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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 | 88 gün önce
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 | 144 gün önce
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 | 271 gün önce
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 | 433 gün önce
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 | 580 gün önce
FDA Advisors Propose To Replace Primary COVID Shots With New Bivalent Shots

FDA Advisors Propose To Replace Primary COVID Shots With New Bivalent Shots

The Food and Drug Administration's independent advisory committee unanimously recommended replacing the current original COVID vaccines used in the U.S. for primary shots with new bivalent omicron shots authorized as boosters, reports said. The committee also considered the proposal for annual COVID vaccination, however, didn't vote on it.
RTTNews | 662 gün önce