Butantan disputes the Ministry of Health and defends the effectiveness of CoronaVac in the elderly

On Saturday (20), the American company Janssen – pharmaceutical arm of Johnson & Johnson – requested the emergency use of the booster vaccine against covid-19 to the National Health Surveillance Agency (Anvisa). The idea is that the second dose of the vaccine against the SARS-CoV-2 coronavirus can be applied after at least two months of the initial dose.

In the order sent to Anvisa, Janssen requests the inclusion of the homologous reinforcement in the package insert, that is, that the second dose is the same as the first. It is worth remembering that this was the only single-dose vaccine against covid-19 approved in Brazil.

Janssen requests authorization from Anvisa for the use of the second dose of the vaccine against covid-19 (Image: Reproduction/E_mikh/Envato)

In addition, Janssen asks that the immunizer be authorized for heterologous vaccination. This occurs when the person receives the complete vaccine schedule (2 doses) of another vaccine, such as the Pfizer/BioNTech formula with mRNA (messenger RNA) technology, and will receive the Janssen formula as a booster (third dose) .

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Since October of this year, the United States has authorized the application of the Janssen vaccine booster dose against covid-19. In the country, the use of the immunizing agent will also be adopted as a heterologous booster for other vaccines against covid-19 authorized by the Food and Drug Administration (FDA).

However, the request that will be evaluated by Anvisa does not consider the third dose of the Janssen vaccine, as proposed by the Ministry of Health. “There is no data available so far to support the need for a second booster dose (third application)” , explains the company, in a statement.

At the moment, Anvisa analyzes the data and studies developed by the company for the use of the vaccine as a booster against covid-19. In addition to Janssen, Pfizer and AstraZeneca have already requested a change in the package insert to include the reinforcement. So far, all requests are under review.

Janssen reinforcement data

In the ENSEMBLE Phase 3 trial, 390,000 volunteers who received Janssen’s covid-19 vaccine participated. With just a single dose, protection against severe cases of infection reached 75%. In addition, this primary vaccination—in a single dose—offers protection and levels of antibodies and CD8+ T cells that last for at least 8 months. This is the longest period evaluated so far.

To increase protection against symptomatic forms of covid-19, a booster dose can be given from two months after the first dose. In this regard, another Phase 3 study, ENSEMBLE 2, demonstrated that the efficacy of two doses of Janssen’s vaccine against moderate forms of covid-19 reached 75.2%. Furthermore, the effectiveness was 100% against severe cases when assessed at least 14 days after the booster dose.

In the Janssen booster dose study, two possible intervals between doses were evaluated: two months and six months. The greatest benefit of the extra dose of immunization was obtained with the longer interval between applications. When applied after six months, the booster provided a 12-fold increase in antibody levels. With the shorter interval between the two doses, antibody levels increased four to six times.

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