How Will UN-healthy Americans Respond to COVID Vaccines?

How Will UN-healthy Americans Respond to COVID Vaccines?

Tuesday, October 6th 2020 at 10:15 am
By: Marco Cáceres

Originally published on http://www.thevaccinereaction.org

If you look at the human clinical trials that have been conducted this year by drug companies developing experimental vaccines for COVID-19, the participants in those trials have all been “healthy adults.” Take, for example, Moderna’s Phase 1 clinical trial for its mRNA-1273 vaccine, which included 45 healthy adults 18 to 55 years old. The same is true for the Phase 1/2 clinical trial for the BNT162b1 vaccine being developed jointly by Pfizer and BioNTech. That trial also involved 45 healthy adults between the ages of 18 and 55 years.1 2 3 4 5 6

The Phase 1 clinical trial for CanSino Biologics’ Ad5-nCoV vaccine included 108 healthy adults 45 to 60 years of age. The Phase 1/2 trial for Novavax’s NVX‑CoV2373 was limited to 131 healthy adults 18 to 59 years old. The Phase 1/2 trial for AstraZeneca/University of Oxford’s AZD1222 (formerly ChAdOx1 nCoV-19) vaccine involved 1,077 healthy adults 18 to 55 years of age.7 8 9 10 11 12

There were two age groups in Johnson & Johnson’s Phase 1/2a clinical trial for its Ad26.COV2.S vaccine. The first group consisted of 402 healthy adults 18 to 55 years old. The second group included 394 healthy elderly adults 65 years of age and older.13

All six of these experimental COVID-19 vaccine programs have at least three things in common. First, they have all moved into the Phase 3 clinical trial stage in which tens of thousands of healthy adults are being recruited to continue testing the safety and efficacy of the vaccines. Second, many of the people who participated in the trials experienced adverse events after getting the vaccines. Third, all of the participants were healthy adults.

Experimental COVID-19 Vaccines Have Produced Many Adverse Events

One reason that these COVID-19 vaccine development programs have proceeded to Phase 3 clinical trials is that the drug companies behind them determined that the earlier trials showed the vaccines stimulated sufficiently strong antibody responses by the immune system to merit further research and testing. The companies also judged the vaccines to be “generally considered” safe,14 15 16 17 18 19 20 21 22 23 24 25 even though the vaccines provoked adverse events in dozens of trial subjects–including some serious or severe adverse events, as in the case of the Moderna mRNA-1273, Pfizer/BioNTech BNT162b1, CanSino Biologics Ad5-nCoV, Novavax NVX‑CoV2373 and Johnson & Johnson Ad26.COV2.S vaccines.1 2 4 7 9 25

No serious or severe adverse events were reported in the Phase 1/2 trial for the AstraZeneca/University of Oxford AZD1222 vaccine before AstraZeneca announced on Sept. 8, 2020 AstraZeneca that it was pausing its Phase 3 trials on the vaccine in United States and the United Kingdom to investigate a case of transverse myelitis (a neurological condition caused by inflammation of the spinal cord) suffered by one of the volunteer trial participants.26 27

Phase 3 Clinical Trial for AZD1222 Still Paused Pending FDA Safety Review

The Phase 3 trial in the U.K. was resumed on Sept. 12 following a review by officials at the U.K.’s Medicines Health Regulatory Authority (MHRA), who reportedly concluded that it was safe to do so. The clinical trial in the U.S. remains on hold while the U.S. Food and Drug Administration (FDA) is investigating the “unexplained illness.” Recent news reports indicate that the FDA may, in fact, be expanding its investigation. FDA commissioner Stephen Hahn said:

We’re here to protect the American public and we’re going to do very significant work with the company to figure out if there’s a significant safety issue or not.28 29
Consistently, reports about the adverse events experienced by clinical trial participants receiving experimental COVID-19 vaccines have tended to downplay the events, with company spokespersons noting that vaccine reactions have been “mild or moderate” and short-lived. While they didn’t hide the fact that there were numerous serious or severe adverse events to the vaccines, neither did they highlight these reactions. Nor did they raise many concerns about the unknown long-term effects of all vaccine adverse events, regardless of their severity.3 12 25 30 31 32

Most People in the U.S. are Not Healthy

Perhaps most concerning is the apparent neglect to acknowledge the elephant in the room, which leads to the obvious question being asked by many Americans concerned about the safety of experimental COVID-19 vaccines being rushed to market: “If these vaccines are only being primarily tested on healthy adult volunteers under age 65 and a good number of them are suffering vaccine adverse events, then how will the elderly over age 65 and unhealthy adults and children react to the vaccines?”

