Nigerian-born principal investigator in Pfizer/BioNTech COVID-19 vaccine trials, Dr. Onyema Ogbuagu, yesterday, reaffirmed the safety of the mRNA-based candidate.
Dr. Ogbuagu, who is being celebrated globally, for his leading role in the Pfizer vaccine clinical trials, is an Associate Professor in the HIV Clinical Trials program of Infectious Diseases in Yale School of Medicine, United States (US).
He gave the assurance, during a Diaspora Speaker Series discussion, put together by Nigerians in Diaspora Commission, NiDCOM and NgEX.
Meanwhile ‘US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted today to recommend the use of the Pfizer-BioNTech COVID-19 vaccine in people 16 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S. Food and Drug Administration (FDA).’
‘This ACIP vote follows the December 1, 2020, ACIP recommendation for a Phase 1a rollout where first priority of COVID-19 vaccines is given to health care personnel treating patients, and residents in nursing homes and other long-term care facilities,’ the firm added in a statement.
Ogbuagu also confirmed it in a tweet. ‘It is authorized for individuals age 16 and above but contraindicated for individuals with severe allergy such as anaphylaxis, which is a major allergy.’
Speaking on the topic, ‘COVID-19: Vaccine Hesitancy, Myths and Reality, Ogbuagu said, ‘the vaccine is safe.’
He allayed fears over widespread hesitancy and concerns about the new vaccine for coronavirus, being raised across the world, including Nigerians in Diaspora and those resident in the country.
According to him there are no limits for immunocompromised people, but warned about decreased response.
He explained that high quality standards and the new technologies, including mRNA were used by Pfizer/BioNTech in the development of the vaccine.
The event featured Senior Special Assistant to the President on Foreign Affairs and Diaspora, Hon Abike Dabir, Coordinator, Presidential Task Force(PTF) on COVID-19, Dr Sani Aliyu, United Kingdom-based, Prof Rotimi Jaiyesimi, and Co-founder NGEX, Dr. Obinna Anusiem.
Dr. Ogbuagu also spoke variously about his expertise and role in the clinical trials of the new vaccine.
‘The vaccine doesn’t alter DNA. It doesn’t affect the genetics. We don’t have answer on how long the immunity lasts. There are two types of immunity. The natural and vaccine-induced immunity.
There is nothing that doesn’t have side effects. We are feel pretty confident that the vaccine is safe.’
‘Vaccine-induced immunity may last longer but vaccine will do a better job of protecting persons.’
‘There are cases of those who have had COVID-19 and recovered. But some of them got re-infected after recovering from the disease, so natural immunity is not the best.’
‘We did not include pregnant women or nursing mothers in the clinical trials. A couple of people were pregnant before, during and after taking the vaccine.’
‘We feel pretty confident about its safety. People will not become zombies after taking the shot. I will take the shot myself. We can do studies on animals and give them high doses for further tests.’
‘We included people with co-morbidities, diabetes, obesity, hypertension, HIV/AIDS. It doesn’t cause infertility, but it may be contraindicated for people on cancer taking chemotherapy and living with organ transplants. They can take it, but they may not have enough antibodies.’
‘The studies were done with high level ethical, social and moral standards to minimize harm and ensure high standard quality procedures.’
‘I believe that airlines should ask passengers to show evidence that they have taken the vaccine.’
Let us learn from the COVID-19 pandemic. Another COVID-19 may not be too far away. There is always the next biologic threat. So we should always be prepared.
‘COVID-19 has unmasked deficiencies in Africa and even in America.’
‘Nigeria and Africa need to develop and support science and research. There is so much talent in the country, but we need to build an enabling environment.’
‘My clinical responsibilities include educating and training medical students, residents and infectious diseases fellows in various capacities in inpatient and outpatient settings and through structured course work and other teaching sessions.’
‘As a faculty of the HIV training track of the Yale-Internal Medicine primary care program and for over 6 years as a faculty of the Human Resources for Health program in Rwanda, I have extensive experience with curriculum development, structuring of residency training programs, and mentoring residents and faculty.’
‘In Rwanda specifically, I have and continue to mentor medical residents and junior faculty in quality improvement and clinical research projects that are locally relevant and addressing important infectious diseases-related problems (particularly HIV/AIDS and antimicrobial resistance).’
‘Furthermore, I have facilitated meaningful educational and research collaborations between faculty and trainees across institutions. As the program director of World Bank and HRSA-funded efforts supporting the Liberia College of Physicians and surgeons (LCPS)–run Internal medicine residency training program.’
‘I have overseen the selection and deployment of faculty to Liberia, and am responsible for educational programs and activities aimed at strengthening the residency training program.’
‘Overall, my expertise and collective experiences to date have positioned me to design and run successful projects around capacity building in low-resource settings including developing and implementing innovative and robust medical training and research programs for faculty, fellows, residents and students.’
‘For five years now, I have been the Director of the Yale AIDS Program HIV clinical trials program, and a principal investigator on numerous pharmacokinetic, phase 2 and 3 safety and efficacy trials of novel antiviral compounds (HIV).’
‘More, recently, given the alarming rate of new infections among men who have sex with men (MSM), I have focused on HIV prevention trials including being a co-principal investigator on a Yale CIRA funded project, which has supported the formation of a cohort of men who have sex with men, who are at high risk for HIV and are engaged in HIV PrEP services in order to study the impact of substance use on retention in care and adherence to PrEP.’
‘I am also a lead investigator on the international DISCOVER trial evaluating TAF/FTC vs TDF/FTC for HIV prevention among MSM and transgender women.’
‘In response to the COVID pandemic, I am Yale principal investigator on multiple investigational therapeutic and preventative clinical trials for COVID-19 including remdesivir (now FDA approved), leronlimab and remdesivir and tocilizumab combination therapy as well as the Pfizer/BioNTech Vaccine trial.’
.Ojukwu is a Fellow of Hubert H Humphrey Fellowship and journalist.
She is a campaigner and advocate for improved socio-economic and health services for all citizens, as well as the implementation of the Sustainable Development Goals(SDGS).
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