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AstraZeneca – Euro Roundup: EMA targets Friday decision on AstraZeneca COVID vaccine
The European Medicines Agency (EMA) aims to decide on approval of COVID-19 Vaccine AstraZeneca on Friday, 29 January. Amid concerns about the lack of clinical data in seniors, EMA may impose a label that restricts use of the vaccine to younger populations.
Emer Cooke, EMA executive director, fielded a series of questions about the AstraZeneca vaccine at a meeting of the Committee on Environment, Public Health and Food Safety (ENVI) on Tuesday. In her introductory remarks, Cooke said the Committee for Human Medicinal Products is meeting this week and is at the finalization stage of the assessment. “We’re very much hoping for a conclusion by the end of this this week,” Cooke said.
AstraZeneca has already secured clearance to sell the vaccine in several other markets, including the UK, but its dataset has limitations when compared to the packages submitted by Moderna and Pfizer/BioNTech.
Sparked by a quickly refuted German media report that COVID-19 Vaccine AstraZeneca is only 8% effective in people aged over 65 years and older, recent reports in European newspapers have focused on the data supporting its use in seniors. Cooke did not directly address the 8% claim, dismissed as “nonsense” by one ENVI member, but did touch on the limitations of the available evidence in seniors.
“The studies that were done, and that have been included in the file so far, have a very small quantity of elderly populations,” Cooke said. “The committee can decide to approve this vaccine depending on what they see the strength of the scientific data. So they could decide—and I’m not going to prejudge any decision because this is a scientific and expert discussion that is ongoing—but it is possible to conclude an authorization that would focus on a particular age group.”
AstraZeneca CEO Pascal Soriot addressed the limitations of the data in an interview with the Italian newspaper la Repubblica, noting that the data that is available suggest the vaccine triggers comparable immune responses in younger and older populations.
“It’s possible that some countries, out of caution, will use our vaccine for the younger group. But honestly, it is fine. There’s not enough vaccines for everybody. So if they want to use another vaccine for older people and our vaccine for younger people, what´s the problem? It’s not a problem. We’re trying to deal with this crisis together,” Soriot said.
Debate Replay, la Repubblica
Enpr-EMA shares guidance to informed consent in pediatric clinical trials
The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) has published guidance on obtaining informed consent from children enrolled in clinical trials.
In creating the guidance, Enpr-EMA’s working group on ethics has sought to provide an informed consent and assent overview tool that researchers can use to design and run ethical pediatric trials in Europe. That goal led the working group to address the different elements that should be included in consent documents aimed at children of various ages.
The guidance says an “explanation of the concept of a clinical trial and the methodology used” should be provided to children aged 10 to 18 years and their legal representatives. However, Enpr-EMA advises against providing that level of information to children aged five years and under. The information is optional in materials aimed at children aged six to nine years.
In contrast, Enpr-EMA recommends giving children as young as two years the right to refuse to take part in a clinical trial. The working group wants researchers to systematically seek the agreement of children even if their assent is not a legal requirement. “Children should be provided with age-appropriate information (with supplementary visual information where appropriate) and have the opportunity to form an opinion or decision,” the guidance states.
Other sections of the guidance address which age groups should be allowed to discuss the trial in the absence of their parents and when to share information about the design of a study and the medical intervention being studied. The guidance recommends including every element in materials aimed at children aged 10 years and older, and none of the elements in trials of infants aged under two years.
Enpr-EMA Guidance
Denmark’s DKMA starts work on regulatory framework for decentralized clinical trials
The Danish Medicines Agency (DKMA) has begun working on a regulatory framework to support the digitalization and decentralization of clinical trials. DKMA’s initial focus is on how clinical trials can be decentralized while safeguarding safety, data quality and the interests of the public.
Interest in decentralized clinical trials rose quickly when COVID-19 began preventing travel and in-person interaction. DKMA has responded to the trend by starting work on a “contemporary and robust regulatory framework” intended to help Denmark “maintain its strong position in clinical research.”
DKMA and Danish clinical trial organization Trial Nation have set up a forum for discussing decentralized studies. DKMA wants to collaborate with sponsors on a “a small number of pilot projects with sub-elements of decentralized clinical trials.” The agency is encouraging sponsors to seek regulatory scientific advice before filing to run a decentralized clinical trial.
DKMA Notice, More
Bioethics committee calls for regulatory strategies on pandemic vaccine testing
The European Union Committee on Bioethics (DH-BIO) has published a report on ensuring equitable access to vaccines during the COVID-19 crisis and future pandemics.
DH-BIO, part of the Council of Europe, created the document to inform the mitigation of systemic disadvantages in healthcare access suffered by some EU citizens. Through the mitigating measures, the committee aims to help the EU abide by its principle of equitable access to healthcare even during crises.
Specifically, DH-BIO wants the EU to develop “regulatory strategies … to ensure that vaccines are developed and tested in an inclusive manner that reflects the populations in which they will be used.” Other regulatory recommendations relate to the need to monitor for adverse events and carry out independent batch testing of vaccines.
