While the Ministry of Health expands the public eligible for reinforcement against covid-19, children under 5 years of age still do not have an immunization agent available to start vaccination coverage. Because? In the United States, the vaccines from Pfizer and Moderna received approval for application in babies from 6 months, but none of the pharmaceutical companies applied to the age group in Brazil. Meanwhile, the request for the use of Coronavac in children aged 3 to 5 years awaits a decision from the National Health Surveillance Agency ( Anvisa ) for about 100 days.

Pediatricians highlight that immunization of little ones against the new coronavirus is increasingly important. This is because Brazil is experiencing an “epidemic” of respiratory viruses in the pediatric population, and although adults have been more affected, covid also leads to the death of young children . At the same time, the country faces a new rise in cases leveraged by more transmissible variants.

The Butantan Institute, a partner of the Chinese laboratory Sinovac, filed a request for the application of Conovac to children aged 3 to 5 years on March 11, but has not received a response. This is the third time that the research center has tried to release the immunizer in this age group. The vaccine is already applied to people from 3 years of age in countries such as China, Chile, Colombia, and Ecuador.

The latest updates given by Anvisa on the process were that, on June 1st, Butantan submitted additional data for analysis, and that, on the 8th, the agency held a meeting with external experts. To Estadão, the regulatory body informed that it had received “opinions from medical societies” and that “it will continue the process”.

The first request for additional data was made by Anvisa on April 14. On May 11, the institute said it had submitted new data to support the request to extend the pediatric use of Coronavac.

In the material, as posted on the official Butantan website, a report was attached that calculated how many deaths would have been avoided if the vaccine had been approved for that age group. “The study demonstrates that at least 1,471 lives would have been saved if children aged 3 to 5 years had been vaccinated between December 1 and March 21, 2022, that we would have 58% fewer hospitalizations, 57% fewer deaths, and 599 hospitalizations avoided.”

A fresh start

This is the third time that Butantan has tried to release the vaccine for the application of the immunizing agent from the age of 3 onwards. In July of last year, the first request was made to include the public from 3 to 17 years of age in the leaflet, which was denied in August. In December, the request was made again.

In January, the research center received authorization from Anvisa to apply the immunizing agent to children aged 6 to 17 years without immunosuppression. The agency found that there was no robust data to support the release for younger children.

Pediatrics doctor Eduardo Jorge da Fonseca Lima, linked to the Brazilian Society of Pediatrics (SBP), says he trusts Anvisa, but that, in fact, the decision “has taken longer than expected”. In his view, the agency may be waiting for the publication of data on the safety and efficacy of the vaccine in children aged 3 to 5 years to be published in a peer-reviewed scientific journal.

Lima highlights that the data presented, sent by the Ministry of Health of Chile, are “very convincing”. The SBP, as well as the Brazilian Society of Infectious Diseases (SBI), the Brazilian Society of Pulmonology and Tisiology (SBPT), the Brazilian Society of Immunizations (SBIR), and the Brazilian Association of Collective Health (Abrasco), were consulted by the agency.

The pediatrician says he cannot talk about the content of the opinion presented by the association to which he is linked, however, he says he hopes that the inclusion in the package insert will be approved:

— Because it is an inactivated platform vaccine, therefore, a platform widely used in pediatrics, is very safe.

Marcelo Otsuka, infectious disease specialist and vice-president of the Department of Infectious Diseases at the São Paulo Pediatric Society (SPSP), agrees that the agency is taking time to position itself:

— It is a delay that does not proceed, that should not occur. These are situations that end up harming the population, not least because we have Coronavac here much more easily than other vaccines.

He follows:

— From the moment we have a serious infection, all the factors that are beneficial for the control or treatment of this infection must have agility. It stands to reason that we need robust data. It is a release that needs to be based on a theory, with very high reliability. Do we have this for Coronavac? We have. Even in Chile, the vaccine has been used for more than 3 years for a long time,” he adds.

The high number of tragic fatalities among children

The delay in the process comes at a time when pediatric vaccination is increasingly essential. Lima highlights that, as much as it affected adults more, there were about 3 thousand deaths of children by covid between 2020 and 2021.

