Sahpra approves single dose J&J vaccines for under-18s
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DURBAN - The South African Health Products Regulatory Authority has approved the registration of the single-dose Johnson & Johnson Covid-19 vaccine for those younger than 18.
The Janssen Pharmaceutical Companies of J&J made the announcement today of the approval, with conditions.
The pharmaceutical giant said data from the Phase 3 ENSEMBLE study showed the Johnson & Johnson COVID-19 vaccine was well tolerated and demonstrated a 67% reduction in symptomatic Covid-19 disease in participants who received the vaccine in comparison to participants given the placebo.
"The onset of protection was observed from day 14 and was maintained 28 days post-vaccination. The data also demonstrated the vaccine was 85% effective in preventing severe disease across all regions studied and showed protection against Covid-19 related hospitalisation and death, beginning 28 days after vaccination.
’’In South Africa, the level of protection against moderate to severe Covid-19 infection was 57%, 28 days post-vaccination," it said.
The growing presence of regional Covid-19 variants underscores the need to look at a pandemic response from a global perspective. In South Africa specifically, the emergent SARS-CoV-2 variant from the B.1.351 lineage has had a critically detrimental effect on the country’s healthcare system, beyond its impact in other parts of the world where it is now rapidly spreading.
J&J said it is committed to making the vaccine available on a not-for-profit basis for emergency pandemic use.
According to Sahpra, the registration signals a significant step in the fight against the pandemic.
Sahpra added that the authorisation is, however, subject to a number of conditions, which includes that the vaccine is supplied and administered in accordance with the NDoH 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,” Sahpra CEO, Dr Boitumelo Semete-Makokotlela, said.
The side effects of the Covid-19 Vaccine Janssen, as outlined in the clinical trial evidence submitted by the applicant, were usually mild or moderate and cleared within a few of days after vaccination. The most common side effects reported were pain at the injection site, headache, tiredness, muscle pain and nausea.
The current assigned provisional shelf-life of the vaccine is 24 months when stored at minus 25°C to minus 15°C. Within these 24 months, the vaccine may be stored for a three-month period at 2°C - 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.