{"id":35882,"date":"2020-11-16T09:15:41","date_gmt":"2020-11-16T16:15:41","guid":{"rendered":"https:\/\/www.uchealth.org\/today\/?p=35882"},"modified":"2024-12-24T08:52:03","modified_gmt":"2024-12-24T15:52:03","slug":"coronavirus-vaccine-trials-continue-as-hospitals-prepare-for-mass-vaccination","status":"publish","type":"post","link":"https:\/\/www.uchealth.org\/today\/coronavirus-vaccine-trials-continue-as-hospitals-prepare-for-mass-vaccination\/","title":{"rendered":"UCHealth coronavirus vaccine trials continue as hospitals prepare for mass vaccination"},"content":{"rendered":"
<\/div>
\"\"
UCHealth expects more good news on the vaccine front and is preparing for mass vaccinations. Photo: Getty Images.<\/figcaption><\/figure>\n

Editor’s note: For the most up-to-date COVID-19 vaccine information, please click here<\/a>.<\/strong><\/em><\/p>\n

Early results from clinical trials have shown that vaccines may be nearly 95% effective in preventing the transimission of COVID-19.<\/p>\n

An independent safety and data monitoring board reported today that early results from the Moderna Phase 3 clinical trials show the company’s vaccine was 94.5% effective.<\/a><\/p>\n

That news followed equally positive preliminary results on Nov. 9 from Pfizer<\/a> showing that the coronavirus vaccine that Pfizer developed with German drugmaker BioNTech looks to be safe and more than 90% effective in preventing COVID-19 transmission.<\/p>\n

While Phase 3 trials continue, Moderna and Pfizer are expected to ask the U.S. Food and Drug Administration for emergency approval for their new vaccines later in the coming weeks. Experts predict that approval could come in mid-to-late December.<\/p>\n

Pfizer expects to have 50 million doses ready to administer by the end of the year. Given that the vaccine involves a booster shot at the 28-day mark, those doses could protect 25 million people. The company says it aims to produce another 1.3 billion doses in 2021.<\/p>\n

Moderna expects to have about 20 million doses of their vaccine ready to ship within the U.S. by year’s end and plans to manufacture and ship about 500 million to 1 billion doses globally in 2021. The Moderna vaccine also requires a booster shot.<\/p>\n

Coronavirus vaccine trials<\/strong><\/h3>\n

The news from Moderna and Pfizer bodes well for the beginning the end of the COVID-19 pandemic and for other coronavirus vaccines. Two of them \u2013 the Moderna and Oxford\/AstraZeneca vaccine \u2013 are in late-stage clinical trials at UCHealth.<\/p>\n

\"Dr.
Dr. Thomas Campbell leads UCHealth\u2019s clinical trial of Moderna\u2019s coronavirus vaccine at UCHealth University of Colorado Hospital on the Anschutz Medical Campus. Photo: UCHealth.<\/figcaption><\/figure>\n

\u201cI think that these early results are very exciting \u2013 they demonstrate very high efficacy in the short term, and the results in the Moderna study are very consistent with the results of the Pfizer study we heard about last week,\u201d said\u00a0Dr. Thomas Campbell<\/a>, the\u00a0University of Colorado School of Medicine\u00a0and UCHealth virologist and infectious-disease specialist who leads the Moderna trial<\/a> at UCHealth. \u201cSo we have two independent scientific experiments that are analyzing two very similar vaccine strategies that give us very high confidence that these results are real.\u201d<\/p>\n

Campbell added, though, that the Moderna trial happening at UCHealth University of Colorado Hospital<\/a>\u00a0on the\u00a0Anschutz Medical Campus<\/a> and 88 other sites will run for a total of two years.<\/p>\n

\u201cIt\u2019s important to continue, because we need to know both longer-term safety and efficacy,\u201d he said.<\/p>\n

\u2018Good immunity\u2019 in studied coronavirus vaccines<\/strong><\/h3>\n

The similarity between the Moderna and Pfizer vaccines also should extend to the Oxford\/AstraZeneca COVID-19 vaccine, says Dr. Gary Luckasen, who is leading the Oxford\/AstraZeneca vaccine trial<\/a> at UCHealth\u2019s northern Colorado hospitals.<\/p>\n

Both the Moderna and Oxford\/AstraZeneca COVID-19 vaccines introduce SARS-CoV-2 (the virus that causes COVID-19) spike proteins to the body just as Pfizer\u2019s vaccine does. But rather than inject SARS-CoV-2 spike proteins directly, the vaccines deliver genetic instructions (via messenger RNA, or mRNA) that make their way into shoulder-muscle cells near the injection site. The Pfizer and Moderna vaccines deliver the genetic instructions to muscle cells in tiny fatty envelopes; the Oxford\/AstraZeneca vaccine does so using a weakened common-cold virus called an adenovirus. Once in the muscle cells, the mRNA instructs those cells to produce SARS-CoV-2 spike proteins that then trigger the immune response. (For background on coronavirus vaccines, check out UCHealth\u2019s vaccine Q&A<\/a>).<\/p>\n

Given the parallels in approach, there\u2019s reason to anticipate good results from the Oxford\/AstraZeneca trial, Luckasen says.<\/p>\n

\"Dr.
Dr. Gary Luckasen leads UCHealth\u2019s clinical trial of the Oxford\/AstraZeneca coronavirus vaccine at UCHealth in northern Colorado. Photo: UCHealth.<\/figcaption><\/figure>\n

