Presentation to the Vaccines and Related Biological Products Advisory Committee.
DMID 21-0012 - Heterologous Platform Boost Study. Homologous and Heterologous Covid-19 Booster Vaccinations. M., Rajakumar, K., Edupuganti, S., Dobrzynski, D., … Beigel, J.
COVID 19 VACCINES TRIAL
In June of 2021, NIH announced the beginning of the trial to understand the safety and effectiveness of mixed boosted vaccine regimens.Ītmar, R.L., Lyke, K. NIH Clinical Trial Evaluating Mixed COVID-19 Vaccine Schedules Begins On October 20, 2021, the FDA announced expanded authorizations for COVID-19 vaccine booster doses, including the authorization of mix-and-match booster dosing. NIAID conducts and supports clinical research to prevent, treat, and better understand COVID-19.įDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines Mix-and-match trial finds additional dose of COVID-19 vaccine safe, immunogenicĪn NIH-supported study assessed booster doses in adults who were fully vaccinated with any authorized or approved COVID-19 vaccine. This will ultimately help protect people from infection and serious disease. The research helps clinicians and decision makers decide who should get a booster dose of COVID-19 vaccine and which vaccine they should receive. The researchers found no sign of safety problems with any of the booster doses.
The participants kept diaries of any side effects. However, at the beginning of the study, people who had received the Johnson & Johnson vaccine already had higher levels of CD8 T-cells than those who received the other vaccines. The levels of both cells increased after the booster in every group except the one that received the Johnson & Johnson vaccine for the original shot and the booster. Researchers also measured the levels of CD4 and CD8 T cells, two types of immune cells that could help fight COVID-19. A booster of a different vaccine caused similar or higher antibody responses than a booster of the same vaccine.Īntibody production is not the only way the immune system responds to vaccines. People produced antibody responses from all three booster vaccines, no matter which vaccine they had originally received. Additional arms of the trial may test other COVID-19 vaccines. If participants develop COVID-19, investigators will perform genetic sequence analyses on the participant samples to see whether the infection was caused by a variant strain of the virus that causes COVID-19. Participants are providing blood samples periodically so the researchers can observe their immune response. Participants received a single booster dose of either the same vaccine as they had in the first place or a different vaccine. The Johnson & Johnson/Janssen vaccine (Ad26.COV2-S), which is authorized under emergency use for people age 18 and older The Moderna vaccine (mRNA-1273), which is authorized under emergency use for people age 18 and older The Pfizer-BioNTech vaccine (BNT162b2), which is approved for people age 16 and older and is authorized under emergency use for children and teens 5 to 15 years old They have enrolled approximately 450 individuals in the first nine study groups who had already received one of the three COVID-19 vaccine regimens currently available in the United States: The researchers are part of NIAID’s Infectious Diseases Clinical Research Consortium. Food and Drug Administration (FDA) has authorized the use of mix-and-match booster doses for currently available COVID-19 vaccines. The goal of this study is to determine whether receiving a booster dose of a different COVID-19 vaccine is safe and how the immune system responds to that dose.īased on initial data from this study, the U.S. The National Institute of Allergy and Infectious Diseases (NIAID) is leading and funding a study in which adults who have been fully vaccinated against COVID-19 receive booster doses of different COVID-19 vaccines. Mixing vaccines may enhance the immune response, and it increases flexibility for when people need a booster dose but doses of the vaccine they first received are not available. Booster shots are a safe and effective way to extend protection against variants of concern. The immune response to COVID-19 vaccines may wane over time. The FDA has authorized the use of mix-and-match booster doses for currently available COVID-19 vaccines based on the results of a NIAID-supported study.
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