056/NEJMc2212772
  71. ↑ 71.0 71.1 Wang Q, Iketani S, Li Z et al Alarming antibody evasion properties of rising SARS-CoV-2 BQ and XBB subvariants. Cell 2022 Dec 14;S0092-8674(22)01531-8 PMID: https://www.ncbi.nlm.nih.gov/pubmed/36580913 PMCID: PMC9747694 Free PMC article
  72. ↑ 72.0 72.1 AMA Morning Rounds. Dec 19, 2022 American Medical Association
    Edwards E Updated booster shot prevents a majority of Covid hospitalizations in older adults. New York Times. Dec 16, 2022 https://www.nbcnews.com/health/health-news/updated-booster-shot-prevents-majority-covid-hospitalizations-older-ad-rcna62073
    Tenforde MW, Weber ZA, Natarajan K, et al. Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID-19- Associated Emergency Department or Urgent Care Encounters and Hospitalizations Among Immunocompetent Adults - VISION Network, Nine States, September-November 2022. MMWR Morb Mortal Wkly Rep. ePub: 16 December 2022. https://www.cdc.gov/mmwr/volumes/71/wr/mm715152e1.htm
    Surie D, DeCuir J, Zhu Y, et al. Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID-19- Associated Hospitalization Among Immunocompetent Adults Aged >= 65 Years - IVY Network, 18 States, September 8-November 30, 2022. MMWR Morb Mortal Wkly Rep. ePub: 16 December 2022 https://www.cdc.gov/mmwr/volumes/71/wr/mm715152e2.htm
  73. ↑ 73.0 73.1 McConeghy KW et al. Infections, hospitalizations, and deaths among US nursing home residents with vs without a SARS-CoV-2 vaccine booster. JAMA Netw Open 2022 Dec 7; 5:e2245417 PMID: https://www.ncbi.nlm.nih.gov/pubmed/36477482 Free article https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2799266
  74. ↑ 74.0 74.1 74.2 Ingram I CDC, FDA Flag Early Signal of Stroke Risk With Bivalent COVID Vaccine. One surveillance system detects potential link in seniors, yet multiple others show none. MedPage Today January 13, 2023 https://www.medpagetoday.com/infectiousdisease/covid19vaccine/102644
  75. ↑ 75.0 75.1 Offit Paul A Bivalent Covid-19 Vaccines - A Cautionary Tale. N Engl J Med. 2023. January 11, 2023 PMID: https://www.ncbi.nlm.nih.gov/pubmed/36630616 https://www.nejm.org/doi/full/10.1056/NEJMp2215780
  76. ↑ 76.0 76.1 Hein I CDC: Bivalent COVID Vaccines Stop Illness From XBB.1.5.
    And Pfizer lab data show better neutralization against latest variants with bivalent shot. MedPage Today January 25, 2023 https://www.medpagetoday.com/infectiousdisease/covid19vaccine/102815
    Link-Gelles R, Ciesla AA, Roper LE et al. Early Estimates of Bivalent mRNA Booster Dose Vaccine Effectiveness in Preventing Symptomatic SARS-CoV-2 Infection Attributable to Omicron BA.5- and XBB/XBB.1.5- Related Sublineages Among Immunocompetent Adults - Increasing Community Access to Testing Program, United States, December 2022-January 2023. MMWR Morb Mortal Wkly Rep. ePub: 25 January 2023. PMID: https://www.ncbi.nlm.nih.gov/pubmed/36580430 PMCID: PMC9812442 Free PMC article https://www.cdc.gov/mmwr/volumes/72/wr/mm7205e1.htm
  77. ↑ 77.0 77.1 Short E Moderna Booster Vaccine Singled Out for Chronic Hives. Chronic spontaneous urticaria more frequent when compared with Pfizer's mRNA vaccine. MedPage Today February 1, 2023 https://www.medpagetoday.com/infectiousdisease/covid19vaccine/102923
    Duperrex O, Tommasini F, Muller YD Incidence of Chronic Spontaneous Urticaria Following Receipt of the COVID-19 Vaccine Booster in Switzerland. JAMA Netw Open. 2023;6(2):e2254298. PMID: https://www.ncbi.nlm.nih.gov/pubmed/36723944 https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2800873
  78. ↑ 78.0 78.1 Tsz Tsun Lai F, Ka Chun Yan V, Ye X Booster vaccination with inactivated whole-virus or mRNA vaccines and COVID-19- related deaths among people with multimorbidity: a cohort study. CMAJ 2023 195(4). Jan 30 https://www.cmaj.ca/content/195/4/E143