\u201cSince the basic protein we\u2019re developing immunity to is similar to what we see with the Pfizer and Moderna vaccines, this should be a vaccine that\u2019s not only well tolerated, but also produces a good amount of immunity,\u201d he said.<\/p>\n

The Oxford\/AstraZeneca trial aims to enroll 1,500 patients at UCHealth Medical Center of the Rockies<\/a> in Loveland in conjunction with UCHealth Poudre Valley Hospital<\/a> in Fort Collins, UCHealth Greeley Hospital<\/a>, and UCHealth Longs Peak Hospital<\/a> in Longmont. Luckasen\u2019s team has enrolled about 300 so far and are adding another 70 or so participants a day, six days a week, Luckasen says.<\/p>\n

The Moderna trial at UCHealth has enrolled 217 \u2013 a number that\u2019s now capped, Campbell says, because the overall trial is fully enrolled. Some participants still need their booster, which, like the Oxford\/AstraZeneca vaccine, happens at the four-week mark.<\/p>\n

Mobilization ahead<\/strong><\/h3>\n

Taken together, the COVID-19 vaccines indeed look promising \u2013 and another eight<\/a> coronavirus vaccines are in late-stage trials around the world, along with dozens of others in earlier human and animal trials. Assuming some or all 11 of that early pack pan out, UCHealth and the rest of the health care system face a big challenge: distributing, administering, and tracking the vaccinations of billions of people around the world. Experts estimate that, assuming no surprises, the general public will be in line for COVID-19 vaccination late in the second quarter or early in the third quarter of 2021 (this assumes that health care workers, essential workers, and those at high risk for serious disease are vaccinated earlier).<\/p>\n

\"A
UCHealth registered nurse and research coordinator Stacie Kenny administers a shot to the first participant of UCHealth\u2019s COVID-19 vaccine study being conducted in northern Colorado. Participants in the study will receive either a placebo vaccine or a vaccine developed by Oxford University and pharmaceutical company AstraZeneca. Photo courtesy of UCHealth.<\/figcaption><\/figure>\n

The biggest hurdle facing the widespread distribution of the Pfizer COVID-19 vaccine will be that it must be stored at minus-94 degrees Fahrenheit. Your standard kitchen freezer chills at about zero Fahrenheit. That\u2019s the difference between a cold winter night and a hot summer day, and one that demands specialized ultra-cold freezers. Once thawed out, the Pfizer COVID-19 vaccine keeps for about five days in a refrigerator. The system ensuring that vaccines maintain safe temperature from manufacture to injection is known as the cold chain<\/a>.<\/p>\n

Nancy Stolpman, UCHealth\u2019s Director of Pharmacy, said UCHealth has done a full assessment of its cold-chain storage capacity across the system. While more ultra-cold freezers will clearly be needed, it\u2019s still unclear how many, she says.<\/p>\n

That\u2019s because much remains uncertain. Will Pfizer, the state, counties, or others have storage capacity? How much of the Pfizer vaccine will be available and when? When might the Moderna, Oxford\/AstraZeneca, or other COVID-19 vaccines become available?<\/p>\n

That\u2019s a key question because the Moderna vaccine and Oxford\/AstraZeneca vaccines will be easier on the cold chain storage. They can be stored and shipped at minus-4 degrees Fahrenheit, a temperature that standard freezers can manage. Also other vaccines in development, including ones from Johnson & Johnson and Novavax, can be<\/a> stored and shipped above freezing at standard-refrigerator temperatures.<\/p>\n

Other wrinkles: Pfizer plans to ship the COVID-19 vaccine in multidose vials, meaning UCHealth must take care to have patients lined up promptly once a vial comes out of deep freeze. UCHealth facilities in Greeley, Steamboat Springs, and Colorado Springs will store COVID-19 vaccine caches for the state (and not just UCHealth). Given the need for a booster, UCHealth must ensure that, once a patient receives the initial dose, the booster\u2019s availability three or four weeks out is guaranteed. That will take good record keeping, which UCHealth\u2019s Epic electronic medical record will help manage, Stolpman says. That recordkeeping will extend to reporting to the Colorado Immunization Information System<\/a>, she adds.<\/p>\n

A team of 30 people from across UCHealth \u2013 pharmacists, infectious-diseases experts, hospital administrators, clinicians and others \u2013 is working through the many aspects of what will, if all goes well on the vaccine-development front, be a true vaccination mobilization. It\u2019s a lot of work amid great uncertainty, Stolpman says, but it\u2019s a great problem to have during a pandemic.<\/p>\n

\u201cThis is fabulous,\u201d she said. \u201cWe appreciate the challenge. We\u2019re welcoming it. We want it.\u201d<\/p>\n

For information about enrollment or questions about UCHealth\u2019s Oxford\/AstraZeneca vaccine trial at UCHealth\u2019s hospitals in northern Colorado, call 970-624-1589 or email <\/em>nococovidresearch@uchealth.org<\/em>.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

Editor’s note: For the most up-to-date COVID-19 vaccine information, please click here. Early results from clinical trials have shown that vaccines may be nearly 95% effective in preventing the transimission of COVID-19. An independent safety and data monitoring board reported today that early results from the Moderna Phase 3 clinical trials show the company’s vaccine […]<\/p>\n","protected":false},"author":23,"featured_media":33991,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[8],"tags":[4859,4860,9069,162,4781],"class_list":["post-35882","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-coronavirus","tag-covid-19","tag-covid-19-vaccine","tag-infectious-diseases","tag-research-in-health-care"],"acf":[],"yoast_head":"\nCOVID-19 vaccine trials continue as hospitals prep for mass 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