COVID-19 Vaccines in Colorado: Your Guide
https://gazette.com/news/covid-19-va...49439cc8c.html
"How soon will vaccines be available?
The first doses of the COVID-19 vaccine are expected to arrive in Colorado as early as Sunday, state officials said Wednesday.
The FDA is expected to grant Pfizer emergency use authorization sometime between Friday and Monday. After the approval, an initial shipment to Colorado — of 46,800 doses, the maximum the state was allowed to order — is expected within 24 hours.
Approximately a week later, the state should receive 95,600 doses of the Moderna vaccine, the maximum allowed at this time. More shipments will come in regularly as they're available.
Who gets the vaccine first, in Phase 1A?
High-risk health care workers and people living in long-term care facilities are at the front of the line in December and January. Also, people in direct contact with COVID-19 patients for 15 minutes or more during a 24-hour period.
How can I find out if I'm in Phase 1?
Those who believe they qualify for a Phase 1 vaccine can call a new hotline at 1-877-462-2911 or visit covid19.colorado.gov/vaccine
Who gets the vaccine next, in Phase 1B?
By the end of February, the state hopes to offer the vaccine to:
Moderate-risk health care workers and responders
Workers with less direct contact with COVID-19 patients
Workers in home health, hospice and dental settings.
Emergency medical services, firefighters, police, correctional employees, dispatchers, other first responders, funeral services and COVID-19 response personnel.
Who gets the vaccine during Phase 2 in the spring?
By the end of spring, the state hopes to have vaccinated:
Higher-risk people and essential workers
People 65 or older.
People any age with obesity, diabetes, chronic lung disease, significant heart disease, chronic kidney disease, cancer or other immunocompromised people.
People whose work involves direct interaction with the public, such as grocery store employees and school staff.
Workers in high density settings such as farms and meat-packing plants.
Workers serving people who live in high-density settings.
Health care workers not covered by Phase 1.
Adults who received a placebo during a clinical trial for COVID-19 vaccines.
Who gets the vaccine last, in Phase 3, during summer?
The general public, which means anyone between 18 and 64 who doesn't have high-risk health conditions.
Who is not included in the state's distribution plan?
Children, military service members, pregnant women or children. According to a previous draft plan released by the Colorado Department of Public Health and Environment, the state expects military members to receive vaccines from the federal government.
The plan also explained that the state expects the federal government to release guidance about the safety and effectiveness of children and pregnant women receiving COVID-19 vaccines and will eventually plan for how to incorporate these populations.
The plan also doesn't give priority to inmates, those living in homeless shelters or college students living in dorms; a draft plan put those groups into higher tiers.
When will vaccines be available to children?
They won't be, according to the state. “At least initially, we expect that COVID-19 vaccines will only be authorized for use in non-pregnant adults,” the state’s joint COVID information center said in a statement. “Safety and efficacy data from clinical trials is still needed before the vaccine is available for children and pregnant people. We fully anticipate being able to vaccinate these populations once the FDA and CDC make the recommendation to do so, and our distribution plan will evolve accordingly.”
When do inmates receive vaccines?
The plan announced Wednesday also has not yet explicitly mentioned inmates or people living in high-density environments, such as dorms and homeless shelters.
I’m high risk for COVID-19 but not a frontline worker. How do I “get in line” to receive the vaccine?
Health care providers and local public health agencies will be administering the vaccine under the plan released by the state, according to a statement from the joint information line, adding that there is no pre-registration process with the state.
Who will administer the shots? Can I go to my doctor’s office or drug store?
The vaccines for priority groups such as health care workers, people living in nursing homes and long-term care facilities will be provided via those facilities themselves. As it becomes more widely available and distributed through the population, it will then become available at more typical, point-of-care centers, like doctors’ offices or pharmacies. Officials have also said that they plan to distribute vaccines in a similar manner to the flu vaccine, which utilized other community spaces and facilities.
How much will my vaccination cost?
