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Moderna applies to US FDA for full nod to its Covid vax

Washington, June 2 (IANS) 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.



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