FDA close to approving another COVID-19 vaccine
The Food and Drug Administration (FDA) advisory committee is scheduled to review the Johnson & Johnson COVID-19 vaccine candidate today. If the vaccine meets the FDA’s requirements for safety and efficacy, it could be granted Emergency Use Authorization (EUA) and become the third COVID-19 vaccine available in the United States.
This important milestone comes at a time when cases continue to mount around the world and the supply of COVID-19 vaccines is not keeping pace with demand. Authorization of a third vaccine could help get more people vaccinated faster.
Over the next several days, we expect to see a flurry of news reports about the regulatory review process, FDA decision and next steps. As we wait to learn more, here are some key things to know about the Johnson & Johnson COVID-19 vaccine candidate.
When will the Johnson & Johnson COVID-19 vaccine become available?
Soon, we hope. If granted EUA by the FDA, there are a few more steps the vaccine candidate must go through, though. As we’ve seen with Moderna and Pfizer COVID-19 vaccines, this process can take several days or longer and include reviews by the Advisory Committee on Immunization Practices and the Western States Pact, representing several of our regions. All these additional steps are to further validate the FDA’s findings, including safety and efficacy, and determination.
Once authorized, the Johnson & Johnson COVID-19 vaccine is expected to be available in limited qualities to start. Over time, and like with other COVID-19 vaccines, supply will grow and more people will have access to it.
How is this vaccine different from the Moderna and Pfizer COVID-19 vaccines?
The COVID-19 vaccines available today in the U.S. and the Johnson & Johnson vaccine candidate all aim to limit the severity of disease and prevent COVID-19 altogether. However, there are some notable distinctions.
Technology: The Moderna and Pfizer vaccines use mRNA technology to teach our body how to protect us from getting infected with COVID-19. The Johnson & Johnson vaccine uses a weakened common virus to teach the body how to react to COVID-19, if we come into contact with it. None of the vaccines give you COVID-19, a cold, or affect your DNA.
Dosing: Both Moderna and Pfizer vaccines require two doses, separated by three to four weeks. The Johnson & Johnson vaccine is only one dose, making it more convenient and accessible.
Safety and Efficacy: The Moderna and Pfizer vaccines are safe and about 95% effective in preventing COVID-19. According to preliminary data, the Johnson & Johnson COVID-19 vaccine is safe and 66-72% effective in preventing moderate to severe COVID-19, and 85% effective in preventing severe disease. This level of protection is considered very good. For comparison sake, the flu vaccine is only about 50% effective and is widely used for the prevention of flu transmission and severe illness.
Storage: The Moderna and Pfizer vaccines need ultra-cold storage and special freezers, whereas the Johnson & Johnson vaccine only needs to be stored at -20º C (about the temperature of your freezer at home) for extended stability. This can make it easier for more facilities and providers to store and administer the vaccine, when and if made available.
Where can I get more information about the Johnson & Johnson COVID-19 vaccine?
To view recent study results, you can visit the Johnson & Johnson website. More information will become available in the days ahead, including from the FDA and Centers for Disease Control and Prevention. Providence leadership and multi-disciplinary vaccine workgroups are monitoring developments closely and will provide updates as they become available.