Anvisa will approve the vaccine from the age of 5, but the government does not have a dose for children

On the eve of Anvisa (National Health Surveillance Agency) approving vaccination against Covid-19 for children aged 5 to 11 years, the government of Jair Bolsonaro (PL) still does not have in hand the specific doses for this group.

Even with the agency’s decision, the youngest cannot be immediately immunized.

The deadline for responding to Pfizer’s request ends on December 24, but the regulatory body will announce on Thursday (16) that it has approved the expansion of the vaccine’s target audience.

Members of the Ministry of Health say they will only advance in the negotiation for the purchase of specific doses for children after the manifestation of Anvisa.

In January 2021, the government published a provisional measure, converted into law in March, to allow the purchase of immunizers even before Anvisa’s approval.

There is still no endorsement in Brazil for the use of vaccines against the new coronavirus in children. Only the Pfizer model can be applied to the 12 to 17 year olds. The pharmacist also wants to ask, in 2022, for permission to vaccinate the public over 6 months of age, as shown by leaf.

The vaccination of children is a sensitive issue in government. Bolsonaro has skewed data to raise doubts about the safety and effectiveness of immunizers, especially in younger people.

“It’s a really complicated decision for any parent,” the president said on Feb. 2 about Pfizer’s vaccine.

“We want, when it comes to vaccine, often, the vaccine is the one that we know what they are. Already proven, which took 5, 10, 20 years, after many tests to be applied in the population. Now this one is very fast. “, he also declared, ignoring that the immunizing agent has a definitive registration from Anvisa.

After the approval of Anvisa, the Bolsonaro government will still have to insert the children in Covid’s vaccination plan and organize the delivery of specific doses to the states.

Wanted, Pfizer and the Ministry of Health did not say whether the contract for the purchase of doses for 2022 includes the model for children.

Anvisa directors received threats because of the analysis of Pfizer’s request. The agency asked for, but did not receive, police protection from its top management and the most exposed technicians.

Pfizer’s vaccines applied to the 5 to 11 year age group and the older ones have the same active ingredient, but some differences in composition.

The dose intended for children is equivalent to ⅓ of that indicated for the group aged 12 and over. The bottle of the youngest immunizing agent has an orange coloration just to differentiate the product.

This vial of the children’s vaccine also holds more doses and can be stored for longer (up to 10 weeks) at temperatures from 2 °C to 8 °C, an interval used in conventional SUS refrigerators. The other model remains for up to 31 days under these conditions.

The Ministry of Health plans, in next year’s vaccination plan, to immunize 70 million children, which depends on Anvisa’s approval. In addition to the Pfizer vaccine, the folder also evaluates the purchase of vaccine models used for a longer period of time in children, such as the inactivated virus, in the case of Coronavac.

But there is no open request at Anvisa to evaluate the use of another brand of vaccine in children. In August, the agency turned down Coronavac’s application to the 3- to 17-year-olds.

Anvisa began evaluating Pfizer’s request for vaccination of children on November 16th.

The agency asked for additions to the drugmaker’s documentation on November 23, which suspended the deadline for analysis. This period was counted again on December 6th.

The agency had asked for information on the response of the immunizing agent against the delta variant, which is predominant in Brazil, in addition to comparing records of adverse reactions in this age group and in older groups, among other manifestations.

Anvisa changed the method of analyzing vaccines in children and met in December with medical institutions linked to child health and immunology.

The objective was to share the vaccine’s efficacy and safety data with the group of external experts so that they can contribute to Anvisa’s technical evaluation process.

Representatives of the SBI (Brazilian Society of Infectology), the Department of Infectology at the SBP (Brazilian Society of Pediatrics), the Albert Einstein Hospital Research Institute, the SBI (Brazilian Society of Immunology) and Abrasco (Brazilian Association of Pediatrics) participated in the meeting. Public Health).