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South African Company Approaches Authorization to Sell J. & J. Covid Shot Across Africa


South African drug maker Aspen Pharmacare announced on Tuesday that it was finalizing the first agreement to control the production of 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 to whom the vaccine will be sold, in what quantities and at what price.

This agreement does not give Aspen the right to produce the drug substance, that is, the actual content of the vaccine. Instead, Johnson & Johnson will order other facilities to manufacture the ingredients to send to Aspen for the company to mix with the vaccine doses.

Stephen Saad, chief executive of Aspen, said his company intends to become a producer of drugs, 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 over the deal.

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

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

Since Aspen was only a contract manufacturer, he had no say in where he shipped the doses he bottled. The arrangement drew fierce criticism after it was revealed by The New York Times. The new agreement could avoid a similar situation in the future.

Strive Masiyiwa, the African Union special envoy for Covid who has tried to negotiate better access to vaccines for the continent, said in a web TV show announcing the agreement between Aspen and Johnson & Johnson that he would help her “sleep easier”.

“This vaccine is going to be produced as a licensed product, which means when we want to talk about buying vaccines, we go to Aspen, we don’t go to J. & J.,” he said. declared. “This gives us one of the main things that we have asked for, which is security of supply, which we did not have as a continent.”

Mr. Masiyiwa described the agreement as the first step towards the development in Africa of a vaccine production industry like India’s. He said big vaccine buyers, including Gavi, the world health organization that supplies childhood vaccines to UNICEF, must start turning to African manufacturers for vaccines purchased for Africa.

Otherwise, he said, “we will not deal with the problem that Africa has found itself in, which is to be forced to stay at the back of the pack. Those with production assets are the ones who control the vaccine supply. “

Aspen is currently producing 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 Aspen production facility comes on stream in March, it will increase production to 35 million doses per month. Mr. Masiyiwa noted that reaching 70 percent immunization coverage in Africa will require 900 million doses of vaccine.

Supporters of wider access to vaccines said the deal fell well short of what is needed to boost African production and close the gap in vaccine coverage.

“The deal gives minimal control to Aspen, which can ensure that vaccines bottled in Africa are no longer shipped to Europe,” said Zain Rizvi, vaccine production and access expert with the advocacy organization. Public Citizen. He also noted that Johnson & Johnson described the deal as “non-binding” in a press release, and he said it looked “more like an aspiration than a commitment.”

“Aspen is still not licensed to produce the drug substance,” he added. “Africans can do more than just bottle and distribute vaccines. They asked to make their own.

Mr Saad said that discussions with Johnson & Johnson over the rights to the drug substance were ongoing and that in any case it would take “a few years” for Aspen to be able to produce it at the South African site of the company. He said the company needed to determine for which type of vaccine the drug substance would be worth producing, given the potential vaccine market in Africa. The Johnson & Johnson vaccine uses an adenovirus to deliver a coronavirus gene to trigger an immune response in those who are vaccinated; producing a vaccine using mRNA would require a different type of facility.

“It’s important because we’ve been saying for a year, ‘Why did they only partially license Aspen? They have to give them a full manufacturing license, ”said Fatima Hassan, who heads the Cape Town Health Justice Initiative. “It’s a step forward but it took a very long time.

The limited scope of this agreement shows why a World Trade Organization waiver on intellectual property rights associated with Covid vaccines and treatments is needed to 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 on Monday that this exceeded the number of people who received a single dose of the vaccine in eight southern African countries (Botswana, Eswatini, Lesotho, Malawi, Mozambique, Namibia, South Africa and Zimbabwe).

Ms Hassan expressed concern that immunization plans in most African countries continue to focus on delivering the Johnson & Johnson vaccine – or, possibly, Aspenovax – as a single-injection regimen. The United States and other countries are proceeding with a two-dose regimen, based on data that shows it offers better protection against infection and disease. Even with increased production capacity of Aspen, and even with single injections, the supply will be far below what is needed to fill the vaccine gap, Ms. Hassan said.

Rebecca robbins contributed report.

nytimes Gt

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