FDA OKs Updated Moderna and Pfizer-BioNTech COVID-19 Vaccines
The FDA has approved and authorized updated Moderna and Pfizer-BioNTech COVID-19 vaccines for the 2024-2025 season, designed to target current variants.
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FDA OKs Updated Moderna and Pfizer-BioNTech COVID-19 Vaccines
The FDA has approved and authorized updated Moderna and Pfizer-BioNTech COVID-19 vaccines for the 2024-2025 season, designed to target current variants.
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FDA Approves Moderna RSV Vaccine
mRESVIA is the first mRNA vaccine approved for a disease other than COVID-19 and is the only RSV vaccine available in single-dose pre-filled syringes.
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FDA Approves mRNA-based RSV Vaccine for Older Adults
The vaccine demonstrated 83.7% efficacy in preventing RSV lower respiratory tract disease in adults aged 60 and older.
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FDA Urges Accurate Dosage of Moderna COVID-19 Vaccine for Children
The FDA has become aware that some providers may not realize the Moderna COVID-19 vaccine vial for ages 6 months to 11 years holds more than the 0.25 mL dose.
Read MoreModerna Flu-COVID Vaccine Begins Phase 3 Study
The first participant has been dosed in a Phase 3 study of Moderna’s Flu-COVID vaccine candidate (mRNA-1083) in the US, according to the company.
Read MorePositive Data for Moderna Flu-COVID Vaccine Combo
Moderna reported positive interim results from the Phase 1/2 trial of its combination vaccine against influenza and COVID-19.
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FDA Approves Updated COVID Vaccines from Pfizer and Moderna
The mRNA vaccines are formulated to more closely target currently circulating variants by including a monovalent component that corresponds to the Omicron variant XBB.1.5.
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FDA Approves Moderna’s Updated COVID-19 Vaccine
The FDA approved Moderna’s updated COVID-19 vaccine (Spikevax) for ages 12 years and above, and issued emergency use authorization for children age 6 months through 11 years old.
Read MoreModerna Makes Regulatory Submissions for RSV Vaccine Candidate
Moderna has submitted marketing authorization applications for its investigational RSV vaccine with the European Medicines Agency, Swissmedic, and the Therapeutic Goods Administration in Australia and initiated a rolling submission of a Biologics License Application to the FDA.
Read MoreModerna Seeks FDA Authorization for Updated COVID-19 Vaccine
Preliminary clinical testing has demonstrated that mRNA-1273.815 is effective in generating an immune response against the current XBB variants of concern.
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Moderna RSV Vaccine 83% Effective, Gets ‘Breakthrough’ Label from FDA
Phase 3 data found the Moderna RSV vaccine was 83.7% effective against RSV-associated lower respiratory tract disease in adults age 60 and older. The FDA has granted the vaccine a Breakthrough Therapy Designation.
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FDA Authorizes Moderna, Pfizer Bivalent Boosters for Children 5 and Older
The FDA has authorized bivalent COVID-19 vaccines from Moderna and Pfizer-BioNTech as a single booster dose in younger age groups, according to the agency.
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Updated Bivalent Vaccines Authorized as COVID Boosters
The FDA authorized updated bivalent COVID vaccines from Moderna and Pfizer-BioNTech for use as single booster doses at least two months following primary or booster vaccination.
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Moderna Submits Omicron-targeting Bivalent Booster Vaccine to FDA
Moderna Inc has completed its submission to the FDA for emergency use authorization for its BA.4/BA.5 Omicron-targeting bivalent booster vaccine, mRNA-1273.222.
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Vaccines: Omicron-specific Covid Booster Shots are Arriving Soon
Updated Covid booster shots targeting omicron’s BA.5 subvariant should be here within in the next three weeks.
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COVID-19 Vaccines Estimated to Have Prevented 20 Million Deaths Worldwide
COVID-19 vaccines reduced the potential global death toll during the pandemic by more than half in the year following their implementation, a mathematical modeling study published in The Lancet Infectious Diseases estimates.
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FDA Authorizes Moderna, Pfizer Vaccines for Children as Young as 6 Months Old
The FDA authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 for in children as young as 6 months old.Â
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FDA Advisory Panel Recommends Moderna, Pfizer Vaccines for Children 6-months and Older
The FDA’s Vaccine and Related Biological Products Advisory Committee voted unanimously in favor of authorizing the Moderna and Pfizer/BioNTech COVID-19 vaccines for children as young as 6-months old.
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Moderna’s Bivalent Booster Candidate Shows Superior Antibody Response to Omicron
A 50 µg dose of Moderna’s bivalent booster candidate, mRNA-1273.214, demonstrated superior neutralizing antibody response against the Omicron variant one month after administration when compared to the original mRNA-1273 vaccine.
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Moderna Developing Bivalent COVID Vaccine Booster
Moderna’s first bivalent COVID vaccine booster candidate, mRNA-1273.211, demonstrated superior neutralizing titers compared to mRNA-1273 against all variants of concern, including Omicron.
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Moderna Requests FDA Authorization of Second Booster for All Adults
Moderna Inc has submitted a request to the US FDA to allow for a second booster (fourth dose) of its COVID-19 vaccine (mRNA-1273) in all US adults.
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FDA Approves Moderna COVID-19 Vaccine
The US FDA has approved the Moderna COVID-19 Vaccine (marketed as “Spikevax”) for the prevention of COVID-19 in individuals 18 years of age and older.Â
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Moderna Booster Interval Authorized for Five Months
The US FDA amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older.
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Omicron: Moderna Booster Increases Antibodies
Moderna’s authorized booster (50 µg) increased Omicron neutralizing antibody levels approximately 37-fold, while a 100 µg booster increased these levels approximately 83-fold.
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