Pfizer Responds to Bolsonaro’s Statement on Labs’ Lack of Interest in Selling Vaccines to Brazil | National newspaper

In the morning, President Jair Bolsonaro received supporters at the entrance to the Palácio da Alvorada. And he declared to them: “Brazil has 210 million inhabitants, so it is a huge consumer market for anything. Didn’t the laboratories have to be interested in selling to the people?” People say I have to go after him. Nerd. Who wants to sell … If I am a seller, I want to present ”.

And he said again that he is not worried about the pressure so that Brazil will soon have a vaccine: “I said that I was not worried about the pressure. Really yes. Because we have to be responsible. Certain things cannot be rushed. You are moving.” with the lives of others. Now, if I go to Anvisa, which is a state agency, ‘I run there, I don’t know what there’, I’m interfering ”.

Hours later, Pfizer in Brazil issued a note in which it said that “on December 14, it held a meeting with Anvisa to clarify doubts about the presentation process for emergency use”; that “the conditions established by the agency require specific analysis for Brazil, which takes more time to prepare.”

Likewise, he said that “the presentation of emergency use also asks for details of the quantity of doses and hours to be used in the country, points that can only be defined in the signing of the definitive contract”; and that “in view of the particularities of Anvisa’s Emergency Use Shipping Guide, it is understood that continuous shipping” – that is, a definitive registration request – “is the fastest process at this time”.

The company reported that “it has already delivered to the agency, through the continuous submission process, the results of Phase 3 of the studies, which means another step towards approval of the vaccine.”

According to Pfizer, the note was in response to President Bolsonaro’s statements and a demonstration that “he does want to sell to Brazil, but that the process here requires more time.” An example, according to Pfizer, is the request for a specific analysis for the Brazilian population. Agencies in other countries that have the emergency use process analyze the data in its entirety and do not request this cut.

Anvisa says that it is at the disposal of the laboratories to discuss the requirements to make safe and effective vaccines feasible for the Brazilian population. The agency’s board, which is responsible for analyzing vaccines, called Pfizer for a meeting on Wednesday (30).

According to the latest Anvisa bulletin, two laboratories delivered partial results of the phase 3 studies: Pfizer on December 5 and AstraZeneca / Fiocruz on December 22. In addition to the efficacy and safety data of the vaccines, they still await a response from Anvisa.

Pfizer is also awaiting approval of two other documents. AstraZeneca is awaiting another stage, the quality assessment. Sinovac / Butantan and Janssen have not yet submitted phase 3 vaccine studies. No laboratory has yet issued an emergency use order, which Anvisa says can be done with phase 3 testing underway. Therefore, AstraZeneca and Pfizer vaccines can now be shipped to order.

In a note sent to Jornal Nacional, the Butantan Institute said that “a team from Anvisa visited the Sinovac factory in early December, conducted an on-site audit and testified that the complex meets international criteria for good practices. The agency also authorized phase 3 clinical trials in Brazil and the importation of nearly 11 million doses of the vaccine. Butantan must send the final results of the efficacy of the vaccine to Anvisa before January 7. ”

In a note, Janssen said that it is “focused on the clinical development of its Covid-19 vaccine candidate, with a phase 3 study underway in Brazil and other countries. Preliminary results of the study are expected to be available by the end of January 2021 ”.

AstraZeneca and Fiocruz did not comment.

Experts argue that when an international agency the size of the FDA, equivalent to Anvisa in the United States, already attests to the Pfizer vaccine, for example, the negotiation must be immediate, and that Brazil is already long overdue and can no longer Wait .

“When we have, in a state of emergency, an FDA, a regulatory agency similar to Anvisa, of great importance, the negotiation has to be immediate. What you have to keep in mind, and people have to take it into account, is that vaccines will quickly enter this shelf to benefit the population ”, evaluates Sergio Cimerman.

In addition to the United States, health agencies in more than 40 countries have already authorized the emergency or definitive use of the Pfizer vaccine. Among them, the 27 members of the European Union, the United Kingdom, Israel and some of our neighbors such as Chile and Argentina.

JN reached out to Anvisa to comment on the Pfizer note. The agency stated that the requirements cited by the laboratory are not an impediment to requests for emergency use as long as the company demonstrates that the benefits of the vaccine outweigh the risks.

* Update: After showing the report, AstraZeneca sent the following note:

“AstraZeneca is committed and working with ANVISA (National Sanitary Surveillance Agency) and other regulatory agencies to bring the vaccine to Brazil, and to the entire world, as soon as possible. The company is following the continuous submission process together with ANVISA and confirms that has submitted all available clinical efficacy and safety data to the regulatory agency in the last week.

The company continues to work with governments, multilateral organizations and employees around the world to ensure broad and equitable access to the vaccine, not for profit during the pandemic. ”