According to the state and the CDC, the vaccine itself is free. But providers can charge an administration fee for giving it. Still, costs should be minimal to nonexistent. No one can be turned away from receiving a vaccine because they can’t pay. Most insurance providers will cover any administrative costs. Even for the uninsured, or for those people whose insurer doesn’t fully cover the whole process, providers can get a reimbursement from the federal government, rather than billing you. Anyone on Medicare and Medicaid will also be charged nothing.
I’m scared of shots. How is it administered, and where?
Both Moderna and Pfizer’s vaccines are administered through a shot in your arm, according to CDPHE and the FDA.
Will we all be required by law to be vaccinated?
The short answer is states do have authority to require their citizens receive vaccinations.
Typically, enforcing vaccine mandates is an easier matter for children than for adults because of common requirements that children must have proof of certain vaccinations to attend school. In June, Gov. Jared Polis signed a bill into law that adds an extra step for parents who choose not to vaccinate their children for nonmedical reasons. Exemption now requires a form signed by a health care professional or the completion of an online course about vaccines, though the law does not apply to homeschooled children.
A mechanism for enforcing vaccination requirements for adults would have to be built into any state mandate.
Can my boss require me to be vaccinated as a condition of my employment?
Based on existing guidance for employers about flu vaccinations, employers would likely have at least some authority to mandate COVID-19 vaccines for their employees.
The Equal Employment Opportunity Commission allows employers to require flu vaccinations for employees, though employees can request medical exemptions under the Americans With Disabilities Act or for exemptions for religious reasons, protected by Title VII.
The EEOC said in the spring that employers could compel employees to get tested for COVID-19 before returning to work. It’s still to be determined whether the EEOC will issue guidance for employers on COVID-19 vaccines.
The Occupational Safety and Health Administration has also said in the past employers have the right to mandate seasonal flu and H1N1 vaccines for employees.
Employers might lean toward encouraging the vaccine rather than requiring it unless their workplaces are high-risk environments for COVID-19 spread. Workers in high-risk environments, such as hospitals, are probably more likely to have COVID-19 vaccine mandates from their employers.
Are there any side effects from taking the vaccine?
Yes, side effects have been reported, according to the FDA and the vaccines’ manufacturers. According to a report issued about the Pfizer vaccine, the FDA said that the most prevalent side effect was an injection site reaction — meaning pain, swelling or discoloration where you receive the shot. Other common side effects included headaches, fatigue and muscle pain. In its report, the FDA wrote that the findings “suggest a favorable safety profile, with no specific safety concerns identified” that would prevent the agency from authorizing the vaccine.
Is it true I might need to get two shots?
Yes, both the Moderna and Pfizer vaccines require two injections, according to CDPHE. You’ll need to wait three weeks between Pfizer shots and four weeks between Moderna injections. It’s imperative that you receive both doses, not just the first. Information released by the Food and Drug Administration shows that the Pfizer vaccination begins to provide some protection after the first dose, but both are needed for the full effect.
Will we need to get vaccinated annually?
“We don’t know and we won’t know until we get one year out from the time the first people got vaccines,” according to Dr. Thomas Campbell, Chief clinical research officer for UCHealth. He is leading the UCHealth’s clinical trial of Moderna’s coronavirus vaccine.
There is concern that immunity will wane over time, said Dr. Greg Poland, an infectious diseases expert and head of the Mayo Clinic’s Vaccine Research Group. Immunity to mild seasonal coronaviruses wanes and people get reinfected, he said. Seasonal coronaviruses cause symptoms associated with the common cold.
How did we develop a vaccine so quickly?
The Pfizer and Moderna COVID-19 vaccines were developed over roughly 12 months, beating the previous record of about four years because the scientific community was building on previous research into coronaviruses, the federal government and private companies were working closely together, and the timeline for clinical trials was compressed, among other factors, experts in the field said.
Typically, vaccines go through three stages of trials that gradually add more participants. In the first stage, 20 to 200 people typically participate in a phase focused on the basic safety and immune response of the vaccine. In phase two, trials would see hundreds of participants, and in phase three, thousands of people take part, said Dr. Sean O’Leary, professor of pediatrics and infectious diseases at the University of Colorado School of School of Medicine.
