A growing proliferation of blog posts, podcasts and online videos presenting confusing information regarding COVID-19 has increased over recent months. Many of these controversies are propagated by physicians speaking to large church audiences. In this blog post, I will address the most common disputes. (I will also continue to update the information on a regular basis at www.cmda.org/coronavirus.)  

 

Fact

The use of hydroxychloroquine, alone or with azithromycin, did not improve the clinical status of patients with mild-to-moderate COVID-19 at 15 days compared to standard care in a randomized, prospective, controlled trial.[1]

 

Fact

As of February 11, 2021, the NIH COVID-19 Treatment Guidelines Panel found that there was insufficient good quality evidence to recommend either for or against the use of Ivermectin for the treatment of COVID-19.[2]

 

Fiction

The SARS-CoV-2 virus was developed as a bioweapon.

 

Fact

Dr. Francis Collins, the co-discoverer of the human genome, has concluded that the SARS-CoV-2 virus developed naturally.^[3]

 

Fiction

Wearing a mask is ineffective in preventing the spread of the SARS-CoV-2 virus.

 

Fact

A review of multiple studies confirms the effectiveness of wearing a mask to reduce the SARS-CoV-2 virus’ community spread.^[4]

 

Fiction

People who have supposedly died from COVID-19 were near the end of their lives and would have died anyway.

 

Fact

As of February 22, 2021, more than 500,000 Americans have died from COVID-19.^[5] The number of Americans who died in World War II was 418,000.^[6] The number of deaths from COVID-19 in 2020 dropped the average life expectancy in the United States by one year, from 78.8 years to 77.8 years.^[7]

 

Fiction

The mRNA vaccine platform has never been used in a vaccine before COVID-19 and has never been tested in humans.

 

Fact

Previous mRNA vaccines have been developed for Rabies,[8] Influenza,[9] Cytomegalovirus,[10] and Zika virus,[11] each undergoing Phase 1 studies in humans.

 

Fiction

All of the COVID-19 vaccines are still at an experimental stage and have not been approved as a vaccine.

 

Fact

Two vaccines (Moderna’s and Pfizer’s mRNA vaccines) have been through all three phases of human trials, with each vaccine enrolling more than 30,000 participants. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the FDA has done an extensive and rigorous review of both vaccines.[12] The FDA issued an Emergency Use Authorization (EUA) for each vaccine.[13]

 

Fiction

There are no independently published animal studies on the mRNA vaccines that address the problem of enhanced immunopathology seen with SARS-CoV-1.

 

Fact

A study on the successful and safe use of the Moderna mRNA vaccine in mice showing lack of enhanced immunopathology with the mRNA vaccine was published in Nature.[14]

 

Fiction

The COVID-19 vaccines will attack a similar protein found in the placenta.

 

Fact

The placental protein syncitin-1 is different and distinct from the spike protein of the SARS-CoV-2 virus. During trials with the Pfizer mRNA vaccine, 23 women became pregnant, and only one woman suffered a pregnancy loss. She did not receive the actual vaccine but was in the placebo group.[15]

 

Fact

The Pfizer COVID-19 vaccine has proven to be safe in over 21,000 participants age 16 and older in their Phase 3 trial, showing 95 percent efficacy in preventing disease from SARS-CoV-2.[16]

 

Fact

The Moderna COVID-19 vaccine has proven to be safe in over 15,000 participants age 18 and older in their Phase 3 trial, showing 94.1 percent efficacy in preventing disease from SARS-CoV-2.[17]

 

Fiction

The mortality rate for COVID-19 in Africa is lower than the rest of the world.

 

Fact

The COVID-19 case fatality rate in Africa has risen sharply to 2.5 percent because of increased COVID testing. This is higher than the global case fatality rate of 2.2 percent. A total of 21 countries on the continent have a case fatality rate above 3 percent.[18]

 

Fiction

The mRNA vaccines will change human DNA.

 

Fact

The mRNA contained in the vaccines never enters the nucleus of the cell where DNA is located.^[19],[20]

 

Fiction

The mRNA from the SARS-CoV-2 vaccines will go equally to every cell in the body.

 

Fact

The biodistribution of the mRNA vaccines is similar to previous vaccines, with the highest concentration occurring within the muscle where the injection is given, followed by the lymphatic drainage system of that muscle. Only trace amounts of the vaccine are found at distant locations.^[21]

 

Fact

The CDC Advisory Committee on Immunization Practices (ACIP) made the following recommendations on vaccine priorities based on supporting evidence regarding risk of severe disease:[22]

 

• Phase 1a: The vaccine will be offered first to frontline healthcare professionals and residents of long-term facilities.

 

• Phase 1b: The vaccine will be offered to persons aged ≥75 years and frontline essential workers who are non-healthcare.

 

• Phase 1c: The vaccine will be offered to persons aged 65 to 74 years, and persons aged 16 to 64 with high-risk medical conditions as well as essential workers not included in Phase 1b.

 

• Phase 2: The vaccine will be offered to all other persons aged ≥16 years not already recommended for vaccination in previous phases.

 

 

[1] Cavalcanti, A.B., Campieri F.G., Rosa, R.G., et. al. Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate COVID-19. (2020). NEJM. 383:2041-52. Available for download at: https://www.nejm.org/doi/full/10.1056/nejmoa2019014

[2] NIH COVID-19 Treatment Guidelines. Ivermectin. (2021). Available at: https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/ivermectin/

[3] Collins, F. Genomic Study Points to Natural Origin of COVID-19. (2020). NIH Directors Blog. Available at: https://directorsblog.nih.gov/2020/03/26/genomic-research-points-to-natural-origin-of-covid-19/.

