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Newsletter no. 9 - February 2021

WHAT'S NEW
Highlights on our activities and initiatives

PAEDIATRIC MEDICINES IN EUROPE

The article "Paediatric Medicines in Europe: The Paediatric Regulation—Is It Time for Reform?”, developed within TEDDY— European Network of Excellence for Paediatric Research by Maddalena Toma (researcher at Fondazione Benzi) as first author, was published on the journal Frontiers in Medicine – Regulatory Science. It aims to investigate the effects of the Regulation (EC) N. 1901/2006 with respect to satisfying the paediatric therapeutic needs, by assessing the new Paediatric medicinal products approved by the European Medicines Agency in the period January 2007 to December 2019. This work underlines that the reasons for the limited development of paediatric medicines in Europe need to be further discussed and that new measures in support of the Regulation should be implemented.

Read more  - Read the full article

RE(ACT) CONGRESS AND IRDIRC CONFERENCE 2021: OUR FOCUS ON THERAPIES FOR CHILDREN WITH RARE DISEASES

We took part in the joint event including the RE(ACT) Congress - International Congress of Research on Rare and Orphan Diseases (6th edition) and IRDiRC - International Rare Diseases Research Consortium - Conference (4th edition) held online on 13-15 January 2021.
Maddalena Toma, researcher at Fondazione Benzi, submitted an abstract on "Orphan paediatric medicines in Europe", published on the
Congress Brochure.
The analysis shows that the number of paediatric Orphan Medicinal Products in Europe is still low and among them, 41 (around 72%) do not cover children at all ages. Neonates and infants are less represented.
Therefore, the authors conclude that the therapeutic possibilities and the quality of life of children with rare diseases need to be enhanced.

 

Read more - Read the abstract

OUR CONTRIBUTION TO THE PUBLIC CONSULTATION ON THE EC-INCEPTION IMPACT ASSESSMENT

Fondazione Gianni Benzi provided its contribution to the public consultation on the revision of the European legislation on medicines for children and rare diseases launched by the European Commission (EC- Inception Impact Assessment - Ref. Ares (2020)7081640 - 25/11/2020), based on the outcome of the evaluation of the medicines for rare diseases and children legislation. The comments, prepared within the European Paediatric Translational Research Infrastructure – EPTRI, underline that both the two Regulations (Paediatric and Rare Diseases) have only partially met the expectations of patients and that there is the need to advance in that direction. 
We also contributed to the
comments submitted by the European Network of Excellence for Paediatric Research - TEDDY and a relevant contribution was provided within the European Joint Programme – Rare Disease as well.

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ACROSS THE WORLD
Insights and updates on COVID-19 emergency

COVID-19: VACCINE DEVELOPED BY MODERNA APPROVED IN EUROPE

The European Medicines Agency (EMA) recommended the conditional marketing authorisation for COVID-19 Vaccine Moderna (mRNA-1273) that the European Commission granted.
EMA’s human medicines committee has thoroughly assessed the data on the quality, safety and efficacy of the vaccine. This 
data was provided by a very large clinical trial (NCT04470427) that involves around 30000 people in total. The vaccine demonstrated a 94.1% efficacy in the trial. The most common side effects were usually mild or moderate and got better within a few days after vaccination.
The vaccine is not currently recommended for children below 18 years of age. However, EMA has agreed with the company on a 
Paediatric Investigation Plan to trial the vaccine in children at a later stage.

 

THIRD COVID-19 VACCINE APPROVED IN EUROPE

The European Medicines Agency recommended granting a conditional marketing authorisation for COVID-19 Vaccine AstraZeneca to prevent COVID-19 disease in people from 18 years of age.
Combined results from 4 clinical trials in the United Kingdom, Brazil and South Africa showed that COVID-19 Vaccine AstraZeneca was safe and effective at preventing COVID-19 in adults. These studies involved around 24000 people altogether.
Most of the participants in these studies were between 18 and 55 years old. There are not yet enough results in older participants (over 55 years old), however protection is expected, given that an immune response is seen in this age group and based on the experience with other vaccines.
Regarding children, a 
Paediatric Investigational Plan was agreed with the company to test the vaccine in children from birth to less than 18 years of age. It includes 3 clinical trials to be conducted to gather evidence on the safety and immunogenicity of the vaccine in the paediatric population by July 2024.

 

Read more 

MORE EVIDENCE ON COMIRNATY® IN CHILDREN

Comirnaty® (BNT162b2) is the first vaccine against COVID-19 approved in Europe for adults and adolescents from 16 to 18 years of age.
Data on efficacy and safety of the vaccine in children under 16 years of age is still not available. The company agreed that paediatric studies will be completed by July 2024, as included in the 
Paediatric Investigational Plan - PIP (EMEA-002861-PIP02-20) according to the European Paediatric Regulation.
The PIP for Comirnaty® foresees that 4 clinical studies shall be conducted to gather needed evidence on the dosage, safety, tolerability and immunogenicity of the vaccine including children from birth to less than 18 years of age.
The company completed enrolling children aged 12 to 15 in one of these study (
NCT04368728) aimed to evaluate the safety, tolerability, immunogenicity, and efficacy of BNT162b2 vaccine. Over 2200 participants aged 12-15, were enrolled until January 2021.

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