Moderna inc, Biotechnology company

Washington, June 2 US-based pharmaceutical and biotechnology company Moderna has sought the US Food and Drug Administration (FDA) for full approval for its mRNA Covid-19 Vaccine for use in people 18 and older.The Moderna Covid-19 Vaccine was approved for emergency use in the US in December. So far, more than 124 million doses of the vaccine have been administered in the country, according to the US Centers for Disease Control and Prevention (CDC)."We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our Covid-19 vaccine," said Stephane Bancel, Chief Executive Officer of Moderna, in a statement on Tuesday."We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission," Bancel added.Early last week, Moderna said that its Covid-19 vaccine was effective in children aged 12 to 17 years old. There were no cases of symptomatic Covid-19 among vaccine recipients, Moderna said, suggesting 100 per cent vaccine efficacy in adolescents, though overall very few among the 3,700 children in the study got sick.Based on the results, Moderna said that it plans in early June to request that regulators in the US and other countries authorise the use of its vaccine in children aged 12 to 17 years old. Last month the FDA cleared Pfizer's request for use of its Covid-19 vaccine in adolescents.Last month, Moderna was also added to the list of World Health Organization (WHO) for emergency use, making it the fifth vaccine to receive emergency validation from the WHO.The WHO's Strategic Advisory Group of Experts on Immunisation (SAGE), found the mNRA-based vaccine to have an efficacy of 94.1 per cent.In addition, the company is also planning a third booster shot. According to data from its Phase 2 study, antibodies produced by a single 50 mg dose of its booster shot was effective against the original form of the virus, as well as against two variants of concern Beta (B1351) and Gamma (P1) first identified in South Africa and Brazil.Disclaimer: This post has been auto-published from an agency feed without any modifications to the text and has not been reviewed by an editor

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Moderna inc, Latest News

New York, July 7 US-based biotechnology company Moderna on Wednesday announced that it has started human trials of ... ...

The Indian drug regulator has urged Pfizer twice in writing to apply for emergency use authorization for its COVID-19 vaccine so that the application is processed well in time but Pfizer has not applied for the license yet, said sources on Tuesday. ...

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Washington, June 30 American biotechnology company Moderna said on Tuesday that its Covid-19 vaccine showed promise in a ... ...

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New York, June 16 Moderna's mRNA Covid vaccine and a protein-based shot is safe for use in young ... ...

Washington, June 11 US-based pharmaceutical and biotechnology company Moderna has sought the US Food and Drug Administration's (FDA) ... ...

Washington, June 2 US-based pharmaceutical and biotechnology company Moderna has sought the US Food and Drug Administration (FDA) ... ...