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Johnson & 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.

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, Johnson & Johnson’s 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 minus 4 degrees Fahrenheit, and will remain stable for at least three months in most standard refrigerators at temperatures of 36 to 46 degrees.

By contrast, Pfizer’s vaccine needs to be stored in ultra-cold freezers that keep it between minus 112 and minus 76 degrees Fahrenheit. Moderna’s vaccine needs to be shipped at between minus 13 and 5 degrees Fahrenheit

Data from Johnson & Johnson’s phase three clinical trial showed it was 66 percent effective in preventing moderate or severe disease, and experts — including Anthony Fauci

Anthony FauciOvernight Defense: New START extended for five years | Austin orders ‘stand down’ to tackle extremism | Panel recommends Biden delay Afghanistan withdrawal Fauci says he hopes he gets another chance to throw out Nationals first pitch after ’embarrassing’ first try CDC chief urges fans to watch Super Bowl virtually or with household MORE, the nation’s leading infectious diseases doctor — praised it as an important tool in the U.S. arsenal.

Experts pointed out that Johnson & Johnson’s numbers shouldn’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.

However, 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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Source: The Hills

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