Immunology
FDA issues EUA for Moderna COVID-19 vaccine
Just one day after a favorable committee recommendation, the U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the messenger RNA (mRNA) COVID-19 vaccine from Moderna. The company's mRNA-1273 vaccine now becomes the second COVID-19 vaccine on the U.S. market, after a vaccine from Pfizer and BioNTech was granted an EUA last week. Read More
FDA committee votes favorably for Moderna COVID-19 vaccine EUA
Moderna's messenger RNA (mRNA) COVID-19 vaccine candidate, mRNA-1273, received a favorable recommendation on December 17 from an advisory committee to the U.S. Food and Drug Administration (FDA). The committee's OK means that mRNA-1273 will probably receive an emergency use authorization (EUA) within days. Read More
Moderna's vaccine data support high efficacy, safety prior to FDA meeting
Moderna has published information supporting a 94.1% efficacy rate for its messenger RNA (mRNA) COVID-19 vaccine, mRNA-1273. The company made the data available ahead of a December 17 committee meeting at the U.S. Food and Drug Administration (FDA) to review the vaccine candidate. Read More
FDA issues EUA for Pfizer, BioNTech COVID-19 vaccine
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine. The move comes after the FDA's Vaccines and Related Biological Products Advisory Committee issued a positive recommendation for the vaccine. Read More
FDA committee gives nod to move Pfizer, BioNTech COVID-19 vaccine toward EUA
A COVID-19 vaccine candidate from Pfizer-BioNTech, BNT162b2, passed a major milestone today when a U.S. Food and Drug Administration (FDA) advisory committee determined that the benefits of the candidate in preventing COVID-19 outweigh its risks. The advice of the committee will likely lead to the issuance of an emergency use authorization (EUA) for the vaccine by the FDA within days. Read More
Analysis confirms 70% efficacy rate for Oxford COVID-19 vaccine
An interim analysis of the Oxford COVID-19 vaccine (AZD1222) reports that it has an acceptable safety profile and vaccine efficacy rate of 70%. The results were published by the University of Oxford and AstraZeneca in the Lancet on December 8. Read More
New study finds SARS-CoV-2 antibodies disappear quickly
Antibodies that develop after infection with the SARS-CoV-2 virus disappear quickly, according to an analysis published in Science Immunology on December 7. The findings could indicate that SARS-CoV-2 infection might not offer long-term immunity from subsequent reinfection with the virus. Read More
New universal flu vaccine targets conserved region of viral surface protein
A new universal influenza vaccine has been developed that targets the stalk portion of the influenza virus surface protein rather than the head portion. This vaccine, which is capable of neutralizing diverse strains of influenza, was evaluated in a phase I clinical study whose results were published in Nature Medicine on December 7. Read More
Regulatory Roundup: Designations come through before year's end
This week's Regulatory Roundup covers activities from November 30 to December 4 and is filled with breakthrough, orphan, and rare disease designations from the U.S. Food and Drug Administration and the European Medicines Agency. Several cancer, immunotherapy, and vaccine companies also submitted biologic license applications to move their candidates forward. Read More
New evidence shows SARS-CoV-2 mutations are not more transmissible
In direct contrast to previous research, researchers found that SARS-CoV-2 mutations are not tied to increased transmissibility in humans. The findings, published in Nature Communications on November 25, suggest that mutations such as D614G, while common, are neutral to viral evolution. Read More
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