DH-BIO Report, EDQM Notice
Other News:
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on decentralized and mutual recognition procedures that are approved or pending. MHRA has revised the guidance, which it only published at the end of 2020, “to clarify that UK national MA applications can be submitted irrespective of applications for the same product in EU.” MHRA Guidance
The Dutch Medicines Evaluation Board (MEB) has re-enabled its decentralized procedure planning tool after resolving security issues, enabling companies to use it to apply for time slots regarding decentralized applications where the Netherlands is the reference state. MEB took the system offline late last year for security reasons. MEB Notice
Emer Cooke, EMA executive director, fielded a series of questions about the AstraZeneca vaccine at a meeting of the Committee on Environment, Public Health and Food Safety (ENVI) on Tuesday. In her introductory remarks, Cooke said the Committee for Human Medicinal Products is meeting this week and is at the finalization stage of the assessment. “We’re very much hoping for a conclusion by the end of this this week,” Cooke said.
AstraZeneca has already secured clearance to sell the vaccine in several other markets, including the UK, but its dataset has limitations when compared to the packages submitted by Moderna and Pfizer/BioNTech.
Sparked by a quickly refuted German media report that COVID-19 Vaccine AstraZeneca is only 8% effective in people aged over 65 years and older, recent reports in European newspapers have focused on the data supporting its use in seniors. Cooke did not directly address the 8% claim, dismissed as “nonsense” by one ENVI member, but did touch on the limitations of the available evidence in seniors.
“The studies that were done, and that have been included in the file so far, have a very small quantity of elderly populations,” Cooke said. “The committee can decide to approve this vaccine depending on what they see the strength of the scientific data. So they could decide—and I’m not going to prejudge any decision because this is a scientific and expert discussion that is ongoing—but it is possible to conclude an authorization that would focus on a particular age group.”
AstraZeneca CEO Pascal Soriot addressed the limitations of the data in an interview with the Italian newspaper la Repubblica, noting that the data that is available suggest the vaccine triggers comparable immune responses in younger and older populations.
“It’s possible that some countries, out of caution, will use our vaccine for the younger group. But honestly, it is fine. There’s not enough vaccines for everybody. So if they want to use another vaccine for older people and our vaccine for younger people, what´s the problem? It’s not a problem. We’re trying to deal with this crisis together,” Soriot said.
Debate Replay, la Repubblica
Enpr-EMA shares guidance to informed consent in pediatric clinical trials
The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) has published guidance on obtaining informed consent from children enrolled in clinical trials.
In creating the guidance, Enpr-EMA’s working group on ethics has sought to provide an informed consent and assent overview tool that researchers can use to design and run ethical pediatric trials in Europe. That goal led the working group to address the different elements that should be included in consent documents aimed at children of various ages.
The guidance says an “explanation of the concept of a clinical trial and the methodology used” should be provided to children aged 10 to 18 years and their legal representatives. However, Enpr-EMA advises against providing that level of information to children aged five years and under. The information is optional in materials aimed at children aged six to nine years.
In contrast, Enpr-EMA recommends giving children as young as two years the right to refuse to take part in a clinical trial. The working group wants researchers to systematically seek the agreement of children even if their assent is not a legal requirement. “Children should be provided with age-appropriate information (with supplementary visual information where appropriate) and have the opportunity to form an opinion or decision,” the guidance states.
Other sections of the guidance address which age groups should be allowed to discuss the trial in the absence of their parents and when to share information about the design of a study and the medical intervention being studied. The guidance recommends including every element in materials aimed at children aged 10 years and older, and none of the elements in trials of infants aged under two years.
Enpr-EMA Guidance
Denmark’s DKMA starts work on regulatory framework for decentralized clinical trials
The Danish Medicines Agency (DKMA) has begun working on a regulatory framework to support the digitalization and decentralization of clinical trials. DKMA’s initial focus is on how clinical trials can be decentralized while safeguarding safety, data quality and the interests of the public.
Interest in decentralized clinical trials rose quickly when COVID-19 began preventing travel and in-person interaction. DKMA has responded to the trend by starting work on a “contemporary and robust regulatory framework” intended to help Denmark “maintain its strong position in clinical research.”
DKMA and Danish clinical trial organization Trial Nation have set up a forum for discussing decentralized studies. DKMA wants to collaborate with sponsors on a “a small number of pilot projects with sub-elements of decentralized clinical trials.” The agency is encouraging sponsors to seek regulatory scientific advice before filing to run a decentralized clinical trial.
DKMA Notice, More
Bioethics committee calls for regulatory strategies on pandemic vaccine testing
The European Union Committee on Bioethics (DH-BIO) has published a report on ensuring equitable access to vaccines during the COVID-19 crisis and future pandemics.
DH-BIO, part of the Council of Europe, created the document to inform the mitigation of systemic disadvantages in healthcare access suffered by some EU citizens. Through the mitigating measures, the committee aims to help the EU abide by its principle of equitable access to healthcare even during crises.
Specifically, DH-BIO wants the EU to develop “regulatory strategies … to ensure that vaccines are developed and tested in an inclusive manner that reflects the populations in which they will be used.” Other regulatory recommendations relate to the need to monitor for adverse events and carry out independent batch testing of vaccines.
DH-BIO Report, EDQM Notice
Other News:
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on decentralized and mutual recognition procedures that are approved or pending. MHRA has revised the guidance, which it only published at the end of 2020, “to clarify that UK national MA applications can be submitted irrespective of applications for the same product in EU.” MHRA Guidance
The Dutch Medicines Evaluation Board (MEB) has re-enabled its decentralized procedure planning tool after resolving security issues, enabling companies to use it to apply for time slots regarding decentralized applications where the Netherlands is the reference state. MEB took the system offline late last year for security reasons. MEB Notice
