Coronavirus vaccine development on fast track, clinical trials set for July
Coronavirus vaccine development is running full steam with two candidates fast-tracked for clinical trials in July, offering hope for a world stunted by the spread of the contagious disease.
The first experimental COVID-19 vaccine in the U.S. made by Cambridge-based Moderna is set to begin a huge study next month to prove if it really can fend off the coronavirus safely and effectively.
The vaccine, called mRNA-1273, will be tested on 30,000 volunteers — some given the real shot and some a dummy shot, the company announced Thursday.
“Moderna is committed to advancing the clinical development of mRNA-1273 as safely and quickly as possible to demonstrate our vaccine’s ability to significantly reduce the risk of COVID-19 disease,” said Moderna Chief Medical Offcier Dr. Tal Zaks in a press release.
Moderna said it already has made enough doses for the pivotal late-stage testing. Still needed before those injections begin are results of how the shot has fared in smaller, earlier-stage studies.
The company said it remains on schedule to be able to deliver about 500 million doses of the vaccine per year, and possibly up to 1 billion doses per year, beginning in 2021.
The company said it has finished enrolling 300 younger adults in its second stage of testing, and has begun studying how older adults react to the vaccine. The initial studies check for side effects and immune response.
Also pushed to the front is Johnson & Johnson’s coronavirus vaccine candidate.
The company announced Wednesday it accelerated the initiation of its first-in-human clinical trial. Initially scheduled to begin in September, the trial is now expected to start in the second half of July.
“Based on the strength of the preclinical data we have seen so far and interactions with the regulatory authorities, we have been able to further accelerate the clinical development of our investigational SARS-CoV-2 vaccine,” said Dr. Paul Stoffels, chief scientific officer with Johnson & Johnson.
The study will take place in the U.S. and Belgium and enroll 1,045 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older to test safety, tolerability and immune response.
The company said it is committed to supplying more than 1 billion doses globally through the course of 2021, provided the vaccine is safe and effective.
In March, Johnson & Johnson announced a collaboration with Beth Israel Hospital to accelerate vaccine development and on Friday, Alex Azar, secretary of Health and Human Services will tour the hospital to address patient care, testing kit advances and groundbreaking COVID-19 research.
Herald wire services contributed to this report.
from Boston Herald https://ift.tt/3dWasDo
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