- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- Fact Check
- Bone Health Fact Check
- Brain Health Fact Check
- Cancer Related Fact Check
- Child Care Fact Check
- Dental and oral health fact check
- Diabetes and metabolic health fact check
- Diet and Nutrition Fact Check
- Eye and ENT Care Fact Check
- Fitness fact check
- Gut health fact check
- Heart health fact check
- Kidney health fact check
- Medical education fact check
- Men's health fact check
- Respiratory fact check
- Skin and hair care fact check
- Vaccine and Immunization fact check
- Women's health fact check
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
Moderna Covid-19 vaccine nears regulatory authorization, clears first USFDA hurdle
New Delhi: Moderna Inc's Covid-19 vaccine appeared to be set for regulatory authorization this week after U.S. Food and Drug Administration staff members did not raise any major new concerns about it in documents released on Tuesday.
The FDA reviewers said a two-dose regimen of Moderna's vaccine was highly effective in preventing confirmed cases of Covid-19 and did not raise any specific safety issues with using the vaccine in adults over the age of 18.
The comments were made in documents prepared for Thursday's meeting of outside experts, who will discuss whether to endorse a U.S. emergency use authorization (EUA) for the Moderna shot.
The FDA typically follows the advice of the panel, but is not required to do so.
Moderna's is the second vaccine the FDA has considered, behind one from Pfizer Inc. and Germany's BioNTech, which was authorized last week.
Hospitals began giving the Pfizer shots on Monday and the United States is counting on the Moderna vaccine to fulfill its promise to inoculate 20 million people this month.
ONE DOSE PROTECTION
The FDA said that there appeared to be some protection for trial participants after the first dose of Moderna's vaccine, which is given in two shots, with 28 days between inoculations, but there was not enough information on longer term protection.
It said that vaccine efficacy was 80.2% in participants who only received one dose at the time of the interim analysis, which was based on data collected as of Nov. 7.
They said that serious side effects in the trial of the vaccine represented medical events that occur in the general population at a similar frequency as observed in the study.
The FDA did flag the possibility that the vaccine was contributing to Bell's palsy, a type of facial paralysis also reported by participants in the Pfizer trial.
Moderna reported four cases of Bell's palsy, including three among people who had the vaccine and 1 in the placebo group. The company said that three of the cases had resolved itself.
Although the FDA said that the trial participants with Bell's palsy had predisposing factors, the "potential contribution of the vaccine to the manifestations of these events of facial palsy cannot be ruled out".
Pfizer reported six cases of Bell's palsy, including 4 in the vaccine arm, which it said was a rate typical of the general population.
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
Next Story