Vaccination testing amended – study leader

Professor Glenda Gray, co-principal investigator of the Sisonke implementation study, says she hopes the South African Health Products Regulatory Authority (Sahpra) will give the green light for vaccination testing to resume.

Sahpra’s decision to suspend the study was announced by Health Minister Zweli Mkhize last week. This was after the US paused its roll-out due to reported blood clots in recipients.

“We have determined to voluntarily suspend our roll-out until the causal relationship between the development of clots and the Johnson & Johnson vaccine is sufficiently interrogated,” Mkhize said.

He said Sahpra would collate information from Johnson & Johnson and other regulatory bodies to make a thorough assessment of the situation.

The Sisonke Protocol had vaccinated 292 623 healthcare workers before it was paused.

Yesterday Gray said she hoped Sahpra would allow the vaccinations to continue.

“We have amended the study to optimise our ability to identify these conditions [blood clots] should they arise and also have developed a plan to manage these conditions in the event of them happening,” she said.

“We will also increase public awareness. The pause gave the regulatory authorities time to review the data and indicate how they wanted us to alter the study to enhance safety.”

Meanwhile, the government has officially launched the second phase of vaccine registration. The launch of the Covid-19 Electronic Vaccination Data System for those over 60 years of age is in preparation for the second phase from 17 May.

It will include essential workers, people in congregate settings and those over 18 with comorbidities. “Those who are turning 60 in 2021 will be eligible. We are doing this to make it easy to implement the vaccination programme guided by our scientists and our ministerial advisory committee. We believe that it’s important that when we open we must prioritise those who are 60 years and over,” Mkhize said.

“This is to ensure that if there is to be any infection, we can protect anyone from getting severe disease or hospitalisation. The prioritisation is just to make it easies to vaccinate and to group people in batches that are manageable.”

South Africans between the ages of 40 to 60 would be prioritised thereafter, with the roll-out due from August to November. Phase 3 will be for those younger than 40.