The South African Health Products Regulatory Authority (SAHPRA) says it has registered the COVID-19 Johnson & Johnson vaccine, known as Janssen, with conditions.
“This registration signals a significant step in the fight against the COVID-19 pandemic,” said SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.
According to Dr Semete-Makokotlela, the authorisation is based on acceptable safety, quality and efficacy data submitted by Janssen Pharmaceutica to SAHPRA as a rolling submission between 11 December 2020 and 17 March 2021.
The conditions include that the vaccine is supplied and administered in accordance with the National Department of Health’s 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 Janssen is administered as a single dose by intramuscular injection to individuals 18 years and older.
Johnson & Johnson possible side effects
According to SAHPRA, the side effects as outlined in the clinical trial evidence were usually mild or moderate and cleared within a few days after vaccination.
The most common side effects reported were pain at the injection site, headache, tiredness, muscle pain and nausea.
Shelf life of Johnson & Johnson Covid-19 vaccine
The current assigned provisional shelf life of the vaccine is 24 months when stored at minus 25 to minus 15 degrees Celsius.
“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.”
Meanwhile the AstraZeneca vaccine’s safety continues to be questioned. Marco Cavaleri, head of the European Medicines Agency (EMA) vaccines strategy, told an Italian newspaper that the EMA would soon be announcing that they have found a “clear link” between the Oxford-AstraZeneca vaccine and extremely rare blood clotting incidents that have occurred amongst a minority of recipients. He said the reason for the clots was still not known, but that they seem to mainly affect younger people.
However the EMA issued a statement later today denying that it has already found a clear link. The EMA told Agence France-Presse that it has “not yet reached a conclusion and the review is currently ongoing”. An announcement is expected tomorrow or Thursday.
South Africa had initially received a million doses of the AstraZeneca vaccine, but decided against using it because it was found to be less effective against the variant discovered in SA in November 2020. According to Health Minister, Dr Zweli Mkhize, the Johnson & Johnson vaccine has been proven effective against this variant, known as 501Y.V2.