TINASHE MAKICHI
Zimbabwe’s drug regulator, the Medicines Control Authority of Zimbabwe (MCAZ), has authorised the use of Johnson & Johnson vaccine in the country, becoming the fifth vaccine to be used in the country.
The authorisation, which was issued on the basis of Section 75 of the Medicines and Allied Substances Control Act (Chapter 15:03), comes amid concerns the spread of Covid-19 is growing.
The authorisation is subject to the condition that the vaccine is administered as a single dose of 0.5m by intramuscular injection only.
The other condition is that procurement and importation of the vaccine will be restricted exclusively to the Ministry of Health and Child Care, unless a written exemption by the permanent secretary in the Ministry.
The emergency use of the vaccine is valid for a period of 12 months or when the public health emergency ends, whichever is shorter. If additional satisfactory data needed for full registration are submitted in an application to the MCAZ, then full marketing authorisation could be granted.
The authorisation was based on the review of the submitted quality, safety and efficacy data and upon performing a benefit risk assessment thereof.
“Those being vaccinated should be instructed to seek immediate medical attention if they develop symptoms of thromboembolism or thrombocytopenia following vaccination,” MCAZ acting director general Richard Rukwata said in a statement.
Rukwata noted that adverse events following immunization forms must be completed for any suspected adverse events including but not limited to thrombosis, thrombocytopenia and Guillain Barre symptoms. These must be submitted to the authority for casualty assessment.
The Johnson & Johnson vaccine is a single-dose vaccine that can help prevent Covid-19.
It’s the third Covid-19 vaccine authorised by the Food and Drug Administration for emergency use in the United States.
Large-scale clinical trials in several locations across the globe found that a single dose of the Johnson & Johnson vaccine was effective at preventing Covid-19. They found that the vaccine can also protect against several viral variants.
Recently, MCAZ approved the use of Ivermectin human oral formulations for the prevention and treatment of Covid-19 as the country battles a third wave of the highly infectious respiratory disease.
Announcing the development, Rukwata said the drug, which is normally used to fight parasitic diseases on livestock, is still under several clinical studies to check on its safety and efficacy in treating coronavirus infections in human beings.
Johnson & Johnson becomes the fifth Covid-19 vaccine to be authorised by Zimbabwe after Sinopharm, Sinovac, Covaxin and Sputnik V. Zimbabwe is ramping up the vaccination drive and targets to inoculate 60% of the population to achieve herd immunity.
