Newsman: Preliminary review by the Food and Drug Administration found the Moderna’s COVID-19 vaccine is safe and effective. The FDA’s briefing document released Tuesday revealed no safety objections from the agency and deemed the vaccine to have a “favorable safety profile.”
The Food and Drug Administration said its preliminary analysis confirmed the effectiveness and safety of Moderna’s COVID-19 vaccine. A panel of outside experts will offer their recommendation Thursday, with a final FDA decision expected soon thereafter. Moderna developed the vaccine candidate in partnership with the National Institutes of Health and requested emergency use authorization on Nov’30th, 2020.
while many vaccine developments are in progress the United States already has purchased 100 million from Pfizer,200 million from Moderna, 300 million vaccine from AstraZeneca, 100 million from Johnson & Johnson 100 million from Novavax and 100 million from SanofiGSK, according to the Operation war speed. A total of 14 million to 20 million vaccine doses are planned to be distributed by the end of the year, followed by 50 to 80 million doses in January and in February. the first 3 million shots are being strictly rationed and prioritize to front-line health workers and nursing home residents with hundreds of millions more shots needed over the coming months to protect most Americans.
The high efficacy of Moderna’s vaccine was noted at 94.5%, assessed at least 14 days after the second dose that Moderna claimed ahead of the Pfizer-BioNTech covid-19 vaccine study.
“Safety data from a November 11, 2020 interim analysis of approximately 30,350 participants … with a median of 7 weeks of follow-up after the second dose supported a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA,” according to the analysis. “These safety data are the primary basis of FDA’s safety review.” The advisory committee for immunization practices(ACIP) considered four groups to possibly recommend for early COVID-19 vaccination if supply is limited, those are Healthcare personnel,Workers in essential and critical industries People with certain underlying medical conditions and Among adults, the risk for severe illness and death from COVID-19 increases with age, with older adults at highest risk
Healthcare personnel continue to be on the front line of the nation’s fight against this deadly pandemic. By providing care to those who are or might be infected with the virus that causes COVID-19, many healthcare personnel have a high risk of being exposed to and getting sick with COVID-19. Learn more about the importance of vaccination for healthcare personnel.
Workers in essential and critical industries are considered part of America’s critical infrastructure, as defined by the Cybersecurity & Infrastructure Security Agencyexternal icon. Current data show that many of these workers are at increased risk for getting COVID-19. Early vaccine access is critical not only to protect them but also to maintain the essential services they provide U.S. communities.
People with certain underlying medical conditions are at increased risk for severe COVID-19 illness, regardless of their age. Severe illness means that the person with COVID-19 may require hospitalization, intensive care, or a ventilator to help them breathe, or that they may even die. Early vaccine access is critical to ensuring the health and safety of this population that is disproportionately affected by COVID-19.Among adults, the risk for severe illness a
