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SAHPRA refuses to release documents relating to Pfizer approval

The special appeals committee hearings into COVID-19 vaccines for children ground to a halt when the parties fought over the health regulator's SAHPRA’s decision to refuse to provide documents consulted to approve the Pfizer jab, reports News24.

During the first day of the hearings (11 February), legal representatives of the SA Health Products Regulatory Authority  and Free the Children – Save the Nation argued over the regulator's decision not to share the explanatory documents from Pfizer. The regulator maintains that the documents are confidential and Free the Children – Save the Nation should get them from Pfizer.

Last July, SAHPRA authorised a paediatric COVID-19 trial on children aged six months to eight years for the Sinovac vaccine. In September, it approved the Pfizer vaccine to be administered to children aged 12 and above. Free the Children – Save the Nation launched an appeal against both decisions last October.

Health Minister Dr Joe Phaahla appointed Advocate Tembeka Ngcukaitobi to chair the committee. Free the Children – Save the Nation recommended Dr Herman Edeling and Dr Stephen Schmidt to be on the committee, while SAHPRA recommended Professor Glenda Gray and Professor Salim Abdool Karim. The committee will determine whether the regulator acted lawfully in making its decisions on the trials and administering vaccines to minors. The committee has the power to overturn the decision and ask for a fresh one or dismiss the appeal, Ngcukaitobi said.

On Friday, SAHPRA’s lawyer, Advocate David Mtshweni, informed Ngcukaitobi he would be seeking a postponement because he had been assigned the case only on Thursday afternoon.


News24 article – Show us the documents, organisation against minors receiving Covid-19 vaccine tells SAHPRA (Open access)


See more from MedicalBrief archives:


Pupils’ COVID jabs vital: Section27 in bid to dismiss ACDP application


Doctor’s lobby group joins ACDP’s urgent application to halt child vaccinations


ACDP applies for interdict to halt vaccine roll-out to children aged 12-17



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