Posted 06 October 2020 | By
A second candidate vaccine against COVID-19 is undergoing rolling review by the European Medicines Agency (EMA), as the agency begins with evaluation of pre-clinical data to support approval of a coronavirus vaccine during the pandemic.
The human medicines committee of the agency, known as CHMP, announced on 6 October that it was initiating a rolling review of the messenger ribonucleic acid (mRNA) vaccine under development by Pfizer in collaboration with the German pharmaceutical company BioNTech.
“The rolling review of these vaccines started with CHMP evaluating the first batches of data. It continues until enough evidence is available to support a formal marketing authorization application,” according to EMA’s web page that lists the vaccine candidates undergoing rolling review.
The announcement follows the 1 October initiation of a similar rolling review for AstraZeneca’s chimpanzee adenovirus vector vaccine candidate, being developed in collaboration with the University of Oxford. (RELATED: EMA kicks off rolling review of AstraZeneca COVID vaccine candidate, Regulatory Focus 01 October 2020)
CHMP’s rolling review process is meant to speed the time to marketing authorization of a vaccine during the public health emergency of the pandemic. “EMA will complete its assessment according to its usual standards for quality, safety and effectiveness,” said EMA in announcing the new rolling review. “While the overall review timeline cannot be forecast yet, the process should be shorter than a regular evaluation due to the time gained during the rolling review.”
The antiviral Veklury (remdesivir) was also assessed – and authorized for COVID-19 treatment – by means of a rolling review by CHMP.
Both vaccine candidates under rolling review by EMA are in Phase 3 clinical trials. According to a press release from Pfizer announcing the rolling review, about 37,000 candidates have been enrolled globally and more than 28,000 have received the second of two vaccines that are required for the Pfizer/BioNTech candidate.
In the US, clinical trials for the AstraZeneca vaccine have been halted since 8 September while the US Food and Drug Administration (FDA) investigates a serious adverse event sustained by a UK vaccine trial participant. However, trials for the AstraZeneca vaccine have re-started in the UK, South Africa, India and Brazil with target enrollment of about 30,000 participants.
EMA
The human medicines committee of the agency, known as CHMP, announced on 6 October that it was initiating a rolling review of the messenger ribonucleic acid (mRNA) vaccine under development by Pfizer in collaboration with the German pharmaceutical company BioNTech.
“The rolling review of these vaccines started with CHMP evaluating the first batches of data. It continues until enough evidence is available to support a formal marketing authorization application,” according to EMA’s web page that lists the vaccine candidates undergoing rolling review.
The announcement follows the 1 October initiation of a similar rolling review for AstraZeneca’s chimpanzee adenovirus vector vaccine candidate, being developed in collaboration with the University of Oxford. (RELATED: EMA kicks off rolling review of AstraZeneca COVID vaccine candidate, Regulatory Focus 01 October 2020)
CHMP’s rolling review process is meant to speed the time to marketing authorization of a vaccine during the public health emergency of the pandemic. “EMA will complete its assessment according to its usual standards for quality, safety and effectiveness,” said EMA in announcing the new rolling review. “While the overall review timeline cannot be forecast yet, the process should be shorter than a regular evaluation due to the time gained during the rolling review.”
The antiviral Veklury (remdesivir) was also assessed – and authorized for COVID-19 treatment – by means of a rolling review by CHMP.
Both vaccine candidates under rolling review by EMA are in Phase 3 clinical trials. According to a press release from Pfizer announcing the rolling review, about 37,000 candidates have been enrolled globally and more than 28,000 have received the second of two vaccines that are required for the Pfizer/BioNTech candidate.
In the US, clinical trials for the AstraZeneca vaccine have been halted since 8 September while the US Food and Drug Administration (FDA) investigates a serious adverse event sustained by a UK vaccine trial participant. However, trials for the AstraZeneca vaccine have re-started in the UK, South Africa, India and Brazil with target enrollment of about 30,000 participants.
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CHMP starts rolling review of Pfizer/BioNTech COVID vaccine - Regulatory Focus
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