J&J vaccine being administered is not formally registered with health products authority

Deputy health minister Joe Phaahla on Friday told parliament the Johnson & Johnson (J&J) vaccine being administered was not formally registered with the SA Health Products Regulatory Authority (Sahpra).

Phaahla also revealed the vaccines being used in the current rollout programme were part of a batch J&J was using to conduct their worldwide human “expanded study.”

“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 and his director-general Sandile Buthelezi were updating parliament on the countrywide rollout of Covid-19 vaccines.

Explaining the vaccine procurement process, Phaahla said the government had engaged with manufacturers including those making Pfizer, Moderna and AstraZeneca vaccines, for some time.

“In the middle of that, as we were negotiating with the manufacturers, we concluded an agreement with AstraZeneca which had delegated the Serum Institute of India as its production company. We were directed by AstraZeneca to conclude negotiations with the institute. We then purchased one million doses of the AstraZeneca vaccine.

“That product was delivered to SA and unfortunately a few days after the vaccine was delivered, the results of the trials in SA came out.

“It showed that, specifically when tested against the 501Y.V2 variant which is prominent in our country, it was found to be not very effective at 22% and that is where the problem came.”

As a result, the government had to look at what else was available for SA.

“The only other vaccine which was tested in terms of phase three in South Africa and had shown to also be effective against the 501Y.V2 variant was the J&J vaccine.”

The government then immediately entered into discussions with J&J.

“We asked if they had any stock of this vaccine which had shown to be effective, including against the 501Y.V2 variant. J&J indicated that as part of their studies, there was very limited stock remaining which they used for the human trials in SA.”

J&J also indicated they had more stock in other countries around the world where most of the trials were being done.

“They said they would be able to bring in their stock to be used in SA while we are waiting for full registration of the J&J vaccine and while we were waiting for the orders being made. The only other order which was concluded was for the AstraZeneca vaccine.”

Phaahla said the agreement with J&J was that the doses remaining around the world, as part of their trial, would be collected, labelled and brought to SA.

“This was so we could use them in the meantime while we wait for further orders of registered vaccines.”

This, said Phaahla, should clear all confusion over whether this was a vaccination rollout programme or a trial programme.

“In essence, technically and legally, this is  expanded research in terms of human trial because of the fact that the doses we are using are the remaining doses from human trial all over the world. Those are the doses we are utilising.

“We wanted to start the rollout of the programme but J&J had not yet acquired registration with the regulatory authorities, including Sahpra. It had just concluded its studies which had shown its vaccine is effective.”

J&J was in the process of submitting documentation to health authorities around the world, said Phaahla.

“We approached the regulatory authority here at home in conjunction with J&J. The agreement was that as long as the expansion of the vaccination programme, which had already started with the phase three trial, would be part of an expanded study using the same product from that study, legally Sahpra would be able to approve that.”

Phaahla said that was the basis on which the current vaccination programme rollout was being undertaken to  provide protection for front-line health workers because the vaccine has been proven to be safe and effective.

“But it is legally regarded as expanded study because the vaccine is not registered.”

In the intervening period, Phaahla said America’s Food and Drug Administration (FDA) has given emergency use authorisation to J&J, which is the same authorisation given to Moderna, AstraZeneca and Pfizer.

“In the US, J&J have the necessary approval. We hope in the not so distant future Sahpra will give the necessary approval.”

He said there were non-disclosure agreements in place that prevented SA from being completely transparent about some of the procurement processes.

The government had told companies that once agreements were reached and signed they would be obliged to report to the nation about how public funds were used.

Regarding the AstraZeneca vaccine, Phaahla said the government was at an advanced stage in finalising agreements for the one million doses to be handed over to the African Union.

“The stock can definitely be used in many other countries, especially in North Africa where the new variant has not yet been recorded. The difficulty is in our neighbouring countries in Southern Africa where the variant has been found.”

He said the stock would be handed over not as a donation but rather as a sale to countries on the continent.

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