Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application

EMAEMA's human medicines committee (CHMP) and its experts have been working intensively over the past weeks to evaluate data submitted by BioNTech and Pfizer in the context of the conditional marketing authorisation (CMA) application for BNT162b2, a COVID‑19 mRNA vaccine.

The rate of progress is reliant on a robust and complete assessment of the quality, safety and efficacy and is determined by availability of additional information from the company to respond to questions raised during the evaluation.

Following receipt yesterday evening of additional data requested by the CHMP from the company and pending the outcome of its evaluation, an exceptional meeting of the CHMP has now been scheduled for 21 December to conclude if possible. The meeting planned for 29 December will be maintained if needed.

The CHMP will conclude its assessment at the earliest possible timepoint and only once the data on the quality, safety and effectiveness of the vaccine are sufficiently robust and complete to determine whether the vaccine’s benefits outweigh its risks.

Once the CHMP recommends a marketing authorisation, the European Commission will then fast track its decision-making process with a view to granting a marketing authorisation valid in all EU and EEA Member States within days.

EMA, its European experts and the European Commission are working towards the first marketing authorisation of a COVID-19 vaccine, with all the safeguards, controls and obligations that a CMA imposes, including:

  • full prescribing information and package leaflet with detailed instructions for safe use;
  • a robust risk-management and safety monitoring plan;
  • manufacturing controls including batch controls for vaccines and conditions for storage;
  • an investigation plan for use in children;
  • legally binding post-approval obligations (i.e. conditions) and a clear legal framework for evaluation of emerging efficacy and safety data.

A marketing authorisation ensures that COVID-19 vaccines meet the same high EU standards as for all vaccines and medicines. It will be valid in all EU Member States at the same time enabling all Member States to benefit from the joint work done at EU level and allowing them to start rolling out their vaccination campaigns at the same time.

Most Popular Now

Johnson & Johnson announces advance purchase a…

Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ) (the Company), has entered into an agreement with the African Vacci...

Pfizer and BioNTech confirm high efficacy and no s…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced updated topline results from analysis of 927 confirmed symptomatic cases of COVID-19 observed in their pi...

Pfizer-BioNTech announce positive topline results …

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that, in a Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SAR...

GSK to support manufacture of Novavax' COVID-19 va…

GSK has reached an agreement in principle with Novavax and the UK Government Vaccines Taskforce to support manufacturing of up to 60 million doses of Novavax' COVID-19 va...

Valneva reports positive Phase 1/2 data for its in…

Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical n...

Clinical trial completion rates decline during COV…

Social distancing and lockdowns may have reduced the spread of COVID-19, but researchers from Penn State College of Medicine also report those actions may have affected c...

BioNTech provides update on vaccine production sta…

BioNTech SE today announced that the European Medicines Agency (EMA) approved the manufacturing of the COVID-19 vaccine drug product at the facility in Marburg. As part o...

COVID-19 convalescent plasma with greater antibody…

Convalescent plasma, the use of survivors' antibodies transfused into sick COVID-19 patients is safe and significantly improves clinical outcomes when using high levels o...

Pfizer and BioNTech request regulatory agencies ex…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today requested amendments to the U.S. Emergency Use Authorization (EUA) of the Pfizer-BioNTech vaccine (BNT162b2) ...

Study identifies possible COVID-19 drugs - includi…

A team led by scientists in the Perelman School of Medicine at the University of Pennsylvania has identified nine potential new COVID-19 treatments, including three that ...

COVID-19 causes 'unexpected' cellular response in …

New insights into the immune response to SARS-CoV-2 infections could bring better treatments for COVID-19 cases. An international team of researchers unexpectedly foun...

Undetected coronavirus variant was in at least 15 …

A highly contagious SARS-CoV-2 variant was unknowingly spreading for months in the United States by October 2020, according to a new study from researchers with The Unive...