What a new single-dose COVID-19 vaccine could mean for Stanislaus County
On Thursday, Johnson & Johnson filed a request for Emergency Use Authorization from the United States Food and Drug Administration for theCOVID-19 vaccine developed at its Janssen Pharmaceutical Companies.
If approved, this would become the third vaccine, but the only single-dose product, available in the U.S. to combat the coronavirus.
The J&J vaccine demonstrated 72% efficacy in the U.S. and 66% overall efficacy against moderate to severe disease, and complete protection against COVID-19 hospitalizations and deaths 28 days after vaccination, according to a company report.
The safety and efficacy of the J&J vaccine were studied globally in more than 43,700 people 18 and older with diverse demographics in eight countries, including the U.S., South Africa, and in Latin America. Virus mutations were emerging during the trial and in South Africa, the efficacy fell to 57%.
Health officials caution against comparing this vaccine’s efficacy to the greater than 94% efficacy seen with Pfizer and Moderna mRNA vaccines, as they were evaluated earlier in the pandemic, likely when fewer mutations were circulating.
Limited safety data have been made public; fever was reported by 9% of vaccinated subjects and no episodes of anaphylaxis were seen.
J&J is conducting studies to assess if a second dose of the vaccine will enhance protection.
Both the Moderna and Pfizer vaccines require two doses. Unlike the Pfizer mRNA vaccine, which requires storage in ultra-cold freezers, the J&J vaccine can be stored at refrigerator temperatures and can be shipped following standard cold chain protocols for routine vaccinations.
In addition to adding more available doses, the single-dose regimen and simpler handling could make this product easier to distribute to a wider variety of locations, such as rural communities, job sites, smaller pharmacies and mobile clinics, to name a few.
Dr. Anthony Fauci, the nation’s top infectious diseases expert, said in an interview with NBC News, “You can just keep it in a refrigerator. It’s relatively cheap and the company can make billions of doses.” He said having another vaccine adds to the ability to fight the pandemic.
Dr. Julie Vaishampayan, Stanislaus County public health officer, shares Fauci’s view that this vaccine brings another useful tool for fighting the pandemic. However, she said having a different dosing regimen adds a “layer of complexity” for handling and administering the vaccine.
Vaishampayan has not yet heard the state’s plans for incorporating new vaccines, such as the J&J shot, into the vaccine rollout, especially with the change to Blue Shield taking over statewide vaccine distributions, announced by Gov. Gavin Newsom on Jan. 27.
J&J vaccine composition
The vaccine is prepared using Janssen’s AdVac vaccine platform, which uses a genetically modified adenovirus that can no longer cause infection and altered to express the genes for the coronavirus spike protein. The adenovirus serves as a carrier to present the spike protein to the immune system, triggering production of antibodies.
Adenoviruses are common causes of respiratory and gastrointestinal infections in humans. The AdVac platform was used for Janssen’s Ebola vaccine that’s approved by the European Commission, as well as other viral vaccines in development, and has been used in more than 200,000 people.
The federal government provided $1 billion to develop and distribute millions of doses of the J&J COVID-19 vaccine, under Operation Warp Speed and an existing partnership with Janssen.
With the request for EUA, FDA scientists and statisticians will perform an independent assessment of the company’s data and the vaccine will be discussed at a public meeting by an outside panel of experts, the Vaccines and Related Biological Products Advisory Committee. Two-week public notice of VRBPAC meetings is required, and the date has not yet been announced, suggesting availability of this vaccine is at least three weeks away.
FDA authorization is expected, and J&J states that it will be able to ship vaccine immediately upon approval.
Two other companies, Novavax and AstraZeneca-Oxford, are expected to submit data to support EUA for their vaccine candidates in a few months.
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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This story was originally published February 5, 2021 at 11:38 AM.
