• Profile
Close

Moderna applies to US FDA for full nod to its COVID vaccine

IANS Jun 04, 2021

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.

For our comprehensive coverage and latest updates on COVID-19 click here.


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 2 June.

"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 the World Health Organisation (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.

Only Doctors with an M3 India account can read this article. Sign up for free or login with your existing account.
4 reasons why Doctors love M3 India
  • Exclusive Write-ups & Webinars by KOLs

  • Nonloggedininfinity icon
    Daily Quiz by specialty
  • Nonloggedinlock icon
    Paid Market Research Surveys
  • Case discussions, News & Journals' summaries
Sign-up / Log In
x
M3 app logo
Choose easy access to M3 India from your mobile!


M3 instruc arrow
Add M3 India to your Home screen
Tap  Chrome menu  and select "Add to Home screen" to pin the M3 India App to your Home screen
Okay