Pfizer & BioNTech phase 3 COVID-19 vaccine trials resume in SA

Pfizer and BioNTech have initiated the enrollment of participants in South Africa for their phase 3 COVID-19 vaccine trials, marking a significant step in the global effort to combat the pandemic. The study aims to enroll approximately 44,000 participants worldwide, with a focus on increasing the trial population to include individuals with chronic illnesses and diverse backgrounds. Dr. Barton Dunganet, Medical Director of Pfizer South Africa, shed light on the partnership and the progress of the trial in a recent interview with CNBC Africa. The collaboration between Pfizer and BioNTech in the vaccine development program began in April, with the recruitment process starting with the first human clinical trials. Following successful results from the phase 1 and phase 2 trials, the phase 3 clinical trial was initiated with regulatory approvals at each stage. The enrollment target of 44,000 participants is nearing completion, with over 35,000 participants globally and 800 patients enrolled in South Africa across four sites in Gauteng, Limpopo, and the Western Cape. Dr. Dunganet emphasized the importance of the vaccine as an additional tool to control the spread of COVID-19, considering that the virus is likely to persist for an extended period. The vaccine is envisioned as a preventive strategy to complement existing non-pharmacological interventions implemented in South Africa, which have contributed to the country's descent to the 10th position in global rankings of COVID-19 cases. Addressing the choice of trial sites, Dr. Dunganet explained that the selection of Gauteng, Limpopo, and the Western Cape reflects a strategic approach to represent the diversity of the South African population. While acknowledging the severity of COVID-19 cases in provinces like the Eastern Cape and KwaZulu-Natal, the decision to focus on broader representation across the country was deemed crucial for generating data that truly reflects the nation's demographic landscape. In response to concerns about the inclusion of individuals with various comorbidities in the trial, Dr. Dunganet assured that there were no deliberate exclusions based on specific health conditions. Participants with chronic illnesses, including stable HIV patients, were welcome to join the trial, underscoring the importance of inclusivity in the study population. Regarding public receptivity to the trial, Dr. Dunganet noted a positive response from participants in South Africa since the enrollment commenced, with no significant resistance reported. As the trial progresses, the estimated timeline for the completion and analysis of results is set for the end of October. Subsequent steps will involve the submission of findings to regulatory bodies for approval, paving the way for potential vaccine market availability. The phase 3 COVID-19 vaccine trials in South Africa mark a pivotal stage in the quest for an effective vaccine against the virus. With a commitment to inclusivity, diversity, and rigorous clinical evaluation, Pfizer and BioNTech aim to contribute to global efforts in combating the ongoing pandemic.