The National Health Surveillance Agency (Anvisa) authorized this Monday, the 1st, the registration of the Pfizer vaccine against the respiratory syncytial virus (RSV), which causes bronchiolitisrespiratory infection that can lead newborns and babies to death. The Abrysvo immunizer is applied to pregnant women and demonstrated 81.8% efficacy to protect against the disease from birth to three months of age. The agency also released the vaccine for the population over 60 years of age, which is a risk group for the disease.
The vaccine was the first indicated for use in pregnant women with the aim of protecting babies against the virus and, in August last year, it received approval from the Food and Drug Administration (FDA). After approval from the American regulatory agency, the pharmaceutical company filed the request for use in Brazil. The United States and Europe approved a single dose of the vaccine for both pregnant women and the elderly.
“After many years searching for strategies against respiratory syncytial virus, the main cause of hospitalization among children under 2 years old, we finally found two important fronts of intervention: a specific antibody to be applied to the baby at birth and, now, vaccination of pregnant women. We hope they will be on the market soon”, says pediatrician Renato Kfouri, vice-president of the Brazilian Society of Immunizations (SBIm).
“The virus causes 80% of bronchiolitis in children and 40% to 50% of pneumonia in the first years of life, causing enormous repercussions, such as visits to emergency services, use of antibiotics, hospitalizations, and parents missing work. The burden of this disease is enormous”, he adds.
In phase 3 tests, which supported approval, the vaccine was also 69.4% effective in protecting against episodes of bronchiolitis in children up to six months of age. According to the pharmaceutical company, the single dose can be applied to pregnant women between weeks 24 and 36 of pregnancy.
“When the mother receives the vaccine, the antibodies she produces cross the placenta, strengthening the baby’s body, whose immune system is still developing. This strategy represents a major advance in protection against RSV, a virus capable of profoundly impacting families”, explained, in a note, Adriana Ribeiro, medical director at Pfizer Brazil
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Also in a note, the company said that the vaccine will still be submitted to the Medicines Market Regulation Chamber (CMED) to have its price defined.
“We reaffirm that Pfizer is prepared to meet Brazil’s needs and remains open to working in partnership with the government and the private network, seeking to protect as many people as possible eligible for the vaccine against a virus that is so challenging for the system. health issues like RSV.”
Dangerous disease for children
Bronchiolitis can lead to serious conditions and even cause death in patients under 2 years of age, especially premature babies and those living with chronic diseases, such as cardiovascular problems.
The virus causes infections of the respiratory tract and lungs, which can lead to pneumonia. In episodes of bronchiolitis, there is a low fever, sore throat, headache and nasal discharge. Parents should be alert if their child starts to show high fever, persistent cough, difficulty breathingwheezing in the chest, in addition to purple lips and nails. In these cases, it is important to seek medical help to determine the need for hospitalization.
Although it is associated with the coldest periods of the year, normally in winter, the infection has affected young children at different times of the year, including summer, indicating a change in the seasonality of the virus.
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According to the latest edition of the InfoGripe Bulletin, from the Oswaldo Cruz Foundation (Fiocruz), the country is facing an increase in cases of Severe Acute Respiratory Syndrome (SRAG) in children and the increase is related to episodes of respiratory syncytial virus.
“If we look only at children, where mainly RSV and rhinovirus are more present in hospitalizations, we clearly see the sign of a significant increase in SARS,” said Marcelo Gomes, coordinator of the bulletin, in a statement about the balance released on March 28 .
Vaccine for the elderly
At the end of last year, a exclusive version for seniors had its registration approved by Anvisa. The immunizer Arexvy, from the pharmaceutical company GSK, which demonstrated 94.1% effectiveness to avoid the risk of serious episodes of virus-related lower respiratory tract illness.
The vaccine is administered to Single dose, intramuscularly, and is recommended for people aged 60 and over. The pharmaceutical company’s request was considered a priority due to the severity of the outcomes after infection.
