Thirty million Covid-19 vaccines manufactured by US pharmaceutical giant Johnson & Johnson (J&J) were destroyed at the Aspen Pharmacare facility in South Africa in June, weeks before a deadly third wave hit the country.
The destroyed doses, manufactured at Aspen’s Gqeberha facility, were compromised due to a contaminated drug substance supplied by J&J’s US partner Emergent Biosolutions, Aspen said.
The doses were from the same factory that ruined 15m doses in March, a WHO conference heard on September 16.
“I had a meeting with one of the manufacturers that is ‘fill and finishing’ in South Africa who told me that 30m doses of the Johnson & Johnson had to be destroyed a few months ago,” said Dr Ayoade Olatunbosun Alakija, who co-chairs the African Union’s Covid-19 Africa Vaccine Delivery Alliance.
“They are not the same as the ones that were destroyed in the US, these were the ones that had actually already been completed, filled and finished in South Africa.
“They were destroyed because they were part of factories 5 and 6 that had problems and the factories are back running in the US, but unfortunately it has affected our backlog,” she told journalists at a WHO press conference on 16 September.
Johnson & Johnson confirmed in an emailed statement that a “contaminated” batch of vaccines from their US manufacturing partner Emergent had been destroyed in June, but did not specify the exact number.
“Specific COVID-19 vaccine manufactured at [Aspen’s] Gqeberha production site and designated for the South African market have to be destroyed due to the Good Manufacturing Practice risk of isolated material in the drug substance supplied to Aspen by Johnson & Johnson from their contract manufacturing partner in the USA, Emergent,” the statement said.
“This… has the potential to negatively impact the vaccine rollout across South Africa and Africa,” it added.
The US pharma giant promised to supply uncontaminated vaccines “within a week,” and deliver additional vaccines to keep the country’s immunisation drive on track.
“Over the next few weeks, Johnson & Johnson will be delivering substantial quantities of compliant finished vaccines to South Africa to replace the lost stock thereby ensuring the momentum in the South African vaccine initiative is maintained.”
The New York Times reported in March that 15m vaccines were destroyed in an incident at an Emergent Biosolutions plant in Baltimore, USA, after workers mixed ingredients for the J&J vaccine and a coronavirus vaccine developed by AstraZeneca, which is produced at the same plant.
Call for transparency
The African Union’s Vaccine Delivery Alliance official stressed the need for honesty and accountability at every stage of the supply chain, from manufacturers producing vaccines, to those procuring and distributing doses to African countries.
“I’m not talking about Emergent, I’m talking about transparency,” she said.
“At the time that the doses had been destroyed we were being told on the African continent that these vaccines would be arriving next week.
“Why were African leaders not told that the vaccine they were paying for had to be destroyed, and were therefore not in that supply chain? We need transparency.”
In many cases vaccines are paid for by African countries with loans and tax dollars, galvanising the need for transparency in the acquisition process, she added.
The defective doses were destroyed weeks before a deadly third wave hit the country in June. Less than 20% of South Africans had been fully vaccinated as authorities eased lockdown measures in September.
In November last year, Aspen Pharmacare struck a deal to make the Covid-19 vaccine candidate being developed by J&J at a factory in South Africa. Africa’s biggest drugmaker agreed to produce 300m doses a year at its plant in Port Elizabeth.
The AU has secured 400m J&J doses for countries to purchase, some of which have been produced in South Africa. But doses are not arriving on time. Africa’s largest economy, Nigeria has paid for more than 29m J&J vaccines but has so far only received 177,000, Alakija said.
Africa passed the grim milestone of 8m Covid cases across the continent last week, with only 3.6% of the continent’s population fully vaccinated. In Europe and the Americas about 55% have now received at least one dose of a vaccine, WHO says.
Covax downgraded its global deliveries forecast by about 25% to 1.4bn doses this year due to India’s export ban and manufacturing problems. The 470m doses now expected by Covax by the end of the year are enough to vaccinate just 17% of all Africans, short of the 40% global target, Gavi, the Geneva-based vaccine alliance says.