Top secret: what’s going on with SA’s vaccine plan?

The Johnson & Johnson (J&J) vaccine SA has bought for 31-million people was approved just before the Easter weekend. However, its registration is subject to conditions that neither the regulator nor the department of health will divulge.

SA’s vaccine programme, which is essential for saving lives and getting the economy going, has been shrouded in secrecy. The processes of the ministerial advisory committee (MAC) are under wraps; talks with the private sector are behind closed doors; and information on how the rollout will proceed is released in dribs and drabs.

Experts on the virus and three people close to the government say many of the MAC’s decisions are political rather than scientific. One source fears the committee is likely to become more politicised with the departure of professors Marc Mendelson and Salim Abdool Karim.

This makes transparency even more critical.

President Cyril Ramaphosa recently promised openness about the vaccine programme: "We remain committed to keeping the nation informed on every step in the vaccine rollout process."

This has not happened.

When approval of the J&J vaccine, a single-dose jab, was announced on the eve of Easter, the CEO of the SA Health Products Regulatory Authority (Sahpra), Boitumelo Semete-Makokotlela, said: "The authorisation is, however, subject to a number of conditions which include that the vaccine is supplied and administered in accordance with the national department of health’s Covid-19 vaccination plan and applicable guidelines."

So what is the department’s plan and conditions of approval?

Asked to explain them, Sahpra spokesperson Yuven Gounden replied: "Please direct these queries to the national department of health."

But the health department’s spokesperson, Lwazi Manzi, said Sahpra had to provide the information and assured the FM that it would do so.

However, on Tuesday, Gounden said the regulator was legally not permitted to release the conditions of the vaccine approval and even had to get permission to state in its media release that one of the conditions was related to the jab’s safety. "I can finally inform you that the question of conditions must be directed to the applicant and not Sahpra," Gounden said.

The FM went back to the health department, which did not comment.

Sahpra itself has no authority when registering a drug to add conditions relating to how it is used, outside of determining if the drug is safe and effective, according to health lawyer Elsabé Klinck.

"Sahpra has no authority over treatment guidelines, and cannot make this a condition. Its mandate ends with what is described in the Medicines Act."

She says the health department cannot use Sahpra to regulate how a vaccine is used.

Andy Gray, a pharmacologist at the University of KwaZulu-Natal, says the approval conditions would ensure that the vaccine cannot be sold as other medicines are.

"That’s important to avoid people buying and selling and making money out of it and perhaps slipping in falsified versions."

But the approval is linked to the health department’s vaccination plan, which is not yet public, and those close to the process say the plan would likely change.

Gray says: "I would really like to see the detailed vaccination plan released, especially if some of the changes that have been hinted at are confirmed — like moving to an age-based prioritisation only for phase 2."

There is also continued secrecy surrounding SA’s vaccine choices.

Health minister Zweli Mkhize recently told parliament’s portfolio committee on health that SA was no longer considering using the Novavax or AstraZeneca vaccines.

While controversy over the AstraZeneca jab has been well-publicised, little is known about why the government has decided not to use Novavax, especially as it is available though the Covid-19 Vaccines Global Access Facility (Covax), of which SA is a member.

Contradictions in the committee’s recommendations … reflect an absence of scientific coherence Shabir Madhi

Mkhize told parliament that SA will not use the Covax allocation of vaccines because they include the two brands that the MAC on vaccines had advised against.

The two-dose Novavax vaccine was trialled in SA in a large study of 4,387 participants.

The results showed the vaccine reduced the chance of contracting Covid by up to 60%, even as the B.1.351 variant — which first emerged in SA — was circulating. No-one who was vaccinated got severely ill, while five people who received the saline placebo became seriously ill.

This, says Wits University dean of health sciences Prof Shabir Madhi, who was involved in the trial, shows Novavax offers 100% protection against severe infection even by the variant.

While SA does not want the Novavax vaccine, which is one of the three trialled and shown to work in SA, Mkhize told parliament SA was interested in vaccines from Russia, China and possibly Cuba. None of these has been evaluated for efficacy against the B.1.351 variant.

Madhi says this doesn’t make sense. "These obvious contradictions in recommendations, purportedly by the MAC, unfortunately seemingly reflect an absence of scientific coherence in its decision-making."

In fact, even the Pfizer jab was chosen before its efficacy against the variant had been demonstrated.

Madhi and Prof Francois Venter, head of Aids research group Ezintsha at Wits, who was on the MAC before being removed, have called for far more transparency and for the committee’s decisions to be made public.

Prof Barry Schoub, head of the MAC on vaccines, says advisories have been handed over to the minister of health to be made public, and the committee will thoroughly evaluate the data for all vaccines.

"We need to review all the data, have a meeting with the scientific staff of Novavax and our local experts, and then critically look at all the information."