J&J’s Janssen Vaccine Performs Well Under More Challenging Conditions Than Previously Authorized Vaccines
The J&J report has been released detailing the results of the phase 3 clinical study for the Covid-19 vaccine. The results show 100% efficacy for preventing death and hospitalizations due to Covid-19. (Ref 1) The new vaccine is an excellent addition to the vaccine options from Pfizer/BioNTech and Moderna which also showed 100% efficacy for preventing death and hospitalizations due to Covid-19. What I found remarkable with the J&J report is that the population tested were in much more challenging conditions when compared to the previous vaccines. This new vaccine was tested November 2020 to January 2021 in the United States, Brazil and South Africa. The incidence of Covid-19 among the placebo group was 2-3 times higher than the incidence during the Pfizer and Moderna studies which ended in November 2020. This indicates the disease was much more prevalent in these areas during that period of time when compared to the time and location for the other studies. We now also know that Covid-19 variants from Brazil and South Africa were emerging during the same period of time in those countries. All of this together means that the J&J vaccine was shown to have excellent performance under challenging conditions. I found no reason to be concerned by the reported efficacy of 66.1% for contracting Covid-19 which compares to the much higher overall efficacy (95% and 94.5%) for the other vaccines currently available.
Polio, smallpox, and measles are diseases that were eradicated with vaccination efforts (Ref 2, Ref 3, Ref 4). For each of these, a concerted effort to EDUCATE the population was necessary to convince the masses to VACCINATE before we could ERADICATE the diseases. As the Covid-19 vaccines become widely available, encouraging everyone the get vaccinated will soon become the most important thing we can do to move towards eradication and normalcy in everyday life. We are fortunate to have vaccine options available via the FDA’s Emergency Use Authorization (EUA) process in the United States and through similar regulatory reviews worldwide. Like the development of vaccines for polio, smallpox, measles and countless others, the development of Covid-19 vaccines will be viewed as a monumental scientific achievement but only if everyone participates.
Each of us need to use the resources and information available so we can feel comfortable getting the vaccine. For many, this is listening to the advice of trusted experts such as Dr. Anthony Fauci, Dr. Michael Osterholm or their personal physician. For others, it is important to know that friends, family members and neighbors are getting vaccinated safely.
As a scientist with experience in the medical products field, I listened to the experts but also felt the need to review the vaccine data to feel comfortable with my decision to get the vaccine. I don’t consider myself a vaccine expert. I am a vaccine advocate and know how to crunch data. Here is what I found when comparing the newly release J&J Janssen vaccine report to the previously release reports on the Pfizer/BioNTech and Moderna vaccines.
In December 2020, I studied the FDA publications regarding each of the Pfizer/BioNTech and Moderna vaccines (Ref 5, Ref 7). I watched much of the public discussions presenting the FDA reports including the insightful Q&A (Ref 6, Ref 8). It is my opinion from this review that both vaccines are extraordinary in their effectiveness and ability to prevent serious illness or death from Covid-19. I can also say that while the FDA worked expeditiously in reviewing these vaccine studies, they did not cut any corners. These were well powered studies (sufficient number of participants) that proved the primary and secondary efficacy end points. As is typical, additional studies are needed to address questions such as whether the vaccines are safe for pregnant women. I understand many of these studies are ongoing.
This week I studied the J&J Janssen report. I have come to the same conclusions for that vaccine as well. Here is the detailed analysis of the data comparing the three vaccines.
Comparison of Studies and Vaccines
Pfizer/BioNTech storage conditions updated to standard freezer conditions on 25 February 2021. (Ref 1, Ref 5, Ref 7,Ref 11)
Vaccine Study Results
As mentioned above, the J&J Janssen vaccine was tested under much more difficult conditions. We can see this when comparing the outcomes for the placebo groups.
Prevalence of Covid-19 in Placebo Groups
* Actual number of deaths in Pfizer placebo group attributed to Covid-19 is zero. However, two deaths were from unknown causes.
As a result of the confidence gained from what I learned, I will get which ever vaccine is offered to me when it is my turn. Looking into the data for each of the vaccine clinical studies has helped me feel safe when getting my shot(s). As mentioned in the opening paragraph, I am not concerned about the lower overall efficacy of the J&J vaccine given the excellent efficacy for preventing hospitalizations and death. This conclusion is further supported by the fact that the J&J vaccine was studied under more challenging conditions visa vie the prevalence of Covid-19 in those countries during the study period. I should also note the convenience of the 1-shot nature of the J&J vaccine and the improved accessibility of the vaccine since it only needs to be stored at standard refrigeration temperatures during shipment and prior to use.
I encourage everyone to review what I have presented and click on the references. In addition, one should always review the latest Fact Sheet for Recipients and Care Givers (Ref 9 for Pfizer, Ref 10 for Moderna) which will be offered to you when you get your vaccine. We can assume a similar fact sheet for the J&J vaccine will soon be available.
In conclusion, all three vaccines offer almost perfect protection from Covid-19 caused severe illness and death. All vaccines show overall excellent efficacy. Data shows that getting the vaccine does not pose an increased safety risk. I encourage everyone to seek information regarding when they can receive a vaccine and where they are available. In my home state, the Minnesota Department of Health has launched a Vaccine Connector Site which allows each of us to register so that we will receive immediate notification when we can get our vaccine. If you are here in Minnesota, I encourage you to register. If you are elsewhere, I encourage you to find similar resources.
EDUCATE – VACCINATE – ERADICATE Covid-19. Stay safe everyone!
References:
1) FDA Briefing Document: Janssen Ad26.COV2.S Vaccine for the Prevention of Covid-19 https://www.fda.gov/media/146217/download
2) CDC: Polio Elimination in the United States https://www.cdc.gov/polio/what-is-polio/polio-us.html
3) CDC: History of Smallpox https://www.cdc.gov/smallpox/history/history.html#:~:text=Almost%20two%20centuries%20after%20Jenner,achievement%20in%20international%20public%20health
4) CDC: Measles History https://www.cdc.gov/measles/about/history.html#:~:text=Measles%20was%20declared%20eliminated%20(absence,control%20in%20the%20Americas%20region
5) Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum (Pfizer) https://www.fda.gov/media/144416/download
6) FDA Advisory Committee reviews Pfizer's Covid-19 vaccine — 12/10/2020 https://youtu.be/tG7CzK5JZYM
7) Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum (Moderna) https://www.fda.gov/media/144673/download
8) FDA panel discusses Moderna's Covid vaccine for emergency use — 12/17/2020 https://youtu.be/94OMGzrQzvQ
9) Pfizer/BioNTech Fact Sheet for Recipients and Care Givers https://www.fda.gov/media/144414/download
10) Moderna Fact Sheet for Recipients and Care Givers https://www.fda.gov/media/144638/download
11) FDA Allows More Flexible, Transportation Conditions for Pfizer-BioNTech Covid-19 Vaccine https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-allows-more-flexible-storage-transportation-conditions-pfizer