Brazil biomedical center to seek emergency use of British COVID-19 vaccine

 Brazil’s Fiocruz biomedical center will request authorization for emergency use of the COVID-19 vaccine developed by AstraZeneca PLC and Oxford University by next Wednesday, its president, Nísia Trindade, said on Thursday.

She said approval of the vaccine in Britain on Wednesday will speed up the regulatory green lights for the vaccine in Brazil, where it is badly needed to fight the world’s second deadliest coronavirus outbreak.

“To avoid delays, and on the basis of authorization in Britain, we decided to also put in the request for emergency use of the vaccine,” she said in an interview.

Brazil, whose right-wing President Jair Bolsonaro is a coronavirus skeptic who says he won’t have a vaccine, has fallen behind neighbors Chile and Argentina where vaccination is already underway. No vaccine has been approved in Brazil yet.

Filing for registration of the British vaccine with health regulator Anvisa cannot be finalized before Jan. 15 as paperwork is still being prepared, such as production control documents for the vaccine, which the federally funded Fiocruz plans to make from scratch at its Rio de Janeiro facility.

“I am optimistic that vaccination can start by the end of January or beginning of February,” Trinidade said.

Fiocruz expects to deliver the first 1 million doses between Feb. 8 and Feb. 12, though that will depend on the arrival of the active pharmaceutical ingredient for the vaccine scheduled for Jan. 9, Trindade said.

By the end of February, Fiocruz plans to have delivered 10 million doses, and from then it will be putting out 3.5 million doses a week, for a total 100 million fill-and-finish doses in the first half of 2021.

In April or May, Fiocruz will have a parallel production line going to make the vaccine entirely in Brazil, though that will still require Anvisa validation, she said. The goal is to deliver 110 million doses in the second half of the year.

Trindade expects Brazil to stick to two-dose vaccination, since the evidence that 1-1/2 doses is more effective still requires further studies worldwide by AstraZeneca.

But she does expect Brazil’s National Immunization Program to separate the two jabs by a 12-week interval, which researchers in Britain have found to be more effective.

The vaccine costs $4 per dose: $3.15 paid to AstraZeneca and the rest for the fill-and-finish process. Fiocruz does not yet have an estimated cost for the vaccine made in Brazil.

https://www.reuters.com/article/us-health-coronavirus-brazil-fiocruz/brazils-fiocruz-to-seek-emergency-use-of-british-covid-19-vaccine-idUSKBN2951PT