Approved for minors, Coronavac has 7 million stopped doses

The Butantan Institute has 7 million doses of Coronavac stopped and that can be intended for vaccination against Covid-19 for the public from 6 to 17 years old. The use of the immunizing agent in this age group was approved this Thursday (20) by Anvisa (National Health Surveillance Agency).

Previously, there were almost 15 million doses without destination, but, according to the institute’s press office, the government of São Paulo announced this Thursday that it will use 8 million of these vaccines to immunize children and adolescents in the state.

The remaining 7 million doses remain available for the PNI (National Immunization Plan) or for state governments, the institute says.

Butantan says that “it will meet the demand, whether from the federal or state government, from whoever needs it”. “Our production condition is the condition to meet any demand”, he adds.

The institute, however, does not have the IFA (Active Pharmaceutical Ingredient) for the production of new doses of Coronavac currently in the country.

The input is the raw material for the development of vaccines and, in the case of Coronavac, it is produced by the Chinese biopharmaceutical company Sinovac. Without API, the production of the immunizing agent is stagnant.

“We are going to produce vaccine according to demand, therefore, at the moment, there is no API in Butantan”, said the agency.

Another issue is the expiration date, scheduled for August this year, of the stopped doses. If not sold, they can be lost.

According to the institute, on the other hand, this is a factor that concerns other government entities. “Application in children and adolescents before the expiration date depends on the distribution and logistics of application in the municipalities”, he said.

The approval of Coronavac for children could be helpful in speeding up vaccination of younger people. According to an estimate by the IBGE (Brazilian Institute of Geography and Statistics), in 2021, there were 20.4 million people aged between 5 and 11. However, the vaccine is given in two doses, doubling the amount of immunizing agent needed for the age group.

Currently, in addition to Coronavac, only Pfizer is authorized to be applied to children and adolescents. For the latter, the pharmaceutical was approved by Anvisa in June 2021. The dose for this age group is similar to that applied to adults.

For children aged 5 to 11 years, authorization was given in December last year, and the dose is different from that applied to other age groups.

At the moment, the Ministry of Health has received 2.4 million pediatric doses from Pfizer. Half were sent by the ministry to the states, according to data from the Ministry’s Vaccine Distribution Panel.

Butantan’s request to Anvisa consisted of authorization of Coronavac for people from three years old, but the regulatory agency understood that there is not enough data to reduce vaccination to this age group, allowing only for those over six years old.

The evaluation also vetoed the use of the immunizer in immunocompromised children and adolescents.