If you find yourself confused about the mixed guidance when it comes to Covid-19 vaccines and safety concerns, you’re not alone.
While the Centers for Disease Control (CDC) is marketing widespread use of the emergency-use vaccines in the U.S. for both old and young alike, many other countries are limiting Covid-19 vaccine use. Health officials around the world are giving varying advice on safety issues as Covid-19 vaccines are given to more people, and more information can be collected.
Below are summaries of some of the concerns that have emerged or been raised by medical officials.
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Additional reading and studies
Nearly every measure finds the Covid infection rate is higher among the vaccinated than among the unvaccinated.
A case study finds suspected link between Ramsay Hunt syndrome and Covid-19 vaccine.
A published pathology report on two children who died of heart issues after their second Pfizer Covid-19 vaccine implicates the vaccine as the cause.
A study finds vaccination impacts and delays women’s periods.
A CDC analysis finds increased risk of Guillain Barre paralysis after Covid vaccination, Dec. 2021
An analysis presented at the American Heart Association and published in the journal Cardiology warns of a “dramatic” increase in heart risk for most people who got Covid-19 RNA vaccine.
US study finds dramatically waned immunity for all 3 vaccines after 6 months: SARS-CoV-2 vaccine protection and deaths among US veterans during 2021
UK study finds no difference in peak viral load between vaccinated and unvaccinated, Oct. 28, 2021: https://www.thelancet.com/action/showPdf?pii=S1473-3099%2821%2900648-4
Israeli data confirms Pfizer vacine immunity wears off after just a few months in all age groups, Oct. 27, 2021: Waning Immunity after the BNT162b2 Vaccine in Israel
Durability of immune responses to the BNT162b2 mRNA vaccine, Sept. 30, 2021: https://www.biorxiv.org/content/10.1101/2021.09.30.462488v1.article-info
Additional case studies of myocarditis in people after Pfizer and Moderna Covid-19 vaccines, Aug. 18, 2021. Available from: https://www.nejm.org/doi/full/10.1056/NEJMc2109975
Transmission of SARS-CoV-2 Delta Variant Among Vaccinated Healthcare Workers, Vietnam, Aug. 10, 2021. Available from: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3897733
Zuckerman DM. Emergency Use Authorizations (EUAs) Versus FDA Approval: Implications for COVID-19 and Public Health. Am J Public Health [Internet]. 2021 Jun;111(6):1065–9. Available from: http://dx.doi.org/10.2105/AJPH.2021.306273
Food and Drug Administration. Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry [Internet]. 2020 [cited 2020 Oct 6]. Available from: https://www.fda.gov/media/139638/download
Food and Drug Administration. FDA Briefing Document. Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19 [Internet]. 2021 [cited 2021 May 28]. Available from: https://www.fda.gov/media/146217/download
CDC. Risk for COVID-19 infection, hospitalization, and death by age group [Internet]. 2021 [cited 2021 May 28]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/covid- data/investigations-discovery/hospitalization-death-by-age.html
CDC. COVID-19 Pandemic Planning Scenarios [Internet]. 2021 [cited 2021 May 28]. Available from:
https://www.cdc.gov/coronavirus/2019-ncov/hcp/planning-scenarios.html
CDC. Estimated disease burden of COVID-19 [Internet]. 2021 [cited 2021 May 28]. Available from:
https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/burden.html
