FDA authorizes Johnson & Johnson vaccine
The US Food and Drug Administration authorized Johnson & Johnson's Covid-19 vaccine Saturday. It is the first single dose Covid-19 vaccine available in the US, and is one that "checks nearly all the boxes."
With more than 28.5 million confirmed Covid-19 cases and over 511,000 reported deaths in the US since the start of the pandemic, and while the demand for vaccine still far exceeds supply, these vaccines can't come soon enough.
"A third safe and effective vaccine is very welcome news," Andy Slavitt, the White House's senior for Covid Response, tweeted on Friday.
The vaccine, made by Janssen, J&J's vaccine arm, is safe and effective, and it's considered flexible. It's a single dose, and it doesn't require special storage.
The vaccine is authorized for people ages 18 and older.
"We need a vaccine that can be quickly mass produced," Dr. Greg Poland, head of the Mayo Clinic's Vaccine Research Group, said Friday. "We'd want to see a reasonable duration of efficacy and protection.
"The Janssen vaccine candidate checks nearly all the boxes."
The vaccine was tested in more than 44,000 people in the US, South Africa and Latin America. Globally, it was 66.1% effective against moderate to severe/critical Covid-19 at least four weeks after vaccination, according to an FDA analysis. In the US, it is considered 72% effective, and offered 86% protection against severe forms of the disease.
"One dose will keep you out of the hospital, keep you out of the intensive care unit, and keep you out of the morgue," Dr. Paul Offit, a vaccine adviser to the FDA, told CNN's Wolf Blitzer on Friday.
The vaccine comes with few side effects, most of which are mild, including pain at the injection site, headache, fatigue and muscle pain.
Overall, non-fatal serious adverse events were infrequent, according to the FDA's analysis, and there were no reported cases of anaphylaxis following vaccination in the trial. There have been a small number of severe allergic reactions with the Moderna and Pfizer/BioNTech vaccines. For example, in the first week of the Pfizer vaccine rollout, there were only 29 cases out of 1.9 million doses administered, according to the US Centers for Disease Control and Prevention.
"If I had a J&J vaccine available today and a Moderna vaccine available tomorrow, I would be happy to take the J&J today. I don't feel like I would need to wait. They are all terrific vaccines for the things that we care about," Dr. Ashish Jha, dean of the Brown University School of Public Health, told a House Ways and Means Health Subcommittee hearing Friday.
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I really would like to believe you that all of the people who attend CPAC 2021 over three days have rec'd their first and second shots of either the Pfizer or the Moderna vaccine more than a month ago.
The event can expect lots of loud talking and exhaling amongst people who do not want to wear mask when social distancing is not possible.
Why would these people want to put their health and that of their loved ones over something so simple to do?
... it is an image without any context. Who placed this electronic display? Could it be an image of Rosa Parks?
... this is a temporary digital image on an a mobile electronic display. It is not a statue nor a monument.
... if this is an image of the Vice President of the United States of America, Kamala Harris, she has assumed a historic first ever woman of colour position in the history of the nation. The will be many schools, bridges and monuments named after her for 100s of year into the future.
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