US-based Johnson & Johnson’s (J&J) single-shot coronavirus vaccine has been unanimously backed by a key Food and Drug Administration (FDA) advisory panel for emergency use.
The backing marks a critical step which paves the way to distribute a third preventative treatment from the US after Pfizer and Moderna vaccines.
The FDA advisory committee plays a key role in approving flu and other vaccines in the US, verifying the shots are safe for public use. While the FDA doesn’t have to follow the advisory committee’s recommendation, it often does. During similar requests by other American drugmakers Pfizer and Moderna, the FDA authorized those companies’ vaccinations a day after the committee backed emergency use authorization.
Single shot advantage
Federal and state health officials in the US have been eagerly awaiting the authorization of J&J’s vaccine. Unlike Pfizer’s and Moderna’s vaccines, which require two doses given three to four weeks apart, J&J’s requires only one dose, easing logistics for health-care providers. J&J’s vaccine can also be stored at refrigerator temperatures for months, unlike the two other vaccines that have to be stored at sub-zero temperatures.
An Emergency Use Approval (EUA) means the FDA will allow some people to receive the vaccine as the agency continues to evaluate data. It isn’t the same as full approval, which requires more data and can typically take several months longer. J&J, like Pfizer and Moderna, has submitted only two months of safety data, but the agency usually requires six months for full approval.
J&J submitted its COVID-19 vaccine data to the FDA on February 4. The vaccine’s level of protection varied by region, J&J said, with the shot demonstrating 66 percent effectiveness overall, 72 percent in the United States, 66 percent in Latin America and 57 percent in South Africa, where the new variant is rapidly spreading. The company also claimed that the vaccine prevented 100 percent of hospitalizations and deaths.
The FDA has indicated it would authorize a COVID-19 vaccine that’s safe and at least 50 percent effective. The committee has endorsed J&J’s vaccine and said in the documents that the clinical trial results and safety data were “consistent with the recommendations set forth in FDA’s Guidance on Emergency Use Authorization for Vaccines to Prevent COVID-19.”