Covid-19

COVID-19

Vaccine trial leaders dismiss top adviser’s claims they could have secured SA access

Vaccine trial leaders dismiss top adviser’s claims they could have secured SA access
Chairperson on the ministerial advisory committee on Covid-19 vaccine developments Prof Barry Schoub. (Photo: Supplied)

Researchers could have secured access to Covid-19 vaccine supplies when they agreed to conduct local clinical trials, SA’s top vaccine adviser Professor Barry Schoub has argued. Trial leaders have dismissed the claims and called on stakeholders to stop shifting blame and develop realistic vaccination plans.

The chairperson of the ministerial advisory committee (MAC) on Covid-19 vaccines, Professor Barry Schoub, has claimed researchers missed the opportunity to leverage the country’s participation in clinical trials to secure access to vaccines once they became available.

Schoub made the comments during an interview with Judge Dennis Davis, published on Wednesday, while the state faces criticism for failing to conclude any bilateral agreements with vaccine manufacturers.

He said the country’s ability to access vaccines went wrong when leaders of clinical trials did not insist that manufacturers are contractually obliged to supply their products to South Africa. 

“It should have been a commitment as part of their arrangement. We didn’t do that. We could have had Johnson & Johnson. We could have had AstraZeneca and to some extent also Pfizer because they were trialled here,” said Schoub.

Clinical trials were conducted in South Africa for the Oxford-AstraZeneca, Johnson & Johnson, Pfizer-BioNTech and Novavax vaccines. The efficacy of vaccines can vary between population groups and by participating in trials, researchers can better understand if the vaccines will be effective in local settings.

Schoub, whose committee reports to Health Minister Zweli Mkhize, put the onus on researchers to secure local access to the vaccines they trialled.

“Now, the negotiations between the vaccine manufacturer and the principal investigator, [which have] got nothing to do with the government at all. They negotiate and they sign a contract,” said Schoub.

“[Vaccine manufacturers] knock on the door and say, ‘Mr Principal Investigator, I’d like to do a trial because we need the trial data to register our product so we can sell our product.’ So we were helping them doing the trial using our facilities,” Schoub added.

“We could very easily at that stage say, ‘Look, can we have a commitment, a signed commitment, not a vague thing that we would like to kind of supply, but a commitment as part of the contract to supply the country,’ and we didn’t do that and we could have done that.”

He said the coronavirus has led to the apportioning of blame and his MAC and the state are the current “whipping boy” as people anxiously await more information about the rollout of a vaccination programme.

Professor Shabir Madhi from Wits University, who also heads the SA Medical Research Council’s (SAMRC) Vaccines and Infectious Diseases Analytics Research Unit, is the national principal investigator for the Oxford-AstraZeneca and Novavax trials.

“This statement attributed to Prof Schoub reflects a lack of understanding regarding the roles and responsibilities of Principal Investigators in clinical trials,” said Madhi and SAMRC President Professor Glenda Gray in a joint response.

“The responsibility of engaging to procure vaccine for the public is the prerogative of the state and it would appear that this an attempt to shift the blame for the failure of the SA government to ensure early access to Covid vaccines,” they continued.

Madhi and Gray said in recent days Schoub had shifted from warning the public of being misled about a vaccine’s ability to bring an end to the pandemic to assuring people the department of health was focused on vaccinating 67% of the population in 2021.

Gray, who leads the local Johnson & Johnson trial along with Professor Linda-Gail Bekker from the Desmond Tutu HIV Centre, questioned why Schoub had criticised trial leaders without having engaged them on the discussions or agreements they had with manufacturers.

Gray said Johnson & Johnson had committed to ensuring South Africa and other countries that participated in trials would have access to its vaccine. She informed Mkhize and Higher Education, Science and Technology Minister Blade Nzimande of the clinical trial plans and said they should contact her if they had any issues.

In a letter to Nzimande in 2020, Johnson & Johnson director Aluwani Museisi outlined how the company was developing a single-dose vaccine and noted its commitment “to bringing an affordable Covid-19 vaccine to the public on a not-for-profit basis for emergency pandemic use”.

Schoub claimed the letter “means nothing in legal terms”.

Pharmaceutical companies have been negotiating vaccine deals with national governments across the globe, as well as the Covax initiative, and it is the state’s responsibility, rather than research institutions, to enter into deals for the millions of doses required.

Madhi and Gray said, “Based on the recently released MAC for vaccine advisories by the national department of health, it seemingly appears that until the 15th December 2020 there was very little thought given to how Covid vaccines would be procured for SA other than a limited quantity (enough for 10% of the population) through the Covax facility.”

News24 has reported that the government delayed initiating discussions with Johnson & Johnson.

The company is submitting a “rolling application” to the SA Health Products Regulatory Authority for the approval of its vaccine, providing information as it becomes available, a sign of the company’s commitment to the country, said Gray.

Pfizer has reportedly offered its vaccine to South Africa at a discounted $10 a dose due to its status as a middle-income country and its participation in trials. Vaccine stock from various suppliers is expected to be limited due to wealthier nations having reached deals during trial phases for large numbers of doses.

More than 200 million doses of the Johnson & Johnson vaccine, currently in its third phase of trials, will be packaged at Aspen Pharmacare’s Port Elizabeth plant, but there is no agreement in place with the government to distribute the jab locally.

South Africa’s leaders have been criticised for failing to agree to advanced market commitments – agreements to purchase vaccines when they become available – with manufacturers, saying they were too costly and risked wasting funds on ineffective products.

Schoub said a commitment for about 40 million vaccine doses required a deposit of about R2.4-billion, a cost which the government “didn’t feel they could take”. He dismissed claims from experts that the state could have entered into an agreement without an upfront payment.

“They are dead wrong. There is an upfront payment which is required for advance market commitment,” said Schoub.

He said Pfizer, AstraZeneca and Johnson & Johnson were at present the most viable vaccines for South Africa. Pfizer’s vaccine must be stored in extremely cold temperatures, but he said it could be suitable for healthcare workers in urban areas.

Russia’s Sputnik V vaccine and China’s Sinopharm vaccine, both in phase three of trials, are also being considered.

Schoub said vaccinating more than 40 million people in 2021 would be a “monumental challenge”, but he cautiously said he thought the department of health could achieve the goal.

Madhi and Gray suggested stakeholders stop shifting blame and start moving forward.

“At this stage, it would be prudent to stop vacillating regarding the importance of Covid vaccines in the fight against the pandemic and the myriad of reasons as to why SA has not concluded agreements to secure Covid vaccines. Rather start working as a collective to develop realistic plans to start vaccinating South Africans against Covid.” DM

Gallery

"Information pertaining to Covid-19, vaccines, how to control the spread of the virus and potential treatments is ever-changing. Under the South African Disaster Management Act Regulation 11(5)(c) it is prohibited to publish information through any medium with the intention to deceive people on government measures to address COVID-19. We are therefore disabling the comment section on this article in order to protect both the commenting member and ourselves from potential liability. Should you have additional information that you think we should know, please email [email protected]"

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