Lisa Bari is a 39-year-old health IT policy exec based in Baltimore, Maryland who is participating in a late-stage trial of Johnson & Johnson’s experimental coronavirus vaccine.
She received the first dose of vaccine or placebo on November 30 and is scheduled to receive the second dose on January 27.
While Bari is in the two-dose phase of the trial, Johnson & Johnson is also running a separate segment testing a one-dose vaccine on 60,000 participants.
So far, Bari said she hasn’t experienced any serious side effects from the first shot, beyond a headache that might or might not be related.
She also said she fully trusts in the vaccine production process, and will take one as soon as it becomes available.
I volunteered for the Johnson & Johnson experimental coronavirus vaccine because I want to do absolutely everything I can to help end the COVID-19 pandemic. I already wear masks everywhere I go, I’m not dining indoors, and I’ve eliminated nearly all socializing that doesn’t happen outdoors or online.
I approached the prospect of a clinical trial from a public health perspective.
I have a public health degree, used to work in the US federal government on health IT policy, and currently serve as the interim CEO of the Strategic Health Information Exchange Collaborative, a national association that represents health information exchanges and networks.
I care deeply about this work and know that the vaccine development process – with multiple candidate vaccines in development – is going to require potentially hundreds of thousands of Americans to agree to take part.
While vaccine trials absolutely must prioritize enrollment of Black people and people of color, the long history of racism and inequitable access to health care means that Black people and people of color have very legitimate reasons to be hesitant about joining clinical trials. As a white person, I understand that my participation may help provide baseline vaccine safety information, and will hopefully encourage other people to join.
After I saw an ad for the ENSEMBLE 2 study, I filled out the online form and was connected to a local study site, which is a primary and urgent care practice.
At the study site, I was informed that they do most of their proactive recruiting from people who visit the urgent care site for COVID-19 testing, which makes a lot of sense.
The ENSEMBLE family of studies are testing Johnson & Johnson’s SARS-CoV-2 vaccine candidate, which uses the same technology as the company’s ZIka and Ebola vaccines. I’ll either get two doses of a vaccine or placebo, 57 days apart.
The Johnson & Johnson vaccine works differently than the Moderna and Pfizer/BioNtech vaccines, which use an mRNA vaccine platform, and require special freezers to store. J&J’s vaccine is expected to be stable at regular refrigerator temperatures, which is really important as we look into scaling vaccine distribution in 2021. Another potential benefit is that this vaccine candidate may provide enough immunity through just one dose.
The SARS-CoV-2 vaccine from J&J works by triggering an immune response to the virus, similar to a flu vaccine.
Vaccines generally “train” your immune system to mount a response, either preventing you from getting sick, or preventing you from passing the virus onto someone else. We don’t know yet if any of the coronavirus vaccine candidates can keep vaccinated people from passing the virus onto someone else, but we do have some initial data to show that the vaccines are successful in keeping people from getting sick.
The ENSEMBLE studies include a one-dose version (60,000 people worldwide), and a two-dose version (30,000 people). I’m in the two-dose arm of the study, and I’ll receive a second dose just under two months after the first.
I don’t know the ingredients per-se, but I do know that the Ad26 vaccine platform is a genetically modified cold virus, that cannot result in a SARS-CoV-2 infection (it’s not a live virus).
The aim of the trial is to learn if the vaccine is safe, if it prevents or lessens COVID, and to determine the possible side effects of the vaccine. Technically the trial runs for over 2 years, but that accounts for long-term follow-up.
The vaccine process itself was very simple.
I received the first dose of vaccine or placebo on November 30.
I reviewed the informed consent form, answered questions about my health history, and had a blood draw and some other basic tests. Then, I was handed a bag with test materials in case I become infected with the coronavirus–one of the purposes of the study is to understand if the vaccine reduces the symptoms and severity of coronavirus infections. Finally, I was randomized into the study, and received either the first dose of the vaccine or a placebo. I was told that I had a 50% chance of receiving the vaccine.
They made me stay for 30 minutes following the vaccine or placebo administration, and then let me go after making follow-up appointments (many are able to be delivered via telemedicine), and handing me a prepaid card.
Appointments are reimbursed at a nominal amount to cover time and transport. I’ve chosen to make donations to GetUsPPE and ProjectN95 with the reimbursement I’ll receive, which are two organizations working to get PPE to frontline health care workers.
I’m not nervous to be participating in the vaccine trial, I’ve never had a serious adverse event from a vaccine, and I trust the process. I’m scheduled to receive the second dose on January 27.
If all goes well with the trial, I believe the vaccine could be in the hands of the public later in 2021.
Just like with the Pfizer/BioNtech and Moderna trials, the next step is to review the data following the second doses, and move to emergency use authorization approval. We are moving towards approval and distribution. But it probably won’t be available to the general public until later in 2021.
I trust in the vaccine process, and will take one as soon as it becomes available.
Vaccine development is a structured process. Many of these vaccine platforms are proven and already in use. The delays in vaccine development are generally based on funding and government coordination, versus scientific or safety issues. In this case, governments got aligned ‘very’ quickly.
Even if the J&J vaccine isn’t approved or doesn’t move forward, I would take another vaccine as soon as it is offered to me.
So far I haven’t had any serious side effects, beyond a mild headache, which could be completely unrelated.
I did have a headache and general fatigue the first day after taking the shot, but it’s hard to know if it’s related or if I’m imagining it. I won’t know for many months if I was in the treatment or control arm, so I’ll keep protecting myself as much as possible.
My family has been very supportive, in some cases jealous of me for participating! We would all love to have the vaccine. My colleagues have also been interested and regularly ask me how the vaccine trial is going.
If we want to get out of this pandemic, we need to make progress on all fronts.
Vaccine trial participation is one method; we all also need to keep each other safe by wearing masks and distancing, as well as finding new treatments. Vaccine development and distribution is critical for long-term immunity without hundreds of thousands of more deaths.
I hope that I can look back on this moment with pride, someday next year when the vaccine is hopefully approved for use. Frontline health care and other essential workers are putting themselves at risk every day, and a small inconvenience and a few blood draws on my part is the least I can do. We all want to see and hug our loved ones again, as soon as possible.
Lisa Bari is a health IT policy expert. She holds an MBA from Purdue University, and an MPH with a concentration in Health Policy and Public Health Leadership from the Harvard T.H. Chan School of Public Health.
Read the original article on Business Insider