J&J Executive Responds To Nurse’s Vaccine Questions
“The job of a vaccine is to train your immune system,” Dr. Nettles explained. “In many senses, the vaccines are doing the same job, but the way they educate your immune system is different.”
In a recent episode of Ask Nurse, Nurse Alice Benjamin, interviewed Rick Nettles, MD, Vice President of Medical Affairs for the Janssen Pharmaceutical Companies of Johnson & Johnson.
As we all know, Johnson & Johnson’s Janssen COVID-19 Vaccine––or the “one and done” vaccine as Nurse Alice dubbed it––has been under scrutiny since its emergency use authorization. The vaccine has been linked to rare cases of thrombosis with thrombocytopenia syndrome (TTS), especially in women age 18 through 49 years. However, the U.S. Centers for Disease Control and Prevention (CDC) has continued to recommend the use of the vaccine, noting that the potential benefits outweigh the potential risks.
But because nursing is all about digging deep and asking the questions that patients really need to know, Nurse Alice, who shared that she herself received the Janssen COVID-19 Vaccine, went directly to the source and spoke with Dr. Nettles about how the vaccine works, his own experience, and what all nurses should know about the safety of COVID-19 vaccines. If you’re wondering if doctors who work for pharmaceutical companies actually have any “real-life” experience, Dr. Nettles completed his infectious disease fellowship at none other than John Hopkins University, so there’s that.
Listen to the full podcast episode now on the Ask Nurse Alice Podcast:
What Makes The Janssen COVID-19 Vaccine Different?
The first question Nurse Alice tackled is a common one: What exactly is the difference between the COVID-19 vaccines? Both the Moderna and Pfizer vaccines are mRNA vaccines, while the Janssen COVID-19 Vaccine is a viral vector vaccine. Dr. Nettles explained that while all the COVID-19 vaccines serve the primary end goal of preparing your body to be ready to fight COVID-19 if it encounters it, the way they do that is different.
“The job of a vaccine is to train your immune system,” Dr. Nettles explained. “In many senses, the vaccines are doing the same job, but the way they educate your immune system is different.”
While the Moderna and Pfizer vaccines use a piece of mRNA code to train your immune system to build up antibodies against the spike protein found on SARS-CoV-2, the Janssen COVID-19 Vaccine uses a modified adenovirus instead. The adenovirus is a common virus that can cause mild cold-like symptoms, but in this case, it’s been modified so it doesn’t actually give individuals an infection and instead, is the vehicle to train the immune system against COVID-19.
The adenovirus technology isn’t new either. Dr. Nettles noted that it has been studied for over a decade and is also used in both an Ebola vaccine regimen (approved in the European Union) and an investigational RSV vaccine that’s currently in phase 3 clinical trials.
Let’s Talk About the Numbers
Next, Nurse Alice dove into the actual numbers about the COVID-19 vaccine, the trials it went through, and its efficacy (in other words, how effective it is at doing what it’s supposed to do, safely?).
Dr. Nettles explained that it’s difficult to compare all the COVID-19 vaccines “head to head” because the vaccines weren’t all tested in the same clinical trial or at the same time, but that the primary efficacy data used with the Janssen COVID-19 vaccine is from a Phase 3 clinical trial called ENSEMBLE that was conducted in fall/winter of 2020 when COVID-19 was at a peak.
Last month, in September, the trial met its primary endpoint, Dr. Nettles noted. He said the trial showed 74% overall efficacy preventing severe or critical COVID-19 disease as well as 89% protection against the need for hospitalization for individuals in the U.S.
“[The vaccine] will reduce your chances of getting COVID-19, but what it's really good at is protecting you against severe COVID-19 that could lead to severe hospitalization or death,” he said.
Dr. Nettles also noted that it’s important to remember that the Janssen COVID-19 vaccine numbers may be especially helpful for people who can’t get a two-dose dose, so even with one vaccine dose, you’re going to get protection.
Additionally, Dr. Nettles pointed out that these were large clinical trials, for instance, the ENSEMBLE trial enrolled >40,000 people across 3 continents, including the U.S. Dr. Nettles, noted that while all the vaccine teams were able to move quickly because of collaboration with the U.S. Food and Drug Administration (FDA), along with ramping up production while still clinical trials, none of that meant a lowered focus on safety.
“We haven’t skipped any steps,” he said. “There's been no cut corners with regards to safety with these vaccines.”
What About the Real World?