This is not an insignificant question, given that most Americans are not healthy. Six out of 10 adults in the U.S. suffer from a chronic disease. Four out of 10 adults in the U.S. suffer from two or more chronic diseases. An estimated 10-20 million (13.5 to 27 percent) American children and adolescents suffer from a chronic illness or disability. An estimated 42.4 percent of adults in the U.S. are obese–9.2 percent qualify as severely obese. An estimated 13.7 million (18.5 percent) American children and adolescents qualify as obese. More than 131 million Americans, or 66 percent of all adults in the U.S., take prescription drugs.33 34 35 36 37

A study published in the journal Mayo Clinic Proceedings in 2016 found that less than three percent of Americans live a health lifestyle. Another study published in the journal Metabolic Syndrome and Related Disorders in 2018 found that only 12 percent of adults in the U.S. are metabolically healthy. These kind of studies abound.38 39

A sick and medicated America is the new norm. Tens of millions of children and adults in the U.S. are not healthy. How many and what kind of adverse events should they expect from experimental COVID-19 vaccines that are only being tested on healthy adults over a short period of time?

References

1 Cáceres M. Healthy Clinical Trial Subjects Suffer Grade 3 Side Effects to Moderna’s mRNA COVID-19 Vaccine. The Vaccine Reaction May 24, 2020.

2 Cáceres M. Volunteer Describes His Serious Reaction in Moderna’s mRNA COVID-19 Vaccine Trial. The Vaccine Reaction May 30, 2020.

3 Jackson LA, et al. An mRNA Vaccine against SARS-CoV-2 — Preliminary Report. NEJM July 14, 2020.

4 Cáceres M. Pfizer/BioNTech’s COVID-19 Vaccine Causes Adverse Reactions in Over Half of Clinical Trial Volunteers. The Vaccine Reaction July 18, 2020.

5 Mulligan MJ, et al. Phase 1/2 Study to Describe the Safety and Immunogenicity of a COVID-19 RNA Vaccine Candidate (BNT162b1) in Adults 18 to 55 Years of Age: Interim Report. medRxXiv July 1, 2020.

6 U.S. National Library of Medicine. A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-2019 in Healthy Adults. ClinicalTrials.gov May 12, 2020.

 

7 Cáceres M. 81 Percent of Clinical Trial Volunteers Suffer Reactions to CanSino Biologics’ COVID-19 Vaccine That Uses HEK293 Human Fetal Cell Lines. The Vaccine Reaction July 6, 2020.

8 Liu A. China’s CanSino Bio advances COVID-19 vaccine into phase 2 on preliminary safety data. Fierce Pharma Apr. 10, 2020.

9 Cáceres M. Novavax’s Adjuvanted COVID-19 Vaccine Caused Severe Adverse Reactions in Clinical Trials. The Vaccine Reaction Sept. 14, 2020.

10 Keech C, et al. Phase 1–2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine. NEJM Sept. 2, 2020.

11 Cáceres M. A Grade 3 Vaccine-Related Adverse Event is Serious. The Vaccine Reaction July 26, 2020.

12 Folegatti PM, et al. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. The Lancet July 20, 2020.

13 Sadoff J, et al. Safety and immunogenicity of the Ad26.COV2.S COVID-19 vaccine candidate: interim results of a phase 1/2a, double-blind, randomized, placebo-controlled trial. medRxiv Sept. 23, 2020.

14 Press release. Experimental COVID-19 vaccine safe, generates immune response. U.S. National Institutes of Health July 14, 2020.