Dan JM, Mateus J, Kato Y, Hastie KM, Yu ED, Faliti CE, et al. Immunological memory to SARS-CoV-2 assessed for up to 8 months after infection. Science [Internet]. 2021 Feb 5;371(6529). Available from: http://dx.doi.org/10.1126/science.abf4063
Turner JS, Kim W, Kalaidina E, Goss CW, Rauseo AM, Schmitz AJ, et al. SARS-CoV-2 infection induces long-lived bone marrow plasma cells in humans. Nature [Internet]. 2021 May 24; Available from: http://dx.doi.org/10.1038/s41586-021-03647-4
Breton G, Mendoza P, Hagglof T, Oliveira TY, Schaefer-Babajew D, Gaebler C, et al. Persistent Cellular Immunity to SARS-CoV-2 Infection. bioRxiv [Internet]. 2020 Dec 9; Available from: http://dx.doi.org/10.1101/2020.12.08.416636
Hall VJ, Foulkes S, Charlett A, Atti A, Monk EJM, Simmons R, et al. SARS-CoV-2 infection rates of antibody-positive compared with antibody-negative health-care workers in England: a large, multicentre, prospective cohort study (SIREN). Lancet [Internet]. 2021 Apr 17;397(10283):1459–69. Available from: http://dx.doi.org/10.1016/S0140-6736(21)00675-9
Krammer F, Srivastava K, Simon V, the PARIS team. Robust spike antibody responses and increased reactogenicity in seropositive individuals after a single dose of SARS-CoV-2 mRNA vaccine [Internet]. bioRxiv. medRxiv; 2021. Available from: http://medrxiv.org/lookup/doi/10.1101/2021.01.29.21250653
Samanovic MI, Cornelius AR, Wilson JP, Karmacharya T, Gray-Gaillard SL, Allen JR, et al. Poor antigen-specific responses to the second BNT162b2 mRNA vaccine dose in SARS-CoV-2-experienced individuals. medRxiv [Internet]. 2021 Feb 9; Available from: http://dx.doi.org/10.1101/2021.02.07.21251311
Camara C, Lozano-Ojalvo D, Lopez-Granados E, Paz-Artal E, Pion M, Correa-Rocha R, et al. Differential effects of the second SARS-CoV-2 mRNA vaccine dose on T cell immunity in naïve and COVID-19 recovered individuals [Internet]. bioRxiv. 2021 [cited 2021 May 28]. p. 2021.03.22.436441. Available from: https://www.biorxiv.org/content/10.1101/2021.03.22.436441v1
Levi R, Azzolini E, Pozzi C, Ubaldi L, Lagioia M, Mantovani A, et al. A cautionary note on recall vaccination in ex-COVID-19 subjects [Internet]. bioRxiv. medRxiv; 2021. Available from: http://medrxiv.org/lookup/doi/10.1101/2021.02.01.21250923
Ogata AF, Cheng C-A, Desjardins M, Senussi Y, Sherman AC, Powell M, et al. Circulating SARS-CoV-2 Vaccine Antigen Detected in the Plasma of mRNA-1273 Vaccine Recipients. Clin Infect Dis [Internet]. 2021 May 20; Available from: http://dx.doi.org/10.1093/cid/ciab465
Kuba K, Imai Y, Rao S, Gao H, Guo F, Guan B, et al. A crucial role of angiotensin converting enzyme 2 (ACE2) in SARS coronavirus-induced lung injury. Nat Med [Internet]. 2005 Aug;11(8):875–9. Available from: http://dx.doi.org/10.1038/nm1267
Chen I-Y, Chang SC, Wu H-Y, Yu T-C, Wei W-C, Lin S, et al. Upregulation of the chemokine (C-C motif) ligand 2 via a severe acute respiratory syndrome coronavirus spike-ACE2 signaling pathway. J Virol [Internet]. 2010 Aug;84(15):7703–12. Available from: http://dx.doi.org/10.1128/JVI.02560-09
Patra T, Meyer K, Geerling L, Isbell TS, Hoft DF, Brien J, et al. SARS-CoV-2 spike protein promotes IL- 6 trans-signaling by activation of angiotensin II receptor signaling in epithelial cells. PLoS Pathog [Internet]. 2020 Dec;16(12):e1009128. Available from: http://dx.doi.org/10.1371/journal.ppat.1009128
Zhang S, Liu Y, Wang X, Yang L, Li H, Wang Y, et al. SARS-CoV-2 binds platelet ACE2 to enhance thrombosis in COVID-19. J Hematol Oncol [Internet]. 2020 Sep 4;13(1):120. Available from: http://dx.doi.org/10.1186/s13045-020-00954-7
