key: cord-1031452-uhpc7w0f authors: Pal, Rimesh; Bhadada, Sanjay Kumar; Misra, Anoop title: COVID-19 vaccination in patients with diabetes mellitus: Current concepts, uncertainties and challenges date: 2021-02-25 journal: Diabetes Metab Syndr DOI: 10.1016/j.dsx.2021.02.026 sha: c9166ba8c9b092ffe1b4fd62bbc8587f9946ff22 doc_id: 1031452 cord_uid: uhpc7w0f BACKGROUND AND AIMS: To summarize the available evidence on the use COVID-19 vaccines in patients with diabetes mellitus. METHODS: We performed a thorough literature search with regard to COVID-19 vaccines in patients with type 1 and type 2 diabetes mellitus. RESULTS: The novel coronavirus disease (COVID-19) tends to portend a poor prognosis in patients with diabetes mellitus (DM). Primary prevention remains the mainstay for mitigating the risks associated with COVID-19 in patients with DM. A significant step in primary prevention is timely vaccination. Routine vaccination against pneumococcal pneumonia, influenza, and hepatitis B is recommended in patients with DM with good efficacy and reasonable safety profile. With clinical data supporting a robust neutralizing antibody response in COVID-19 patients with DM, vaccination in individuals with DM is justified. In fact, as the burden of the disease is borne by people with DM, COVID-19 vaccination should be prioritized in individuals with DM. Multiple unresolved issues with regard to preferred vaccine type, vaccine efficacy and durability, frequency of administration, vaccination in children (<18 years) and pregnant/lactating women remain, and need to be addressed through future research. CONCLUSIONS: Patients with type 1 and type 2 diabetes mellitus are at a high risk of poor prognosis with COVID-19 and vaccination should be prioritized in them. However, many unresolved issues with regard to COVID-19 vaccination need to be addressed through future research. with . 104 Several recent studies have shown that both people with T2D and T1D have an 105 increased vulnerability to severe illness from COVID-19 compared with people 106 without DM. In relative terms, patients with T1D and those with T2D had similar 107 adjusted odds ratios (ORs) for hospitalization (3.90 for T1D vs. 3.36 for T2D), 108 severity of illness (3.35 vs. 3.42) (6), and in-hospital mortality (3.51 vs. 2.02) (7). 109 Besides, good glycemic control before hospital admission, as indicated by glycated 110 hemoglobin (HbA 1c ), has not been associated with improved outcomes in patients 111 with DM admitted for . Thus, primary prevention remains the mainstay 112 for mitigating the risks associated with COVID-19 in patients with DM. 113 A significant step in primary prevention of infections is timely and appropriate 114 vaccination. Routine vaccination against pneumococcal pneumonia, influenza, and 115 hepatitis B is recommended in patients with DM (9) . Although prior studies have 116 shown impaired antibody response to influenza and hepatitis B vaccines in patients 117 with DM (10,11), with recent advances in the development of vaccines, people with 118 DM are able to mount an appropriate immune response post-vaccination. In multiple 119 case-control studies, the efficacy and safety of pneumococcal vaccine have been 120 reported as ranging from 56% to 81% (12,13 Hitherto, data with regard to immune response in DM patients with COVID-19 are 143 limited. One preliminary report from India had demonstrated impaired anti-SARS-144 CoV-2 response in non-severe COVID-19 patients with T2D. Total anti-SARS-CoV-145 2 antibody (IgG+IgM), as measured by electrochemiluminescence immunoassay, 146 were undetectable in 3 out of 9 patients with T2D when estimated at a median 147 imply that while most people with T2D would be ideal candidates for COVID-19 184 vaccines, many patients with T1D would be deprived of the same. In addition, 185 multiple other questions with regard to COVID-19 vaccination exist that have been 186 summarized in Table 2 . 187 The choice of the vaccine remains a major issue and in lieu of the limited clinical 188 evidence, it should be guided by availability; in the Indian setting, with no data 189 available from phase 3 clinical trials, either COVAXIN TM or COVISHIELD TM could 190 be used for vaccinating people with DM. Further research focusing on many 191 unresolved issues is warranted ( Table 3) . Which vaccine is to be preferred? How effective would the COVID-19 vaccines be in the real world? How durable would the protection be in the real world? Would COVID-19 vaccination need to be repeated semi-annually or annually? Would COVID-19 vaccination be justified in a child or adolescent (< 16 years) with diabetes mellitus? Are COVID-19 vaccines safe in pregnant or lactating women with diabetes mellitus? Would complications in patients with longstanding diabetes mellitus (like chronic kidney disease) affect vaccine efficacy and/or durability? Could COVID-19 vaccines be administered in the presence of active infections which are otherwise common in patients with diabetes mellitus? Could anti-diabetic drugs modulate the efficacy of COVID-19 vaccines? Would serious adverse events following COVID-19 vaccination be more frequent? Would vaccination with the currently available COVID-19 vaccines be less effective in view of the rapid development of new strains of the SARS-CoV-2? Could mixing of COVID-19 vaccines boost immune response? • Vaccination against