Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in the European Union
Pfizer
Pharmaceutical R&D Developer
BioNTech
Developer of Novel Biologics
Committee for Medicinal Products for Human Use
Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.
SmartCom Finance APP learned that the booster vaccine developed by Pfizer (PFE.US)/BioNTech (BNTX.US) targeting the BA.4 and BA.5 Omicron variants has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The European Commission will review the CHMP recommendation and is expected to make a final decision soon. If authorized, the Pfizer/BioNTech bivalent Omicron variant COVID-19 vaccine targeting BA.4 and BA.5 will be supplied to all 27 EU member states supporting the European vaccination campaign within the next few days. Local supply may vary depending on the requirements of individual national governments.
It is reported that in early September, Pfizer and BioNTech obtained a conditional marketing authorization in the EU for their bivalent COVID-19 vaccine targeting the Omicron variant BA.1. In addition, on August 31, the U.S. Food and Drug Administration (FDA) authorized the use of the COVID-19 vaccine targeting the BA.4/BA.5 Omicron variants as a booster shot for individuals aged 12 years and older.
Finally, the two companies noted that they also plan to submit data to other regulatory authorities in the coming weeks, and intend to submit data to the FDA and EMA, as they prepare to apply for authorization of an Omicron bivalent vaccine suitable for children under 12.