The National Health Surveillance Agency (Anvisa) approved a resolution changing the package insert for the vaccine from Pfizer (Comirnaty) to include the possibility of a booster dose and that the additional application be made six months after the completion of the vaccine cycle for people to from 18 years old. Approval was conditional on monitoring the use of the booster dose and possible adverse effects.
However, at a meeting of the collegiate board on Wednesday (24), vote was approved, with questions and recommendations to the Ministry of Health, to carry out the booster dose campaign for this and other immunizing agents, announced last week.
This is because the ministry informed, on the 16th of this month, that it would apply the booster doses for all citizens aged 18 and over. Until then, the National Immunization Program (PNI) only directed booster doses for the elderly, immunosuppressed and health professionals.
Last week, however, no vaccine against covid-19 was authorized by Anvisa for the additional dose. The agency then sent a letter to the Ministry of Health requesting clarification on the announced campaign. The letter was answered today, with partial answers.
As of today, the application of the booster dose from Pfizer will be supported by permission from Anvisa, but the others, not yet. The Oxford/AstraZeneca consortium, which has a partnership in Brazil with the Oswaldo Cruz Foundation (Fiocruz), requested on the 17th of this month the authorization of the third dose for those who took the first two of the same immunizing agent.
Janssen also filed a request with Anvisa for the application of the booster dose both in those who took the single dose of the pharmaceutical company and in those who received doses from other brands. The application was made on the 19th of November. Anvisa must carry out the assessment within 30 days.
Orders from the Oxford/AstraZeneca consortium and Janssen are still being analyzed by the Anvisa team. CoronaVac, from the pharmaceutical company Sinovac in partnership with the Butantan Institute, has not yet requested the update to include the third dose.
While the change in Pfizer’s vaccine package insert was decided by the technical team and published in the official diary Today, the Collegiate Board discussed guidelines for booster doses in general. The reporter on the subject, Meiruze Freitas, questioned the fact that the Ministry of Health had not forwarded the campaign after approval by Anvisa. Even so, Meiruze recognized, with recommendations, the benefit of the booster dose.
“The most appropriate thing would be for the ministry to have approved, through an ANVISA regulatory rite, the inclusion of the booster dose, allowing this posology in the package insert of the different vaccines. However, reality forces us to look at the whole scenario, and the situation we see, as one of greater control from the point of view of sanitary surveillance”, said Meiruze.
The rapporteur mentioned studies by both pharmaceutical companies and health authorities in other countries that indicate a safety profile after taking the booster dose similar to the second dose. Also according to Meiruze, scientific research has shown an improvement in the immune response of people who received additional doses six months after the completion of the original vaccine cycle.
As for those who took the booster dose with a vaccine different from the originals, Anvisa sees no risk. Therefore, people who already had the application of the additional dose with a different brand from the one used in the primary vaccine cycle, at first, would not have great possibilities of adverse effects.
However, given the fact that more data are needed to monitor adverse events from Pfizer’s vaccine and the fact that other brands still do not have authorization, the rapporteur presented a set of recommendations about the campaign to the Ministry of Health.
According to Meiruze Freitas, the Ministry of Health has already informed Anvisa of changes in relation to what was announced last week. People vaccinated with immunizers from Pfizer and Janssen should take the booster dose of the same brand as above. Those who received doses from Oxford/AstraZeneca and CoronaVac will receive booster vaccine from another brand, such as Pfizer.
These are the recommendations made by the rapporteur:
Use of the homologous vaccine schedule (the same booster dose as the originals taken) for the Pfizer vaccine;
Use of the homologous scheme also for Janssen and Oxford/AstraZeneca vaccines until there is a decision by Anvisa on the orders of the two consortia;
In the case of application of a booster dose for people who took CoronaVac, the use of Pfizer vaccine (the only one provided for in the package insert) as a booster dose;
Adoption of an additional program to monitor the use of vaccines in disagreement with the package insert;
Establish monitoring of vaccine schedules, including the risks of the adopted strategy and serious adverse reactions, such as thrombocytopenia, Guilllain-Barré syndrome, lymphadenopathy, myocarditis and pericarditis;
Continuing studies by Fiocruz on the application of additional doses;
Postponement of the additional dose of messenger RNA vaccines, such as Pfizer, for people who have had myocarditis after previous doses;
Ongoing reviews of information regarding the safety, efficacy and immunogenicity of booster doses;
Coordination with states and municipalities for pharmacovigilance procedures and monitoring the effects of booster dose vaccine schedules.
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