- The first interim analysis of COVID-19 vaccine was based on 95 cases
- The interim analysis did not report any significant safety concerns
- Vaccine can remain stable when refrigerated at between 2°C -8°C for 30 days
Massachusetts: US biotech company Moderna on Monday (November 16) announced a new potential COVID-19 vaccine, which has been shown to be 94.5 per cent effective at protecting people from coronavirus, according to interim results from late-stage clinical trials. This announcement followed announcements by US giant Pfizer and Germany’s BioNTech who said their vaccine, was found to be more than 90 per cent effective. Both shots rely on a technology called messenger RNA, which is designed to transform the body’s own cells to making the vaccine.
Stephane Bancel, Moderna’s chief executive termed it as a “pivotal” moment in the development of the vaccine, on which the company had been working since early this January.
This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease, said Stephane Bancel in a statement.
Moderna also said it expected its vaccine to remain stable when refrigerated at between 2C and 8C for 30 days, significantly longer than the shot developed by BioNTech-Pfizer, which can survive in a normal fridge for only up to five days and must otherwise be stored at minus 75C.
The independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5 per cent, the company said in a statement.
This study, known as the COVE study, enrolled more than 30,000 participants in the U.S. 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 U.S. Department of Health and Human Services.
The company said that the first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5 per cent (p <0.0001), the company said.
These are obviously very exciting results, said Dr. Anthony Fauci, the US’ top infectious disease doctor was quoted as saying by CNN. It’s just as good as it gets — 94.5 per cent is truly outstanding, CNN reported.
The interim analysis did not report any significant safety concerns. A review of solicited adverse events indicated that the vaccine was generally well tolerated. The majority of adverse events were mild or moderate in severity, the company said. It said some participants had severe fatigue, muscle pain, joint pain and headaches after getting the vaccine, though the side effects were generally short-lived.
Meanwhile, Russia’s Sputnik V is 92 per cent effective at protecting people from COVID-19 according to the first interim analysis released last week.
The Sputnik V vaccine efficacy amounted to 92 per cent (calculation based on the 20 confirmed COVID-19 cases split between vaccinated individuals and those who received the placebo), the Russian Direct Investment Fund (RDIF) read a statement.
The US surpassed 11 million coronavirus cases on Sunday (November 15).
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)
NDTV – Dettol Banega Swasth India campaign is an extension of the five-year-old Banega Swachh India initiative helmed by Campaign Ambassador Amitabh Bachchan. It aims to spread awareness about critical health issues facing the country. In wake of the current COVID-19 pandemic, the need for WASH (Water, Sanitation and Hygiene) is reaffirmed as handwashing is one of the ways to prevent Coronavirus infection and other diseases. The campaign highlights the importance of nutrition and healthcare for women and children to prevent maternal and child mortality, fight malnutrition, stunting, wasting, anaemia and disease prevention through vaccines. Importance of programmes like Public Distribution System (PDS), Mid-day Meal Scheme, POSHAN Abhiyan and the role of Aganwadis and ASHA workers are also covered. Only a Swachh or clean India where toilets are used and open defecation free (ODF) status achieved as part of the Swachh Bharat Abhiyan launched by Prime Minister Narendra Modi in 2014, can eradicate diseases like diahorrea and become a Swasth or healthy India. The campaign will continue to cover issues like air pollution, waste management, plastic ban, manual scavenging and sanitation workers and menstrual hygiene.