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Research and Development for COVID-19 Vaccines
Published in Srijan Goswami, Chiranjeeb Dey, COVID-19 and SARS-CoV-2, 2022
Srijan Goswami, Ushmita Gupta Bakshi
The COVID-19 vaccine developed by Moderna is administered intramuscularly in two separate doses at one-month intervals. As per the revised report of August 27, 2021, this is an unapproved vaccine authorized under EUA by the FDA to be administered to individuals 18 years and older. Individuals having conditions such as allergy or autoimmune conditions, inflammatory cardiovascular disorders, tendency of fever, bleeding disorders, using blood thinning medications, compromised immune system, using immunosuppressive treatments, are pregnant or planning to conceive, are breastfeeding, have received a different COVID-19 vaccine, or other underlying conditions should consult their physician before taking the vaccine. The vaccine is not recommended for individuals who had severe allergic reactions after the first dose of the vaccine and/or are allergic to any ingredients of the vaccine. After receiving the first dose, it is recommended that the second dose must be completed within the given time period. A third dose of the vaccine may be administered to immunocompromised individuals. During ongoing clinical trials, ~15,400 candidates of 18 years of age and above received at least one dose of the COVID-19 vaccine developed by Moderna. The mentioned vaccine was reported to be able to prevent COVID-19 during clinical trials. But the researchers do not guarantee full protection, and the duration of protection provided by the vaccine cannot be determined. It is recommended that physical hygiene precautions for preventing COVID-19 be maintained. There may be a possibility of adverse reactions in individuals receiving the vaccine, which include severe allergic reactions such as difficulty breathing, swelling of the face and throat, tachycardia, skin rashes, dizziness, severe weakness, myocarditis, and pericarditis as recorded during clinical trials. General common side effects include injection site reactions, fatigue, headache, muscle pain, joint pain, chills, nausea, vomiting, and fever. According to the FDA, the possible range of adverse vaccine reactions is still not completely known and there is a possibility of unknown unexpected adverse reactions. In case any individual experiences unknown unexpected adverse reactions after receiving the vaccine, they should seek emergency medical attention at the nearest emergency healthcare facility. There are no prominent data to confirm or deny the impact of the Moderna COVID-19 vaccine on pregnant or breastfeeding mothers (US Department of Health and Human Services, 2021; ModernaTX, Inc., 2021).
Reactivation of Graves’ Disease and Thyroid Eye Disease following COVID-19 Vaccination – A Case Report
Published in Ocular Immunology and Inflammation, 2023
Chien-Wei Hung, Chih-Heng Hung
A 51-year-old Asian male had a history of well-controlled GD under regular follow-up, treated with carbimazole (10 mg per day) for 10 years, and TED with post bilateral (OU) orbital decompression 7 years ago. Recent thyroid function tests showed stable results. However, two weeks after the administration of the second dose of the BNT162B2 messenger ribonucleic acid (mRNA) (Pfizer-BioNTech) COVID-19 vaccine, he presented symptoms of anxiety, persistent tiredness and weakness. Five weeks after the injection, thyroid function tests showed elevated levels of thyroxine (free T4) (2.30 ng/dL; normal range, 0.93–1.70 ng/dL) and low levels of thyroid-stimulating hormone (TSH) (< 0.01 uIU/mL; normal range, 0.27–4.20 uIU/mL). During the follow-up period, the antithyroid drug was as previously prescribed with carbimazole (10 mg per day). Five months after the second dose of the Pfizer-BioNTech COVID-19 vaccine, he received the booster shot of the mRNA-1273 (Moderna) COVID-19 vaccine. Follow-up thyroid function tests showed worsened free T4 (7.77 ng/dL) and TSH (< 0.01 uIU/mL), and carbimazole (30 mg per day) was prescribed for another 3 months. The patient subsequently experienced hypothyroidism, and the antithyroid drug was halted for one month. After that, thyroid function tests showed elevated free T4 (6.31 ng/dL) and low levels of TSH (< 0.01 uIU/mL). Since then, the patient received carbimazole (10 mg per day), and recent thyroid function tests showed stable results for 2 months. Reactivation of GD lasted for a total duration of 11 months.
Hospitalist perspectives on barriers to recommend and potential benefit of the COVID-19 vaccine
Published in Hospital Practice, 2021
Sagar B. Dugani, Holly L. Geyer, Michael J. Maniaci, Karen M. Fischer, Ivana T. Croghan, Trevor J. Coons, Elizabeth L. Canan, M. Caroline Burton
On 11 December 2020, the U.S. Food & Drug Administration (FDA) authorized the emergency use of Pfizer-BioNTech COVID-19 vaccine in the U.S.A. based on 94.1% efficacy in a randomized, double-blinded, placebo-controlled trial [4,5]. On 18 December 2020, the U.S. FDA authorized emergency use of the Moderna COVID-19 vaccine based on similar efficacy data [6,7]. The rapid development of a vaccine within 12 months of molecular identification of COVID-19 and concern for adverse reactions led to COVID vaccine hesitancy [5,6,8]. The Centers for Disease Control and Prevention (CDC) developed a ‘Vaccinate with Confidence’ national strategy to reinforce confidence in COVID-19 vaccines and advance people along the refusal-passive acceptance-demand continuum of accepting a vaccine [8]. Integral to the CDC’s national strategy is to Empower Healthcare Personnel by promoting ‘confidence among healthcare personnel’ to get vaccinated and ‘recommend vaccination to their patients’ [8]. Hospitalists provide direct care to patients with and without COVID-19 and have opportunities to counsel patients on the vaccine based on the patient’s comorbidities and medical history. Previous studies have reported hospitalists’ perspectives on pneumococcal vaccines; however, hospitalist perspectives on the COVID-19 vaccine, including perceived benefits and barriers to recommend, are not known [9,10]. There was increased urgency to determine hospitalist perspectives and barriers because of the immediate availability of the COVID-19 vaccine starting in December 2020.
TLR4 as a therapeutic target for respiratory and neurological complications of SARS-CoV-2
Published in Expert Opinion on Therapeutic Targets, 2021
Dhriti Kaushik, Ranjana Bhandari, Anurag Kuhad
Definitive drug therapy for SARS-CoV-2 has not been achieved so far. Success has come in the form of vaccines which is the only solution in the current scenario. With some vaccines already hitting the immunisation process, many are under clinical trials as well [134]. Around 7 different vaccines have been rolled out in the countries while more than 200 vaccine candidates are under development. The first vaccine to get a nod for the Emergency Use Authorization (EUA) status was the one developed by Pfizer BioNTech. Recently, the vaccine developed by Astra Zeneca/Oxford was given the green light for emergency use. A version of this vaccine is manufactured by The Serum Institute of India with the name Covishield. Covaxin is another whole virus vaccine developed by Bharat Biotech currently in use. Sputnik V vaccine is developed by Russia that uses the spike protein of adenoviruses. Dr. Reddy’s has recently completed Phase 3 trials for Sputnik V and the results are awaited. Moderna Covid-19 vaccine is also given EUA status for distribution in the US.