Will J&J Be Next?
The next COVID vaccines. Plus, KC-area vaccine info.
Updated 2/28/21:
Between the “sameness” of our days and Pandemic headline-fatigue, it’s easy to shrink the magnitude of this international crisis into our own bubbles and lose sight of the mountain of challenges that are being overcome. At the time of this update, about 7.5% of Americans have been fully vaccinated against the COVID-19 virus. Data remains clear that vaccination will prevent severe COVID disease and death, and mass vaccination programs are key to ending this Pandemic.
I urge you to get any COVID vaccine when you are offered.
To reach the community immunity we need to go back to our 2019 lives, we will need more vaccines. Meaning, we need more physical product to put into the arms of the people who are waiting. To do this, we need more companies to get in the vaccine production game.
The good news? More are on the way. While companies rally to help the cause, there are two vaccines currently in Phase 3 trials that experts expect will be the next to submit documents to the VRBPAC.
Like the mRNA vaccines of which most of you are familiar, the new players target the troublesome SARS-CoV-2 spike protein. Remember, it’s the spike protein on the SARS-CoV-2 virus that attaches to our human cells and causes infection. Interfere with this spike-to-cell, or “lock and key,” mechanism and the virus cannot infect. We defend against the virus with protein blobs (or antibodies) that coat the spike protein, effectively changing the shape of the key. If the key doesn't fit, the virus cannot infect.
Unlike the mRNA vaccines, the new players help our bodies make these protective protein blobs using recombinant viral vectors. To simplify things in my brain, I think of these vaccines like a trojan horse. Scientists take the outer shell of a common cold virus and put genetic instructions for the SARS-CoV-2 spike protein on the inside. Once injected, the viral shell slips inside our cells. But rather than causing infection, our cells begin to produce spike protein. The spikes move to the cell surface and voila - our immune system begins to make protective antibodies. (Here’s a nice review of viral vector vaccines from The Scientist.)
2/28/21 UPDATE: J/J&J vaccine has been issued an EUA based on the data presented to the FDA. The data, as well as the entire meeting, has been made available to the public.
Johnson and Johnson/Janssen is using an uncommon human common cold virus to create their vaccine. Phase 1/2 trial data showed promising results with a large majority of vaccine recipients producing spike protein antibodies after one dose. The reason this vaccine is exciting to all of us lurking around the virtual science-nerd water cooler is the one-dose simplicity and the vaccine’s ability to be stored in a normal refrigerator. No super-cold chain logistics or chasing down people for their second dose. Plus, this vaccine uses known technology. J&J makes a well-tolerated and efficacious Ebola vaccine using this same vector.
The US has purchased 100 million doses of the J&J vaccine, but production rates are going more slowly than planned. Critics also are skeptical of the effectiveness of the vaccine in a larger population since some individuals will have antibodies that neutralize the adenoviral vector, not allowing their body to absorb or produce the spike protein instructions. I’m eager to see additional study data to address this questions and for data in children 12-18 years. Getting a vaccine that will begin protecting recipients in a matter of weeks could be highly effective in decreasing community rates and slowing viral spread.
The Oxford/Astra Zeneca vaccine is off to the races in a few other countries, but has not been given an EUA in the US. This vaccine uses the shell of a simian virus and has been shown to be effective through prior work on a MERS vaccine. Unfortunately, initial O/AZ Phase 3 data was confounded by a dosing mistake that caused difficulty interpreting the final results. However, there was a glimmer of efficacy in some trial participants.
A vaccine with potential benefit should not be scrapped. We. Need. More. Vaccines. But, it is most prudent for the FDA to demand additional clarity and confirmation. To that end, trials continue to determine an optimal dosing strategy. The US has purchased 300 million doses of the vaccine and adding them to the distribution chain would be a welcomed boost in the coming months. O/AZ is also planning on adding younger children to US vaccine trials.
How additional vaccines will be added to current distribution efforts is not clear at this time. In the distant future, it is possible that your vaccination opportunity could involve choosing between various vaccine products. But until that time comes, feel comfortable and confident in the vaccine you are offered.
For more insights into the vaccine race, I recommend the NYT vaccine tracker. In addition, all meetings for EUA approval are fully accessible to the public. The calendar of events can be found on the FDA’s site.
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