RIO DE JANEIRO (Reuters) – Pfizer is encountering difficulty in registering its COVID-19 vaccine for emergency use in Brazil due to the level of detail required by the regulator, Health Minister Eduardo Pazuello said on Thursday.
The health minister’s comments could raise tensions with Pfizer, whose vaccine is already being used in Britain and the United States. They will also fuel concerns from critics who argue that Brazil’s vaccine rollout is progressing too slowly, just as the virus roars back to life.
Vaccines are seen as crucial to ending the outbreak in Brazil, its death toll second only to the United States at more than 180,000 people. President Jair Bolsonaro, already under fire for his handling of the pandemic, is one of the world’s most prominent COVID-19 skeptics, and has said he will not take any vaccine.
Addressing lawmakers on Thursday, Pazuello said he spoke with Pfizer’s country manager on Sunday and directed him to meet with officials from health regulator Anvisa. After meeting Anvisa officials, the manager told the health minister that he had expected the emergency use process to be less onerous, Pazuello said.
“‘I thought it was simpler, but the agency is very detailed,'” Pazuello quoted the unnamed Pfizer executive as saying.
Pfizer Brazil’s country manager, Carlos Murillo, could not immediately be reached for comment. In a series of statements on Thursday, Pfizer said it could not comment on talks with the government.
Its statements confirmed that Anvisa had made specific requests that required more time. As a result, it said that seeking full regulatory approval for its vaccine – rather than a more onerous emergency use authorization – was the fastest course of action at this time.
It said the Anvisa requirement for specific country data was more onerous than other regulatory agencies, which were happy to analyze the trial information as a whole.
Pazuello said Pfizer had presented a variety of demands in order to close the deal, including a waiver of liability. “We are thinking of accepting,” Pazuello said of the demands.
In its statements Pfizer said many countries had agreed to waive liability, including in Latin America.
Anvisa confirmed that Pfizer had yet to apply to register its vaccine. It said that information provided by Pfizer was “not the complete data necessary to judge the safety, efficacy and quality of a vaccine for registration.”
The regulator added that so far no vaccine producer had applied for full registration or approval for emergency use.
A source with knowledge of Pfizer’s position said it was only going to apply for an emergency use authorization once the Brazilian government signed a contract to buy its vaccine.
Brazil’s federal government has repeatedly changed the date by which it expects to start inoculations. After a lull of a few months, infections are rising again sharply, hitting a fresh daily record on Wednesday of 70,000 new cases.
Brazil expects to receive some 24 million COVID-19 vaccines by January, Pazuello said.
He said Brazil expected Pfizer to provide 500,000 of those doses next month, China’s Sinovac to provide 9 million doses and AstraZeneca to provide 15 million doses.
Brazil expects to reach 37.7 million vaccine doses by February, with another 31 million doses arriving in March, the minister added.
(Reporting by Pedro Fonseca; Writing by Stephen Eisenhammer and Gabriel Stargardter; Editing by Brad Haynes and Howard Goller)