Suresh SJ, Suzuki YJ. SARS-CoV-2 Spike Protein and Lung Vascular Cells. Journal of Respiration [Internet]. 2020 Dec 31 [cited 2021 May 25];1(1):40–8. Available from: https://www.mdpi.com/2673-527X/1/1/4
Angeli F, Spanevello A, Reboldi G, Visca D, Verdecchia P. SARS-CoV-2 vaccines: Lights and shadows. Eur J Intern Med [Internet]. 2021 Apr 30; Available from: http://dx.doi.org/10.1016/j.ejim.2021.04.019
Han M, Pandey D. ZMPSTE24 Regulates SARS-CoV-2 Spike Protein-enhanced Expression of Endothelial Plasminogen Activator Inhibitor-1. Am J Respir Cell Mol Biol [Internet]. 2021 May 18; Available from: http://dx.doi.org/10.1165/rcmb.2020-0544OC
Rhea EM, Logsdon AF, Hansen KM, Williams LM, Reed MJ, Baumann KK, et al. The S1 protein of SARS-CoV-2 crosses the blood-brain barrier in mice. Nat Neurosci [Internet]. 2021 Mar;24(3):368– 78. Available from: http://dx.doi.org/10.1038/s41593-020-00771-8
Idrees D, Kumar V. SARS-CoV-2 spike protein interactions with amyloidogenic proteins: Potential clues to neurodegeneration. Biochem Biophys Res Commun [Internet]. 2021 May 21;554:94–8. Available from: http://dx.doi.org/10.1016/j.bbrc.2021.03.100
Lei Y, Zhang J, Schiavon CR, He M, Chen L, Shen H, et al. SARS-CoV-2 Spike Protein Impairs Endothelial Function via Downregulation of ACE 2. Circ Res [Internet]. 2021 Apr 30;128(9):1323–6. Available from: http://dx.doi.org/10.1161/CIRCRESAHA.121.318902
Zhang L, Richards A, Barrasa MI, Hughes SH, Young RA, Jaenisch R. Reverse-transcribed SARS-CoV-2 RNA can integrate into the genome of cultured human cells and can be expressed in patient- derived tissues. Proc Natl Acad Sci U S A [Internet]. 2021 May 25;118(21). Available from: http://dx.doi.org/10.1073/pnas.2105968118
Suzuki YJ, Nikolaienko SI, Dibrova VA, Dibrova YV, Vasylyk VM, Novikov MY, et al. SARS-CoV-2 spike protein-mediated cell signaling in lung vascular cells. Vascul Pharmacol [Internet]. 2021 Apr;137:106823. Available from: http://dx.doi.org/10.1016/j.vph.2020.106823
Suzuki YJ, Gychka SG. SARS-CoV-2 Spike Protein Elicits Cell Signaling in Human Host Cells: Implications for Possible Consequences of COVID-19 Vaccines. Vaccines (Basel) [Internet]. 2021 Jan 11;9(1). Available from: http://dx.doi.org/10.3390/vaccines9010036
Ogata AF, Maley AM, Wu C, Gilboa T, Norman M, Lazarovits R, et al. Ultra-sensitive Serial Profiling of SARS-CoV-2 Antigens and Antibodies in Plasma to Understand Disease Progression in COVID-19 Patients with Severe Disease. Clin Chem [Internet]. 2020 Sep 8; Available from: http://dx.doi.org/10.1093/clinchem/hvaa213
Kloc M, Uosef A, Kubiak JZ, Ghobrial RM. Exaptation of Retroviral Syncytin for Development of Syncytialized Placenta, Its Limited Homology to the SARS-CoV-2 Spike Protein and Arguments against Disturbing Narrative in the Context of COVID-19 Vaccination. Biology [Internet]. 2021 Mar 19;10(3). Available from: http://dx.doi.org/10.3390/biology10030238
Khan I, Hatiboglu MA. Can COVID-19 induce glioma tumorogenesis through binding cell receptors? Med Hypotheses [Internet]. 2020 Nov;144:110009. Available from: http://dx.doi.org/10.1016/j.mehy.2020.110009
Singh N, Bharara Singh A. S2 subunit of SARS-nCoV-2 interacts with tumor suppressor protein p53 and BRCA: an in silico study. Transl Oncol [Internet]. 2020 Oct;13(10):100814. Available from: http://dx.doi.org/10.1016/j.tranon.2020.100814
