- Lisa Bari is 39 years old
HealthBaltimore, Maryland-based IT policy executive participating in a late-stage trial of Johnson & Johnson’s experimental coronavirus vaccine.
- She received the first dose of the 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 has not experienced any serious side effects since the first injection, beyond a headache that may or may not be related.
- He also said that he has full confidence in the vaccine production process and will take one as soon as it is available.
I volunteered for Johnson & Johnson’s experimental coronavirus vaccine because I want to do absolutely everything I can to help end the
I approached the perspective of a clinical trial from a public health perspective.
I have a degree in public health, I 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 representing exchanges and networks of health information.
I am deeply concerned about this work and know that the vaccine development process, with multiple candidate vaccines in development, will potentially require hundreds of thousands of Americans to agree to participate. While vaccine trials must absolutely prioritize the enrollment of blacks and people of color, the long history of racism and unequal access to health care means that blacks and people of color have very legitimate reasons to hesitate. join clinical trials. As a white person, I understand that my participation can help provide some basic information on vaccine safety and hopefully encourage other people to join.
read more: Inside the powerful political machines that COVID-19 vaccine makers Pfizer, Moderna and AstraZeneca have built in DC
After seeing an advertisement for the ENSEMBLE 2 study, I completed the online form and 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 recruitment of people who visit the urgent care site for COVID-19 testing, which makes perfect sense.
The ENSEMBLE family of studies is testing Johnson & Johnson’s SARS-CoV-2 vaccine candidate, which uses the same technology as the company’s ZIka and Ebola vaccines. I will receive two doses of a vaccine or a 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 for storage. The J&J vaccine is expected to be stable at regular refrigerator temperatures, which is really important as we seek to scale the vaccine distribution in 2021. Another potential benefit is that this candidate vaccine can provide sufficient immunity with a single dose.
J&J SARS-CoV-2 vaccine works by triggering an immune response to the virus, similar to a flu vaccine.
Vaccines generally “train” your immune system to make a response, either by keeping you from getting sick or by preventing you from passing the virus to another person. We don’t yet know if any of the coronavirus vaccine candidates can prevent vaccinated people from transmitting the virus to someone else, but we do have some initial data showing that 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 am in the two dose group of the study and will receive a second dose just under two months after the first.
I don’t know the ingredients themselves, but I do know that the Ad26 vaccine platform is a genetically modified cold virus, which cannot result in a SARS-CoV-2 infection (it is not a live virus).
The aim of the trial is to know if the vaccine is safe, if it prevents or reduces COVID and to determine the possible side effects of the vaccine. Technically, the test lasts for more than 2 years, but that represents a long-term follow-up.
The vaccine process itself was very simple.
I received the first dose of vaccine or placebo on November 30. I went through the informed consent form, answered questions about my medical history, and had my blood drawn and some other basic tests performed. Then they gave me a bag with test materials in case I got infected with the coronavirus; One of the purposes of the study is to understand whether the vaccine reduces the symptoms and severity of coronavirus infections. Eventually I was randomly assigned to the study and received the first dose of the vaccine or a placebo. They told me I had a 50% chance of getting the vaccine.
They made me stay for 30 minutes after the vaccine or placebo administration, and then they let me go after making follow-up appointments (many can be delivered via telemedicine) and give me a prepaid card.
Appointments are reimbursed at a nominal amount to cover time and transportation. I chose to donate to GetUsPPE and ProjectN95 with the refund I will receive, which are two organizations working to bring PPE to frontline healthcare workers.
I am not nervous about participating in the vaccine trial, I have never had a serious adverse event from a vaccine and I am confident in the process. I am scheduled to receive the second dose on January 27th.
If all goes well with the trial, I think the vaccine could be in the hands of the public later in 2021.
As with the Pfizer / BioNtech and Moderna trials, the next step is to review the data after the second doses and move on to emergency use authorization approval. We are moving towards approval and distribution. But it probably won’t be available to the general public until late 2021.
read more: Drug Makers Behind 3 Coronavirus Vaccines Say They Work. Here’s everything we know about the race for a vaccine and when you might get it.
I am confident in the vaccine process and will take one as soon as it is available.
Vaccine development is a structured process. Many of these vaccine platforms are proven and are already in use. Delays in vaccine development are generally based on government funding and coordination, versus scientific or safety issues. In this case, governments lined up ‘very’ quickly.
Even if the J&J vaccine is not approved or progressed, I would take another vaccine as soon as it is offered to me.
So far I have had no serious side effects, other than a mild headache, which may not be related.
I had a headache and general fatigue the first day after getting the injection, but it’s hard to tell 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 will continue to protect myself as much as possible.
My family has been very supportive, in some cases they have envied 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 move forward on all fronts.
Participation in vaccine trials is one method; We all must also stay safe by wearing masks and distancing ourselves, as well as finding new treatments. The development and distribution of vaccines is critical for long-term immunity without hundreds of thousands more deaths.
I look forward to remembering this moment with pride, sometime next year when the use of the vaccine is approved. Frontline healthcare and other essential workers are putting themselves at risk every day, and the least I can do is a little inconvenience and a few blood draws on my part. We all want to see and hug our loved ones again, as soon as possible.
Lisa Bari is a health IT policy expert. He has an MBA from Purdue University and an MPH with a concentration in health policy and public health leadership from the Harvard TH Chan School of Public Health.