US FDA plans to give authorisation to Moderna for emergency use

Earlier on November 30, 2020,  Moderna had informed that it has submitted the results of COVID-19 vaccine trials to the Food and Drug Administration (FDA) to obtain the emergency use authorization for the vaccine.

Created On: Dec 18, 2020 19:18 ISTModified On: Dec 18, 2020 19:18 IST
Moderna submits vaccine data

The United States Food and Drug Administration's advisors have voted in favour of recommending that the agency must give emergency use authorization to the COVID vaccine of Moderna. The FDA officials have stated that they plan on moving ahead with the authorisation. 

Earlier on November 30, 2020,  Moderna had informed that it has submitted the results of COVID-19 vaccine trials to the Food and Drug Administration (FDA) to obtain the emergency use authorization for the vaccine.

Moderna mentioned the submission of data for the emergency use authorization for mRNA-1273 to the US FDA. It further added that its COVID vaccine efficacy was 94.1 percent and had reached 100% in severe cases. The firm assured that the vaccine is well tolerated and devoid of serious safety concerns.

US FDA plans to give permission to Moderna:

Dr. Stephen Hahn, FDA Commissioner and the Director of FDA's Centre for Biologics Evaluation and Research, Dr. Peter Marks informed through a statement that following the positive outcome of the advisory committee meeting regarding the Corona vaccine of Moderna, the US FDA has informed the sponsor that it will be working rapidly towards the issuance and finalization of an emergency use authorisation. 

The statement further added that the agency has also notified the operation Warp Speed and the Centres for Disease Control and Prevention so that they can timely execute their plans for the vaccine distribution. 

Similarity with Pfizer vaccine:

The Vaccines and Related Biological Products Advisory Committee had voted 20-0 with one absentation for recommending EUA for the Moderna Vaccine, which is also very similar in composition, design, safety, and efficacy to Pfizer vaccine. As per one committee member, it looks like the benefits of the vaccine have outweigh the risks.

Moderna’s request for Emergency Use Authorisation:

Moderna, the US Biotech company in a recent announcement informed that it has submitted the results of trials and plans on requesting an emergency use authorisation from the US FDA. It will also request conditional approval from the European Medicines Agency- EMA, after the final results of the late-stage study have indicated that its COVID vaccine candidate is 94.1% effective.

As per the statement by the company, the primary efficacy analysis of mRNA-1273 phase 3 study which was conducted on 196 cases has confirmed the high-efficacy observed at the first interim analysis.

White House credits President Trump for latest development:

Kayleigh McEnany, the White House Press Secretary credited the latest development on the COVID vaccine to Donald Trump’s ingenuity at work. According to the Press Secretary, President Trump’s Operation Warp Speed has shown an astounding success by delivering multiple COVID vaccines in RECORD Time.

The announcement by MODERNA that it will apply for EUA after its vaccine has shown 94% efficacy is just another example of Donald Trump's ingenuity at work.

Take Weekly Tests on app for exam prep and compete with others. Download Current Affairs and GK app

एग्जाम की तैयारी के लिए ऐप पर वीकली टेस्ट लें और दूसरों के साथ प्रतिस्पर्धा करें। डाउनलोड करें करेंट अफेयर्स ऐप

AndroidIOS
Comment ()
Jagran Play
रोमांचक गेम्स खेलें और जीतें एक लाख रुपए तक कैश
ludo_expresssnakes_laddergolden_goalquiz_master

Post Comment

0 + 6 =
Post

Comments