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Sahpra investigating 1,490 'adverse effects' from J&J and Pfizer jabs

“As at July 7, we had received 1,494 or so safety reports, 564 for the Pfizer vaccine, 930 for the J&J,” said Sahpra CEO Dr Boitumelo Semete-Makokotlela.

21 July 2021 - 18:49 By amanda khoza
Sahpra is investigating adverse findings from administering Pfizer and J&J vaccines in SA.
Sahpra is investigating adverse findings from administering Pfizer and J&J vaccines in SA.

The South African Health Products Regulatory Authority (Sahpra) said on Wednesday it was investigating adverse findings reported from administering the Johnson & Johnson and Pfizer vaccines in SA.

“As at July 7, we had received 1,494 or so safety reports, 564 for the Pfizer vaccine, 930 for the J&J vaccine,” said Sahpra CEO Dr Boitumelo Semete- Makokotlela.

Briefing parliament's portfolio committee on health, Semete-Makokotlela said a report would be released on Friday detailing the analysis being conducted on the adverse findings reported on the two vaccines now being administered in SA.

“In total there have been 3,730 adverse events after immunisations that have been reported and analysed against the Pfizer and J&J. There are also those who have been reported in terms of special interest,” she said.

She told the committee that the regulator is investigating causes of deaths in such cases.

“These fatalities do not, at this point, outnumber what you would see generally in the public. But be that as it may, we are doing causality assessments.”

Giving an update on the various applications that were being reviewed, she said vaccines granted emergency use by the World Health Organisation include Pfizer, AstraZeneca and  Johnson & Johnson.

“The Moderna vaccine is [part of] ongoing assessment. We also have Sinopharm, that received its emergency use go-ahead from the WHO on May 7, as well as Sinovac on June 1. There were a number of vaccines under evaluation and some were undergoing clinical studies,” she said.

There are about 21 vaccines, including Sputnik and Novavax, under review by the World Health Organisation.

In SA, Semete-Makokotlela said, Sahpra has had pre-submission meetings with J&J, AstraZeneca, Prizer, Sputnik V and Sinovac since 2020.

“We had a meeting in December with Moderna, a possible applicant, wherein they indicated an intention to submit an application — however, they have not. These meetings continue to take place.

“To date, authorised under section 21, are AstraZeneca, Pfizer and J&J that have conditional market authorisation. Sinovac was recently authorised. The time it takes to authorise on average, depending on the quality of the submission, is about 90 working days.”

She said Sahpra was reviewing the Sputnik V and Sinopharm vaccines.

On the use of ivermectin for treating Covid-19, Semete-Makokotlela said Sahpra continues to monitor studies being conducted worldwide.

“As we sit, there is no evidence that there is clinical benefit and our position remains that it should be used under controlled mechanisms.”

The EFF’s Naledi Chirwa asked Semete-Makokotlela to clarify which exact adverse effects were being investigated, while the DA’s Evelyn Wilson expressed concern over the number of adverse findings, particularly with the Pfizer vaccines, saying: “It is concerning that Pfizer has a bigger reaction than the J&J. Why is that the case?”

The ANC’s Tshilidzi Munyai proposed that another meeting be called to discuss adverse findings and how the country should handle the matter. 

Responding, Prof Helen Rees explained that it was important for Sahpra to make sure that the vaccines that were approved could be trusted.

“We are in the middle of a pandemic and it cannot be business as usual, which is why everything that has to do with Covid-19 is fast-tracked but it does not mean that corners are cut.”

She explained: “When we started introducing the vaccines, we started with the over 60s and the people in that age group are more likely to get things like heart problems, stroke and thrombosis or other problems with respiratory diseases because they have many more comorbidities.

“So when you see something like respiratory difficulties, the question that must be asked is whether it was caused by the vaccines or was that going to happen to that person because of other factors?”

Rees said when the data is collected, Sahpra investigates how common the problem is.

“SA does not do this alone — all of that safety data collected is shared with the WHO and many other countries are collecting this data as well.”