About 2.4 million doses of the one-shot Johnson & Johnson vaccines are currently ready to be distributed in the company’s Belgian factory in Beerse, but have to wait for the green light from the American Food and Drug Administration (FDA) before they will be released.
The doses are part of a larger batch of 30 million doses in Europe blocked from distribution while the European Medicines Agency (EMA) is waiting for a report from the FDA, according to EMA deputy director Noël Wathion.
The report, which is expected by the end of this week, should give clarity about whether or not the vaccines were produced in a safe and correct way, he explained on Flemish radio.
A few weeks ago, problems were discovered during an inspection of a factory at a subcontractor of Johnson & Johnson in the US city of Baltimore, as components of the J&J vaccine are said to have been swapped with those of AstraZeneca.
“A total of three contaminated lots came to Europe,” Wathion said. “The vaccines from one lot were also effectively put into circulation. After quality control, everything appeared to be okay, so we did not recall them.”
The other two lots are still on hold, however, because the EMA is investigating the exact cause of the contamination and whether additional measures need to be taken in the company.
“At the moment, the FDA is still carrying out an inspection to determine whether the lots that have already been produced comply with the correct procedures,” he said.
Once the EMA has that report, it can decide to release the batches that have already been delivered to the EU, according to Wathion.
The Vaccination Taskforce confirmed that the majority of Johnson & Johnson vaccines intended for Belgium are also on hold. “We have received confirmation that we will have sufficient vaccines if those affected lots are released,” they told De Morgen.
On Tuesday, Flemish Welfare Minister Wouter Beke stated in the Flemish parliament that the aim of giving every adult their first dose by 11 July could be in jeopardy if those doses will not arrive soon.
“If we cannot count on those vaccines, we will only achieve 85% vaccination coverage by 11 July,” he said.
Belgium is counting on a total of 1.4 million single-dose Johnson & Johnson vaccines that should be delivered by the end of June, but only about 143,000 were received so far.
The Johnson & Johnson vaccine is crucial to the timing of Belgium’s entire vaccination campaign, as the advantage is that only a single dose is required for full protection.
If the vaccines do not arrive on time, Belgium will have to look for extra doses of the other vaccines. However, as they all require two shots, it would cause a major delay in the overall campaign, according to the Taskforce.
It should only be “a temporary problem,” said Wathion, who added that the EMA wants “to get this resolved as soon as possible.” However, he cannot give a concrete timing for the release of the vaccines.