The South African Health Products Regulatory Authority (SAHPRA) has officially registered the Johnson&Johnson vaccine. The vaccine, also known as Janssen, has however been registered with conditions.
According to SAHPRA CEO, Dr Boitumelo Semete-Makokotlela, the vaccine has been authorised for meeting the acceptable safety and quality standards.
These standards are according to data submitted by Johnson&Johnson between 11 December 2020 and 17 March 2021.
“The authorisation is, however, subject to a number of conditions which includes that the vaccine is supplied and administered in accordance with the National Department of Health COVID-19 vaccination plan and applicable guidelines.
“Further conditions relate to the reporting of the results of ongoing studies and conformance with pharmacovigilance activities as outlined in the approved risk management plan, including the submission of periodic safety updates,” she explained.
The vaccine is administered in a single dose injection to individuals 18 years and older.
Those who are injected with the vaccine can expect to feel mild symptoms within a few days.
"Some of the side effects of COVID-19 Vaccine Janssen as outlined in the clinical trial evidence submitted by the applicant were usually mild or moderate and cleared within a couple of days after vaccination. The most common ones were pain at the injection site, headache, tiredness, muscle pain and nausea."
Former chair of the Ministerial Advisory Committee, Professor Abdool Karim, said side effects happen naturally with all kinds of medication.
“Any medication you take will have side effects. There is no such thing as a medication with no side effects and vaccines do have side effects. Most of them are pretty minor, they involve a bit of pain and a bit of swelling at the side of the injection as you would get with receiving a measles vaccine or any other vaccine for that matter.
“We have found certainly with six vaccines that have released their results that the safety profile of the vaccines is really good. So there’s no reason to be concerned if somebody does encounter side effects, there’s a reporting mechanism we have in place.” said Karim.
The Johnson&Johnson vaccine is designed to have a shelf-life of 24 months when stored at -25°C to – 15°C
“Within these 24 months, the vaccine may be stored for a three-month period at 2 to 8 degrees Celsius. Once the vaccine has been thawed, it cannot be refrozen. The vaccine should be discarded within six hours after opening or at the end of an immunisation session, whichever comes first.” said SAHPRA.