South Africa’s pharma regulator approves Johnson & Johnson’s Covid-19 vaccine

South Africa’s pharma regulator approves Johnson & Johnson’s Covid-19 vaccine



SOUTH AFRICA – The South African Health Products Authority (SAHPRA) has granted a conditional approval for the Johnson & Johnson Covid-19 vaccine, a significant step in Africa’s quest to stop the spread of the Covid-19 pandemic across the Continent.

The approval comes just days after the announcement by the American pharmaceutical giant that it is set to provide up to 400 million doses of its highly effective vaccine to African countries that have continued to voice their concerns over ‘vaccine nationalism’ – or the near monopoly by more resourceful countries such as US, UK, EU, China and India to hoard supplies of the critical vaccines, shutting off supplies to poorer nations.

The vaccines will be manufactured in South Africa by Africa’s leading drug giant, Aspen for distribution into most African countries. It had earlier been granted approval by the US in late February and by the EU in mid March 2020.

SAHPRA says that the vaccine is effective against severe acute respiratory syndrome coronavirus 2, or COVID-19

“This authorisation is based on acceptable safety, quality and efficacy data submitted by Janssen Pharmaceutica (Pty) Ltd to SAHPRA as a rolling submission over the period 11 December 2020 to 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 NDoH Covid -19 vaccination plan and applicable guidelines,” the regulator said in a statement.

It added that further conditions to the approval relate to the submission of periodic safety updates in accordance with the regulator’s guidance, the reporting of the results of ongoing studies and conformance with vigilance activities as outlined in the approved risk management plan.

Contrary to the other approved and available vaccines around the World, the Johnson & Johnson has two clear advantages that will make it particularly adapted to the poor infrastructure in Africa’s healthcare system.

“From the beginning of this pandemic, Johnson & Johnson has recognized that no one is safe until everyone is safe, and we have been committed to equitable, global access to new COVID-19 vaccines. Our support for the COVAX Facility, combined with supplementary agreements with countries and regions, will help accelerate global progress toward ending the COVID-19 pandemic,” said Alex Gorsky, the Chairman and CEO of Johnson & Johnson said at the signing of the agreement to supply African countries with the vaccine, majority of which will be availed from the third quarter of 2021.

Meets African vaccine challenges

One key advantage is that it can be administered as a single dose by intramuscular injection to individuals 18 years and older. One of the vaccines, the Oxford-AstraZeneca vaccine, has had bad press after regulators in Europe suspended its use in late March 2021.

The other is its ease of storage in regular refrigeration conditions and its long shelf life. “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 – 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,” the regulator noted.

By manufacturing the vaccine in South Africa, Johnson & Johnson has rallied to the call to boost vaccine supplies within African countries, where, according to the WHO, only a few countries have capability of making such vaccines.

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