NM lab begins giving doses in COVID-19 vaccine study - Albuquerque Journal

NM lab begins giving doses in COVID-19 vaccine study

Copyright © 2020 Albuquerque Journal

New Mexico volunteers enrolled in a trial for AstraZeneca’s COVID-19 vaccine began receiving either the experimental drug or a placebo Wednesday, marking the official beginning of the drug’s Phase 3 testing, according to a news release from the company running the clinical study locally.

Louisiana-based clinical research company MedPharmics LLC announced in early August ithat t would be looking for at least 340 research volunteers in New Mexico as part of the trial for the drug before its developers seek approval from the U.S. Food and Drug Administration to commercially distribute it.

More than 300 people have expressed an interest in enrolling in the study, said Elizabeth Farlie, a MedPharmics business operations manager. Farlie didn’t say how many of those people have begun receiving doses already.

Kate Chalamidas, the company’s site manager, said New Mexico hasn’t met its quota for participants.

“It’s going to take about four to eight weeks or more to complete enrollment in New Mexico,” she said.

Research volunteers in the clinical trial for the drug, developed by AstraZeneca and Oxford University, will be compensated for their time and travel, but enrollment is limited.

To be eligible, potential applicants must:

n Be 18 years-old or older.

n Be in good or stable health, those with underlying conditions are still encouraged to apply.

n Have an increased risk of becoming infected with COVID-19.

n Have not been previously diagnosed with COVID-19.

Farlie said those participating in the study will be given a “nice compensation package,” though she didn’t provide specifics.

“When we meet the patient, we tell them, ‘The point of this trial is to be a medical hero and to benefit medical research,'” Farlie said.

The Journal previously reported that for every two people given the experimental drug, one will be given a placebo. During the two-year trial period, volunteers are required to participate in “seven routine visits and two phone interviews.” Vaccines will be administered twice, one month apart, and blood samples will be drawn for testing. Any trial participants who develop COVID-19 symptoms will be medically evaluated, and women of childbearing potential are required to use “highly effective” birth control for almost a month before the first injection as well as for about two months after the second injection.

Volunteers who have histories of severe reactions to any vaccine as well as those on medications that can affect the immune system will be excluded from the study.

“All trials are heavily regulated,” Farlie said. “You want to make sure that every part of the trial has been looked at.”

Interested applicants may call 505-243-1627 or visit www.c19vaccinestudy.com.

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