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Moderna COVID-19 Vaccine Manufactured in Korea by Samsung Biologics Receives Marketing Authorization from Ministry of Food and Drug Safety of Korea prnasia
December 14, 2021
Moderna (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced today that the Ministry of Food and Drug Safety of Korea (MFDS) has issued a marketing authorization...
Moderna amends Covid-19 vaccine supply deal with Gavi Pharmaceutical-Technology
December 14, 2021
Moderna has amended an existing contract with Gavi, the Vaccine Alliance, to expedite the supply of 20 million doses of its Covid-19 vaccine to COVAX by the end of this year.
Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 16 Years and Older AmericanPharmaceuticalReview
December 13, 2021
Pfizer Inc. and BioNTech SE announced that the FDA has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include individuals 16 years of age and older. The booster dose is to be administered at...
FDA expands eligibility for Pfizer-BioNTech COVID-19 booster dose to 16- and 17-year-olds WorldPharmaNews
December 10, 2021
Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 16 and 17 years of age at least six...
FDA OKs Antibody Cocktail to Help Immune-Compromised Fend Off COVID Drugs
December 10, 2021
The U.S. Food and Drug Administration on Wednesday granted emergency approval of a new antibody cocktail to prevent COVID infection in people who have weakened immune systems or who can't tolerate COVID vaccines.
Press Release Johnson & Johnson COVID-19 Booster, Administered Six Months After Two-Dose Regimen of BNT162b2, Shows Substantial Increase in Antibody and T-cell Responses FirstWordPharma
December 06, 2021
Preliminary Phase 2 study and a sub-study demonstrate value of mix-and-match approach; Johnson & Johnson booster increased neutralizing and binding antibodies, similar to boosting with BNT162b2, and showed strong increase in T-cell responses.
Cadence Education Announces Covid-19 Vaccine Requirements for all Employees prnewswire
September 10, 2021
Cadence Education, LLC ("Cadence Education"), one of the largest providers of early childhood education in North America, is announcing all employees will be required to be vaccinated against the COVID-19 virus ...
FDA Warns Against 'Off-Label' Use of Pfizer COVID-19 Vaccine in Younger Children drugs
August 25, 2021
"Off-label" use of the Pfizer COVID-19 vaccine in children younger than 12 years is "not appropriate," the U.S. Food and Drug Administration warned Monday. The American Academy of Pediatrics (AAP) also "strongly discourages" such use.
United Biomedical seeks appeal after EUA denied firstwordpharma
August 24, 2021
United Biomedical Asia has urged the government to give its COVID-19 vaccine candidate, UB-612, a second chance after its application for emergency use authorization (EUA) was denied last week, Taipei Times reported.
Pfizer-BioNTech shot becomes first COVID-19 vaccine to gain full FDA approval cphi-online
August 24, 2021
Pfizer and BioNTech’s shot on Monday became the first COVID-19 vaccine to be granted full approval by the US Food and Drug Administration.

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