There is a third COVID-19 vaccine in the mix now that the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices gave the go-ahead on Sunday, Feb. 28 for Johnson & Johnson’s one-dose COVID vaccine to be approved for Emergency Use Authorization. A U.S. Food and Drug Administration Advisory Committee gave their approval on Saturday, Feb. 27.
Johnson & Johnson began shipping its vaccine immediately, expecting to deliver more than 20 million doses to the U.S. in March, and 100 million doses in the first half of 2021.
This will help meet the high demand for COVID vaccine in the U. S. – with the added benefits of requiring only a single dose, and not needing the cold/ultra-cold storage temperatures of Moderna and Pfizer/BioNTech vaccines – both which require individuals to get two doses, a few weeks apart. The J&J vaccine produced by its Janssen division requires regular refrigeration.
Globally, it tested 66.1% effective against moderate to severe/critical COVID-19 at least four weeks after vaccination, according to an FDA analysis. In the US, it is considered 72% effective, and offers 86% protection against severe forms of the disease.
CDC Director Dr. Rochelle P. Walensky, who signed the recommendation to use J&J’s Janssen’s COVID-19 vaccines for persons age 18 and older, said the vaccine is another important tool in their toolbox to equitably vaccinate as many people as possible, as quickly as possible.
“This vaccine does not need to be kept in a freezer and can be stored at refrigerated temperatures – so it is easy to transport and store and allows for expanded availability in most community settings and mobile sites, as supply scales up,” Walensky said in a media statement. “This third safe, effective COVID-19 vaccine comes at a potentially pivotal time. CDC’s latest data suggest that recent declines in COVID-19 cases may be stalling and potentially leveling off at still very high numbers. That is why it is so critical that we remain vigilant and consistently take all of the mitigation steps we know work to stop the spread of COVID-19 while we work our way toward mass vaccination.”
She said having different types of vaccines available for use, especially ones with different dosing recommendations and storage and handling requirements, can offer more options and flexibility for the public, jurisdictions and vaccine providers. She added that getting vaccinated with the first vaccine available to you will help protect everyone from COVID-19.
Following the approval, Johnson & Johnson CEO Alex Gorsky stated, “As we continue to pursue regulatory authorization around the world, our company is on track to meet our manufacturing goals, committed to making our vaccine available on a not-for-profit basis for pandemic emergency use and confident in the strength of the data from our clinical trials. Tested at the height of the pandemic, our vaccine has shown its potential to significantly reduce the burden of severe disease with just one immunization.”
According to the J&J, its Janssen version of the COVID vaccine uses an inactivated adenovirus, which is a type of virus that causes the common cold, to carry a gene from the coronavirus to human cells. “The cells then produce coronavirus proteins (not the virus itself) to mimic the virus, which helps prime the immune system to fight off later infection if the body encounters the coronavirus.”
J&J reports its vaccine was tested on more than 44,000 individuals of different ages and ethnicities across eight countries and three continents. In the U.S., Latin America and South America in its ENSEMBLE clinical trial, J&J says its vaccine is “72% effective in the U.S. and 66% effective overall at preventing moderate to severe COVID-19, 28 days after vaccination; and 85% effective overall in preventing severe disease and demonstrated complete protection against COVID-19 related hospitalization and death at day 28.”