Johnson & Johnson requests emergency use authoriza
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The Hill logoJohnson & Johnson requests emergency use authorization of its COVID-19 vaccine
Johnson & Johnson on Thursday filed an application for emergency use authorization for its single-shot coronavirus vaccine, bringing it one step closer to helping the U.S. fight against the virus.
a close up of a bottle: Johnson & Johnson requests emergency use authorization of its COVID-19 vaccine© Getty Images Johnson & Johnson requests emergency use authorization of its COVID-19 vaccine
The next step is for the Food and Drug Administration (FDA) to convene a meeting of its vaccine advisory panel to review the evidence, which could happen in as little as two weeks.
In a statement, the company said it "expects to have product available to ship immediately following authorization," but did not specify how much. It still expects to meet its commitment of supplying 100 million doses by the middle of the year.
"Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping. With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible," Paul Stoffels, vice chairman of the executive committee and chief scientific officer, said in a statement.
The Johnson & Johnson vaccine only requires one dose, as opposed to the two-dose vaccines from Pfizer and Moderna, meaning it will be easier to distribute.
It's also much easier to store. The shot is estimated to remain stable for two years at -4 degrees Fahrenheit, and will remain stable for at least three months in most standard refrigerators at temperatures of 36 to 46 degrees..
Gallery: The CDC Just Made This Major Update to Its Vaccine Guidelines (Best Life)
a hand holding a toothbrush: The COVID vaccine has only been available in the country since December, and the U.S. has already administered more than 17 million doses. Even so, the vaccine rollout has not exactly been a smooth endeavor, with some states already running out of vaccines. These issues may force some recommendations from the Centers for Disease Control and Prevention (CDC) to change over time. In fact, the CDC just made a major update to their vaccine guidelines concerning the timeline of the second dose. Read on to find out what this change means for you, and for more on the second shot, Dr. Fauci Says He Had These Side Effects From His Second Vaccine Dose.Read the original article on Best Life.
By comparison, Pfizer's vaccine needs to be stored in ultra cold freezers that keep it between negative 112 and negative 76 degrees Fahrenheit. Moderna's vaccine needs to be shipped at between negative 13 and 5 degrees Fahrenheit
Data from Johnson & Johnson's phase 3 clinical trial showed it was 66 percent effective in preventing moderate or severe disease, and experts including Anthony Fauci, the nation's leading infectious disease doctor, praised it as an important tool in the U.S. arsenal.
Experts pointed out that J&J's numbers can't be used as a direct comparison to Pfizer's and Moderna's vaccines, which were found to be 95 percent and 94 percent effective, respectively.
There is a warning sign from the variant found in South Africa. The efficacy dropped from 72 percent in the United States to 57 percent in South Africa, where a new coronavirus variant is prevalent.
That new variant has been more resistant to vaccines, causing concern among experts. Still, a range of vaccines will likely provide protection against the variant.
Experts say the best way to prevent further mutations and more potentially dangerous variants is for people to get vaccinated as quickly as possible, because more immune people means less chance for the virus to spread and evolve.
With its relatively easy storage requirements and ease of administration, the Johnson & Johnson vaccine could be a real help, if it is authorized and given to enough people fast enough.
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