Update: The Janssen COVID Vaccine

Unanimous endorsement of the new one-dose COVID vaccine

The US Food and Drug Administration (FDA) convened a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) today. The sole purpose of the meeting was to determine if the benefits of the single dose COVID vaccine developed by Janssen Pharmaceuticals (owned by Johnson & Johnson - J&J) outweigh the risks for adults 18 years of age and older.

After a full day of presentations, public comments, and debate, the 22 members of VRBPAC voted unanimously that “YES” the benefits of the new COVID vaccine outweigh the risks for adults 18 and older. With this approval, FDA can now issue an Emergency Use Authorization (EUA) for the Jannsen/J&J COVID vaccine. The EUA is expected tomorrow.

After FDA issues the EUA, CDC’s Advisory Committee on Immunization Practices (ACIP) will meet on Sunday & Monday to discuss implementation/administration of the vaccine and clinical considerations.

J&J said it will have 100 million doses ready for distribution by April 1st.

---

Today’s VRBPAC began with a pandemic update. The key public health messages shared were:

1. Mitigation strategies - face masks, physical distancing, hand-washing, and maintaining small social circles - are working to decrease community spread.

2. The COVID-19 variants are here, and they are of CONCERN. In the US, we can expect the B.1.1.7 variant (UK) to be the dominant form of the virus by March 23.

3. As the variants spread throughout our communities, we will need to continue to be vigilant and use the mitigation strategies (#1 above) that are known to work.

4. We are nowhere close to having herd immunity.

5. Vaccines are safe and effective.

Following the pandemic update, the research team from Janssen presented the results of their pre-clinical and clinical trials. Their conclusion: the one dose vaccine is both safe and effective.

The afternoon session was full of public comments, Q&A, and debate. Two key points to highlight — first, Janssen is continuing to study their vaccine. The current clinical trial of the single dose vaccine is still ongoing (named ENSEMBLE). Janssen plans to keep all 40,000+ people enrolled in the study. If an EUA is granted, Janssen will reorganize their clinical trial and convert it into a case-crossover study (where those in the placebo group get the vaccine and cross-over to the treated group and the group that received the vaccine get placebo shots and cross-over to the placebo group). The goal is to keep everyone enrolled and the study blinded (no one knows which shot they received first). Ultimately, Janssen would like to have long-term efficacy and safety data from this trial.

The second point of discussion was about a second clinical trial (named ENSEMBLE2) that is underway by Janssen to look at the safety and efficacy of two doses of the vaccine. Janssen is hoping that in the coming months they will have data to show that the efficacy of the vaccine increases with multiple doses. This is exciting research; however, there was a lot of concern about how FDA and ACIP will create policy and clinical guidance with these new results. For instance, if the two doses are more efficacious, will people who have already received a first dose “jump the line” to get their second? or will we wait to vaccinate everyone who is “in line already”? There was also a lot of conversation regarding how confusing this will be to communicate to the public. At the end of the day, the committee focused on the safety and efficacy of the single dose vaccine; deciding that this vaccine is needed now.

The meeting concluded with members of the VRBPAC having the opportunity to explain why they believe the benefits of the vaccine outweigh the risks. Again and again, the committee members stressed the importance of increasing the vaccine supply. We need to get more people vaccinated! Additionally, they stressed that all three vaccines — Pfizer, Moderna, and (now) Janssen — are safe and effective. One vaccine is not better than another, and we each need to be willing to take the vaccine that is offered to us when our turn comes!

The Sunday/Monday meeting of the ACIP will also be livestreamed, and I will provide a summary early next week.

.