danlb_2000
Premium Member
"The Food and Drug Administration released a detailed analysis Tuesday morning of the COVID-19 vaccine from drugmaker Moderna that supports the authorization of the company's vaccine for emergency use.
The FDA's briefing document along with one from Moderna were posted two days before a group of experts will convene to advise the agency on whether to grant the vaccine emergency authorization for use, or EUA, during the pandemic.
The agency's analysis finds the vaccine has a "favorable safety profile" and that there are "no specific safety concerns identified that would preclude issuance of an EUA." Serious reactions were rare. Side effects are common, however, with a majority of study volunteers experiencing pain at the site of injection, fatigue and headaches.
The analysis also affirms the effectiveness of the vaccine. It is 95% overall, assessed at least two weeks after the second dose of vaccine. The vaccine shots are given 28 days apart.
The vaccine is less effective in older people, the FDA analysis finds. For people ages 18 to less than 65, the effectiveness is 96%, compared with 86% for people 65 and older."
FDA Analysis Of Moderna COVID-19 Vaccine Finds It Effective And Safe
Two days before a panel of experts is set to review Moderna's COVID-19 vaccine and advise the Food and Drug Administration, documents show the vaccine is 94% effective and well-tolerated.www.npr.org
Here is a link to the briefing document -
Do we know if Pfizer's has lower effectivity for older people?