The EMA has issued a consent opinion for the use of Moderna’s bivalent vaccine booster member vi omicron in the EU

The EMA has issued a consent opinion for the use of Moderna’s bivalent vaccine booster member vi omicron in the EU
The EMA has issued a consent opinion for the use of Moderna’s bivalent vaccine booster member vi omicron in the EU

CAMBRIDGE, MA / ACCESSWIRE / 1st of 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company that pioneers information RNA (mRNA) drugs and vaccines, announced on the 1st that the Committee for Human Medicines (CHMP) of the European Medicines Agency (EMA) has issued a favorable opinion for conditional approval of mRNA-1273.214, a bivalent booster vaccine containing the original Spikevax vaccine (mRNA-1273) and the vi subvariant BA.1 vaccine, a noteworthy variant of micron from a series of five-generation bivalent vaccines from Moderna. On the basis of the consensus opinion of the CHMP, the European Commission issued a decision on the conditional approval of mRNA-1273.214 to be used as a booster dose for active infection or disease caused by the SARS-CoV-2 virus in persons aged 12 years and older, inclusive, after completion of at least one primary infection or disease COVID-19.

We are grateful to the CHMP for the favorable opinion that the committee supported the set of clinical data on mRNA-1273.214 and its ability to ensure the protection of Europeans against the disease of COVID-19 and those consequences related to it, stated the general editor of the company Moderna Stephane Bancel. We will avoid the first decision of the European Commission on the conditional approval of the bivalent vi omicron booster vaccine, and it is likely that we will have the opportunity to offer European countries a five-generation booster vaccine in the fight against the disease COVID-19.

The CHMP opinion is based on data from a phase 2/3 clinical trial in which mRNA-1273.214 met all primary objective parameters, including superior production of neutralizing antibodies vi omicron (BA.1) compared to its conditionally approved booster dose of the Spikevax vaccine (mRNA-1273). 50 micrograms in subjects without previous infection. A booster dose of mRNA-1273.214 bivalent vaccine containing the original Spikevax vaccine and the vi subvariant BA.1 omicron vaccine increased the geometric mean titer (GMT) of neutralizing antibody to one-eighth of baseline levels. In addition, a bivalent vaccine containing the original Spikevax vaccine and the vi subvariant BA.1 omicron vaccine (mRNA-1273.214) increased the titers of neutralizing antibodies to the vi subvariants BA.4 and BA.5 omicron compared to the Spikevax vaccine (mRNA-1273), regardless of history of infection and age, including subjects aged 65 and over. mRNA-1273.214 was generally approved and had a reactogenicity and safety profile comparable to its conditionally approved booster vaccine.

Consensus opinion shortly after the conclusion of the agreement between Moderna and the European Commission on the transfer of contracted amounts of the Moderna vi vaccine against COVID-19 (Spikevax, mRNA-1273) to the bivalent vaccine of Moderna vi omicron, which will be approved by the regulatory body within the year 2022. According to the European Commission, it has committed itself to the purchase of another 15 million vials of vi omicron booster vaccines from the Moderna company.

To date, Moderna has received conditional approval of bivalent vi omicron booster vaccines in the United States of America, Australia, Austria and the United Kingdom, and has filed for approval with regulatory bodies worldwide.

The article is in Czech

Tags: EMA issued consent opinion Modernas bivalent vaccine booster member omicron

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