No registration with Anvisa, future of CoronaVac in Brazil is uncertain – News

The first vaccine against covid-19 applied in Brazil, CoronaVac may have its days counted to stop being used in the PNI (National Immunization Program).

The immunizing agent has not yet obtained health registration at Anvisa (National Health Surveillance Agency) — it is applied under temporary authorization for emergency use since January.

In addition, Instituto Butantan is about to conclude its second contract with the Ministry of Health and there are no negotiations for future purchases.

92.8 million doses have already been delivered. Another 7.2 million must be sent to the federal government by the end of this month.

Signaling that CoronaVac is in danger of no longer being used came from the ministry itself in recent days.

First, the folder did not include the vaccine that can be applied as a booster or third dose: preferably Pfizer/BioNTech, but, in the absence, AstraZeneca/Fiocruz or Janssen are also allowed.

The decision was not well received at the Butantan Institute. The director of the research center, Dimas Covas, stated in an interview that the federal government has acted to “de-characterize and discredit” CoronaVac.

Then, in an interview with R7, on Wednesday (1), the Minister of Health, Marcelo Queiroga, was even more emphatic when he said that no vaccine without definitive registration with Anvisa will remain in the PNI (National Immunization Program) after the public health emergency period, effective through a decree of February 6, 2020.

Currently, only Pfizer and AstraZeneca have health registration with Anvisa. CoronaVac and Janssen are authorized for emergency use, which, according to Queiroga, limits these products to the period in which there is still an “emergency character” of the pandemic.

“These vaccines that have emergency registration are used at this time because we are experiencing a health emergency and those that have permanent registration are not sufficient to meet the needs of our system. […] Once the emergency character ceases, this provisional registration will no longer serve as a ticket to the Brazilian health system.”

Low efficacy in elderly and immunocompromised

The Ministry of Health recently announced the application of a booster dose to elderly people vaccinated for more than six months. 70% of them received CoronaVac. A third dose will also be applied to immunocompromised people, such as transplant recipients, cancer patients, among others.

The decision came at a time when states such as São Paulo and Rio de Janeiro observed an interruption in the downward curve in hospital admissions for the elderly.

Studies, such as one conducted by Fiocruz (Oswaldo Cruz Foundation), also pointed to less protection against deaths in elderly people who received CoronaVac.

Physician Renato Kfouri, member of the board of SBIm (Brazilian Society of Immunizations) and of the Technical Chamber of the PNI (National Immunization Program), points out that it is already clear that CoronaVac is not the ideal vaccine for the elderly and immunocompromised.

But, according to him, this does not totally exclude it from the PNI, as other groups could benefit, such as children and adolescents.

“For children, it is still unknown, because these vaccines are still being studied. CoronaVac already has preliminary data. To say that we will no longer use CoronaVac, it is impossible today to make a prediction like that. I think it’s quite possible that we have space for CoronaVac for children and teenagers. It’s an extremely safe platform vaccines.”

On August 18, Anvisa’s Board of Directors unanimously rejected a request from the Butantan Institute to extend the emergency use authorization of CoronaVac to the public aged 3 years or older.

The agency understood that the study presented was insufficient. “It is necessary to conduct a phase 3 clinical trial with a robust number of participants […] It is necessary to generate more data so that the efficacy and safety of the vaccine in the pediatric population can be affirmed”, justified the rapporteur of the process, director Meiruze Freitas.

health registry

The absence of health registration at Anvisa would frustrate the Instituto Butantan’s plans to sell CoronaVac to the states in the future.

Once the pandemic health emergency decree was revoked, the vaccine could only be used again when it obtained registration from the regulatory agency.

To date, Instituto Butantan has not presented data on the immunogenicity of CoronaVac to Anvisa. This information demonstrates the ability of the immunizing agent to stimulate the production of antibodies in the body of the vaccinated and for how long they remain active.

Anvisa made the emergency use approval of CoronaVac conditional, in January, on the signing of a term by Butantan in which the institute undertook to present the immunogenicity data.

“The issue of definitive registration is important. You have to know what Anvisa is asking for, what Butantan is not delivering and why it is not delivering. There is a pre-print of ProfisCov, which is the licensing study for CoronaVac, which has not been published until today. It must be being reviewed by some magazine there, but until today they have not accepted it for publication, which also creates a scenario of distrust in relation to some details that may be, perhaps, the same that Anvisa is charging “, observes Kfouri.

Asked about the reason for not having requested the sanitary registration to Anvisa so far, the Butantan Institute said only that “it values ​​dialogue and maintains an open channel” with the regulatory body.

He also added that “data from the CoronaVac immunogenicity study have not yet been fully delivered to the agency due to divergences in the method of analysis.”

national production

The two vaccines that are guaranteed in the PNI, if the requirement for sanitary registration is maintained, must have national production next year.

Fiocruz’s Institute of Technology in Immunobiologicals (Bio-Manguinhos) is in the process of being validated in order to manufacture the API (active pharmaceutical ingredient) for AstraZeneca’s vaccine.

When this stage is completed, the factory will no longer depend on the import of raw material, which should take place later this year.

The Pfizer/BioNTech vaccine will be manufactured by the private sector, after an agreement with Eurofarma. The forecast is up to 100 million doses per year.

Butantan is expanding the industrial park for the production of CoronaVac, a project that should be completed next year. That way you also don’t need to import IFA anymore.

“The national production that can be glimpsed […] it gives us peace of mind in the long and medium term of self-sufficiency in production, and that we can do in 2022 what we didn’t do this year, to customize the indication of vaccines [de acordo com o grupo]”, points out Kfouri.

The doctor remembers that this year the vaccines were applied to the most vulnerable groups as they arrived, and that “we didn’t necessarily make the best choices”, but that was what was available.

“Next year, these lessons learned may translate into a broader menu, targeting vaccines for specific groups.”

For the expert, it is also necessary to take into account a possible need to update the formulas of vaccines in view of the coronavirus variants that have emerged — all immunizing agents in use today are made from the original strain, identified in Wuhan (China).

“We are still in a terrain of many uncertainties. It is not possible to plan for the coming year without knowing who will need to vaccinate, with which vaccine, the quantity, the formulation. The reasoning is not that simple. If we think that only one dose is needed. for the most vulnerable, there is no doubt that we will need much less vaccine,” he concludes.