Durban - The national department of health came under fire from some members of parliament's portfolio committee on health for what it termed as misleading information on the Johnson & Johnson vaccine which is a study instead of a full vaccine rollout.
The vaccine targeted at healthcare workers and labelled as the Sisonke Protocol has already been administered 92 029 public and private frontline healthcare workers from the Johnson & Johnson vaccines batches.
However, members of the portfolio committee expressed deep dissatisfaction over the vaccines after Deputy Health Minister Dr Joe Phaahla and the department’s Director-General Dr Sandile Buthelezi reported yesterday on the rollout programme.
Phaahla and Buthelezi faced the brunt of the members of the committee as they lashed out at the department for “misleading” and failing to clarify whether the Johnson & Johnson vaccines were an official rollout or clinical trial.
Addressing the health portfolio committee, Phaahla said that the Johnson & Johnson vaccines had not yet been formally registered and approved by the country’s regulatory health body the South African Health Products Regulatory Authority (Sahpra).
He said that the Johnson & Johnson vaccine had been tested in South Africa on human trials in terms of Phase 3, around November and December last year, and it had shown to be effective against the 501Y.V2 variant with more than a 57% effectiveness in terms of the variant when the variant was becoming dominant late last year.
“It was the only other vaccine that had done human trials in South Africa and shown results not general in terms of the main, original, Covid-19 virus which is all over the world.
Phaahla said that the Johnson & Johnson vaccine was “technically and legally” an expanded research in terms of human trials because the doses that were being used in the country were the remaining doses from human trials all over the world.
“It is legally regarded as an expanded study because as we are rolling out, the vaccine is not registered. The documentation for the application for registration of the vaccine has been submitted to Sahpra and documentation has also been submitted to other authorities,” Phaahla said.
He added that because South Africa was eager to start with the programme and Johnson & Johnson had not yet acquired registration of the vaccine with the regulatory authorities, including Sahpra, it meant that it would be considered an expanded study.
Naledi Chirwa, EFF MP, slammed the department for misleading the public and not clarifying that the vaccines were human trials and not a full rollout programme of the Johnson & Johnson vaccine.
“It is concerning that the minister and department subverted the ethical process of the trial in regards to firstly performing on healthcare workers participating in this trial.”
Another member of the committee, NFP MP Shaik Emam Manzoor, hit out at the department, criticising it for being unethical in its conduct around communication in terms of the vaccine and failing to get the consent of frontline healthcare workers to conduct human trials on them.
“It is my understanding that this matter needs to be escalated and if necessary find measures for people to be held accountable for this because many people that have taken these vaccines are of the opinion that this is a rollout for healthcare workers to protect them first.
“In my understanding, what the National Department of Health and Sahpra have done is unethical, because normally in a trial, you would call for people to participate,” Shaikh Eman said.