{"id":4782,"date":"2025-07-22T20:39:34","date_gmt":"2025-07-23T02:39:34","guid":{"rendered":"https:\/\/allphasepharma.com\/dir\/?p=4782"},"modified":"2025-07-22T20:41:07","modified_gmt":"2025-07-23T02:41:07","slug":"much-ado-about-nothing-covid-19-vaccination-for-healthy-children","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2025\/07\/22\/4782\/much-ado-about-nothing-covid-19-vaccination-for-healthy-children\/","title":{"rendered":"MUCH ADO ABOUT NOTHING: Covid-19 Vaccination for Healthy Children"},"content":{"rendered":"\n

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Oh, what a disaster: all the ACIP members were replaced for no good reason, the best and the brightest.  Now children will die as incompetence rules supreme.  The CDC\u2019s guidance on Covid vaccination of healthy kids is being ignored, being made light of and challenged.  We are looking at governmental overreach, un-scientific decision making<\/em>. <\/p>\n\n\n\n

These are some of the claims being made. <\/p>\n\n\n\n

For details of the tug-of-war between HHS and CDC\/ACIP, we refer you to the Schwartz NEJM article which declares the supremacy of the ACIP as the \u2018gold standard\u2019 guidance issuer for the US vaccine recommendations and these should not be challenged. He and many others have been complaining about recent changes, the process and the challenge of ACIP promulgated wisdom.[1]<\/a><\/p>\n\n\n\n

If this all sounds like political theater, political grandstanding of politicians playing doctors, overdramatizing a rather minor issue, we are with you.  The press, echoing opinion leaders and some former committee members, drive a very partisan agenda here, creating breaking news.  It\u2019s like a storm in a tea pot.<\/p>\n\n\n\n

Let\u2019s take a step back and try to put things into perspective.  Not everything is black and white, a yes or no, not all is data-driven and fact-based.  There are grey zones for many areas of medicine and vaccinology, with gaps often patched up with well meant advice but occasionally showing committee bias in the way data are being interpreted. <\/p>\n\n\n\n

First, there is absolutely nothing wrong with the exchange of the ACIP panel members.  This is a job that can be adequately handled by many vaccine and immunology specialists in the big wide USA, which has plenty of experts.  That is not to say that the prior ACIP members were in any way unqualified or delinquent in their duty, just the opposite.  We just want to state the basic fact that these committee memberships can be revoked for good reasons, bad reasons, or no reasons.  The ACIP committee members are not supreme court judges with life-time positions and are replaceable.<\/p>\n\n\n\n

Second, there is this outcry about diverging views, whether or not to vaccinate children age 6 mo to 18 years who are healthy.  ACIP\/CDC recommended to vaccinate, HHS said it was not necessary.  Well, other health authorities beg to differ from ACIP; for example, WHO feels that vaccination is not warranted in this group. <\/p>\n\n\n

\n

Why is not everyone in the world following the judgement of our US grandees and gurus?\u00a0 Is WHO expertise inferior to ACIP?\u00a0\u00a0<\/span><\/p>\n<\/blockquote>\n\n\n

How about the Europeans?  EMA also has committees looking at the same data as their US colleagues.  Guess what \u2013 they did not recommend vaccination for healthy children in that particular age group.  For instance, Germany\u2019s expert panel (STIKO) has come out saying that only immunocompromised children should be vaccinated, because there is no evidence that healthy children would benefit.[2]<\/a> <\/p>\n\n\n\n

Let\u2019s be clear: WHO, RKI and ACIP agree on most recommendations when it comes to Covid vaccines.  We are talking about PROs and CONs of vaccinating healthy children, a controversy that is making people excited for no good reason.  Good people can have slightly different opinions about the value of vaccination in a particular subgroup, and all the furor here in the US seems just much ado about nothing. <\/p>\n\n\n\n

