Johnson & Johnson is the first pharmaceutical company in South Africa to register a COVID-19 vaccination. The news was announced by the South African Health Products Regulatory Authority (Sahpra) on Monday, December 14.
Sahpra chief executive, Boitumelo Semete, spoke during a press briefing on Monday, confirming that Johnson & Johnson’s application was received on Thursday, December 10. An official review process has now started, and will be carried out by Sahpra.
According to Semete, Sahpra would focus on the quality, safety and efficacy of the vaccine. She added that a number of pre-submission discussions were also carried out between the regulator and various pharmaceutical companies, which advised on the data required for a successful submission.
Johnson & Johnson has stated that they are looking for subjects to participate in the vaccine candidate’s trials, and is working with ENSEMBLE Studies to do so.
“If you take part in one of the ENSEMBLE Studies, you will be in the study for up to 2 years and 3 months. You will have up to 10 visits (either at home, the study center, or clinic) with the study doctor or clinical research staff,” ENSEMBLE said on its website.
“If you qualify for one of the ENSEMBLE Studies, you will be randomly assigned by chance (like flipping a coin) to 1 of 2 groups within the study. Depending on which group you are assigned, you will receive either investigational vaccine or placebo. A placebo looks just like the investigational vaccine and is given the same way, but instead of containing an active vaccine it contains a saline (salt) solution with no active ingredients. During your participation, you will either receive 1 or 2 investigational vaccine injections OR 1 or 2 placebo injections. During the study, neither you nor the study staff will know which group you are in. In a medical emergency, the study staff can quickly find out which group you are in.”
During a “family meeting” hosted by President Cyril Ramaphosa on Monday, he confirmed South Africa is in the process of finalising its COVAX facility. According to the World Health Organization (WHO), this is a global initiative aimed at working with vaccine manufacturers to provide countries worldwide equitable access to safe and effective vaccines, once they are licensed and approved.
“COVAX currently has the world’s largest and most diverse COVID-19 vaccine portfolio – including nine candidate vaccines, with a further nine under evaluation and conversations underway with other mayor producers,” WHO said.
“It is anticipated that we could have access to a suitable vaccine by the second quarter of 2021 and will initially receive quantities for at least 10% of the population,” Ramaphosa said. “While this gives us hope, the reality is that it will take some time before we can vaccinate enough South Africans to be assured of little to no transmission of the virus, and it will be a costly undertaking. We need to prepare for this, and be ready to make the difficult decisions about where to find the money and when to deploy it.”