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Chile could greenlight AstraZeneca vaccine ‘within days of US/UK approval’

 

AstraZeneca has filed data with Chilean regulators for the emergency roll-out of its COVID-19 vaccine in the country and could get a green light “weeks or even days” after approval by European or American regulators, the government’s point person for vaccine procurement told Reuters.
The UK-based company has been conducting late-stage trials of its vaccine, developed with Oxford University, in Chile as well as in Brazil, the UK, the United States and South Africa.
Chile has signed a deal to buy 14.4 million doses of the drug, an amount that would vaccinate half that number of people, or nearly 40% of the country’s population.
Chile is already among the best-placed in the region for vaccine deals, with an agreement for 10 million doses from Pfizer BioNtech, 60 million doses over three years from China’s Sinovac and 7.6 million vaccine doses through the global vaccine distribution scheme COVAX.
Rodrigo Yanez, the Chilean trade vice-minister tasked with negotiating its vaccine supplies, said in an interview on Monday that AstraZeneca had already submitted paperwork to Chile’s Public Health Institute (ISP) for widespread emergency use of the vaccine.
He said the firm could make use of approval by trusted foreign health regulators to fast-track local approval.
Pfizer Inc and BioNTech used similar approval for its vaccine by the U.S. Food and Drug Administration to get the nod from Chilean regulators five days later, making Chile the first South American country to start vaccinating its population last week.
“If the UK health regulator, the European Medicines Agency (EMA) or the FDA approves – which will likely be between January and February, the approval for use in Chile could be in weeks or even days,” Yanez said.
The ISP told Reuters that AstraZeneca had yet to make a formal request for approval. “What we have had is lobby meetings with the background material presented, and fluid cooperation to move forward with the review of documents,” said its director, Heriberto Garcia, adding that regulatory approval in the UK, its home market, would be essential.
An AstraZeneca spokesperson declined to comment.
Data from the Oxford vaccine late-stage trials has suggested efficacy was 62% for trial participants given two full doses, but a more robust 90% for a smaller sub-group given first a half, then a full dose. The university said this week, however, that a two-dose regime generates a better immune response.
Yanez said Chile had signed a deal to buy the “traditional” two-dose vaccine, but that the contract was “flexible,” adding: “we can vary dosage according to what our own health experts and the company proposes.”
Yanez said Chile had a preliminary agreement to buy four million doses of the single-dose vaccine from Johnson & Johnson but was also pursuing a “Plan B” with other laboratories, including Novavax and CureVac if the J&J deal did not come through. here
He said Chile’s 400,000 health workers would get the Pfizer vaccine in the first quarter, while a second vaccine to be approved – he predicted that of Sinovac – would cover the rest of its high-risk population in the same period.
On Monday, Brazil’s licensed distributor for the AstraZeneca vaccine said it would seek regulatory approval on January 15.
Mexican Foreign Minister Marcelo Ebrard said last week he expected AstraZeneca to request emergency authorization in Mexico for its vaccine in January.

 

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