FDA, J&J Vaccine Imminent Approval “Safe And Effective”
The US Food and Drug Administration (FDA) acknowledged the preventive effect and safety of the Johnson & Johnson (J&J) Covid- 19 vaccine on the 24th
Johnson & Johnson requested the FDA to approve the emergency use of the vaccine on the 4th. The FDA advisory committee recommends urgent use of this vaccine, and if FDA accepts it, only the approval of the Centers for Disease Control and Prevention (CDC) remains.
Vaccination Advisory Committee, a CDC advisory body, also held emergency meetings on the 28th of this month and the 1st of the following month.
The Vaccine and Biological Drugs Advisory Committee (VRBPAC), an FDA advisory body, decides at a meeting whether to recommend approval for emergency use in J&J vaccines.
If the advisory committee accepts the recommendation, the Johnson & Johnson vaccine will be approved for emergency use in the United States for the third time after Pfizer-Bioentech and Modena.
The FDA analyzed that Johnson & Johnson’s phase 3 clinical trials conducted on 44,000 people in the United States and South Africa showed 72% preventive effects in the United States and 64% in South Africa.
The prevention effect in South Africa, where the mutant virus is spreading, is 7 percentage points higher than the 57% announced by Johnson & Johnson at the end of last month.
This is above the FDA’s lowest standard of 50%. However, it is lower than Pfizer (95%) and Modena (94.1%).
The preventive effect against severe Corona 19 was 86% in the United States and 82% in South Africa. This means that if you get the Johnson & Johnson vaccine, your chances of being hospitalized or killed by Corona 19 are significantly lower.
In addition, the Johnson & Johnson vaccine had significantly milder side effects than Pfizer and Modena, and no serious allergic reactions such as anaphylaxis were reported, the FDA said.
It is expected that the FDA will approve the emergency use of the Johnson & Johnson vaccine on the 27th, with positive analysis results.
The J&J vaccine has the advantage of being able to store at least 3 months at a general refrigeration temperature, which is sufficient as a single vaccination, unlike other vaccines that have sufficient preventive effect when inoculated twice.
If approval for emergency use is granted, J&J said it could supply 4 million doses in the US first. It plans to supply 20 million doses by the end of next month and 100 million doses by the end of June.
FDA, J&J Vaccine Imminent Approval "Safe And Effective" - /10