Alisia Martinez’s itchy armpit made her cousin jealous.
Martinez began experiencing the underarm annoyance after her injection for a COVID-19 vaccine trial. The product from vaccine developer Moderna also drained her energy and left her arm sore.
Trial participants are left in the dark about whether they receive a vaccine or a placebo in order to ensure the integrity of results. But Martinez thought the brief and common side effects were a sign she received the actual vaccine.
Common Moderna Vaccine Side Effects
- sore injection site
- tiredness
- headache
- muscle pain
- chills
- joint pain
- swollen lymph nodes in injection arm
- nausea
- vomiting
- fever
Source: FDA
Her cousin and fellow trial participant, Jennifer Bernal, thought so too.
“We joke about it because, yeah, she was like, ‘what the heck, I wanted it’,” Martinez said, laughing.
Bernal received her Moderna injection a week earlier than Martinez but experienced none of the symptoms, leaving her to suspect she got a placebo.
“Not bitter or anything, but just, like, envious for sure,” Bernal said with a smile.
But the official answer will come as manufacturing companies — especially Pfizer and Moderna, the first two to receive an emergency use authorization — choose to notify placebo recipients and potentially offer them the approved product.
Pfizer, which received the first emergency use approval earlier this month for its vaccine developed with BioNTech, told KPBS it was seeking the OK from federal regulators to notify placebo recipients as they become eligible for the vaccine based on federal prioritization schedules. A spokeswoman for the clinical research company managing trial sites said that process began on Thursday.
Moderna did not reply to KPBS requests for comment but the journal Nature reported the Massachusetts biotech firm will notify all those who received the dummy shot, regardless of eligibility.
Bernal said she joined the Moderna trial with hope she’d receive a product that could give her immunity against COVID-19 and further protect her family, but also to be part of the effort to keep others safe.
“I was reading about all of these people being admitted to the hospital and being alone. And the only contact they had was with people in masks and shields on their face in these crazy suits...I can't imagine what those patients are going through right now,” Bernal said.
But she does have an idea. She witnessed her wife on a ventilator following complications from giving birth to their daughter earlier this year.
“Every time that they have to clear it out, it’s just — it looked really excruciating,” Bernal said during an interview outside her Spring Valley home.
Her wife returned home to their son and newborn daughter just before California’s stay-home order in March.
“When she finally got everything out, I asked her, I'm like, what did that feel like? And she said it felt like somebody was sucking the air out of your lungs,” Bernal said her wife told her of the process to clear the breathing tube.
Martinez, Bernal’s cousin, said she too wanted protection for her and her three daughters due to her job working in an Amazon warehouse. But she also thought of the young baby Angelina — the daughter of another cousin — that she used to nanny for whose mitochondrial disease made her vulnerable to even a common cold.
“I wish there would have been a cure for what she had, and so with this, I know there's people who are losing their loved ones,” Martinez said in a Zoom interview.
The child who enjoyed the Baby Shark song and had a “cheesy smile and little cackle,” died at 19 months old from Leigh syndrome.
“If I can help somebody else not have to have that kind of pain, I'm open to doing my part,” Martinez said.
Martinez has been temporarily living with Bernal and joined the Moderna trial after her cousin did. The two also bring much-needed diversity to the trials — Martinez is Mexican-American and Bernal is Jewish and of Mexican and Italian descent.
“I was healthy and I'm kind of middle aged and diverse in my background — I have a couple of different ethnicities going on. I figured I'd be a good test subject for it,” Bernal said.
The worldwide spotlight on a COVID-19 vaccine increased awareness about the need to improve diversity in clinical trials, said Paul Evans, president and CEO of Velocity Clinical Research. The North Carolina-based company is managing trials for six leading vaccine developers — Pfizer, Moderna, Janssen Pharmaceuticals, AstraZeneca, Novavax and Sanofi.
Demographics of Moderna Trial Volunteers
- White: 63%
- Latinx/Hispanic: 20%
- Black: 10%
- Asian: 4%
- All others: 3%
Source: Moderna data as of October 2020
"I just get the feeling from all the people I interact with in the industry generally that this time it's for real," Evans said. "This time we will make the difference. I mean, we're doing things in my company that previously you could argue we should have done them."
He said that includes examining the accessibility of trial site locations and the demographics of Velocity's staff.
"These are all things that you could say, 'Well, you know, that's not innovative thinking.' You'd probably be right. But these are things that in the past people didn't actually do anything about. We talked about it, but we didn't do anything about it," Evans said.
Martinez’s side effects from the trial were brief and among the common reactions reported. However, it's unclear the itchy armpit was a result of the injection. Yet Bernal is convinced the symptoms mean her cousin got what she calls “the good stuff” but said there’s no hard feelings.
“Obviously, I really wanted the immunity, but I'm glad for her because she does have three kids,” Bernal said.
In an email Bernal received Saturday, Velocity Clinical Research said Moderna trial participants who wish to be unblinded would have the opportunity. Those who received the placebo and want the vaccine would be offered the product, a process that could begin in one to two weeks, the email said.
