On Saturday, February 27, 2021, the U.S. Food & Drug Administration (FDA) announced they have granted emergency use authorization (EUA) for a third COVID-19 vaccine candidate, this one from Janssen, a Johnson & Johnson company. Non-grandfathered health plans will have to cover the vaccine in- or out-of-network without cost sharing within 15 days for individuals 18 years of age or older.
This vaccine is significant in that it only requires a single dose rather than two doses, and can be stored under normal refrigeration for several months, not requiring super cold transfer and storage capabilities. It demonstrated up to 85% effectiveness in preventing moderate to severe COVID-19 symptoms, so not quite as high as the 95%+ effectiveness of the two mRNA vaccines previously granted EUAs but still meeting a very high standard. The FDA includes the same exact disclaimer they had provided with the other two vaccine EUAs: “At this time, data are not available to determine how long the vaccine will provide protection, nor is there evidence the vaccine prevents transmission of SARS-CoV-2 from person to person.”
“The Janssen COVID-19 Vaccine is manufactured using a specific type of virus called adenovirus type 26 (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. While adenoviruses are a group of viruses that are relatively common, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine 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.”
There are negotiations underway to have Merck help Janssen manufacture this vaccine in order to provide a more robust supply. President Biden has indicated that if this partnership can happen, then there should be enough vaccines for every adult in America to have a shot by the end of May.
IMA will continue to monitor regulator guidance and offer meaningful, practical, timely information.
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