Africa's first Covid-19 vaccine factory has not received a single order

JOHANNESBURG – The first factory in Africa authorized to produce Covid-19 vaccines for the African market has not received any orders an...


JOHANNESBURG – The first factory in Africa authorized to produce Covid-19 vaccines for the African market has not received any orders and could close this production line within weeks if the situation does not change, according to company executives , Aspen Pharmacare .

The factory, located in the South African coastal town 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 to start manufacturing Covid vaccines in November 2021.

But no buyers have emerged, as Africa’s slow distribution of vaccines has left health agencies with a backlog of supplies. Commercial production never started, which officials say is an ominous sign for other African countries that had considered making Covid-19 vaccines.

Throughout the coronavirus pandemic, many African countries have fallen far behind much of the world in getting their people vaccinated – and some countries have had difficulty distributing the doses they received.

Less than 20% of the total population in Africa is fully vaccinated against the coronavirus. Officials and politicians blamed wealthy countries for hoarding vaccine doses when vaccines first became available. Countries dependent on vaccine donations were at the back of the pack. Building capacity to manufacture vaccine doses in Africa has been touted as a solution to this vaccine inequity as well as a way to prepare for future pandemics.

south african drug maker Aspen Pharmacare was hailed when it signed a deal with Johnson & Johnson in November last year that would allow it to produce and market the single-dose vaccine under the name Aspenovax. The vaccine, identical to that created by Johnson & Johnson, was intended for the African market.

But the initial enthusiasm didn’t lead to purchases, for complicated reasons.

South African President Cyril Ramaphosa, speaking at a White House global pandemic summit on Thursday, blamed “international agencies” for failing to purchase vaccines from a pioneering African manufacturer.

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

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

Gavi said in the statement: “Covax is still under contract with J&J and we would be very happy for any doses we are still waiting to supply from Aspen. We have communicated this to J&J. However, again, this is solely a decision for J&J to make.”

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.

Vaccine purchase contracts are protected by non-disclosure agreements which made the process opaque.

Johnson & Johnson said the licensing agreement between it and the South African manufacturer allows Aspen to “fill and finish” its vaccine as well as produce its own Aspenovax vaccine.

“Gavi may source Aspenovax from Aspen independently of any vaccine purchase agreement with Johnson & Johnson,” the company said in a statement.

US regulators have restricted the use of the Johnson & Johnson vaccine, preferring Pfizer-BioNTech and Moderna vaccines instead. But recent evidence suggests that over time the Johnson & Johnson vaccine prevents infection and disease about as effective as the othersand may prove to offer longer lasting protection.

Gavi said the limitation from US regulators would not discourage it from buying the single-dose vaccine if demand increases. Based on adenovirus vaccines like Johnson & Johnson don’t need sub-zero storage like Pfizer and Moderna vaccines, both mRNA vaccines. This makes it an attractive choice in countries that lack the necessary medical infrastructure, the nonprofit organization added.

Stavros Nicolaou, Aspen’s strategic business development manager, said if there are no orders in the next six weeks, Aspen plans to reallocate the sterile production line to produce anesthetics and other drugs. The company said it was concerned that all 500 staff trained to produce vaccines could be redirected to other manufacturing lines.

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

In discussions with multilateral agencies, Aspen hoped orders would arrive in early 2022, in time to begin producing commercial batches of the Aspenovax vaccine by the end of March.

But by then, the agencies had already obtained enough vaccine from other sources to launch large-scale vaccination campaigns. These efforts have been hampered by logistical and other issues that have slowed vaccinations, leaving the continent with a glut of ongoing doses.

Recent studies have found 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 driven down demand and it remains low. Some public health officials advocate reducing large-scale vaccination efforts and instead focusing on the most vulnerable groups.

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

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

Aspen’s vaccine “came very late in the process,” said Dr Abdou Salam Gueye, director of emergency preparedness and response for the WHO’s Africa region. The global health agency and its partners have focused on delivering vaccines to patients, rather than purchasing additional vaccine doses, he added.

Unicef, which is the world’s largest purchaser of vaccines, said vaccines made in South Africa have not yet passed all WHO approvals.

“Aspen products have not yet received a WHO ‘Emergency Use List’ and cannot be purchased by UNICEF until it is in place,” said Gisela Henrique , deputy director of UNICEF’s supply division.

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 boost vaccine manufacturing in Africa.

Dr Nkengasong, who said he had been in talks with Aspen as well as African leaders to find a solution, described the lack of orders as “very worrying”, adding that it would discourage other African companies from developing capacity. to manufacture Covid -19 vaccines.

“If these companies weren’t supported, the whole statement and commitment that we all made at the height of this pandemic really wouldn’t have been translated into action,” he said.

The report was provided by Jean Eligon from Johannesburg, Lauren McCarthy from New York and Stephanie Nolen from Halifax, Nova Scotia.

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Newsrust - US Top News: Africa's first Covid-19 vaccine factory has not received a single order
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