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Sahpra registers J&J vaccine with conditions

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  • Sahpra says it registered the J&J vaccine on 31 March 2021 with conditions.
  • One of these conditions is that the vaccine must be supplied and administered in accordance with the national Health’s Department Covid-19 vaccination plan and applicable guidelines.
  • South Africa plans to roll out phase two of its vaccination programme in May and more J&J doses are expected to arrive in the country.

The South African Health Products Regulatory Authority (Sahpra) has registered the Johnson & Johnson (J&J) vaccine with conditions.

It said the vaccine, developed by J&J’s vaccine arm Janssen Pharmaceutical Companies, was registered on Wednesday, 31 March 2021.

The registration was done in terms of Section 15(6a) of the Medicines and Related Substance Act 101 of 1965, allowing it to register a medicine subject to certain conditions.

READ | ‘Everything is on course’ – Mkhize assures SA that 1 million vaccines will arrive later this month

“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’s] Covid-19 vaccination plan and applicable guidelines,” Sahpra CEO, Dr Boitumelo Semete-Makokotlela said in a statement posted on its website on Thursday.

Further conditions related to the submission of periodic safety updates according to its guidance, the reporting of the results of ongoing studies and conformance with pharmacovigilance activities as outlined in the approved risk management plan.

Semete-Makokotlela also said:

“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 (Pty) Ltd to Sahpra as a rolling submission over the period 11 December 2020 to 17 March 2021.”

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The J&J vaccine is administered as a single dose to persons aged 18 and older.

According to the clinical trial submitted by Janssen, side effects of the vaccine were mild or moderate within a few days after vaccination.

Addressing the nation on Tuesday, President Cyril Ramaphosa said more than 250 000 health workers had, to date, taken the J&J vaccine as part of the Sisonke trial, News24 reported.

He also announced that the government secured 11 million J&J vaccine doses, adding it was finalising securing a further 20 million with the pharmaceutical company.

Ramaphosa said the government was finalising another 20 million doses of the Pfizer vaccine as it prepared for phase two of the vaccination programme in mid-May.

The president said the supply would provide the country with enough vaccines for 41 million people.

The current assigned provisional shelf-life for the J&J vaccine is 24 months when stored at -25C to – 15C. Within these 24 months, it may be stored for a three month period at 2C – 8C.

Once thawed, the vaccine cannot be re-frozen and should be discarded within six hours after being opened and used.

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Source: News24

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