BME215e: The ongoing global pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections is causing deaths daily: Clinical Trials Report, SUSS

Question 1

The ongoing global pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections is causing deaths daily since its origin. Various researchers and pharmaceutical companies have developed a number of vaccines to fight this coronavirus.

(a) As a clinical trial student, you are required to prepare a report on one (your choice) of the approved in-market vaccines used under the Singapore’s National Vaccination programme. The report should include the following information.

(I) Discuss in detail the vaccine development process involved/followed by the pharmaceutical company you have selected.

(ii) Analyze the pros and cons of their vaccine. Include in your write-up, information of the vaccine efficacy and adverse events.

(iii) What are your views on the selected vaccine? Include supporting details to back up your answer.

(b) Write a critical appraisal on any TWO (2) of the following published papers:

(I) McMenamin ME, Nealon J, Lin Yet al.. Vaccine effectiveness of one, two and three doses of BNT162b2 and CoronaVac against COVID-19 in Hong Kong: a population-based observational study. Lancet Infectious Diseases, 2022, https://doi.org/10.1016/S1473-3099(22)00345-0

(ii) Tandon M, Wu W, Moore K, Winchester S. SARS-CoV-2 accelerated clearance using a novel nitric oxide nasal spray (NONS) treatment: A randomized trial. The Lancet Regional Health-Southeast Asia, 2022; 00: 100036.

(iii) Daniel RF, Melissa M H, Laith J A-R, et al.. Duration of effectiveness of vaccines against SARS-CoV-2 infection and COVID-19 disease: results of a systematic review and meta-regression. Lancet, 2022; 399: 924-44.

(iv) Moreira ED, Kitchin N, Xu X, Dychter SS et al., Safety and efficacy of a third dose of BNT162b2 COVID-19 vaccine. N Engl Med, 2022; 386:1910-21.

(v) Andrews N, Stowe J, Kirsebom F et al,. COVID-19 vaccine effectiveness against the Omicron (B1.1.1.529) variant. N Engl Med, 2022; 386: 1532-46.

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