ANI
01 Dec 2020, 02:56 GMT+10
Washington [US], November 30 (ANI): US biotech company Moderna on Monday announced that it plans to request an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA) after the final results from a late-stage study indicated its Covid-19 vaccine candidate is 94.1 per cent effective.
Moderna also said that its vaccine candidate had 100 per cent efficacy against severe disease. There were zero such COVID-19 cases among those vaccinated, but 30 in the placebo group.
According to an official statement by the company, the primary efficacy analysis of the "Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis. The data analysis indicates a vaccine efficacy of 94.1 per cent. Safety data continue to accrue and the study continues to be monitored by an independent, NIH-appointed Data Safety Monitoring Board (DSMB)."Moderna plans to request an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA).
The Phase 3 study, known as the COVE study, enrolled more than 30,000 participants in the US and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.
"This positive primary analysis confirms the ability of our vaccine to prevent Covid-19 disease with 94.1 per cent efficacy and importantly, the ability to prevent severe Covid-19 disease. We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations and death," said Stephane Bancel, Chief Executive Officer of Moderna.
The company also said that it has already initiated the rolling review process with the EMA, Health Canada, SwissMedic, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), Ministry of Health in Israel, and Health Sciences Authority in Singapore and intends to seek Prequalification (PQ) and/or Emergency Use Listing (EUL) with the World Health Organization (WHO).
"Moderna announced that the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the safety and efficacy data package for mRNA-1273 will likely be scheduled for Thursday, December 17," read the statement.
According to the latest data by Johns Hopkins University, as many as 13,389,786 people have been tested COVID-19 positive and 266,932 deaths been reported in the US till now. (ANI)
Get a daily dose of Nepal National news through our daily email, its complimentary and keeps you fully up to date with world and business news as well.
Publish news of your business, community or sports group, personnel appointments, major event and more by submitting a news release to Nepal National.
More InformationALBUQUERQUE, New Mexico - Nearly 60 percent of residents rate Albuquerque's quality of life as excellent or good, according to ...
NEW YORK, New York - U.S. industrial stocks closed lower on Friday as fears of prolonged lockdowns due to the ...
PARIS, France - The International Energy Agency (IEA) reduced its 2021 global oil forecast this week as fresh coronavirus lockdowns ...
SYDNEY, NSW, Australia - Stocks in Asia were sold off on Friday.All the major indices lost ground, while the rout ...
LIMERICK, Ireland - A boost for Ireland's expanding tech sector are plans by a giant telco supplier to recruit scores ...
NEW YORK, New York - Wall Street took a breather on Thursday, a day after the major indices hit record ...
KUALA LUMPUR, Malaysia: The family of a French-Irish teenage girl will challenge an inquest ruling that their daughter died by ...
ISLAMABAD, Pakistan - The federal government has appointed former Supreme Court judge Azmat Saeed as head of the inquiry committee ...
ISLAMABAD, Pakistan: Foreign Minister Shah Mahmood Qureshi on Wednesday said Pakistan was optimistic about enhancing ties with the US administration ...
Galle [Sri Lanka], January 23 (ANI): England pacer James Anderson on Saturday said that it was a good effort from ...
Pansar (Jammu and Kashmir) [India], January 23 (ANI): After another tunnel was detected in the Pansar area of Jammu and ...
Islamabad [Pakistan], January 23 (ANI): Amid the controversy surrounding the Broadsheet saga, a Pakistani journalist has warned people in Islamabad ...