[4] Brooks, J.T. & Butler, J.C. Effectiveness of mask wearing to control community spread of SARS-CoV-2. (2021). JAMA.  doi:10.1001/jama.2021.1505. Available online here.

[5] Centers for Disease Control and Prevention. COVID Data Tracker. Available online at: https://covid.cdc.gov/covid-data-tracker/#cases_casesper100klast7days

[6] The National WWII Museum. Research Starters: Worldwide Deaths in World War II. Available online at: https://www.nationalww2museum.org/students-teachers/student-resources/research-starters/research-starters-worldwide-deaths-world-war

[7] Thompson, D. U.S. Life expectancy drops 1 full year due to COVID-19. (2021). WebMD News. Available at: https://www.webmd.com/lung/news/20210218/us-life-expectancy-drops-1-full-year-due-to-covid19#1.

[8] Alberer, M., Gnad-Vogt, U., Hong, H.A., Mehr, K.T., Backert, L., Finak, G., Gottardo, R., Bica, M.A., Garofano, A., Koch, S.D., Fotin-Mleczek, M., Hoerr, I., Clemens, R., & Von Sonnenburg, F. Safety and immunogenicity of a mRNA rabies vaccine in healthy adults: an open-label, non-randomised, prospective, first-in-human phase 1 clinical trial. (2017). Lancet  DOI: 10.1016/S0140-6736(17)31665-3

[9] Feldman, R.A., Fugn, R., Smolenov, I., Ribeiro, A., Panther, L., Watson, M., Senn, J.J., Smith, M., Almarsson, O., Pujar, H.S., Laska, M.E., Thompson, J., Zaks, T., & Ciaramella, G. mRNA vaccines against H10N8 and H7N9 influenza viruses of pandemic potential are immunogenic and well tolerated in health adults in phase 1 randomized clinical trials. (2019). Vaccine. 37:3326-3334.

[10] Moderna Press Releases. Moderna announces additional positive phase 1 data from cytomegalovirus (CMV) vaccine (mRNA-1647) and first participant dosed in phase 2 study. (2020). Available online at: https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-additional-positive-phase-1-data

[11] Moderna Press Releases. Moderna Highlights Opportunity of mRNA Vaccines at its first vaccines day. (2020). Available online at: https://investors.modernatx.com/news-releases/news-release-details/moderna-highlights-opportunity-mrna-vaccines-its-first-vaccines

[12] U.S. Food & Drug Administration. Emergency Use Authorization for Vaccines Explained. (2020). Available online at: https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

[13] U.S. Food & Drug Administration. FDA takes additional action in fight against COVID-19 by issuing emergency use authorization for second COVID-19 Vaccine. (2020). Available online at: https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid

[14] Corbett, K. S., Edwards, D.K. & Leist, S.R. et. al. SARS-CoV-2 mRNA vaccine design enabled by prototype pathogen preparedness. (2020). Nature. 586:567-571. Available online at: https://www.nature.com/articles/s41586-020-2622-0

[15] Johns Hopkins Medicine. COVID-19 Vaccines: Myth versus fact. (2021). Available online at: https://www.hopkinsmedicine.org/health/conditions-and-diseases/coronavirus/covid-19-vaccines-myth-versus-fact 

[16] Polack, F.P., Thomas, S.J., Kitchin, N. et. al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. (2020). NEJM. 383(27): 2603-2615. Available online at: https://www.nejm.org/doi/full/10.1056/NEJMoa2034577.

[17] Baden, L.R., El Shaly, H.M., Essink, B. et. al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 vaccine. (2021). NEJM. 384(5): 403-416. Available online at: https://www.nejm.org/doi/full/10.1056/NEJMoa2035389.

[18] Reuters. Africa’s COVID-19 case fatality rate surpasses global level. (2021). Available online at: https://www.reuters.com/article/uk-health-coronavirus-africa/africas-covid-19-case-fatality-rate-surpasses-global-level-idUSKBN29Q167. 

[19] Centers for Disease Control and Prevention. Understanding mRNA COVID-19 Vaccines. (2020). Available at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html.

[20] Nebraska Medicine. How mRNA Vaccines Work. (2020). Available at: https://www.nebraskamed.com/COVID/how-mrna-vaccines-work.

[21] Bahl, K., Senn, J.J. Yuzhadov, O., Bulychev, A., Brito, L.A., Hassett, K.J., Laska, M. E., Smith, M., Almarsson, O., Thompson, J., Ribeiro, M., Watso, M., Zaks, T., & Ciaramella, G. Preclinical and clinical demonstration of immunogenicity by mRNA vaccines against h10N8 and H7N9 influenza viruses. (2017). Molecular Therapy. 25(6): 1316-1327. Available at: https://www.cell.com/molecular-therapy-family/molecular-therapy/fulltext/S1525-0016(17)30156-9?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS1525001617301569%3Fshowall%3Dtrue.

[22] Dooling, K., Marin, M., Wallace, M., McClung, N., Chamberland, M., Lee, G.M., Talbot, H.K., Romero, J.R., Bell, B.P., & Oliver, S.E. The Advisory Committee on Immunization Practices’ Updated Interim Recommendation for Allocation of COVID-19 Vaccine- United States, December 2020. (2021). MMWR 69(51-52):1657-1660. Available online at: https://www.cdc.gov/mmwr/volumes/69/wr/mm695152e2.htm?s_cid=mm695152e2_w.