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

The South African drug maker Aspen Pharmacare announced on Tuesday that it was finalizing the first agreement to control 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 stops short of giving Aspen rights to produce the drug substance — that is, the actual contents of the vaccine. Instead, Johnson & Johnson will direct other facilities to make the ingredients to send to Aspen for the company to blend into vaccine doses.

Stephen Saad, Aspen’s chief executive, said his company intended to become a drug substance producer but it would take two years to reach the goal.

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

The control over intellectual property of Covid vaccines has become a point of increasing contention in the debate over how best to address 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 plant in the city of Gqeberha were exported to Europe and other parts of the world, at a time when many African countries had vaccinated fewer than five percent of their citizens.

Because Aspen was only a contract manufacturer, it had no say on where it was shipping the doses it had bottled. The arrangement generated harsh criticism after it was revealed by The New York Times. The new agreement could avert a similar situation in the future.

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

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

Mr. Masiyiwa described this agreement as the first step toward Africa’s development of a vaccine production industry like that in India. He said that the bulk buyers of vaccines, including Gavi, the global health organization that supplies childhood shots to Unicef, must start looking to African industrialists for vaccines procured for Africa.

Otherwise, he said, “we will not deal with the problem Africa found itself in, which is to be forced to the back of the queue. Those with production assets are the ones 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 fulfill the bloc’s supply deal with Johnson & Johnson. Mr. Saad said that when a new Aspen production facility comes online in March, that will expand production to 35 million doses per month. Mr. Masiyiwa noted that getting to 70 percent vaccination coverage in Africa will require 900 million doses of vaccines.

Advocates of broader vaccine access said the agreement fell far short of what is needed to spur African production and close the vaccine coverage gap.

“The deal gives a modicum of more control to Aspen, who can ensure that vaccines bottled in Africa no longer get shipped to Europe,” said Zain Rizvi, an expert on vaccine production and access with the advocacy organization Public Citizen. He also noted that Johnson & Johnson described the agreement as “nonbinding” in a news release, and he said it sounded “more like an aspiration than a commitment.”

“Aspen is still not allowed to produce the drug substance,” he added. “Africans can do a lot more than just bottle and distribute vaccines. They have been asking to make their own.”

Mr. Saad said the discussion with Johnson & Johnson about the rights to the drug substance was ongoing, and that, in any case, it would take Aspen “a couple of years” to be able to produce it at the company’s South African site. He said that the company needed to consider what kind of vaccine 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 from the coronavirus to trigger immune response in those who get the shot; production for a vaccine that uses mRNA would require a different kind of facility.

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

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

Ms. Hassan expressed concern that most African nation’s vaccination plans continue to focus on delivery of the Johnson & Johnson vaccine — or, eventually, Aspenovax — as a single-shot regimen. The U.S. and other countries are proceeding with a two-dose regimen, based on data that shows it offers greater protection from infection and illness. Even with boosted capacity from Aspen’s production, and even with single shots, supply will be far short of what is needed to make up the vaccine gap, Ms. Hassan said.

Rebecca Robbins contributed reporting.