South Africa – Two vaccine manufacturers– Novovax and Serum Institute of India– are seeking EUA in South Africa for emergency use. It means that if given clearance by the South African Health Products Regulatory Agency (SAHPRA), these vaccines can be used in South Africa as well.
Till now, as per the gathered report, the two companies have made a regulatory submission to the concerned agency where it sekkes EUA for the vaccines candidate with Matrix-M adjuvant.
After it is authorised by the body, SII will produce and also market the nanoparticle protein-based shot as ‘Covovax’ in the region.
The last filing was done only recently and that comprises the result from Phase III clinical trials– PREVENT-19 and a UK trial. As far as PREVENT-19 is concerned, it was reported that nearly 30,000 subjects were enrolled in the United States and Mexico. As for the UK trial, there are only 15,000 subjects.
The early level of report compilation shows that the shot showed an encouraging safety profile. The report also claimed that the vaccine at an early level does not show adverse events and is overall balanced across other vaccines and placebo arms.
Common symptoms which a person can experience after being vaccinated with this shot are Headache, myalgia, nausea, arthralgia, and tenderness/pain at the injection site. Any symptoms other than these were also counted among the common symptom criteria. Novavax president and CEO Stanley Erck said, “Novavax is thankful for our long-standing history of partnership in South Africa to advance much-needed vaccines.” He also added that the competency of the vaccine can further be stressed by the Phase IIb clinical trial and booster study of the much talked about protein based vaccine.