While clinical trial efficacy is necessary and helpful, of course, Nurse Alice hit Dr. Nettles with the real question: What about in the real world, where new variants crop up that weren’t even around when the vaccine trials were going on?
Dr. Nettles assured Nurse Alice that so far, real-world data is also mirroring what clinical trials found. He noted that, during a time when Delta was highly circulating, they compared 390,000 people who received the Janssen COVID-19 Vaccine to 1.5 million that hadn’t been vaccinated (as best as we could tell) and came up with near-identical numbers as the trial: 79% efficacy against COVID-19 infection and 81% protection against COVID-19 related hospitalization.
“That confirmed that in the real world, the US, the vaccine appears to be working,” Dr. Nettles explained.
Are Boosters Necessary for The Janssen COVID-19 Vaccine?
While the single-dose approach was helpful in many ways during a pandemic (no ultra-cold storage needed, for instance), Dr. Nettles also told Nurse Alice that his team has been working at looking at the results of getting a second dose either two months or six months after the first dose.
He said that the good news is that the antibody levels are still durable for at least eight to nine months after the initial dose, so for most people who received the Janssen vaccine, “they’re not that far out yet.”
However, the interim results from ENSEMBLE 2 showed that a booster two months after the first dose was 94% protection against symptomatic (moderate to severe/critical) COVID-19, 100% against the need for hospitalization, and an increase in antibody levels 4 to 6 fold.
In response to this data, on October 20 the U.S. Food Drug Administration (FDA) issued an amendment to the Emergency Use Authorization (EUA) to include booster dose information and on October 21, the U.S. Centers for Disease Control and Prevention (CDC) recommended a booster dose for individuals 18 years and older at least 2 months after primary vaccination with the Janssen COVID-19 Vaccine.
The podcast was recorded before these recommendations.
Let’s Talk about Rare Complications
Last, but certainly not least, Nurse Alice tackled the tough topic of thrombosis with thrombocytopenia syndrome (TTS). She asked Dr. Nettles to explain what to look for with TTS and the Janssen COVID-19 Vaccine specifically.
He explained that while TTS is rare, occurring in only about three individuals per million, it’s important to know the risk factors and symptoms in case you have a patient experiencing it.
What’s unique about TTS with the Janssen COVID-19 Vaccine, Dr. Nettles noted, is that it involves blood clots and low platelet counts, which he explained is a “very unusual combination.” Additionally, blood clots are found in uncommon places and not in the legs.
Because of how the blood clots present, and the fact that they occur in combination with low platelet counts, he also pointed out how they aren’t treated like DVT-type blood clots either, so blood thinners may not be the way to go to treat them. Therefore, if you identify that a patient may be experiencing TTS, it’s important to ask them if they had the Janssen COVID-19 Vaccine and when, because it might help guide diagnosis and treatment.
Look for:
- Reporting of these blood clots and low levels of platelets has been highest in females ages 18 through 49 years
- Persistent abdominal pain
- Severe or persistent headaches or blurred vision
- Symptoms began approximately one to two weeks after vaccination
Dr. Nettles also explains that Guillain-Barré Syndrome (GBS) is another rare complication that has been associated with the Janssen COVID-19 Vaccine. The condition causes ascending weakness in arms and legs and can progress to be more serious and require hospitalization. GBS is a more well-known side effect that can occur with other vaccines but has been seen with the Janssen COVID-19 Vaccine. In most of these people, symptoms began within 42 days following our COVID-19 vaccine.
Despite the rare side effects that have been documented, Dr. Nettles ended his conversation with Nurse Alice by reminding everyone that all the COVID-19 vaccines––including the J&J––have been found to meet their primary endpoints.
“For those who haven’t been vaccinated, this is a dangerous time with the Delta variant and I would really strongly urge you to talk with a healthcare provider about the three vaccines and decide which one’s right for you. They have their pros and cons; they’re available, mostly, at any drugstore right now, and they’re free, so really, have that conversation with your healthcare provider and decide which one’s right for you. It’s really an important thing you can do to protect yourself and your family.”
“We’ll work as fast as we can to get that booster information for individuals like you, Nurse Alice, who received our COVID-19 Vaccine, should the FDA decide that’s warranted,” he added.
He also encouraged anyone who has questions about the Janssen COVID-19 Vaccine or wants to follow ongoing developments and news can find more information on https://www.janssencovid19vaccine.com/.
Information accurate as of October 1, 2021.
