Vaccine rollout suspension not ‘all doom and gloom’. We have alternatives

The news that the AstraZeneca vaccine offered scant protection against Covid-19 was a temporary setback in SA’s war on the virus. 

This is the view of Business For SA’s health working group chairperson Stavros Nicolaou, who said the setback which saw the health department suspend plans to vaccinate the country’s health-care workers might even have a silver lining. 

“I don’t think it’s all doom and gloom,” said Nicolaou, who is also the senior executive of strategic trade at Aspen Pharmacare, which has been contracted to fill 300 million doses of Johnson & Johnson (JNJ) vaccine at its Port Elizabeth plant. 

“Rather we find out now before we start vaccinating than go through four weeks of vaccinating and have doctors and nurses in an ICU thinking they have a level of protection that they don’t have.” 

The health department suspended the vaccine rollout when it emerged that the AstraZeneca vaccine, of which one million doses arrived on February 1 from the Serum Institute in India, offered protection levels as low as 10% against developing severe illness from Covid-19. 

“This news would have been tragic two weeks ago,” said Nicolaou. “But we have the Johnson & Johnson vaccine in reserve.” 

The JNJ vaccine, of which SA has secured about 450,000 doses, may turn out to be an unexpected boost to the country’s vaccination programme. JNJ’s findings in respect of the SA variant were “very satisfactory”, he said. 

Third-phase clinical data released last week showed the vaccine offered 57% protection against the SA variant of the virus. 

The JNJ study covered about 45,000 patients in multiple centres around the world, including an arm in SA in which 6,300 patients took part and included some with HIV. 

“Geographically, the level of protection for the combined endpoints of moderate and severe disease varied: 72% in the United States; 66% in Latin American countries; and 57% in South Africa, 28 days post-vaccination,” the company said. 

“The investigational vaccine was reportedly 85% effective in preventing severe/critical Covid-19 across all geographical regions.”

No deaths were reported among those who received the vaccine.

“The most important thing to look at with any vaccine is to determine what are the levels of hospitalisation, what are the levels of prevention of severe disease and what are the levels of prevention of mortality,” said Nicolaou. “There is significant diminution of hospitalisation, serious disease and death.”

The JNJ doses were secured in a separate deal between government and that company and had nothing to do with Aspen’s contract with the global health-care giant. The doses would be drawn from supplies produced for the JNJ clinical trials.

“They can make an initial 300,000 available and a further quantum of that,” said Nicolaou. Some 150,000 extra doses are said to be available on top of the 300,000 doses already secured.

The JNJ vaccine is a single-shot jab, which means the supply is equivalent to about 900,000 doses of the AstraZeneca vaccine.

The latter vaccine could be used in a possible implementation study in which it would be given to 50,000 health-care workers to determine its effectiveness in preventing severe to critical illness.  

“We know that there were unacceptable efficacy levels for mild to moderate disease with the South African strain, but we don’t know how it performs with severe to critical disease,” said Nicolaou.

If it’s not going to do it for mild to moderate disease, then the chances are it’s not going to do it for severe to critical. But you still have to measure those parameters.

—  Business For SA’s health working group chairperson Stavros Nicolaou

The immune response that the vaccine triggered was unlikely to work against the new spike protein, however.

“If it’s not going to do it for mild to moderate disease, then the chances are it’s not going to do it for severe to critical. But you still have to measure those parameters.”

There were between 3,000 and 4,000 variants of the SARS-CoV-2 virus circulating. “A handful of them are more problematic than others,” said Nicolaou. “Some would have down-mutated rather than up-mutated”.

While the new SA variant was about 50% more transmissible, it was unclear if it was more virulent.

“You can only work it out through mortality rates,” he said. SA’s mortality rate sat at about 2.8% during the first wave, while it was about 3.1% in the second wave. The slight increase could be attributed to the rate at which SA ran out of ICU beds as the second wave peaked, he said.

More analysis was needed, said Nicolaou, adding that mortality rates could have improved as a result of better treatments.

“In the first wave we never saw the effects of dexamethasone, [which] reduces mortality in patients who are being ventilated by up to 30%.”

AstraZeneca’s troubles were not unexpected. Developing a successful vaccine often took years as a result of prolonged periods of trial and error.

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In the case of the SARS-CoV-2 virus, however, the fact that candidate vaccines needed to target one virus had speeded up the process, said Dr Morena Makhoana, head of Cape Town-based biopharmaceutical company Biovac.

“The different variants put a different spin on it,” said Makhoana. “But for now the developers have just had to figure out one thing, spike proteins, and that’s why they were able to get it out of the starting blocks so quickly.”

In November, Biovac was cleared to begin formulating Prevnar 13, a childhood anti-pneumonia vaccine, on behalf of US-based pharma giant Pfizer. The vaccine contained 13 elements which needed to be blended.

The technological transfer that would ensure Biovac carried out the work exactly to Pfizer’s requirements took three to four years to complete, said Makhoana.

Despite widespread conspiracy theories and anti-vaxxer movements, vaccines remained one of the key tools in health care, he said.

“My children won’t come across some of the diseases that [we] had when I grew up and that’s because of vaccines,” he said.

Makhoana was concerned about the anti-vaxxer trend, however. “It’s a lot more rife in western world, but it’s been growing in SA. It’s like fake news that travels so much faster than we can respond with facts,” he said.