— It is one of the vaccine-preventable infectious diseases that had the greatest impact in Brazil in recent years.

On the other hand, there are uncertainties about the long-term covid syndrome in younger people:

– Today there is a line of understanding that mysterious hepatitis is associated with a form of long covid. It’s one more concern — says the pediatrician linked to the SBP.

In addition, as Lima explains, the country is experiencing “the worst epidemic of respiratory diseases in pediatrics in recent years”. He points out, however, that covid does not represent the majority of cases. As Estadão showed at the end of May, states such as São Paulo, Rio Grande do Sul, Santa Catarina, and Pernambuco saw an explosion of hospitalized children, which has caused an overload in the units, with a lack of ICU beds and deaths waiting for a vacancy.

Otsuka recalls that the country is also experiencing a new high in covid cases, driven by the BA.4 and BA.5 sublines of Ômicron. According to the World Health Organization, both carry a mutation that seems to be related to greater transmissibility and immune escape – either from previous infections or from the vaccine.

— As soon as we have a population that is susceptible to infection, we provide greater circulation and greater chances of mutations in variants that may eventually be more serious. BA.4 and BA.5, in a certain way, have a greater pulmonary severity than BA.1 — he emphasizes.

On Monday, the 20th, the Ministry of Health reported that only 37.5% of children aged 5 to 11 completed a two-dose primary vaccine against covid. Lima considers this rate to be “worrying”. The pediatrician assesses that the result below expectations is due to the association of fake news with a government’s “inertia” in disseminating information that reassures parents and encourages them to vaccinate their little ones.

“It’s not parental sloppiness.” It is the fear of adverse events, which is why we emphasize so much that the adverse events of vaccines already administered in Brazil in the children, whether Coronavac or Pfizer, are, in the dense majority, mild – highlights the doctor. In addition to more campaigns, he calls for immunization in schools.

Pfizer and Moderna, which have FDA permission in the U.S., have not requested to utilize immunizations in Brazil for 6-month-olds and older

The Food and Drug Administration (FDA), an American body equivalent to Anvisa, expanded on Friday, 17, the application of the Pfizer and Moderna anti-covid vaccines to babies over 6 months of age. The agency concluded that the benefits outweigh the risks, and attested to the safety and efficacy of the immunizers. The decision was endorsed by the Centers for Disease Control and Prevention (CDC).

According to Anvisa, none of the pharmaceutical companies filed a request for expansion for this audience in Brazil. Asked if, in the face of the approval of the American body, it was mobilized to encourage pharmaceutical companies to file a request in the country, the Ministry of Health replied only that “it considers vaccination of all audiences as long as it is approved by Anvisa”. To Estadão, Pfizer Brazil said that the company works to submit requests to other agencies, including Anvisa, however, “there is still no exact date for submission”.

In the US, Pfizer’s immunizer has been approved for a three-dose primary regimen. The first two are applied at an interval of three weeks. The third injection is given at least eight weeks after the second. The dosage is 3µg (micrograms).

For children aged 5 to 11 years, the dosage used is 10 micrograms and for people aged 12 years and over, 30 micrograms. For both, the primary regimen is two doses.

On Tuesday, 21, Anvisa received a request from Pfizer for the inclusion of the booster dose in the package insert of the vaccine for children aged 5 to 11 years. The request is to apply the injection 5 months after the second. The analysis period is 30 days. The booster of the immunizer is already approved for children aged 12 and over.

Moderna still does not have a record for the application of the Spikevax immunizer in any age group in the country. But it signed a contract with Zodiac Produtos Farmacêuticos, Adium’s subsidiary in Brazil, to distribute doses here.

In May, to Estadão, Zodiac said that it intended to submit the immunizing agent to the agency’s sieve in the first half of this year. That hasn’t happened yet. “As there is the inclusion of indications for all age groups, the documentation is more extensive and demands more work. All efforts are being made, so that submission to the Health Authority and availability to the population occurs as soon as possible”, stated in a note.

In the case of Moderna, the FDA included in the package insert the use of an immunizer for children aged 6 months to 17 years. The immunizer is administered in a primary series of two doses – one month apart – with a booster release (third dose) at least one month after completing the cycle for some immunosuppressed individuals.