The governor of São Paulo, João Doria (PSDB), said this Saturday (4) that will maintain the decision to reduce the interval of application of the booster dose of the vaccine against Covid-19 in the state, even after the recommendation made by the National Health Surveillance Agency (Anvisa) for the measure to be revised.
In a press conference held in New York, in the United States, the governor stated that Anvisa has no power to prohibit state decisions.
“São Paulo will follow the guidance of its scientific committee. Anvisa does not have the power to determine, prohibit state decisions. Constitutionally, in fact, this was reinforced by a recent decision of the STF: it is up to the states to define their vaccination policies and their health policies”, said Doria.
On the night of Friday (3), Anvisa responded to a letter from the Municipal Health Department and recommended that the city reassess the decision to reduce the booster dose interval of the Covid-19 vaccine from 5 to 4 months.
The agency said there is no evidence that the benefits of anticipation outweigh the unknown risks of application other than what is stated in the package insert for immunizing agents.
The measure is already in effect in the city of São Paulo since Thursday (2). The state administration also decided to reduce the interval, under the justification of concern with the arrival of the omicron variant in Brazil.
“At the moment, we don’t know whether the benefits outweigh the risks for using a 4-month booster for all adults aged 18 and over, regardless of the vaccine offered and the primary vaccine schedule. We alert that the generalized reduction of the interval for the application of the booster dose of the different vaccines against Covid-19 can favor the increase and the appearance of unknown adverse reactions”, says the note from Anvisa.
The agency also cites that “asymmetry in access to vaccines in the country should be avoided and that vaccination strategies be coordinated, considering exclusively the public interest.”
Anvisa’s positioning points:
- that Agency-approved vaccines are the most effective way to control the spread of Sars-Cov-2, including preventing the more serious consequences of Covid-19 such as number of hospitalizations and deaths.
- there are few data on the comparative safety and immunogenicity of different Covid-19 vaccines given as a booster dose. However, in the context of the epidemiological setting and the monitoring of effectiveness studies by age group, the use of a single booster dose is indicated for those who have already completed the primary course of vaccination against Covid-19 six months ago.
- that a shorter interval period can be considered as long as it is supported by robust studies, supported by epidemiological data, with adequate monitoring of adverse reactions and with the conduction of vaccine effectiveness studies.
- the need to implement an additional program for monitoring and pharmacovigilance of the use of immunizers in disagreement with the package insert.
- that national immunization policy makers should establish criteria to choose which booster vaccines will be used in the Brazilian population. This decision should be based on immunological considerations, known adverse effect profiles, availability in the country, and ultimately what level of reinforcement is sufficient in the context of national strategic disease control objectives.
- strongly recommended that asymmetry in access to vaccines be avoided in the country and that vaccination strategies be coordinated, exclusively considering the public interest.
- that the implementation of vaccination campaigns in Brazil, including the use of booster doses, continues to be the prerogative of the National Immunization Program of the Ministry of Health (PNI/MS), which is responsible for guiding vaccination campaigns in the country. The PNI/MS, together with State and Municipal health managers, is in the best position to assess and consider local conditions, including virus spread (especially with regard to any strains of concern), vaccine availability and capacities. of national health systems.
- that, at present, we do not know whether the benefits outweigh the risks of using a 4-month booster for all adults aged 18 years and over, regardless of the vaccine offered and the primary vaccine schedule. We alert that the generalized reduction of the interval for the application of the booster dose of the different vaccines against COVID-19 may favor the increase and the appearance of unknown adverse reactions.
- Finally, he recommended that the Municipality of São Paulo reassess the strategy of generalized anticipation of application of the booster dose.
Interval reduction
The state government announced on Thursday (2) the reduction of 5 to 4 months the interval for the application of the additional dose of the vaccine against Covid-19 in São Paulo.
The measure applies to those who took two doses of immunizing CoronaVac, AstraZeneca and Pfizer, and will reach about 10 million people who were vaccinated in July and August. The State Department of Health stated that the booster dose can be any immunizing agent. The Municipal Secretary says that the dose should preferably be from Pfizer.
For the decision, the scientific committee of the state management considered the three cases of the omicron variant in São Paulo.
For the members of the committee, as Brazil does not yet require the presentation of proof of the complete vaccination schedule for travelers, the measure is necessary since the state “is the gateway for people from all over the world”. The committee also considered the proximity of the holiday season.
“The state currently has the logistical and technical conditions to expand vaccination and reduce the interval for applying doses so that everyone can be even more protected. It is also worth emphasizing the need for those who have not yet taken the second dose, return to health centers to be immunized”, said the Secretary of State for Health of São Paulo, Jean Gorinchteyn.
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In capital, the reduction of the break has already started to be followed on Thursday. The other cities must define when they start to apply the booster dose with a shorter interval.
Since Tuesday (30), anyone over 18 years old who took the Janssen vaccine for at least two months, began to be vaccinated with Pfizer in the city of São Paulo.
The government has autonomy to define the state’s vaccination schedule. Since the beginning of the pandemic, states and municipalities have adopted different calendars from the National Immunization Plan and applying the Covid-19 vaccine according to its rules. It is not yet defined whether the Covid-19 vaccine will enter the annual vaccination calendar.
For the same reasons given for the reduction of the interval of the extra dose, the government backed down and maintained the mandatory use of masks. The state administration planned to make the use of masks outdoors more flexible on December 11th. This Thursday (2), however, João Doria’s management also backed down and gave up on releasing the population from using masks outdoors.