Vaccines Approved Abroad Will Be Backed For Emergency Use In Brazil, Governors Say | Politics

According to state governments, the National Health Surveillance Agency (Anvisa) will have 72 hours to comment on this statement. If the term expires and there is no statement by Anvisa, exceptional authorization is granted.

The deadline is already foreseen in a law approved in February and related to the state of public calamity, decreed on the occasion of the new coronavirus pandemic.

At the meeting on Tuesday, the governors questioned the Ministry of Health about this commitment to the rapid approval of vaccines that have external approval. According to state administrators, the federal government reaffirmed that it will follow the rule.

• The use of Covid vaccines in Brazil can be based on the endorsement of a foreign agency; understand the cool scenery

“What he [Pazuello] it is clear that action is being taken. Everything that [vacina] that has certification from the international agency will be evaluated in 72 hours by Anvisa, according to the law, and will be applied as in emergency use. Not in politics [de vacinação] extended to all, but to those who are in a higher risk situation, such as our medical class ”, declared the governor of Goiás, Ronaldo Caiado (DEM).

The meeting between Pazuello and governors took place in the Planalto Palace, but part of the politicians participated by videoconference. The minister provided an overview of the vaccines that are candidates to be registered with Anvisa, such as the one from Oxford, the one from the Sinovac association / Butantan Institute and the one from the Pfizer laboratory.

According to the minister, Anvisa needs 60 days to evaluate the vaccines and grant the final registration. The Oxford vaccine, for example, is expected to complete the third phase of studies this month, with the possibility of a final registration in February (see details below).

The Goiás governor also declared that the federal government “made it clear” that it will buy “each and every one of the vaccines, as long as it is certified by those international organizations.” However, emergency use will not be widespread.

According to Caiado, The vaccine with emergency authorization would apply to people at risk, such as the elderly and health professionals..

The governor of Pará, Helder Barbalho (MDB), said that he considered “premature” to set deadlines for the application of vaccines, even in an emergency.

“We agreed that any vaccine that is authorized by the four international agencies, immediately, in accordance with federal law, within the following 72 hours, Anvisa will be in charge of revalidating it, certifying it for use in the national territory,” he said.

OR G1 requested Anvisa’s position on compliance with this standard and the parameters for the emergency use of vaccines and awaits his return.

The law provides for emergency endorsement

The legislation cited by the governors is Law 13,979, of February, which defines actions to face the new coronavirus pandemic.

In accordance with the law, the authorities may grant “exceptional and temporary authorization for the importation and distribution of any material, medicines, equipment and supplies in the health area subject to health surveillance without registration in Anvisa that is considered essential to help combat the coronavirus pandemic ”. .

The law establishes that this exceptional authorization can be made, provided that the product – the vaccine, in this case – has been registered by at least one of the four foreign health authorities, with functions similar to those of Anvisa.

The list is made up of agencies from the United States, the European Union, China and Japan.

According to the law, the exceptional authorization must be granted by Anvisa within the 72 hours following the presentation of the request to the agency, “the authorization of any other body of the direct or indirect public administration for the specified products is exempt. , being granted automatically if the term without manifestation ”.

After the meeting, Helder Barbalho stated that the governors do not want to go over Anvisa and did not indicate their intention to start vaccination without the endorsement of the Brazilian agency.

“There is no intention, on the part of the governors, to nullify or ignore Anvisa. We need the vaccine to be regulated. Without this statement from Anvisa, it would certainly be a wrong attitude and no governor showed interest in vaccinating or enabling it without Anvisa.” He has given his agreement, ”he said.

“There should be no distinction between vaccines. All vaccines authorized for their use must be purchased. This was a commitment that Minister Pazuello made with all the governors,” he added.

The governors once again asked the Ministry of Health to commit to a National Vaccination Plan, in order to avoid the dispute between states over the acquisition of doses.

Representatives of some states, for example, expressed their opposition to a scenario in which the government of São Paulo, through the Butantan Institute, began to vaccinate its citizens first.

“What worries us? The moment in which the governor of São Paulo in his social network says to start the vaccination from January 25. We also saw a mayor of the party, from Curitiba, thanking him for being able to immunize the entire area health of the capital of Paraná. Now, this is something that puts the credibility of all governors at stake. This role of the PNI is not the responsibility of the governor. It is the responsibility of the federal government, “said Caiado.

The governors also reported after the meeting that the This Wednesday (9), the Ministry of Health must present a logistics plan for the distribution of vaccines.

Oxford vaccine in February

At the same meeting, Minister Eduardo Pazuello predicted that the Covid-19 vaccine developed by the University of Oxford and the pharmaceutical AstraZeneca would have the registration approved by the National Health Surveillance Agency (Anvisa) at the end of February.

The government allocated R $ 1.99 billion to the Ministry of Health to allow the production and / or acquisition of 100 million doses of the so-called Oxford vaccine.

Pazuello was asked about the developmental stage of the immunizer. The Ministry of Health announced in June the association for national research and production of the vaccine, in partnership with the university and the pharmaceutical company.

“This is AstraZeneca, what stage are you at? Prediction to present Anvisa (in December). Record prediction? said.

According to Pazuello, the Oxford vaccine is almost completing phase 3 of the trials. Then, the procedure must be sent to Anvisa, which will evaluate if it can grant the registration. According to the minister, these documents should be sent to the agency at the end of this month.

“If this happens, we will only have an effective AstraZeneca registration at the end of February, even if 15 million doses are reached in January. Anvisa will continue within its technical criteria. It will surely do so as soon as possible,” explained Pazuello.

As an example of a vaccine that could receive authorization for emergency use, the governors cited the immunizer being developed by the Pfizer laboratory. The FDA, the US regulatory agency equivalent to Anvisa, may endorse the vaccine in the coming days or weeks.

“With the recognition of the US agency, Anvisa will be provoked to pronounce itself, validate or not validate. Either you have a problem with this vaccine or you will have to validate it ”, explained the governor of Piauí, Wellington Dias (PT).

“It was not validated in 72 hours, it is automatically approved for the safety and effectiveness of the agency that is recognized in that law and also in the World Health Organization,” he continued.

During the meeting, Pazuello reported that the Brazilian government is negotiating with Pfizer the purchase of 70 million doses, of which 8.5 million would be delivered in the first half.

In the case of the Oxford / AstraZeneca vaccine, the government closed a laboratory with 260 million doses during 2021, and the delivery of 15 million doses is expected in January.

“The minister makes a commitment to vaccinate all Brazilians. That was the main charge. If we buy the first vaccine, what is already contracted is expected to be delivered in January. If in January these contracted vaccines already have authorization from Anvisa” . or it has the validation through the validation process of one of the recognized agencies, so, in this case, we have possibilities in January, having the vaccine, to be able to vaccinate ”, said Dias.