There is another little wrinkle here.  Treatment \u2018recommendations\u2019 and \u2018guidances\u2019, be it from the FDA or produced by a professional society, have long since become the de-facto go-to standard for doctors to avoid litigation.  Most practitioners cannot afford to deviate from these rule books; they would set themselves up for law suits, having to defend their course of action and any deviation from the true path that leads to redemption. Therefore, these recommendations become the doctrine to follow, and self-preservation takes the front seat.  In the name of \u2018evidence-based medicine\u2019, patients are no longer treated as individuals but as some kind of case fitting a study population for which experts have come up with recommendations.<\/p>\n\n\n\n

To be fair, these Expert recommendations often carry a statement that practitioners should use their best judgement as each case demands.   However, the reality is that non-adherence to guidelines can be quite dangerous.  So here we are: if CDC and\/or ACIP recommend something, we will have to document in the Medical Record why we did not follow their supreme leadership.  <\/p>\n\n\n\n

If you care to study expert opinions, recommendations, guidances from professional societies, you will find that most have adopted a standardized format for judging the evidence that their recommendations are based on.  Here is an example from the ATS\/IDSA Guidelines; we quote [3]<\/a>:<\/p>\n\n\n\n

\u201cWe followed the GRADE standards for evaluating the evidence \u2026 and assigned a quality of evidence rating of high, moderate, low, or very low. \u201c<\/p>\n\n\n\n

\u201c…recommendations that were based on low or very low quality of evidence and not believed to represent standards of care were labeled as
conditional recommendations.\u201d<\/p>\n\n\n\n

Linguistics matter here and demand attention.  Sometimes recommendations come in the form of \u201cwe recommend\u201d, sometimes as \u201cwe suggest\u201d.  Fair enough, this is an admission of the panel\u2019s discomfort with its own recommendations.  What should we make of recommendations that are based on \u2018low\u2019 or \u2018very low quality\u2019 of evidence? [4]<\/a>  And why are such \u2018baseless\u2019 recommendations even making it into guideline documents?<\/p>\n\n\n\n

Let\u2019s accept a simple fact: sometimes medical practice is not on rock-solid ground and opinions come into play.  When this happens, like for the Covid-19 vaccination in children, a prudent expert, newscaster or op-ed writer would refrain from inflammatory remarks and instead point out that what we have is a toss-up.  No need to get angry, no need to write partisan articles with headless headlines. <\/p>\n\n\n\n

And yes, it\u2019s political rancor that drives this useless debate. It\u2019s really much ado about nothing.  Fortunately, we have a solution, and here is our own \u201cstrong recommendation\u201d based on \u201chigh quality evidence\u201d:  We suggest ACIP and HHS issue separate sets of Covid-19 vaccination guidelines, clearly dated, marked and color-coded, one for Democrats and one for Republicans.  <\/p>\n\n\n\n

\"\"<\/a><\/figure>\n\n\n\n
\"\"<\/a><\/figure>\n\n\n\n

It may not save lives but could take the wind out of some lawsuits.<\/p>\n\n\n\n

We applaud the language found in the ACIP\u2019s latest revision regarding pediatric vaccination.  ACIP has now chosen the wording \u201cShared clinical decision-making\u201d, leaving it to the clinician and parent\/guardian to decide, if a healthy child should get the Covid vaccine from Pfizer or Moderna or none at all.[5]<\/a>   This is truly solomonic wording that everyone should be able to live with; it basically says that there is insufficient evidence to make a risk\/benefit recommendation. <\/p>\n\n\n\n

\n\n\n\n

APPENDIX<\/strong><\/p>\n\n\n\n

SPIKEVAX \/ Moderna Package Insert<\/strong> (actually a book of 78 pages!!!)  Its label, revised 7\/2025, says that SPIKEVAX is approved for use in individuals who are:<\/p>\n\n\n\n

\u2022 65 years of age and older, or<\/p>\n\n\n\n

\u2022 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19<\/p>\n\n\n\n

COMIRNATY \/ Pfizer-BioNTek Package Insert<\/strong>, revised 6\/2025 (39 pages) says that it is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.<\/p>\n\n\n\n

