FDA panel recommends authorizing single-dose COVID-19 vaccine; when will it get here?
On Friday, Johnson & Johnson received the go-ahead for Emergency Use Authorization for their single-dose COVID-19 vaccine for adults 18 and older from an advisory panel to the United States Food and Drug Administration.
With efficacy of 72% in U.S. trials, this will be the third vaccine available, joining the Pfizer and Moderna mRNA shots. In contrast to the required freezer storage for those vaccines, the J & J can be stored at standard refrigerator temperatures of 2 to 8 degrees Celsius.
On Friday, Gov. Gavin Newsom said in a press conference in Fresno that he is expecting more than 380,000 doses of the J & J vaccine next week, and every week for the following three weeks.
Authorization of the J & J vaccine brings good news to Stanislaus County and the Central Valley, because it should increase the number of available vaccines, as there has been a disproportionate shortage in doses arriving to the area.
In addition, the single-dose regimen and simpler handling should make the J & J vaccine easier to distribute to more “user-friendly” locations, such as farm workers at their job sites, community-based small pharmacies and mobile clinics, among others.
Vaccine evaluation
FDA scientists and statisticians presented their independent assessment of the company’s data during a public meeting of the outside panel of experts, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), which recommended authorization.
The FDA doesn’t have to follow the VRBPAC’s recommendations, but usually does. EUA is not the same as full licensure of a vaccine, but permits use of a product during extreme threats to the public, such as the pandemic.
The efficacy trial of the J & J single-dose vaccine was performed with more than 40,000 volunteers, 18 and older, in the U.S, South Africa and Latin America. Participants had diverse demographic characteristics, and 40% had underlying medical conditions and 20% were 65 and older.
In the U.S., efficacy was 72% against moderate to severe COVID-19 at least 28 days after vaccination.
Across all geographic areas, the efficacy was about 66% against moderate to severe disease, and rose to 85% for protection against hospitalizations and deaths.
Efficacy appeared to decrease in individuals with co-morbidity conditions such as diabetes and obesity to about 59%, especially among those older than 60, compared to 69% for those without health problems. However, the number of cases was too small to be conclusive.
Health officials caution against comparing this vaccine’s efficacy to the more than 94% efficacy seen with Pfizer and Moderna mRNA vaccines, as they were evaluated earlier in the pandemic, likely when fewer mutations were circulating.
“Take the shot, when it’s your turn,” Newsom said, “Take any of these shots; It’s going to save your life.”
The J & J vaccine was considered well tolerated. The most common side effects were injection site pain, headache, muscle aches and fatigue, occurring in one-third to one-half of volunteers. Individuals 60 and older had fewer reactions than people 18 to 59. No events of anaphylaxis were reported.
The vaccine is prepared by J & J’s Janssens Pharmaceutical Companies, using their AdVac® platform, which uses a genetically modified adenovirus that can no longer multiply in humans, as the delivery system to present the spike protein of the coronavirus to the immune system triggering an immune response.
The company has an ongoing trial testing if a two-dose regimen increases protection. They also plan to start trials in adolescents in the spring.
J & J executive reported to congress that they can immediately ship 4 million doses of vaccine upon receiving the EUA, and plan to ship 20 million doses by the end of March.
Dr. Julie Vaishampayan, Stanislaus County public health officer, said in an email earlier this month that she has not heard the state’s plan to incorporate the J & J vaccine into the vaccine rollout.
Blue Shield has taken over statewide responsibility for COVID-19 vaccine distributions, but has not been transparent about their plans. In his Friday press conference, Newsom assured that the contractor would increase their transparency.
This story was produced with financial support from The Stanislaus County Office of Education and the Stanislaus Community Foundation, along with the GroundTruth Project’s Report for America initiative. The Modesto Bee maintains full editorial control of this work.
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