  79. ↑ 79.0 79.1 Wu N, Joyal-Desmarais K, Ribeiro PAB et al Long-term effectiveness of COVID-19 vaccines against infections, hospitalisations, and mortality in adults: findings from a rapid living systematic evidence synthesis and meta-analysis up to December, 2022. Lancet Respir Med. 2023. Feb 10. PMID: https://www.ncbi.nlm.nih.gov/pubmed/36780914 PMCID: PMC9917454 Free PMC article https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(23)00015-2/fulltext
  80. ↑ 80.0 80.1 Jabagi MJ et al Stroke, Myocardial Infarction, and Pulmonary Embolism after Bivalent Booster. N Engl J Med 2023. March 29. PMID: https://www.ncbi.nlm.nih.gov/pubmed/36988584 https://www.nejm.org/doi/full/10.1056/NEJMc2302134
  81. ↑ 81.0 81.1 AMA Morning Rounds. April 19, 2023 Amercian Medical Association
    Fiore K Second Omicron Booster Authorized Here's the FDA's latest update on COVID vaccines. MedPage Today April 18, 2023 https://www.medpagetoday.com/infectiousdisease/covid19vaccine/104072
  82. ↑ 82.0 82.1 82.2 82.3 Moore JP Why Is One Dose Suddenly Enough for the mRNA COVID Vaccines? FDA and CDC have made yet another questionable decision. MedPage Today. May 2, 2023 https://www.medpagetoday.com/opinion/second-opinions/104295
  83. ↑ 83.0 83.1 83.2 Arbel R et al. Effectiveness of a bivalent mRNA vaccine booster dose to prevent severe COVID-19 outcomes: A retrospective cohort study. Lancet Infect Dis 2023 Apr 13; [e-pub]. PMID: https://www.ncbi.nlm.nih.gov/pubmed/37062302 PMCID: PMC10156150 Free PMC article https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(23)00122-6/fulltext
    Lin D-Y et al. Durability of bivalent boosters against omicron subvariants. N Engl J Med 2023 May 11; 388:1818. PMID: https://www.ncbi.nlm.nih.gov/pubmed/37043647 PMCID: PMC10120009 Free PMC article https://www.nejm.org/doi/10.1056/NEJMc2302462
  84. ↑ 84.0 84.1 Lane EG et al. Time for resolution of COVID-19 vaccine-related axillary lymphadenopathy and associated factors. AJR Am J Roentgenol 2022 Oct; 219:559. PMID: https://www.ncbi.nlm.nih.gov/pubmed/35583425 https://www.ajronline.org/doi/10.2214/AJR.22.27687
    Mema E et al. Axillary lymphadenopathy after a COVID-19 vaccine booster dose: Time to resolution on ultrasound follow-up and associated factors. AJR Am J Roentgenol 2023 Aug; 221:175. PMID: https://www.ncbi.nlm.nih.gov/pubmed/36883774 https://www.ajronline.org/doi/10.2214/AJR.22.28970
    Mullen LA. Editorial comment: Duration of axillary lymphadenopathy after COVID-19 vaccine booster administration. AJR Am J Roentgenol 2023 Aug; 221:183. PMID: https://www.ncbi.nlm.nih.gov/pubmed/36946901 https://www.ajronline.org/doi/10.2214/AJR.23.29309
  85. ↑ 85.0 85.1 AMA Morning Rounds, Oct 4, 2023 American Medical Association
  86. ↑ 86.0 86.1 Link-Gelles R, Ciesla AA, Mak J, et al. Early Estimates of Updated 2023-2024 (Monovalent XBB.1.5) COVID-19 Vaccine Effectiveness Against Symptomatic SARS-CoV-2 Infection Attributable to Co-Circulating Omicron Variants Among Immunocompetent Adults - Increasing Community Access to Testing Program, United States, September 2023-January 2024. MMWR Morb Mortal Wkly Rep 2024;73:77-83 PMID: https://www.ncbi.nlm.nih.gov/pubmed/38300853 https://www.cdc.gov/mmwr/volumes/73/wr/mm7304a2.htm
  87. ↑ 87.0 87.1 Lu Y et al. Stroke risk after COVID-19 bivalent vaccination among US older adults. JAMA 2024 Mar 19; 331:938. PMID: https://www.ncbi.nlm.nih.gov/pubmed/38502075 PMCID: PMC10951737 (available on 2024-09-19) https://jamanetwork.com/journals/jama/fullarticle/2816237
  88. ↑ 88.0 88.1 Moniuszko S. Gualtieri AE New COVID vaccine for 2024, isolation guidelines, free tests and more questions, answered. CBS News. Sept 4, 2024 https://www.cbsnews.com/news/covid-2024-guidelines-isolation-tests-vaccine/
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