South African Company Approaches License to Sell J. & J. Covid Shot


South African pharmaceutical manufacturer Aspen Pharmacare announced on Tuesday that it has completed the first agreement to control the production of a Covid-19 vaccine in Africa.

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

This agreement falls short of giving Aspen the rights to manufacture the drug substance—that is, the actual ingredients of the vaccine. Instead, Johnson & Johnson will direct other facilities to make the materials that will be sent to Aspen for mixing into the company’s vaccine doses.

Aspen’s CEO, Stephen Saad, said his company plans to become a drug producer, but it will take two years to reach the target.

Johnson and Johnson confirmed in a statement He said he had reached an “advanced stage in his talks” about the deal with Aspen.

Control over the intellectual property of Covid vaccines has become a growing point of contention in debates over how best to tackle the disease. Big gap in vaccine access in Africa.

Aspen is already bottling Johnson & Johnson Covid vaccines under an earlier deal. Earlier this year, millions of doses bottled at his plant in Aspen’s Gqeberha were exported to Europe and other parts of the world at a time when many African countries are vaccinating less than five percent of their citizens.

As Aspen was only a contract manufacturer, it had no say in where it shipped the doses it bottled. The edit caused harsh criticism after its publication. revealed by New York Times. The new agreement could prevent a similar situation in the future.

Announcing the agreement between Aspen and Johnson & Johnson, Strive Masiyiwa, the African Union’s special envoy for Covid, which is seeking to provide greater vaccine access for the continent, said in a webcast that it would help him “sleep more easily”.

“This vaccine will be manufactured as a licensed product, so when we want to talk about buying a vaccine, we go to Aspen, we don’t go to J. & J.,” he said. “It gives us one of the most important things we look for, which is security of supply, which we don’t have as a continent.”

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

Otherwise, “We won’t be dealing with the problem that Africa is in, which will be forced to the back of the line. Those who own the manufacturing assets are the ones who control the vaccine supply.”

Aspen is currently producing 20 million doses per month of Johnson & Johnson vaccine, which the block supplies to the African Union to fulfill its supply agreement with Johnson & Johnson. Mr. Saad said that when a new Aspen manufacturing facility goes live in March, he will increase production to 35 million doses per month. Mr Masiyiwa noted that reaching 70 percent of vaccine coverage in Africa would require 900 million doses of the vaccine.

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

“The agreement gives Aspen a bit more control, which could ensure that vaccines bottled in Africa are no longer shipped to Europe,” said Zain Rizvi, a specialist in vaccine production and accessibility with advocacy organization Public Citizen. He also said that Johnson & Johnson described the deal in a news release as “non-binding” and that it “seemed more like a desire than a commitment”.

“Aspen is still not allowed to manufacture drugs,” he added. “Africans can do much more than bottle and distribute vaccines. They wanted them to make it themselves.”

Mr. Saad said discussions with Johnson & Johnson about the rights to the drug are ongoing and that it will take “a few years” for Aspen to produce it at the company’s South African site, in any event. He said that given the potential vaccine market in Africa, the company should consider what kind of vaccine would be worth producing the drug substance. The Johnson & Johnson vaccine uses an adenovirus to deliver a gene from the coronavirus to trigger an immune response in those who are vaccinated; Production of a vaccine using mRNA will require a different type of facility.

“This is important because for a year they were like, ‘Why did they only give Aspen a partial license? “They need to give them a full production license,” he said. “It’s a step forward, but it took a very long time.”

The limited scope of this agreement is why a World Trade Organization Intellectual property rights associated with Covid vaccines and that treatments are necessary to start this process.

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

Ms Hassan expressed her concern that most African nations’ vaccination plans continue to focus on the delivery of the Johnson & Johnson vaccine – or ultimately Aspenovax – as a one-time regimen. The United States and other countries follow a two-dose regimen based on data showing greater protection from infection and disease. Hassan said that even with the increased capacity of Aspen’s production and a single shot, the supply would be far less than needed to fill the vaccine gap.

Rebecca Robbins contributing reporting.



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