Johnson & Johnson COVID-19 Vaccine Applies for Emergency Use Authorization
Johnson & Johnson filed an application for emergency use authorization on Thursday for its single-shot COVID-19 vaccine, which brings it one step closer to helping the U.S. fight against the COVID-19 pandemic.
After the company's filing, the Food and Drug Administration would meet with its vaccine advisory panel to review the evidence, which could begin in as little as two weeks, according to The Hill report.
The company said it expects to have the product available to ship immediately after the authorization. However, it did not specify how many doses would be shipped after its vaccine passes for EUA. Johnson & Johnson seeks to meet its commitment of supplying 100 million doses by the middle of the year.
Paul Stoffels, Johnson & Johnson's vice chairman of the executive committee and chief scientific officer, said in the company's statement that upon authorization of their investigational COVID-19 vaccine for emergency use, they are ready to start 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," Stoffels was quoted on the company's statement.
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Johnson & Johnson Vaccine
Unlike the COVID-19 vaccine candidates of Pfizer and Moderna, the Johnson & Johnson vaccine only requires one dose, which could pose an easier distribution of the doses.
In addition, Pfizer's vaccine needs to be stored in ultra-cold freezers that keep it between minus 112 and minus 76 degrees Fahrenheit. For Moderna's vaccine, it needs to be stored between minus 13 and 15-degrees Fahrenheit.
Based on Johnson & Johnson's phase three trial, it showed that it was 66 percent effective in preventing moderate or severe disease. Experts, including the nation's top infectious disease expert, Dr. Anthony Fauci, promotes the vaccine as an important tool in the U.S. arsenal.
The company's vaccine has shown to be 66 percent effective overall in preventing moderate to severe COVID-19, four weeks after the shot is vaccinated. Johnson & Johnson added that the vaccine was 72 percent effective in the United States, compared to 66 percent in Latin America, and 57 percent in South Africa, according to an NPR report.
The company also noted that the vaccine is 85 percent effective in preventing severe forms of COVID-19 and the efficacy of the treatment is increased over time.
The FDA is seen to hold the first meeting of outside advisers on the application on Feb. 26. Once the advisers approve of the vaccine, a decision to authorize its use could be seen soon afterward.
New Strain of COVID-19
Meanwhile, Fauci acknowledged that vaccines seem to be less effective against a rapidly spreading COVID-19 variant first discovered in South Africa. However, the health expert claimed that it still offers strong protection against a variant identified in the United Kingdom.
Fauci said that the vaccines reduce the rates of serious disease, hospitalization, and death.
"Even when you have a variant circulating in which you may not have a 95% efficacy to prevent infection, it is very important that you might very very positively prevent serious illness and serious disease," Fauci was quoted on a Forbes report.
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