South African Company Approaching License to Sell J. & J. Covid Shot Across Africa

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South African drug maker Aspen Pharmacare announced on Tuesday that it was finalizing the first agreement to manufacture a Covid-19 vaccine in Africa.

The deal, with Johnson & Johnson, would allow Aspen to bottle and market the Johnson & Johnson vaccine across Africa under the brand name Aspenovax. Aspen would then have the right to determine who the vaccine is sold to, in what quantities and at what price.

This agreement does not give Aspen any rights to manufacture the drug – that is, the actual contents of the vaccine. Instead, Johnson & Johnson will contract other facilities to make the ingredients to be shipped to Aspen so the company can mix it into vaccine doses.

Stephen Saad, the CEO of Aspen, said his company planned to become a drug manufacturer, but it would take two years to reach the target.

Johnson & Johnson confirmed in a statement that it had reached “an advanced stage in its discussions” with Aspen about the deal.

Intellectual property control of Covid vaccines has become a point of increasing discussion in the debate over how best to close the huge gap in vaccine access in Africa.

Aspen already bottles Johnson & Johnson Covid vaccines under a previous agreement. Earlier this year, millions of doses bottled at Aspen’s factory in the city of Gqeberha were exported to Europe and other parts of the world, at a time when many African countries had less than five percent of their citizens vaccinated.

Because Aspen was only a contract manufacturer, it had no control over where it sent the bottled doses. The arrangement received harsh criticism after it was revealed by The New York Times. The new agreement could prevent a similar situation in the future.

Strive Masiyiwa, the African Union’s special envoy for Covid who has been trying to increase access to vaccines for the continent, said in a web broadcast announcing the deal between Aspen and Johnson & Johnson it would help him “sleep easier” .

“This vaccine will be produced as a licensed product, which means if we want to talk about buying vaccines, we’re going to Aspen, not J. & J,” he said. “It gives us one of the most important things we’ve asked for, which is the security of supply, which we haven’t had as a continent.”

Mr Masiyiwa described this agreement as the first step towards Africa’s development of a vaccine manufacturing industry like the one in India. He said bulk vaccine buyers, including Gavi, the global health organization that supplies Unicef ​​injections for children, should seek out African industrialists for vaccines purchased for Africa.

Otherwise, he said, we will not solve Africa’s problem, which is that we have to get back in line. Those with means of production are the ones who control the delivery of vaccines.”

Aspen currently produces 20 million doses per month of the Johnson & Johnson vaccine, which the company supplies to the African Union to fulfill the bloc’s supply agreement with Johnson & Johnson. Mr Saad said that when a new manufacturing facility in Aspen comes online in March, production will expand to 35 million doses per month. Mr Masiyiwa noted that achieving a 70 percent vaccination rate in Africa would require 900 million doses of vaccines.

Proponents of wider access to vaccines said the agreement fell far short of what is needed to boost African production and close the gap in vaccine coverage.

“The deal gives a little more control to Aspen, which can ensure that vaccines bottled in Africa are no longer shipped to Europe,” said Zain Rizvi, a vaccine manufacturing and access expert at the advocacy group Public Citizen. He also noted that Johnson & Johnson described the agreement as “non-binding” in a press release, saying it “sounded more like an ambition than a commitment.”

“Aspen is still not allowed to manufacture the drug,” he added. “Africans can do much more than just fill and distribute vaccines. They have asked to make them themselves.”

Mr Saad said discussions with Johnson & Johnson over the rights to the drug were ongoing, and that it would take at least Aspen “a few years” to produce it at the company’s South African site. He said the company needed to consider what kind of vaccine it would be worth producing the drug substance for, given the potential vaccine market in Africa. The Johnson & Johnson vaccine uses an adenovirus to deliver a gene of the coronavirus to elicit an immune response in those who receive the injection; production for a vaccine using mRNA would require a different kind of facility.

“This is important because for a year now we’ve been saying, ‘Why have they only partially licensed Aspen? They have to give them a full production license,” said Fatima Hassan, head of the Health Justice Initiative in Cape Town. “It’s a step forward, but it took a very long time.”

The limited scope of this agreement highlights why a World Trade Organization waiver of intellectual property rights related to Covid vaccines and treatments is needed to kick-start this process, she said.

More than 40 million people in the United States have received a booster dose of a Covid vaccine, according to the Centers for Disease Control and Prevention. Public Citizen reported Monday that this was more than the number of people who had received a single vaccine dose in eight South African countries (Botswana, Eswatini, Lesotho, Malawi, Mozambique, Namibia, South Africa and Zimbabwe).

Ms Hassan expressed concern that most African countries’ vaccination plans continue to focus on the delivery of the Johnson & Johnson vaccine – or, ultimately, Aspenovax – as a single regimen. The US and other countries are continuing with a two-dose regimen, based on data showing it provides better protection against infection and disease. Even with increased Aspen production capacity, and even single injections, supply will fall far short of what is needed to close the vaccine gap, Ms Hassan said.

Rebecca Robbins reporting contributed.

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