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RIO DE JANEIRO: Pfizer is having difficulty 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 (December 17).
The Health Minister’s comments could heighten tensions with Pfizer, whose vaccine is already being used in Britain and the United States. They will also fuel the concerns of critics who argue that the launch of the vaccine in Brazil is progressing too slowly, just as the virus comes to life.
Vaccines are considered crucial to ending the outbreak in Brazil, and its death toll is second only to the United States with more than 180,000 people. President Jair Bolsonaro, already under fire for his handling of the pandemic, is one of the most prominent COVID-19 skeptics in the world and has said he will not take any vaccines.
Addressing lawmakers 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 with Anvisa officials, the manager told the health minister that he expected the emergency use process to be less burdensome, Pazuello said.
“‘I thought it was simpler, but the agency is very detailed,'” Pazuello quoted the anonymous Pfizer executive as saying.
Pfizer Brazil Country Manager Carlos Murillo could not be immediately reached for comment. In a series of statements Thursday, Pfizer said it could not comment on the talks with the government.
Their statements confirmed that Anvisa had made specific requests that required more time. As a result, he said that seeking full regulatory approval for his vaccine, rather than a more onerous emergency use authorization, was the quickest course of action at this time.
He said Anvisa’s requirement for country-specific data was more onerous than other regulatory agencies, which were happy to analyze the trial information as a whole.
Pazuello said that Pfizer had filed a variety of lawsuits to close the deal, including a liability waiver. “We are thinking of accepting,” Pazuello said of the demands.
In its remarks, Pfizer said that many countries had agreed to waive liability, including in Latin America.
Anvisa confirmed that Pfizer had yet to request its vaccine registration. He said the information provided by Pfizer “was not the complete information necessary to judge the safety, efficacy and quality of a vaccine for registration.”
The regulator added that no vaccine producer has so far applied for full registration or approval for emergency use.
A source with knowledge of Pfizer’s position said it would only request an emergency use authorization once the Brazilian government has signed a contract to purchase its vaccine.
Brazil’s federal government has repeatedly changed the date it expects to start vaccinations. After a hiatus of a few months, infections are increasing again drastically, reaching a new daily record Wednesday of 70,000 new cases.
Brazil expects to receive some 24 million COVID-19 vaccines by January, Pazuello said.
He said Brazil expects 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 doses of vaccines in February, and another 31 million doses will arrive in March, the minister added.
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