JOHANNESBURG — The first factory in Africa to be licensed to produce Covid-19 vaccines for the African market has not received any orders and could close that production line in weeks if the situation doesn’t change, company executives said. Aspen Pharmacare .

The factory, in the South African coastal city of Gqeberha, formerly known as Port Elizabeth, was celebrated as a solution to the continent’s unequal access to vaccines when it announced a deal in November 2021 to start producing Covid vaccines.

But no buyers have appeared as slow vaccine distribution in Africa has left health authorities behind in delivery. Commercial production never started, which officials say is an ominous sign for other African countries that had considered producing Covid-19 vaccines.

During the coronavirus pandemic, many African countries have lagged far behind much of the world in vaccinating their people — and some countries have struggled with distributing the doses they did receive.

Less than 20 percent of the total population in Africa has been fully vaccinated against the coronavirus. Officials and politicians blamed rich countries for hoarding vaccine doses when vaccines first became available. Countries that depended on vaccine donations were at the back of the line. Building the capacity to produce vaccine doses in Africa was heralded as a solution to this vaccine inequality and as a way to prepare for future pandemics.

South African drugmaker Aspen Pharmacare was hailed when it struck a deal with Johnson & Johnson in November last year that would allow it to manufacture and market the single-dose vaccine as Aspenovax. The vaccine, identical to Johnson & Johnson’s, was intended for the African market.

But the initial enthusiasm did not lead to purchases for complex reasons.

Speaking at a global summit on the pandemic hosted by the White House on Thursday, South African President Cyril Ramaphosa accused “international agencies” of not buying vaccines from a pioneering African manufacturer.

“This immediately devalues ​​the whole process of local production and local production of vaccines. This, ladies and gentlemen, must change,” Mr Ramaphosa said.

Gavi, an international nonprofit that manages vaccine procurement agreements for low-income countries through the Covax alliance, said in a statement that the company has supplied vaccines from sources of its choice under its existing contract with Johnson & Johnson. Of the nearly 450 million vaccine doses Gavi shipped to Africa, 28 percent were the Johnson & Johnson vaccine, second only to Pfizer-BioNTech’s, at 30 percent.

Gavi said in the statement: “Covax is still under contract with J&J and we would be very happy with any doses that we still expect to be provided by Aspen. We have communicated this to J&J. But again, this is solely a decision that rests with J&J.”

But given the unpredictable demand for Covid vaccines in Africa, Gavi also said it could not guarantee it would be able to buy directly from Aspenovax in the coming year.

Vaccination contracts are protected by nondisclosure agreements that have made the process opaque.

Johnson & Johnson has not yet responded to a request for comment.

US regulators have restricted the use of the Johnson & Johnson injection, preferring the Pfizer-BioNTech and Moderna vaccines instead. But recent evidence suggests that the Johnson & Johnson vaccine prevents infections and disease over time about as effectively as the others, possibly providing more lasting protection.

Gavi said the restriction from US regulators would not discourage the company from purchasing the single-dose vaccine if demand increased. Adenovirus-based vaccines such as those from Johnson & Johnson do not require freezing storage, as do the Pfizer and Moderna vaccines, both mRNA vaccines. That makes it an attractive choice in countries that lack the necessary medical infrastructure, the nonprofit added.

Stavros Nicolaou, Aspen’s head of strategic trade development, said that if there are no orders in the next six weeks, Aspen plans to reuse the sterile production line for the production of anesthetics and other drugs. The company said it fears that not all 500 employees trained to produce vaccines could be transferred to other production lines.

“That goodwill” that accompanied the initial launch, said Mr Nicolaou, “has not been matched by orders from the multilateral purchasing agencies.”

In talks with multilateral agencies, Aspen hoped that orders would come in early 2022, in time to begin production of commercial batches of the Aspenovax vaccine at the end of March.

But by that time, the agencies had already obtained enough vaccines from other sources to launch large-scale vaccination campaigns. Those efforts were hampered by logistical and other issues that delayed vaccinations, leaving the continent with a plethora of doses underway.

Recent studies have shown that more than two-thirds of Africans had already had a Covid infection before the Omicron wave, but reported death rates remain among the lowest in the world. That, combined with the long wait for vaccines, has reduced demand and remains low. Some public health officials are advocating scaling back large-scale vaccination efforts and focusing instead on the most vulnerable.

As a result, the African Union and agencies like Covax have also not placed any new orders with other manufacturers in recent months.

“Our disappointment remains that Aspen’s capacity has been known for some time and we would have liked to have planned it into the procurement process,” said Mr. Nicolaou.

Aspen’s vaccine “came very late in the process,” said Dr. Abdou Salam Gueye, WHO’s Director of Emergency Preparedness and Response for the Africa Region. The global health agency and its partners have shifted their focus to delivering vaccines to patients, rather than purchasing additional doses of vaccine, he added.

Unicef, the world’s largest buyer of vaccines, said South African-made vaccines had not yet passed all WHO approvals.

“The Aspen products have not yet received an Emergency Use Listing from the WHO and will not be available for purchase by UNICEF until there is,” said Gisela Henrique, UNICEF’s deputy director of supply.

dr. John Nkengasong, the outgoing head of the African Union’s Centers for Disease Control and Prevention, recalled a 2021 summit where thousands took part in a Zoom call to pledge to build African vaccine production.

dr. Nkengasong, who said he was in talks with both Aspen and African leaders to find a solution, described the lack of orders as “deeply worrisome”, adding that it would discourage other African companies from developing the capacity to Covid -19 vaccines.

“If those companies are not supported, the entire statement and commitment that we all made at the height of this pandemic would really not have been translated into fact,” he said.

Reporting contributed by John Eligon from Johannesburg, Lauren McCarthy from New York and Stephanie Nolen from Halifax, Nova Scotia,

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