We now have a third, safe and effective COVID-19 vaccine.


We have GREAT news! We now have a third, safe and effective COVID-19 vaccine.

The FDA has granted Emergency Use Authorization (EUA) to the Janssen (Johnson & Johnson) vaccine.

The Advisory Committee on Immunization Practices (ACIP) met this weekend to review and make recommendations on the this vaccine. Janssen is a pharmaceutical company owned by Johnson & Johnson (you might see the vaccine called either Janssen or Johnson & Johnson. They are the same thing). You can read all the information presented at the meeting here but we wanted to sum up the big take home points!

➡️How does the Janssen vaccine work?

This vaccine is a non-replicating viral vector vaccine. The vaccine uses an adenovirus (the virus that causes the common cold). Adenoviruses have DNA inside of them. The virus is modified so that it can get inside of cells but can’t replicate itself or make someone sick, but the gene for the spike protein can be read by the cell, made into messenger RNA, and then made into the spike protein itself which is displayed on the outside of cells. The immune system recognizes this protein and kicks in to develop immunity. Importantly, the DNA does not integrate into or change your DNA.

➡️Who can get the vaccine?

The ACIP RECOMMENDS the vaccine for people 18 years old and up.

Do not get the vaccine if you have an allergic reaction to any of its components. You can find a list of the components here.

➡️How effective is the vaccine?

Overall, this vaccine protects against moderate to severe COVID-19 disease about 66% of the time 28 days after the shot. It is 83.5% effective at preventing severe disease. It is 93% effective at preventing hospitalization after only 2 weeks! There were NO COVID-19 related deaths in the vaccinated group.

Vaccine efficacy was a little higher in the US (72%) compared to South Africa (64%) where the new variant is circulating. HOWEVER, protection against severe disease was similar.

Even though this vaccine has a lower reported efficacy than the Pfizer or Moderna vaccines, remember that none of the vaccines have been compared directly to each other in a clinical trial. This means that the trials were all conducted under different circumstances, making them tough to compare. All three vaccines are very effective, particularly at preventing serious illness, hospitalization, and death.

➡️How safe is the vaccine?

There are expected side effects of the vaccine, like headache, sore arm or muscles, and feeling tired. The rates of side effects were similar (potentially even less!) to the mRNA vaccines. About ½ had a local injection site reaction (like pain or swelling) and about 55% had a systemic reaction (like fever or muscle aches). The most common reported side effects were injection site pain (48.6%), headache (38.9%), fatigue (38.2%), myalgia (33.2%), nausea (14.2%), and fever (9.0%).

Serious adverse events are when big bad things happen, like being hospitalized or suffering permanent disability. There was no real difference in the rates of these events between the placebo and vaccine. And, of course, safety monitoring is ongoing!

➡️How many shots do I have to get?

This is the BEST part. This vaccine takes only 1 shot to work.

➡️Other good news?

The vaccine can be stored much more easily than the mRNA vaccines and doesn’t need the ultra-cold storage. Janssen is reporting they have 4 million doses available now and are planning on 20 million doses by the end of the March and 100 million doses by the end of June. This will increase access to the vaccine.

All the currently authorized COVID-19 vaccines can be administered to people who are immunocompromised, have autoimmune conditions, or are pregnant or breastfeeding. If you are one of these folks, talk with your clinician to help you make a decision that is right for you.

Y’all, this is incredible news. We continue to be grateful to all the scientists, healthcare workers, study volunteers, public health experts, epidemiologists, logistical planners, and EVERYONE who worked to make another vaccine a reality.

Janssen FDA Briefing Document

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