The J&J Vaccine - Safety & Efficacy
Part 2 of a 2 part series devoted to the production, safety, and efficacy of the J&J COVID-19 vaccine
Miss the first part of this special series?
Be sure to check out Unpacking the Production and Products in the J&J Vaccine
The first cases of COVID-19 have been traced back to October 2019. After 18 months of this virus infecting humans worldwide, we need immunity in order to slow the spread of disease and the development of variants.
“These variants that are more transmissible and potentially even more lethal are on the rise. I think time is really what we’re fighting against.” ~Dr. Akiko Iwasaki, Yale School of Medicine.
As we race against time, vaccines are essential to creating immunity.
The J&J vaccine is safe & effective. It is —
Given in a single dose (one shot!)
85% protective against severe disease
65.5% protective against COVID-19 diagnosis
Associated with fewer side effects
Before diving deep into the J&J vaccine trial and its outcomes. I want to be clear about these five important facts (memorize them before reading below the line!) —
Vaccines save lives and prevent suffering.
The Pfizer, Moderna, and J&J vaccines are safe and effective.
The Pfizer, Moderna, and J&J vaccines do NOT contain the SARS-CoV-2 virus, and therefore, cannot cause COVID-19.
The J&J vaccine is effective at preventing severe disease, hospitalizations, and death caused by COVID-19.
The J&J vaccine reduces the number of infections of COVID-19 by about 65.5%
The J&J COVID vaccine is administered in one dose. It is safe and effective.
The efficacy of the J&J vaccine — preventing just 65.5% of COVID diagnoses — is amazing. The J&J vaccine is an essential part of our work to stop the spread of the SARS-CoV-2 virus. And while other vaccines are more efficacious (Pfizer and Modera reported vaccine efficacy of ~95%), there are some key differences in the timing and design of the different clinical trials. These differences matter; they need to be understood.
Global Trial In the Time of Variants — the J&J vaccine trial was conducted in eight countries and three regions (North America, Latin America, Africa) in late 2020/early 2021. Data was being collected from trial participants in South Africa as the B.1.351 variant was spreading. In fact, the majority of the participants in the J&J trial in South Africa were infected with the B.1.351 variant. And yet… 14 days after vaccination, the vaccine prevented 57% of severe COVID-19 cases, and after 28 days it prevented 81.7% of severe disease. These results are EXTRAORDINARILY IMPORTANT as severe disease was reduced even in a region where a new variant of the virus was common.
The Pfizer and Moderna trials were primarily conducted in the US. And both companies submitted their data and EUA applications before the variants became popular.
J&J Clinical Trial Endpoints — at the beginning of a clinical trial, the research team has to define the study endpoints (the measures of disease that will be used in the efficacy calculations). There was no collective effort to establish shared endpoints among the vaccine developers, and J&J’s endpoints are notably different than Pfizer's and Moderna’s. Trials are designed to ensure a vaccine’s safety and efficacy; they are NOT designed to pit different vaccines against each other.
The J&J trial sought to determine whether one dose of its vaccine protected against moderate to severe COVID illness, which was defined as a combination of a positive COVID test and at least one severe symptom, such as shortness of breath, beginning at day 14 after a single shot. This is different from the endpoints defined by Pfizer and Moderna, which were both looking primarily for any symptomatic COVID infection.
All three companies demonstrated that their vaccines prevent hospitalizations and death from COVID-19. Comparing the measures of efficacy and judging one vaccine as better than another is not a fair comparison. Remember — trials are designed to ensure a vaccine’s safety and efficacy; they are NOT designed to pit different vaccines against each other.
Side Effects — J&J reported no serious, long-term side effects associated with the receipt of the vaccine. The most common side effects reported were injection site pain, fatigue, headache, muscle pain, and joint pain. The proportion of people experiencing side effects after receiving the J&J vaccine was noticeably less than the proportion of people receiving the Pfizer and Moderna vaccines. J&J also reported that side effects were more common in younger adults, who have a more robust immune system.
The question that remains is — SO WHAT?
Why is it important to understand the details of the J&J vaccine?
The answer is actually simple… COVID-19 is a devastating disease. The need for vaccines is incredible; we need immunity (individually and throughout our communities) if we want to travel, go to school in-person every day of the week, have county fairs and summer picnics, or hug our friends and family. Vaccines are essential to building immunity.
The J&J vaccine is safe and effective. With the approval of the J&J vaccine, supply will increase and provide protection to those who receive the vaccine.
As we continue to roll out the vaccine, individuals are unlikely to be offered a choice of which vaccine they want. Supplies are too scarce. For now, the vaccine available at the time and place where you are being vaccinated is the vaccine you should get. It is important to remember —
Vaccines save lives and prevent suffering.
The Pfizer, Moderna, and J&J vaccines are safe and effective.
The Pfizer, Moderna, and J&J vaccines do NOT contain the SARS-CoV-2 virus, and therefore, cannot cause COVID-19.