Soni Dhruve, Shukla Sunita C, Gogtay Nithya J, Pandit Sukant, Nadkar Milind Y
DM Resident, Department of Clinical Pharmacology, Seth Gordhandas Sunderdas Medical College and King Edward Memorial Hospital, Mumbai, Maharashtra, India.
Visiting Consultant Allergist, Department of Clinical Pharmacology, Seth Gordhandas Sunderdas Medical College and King Edward Memorial Hospital, Mumbai, Maharashtra, India, Corresponding Author.
J Assoc Physicians India. 2025 Jul;73(7):44-46. doi: 10.59556/japi.73.1041.
Vaccination has formed the mainstay for mitigation of the COVID-19 pandemic. Vaccine-induced allergic reactions, though rare, have made it difficult to ensure complete coverage of COVID-19 vaccination. Initial guideline issued by the Government of India contraindicated vaccination in those with food or drug allergies. Allergic reactions largely result from excipients such as polysorbate 80 (P-80) (present in COVISHIELD™) and polyethylene glycol (PEG) [present in the messenger ribonucleic acid (mRNA) vaccines]. The present study was carried out with the objective of allergy testing in those with a history of allergic diathesis to generate objective evidence to the extent of true allergies to COVID-19 vaccination.
After approval from the Institutional Ethics Committee, written informed consent was obtained for this prospective, open-label study in 100 participants. Allergic response assessment in participants with a history of any allergies, yet unvaccinated to COVID-19, or have taken the first dose and were due for second dose, or had taken the second dose and were due for the precautionary dose, was done by skin prick test (SPT) followed by intradermal testing (IDT) injection with COVISHIELD™ vaccine, P-80, and PEG individually. Based on the result of the skin test (either positive or negative), participants were given advice regarding vaccination.
Of the 100 enrolled participants, = 75 had taken both doses of any COVID-19 vaccine, = 15 had taken only the first dose of any COVID-19 vaccine, and = 10 were yet unvaccinated. There was no [0/92 (0%) and 0/98 (0%)] positive test with PEG and P-80, respectively. Only 02/98 (2.04%) returned a positive test with full strength (1:1) COVISHIELD™ vaccine IDT but not with SPT.
This study indicates a low risk of allergy to PEG, P-80, and COVISHIELD™. Where feasible, allergy testing and counseling can be offered to unvaccinated or partially vaccinated individuals with a history of allergic diathesis.
疫苗接种一直是缓解新冠疫情的主要手段。疫苗引起的过敏反应虽罕见，但却难以确保新冠疫苗接种的全面覆盖。印度政府发布的初始指南指出，对食物或药物过敏者禁忌接种疫苗。过敏反应主要源于辅料，如聚山梨酯80（P - 80）（存在于科兴疫苗™中）和聚乙二醇（PEG）[存在于信使核糖核酸（mRNA）疫苗中]。本研究旨在对有过敏体质病史者进行过敏测试，以获取关于新冠疫苗接种真正过敏程度的客观证据。
经机构伦理委员会批准后，在100名参与者中开展了这项前瞻性、开放标签研究，并获得了书面知情同意书。对有任何过敏史但未接种新冠疫苗者、或已接种第一剂且应接种第二剂者、或已接种第二剂且应接种加强针者，通过皮肤点刺试验（SPT）进行过敏反应评估，随后分别用科兴疫苗™、P - 80和PEG进行皮内试验（IDT）注射。根据皮肤试验结果（阳性或阴性），为参与者提供疫苗接种建议。
在100名登记参与者中，75人接种了两剂任何新冠疫苗，15人仅接种了第一剂任何新冠疫苗，10人尚未接种。PEG和P - 80的检测结果均为阴性[分别为0/92（0%）和0/98（0%）]。仅2/98（2.04%）的参与者在皮内试验中对全强度（1:1）的科兴疫苗™呈阳性反应，但皮肤点刺试验为阴性。
本研究表明对PEG、P - 80和科兴疫苗™过敏的风险较低。在可行的情况下，可为有过敏体质病史的未接种或部分接种者提供过敏测试和咨询服务。
