FDA Grants EUA for J&J's 1-Dose COVID-19 Vaccine

As expected, the FDA Saturday signed off on an emergency use authorization (EUA) for the country’s third US COVID-19 vaccine, a 1-shot vaccine produced by Janssen, a subsidiary of Johnson & Johnson (J&J).

On Friday, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), a panel of outside infectious disease experts, other doctors, and medical researchers, voted unanimously that the benefits of the vaccine outweigh its risks in people age 18 and over.

Under an EUA, the benefits of the vaccine are considered to outweigh any risks and it is still considered unapproved while it is further analyzed under an Investigational New Drug Application until it is licensed under a Biologics License Application.

On Sunday, the CDC’s Advisory Committee on Immunization Practices (ACIP) will meet to discuss and vote on recommendations about how to put the latest vaccine into clinical practice.

The last EUA was granted on December 18, 2020, for the Moderna vaccine, a week after the agency cleared the Pfizer/BioNTech vaccine. Both the Pfizer and Moderna vaccine use messenger RNA technology and are given in 2 doses, 21 days apart and 28 days apart, respectively.

The J&J vaccine, Ad26.COV2.S, is a replication-incompetent adenovirus type 26 (Ad26) vectored vaccine encoding a stabilized variant of the SARS-CoV-2 S protein, meaning it helps prime the immune system to fight coronavirus. The vaccine platform has also been used for the company’s Ebola vaccine and construct its Zika, RSV, and HIV investigational vaccine candidates.

Each vial, which can be stored at normal refrigerator temperatures, has 5 doses per vial.

J&J plans to begin trials of the vaccine in pregnant women as well as adolescents, and a trial looking at a 2-shot version is also underway.

Shortly after the FDA announcement, President Joe Biden called it an "exciting development" but urged Americans not to pretend the fight is over.

"We know that the more people get vaccinated, the faster we will overcome the virus, get back to our friends and loved ones, and get our economy back on track," he said in a statement. Echoing caution that was issued by his top health officials Friday, he said, "As I have said many times, things are still likely to get worse again as new variants spread, and the current improvement could reverse."

J&J reiterated Saturday that it plans to ship enough doses to vaccinate 20 million individuals by the end of March, and 100 million doses by the first half of the year.