Copyright © 2020 Albuquerque Journal
A clinical research company with an Albuquerque site will be home to the first COVID-19 vaccine study to enroll research volunteers in New Mexico, a company spokeswoman said.
Louisiana-based MedPharmics LLC, which has operated an Albuquerque location for the past two years, has been selected to participate in a global study for a vaccine developed by AstraZeneca and Oxford University.
“We’re very, very excited that we have this partnership together,” MedPharmics business operations manager Elizabeth Farlie told the Journal in an interview Friday afternoon.
The company is currently soliciting volunteers for the two-year, phase 3 study, which is the last phase drugs go through before seeking final approval from the U.S. Food and Drug Administration. Adults age 18 or older who are healthy or medically stable are welcome to participate. Applicants will be excluded if they have had a prior COVID-19 infection, if they are on medications that can affect the immune system (such as chronic use of corticosteroids), or if they have a history of a severe reaction to any vaccine, a news release from the company said.
During the two-year trial, volunteers will undergo seven routine visits and two phone interviews. The vaccine is administered in two injections given one month apart, and participants’ blood will be drawn for testing at each routine visit, the release said.
Trial participants also will be seen and evaluated if they develop COVID-19 symptoms.
Any women of child-bearing potential must agree to use a “highly effective” birth control method during the 28 days before the first injection and for 60 days after the second injection, the release said.
Volunteers have a two in three chance of receiving the study vaccine, and a one in three chance of receiving a placebo treatment. Participants will be compensated for time and travel.
While the study period is lengthy, Farlie said the most intensive part for volunteers will be during the first one to two months.
The company has a goal of signing up 340 research volunteers in New Mexico, though Farlie said the company is seeking about 30,000 participants across the nation. MedPharmics is based in Metairie, Louisiana, and has sites in a number of other states including Arizona.
The company learned it had been awarded the study last week, and is currently scheduling interviews with its principal investigator, Dr. Quito Osuna Carr. While the company has only just begun soliciting volunteers, Farlie said public reaction has already been massive.
“The phone has been ringing off the hook,” she said. “… I have yet to run across a person who isn’t interested, and they don’t even care about the money. That’s how strong people feel about this.”
Farlie said the company will finalize its patient compensation structure next week.
Farlie said MedPharmics has been told to expect to start enrolling patients the week of Aug. 17. For now, anyone interested in the study can contact the company at 505-243-1627.
Farlie said the trial is heavily regulated.
“This is not anything being rushed to market,” she said.
A number of other companies around the world – including Moderna, Pfizer and Johnson & Johnson – are in various stages of testing their own COVID-19 vaccines.