15 Weintraub K, Heath D. Moderna’s COVID-19 vaccine candidate appears to be safe and provide some immunity, new data from early trial shows. USA Today July 15, 2020.

16 Gumbrecht J, Thomas N, Vigue D, Howard J. Oxford’s Covid-19 vaccine appears safe and induces immune response, early results suggest, but more research is needed. CNN July 21, 2020.

17 Mundell EJ. Pfizer’s COVID Vaccine Shows ‘Robust’ Results in Early Trial. U.S. News & World Report Aug. 12, 2020.

18 Phelamei S. Chinese COVID-19 vaccine appears safe in early human trial: CanSino Bio’s Ad5-nCoV triggers immune response. TimesNowNews.com May 23, 2020.

19 PRNewswire. COVID-19 Vaccines Test Safe & Effective by China & UK teams: the Lancet. Science and Technology Daily July 23, 2020.

20 HospiMedica International staff writers. New Novavax COVID-19 Vaccine Phase 1 Data Reaffirms Safety Profile and Ability to Elicit Immune Response. HospiMedica.com Sept. 7, 2020.

21 Phelamei S. Novavax coronavirus vaccine appears safe in early trials; J&J COVID jab prevents severe illness in hamsters. TimesNowNews.com Sept. 4, 2020.

22 Elam Y. Coronavirus: Oxford/AstraZeneca Phase 1/2 trial shows safe, immunogenic vaccine, S&P 500 positive. FXStreet July 20, 2020.

23 Gumbrecht J, Thomas N, Vigue D, Howard J. Oxford vaccine is safe and induces immune response, early results suggest. CNN July 21, 2020.

24 Kallingal M, Kane A, Bonifield J, Mascarenhas L. Johnson and Johnson vaccine produced strong immune response, early results say. CNN Sept. 24, 2020.

25 Sadoff J, et al. Safety and immunogenicity of the Ad26.COV2.S COVID-19 vaccine candidate: interim results of a phase 1/2a, double-blind, randomized, placebo-controlled trial. medRxiv Sept. 23, 2020.

26 Cáceres B. AstraZeneca Halts, Resumes COVID-19 Vaccine Trial After Serious Neurological Event. The Vaccine Reaction Sept. 14, 2020.

27 Transverse myelitis. Mayo Clinic.

28 Press release. COVID-19 vaccine AZD1222 clinical trials resumed in the UK. AstraZeneca Sept. 12, 2020.

29 Genovese D.  FDA widens probe into AstraZeneca’s US coronavirus vaccine trial: report. Fox Business Oct. 1, 2020.

30 Garde D. Novavax’s Covid-19 vaccine shows promising immune response, early data show. STAT Aug. 4, 2020.

31 Feng-Cai Z, et al. Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial. The Lancet June 13, 2020; 395: 1845-1854.

32 Press release. Pfizer and BioNTech share positive early data on lead mRNA vaccine candidate BNT162B2 against COVID-19. Pfizer Aug. 20, 2020.

33 Chronic Diseases in America. U.S. Centers for Disease Control and Prevention.

34 Chronic. HealthChildren.og.

35 Adult Obesity Facts. CDC.

36 Childhood Obesity Facts. CDC.

37 Healthy Policy Institute. Prescription Drugs. Georgetown University McCourt School of Public Policy.

38 Beck J. Less Than 3 Percent of Americans Live a ‘Healthy Lifestyle’. The Atlantic Mar. 23, 2016.

39 University of North Carolina at Chapel Hill. Only 12 percent of American adults are metabolically healthy, study finds. Medical Xpress Nov. 28, 2018.

Marco Cáceres is Managing Editor of the The Vaccine Reaction online journal newspaper, launched in 2015. He is responsible for managing the editorial staff, guiding the selection of topics covered, identifying guest writers, and promoting the publication online. A regular TVR columnist, he specializes in analyzing trending vaccine-related news for which he writes a series of articles. Marco is a professional writer and market forecast analyst. He has worked for three decades in the space industry analyzing and forecasting the market for satellites and rockets.