People need both doses of coronavirus vaccines - FDA

▴ People need both doses of coronavirus vaccines - FDA
Pfizer or Moderna 2 doses are needed for effectiveness

Anyone who receives the Moderna or Pfizer vaccine must get two full doses, two top US Food and Drug Administration officials said Monday.

They also dismissed other ideas for stretching the vaccine supply and said people who are speculating about the possibility of making do with just one dose or cutting doses in half are misinterpreting the data.

"We have been following the discussions and news reports about reducing the number of doses, extending the length of time between doses, changing the dose (half-dose), or mixing and matching vaccines in order to immunize more people against COVID-19," FDA Commissioner Dr Stephen Hahn and Dr Peter Marks, who heads FDA's vaccine division, said in a statement.

"These are all reasonable questions to consider and evaluate in clinical trials. However, at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence. Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19," they added.
Operation Warp Speed's top adviser, Moncef Slaoui, told CNN Sunday that the FDA would consider giving half-doses of Moderna's Covid-19 vaccine to people 18 to 55 -- which could make the vaccine available to twice as many people in this age group.
Slaoui said earlier data show that the vaccine appeared to elicit effective antibody responses among volunteers under age 55 who received either the full 100-microgram dose or a half dose. While an FDA briefing document last month also references these "comparable" immune responses from Moderna's phase 2 study, the full data have not yet been published.
But Marks and Hahn said these findings covered only a very few people who were not followed for long to see if their immune responses held up over time.
"What we have seen is that the data in the firms' submissions regarding the first dose is commonly being misinterpreted. In the phase 3 trials, 98% of participants in the Pfizer-BioNTech trial and 92% of participants in the Moderna trial received two doses of the vaccine at either a three- or four-week interval, respectively," they wrote.

https://edition.cnn.com/2021/01/04/health/fda-coronavirus-vaccines-doses/index.html 

Tags : #

About the Author


Team Medicircle

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

The Ethics of Live Surgery Broadcasts: NMC Seeks Public OpinionMay 17, 2024
Successful Removal of 3.7 KG Large Abdominal Tumor from 14-Year-Old Somalian Girl at KIMS Cuddles HospitalMay 16, 2024
iLEAD Sets a Precedent by Launching a Graphic Anthology Authored by Multimedia, Animation and Graphics Students May 16, 2024
Ramaiah Memorial Hospital Launches Novel Intra-Operative Radiation Therapy (IORT); Achieves significant advancement in Cancer Treatment to Enhance Quality of LifeMay 16, 2024
IIITH Announces Product Management Summer SchoolMay 16, 2024
Çelebi India's Delhi Cargo Terminal Successfully Handles Airbus H125 Helicopter ShipmentMay 16, 2024
Plant-Based Diets and Prostate Cancer: New UCSF Study Shows Promising ResultsMay 16, 2024
National Medical Commission Approves 112 New Medical CollegesMay 16, 2024
Study Suggests That Chemotherapy Results in Physical Decline for Older Women with Breast CancerMay 16, 2024
Google DeepMind's AlphaFold 3: Revolutionizing Drug Discovery with AIMay 16, 2024
Hester Biosciences Ltd reports Consolidated Revenue growth of 18% at Rs. 79.3 crore, EBITDA up 37% to Rs. 16.4 crore and Net Profit up 12% to Rs. 6.40 crore in Q4FY24May 16, 2024
Akshay Tritiya Parna Mahotsav heldMay 16, 2024
IT Minister Sridhar Babu to grace the 10th National Facilities Managers Summit-2024, to be held in the cityMay 15, 2024
Alarming Study Reveals Cancer-Causing Chemicals in Car InteriorsMay 15, 2024
India's Thalassemia Challenge: The Importance of Early Screening and TreatmentMay 15, 2024
The Dangers of Ultra-Processed Foods: A 30-Year Study Raises AlarmsMay 15, 2024
Unique Genetic Risk Factors for Breast Cancer Found in African Ancestry StudyMay 15, 2024
AsiaMedic partners with Sunway to establish new diagnostic imaging centreMay 14, 2024
Kamineni Doctors Successfully Remove Bone Stuck Near Heart in Elderly PatientMay 14, 2024
On International Nurses Day, American Oncology Institute (AOI) launches #TheExtraordinaryCareGiver Campaign as Tribute to Oncology NursesMay 14, 2024