COVID-19 should be prioritized in patients with type 1 and type 2 diabetes mellitus. • Multiple unresolved issues with regard to COVID-19 vaccination need to be addressed through future research. J o u r n a l P r e -p r o o f The purpose of this form is to provide readers of your manuscript with information about your other interests that could influence how they receive and understand your work. The form has five parts. Each author should submit a separate form. Provide complete information and double-check the manuscript number. If you are NOT the corresponding author please insert his or her name. Please provide information about the work that you have submitted for publication. The time frame for this reporting is that of the work itself, from the initial conception and planning to the present. The idea is to provide for the reader information about resources that you received, either directly or indirectly (via your institution), to enable you to complete the work. If you check the "No" box it means that you did the work without receiving any financial support from any third party --that is, the work was supported by funds from the same institution that pays your salary and that institution did not receive third-party funds to pay you. If you or your institution did receive funds from a third party to support the work, check "Yes" along with the appropriate boxes to indicate the type of support and whether you or your institution received it. Please report all sources of revenue relevant to the submitted work that accrued either directly to you or were paid to your institution on your behalf over the 36 months prior to submission of the work. This should include all monies from sources with relevance to the submitted work, not just monies from the entity that sponsored the research. If there is any question, it is usually better to disclose a relationship than not to do so. Please note that your interactions with the work's sponsor outside the submitted work should be listed here. For each category list each entity on a separate line. Use as many lines as necessary to provide complete information. In addition, please disclose relationships that fall outside the 36-month window that readers may want to know about and could reasonably criticize you for not disclosing (for example, long-term financial relationships that are now ended). The goal of this section is to provide information for our reviewers and readers about your interactions with entities in the biomedical arena that could be perceived to influence, or that give the appearance of potentially influencing, what you wrote in the submitted work. You should disclose interactions with ANY entity that could be considered broadly relevant to the work. For example, if your article is about testing an epidermal growth factor receptor (EGFR) antagonist in lung cancer, you should report all associations with entities pursuing diagnostic or therapeutic strategies in cancer in general, not just in the area of EGFR or lung cancer. For grants you have received for work outside the submitted work, you should disclose support ONLY from entities that could be perceived to benefit financially from the published work, such as drug companies, or foundations supported by entities that could be perceived to have a financial stake in the outcome. Public funding sources, such as the NIH or the MRC, need not be disclosed. For example, if the NIH sponsored a piece of work you have been involved in but drugs were provided by a pharmaceutical company, you need only list the pharmaceutical company. J o u r n a l P r e -p r o o f Do you have any relevant nonfinancial associations or interests (personal, professional, political, institutional, religious, or other) that a reasonable reader would want to know about in relation to the submitted work? Yes, the following relevant nonfinancial relationships/conditions/circumstances are present At the time of manuscript acceptance, journals will ask authors to confirm and, if necessary, update their disclosure statements. On occasion, journals may ask authors to disclose further information about reported relationships J o u r n a l P r e -p r o o f Did you or your institution at any time receive payment or support in kind for any aspect of the submitted work (including but not limited to grants, data monitoring board, study design, manuscript preparation, statistical analysis, etc…)? Yes, specify nature of compensation Section 3. Information about relevant financial relationships outside the submitted work.Place a check in the appropriate boxes in the table to indicate whether you have financial relationships (regardless of amount of compensation) with any entities that have an interest related to the submitted work. Use one line for each entity; add as many lines as you need. Use the comments column to indicate any additional information that you think a reader or editor would want to know about the compensation. Report relationships that were present during the 36 months prior to submission. In addition please disclose relationships that fall outside the 36-month window that readers may want to know about and could reasonably criticize you for not disclosing (for example, long-term financial relationships that are now ended).If you have more than one relationship, click "Add +" to add a row. Click "Del ×" to delete an extra row.