The European Medicines Agency (EMA) Committee of Inquiry (CHMP) will hold an extraordinary meeting on 21 December on the Pfizer-BioNTech vaccine, but the announcement does not guarantee that the vaccine will be approved on the same day.
“After the receipt of additional data requested by CHMP from the company yesterday afternoon and pending the result of their evaluation, an extraordinary meeting of CHMP is scheduled for December 21. to conclude if possible. The meeting scheduled for December 29 will be held if necessary “, it is stressed.
In a statement, the Agency also responded to criticisms of delayed approval, stating that “the pace of progress depends on a reliable and complete assessment of quality, safety and effectiveness and is determined by the availability of additional information from the company to answer questions during the evaluation “.
According to Coreper, the CHMP “will complete its evaluation as soon as possible and only when the data on the quality, safety and efficacy of the vaccine are strong and complete enough to determine if the benefits of the vaccine outweigh its risks “.
“Once the CHMP has established a marketing authorization, the European Commission will expedite its marketing authorization decision-making process, which is valid in all EU and EEA Member States within days,” the statement said.
The EMA is expected to issue a positive verdict on the first vaccine against COVID-19 on December 23, a German government source told Reuters earlier.
Ate ️ Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorization application: https://t.co/7UbMtZn8eK
– EU Medicines Agency (@EMA_News) December 15, 2020