Recommendation serves to prevent people sensitive to the components from having an extreme reaction to the vaccine, which can be administered to teenagers from 16 years old
A National Health Surveillance Agency (Anvisa) detailed this Tuesday, 23, information on the definitive registration of the vaccine of Pfizer / BionTech in Brazil. As in the case of U.S, the country must adopt an observation period of at least 15 minutes for those immunized, trying to avoid side effects. “In the package insert that will be made available there is a recommendation to observe individuals who have been vaccinated for at least 15 minutes, careful observation. Precisely because cases of anaphylaxis can occur. There are even contraindications for those individuals who are allergic to components of the vaccine formula, as it was also observed during these applications that there is a possibility of hypersensitivity, of allergy, for those individuals who have a history of allergies to other vaccines and other agents ”, said Maria Fernanda Reis, manager of evaluation of biological products at Anvisa.
The agency detailed that the definitive registration, first in the country for a vaccine against Covid-19, was authorized under the seal of resolution No. 415 of 2020, which modifies criteria established in the year 2010, optimizing the time of pharmacists and the regulatory agency . The resolution allows the concession for the definitive use of the immunizer to be given without the presentation of all the necessary data, but before a term of commitment for the presentation of the same future. The registration, which lasts three years and was classified as “conditional” by Anvisa, can be suspended if the requested information is not provided according to the schedule or adverse events outside the curve shown in the preliminary studies are noticed in the population.
“Registration allows the company to import, vaccines that are manufactured abroad can be imported into Brazil, they can be produced if necessary, and the company can exhibit for sale according to its use or deliver for consumption, distribute in institutional programs ”, explained the general manager of Medicines and Biological Products at Anvisa, Gustavo Mendes. According to him, the first clinical trials of part three of the vaccine were allowed in July 2020 and the first data on continuous submission were sent in November. The choice to request the definitive registration, and not the emergency use, was made by Pfizer itself and the request was submitted to Anvisa on February 5, being approved this Tuesday. “The term, which initially would be 60 days according to our resolution, was reduced to 18 days because we were able to receive all this information, in addition to the fact that we dedicated ourselves day and night,” he said.
Despite the permission for vaccines to be imported and marketed by Anvisa, there is still no clarity on whether the immunizers will be available to the private sector soon. “Anvisa grants the registration, it means that the company is authorized to negotiate the form of both availability and sale of the vaccine according to its criteria. It could, if there is a negotiation between the responsible entity and the company. It is important to make it clear that Anvisa does not take merit, which is the responsibility of other bodies, on whether it is possible to make it available to the private sector or not ”, detailed the manager. Pfizer has yet to comment on whether it intends to market the immunizer immediately.
Storage conditions and age of the immunized
According to data from the company itself, the vaccine from Pfizer / BionTech can be administered to people from 16 years of age and the interval between first and second dose should be 21 days. So far, the two vaccines in emergency use in Brazil only allow vaccination for people over 18 years old. Anyone who has no reactions to the active ingredients present in the package insert can be immunized. The expiration date of vaccines when stored at -60ºC is six months. If stored under refrigeration conditions common in the country, from 2ºC to 8ºC, they can be preserved for five days. In the case of room temperature (about 30ºC) it is considered useful for application within 2 hours.