\n\n\n\n

Here are the WHO recommendations:<\/strong><\/p>\n\n\n\n

\"\"<\/a><\/figure>\n\n\n\n

Figure 1- WHO Recommendations<\/p>\n\n\n\n

<\/p>\n\n\n\n

Here are the former<\/span> recommendations from HHS\/CDC:<\/strong><\/p>\n\n\n\n

\"\"<\/a><\/figure>\n\n\n\n

Figure 2:  U.S. Department of Health and Human Services  |  Centers for Disease Control and Prevention  |  MMWR | September 19, 2024 | Vol. 73 | No. 37<\/p>\n\n\n\n

\n\n\n\n

ABBREVIATIONS<\/strong>
ACIP\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Advisory Committee of Immunization Practices
GRADE Grading of Recommendations, Assessment, Development,and Evaluation
HHS\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 US Dept. of Health and Human Services
RKI\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 Robert-Koch Institut
SAGE\u00a0\u00a0\u00a0\u00a0\u00a0 Strategic Advisory Group of Experts on Immunization
STIKO\u00a0\u00a0\u00a0\u00a0 St\u00e4ndige Impfkommission am Robert Koch-Institut
(Standing Immunization Committee at the Robert Koch Institute)<\/p>\n\n\n\n

\n\n\n\n

REFERENCESS<\/strong>
[1]<\/a> Schwartz J.\u00a0 Revised Recommendations for Covid-19 Vaccines – U.S. Vaccination Policy under Threat.\u00a0 NEJM 2025 DOI: 10.1056\/NEJMp2507766
[2]<\/a> https:\/\/www.rki.de\/SharedDocs\/FAQs\/DE\/Impfen\/COVID-19\/FAQ_Liste_Impfung_Kinder_Jugendliche.html?nn=16777208#entry_16870024
[3]<\/a> Metlay J.\u00a0 Diagnosis and Treatment of Adults with Community-acquired Pneumonia.\u00a0 An Official Clinical Practice Guideline of the American Thoracic Society and Infectious Diseases Society of America.\u00a0 Am J Respir Crit Care Med 200,\u00a0 e45\u2013e67, 2019
[4]<\/a> strong recommendation, low quality of evidence (for Questions 1, 7, 14)
conditional recommendation, low quality of evidence (for Questions 2, 3, 6,\u00a09, 10, 12, 13)
[5]<\/a> https:\/\/www.cdc.gov\/vaccines\/hcp\/imz-schedules\/child-adolescent-notes.html#note-covid-19<\/p>\n\n\n\n

<\/p>\n\n\n","protected":false},"excerpt":{"rendered":"

Oh, what a disaster: all the ACIP members were replaced for no good reason, the best and the brightest.  Now children will die as incompetence rules supreme.  The CDC\u2019s guidance on Covid vaccination of healthy kids is being ignored, being made light of and challenged.  We are looking at governmental Continue reading MUCH ADO ABOUT NOTHING: Covid-19 Vaccination for Healthy Children<\/span>→<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":4784,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[227,3,18],"tags":[1695,1271,2343,2345,2336,2334,2340,2337,1583,1747,2338,2342,655,2341,2344,2335,2339],"class_list":["post-4782","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-recent_literature","category-the_news","category-the_viewpoint","tag-acip","tag-allphase-pharma-consulting","tag-biontek","tag-comirnaty","tag-covid-19-recommendations","tag-covid-19-vaccination","tag-ema-vaccination-guideline","tag-guidelines-based-on-low-quality-data","tag-harald-reinhart","tag-hhs","tag-legal-implications-of-guidelines","tag-moderna","tag-pfizer","tag-rki","tag-spikevax","tag-stiko","tag-who-vaccination-guideline"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/07\/HR_MUCH-ADO.jpg?fit=640%2C180&ssl=1","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-1f8","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":5814,"url":"https:\/\/allphasepharma.com\/dir\/2025\/11\/27\/5814\/obeldesivir-fails-in-yet-another-study\/","url_meta":{"origin":4782,"position":0},"title":"Obeldesivir 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