Moderna Says Both Bivalent Omicron-targeting Booster Candidates Trigger Superior Antibody Response

RTTNews | 772 days ago
Moderna Says Both Bivalent Omicron-targeting Booster Candidates Trigger Superior Antibody Response

(RTTNews) - Biotechnology company Moderna, Inc. (MRNA) announced Monday that both of Moderna's bivalent Omicron-targeting booster candidates, mRNA-1273.214 and mRNA-1273.222, trigger a superior antibody response compared to a booster dose of mRNA-1273, the Company's prototype vaccine, against Omicron (BA.4/BA.5) in Phase 2/3 clinical trials.

Both bivalent vaccines also met non-inferiority immunogenicity criteria to the original strain.

In a Phase 2/3 study in over 500 adults, a 50 µg booster dose of mRNA-1273.222 elicited a superior neutralizing antibody response against Omicron BA.4/BA.5 variants when compared to a 50 µg booster dose of mRNA-1273 in 511 previously vaccinated and boosted participants (ages 19-89 years).

Importantly, results were consistent between participants aged 65 years and older and those aged 18 to 65.

In an exploratory analysis of approximately 40 participants using research assays, both bivalent vaccines demonstrated robust neutralizing activity against BQ.1.1, an emerging threat globally, despite an approximately 5-fold drop in titers compared to BA.4/BA.5.

The frequency of adverse reactions with mRNA-1273.222 and mRNA-1273.214 were similar or lower than that of either a second or third dose of the original vaccine.

read more
FDA Approves Updated Pfizer, Moderna Covid Vaccines Against Current Variants

FDA Approves Updated Pfizer, Moderna Covid Vaccines Against Current Variants

The U.S. Food and Drug Administration approved and granted emergency use authorization or EUA for updated Covid vaccines from Pfizer Inc. and ModernaTX Inc. for use against currently circulating variants. The approval for the updated mRNA COVID-19 vaccines (2024-2025 formula) comes as the Covid cases are surging in the United States.
RTTNews | 124 days ago
Moderna Says CHMP Recommends Marketing Authorization For MRESVIA RSV Vaccine In EU

Moderna Says CHMP Recommends Marketing Authorization For MRESVIA RSV Vaccine In EU

Moderna, Inc. (MRNA) announced Friday that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of marketing authorization in the European Union for mRESVIA (mRNA-1345) to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.
RTTNews | 180 days ago
Moderna Stock Up 6% As Q4 Results Top Estimates

Moderna Stock Up 6% As Q4 Results Top Estimates

Biotechnology company Moderna reported a profit for the fourth quarter that plunged from last year, reflecting a sharp drop in COVID-19 vaccines sales. However, both earnings per share and revenues for the quarter topped analysts' expectations. The company also reaffirmed its 2024 product sales outlook.
RTTNews | 307 days ago
CDC Recommends Updated Pfizer, Moderna COVID-19 Vaccine

CDC Recommends Updated Pfizer, Moderna COVID-19 Vaccine

The Centers for Disease Control and Prevention or CDC has recommended everyone 6 months and older to get an updated COVID-19 vaccine ahead of the virus season this fall and winter. The agency expects the updated COVID-19 vaccines from Pfizer-BioNTech and Moderna, which was approved by the U.S. Food and Drug Administration earlier this week, to be available later this week.
RTTNews | 469 days ago
FDA Authorizes Changes To Simplify Use Of Moderna, Pfizer Bivalent COVID-19 Vaccines

FDA Authorizes Changes To Simplify Use Of Moderna, Pfizer Bivalent COVID-19 Vaccines

The U.S. Food and Drug Administration said it has amended the emergency use authorizations or EUAs of COVID-19 bivalent mRNA vaccines of ModernaTX Inc. and Pfizer-BioNTech to simplify the vaccination schedule for most individuals. With the changes, the current bivalent vaccines, for original and omicron BA.4/BA.5 strains, can be used for all doses administered to individuals 6 months of age and...
RTTNews | 616 days ago