A: The news is GOOD!!
TL;DR: The single-shot vaccine provides strong protection against COVID-19 severe disease and death, and requires only normal refrigeration.
Johnson & Johnson is a “viral vector” vaccine, in which a non-replicating adenovirus (a cause of common cold) is used as a delivery service for instructions to create the coronavirus spike protein. The adenovirus itself cannot replicate or cause illness.
New analysis of Phase III trial data by the US Federal Drug Administration (FDA) was released today ahead of Friday’s advisory panel meeting for Emergency Use Authorization (EUA). This is a more detailed update of press results released by the company on January 29th.
💉Vaccine Efficacy (28 days after vaccination, from approximately 40,000 participants):
➡️ 66% reduction in moderate to severe disease
➡️ 86% reduction in severe disease
➡️ NO hospitalizations or deaths in vaccine group
Vaccine efficacy was slightly higher in the US (72%) compared to South Africa (64%) where a new variant is circulating, but protection against severe disease was similar in both settings.
Side effects: The most frequently reported side effects were headache (vaccine vs. placebo: 38.9% vs 23.7%) and fatigue (38.2% vs. 21.5%).
In a bonus analysis compared to other trials, a smaller group was followed to measure asymptomatic infection by testing their blood at follow-up for evidence of previous infection (for those seronegative at baseline). While there was a small reduction in asymptomatic infection in the vaccine group up to 29 days (22.6%), this rose to *74.2%* after Day 29.
These data are still preliminary as a larger group is still being followed which will give more precise estimates, but this still looks VERY PROMISING as to the ability of the vaccine to prevent asymptomatic infection and thus onward transmission, something we are also seeing for the Pfizer vaccine in real life.
Why such a big difference *after* 29 days? In the J&J Phase II trial data, neutralizing antibodies against SARS-CoV-2 were detected in 90% of participants 29 days after the 1st dose and in 100% by day 57. Antibody titers further increased and stabilized over 71 days of follow-up, suggesting immune response gets even stronger more than 4 weeks after vaccination (AMAZING, RIGHT?!).
🤔 But wait, should I be worried that the efficacy is not as high as Pfizer & Moderna? Should I hold out for those or take the J&J vaccine if offered?
💥 “THE BEST VACCINE IS THE ONE YOU CAN GET TOMORROW.”
-wise words from our amazing co-founder Dr. Alison Buttenheim recently testifying to the U.S. House Committee on Science, Space & Technology.
➡️ Since all of these vaccines are effective at preventing severe disease and death, you shouldn’t hesitate to take the first one offered to you. The difference between the efficacy of the vaccines for milder disease is less important and may not be as precise as it seems, since the Johnson & Johnson vaccine was tested in different countries with different circulating variants compared to the Pfizer and Moderna vaccines.
⬇️ BOTTOM LINE:
❇️ The J&J vaccine is highly effective at preventing severe disease, hospitalization, and death.
❇️ An effective one-dose regime is a game-changer for speeding up roll out of the vaccine and simplifying the process for many around the world.
❇️ The J&J vaccine is also less fragile than the mRNA vaccines & can be stored at regular refrigerator temperatures, another huge boon to logistics.
❇️ Having another approved vaccine will boost overall global supplies & get more people vaccinated FASTER—which is our best way back to normal life.
Love,
Those Nerdy Girls
Further reading:
“New analyses show Johnson & Johnson’s one-dose vaccine works well”
Full FDA Document (Meeting Briefing Document-FDA)
“Why the Johnson & Johnson Vaccine Has Gotten a Bad Rap – And Why That’s Not Fair”
