The Johnson and Johnson Vaccine against COVID 19 was approved for Emergency Use Authorization in the United States on Saturday Feb 27, 2021. The main questions are does the clinical trial data show that the vaccine offers meaningful, measurable protection from Covid-19 disease? After this vaccine is administered, will it cause fewer people to get sick, cause fewer people to get severely ill from Covid-19, or cause fewer people to transmit the virus after exposure? The initial release of findings from clinical trials was meant with disappointment because the vaccine showed only a 66% efficacy against the disease a general population. But if you have been listening to this podcast, in particular, "Episode 10: Which COVID-19 vaccine is the best for you?” and “Episode 12: How Does the New Johnson & Johnson Covid-19 Vaccine Work and Why is This different from mRNA Vaccines?”, you know that I think this generation of vaccines against SARS-CoV-2 is pretty special. T It is a miracle that we have this plethora of vaccines when history tells us that it is rare to even have one this soon. In a continuation of last week’s deep dive into the Johnson and Johnson vaccine, we will examine the topics discussed in the final hearing before the FDA granted Emergency Use Authorization. Topics include the vaccine efficacy in moderate and severe COVID-19 across different age groups, efficacy against the variants, and in efficacy in different regions of the world, and an explanation as to why these data points matter; its ability to confer long term immunity; the ability to stop asymptomatic transmission; the vaccine’s side effects; and its safety in children, pregnant women, and the immune compromised.

Disclaimer: I am not giving medical advice. All medical decisions need to be made by you, your doctor, and any close circle of friends and family who are your advisors. I am giving you the latest FDA recommendations and my knowledge of the immune system and science behind the medicine.

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The Johnson & Johnson vaccine against COVID-19 is moving forward with positive clinical trial results and expects to seek emergency use authorization from the U.S. Food and Drug Administration (FDA). The company is working with its pharmaceutical arm Janssen to develop the vaccine under the project names Ensemble and Ensemble 2. The company enrolled participants for its late-stage trials in December 2020 and will test its vaccine with two different doses. The first dose uses only one shot, while the second formulation calls for two shots. The Johnson & Johnson vaccine is a recombinant viral vaccine that uses a live, attenuated, and weakened adenovirus as the vector. A because of this is sometimes referred to as a viral vector vaccine. This technology has been around since the 1970’s and has been used in other therapeutics including in a vaccine against rabies. We will discuss what that means and how it is different from the mRNA vaccines released from Pfizer/BioNTech and Moderna. We will discuss how this vaccine works and what makes it different from the mRNAs vaccines approved in the U.S. in December 2020. We will also look at issues concerning its efficacy, its ability to confer long-term immunity, and its success rate against the variants.

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As new variants of Sars-Covid-2 sweep across the globe, the efficiency and the speed of new infection and re-infection cases have given pause to those who thought a good vaccine would help diminish the virus quickly. In the time since those initial predictions, some good things have happened. We have had several vaccines come online and countries are starting their vaccination programs. And a significant portion of the of the world’s population has been exposed to the virus through natural infection, which studies show conveys some immunity to the virus for some amount of time. While these developments should give many a cause for hope, the emerging variants have shown to be effective at evading some vaccines and causing new infection patterns, which include a greater infection rate and early evidence of increased infection among school age children. What does this mean for ridding the world of this virus? Will the virus be eradicated? Or will the virus become endemic or seasonal? We will discuss all of these topics in this episode.

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