FDA committee expected to recommend Pfizer vaccine for approval

Colorado sees ‘high plateau’ in cases, hospitalizations

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, 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)

A COVID-19 vaccine developed by pharmaceutical companies Pfizer and BioNTech is expected to secure the recommendation of a Food and Drug Administration advisory committee Dec. 10, clearing a major hurdle.

Even after the FDA’s Vaccines and Related Biological Products Advisory Committee issues its final decision — expected in the afternoon of Dec. 10 — a few more days remain until health workers in Colorado and other states can begin inoculations.

First, a Centers for Disease Control and Prevention advisory committee must issue its own recommendations. That committee, the Advisory Committee on Immunization Practices, is scheduled to hold public meetings on Dec. 11 and 13.

At a news briefing Dec. 9, Scott Bookman, Colorado’s COVID-19 incident commander, said the state expects to receive its first shipment of the Pfizer vaccine sometime between Dec. 13 and 16. That shipment will include 46,800 doses of vaccine prioritized for health workers who interact regularly with COVID patients, as well as long-term care facility residents and staff.

Colorado expects 95,600 doses of Moderna’s COVID-19 vaccine this month, officials say

According to an FDA brief for the Dec. 10 vaccine advisory committee meeting, Pfizer’s analysis of its vaccine included 36,621 participants. Half of the participants received a placebo, and half received the vaccine.

Of the 18,000 or so people who received both doses of the vaccine, eight people contracted COVID-19 at least one week after receiving their second dose. In the placebo group, 162 people contracted COVID-19.

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)

Those numbers suggest the Pfizer vaccine is 95% effective against COVID-19 — which is impressive, according to health professionals.

“The traditional (vaccine efficacy threshold) is over 50%, so if you’re at 95%, you’ve done something a hell of a lot better,” Gary Luckasen, a UCHealth researcher who’s the principal investigator on a trial of a third vaccine, told Newsline in November. If “you would have had 100 cases of COVID, and you have five, I mean, that is dramatic.”

The most common side effects of the Pfizer vaccine were injection site reactions, fatigue, headache, muscle pain, chills, joint pain and fever, according to the FDA brief. Severe effects occurred in up to about 1 in every 22 participants.

The FDA committee will consider whether to recommend the Pfizer vaccine for people ages 16 and older under an emergency use authorization. However, 16- and 17-year-olds haven’t been studied as much as adult participants.

Children ages 16 to 18 were first included in the Pfizer trials in September. Colorado’s COVID-19 vaccination plan does not include vaccinating people younger than 18.

In Colorado’s current plan, the final group to receive the vaccine — people ages 18 through 64 without high-risk health conditions — is slated for summer vaccination. During the Dec. 9 briefing with Bookman, Polis said that group could be amended to include younger people, once the vaccine is considered safe for them.

Pfizer also began studying vaccine safety and efficacy for children as young as 12 in October. Pregnant women, however, have so far been excluded from the Pfizer trials.

The FDA committee will consider a second vaccine, from pharmaceutical company Moderna, for emergency use authorization on Dec. 17. Pending that decision, Colorado expects to receive 95,600 doses in its first shipment of that vaccine during the week of Dec. 21.

The state anticipates receiving additional vaccine shipments each week after it receives the first Moderna shipment, Bookman said.

Some other countries are ahead of the United States in authorizing the Pfizer vaccine. Canada’s health regulator authorized the Pfizer vaccine Dec. 9, one day before the FDA’s vaccine advisory committee met to discuss their recommendation.

During the FDA committee meeting, Aron Hall, co-lead of the CDC’s COVID-19 epidemiology task force, provided a sobering update for committee members on the virus’ spread across the United States.

Dr. Aron Hall
Dr. Aron Hall, co-lead of the CDC’s COVID-19 epidemiology task force, presented to the FDA’s Vaccines and Related Biological Products Advisory Committee on Dec. 10, 2020. (Screenshot)

Nationwide, more than 285,000 people have died from COVID-19. That’s greater than the populations of Fort Collins and Westminster combined.

Hall said the latest CDC data shows severe obesity, chronic kidney disease and diabetes represent the most significant health-related risk factors for COVID-19 hospitalization, when controlling for age, race and ethnicity. The virus has disproportionately affected people of color, who are more likely than white people to become hospitalized or die after contracting COVID-19.

In Colorado, 3,639 people have died with COVID-19 since the pandemic began, including 2,933 people whose death was directly attributed to the disease.

Officials said Dec. 3 that if the state’s transmission control remains at 71% and people create a holiday surge with unsafe gatherings, Colorado’s death count will number 5,809 by the new year, according to state modeling.

But some of the state’s data from the past two weeks is drawing cautious optimism from health officials who feared that new cases and hospitalizations would climb even higher following the Thanksgiving holiday — leading to even more deaths.

Both cases and hospitalizations are showing a “high plateau” in Colorado’s data, state epidemiologist Rachel Herlihy said during a meeting of the Governor’s Expert Emergency Epidemic Response Committee on Dec. 10.

“The impact of Thanksgiving should be observable really this week, but so far we’ve not yet seen an increase,” Herlihy said. “At this point, it’s continuing to be unclear to us if we need another few days to try and detect any sort of an increase that might be associated with a Thanksgiving holiday” or whether public health measures to suppress virus transmission have worked.

COVID-19 case trends
This figure from the Colorado Department of Public Health and Environment shows the state’s trend of daily new cases of COVID-19. (CDPHE)

Daily new cases steadily increased from October through mid-November, peaking the week of Nov. 12, when an average of 5,068 new cases were reported each day. Over the week of Dec. 2, an average of 4,207 cases were reported daily.

Hospital admissions peaked the week of Nov. 19, when an average of 280 COVID-19 admissions were reported daily to the Colorado Department of Public Health and Environment. For the week of Dec. 2, an average of 141 people were admitted each day.

HELP US GROW
Make a tax-deductible donation.