Johannesburg - Concerned South African Health Products Regulatory Authority (SAHPRA) board members are outraged that the government announced “a rollout of the Johnson & Johnson vaccine” when in fact “it is just another clinical trial” by the American pharmaceutical company.
Several board members demanded answers from SAHPRA board chairperson Helen Rees in their official WhatsApp group - that Independent Media has seen - to clarify why “Johnson & Johnson phase 3B clinical trial” is being called a rollout.
"They must stop misleading our people and allowing them to be used as guinea pigs. This is a clinical trial and not a rollout. The vaccine is still yet to be registered in South Africa," said one of the board members speaking to Independent Media, yesterday.
One of the board members asked: "The president is reporting in parliament about a 'roll-out' of the J&J vaccine. Can the current 3B clinical trial be termed a rollout?"
Rees responded: "There is good phase 3B safety and efficacy data on J & J, including from SA. The reason it's a 3B study is that the first vaccines are a donation from J & J and were manufactured for the phase 3B trial so the manufacturer wanted these doses to be given out as part of an open-label phase 3B study. We will generate more safety and efficacy data by doing this in the context of our variant."
The SAHPRA committee responsible for technical matters, on Friday, had an urgent meeting to discuss issues raised on the board’s WhatsApp group. The J&J vaccine dominated the heated discussion which ensued, which lasted more than three hours.
"We left the meeting with more questions than answers, and there are no clear answers as to why (the) J&J vaccine is being prioritised against the others," said one of the people who attended the meeting.
A second person who also attended the meeting asked whether Johnson & Johnson had applied for a protocol deviation to include just frontline healthcare workers.
"We know there was a protocol deviation application to include the president and his deputy, but now we understand that even administrative secretaries have been vaccinated.
"We would like to appeal to all pharmaceutical companies, don't use South Africans as your guinea pigs. We do urgently need vaccines against Covid-19, but proper trials must be done and SAHPRA must approve the product before you can start giving them to our people. Johnson & Johnson vaccine isn't yet registered in South Africa, but it is being marketed, by some government officials and doctors, as if it is the only vaccine available in the world today," the member said.
Asked for comment, Johnson & Johnson vaccine trial lead investigator, Professor Glenda Gray, yesterday admitted that this wasn’t a roll out but an early access programme.
“It is wrong to call it a roll out and we have always stressed that this was a phase 3B label study or early access program until the J & J vaccine is registered in South Africa,” She said.
Gray also confirmed that there were five cases of alleged reaction to the Johnson & Johnson jab reported in South Africa, but that only one fits the criteria of a reaction to the vaccine.
“We do expect a number of cases to be reported about reaction to the vaccine and we will investigate all of them to see if they fit into the criteria of reaction to the vaccine. So far, after our investigation, only one case from the North West province fitting the criteria of anaphylaxis and that health worker was treated and she is now fine.”
Johnson & Johnson on Friday admitted that it received preliminary reports of two cases of severe allergic reactions, including one case of anaphylaxis in South Africa.
Reuters reported that Johnson & Johnson head of clinical development and medical affairs, Dr Macaya Douoguih, confirmed that "a case of anaphylaxis was observed in an ongoing trial of healthcare workers in South Africa."
The Independent Media knows of one nurse from Mpumalanga who was rushed to the hospital shortly after taking the Johnson & Johnson jab.
"The nurse reacted badly, shortly after she was vaccinated, last Saturday. Her blood pressure became abnormally high, and she was rushed to the hospital where she was admitted," a close family member, who asked not to be named to protect her identity, said.
One of the questions that SAPHRA Chief executive Dr Boitumelo Semete was asked during the meeting, on Friday, was who would be liable for compensation related to adverse drug reactions, especially, concerning the Johnson & Johnson vaccine.
"The CEO said she would consult with legal counsel," said one of the SAPHRA board members.
It also transpired during Friday's meeting that people taking the Johnson & Johnson jabs are asked to sign consent forms.
"We don't know what's stated in those consent forms, but in a normal clinical trial, the sponsor, in this case, Johnson & Johnson, would be the one docking out those millions per event."
A doctor, speaking on the condition of anonymity, said research was continuously being done, hence, they could find the new variant.
"After the initial trial, they had to find a new cohort to test the new strain, meaning they had to do more tests to see if it would be effective against the new strain/variant," said the doctor.
She added, that when you roll out the vaccine, it means you are know for sure that it's effective and can be given to everyone.
"It means you must now be sure that those with comorbidities can take it, the young and old can also take it, without any complications," she said.
In response to our questions, the Department of Health said allergic reactions to all Covid-19 vaccines are rare. “However, we do expect allergic reactions to happen.”
“Severe reactions such as anaphylaxis are being closely monitored worldwide and affect at most one or two people per one million vaccines administered.
“Similarly in South Africa, an extensive safety reporting mechanism is in place with careful follow up of any significant adverse events. To date, although there have been reports of usual vaccine side-effects (“reactogenicity”) as expected and some cases of allergic reactions, all cases have been appropriately managed without any long term consequences.
“We have experienced one severe allergic reaction or anaphylaxis in a female health care worker. This required hospital management- the vaccinee has made a rapid and full recovery.
“The risk of reactions is being managed through assessment of allergy prior to vaccination, discussion with the Sisonke Safety Desk staff and extended observation periods for those people at risk.
“The risk of Covid-19 far outweighs the risk of a reaction, and should not limit provision of this life-saving vaccine to people living with allergy.
“We encourage health workers with a history of a reaction to a vaccine or medication to disclose this to our trained vaccinator staff who will complete a risk assessment, and monitor them closely after vaccination”.
The Independent Media reported three weeks ago that there was a tussle between President Cyril Ramaphosa and Health Minister Zweli Mkhize over what is seen favouring the Johnson & Johnson vaccine over other vaccines.
Mkhize preferred the Russian vaccine Sputnik for South Africa, while Ramaphosa wanted the American Johnson & Johnson.
SAHPRA spokesperson Yuven Gounder, yesterday, confirmed that the Johnson & Johnson vaccine is still undergoing a process of registration.
"As we speak now, Johnson & Johnson vaccine isn't registered with SAHPRA, and they are going through the third review as there are four different reviews undertaken before the product can be registered," Gounder said.
The US government on Saturday authorised Johnson & Johnson's vaccine, Reuters reported.
The US Food and Drug Administration announced the emergency use authorization of the J&J vaccine for adults aged 18 and older following Friday's unanimous endorsement by the agency's panel of outside experts. Shipments to vaccination sites are expected to begin Sunday or Monday.
Sunday Independent and Reuters