Madla CM, Gavins FKH, Merchant H, Orlu M, Murdan S, Basit AW. Let’s Talk About Sex: Differences in Drug Therapy in Males and Females. Adv Drug Deliv Rev [Internet]. 2021 May 17; Available from: http://dx.doi.org/10.1016/j.addr.2021.05.014
European Medicines Agency. Assessment Report. Comirnaty (COVID-19 mRNA vaccine (nucleoside- modified)), EMA/707383/2020 Corr.1 [Internet]. 2021 Feb [cited 2021 Apr 13]. Available from: https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public- assessment-report_en.pdf#page=45
European Medicines Agency. Assessment Report. COVID-19 Vaccine Moderna (COVID-19 mRNA Vaccine (nucleoside-modified)), EMA/15689/2021 Corr.1 [Internet]. 2021 Mar [cited 2021 Apr 13]. Available from: https://www.ema.europa.eu/en/documents/assessment-report/covid-19-vaccine- moderna-epar-public-assessment-report_en.pdf#page=47
European Medicines Agency. Assessment Report. COVID-19 Vaccine Janssen, EMA/158424/2021 [Internet]. 2021 Mar [cited 2021 Apr 13]. Available from: https://www.ema.europa.eu/en/documents/assessment-report/covid-19-vaccine-janssen-epar- public-assessment-report_en.pdf#page=50
Pfizer. SARS-CoV- 2 mRNA Vaccine (BNT162, PF-07302048) 2.6.4 Yakubutsu dōtai shiken no gaiyō bun [summary of pharmacokinetic studies] [Internet]. 2021 [cited 2021 May 28]. Available from: https://www.pmda.go.jp/drugs/2021/P20210212001/672212000_30300AMX00231_I100_1.pdf#pa ge=16
CDC. Selected adverse events reported after COVID-19 vaccination [Internet]. 2021 [cited 2021 May 28]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse- events.html
Doshi P. FDA response to BMJ on reports of death after covid-19 vaccination [Internet]. 2021 [cited 2021 May 28]. Available from: https://www.bmj.com/content/372/bmj.n149/rr-25
Wyller TB, Kittang BR, Ranhoff AH, Harg P, Myrstad M. Nursing home deaths after COVID-19 vaccination. Tidsskr Nor Laegeforen [Internet]. 2021 May 20;141. Available from: http://dx.doi.org/10.4045/tidsskr.21.0383
Torjesen I. Covid-19: Pfizer-BioNTech vaccine is “likely” responsible for deaths of some elderly patients, Norwegian review finds. BMJ [Internet]. 2021 May 27 [cited 2021 May 28];373. Available from: https://www.bmj.com/content/373/bmj.n1372
Food and Drug Administration. Coronavirus (COVID-19) update: FDA Issues Policies to guide medical product developers addressing virus variants [Internet]. 2021 [cited 2021 May 28]. Available from: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19- update-fda-issues-policies-guide-medical-product-developers-addressing-virus
Owens C. Vaccine boosters could be necessary as soon as September [Internet]. Axios. 2021 [cited 2021 May 28]. Available from: https://www.axios.com/coronavirus-vaccines-boosters-pfizer- moderna-e8d6bed6-8238-4e52-9959-ca4c6a6e0d5a.html
Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med [Internet]. 2020 Dec 31;383(27):2603–15. Available from: http://dx.doi.org/10.1056/NEJMoa2034577
Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, et al. Efficacy and Safety of the mRNA- 1273 SARS-CoV-2 Vaccine. N Engl J Med [Internet]. 2021 Feb 4;384(5):403–16. Available from: http://dx.doi.org/10.1056/NEJMoa2035389
Thacker PD. Covid-19: How independent were the US and British vaccine advisory committees? BMJ [Internet]. 2021 May 26;373:n1283. Available from: http://dx.doi.org/10.1136/bmj.n1283
Moderna. SARS-CoV- 2 mRNA Vaccine (Moderna) 2.6.4 Yakubutsu dōtai shiken no gaiyō bun [summary of pharmacokinetic studies] [Internet]. 2021 [cited 2021 May 29]. Available from: https://www.pmda.go.jp/drugs/2021/P20210519003/400256000_30300AMX00266_I100_1.pdf#pa ge=7
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