Novavax has announced that its COVID-19 vaccine, NVX-CoV2373, demonstrated 100 percent protection against moderate or severe illness and 90.4 percent efficacy overall in a Phase 3 clinical...
FDA recently updated its letter of authorization for Johnson & Johnson’s COVID-19 vaccine to help facilitate potential export to other countries.
Under the revised letter, FDA...
The Biden Administration recently announced that the US government will procure nearly 1.7 million courses of Merck’s investigational antiviral COVID-19 treatment,...
Pfizer and BioNTech will provide the US government with 500 million doses of their COVID-19 vaccine; the allotment includes 200 million doses in 2021 and 300 million doses in 2022 at a not-for-profit...
Abbott and Walgreens recently launched a pilot program to increase access to rapid COVID-19 testing for Pennsylvania Electronic Benefit Transfer (EBT) cardholders in the city of Philadelphia.
Under...
Moderna and UNICEF recently signed a long-term agreement for the supply of COVID-19 vaccine on behalf of the COVAX Facility, part of the agreement announced in May.
UNICEF and its procurement...
Moderna recently announced that it initiated the rolling submission process for a Biologics License Application (BLA) for its mRNA COVID-19 vaccine.
The company will continue to submit data to support...
Moderna and Aldevron recently expanded their partnership to support Moderna’s mRNA COVID-19 vaccine and clinical development therapeutic pipeline.
Aldevron is a provider of plasmid DNA,...
FDA recently issued an emergency use authorization (EUA) for GSK and Vir Biotechnology’s COVID-19 antibody therapy, sotrovimab.
The therapy is intended to treat mild-to-moderate coronavirus in...
Although COVID-19 treatments azithromycin and hydroxychloroquine were often used in patients early in the pandemic, use decreased significantly by the end of 2020. But for drugs such as remdesivir and...
AstraZeneca’s COVID-19 vaccine, Vaxzevria, was recently granted emergency use in Japan for active immunization of individuals 18 years of age and older.
The Japanese Ministry of Health,...
Moderna recently announced that the Phase 2/3 study of its COVID-19 vaccine in adolescents met its primary immunogenicity endpoint, successfully bridging immune response to the adult...
GSK and Sanofi’s COVID-19 vaccine candidate achieved strong rates of neutralizing antibody responses in a Phase 2 clinical trial, according to a recent press release.
The Phase 2 trial enrolled...
FDA recently released guidance about evaluating COVID-19 drugs and biological products for the treatment or prevention of the coronavirus.
In section A, the agency stated that all sponsors developing...
A multisite test-negative design case-control CDC study recently found that the mRNA COVID-19 vaccines from Pfizer and Moderna are highly effective against symptomatic coronavirus.
The study analyzed...
Moderna recently announced a supply agreement with the government of Australia for 25 million doses of its mRNA COVID-19 vaccine and booster variant candidate.
Ten million doses of...
EMA’s safety committee recently reviewed a number of risk and safety signals related to various COVID-19 vaccines
First, the committee known as PRAC (Pharmacovigilance Risk Assessment Committee)...
Pfizer and BioNTech recently announced the initiation of a Biologics License Application for full FDA approval of their mRNA COVID-19 vaccine
With the application, the companies submitted data t from...
FDA recently expanded the emergency use authorization for the Pfizer COVID-19 vaccine to include adolescents 12 through 15 years of age.
The agency amended the original emergency use authorization...
United States Trade Representative Katherine Tai announced the Biden-Harris Administration’s support for waiving COVID-19 vaccine intellectual property in order to speed up vaccine distribution...
