'Significant step' as health authority approves J&J Covid-19 vaccine — with conditions

Sahpra has approved a J&J Covid-19 vaccine, developed by its vaccine unit Janssen Pharmaceutica.
Sahpra has approved a J&J Covid-19 vaccine, developed by its vaccine unit Janssen Pharmaceutica.
Image: Sahpra website

SA has recorded another positive development in the fight against Covid-19, as the SA Health Products Regulatory Authority (Sahpra) approved the Johnson & Johnson vaccine — albeit with some conditions.

In a statement, Sahpra said it had registered the single-dose vaccine, which is developed by the J&J vaccine arm Janssen Pharmaceutical Companies, on March 31. One of the conditions include that the vaccine should be supplied and administered under the national department of health’s Covid-19 vaccination plan and applicable guidelines.

The regulatory body said the Covid-19 vaccine was an adenovirus type 26 vectored vaccine indicated for active immunisation against SARS-CoV-2. The administration of the Janssen Covid-19 Vaccine may contribute to protection against Covid-19.

“This registration signals a significant step in the fight against the Covid-19 pandemic. This authorisation is based on acceptable safety, quality and efficacy data submitted by Janssen Pharmaceutica to Sahpra as a rolling submission over the period December 11 2020 to March 17 2021,” said the regulatory authority.

According to the Sahpra statement, the side effects of the vaccine 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.

Sahpra said the current assigned provisional shelf-life of the vaccine is 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°C to 8°C. 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.