(Reuters) – Pfizer Inc has applied for full regulatory approval in Brazil of its COVID-19 vaccine developed with BioNTech Se, Brazilian health regulator Anvisa said on Saturday.
It is the second vaccine submitted for registration in Brazil. AstraZeneca Plc applied on Jan. 29 for full regulatory approval of the vaccine it developed with Oxford University, and will make it in Brazil in partnership with the federally funded Fiocruz biomedical center.
Pfizer said it filed for registration on Friday for its vaccine called BNT162b2, backed up by late-stage trials on 44,000 volunteers in six countries – 2,900 of them in Brazil.
The vaccine has an overall efficacy of 95%, and efficacy of 94% in people aged over 65, the U.S. drugmaker said in a statement.
President Jair Bolsonaro, who says he will not take any COVID-19 shot, is under pressure after a slow and patchy vaccine roll-out in Brazil, which now faces a second wave of infections.
Bolsonaro referred to the virus as a “little flu” but his government faces mounting criticism over its handling of the world’s second-deadliest coronavirus outbreak.
For the past month, more than 1,000 deaths from COVID-19 have been reported daily in Brazil, and the total has passed 230,000, according to health ministry data.
The AstraZeneca vaccine is the central pillar of the federal government’s vaccine plan, and the government has ordered material for Fiocruz to make up to 100 million shots.
A first shipment from China of active ingredients needed to make the British vaccine locally was due to arrive later on Saturday in Rio de Janeiro, where Fiocruz is based.
The Fiocruz fill-and-finish production line was initially scheduled to start production in December, but has sat after delays getting the first shipment of supplies from China.
To start inoculating its 210 million people, Brazil has relied on the Chinese vaccine developed by Sinovac Biotech Ltd and 2 million ready-to-use AstraZeneca shots imported from India last month.