mRNA Drugs: Pros, Cons, and Prospects
Pharma Mirror
OCTOBER 16, 2023
The first mRNA drug (BNT162b2 vaccine) was granted emergency use authorization by the FDA in December 2020 and approved for marketing in August 2021.
Pharma Mirror
OCTOBER 16, 2023
The first mRNA drug (BNT162b2 vaccine) was granted emergency use authorization by the FDA in December 2020 and approved for marketing in August 2021.
Pharmaceutical Technology
MAY 29, 2023
Novavax has received positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for full marketing authorisation (MA) of its Covid vaccine, Nuvaxovid (NVX-CoV2373) , in the European Union (EU). The safety and efficacy of Nuvaxovid was evaluated as a primary series.
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Pharmaceutical Technology
APRIL 11, 2023
The approval enables the company to manufacture and market azithromycin to treat infections such as bronchitis, pneumonia and sexually transmitted diseases (STDs). The vaccine, which generates the SARS-CoV-2 viral spike protein on administration, induces the immune system’s cellular and humoral arm-mediated immune response.
BioPharma Reporter
DECEMBER 11, 2020
Sanofi and GSK announced a delay on Friday in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly, saying clinical trials showed an insufficient immune response in older people.
Pharmaceutical Technology
MARCH 31, 2023
Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March. Bimervax is a recombinant protein subunit vaccine, marketed by the Girona, Spain-based Hipra.
Pharmaceutical Technology
JANUARY 19, 2023
Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain. The expanded manufacturing and marketing approval was based on the data obtained from the Phase II trial, conducted in Australia and the US; a separate Phase II trial held in South Africa; and the UK-sponsored COV-BOOST trial.
The Pharma Data
JUNE 29, 2021
A sub-analysis from the Oxford-led COV001 and COV002 trials with Vaxzevria induced strong immune responses following either a prolonged second dose interval of up to 45 weeks or following a third boosting dose. There is an excellent response to a second dose, even after a 10 month delay from the first.”.
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