Johnson & Johnson's JNJ single-shot coronavirus vaccine candidate has been cleared as the third vaccine in the U.S. for emergency use, a day after it received the unanimous backing of an independent Food and Drug Administration expert panel.
What Happened: J&J's vaccine has been issued authorization to prevent COVID-19 caused by SARS-CoV2, allowing it to be distributed in the U.S. for use in individuals 18 years of age and older, the FDA said in a statement.
"The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States," said Acting FDA Commissioner Janet Woodcock.
The authorization allows the use of the vaccine even as more data are being gathered.
J&J said it expects to file a biologic license application later in 2021, that will allow full approval of the vaccine.
"This milestone follows a year of incredible work by our dedicated teams and unprecedented collaboration with health leaders around the world — all of whom shared a goal of bringing a single-shot vaccine to the public," Alex Gorsky, CEO of J&J, said.
Adcom Solidly Behind Vaccine: The FDA's 22-member Vaccines and Related Biological Products Advisory Committee, which met Friday to request for emergency use authorization, voted unanimously to authorize the vaccine candidate, deeming the benefits of the vaccine to outweigh the known risks.
Although committee members expressed concerns over lower efficacy in adults over 60 years old and with comorbidities, it was finally decided that this subgroup was too small a population to draw broader conclusions.
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Backed By Solid Data: The authorization is based on a totality of evidence provided by the company, including efficacy and safety data from the Phase 3 ENSEMBLE trial, which showed that the vaccine was 66% effective in preventing moderate-to-severe cases of the disease.
Know The Vaccine: J&J's vaccine, developed by its Janssen subsidiary, is manufactured using a specific type of virus called adenovirus type 26, or Ad26. The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive spike protein of the SARS-CoV-2 virus.
Ad26, a group of viruses that often causes cold symptoms, is modified so that it cannot replicate in the human body to cause illness. After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.
The overall efficacy, however, pales before the 95% efficacy reported by Moderna Inc MRNA and Pfizer Inc. PFE-BioNTech SE – ADR BNTX for their vaccines.
Moderna and Pfizer-BioNTech received authorizations for their vaccine candidates in December.
But J&J's single-shot option is a selling point, especially as it is being rolled out on a larger scale to combat the virus. J&J's vaccine also confers logistical advantages, as it can remain stable for two years at -20 degrees Celsius, at least three months of which can be at temperatures of 2-8 degrees Celsius. However, vaccines of Moderna and Pfizer require cold-chain logistics to stay effective.
What's Next: J&J said it has begun shipping its COVID-19 vaccines to the U.S. government and expects to deliver enough single-shot vaccines by the end of March to enable the full vaccination of more than 20 million people in the U.S. The company plans to deliver 100 million single-dose vaccines to the U.S. during the first half of 2021, it added.
The U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices will provide a recommendation on the use and roll-out of the vaccine candidate.
J&J also has an application pending before European regulators for obtaining conditional marketing authorization in the region. The World Health Organization is reviewing an emergency-use listing for authorizing the vaccine.
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