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

South African drugmaker Aspen Pharmacare announced on Tuesday that it is finalizing the first agreement to control the production of a COVID-19 vaccine in Africa.

The deal with Johnson & Johnson will allow Aspen to bottle and market the Johnson & Johnson vaccine across Africa under the Aspenovax brand name. Aspen would then have the right to determine to whom the vaccine would be sold, in what quantity and at what cost.

The agreement prevents Aspen from granting the right to produce the drug substance – that is, the actual ingredients of the vaccine. Instead, Johnson & Johnson will direct the company to other facilities to make materials to send to Aspen to be mixed into vaccine doses.

Aspen Chief Executive Officer Stephen Saad said his company intended to become a drug substance producer, but it would take two years to reach that goal.

johnson and johnson confirmed in a statement that it had reached “an advanced stage in its discussions” with Aspen regarding the agreement.

Control over the intellectual property of COVID vaccines has become a point of growing controversy in the debate as to how best to address it Huge gap in vaccine access in Africa,

Aspen already provides the Johnson & Johnson Kovid vaccine under a previous agreement. Earlier this year, millions of doses bottled at Aspen’s plant in the city of Gakbarha were exported to Europe and other parts of the world, at a time when many African countries vaccinated less than five percent of their citizens.

Since Aspen was only a contract manufacturer, it had no say in where it was shipping the bottled dosages. After the arrangement came harsh criticism revealed by the new York Times. The new agreement could avert a similar situation in the future.

Strive Maseiwa, the African Union’s special envoy for Covid, who is trying to broker greater vaccine access to the continent, announced the deal between Aspen and Johnson & Johnson in a web telecast, saying it would allow them to “Easy sleep” will help.

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

Mr. Masiwa described this agreement as the first step towards the development of a vaccine production industry in Africa like India. He said UNICEF should start looking for African industrialists to buy vaccines for Africa to wholesale buyers of vaccines, including Gavi, the global health organization that supplies childhood shots.

Otherwise, he said, “we will not deal with the problem that Africa has found itself in, which has to be forced at the back of the queue. Those with production assets are those who control the supply of vaccines.”

Aspen currently produces 20 million doses per month of the Johnson & Johnson vaccine, which the company is supplying to the African Union to complete the block’s supply deal with Johnson & Johnson. Mr. Saad said that when a new Aspen production facility goes online in March, it will increase production to 35 million doses per month. Mr Masiwa said 900 million doses of vaccines would be needed to achieve 70 percent vaccination coverage in Africa.

Advocates of broader vaccine access said the agreement fell short of time to boost African production and close the vaccine coverage gap.

“The deal gives Aspen greater control, which could ensure that vaccines bottled in Africa will no longer be shipped to Europe,” said Jan Rizvi, a vaccine production and advocacy organization outreach with Public Citizen. He also noted that Johnson & Johnson described the agreement as “non-binding” in a news release, adding that it “looked more like an aspiration than a commitment.”

“Aspen is still not allowed to produce narcotics,” he said. “Africans can do much more than just deliver bottles and vaccines. They are asking to make their own. ,

Mr Saad said discussions were underway with Johnson & Johnson about the rights to the drug substance, and in any case, it would take “a few years” for Aspen to produce it at the company’s South African site. He said the company needs to consider what kind of vaccine drug substance can be produced considering the potential vaccine market in Africa. The Johnson & Johnson vaccine uses an adenovirus to deliver a gene from the coronavirus to trigger an immune response in those receiving the shot; A different kind of facility would be needed to produce a vaccine that uses mRNA.

“This is important because we’ve been saying for a year, ‘Why have they only given a partial license to Aspen? They need to give them a full manufacturing license,'” said Fatima Hassan, who heads the Health Justice Initiative in Cape Town. Said. “It is a step forward but it has taken a very long time.”

The limited scope of this agreement sheds light on why the WTO exempts it. Intellectual Property Rights Related to Kovid Vaccines And treatment is essential 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 Centers for Disease Control and Prevention, This is more than the number of people receiving a single vaccine dose in eight southern African countries (Botswana, Eswatini, Lesotho, Malawi, Mozambique, Namibia, South Africa and Zimbabwe), Public Citizen reported on Monday.

Ms Hassan expressed concern that most African countries’ vaccination plans continue to focus on the delivery of the Johnson & Johnson vaccine – or, eventually, Aspenovax – as a single-shot regimen. The US and other countries are moving forward with a two-dose regimen, based on data showing it offers greater protection against infection and disease. Even with the increased capacity from Aspen’s production, and even with single shots, supplies would be too short to meet the vaccine shortage, Ms Hassan said.

Rebecca Robbins Contributed to reporting.

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