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Johnson & Johnson COVID-19 Vaccine was Submitted for EUA
Johnson & Johnson submitted its single-shot COVID-19 vaccine to U.S. regulators recently for emergency use authorization after the vaccine was shown to be effective against illness and preventing severe disease and death.
Johnson & Johnson submitted its single-shot COVID-19 vaccine to U.S. regulators recently for emergency use authorization after the vaccine was shown to be effective against illness and preventing severe disease and death.
According to a statement by Paul Stoffels, chief scientific officer of Johnson & Johnson, the submission is “a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic.”
If the vaccine is approved by the FDA, it would be the third authorized shot in the U.S. FDA officials announced outside experts would discuss the vaccine at a public meeting February 26.
The company announced its vaccine was 66% effective overall at preventing moderate to severe illness in a global clinical trial in a release last week. It also said J&J's vaccine offered the best protection against severe cases of disease, proving 85% effective.
Stoffels added the company would be ready to ship doses immediately upon authorization but did not specify the number. In a report by the Washington Post, government officials told them doses could be in the single-digit millions.
It's also been reported the J&J vaccine can be stored at refrigerator temperatures for several months.
In the meantime to approval, the FDA said it will propose draft guidelines on how manufacturers of COVID-19 vaccines, therapeutics and diagnostic tests should deal with new variants of the virus.
Janet Woodcock, the FDA’s acting commissioner, pledged to pursue streamlined processes to get updated products to health-care personnel. She said the FDA would not “create obstacles” to authorizing tools that could be useful.
Woodcock said in a statement that the FDA has anticipated the emergence of variants and does not believe there will be “the need to start at square one with any of these products.”
Bridging the Diversity Gap in Rare Disease Clinical Trials with Harsha Rajasimha of IndoUSrare
November 8th 2023Briana Contreras, an editor with Managed Healthcare Executive, spoke with Harsha Rajasimha, MD, founder and executive chairman of IndoUSrare, in this month's episode of Tuning in to the C-Suite podcast. The conversation was about how the disparity in diversity and ethnicity in rare disease clinical trials in the U.S. has led to gaps in understanding diseases and conditions, jeopardizing universal health, and increasing the economic burden of healthcare.
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Managing Editor of Managed Healthcare Executive, Peter Wehrwein, had a discussion with William Shrank, M.D., a venture partner with Andreessen Horowitz, a venture capital firm in Menlo Park, California, about how artificial intelligence's role is improving healthcare, where we are today with value-based care and the ongoing efforts of reducing waste in the healthcare space for this episode of the "What's on Your Mind" podcast series.
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35th World AIDS Day Marks 20 Years of PEPFAR: Challenges and Strategies to Combat HIV/AIDS
November 29th 2023PEPFAR, having invested $100 billion and saved 25 million lives in the global fight against HIV/AIDS, faces Congressional hurdles in its reauthorization due to abortion debates. Despite widespread support and no evidence of abortion-related activities, the legislative process is at a standstill. Members of PEPFAR and authors of a recent editorial stress the significance of PEPFAR and advocate for integrating behavioral and social science into healthcare programs to achieve UNAIDS targets and address barriers in HIV/AIDS testing and treatment.
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