(Alliance News) - AstraZeneca PLC on Wednesday clarified that the Covid-19 vaccine doses at its Anagni plant in Italy are not a stockpile, but instead are awaiting quality-control clearance.
The Anglo-Swedish drugmaker also noted there are no exports currently planned other than to Covax countries from the plant.
"There are 13 million doses of vaccine waiting for quality control release to be dispatched to Covax as part of the company's commitment to supply millions of doses to low-income countries. The vaccine was made outside the EU and brought to the Anagni plant to be filled into vials. The EU fully supports supplying low-and middle-income countries through the COVAX facility," AstraZeneca said.
Covax is the Covid-19 Vaccines Global Access initiative, aimed at equitable access to Covid-19 vaccines and led by international bodies such as the World Health Organization.
AstraZeneca said there are another 16 million doses waiting for quality control release to be dispatched to Europe. About 10 million doses will be delivered to EU countries during the last week of March, and the balance to be delivered in April as the doses are approved for release after quality control.
"It is incorrect to describe this as a stockpile," the UK company said.
It continued: "The process of manufacturing vaccines is very complex and time consuming. In particular, vaccine doses must wait for quality control clearance after the filling of vials is completed."
The update from the Anagni plant followed news AstraZeneca revised down by three percentage points the effectiveness of its Covid-19 vaccine, after US authorities raised concerns that results reported from its US trial were outdated.
The company now says its vaccine is 76% rather than 79% effective at preventing any kind of symptomatic Covid.
It remains 100% effective against severe Covid, it added.
The move came after an independent panel of experts appointed to supervise the trial expressed concern that AstraZeneca had failed to include updated data in its initially released figure.
The US National Institutes of Health then issued a highly unusual statement asking AstraZeneca to work with the panel and issue a new press release.
"We look forward to filing our regulatory submission for Emergency Use Authorization in the US and preparing for the rollout of millions of doses across America," said Mene Pangalos executive vice president of biopharmaceuticals research & development.
The new figure is based on 190 people who fell sick among 32,449 trial participants across the US, Peru and Chile, two-thirds of whom received the vaccine while the rest received a placebo.
The previous figure was based on 141 cases, with a cut-off in mid-February.
The company added there are 14 additional or probable Covid cases left to be adjudicated.
Depending on whether these occurred in the vaccine or placebo group, the final efficacy figure could go up or down a few percentage points.
The company added the vaccine efficacy in people 65-years-old and over was 85%, but the statistical range for this figure – anywhere between 58% and 95% – make it less meaningful and the sample size was not mentioned.
Eight cases of severe Covid occurred - all in the placebo group.
AstraZeneca was an early frontrunner in the global race to develop a Covid vaccine, and was heavily favored by the US, which ordered 300 million doses - more than its first orders for Moderna Inc's and Pfizer Inc's shots.
But a series of communications blunders eroded US agencies' confidence.
The US now has three authorised vaccines - Moderna Inc, Pfizer Inc and Johnson & Johnson - and should have enough supply to more than cover the adult population by the end of May.
However, authorisation by the US Food & Drug Administration – considered the gold standard regulator – would go a long way to calm global doubts over the AstraZeneca vaccine.
Several European countries paused rollout of the shot over potential blood clot risks before later resuming its use.
The European Medicines Agency deemed the vaccine safe and said it was not associated with blood clotting generally – but added it could not rule out a link to two highly rare forms of clotting, and suggested these risks be mentioned on a warning label.
By Paul McGowan; paulmcgowan@alliancenews.com
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