Janssen’s Health Decision for 2nd dose surprises members of the folder, Anvisa and the laboratory

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The announcement of the application of the second dose and the booster dose of the Janssen vaccine for Covid-19 made by the Ministry of Health on Tuesday (16) caught health managers, Anvisa (National Health Surveillance Agency) and even the laboratory producing the vaccine by surprise.

According to the folder’s announcement, the immunizing agent, which had been used in a single dose, will now be used in two applications, as is already the case with Pfizer, AstraZ eneca and Coronavac injections.

The second dose should be given two months after the first in the adult population. The booster dose should be used after five months of the complete primary regimen. The recommendation is to use a different immunizer, preferably from Pfizer.

Although there is still no formal request to Anvisa from the laboratory about applying the second dose and the booster dose, the Ministry of Health can make this type of definition.

This is because the legislation leaves room for the minister to “determine the performance of actions provided for in the competences” of Anvisa, such as deciding on the application of vaccines.

But the minister can only take this type of initiative in cases “that imply a risk to the health of the population” or in scenarios of inaction by Anvisa, even in accordance with current rules.

In reading the agency’s technicians, the ministry should formalize that it acted in place of the regulatory body, in a publication in the Federal Official Gazette, for example, in addition to explaining the reasons for this initiative.

Anvisa technicians were also taken by surprise by the decision to extend the booster dose to all adults. Before, the application was restricted to people over 60 years old or from risk groups.

Agency members had spoken out in early discussions about the booster dose. They were surprised that they weren’t called now.

Despite the discomfort, Anvisa does not want to come into conflict with the ministry. The fear is that the questions will fuel anti-vaccine discourses.

There is still no closed strategy among the agency’s members, but the preliminary idea is to demand from the ministry the data that supported the decision about Janssen, in addition to those about expanding the group able to receive a booster dose.

A point that worries Anvisa is how to organize the monitoring of adverse reactions to vaccines. In the agency’s reading, this is one of the topics that should have been previously discussed with the ministry.

This Tuesday’s announcements also took part of minister Marcelo Queiroga’s team by surprise. Decisions about Covid-19 have been made in restricted groups and the PNI (National Immunization Program) has been without command since the end of June.

The argument of Queiroga’s assistants is that both the change in the application of the Janssen dose and the expansion of the booster vaccine’s audience follow international experiences.

In a statement, however, Anvisa said that initiatives of this type were previously discussed with regulatory agencies in several countries.

“Before incorporating the booster dose of vaccines, countries like the United States, Canada, Indonesia, Great Britain, Israel, members of the European Community and others submitted the strategy for prior evaluation by their regulatory authorities. Primarily, the third or dose of booster was indicated for people with weakened immune systems, the elderly and health professionals,” said the Brazilian agency.

In the same text, Anvisa states that it is important to differentiate the vaccination schedule provided for in the package insert and the vaccination and reinforcement strategy.

The scheme provided for in the package insert and approved by Anvisa, number of doses and intervals, indicates how to use the vaccine, which, according to studies, produce the best immunization results.

The vaccination and reinforcement strategy, on the other hand, is a decision by the health authority on how a given immunizing agent will be applied in the population in order to obtain the best vaccination coverage, and the strategies for monitoring adverse reactions.

The regulatory agency also said that the decision on the booster dose should consider the epidemiological scenario, the effectiveness studies, the circulation of variant strains and the safety of vaccines, as well as an effective strategy for monitoring adverse reactions and capturing signals of interest for pharmacovigilance.

According to Anvisa, the forecast is that until next week Janssen delivers the studies to Anvisa on the efficacy and safety of the booster dose of its vaccine.

According to the Ministry of Health, the orientation follows a global trend. However, the decision of the American regulatory agency considered the second dose as reinforcement. All adults who received Janssen, a single dose, more than two months ago are eligible for the booster.

“Those who took Janssen will complete the vaccination schedule. Although it is a single dose, it’s up to us [Ministério da Saúde] the definitions. The person will take two doses, at an interval of two months”, said the Extraordinary Covid-19 Coping Secretary, Rosana Leite de Melo.

The announcement was made at a press conference at the Ministry of Health on Tuesday, when the folder informed that the booster dose against Covid was released for the entire adult population of the country.

After questioning when people can look for health centers, Melo said that the Ministry of Health should release vaccines from Friday (19) to states and municipalities.

“We ordinarily distribute two agendas [por semana]. This one from Janssen is from Friday if they are all released. They arrived yesterday and will be distributed with all the information”, he said.

Janssen, the pharmaceutical arm of Johnson & Johnson, said a second dose of its Covid-19 vaccine, given about two months after the first, increased its effectiveness to 94% in the United States against moderate or severe forms of the disease.

Protection with a single dose of the vaccine, which is used in several countries, including Brazil, is 70%.

​The drugmaker added that the second dose increased antibody levels four to six times. When given six months after the first, antibody levels increased 12-fold.

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