A Logical 10-Step Approach to Covid-19 Booster Shots
By: Satyanarayan Hegde, MD, Beth Harkness, BSN, RN, CPN, Harry Opsimos, MD, ScM, Jack Sharp, MD, Amjad Tuffaha, MBBS, Bulent Karadag, MD, Jane Black, MD, and David Birnkrant, MD
The President’s Team, guided by the National Institutes of Health (NIH), initially said that everyone in the U.S. who was 8 months out from the primary series of vaccination should get a Covid-19 booster shot[i].
The Food and Drug Administration (FDA), Advisory Committee on Immunization Practices (ACIP), and Centers for Disease Control (CDC) disagreed, and said that the booster shot roll-out should be scaled back[ii].
Who got it right??Let’s review each step in the decision-making process and see what course of action turns out to be most logical. There are ten steps:
1.??????The Covid-19 vaccines administered in the U.S. were highly effective against the original virus[iii].
2.??????Vaccinating as many people as possible prevented disease[iv].
3.??????However, vaccination of the U.S. population did not occur quickly and widely enough to prevent variants from arising and increasing in prevalence[v].
4.??????Among these variants is a highly successful one, Delta, which is now predominating and causing a marked rise in infections, hospitalizations, and deaths[vi].
Vaccine-induced immunity wanes over time. However, there remains a protection against severe hospitalizations and deaths, likely due to vaccine-induced cellular immunity.
5.??????Vaccines are less effective against Delta. One major reason: vaccine-induced immunity wanes over time, and about 6 to 8 months after the primary series of vaccines, immunity to the Delta variant begins to diminish[vii].
6.??????With waning immunity, Delta can cause breakthrough infections in vaccinated individuals[viii].
7.??????On the positive side:?even when vaccine-induced antibody levels against Covid-19 have fallen, there remains good protection against severe hospitalization and death, likely due to vaccine-induced cellular immunity[ix].
8.??????However, if immunity wanes in vaccinated individuals and boosters are not provided, an increase in Covid-19 infections is likely. With increased infections of any severity, we can expect:
b.??????Covid-19 to spread, as individuals with even mild diseases infect others due to the high viral loads induced by the Delta variant in both vaccinated and unvaccinated individuals[xi]. And,
c.??????High risk groups, such as the elderly and immune suppressed, to experience increased hospitalizations and deaths, as they are more vulnerable to severe illness[xii].
9.??????Therefore, the goal of booster shots should be to prevent breakthrough Covid-19 infections of any severity, and not merely to prevent Covid-related hospitalizations and deaths.
10.??In light of (9) above, booster shots are indicated in everyone whose vaccine-induced immunity to Covid-19 is waning, with boosters first provided to individuals at highest risk of Covid-related hospitalization or death.
That is what The President was trying to enact. That is the vaccination plan occurring in Israel[xiii].
What has led to the disagreement among our scientific experts?
1.?The FDA and CDC adopted a standard for evaluating booster shots based on acuity of illness, defining vaccine effectiveness as “prevention of Covid-19 hospitalizations and deaths” instead of “prevention of Covid-19 breakthrough infections of any severity[xiv].”
However, this standard is misguided, as it views mild Covid-19 illness as an acceptable outcome and thereby derails the decision-making process outlined above (see #8 a, b, and c).?And we do not apply this same standard to non-Covid vaccines. For example, we administer millions of polio and diphtheria boosters in order to prevent resurgence of diseases that have essentially been eliminated in the U.S.[xv]
2.?There is concern over lack of access to Covid vaccines in the developing world[xvi].
However, injustices over vaccine access are not new and vaccine disparity is a geopolitical problem that should be addressed by improving vaccine distribution to the developing world. Disparities in Covid vaccination cannot be solved by restricting booster shots in the U.S[xvii].
The NIH and The President’s Team got it right. When their vaccine-induced immunity wanes, booster shots should be rolled out to the overall U.S. population, starting with the subgroups most vulnerable to severe illness and death.
At the same time, efforts should be maximized to overcome vaccine hesitancy with the goal of vaccinating our entire population and achieving herd immunity.
Developed nations should work to get Covid-19 vaccine (and other needed vaccinations) to developing nations, as vaccine disparities are unethical and unjust.
References
[i] https://khn.org/news/article/how-fauci-and-the-nih-got-ahead-of-the-fda-and-cdc-in-backing-boosters/
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[ii] https://apnews.com/article/fda-panel-rejects-widespread-pfizer-booster-shots-1cd1cf6a5c5c02b63f8a7324807a59f1
[iii] https://www.reuters.com/article/health-coronavirus-vaccines-int/pfizer-moderna-covid-19-vaccines-highly-effective-after-first-shot-in-real-world-use-u-s-study-shows-idUSKBN2BL2UW
[iv][iv] https://www.healthline.com/health-news/covid-19-vaccines-saved-140000-lives-over-first-5-months-of-2021
[viii] https://www.npr.org/sections/goatsandsoda/2021/08/20/1029628471/highly-vaccinated-israel-is-seeing-a-dramatic-surge-in-new-covid-cases-heres-why
[ix] https://www.pennmedicine.org/news/news-releases/2021/august/penn-study-details-robust-tcell-response-to-mrna-covid19-vaccines
[xii] https://publichealth.jhu.edu/2021/covid-19-vaccines-and-immunocompromised-people-fully-vaccinated-and-not-protected
[xiii] https://www.reuters.com/world/middle-east/israel-offers-covid-19-booster-shots-all-vaccinated-people-2021-08-29/
[xiv] https://www.cidrap.umn.edu/news-perspective/2021/09/following-fda-acip-recommends-covid-19-booster-shots
[xvi] https://www.who.int/news/item/22-07-2021-vaccine-inequity-undermining-global-economic-recovery
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About the authors
Pediatric Pulmonologist. Asthma Specialist. Sleep Medicine Specialist.
3 年Hi Satya, great start for discussion. I have concerns: How do we know boosting will stop spread? Vaccines do not appear to be sterilizing like other diseases. Stopping emergence of variants and spread is only hypothetical and has not been shown anywhere. DC recommendations for boosters seemed to occur without any useful data about booster safety/efficacy. Serologic boosting does not equal the stated goals of boosting, merely presumed. Toxicity associated with multiple boosters has not been ruled out in any prospective way. Vaccines have had enduring benefit from morbidity and mortality, which should be intended use.
Founder @ Sirica Therapeutics | Building Innovative Autism Therapy
3 年Great analysis, Dr.Satyanarayan (Satya) H.