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Home ยป EU Regulators Approve First RSV Vaccine for Infants
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EU Regulators Approve First RSV Vaccine for Infants

Adrian GarrettBy Adrian GarrettJuly 23, 2023No Comments3 Mins Read
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European Medicines Agency Approves New Vaccine for Infants Against Respiratory Syncytial Virus (RSV)

Matzav Blog – In a significant development in the field of pediatric medicine, the European Medicines Agency (EMA) has given its recommendation for the authorisation of a new vaccine to protect infants against Respiratory Syncytial Virus (RSV). RSV is a highly contagious respiratory virus and is considered one of the leading causes of paediatric hospitalisation in Europe.

The vaccine, named Abrysvo, is a breakthrough as it would be the first RSV vaccine that can be administered to infants from birth to six months of age, following the vaccination of their mothers during pregnancy. RSV typically causes cold-like symptoms in children and adults, but can be severe, particularly in older adults aged 50 and above. It can lead to serious complications such as bronchiolitis, pneumonia, and fatal respiratory distress.

The authorisation of Abrysvo by the EMA was based on the positive results of two randomised studies involving pregnant participants and older adults. The trials demonstrated the safety and efficacy of the vaccine in preventing RSV infections in both populations. Common side effects observed in pregnant individuals who received the vaccine included muscle pain, vaccination site pain, and headache. In older adults, the main side effect reported was vaccination site pain.

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Abrysvo, developed by the renowned US pharmaceutical company Pfizer, has already been approved for use in older adults in the United States. This latest approval by the EMA marks an important milestone in the fight against RSV, especially for the vulnerable infant population. It offers hope for a safer and healthier future for young children and their families.

Interestingly, this approval comes shortly after another RSV vaccine developed by GSK was given the go-ahead for use in older adults by the European Commission. These recent developments signify a strong commitment by the medical community towards combating the significant burden of RSV infections, particularly in vulnerable populations.

RSV is responsible for an alarming number of hospitalisations each year for children under the age of five in the European Union, Norway, and the United Kingdom. The statistics show an average of 213,000 hospitalisations annually, highlighting the urgent need for effective preventive measures, such as vaccines, to protect the youngest members of society.

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The approval of Abrysvo for infants in Europe brings renewed hope for reducing the impact of RSV and preventing unnecessary hospitalisations among the most vulnerable population. With the combined efforts of pharmaceutical companies, medical professionals, and regulatory bodies, progress is being made in the ongoing battle against RSV. It is a significant step towards achieving a healthier future for children across the continent and beyond.

Adrian Garrett

“Zombie enthusiast. Subtly charming travel practitioner. Webaholic. Internet expert.”

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Adrian Garrett

"Zombie enthusiast. Subtly charming travel practitioner. Webaholic. Internet expert."

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