AstraZeneca expects the EU drug regulator to give approval for a factory in the Netherlands that is at the center of a row between Britain and the European Union over COVID-19 vaccine supplies later this month or in early April, a senior executive said on Monday.
The status of the Leiden-based plant, which is run by sub-contractor Halix and is helping to make the AstraZeneca shot, is closely watched as it is listed as a supplier of vaccines in both the contracts that AstraZeneca has signed with Britain and with the European Union.
“We are well on track in order to get the approval by EMA (European Medicines Agency) in the course of March, beginning of April, and this is exactly according to our plan,” said Ruud Dobber, executive vice president of the BioPharmaceuticals business on a briefing.
Executives would not be drawn on when Britain’s drug watchdog may give the nod to accept Halix-produced shots.
After falling far behind post-Brexit Britain and the United States in rolling out vaccines, the EU’s leaders are set to discuss imposing a ban on vaccine exports to Britain at a summit on Thursday.
Without regulatory approval, vaccines produced at Halix cannot be used in either the EU or Britain.
Astra executives said the site would play a relatively small role in supplies to the EU, which mostly relied on production from a Belgium site and another one in the United States.
On the briefing, Mene Pangalos, head of BioPharmaceuticals R&D, said one batch of Halix-produced shots had been sent to Britain ahead of approval from the Medicines and Healthcare products Regulatory Agency (MHRA).
Dobber said the US authorities are “very excited” by its interim analysis of data from its US clinical trial, which shows the vaccine is 79 percent effective in preventing symptomatic COVID-19.
But it is up to the US government to decide how they are distributed, he said.
Asked if there was any indication how the shots that will be supplied to the US government under its supply contract may be used, he said he would be “very surprised” if they were not deployed to vaccinate Americans.
He said the company can supply 50 million doses to the United States in the first month after approval and 15-20 million doses on average after that.