UCHealth researcher: Preliminary COVID-19 vaccine data is something to celebrate

Early results from a third trial could come after Thanksgiving

Gary Luckasen
Dr. Gary Luckasen is a cardiologist and medical director of UCHealth’s clinical research program in northern Colorado. He is the principal investigator for UCHealth’s Phase 3 trial of a COVID-19 vaccine developed by Oxford University and pharmaceutical company AstraZeneca. (Courtesy Kelly Tracer/UCHealth)

Though several dark months remain ahead in the COVID-19 pandemic, state officials have called positive vaccine news a “light at the end of the tunnel” for the public health crisis.

Preliminary data from Moderna, released by the pharmaceutical company on Nov. 16, showed its vaccine was 94% more effective than the placebo. That news follows a similar announcement from Pfizer and BioNTech on Nov. 9, when those companies announced early data showing their vaccine was more than 90% effective.

More positive news should be coming soon, according to Dr. Gary Luckasen, a UCHealth researcher who’s the principal investigator on a trial of a third vaccine.

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Luckasen — cardiologist and medical director of UCHealth’s clinical research program in northern Colorado — is leading a Colorado trial for the vaccine being developed by University of Oxford along with pharmaceutical company AstraZeneca. The UCHealth trial has enrolled 525 people so far and, when complete, will have enrolled 1,500 participants. The official study site is the McKee Pavilion at The Ranch in Loveland.

UCHealth vaccine trial
UCHealth registered nurse and research coordinator Stacie Kenny administers a shot to the first participant in UCHealth’s COVID-19 vaccine study being conducted in northern Colorado. Participants in the study receive either a placebo vaccine or a vaccine developed by Oxford University and pharmaceutical company AstraZeneca. (Courtesy UCHealth)

The Oxford/AstraZeneca trials were paused for about six weeks earlier this year because of a potential safety concern, but the U.S. Food and Drug Administration and agencies in other nations allowed them to continue in late October, following an investigation by regulators.

Luckasen said he expects Oxford and AstraZeneca to issue an early announcement about their vaccine’s efficacy, before trials have concluded, “probably after Thanksgiving or early December” — similar to those already released by Pfizer and Moderna.

The announcements from Pfizer and Moderna alone are worth celebrating, Luckasen said — though none of the Phase 3 trials are complete — and he invoked a metaphor to describe how people should react to the early results: “They should be throwing parties.”

“The traditional (vaccine efficacy threshold) is over 50%, so if you’re at 95%, you’ve done something a hell of a lot better,” Luckasen said. If “you would have had 100 cases of COVID, and you have five, I mean, that is dramatic.”

The Moderna, Pfizer and AstraZeneca vaccines all direct the body to start producing COVID-19 “spike proteins” that are the same as those located on the outside of the coronavirus, therefore triggering an immune response — and producing antibodies to fight the virus — without causing a coronavirus infection. The Moderna and Pfizer vaccines deliver the genetic instructions, or “messenger RNA,” to muscle cells in tiny fatty envelopes, while the Oxford/AstraZeneca vaccine uses an inactive common-cold virus.

Pfizer’s vaccine requires ultra-cold storage, which could present distribution challenges, while the other two require a “typical freezer situation,” Luckasen said.

“The biggest issue for all of these … is that we don’t have any data to say how well they’re going to do in six months or one year — whether you have to be revaccinated, whether there’s permanent immunity or not — so a lot of unanswered questions,” he added.

When can Coloradans expect a vaccine?

Dr. Eric France, chief medical officer at the Colorado Department of Public Health and Environment, told reporters Nov. 12 that it might be summer before enough vaccine doses are available for everyone eligible for a vaccine to get one.

“There’s a lot of reason for excitement,” France said, predicting that the first doses could be available before the end of the year, based on the preliminary data. “At the same time, though, recognize that each of us will be in a different place in line when it comes to receiving this vaccine.”

In a CDPHE-issued statement Nov. 16 following Moderna’s announcement, France called the early results “great news” while urging Coloradans not to let down their guard. That includes wearing masks, maintaining physical distance from others, and refraining from socializing with people outside of one’s own household.

“Vaccines will change the course of the pandemic, helping us to dramatically slow the spread of COVID-19, but we must remain extremely diligent until a vaccine is available to the masses, which will take time,” France said. “We are currently having exponential increases in cases, and we must do all we can to ensure that hospitals can provide care to those who need it.”

UCHealth vaccine trial
UCHealth nurse Stacie Kenny, right, verifies records with Megan Collett, certified clinical research coordinator, before a shot is administered. (Courtesy UCHealth)

CDPHE’s draft vaccine distribution plan, submitted to the Centers for Disease Control and Prevention on Oct. 16, assigns Coloradans to several vaccination phases based on their priority group.

The first people to get vaccines will be those assigned to phase 1A, which includes inpatient health care workers, such as staff at assisted living facilities; and outpatient health care workers, such as home health workers and pharmacists.

The next phase, 1B, includes paramedics, firefighters, police officers, public health workers and correctional staff.

The remaining phases are as follows:

Phase 1C: Highest-risk individuals, including residents of assisted living, long-term care and nursing home facilities
Phase 2A: Residents of congregate housing, including adults experiencing homelessness, adult residents of group homes, ski industry workers, some agricultural workers and students living in dorms or other shared housing; plus essential workers, such as grocery store workers, teachers, child care workers, meat-packing workers, and people serving those who live in homeless shelters or group homes
Phase 2B: Higher-risk individuals, including adults 65 and older; adults with obesity, diabetes, chronic lung disease, heart disease, chronic kidney disease requiring dialysis, cancer and immunocompromised status; and adults who received a placebo shot during a COVID-19 vaccine trial
Phase 3: Adults younger than 65 without medical conditions that would place them at higher risk of severe symptoms from COVID-19

Medical supplies
Medical supplies sit on a table at the Loveland study site of UCHealth’s northern Colorado COVID-19 vaccine trial. (Courtesy UCHealth)

The first doses of vaccine are expected to be available starting in December, Diana Herrero, the interim deputy director of CDPHE’s Division of Disease Control and Public Health Response, said during a meeting of the Governor’s Expert Emergency Epidemic Response Committee on Nov. 12.

Gov. Polis has said that the state expects to receive around 100,000 to 200,000 doses before the end of the year.

Pfizer and Moderna have each promised the United States at least 100 million doses, which wouldn’t all be available at once.

The vaccines will be allocated to each state based on population alone, Herrero said. That means Colorado would receive approximately 3.5 million doses, which is about 60% of the state’s population. COVID-19 vaccine trials have so far largely excluded children and pregnant women, so those groups would not be able to get a vaccine until data shows it is safe for them.

But if AstraZeneca’s vaccine is available around the same time as Pfizer’s and Moderna’s, that would considerably speed up the process by which most adults who want a vaccine are able to get one. The United States has entered into a deal with the company to receive 300 million doses.

Oxford and AstraZeneca are still enrolling study participants, and Luckasen recommended Coloradans consider signing up for the UCHealth trial.

“The general public’s not going to get (a vaccine) for a certain amount of time, and that may be months,” he said. “The risk of all of these vaccines of causing problems has been extremely low, and that’s preliminary data from a good number of the trials — so that should encourage people to be a little more aggressive in trying to protect themselves and their families.”

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