Companies typically space out the stages, in part, because phase three trials in particular can be expensive, he said. Federal government funding helped to compress the timeline for development in some cases. Moderna received federal funding while Pfizer did not, he said.
Public interest in the vaccines was also strong, so recruitment for the trials was accelerated, said Dr. Thomas Campbell, chief clinical research officer for UCHealth. He is leading the UCHealth’s clinical trial of Moderna’s coronavirus vaccine.
The companies also did not wait for approval from the FDA to start producing the vaccines, he said.
The type of vaccines that Pfizer and Moderna are producing is also easier to manufacture than some older vaccines because it does not require large quantities of the virus or parts of the vaccines to be produced in the lab, which can be tough, he said. The annual flu vaccine relies on this process.
How do we know the shots are safe and we won’t see adverse side effects over time?
More than 70,000 people have received the vaccines and there has been no evidence of any significant safety issues after 12 to 14 weeks of data collection, said Dr. Greg Poland, an infectious diseases expert and head of the Mayo Clinic’s Vaccine Research Group. Vaccine side effects are expected within minutes or days, he said.
Long-term complications from a vaccine are rare, although possible in some immunocompromised people, said Dr. Sean O’Leary, professor of pediatrics and infectious diseases at the University of Colorado School of School of Medicine. However, medical professionals typically do not give vaccines to patients with those conditions anyway, he said.
What’s the difference between the Pfizer and Moderna vaccinations, the two most likely to be approved by the FDA first?
The vaccines both create immunity in the same way and are both effective about 95% of the time, said Dr. Thomas Campbell, chief clinical research officer for UCHealth. There could be differences in how effective they are over time, he said.
Will the state track and publish statistics about vaccination rates in my area?
Probably some.
The agency will use the Colorado Immunization Information System to provide the local statistics about vaccination rates, according to a spokesperson, which could also be used to inform the efforts to effectively distribute the vaccine: “CDPHE is still identifying specific metrics that will be shared publicly — likely through a data dashboard — throughout the COVID-19 vaccine response. We will share that information when we have it.”
Will the state be tracking the vaccination status of individual Coloradans?
Yes.
“Colorado will use the Colorado Immunization Information System (CIIS) to monitor doses administered, inventory levels, vaccine orders, distribution to vaccination providers and any repositioning of vaccine between vaccination providers during Phase 1 to ensure end-to-end visibility of all doses,” a CDPHE spokesperson wrote in an email. “CIIS is a confidential, population-based, secure computerized system that collects and consolidates individual-level vaccination and exemption data for Coloradans of all ages from a variety of sources.”
The system will track the progress of individuals’ vaccination series “because of the need for a second dose,” the spokesperson wrote in an email.
Will the state health department be sharing vaccination information with other agencies?
Yes.
The CIIS system will allow other agencies to access the vaccination information, a CDPHE spokesperson wrote in an email. “Other government agencies may have access to some of this information if they have authorized access to CIIS. No additional government agencies will have access to everything in CIIS — it would be limited to information about their patient populations.”
The state will not report personally identifying information to the U.S. Centers for Disease Control, the spokesperson wrote. “Colorado will be sharing de-identified, record-level data on the doses administered in our state, along with vaccine inventory data on a daily basis. Because Coloradans’ privacy is a priority, CDPHE negotiated with the CDC to ensure that personally identifying information was not going to be reported from the state to CDC. This complies with Colorado statute.”
Information about individual Coloradans will be kept secure, the CDPHE spokesperson said. “It would be a violation of privacy laws to post a list of individuals who have been vaccinated publicly… Authorized individuals can access immunization information in CIIS only for clinical (including data entry), quality assurance, public health or school entry law purposes. All individuals accessing CIIS are required to treat all information in CIIS as confidential.”
The spokesperson offered the agency’s CIIS policies and procedures webpage and to Colorado Revised Statutes 25-4-2403 for more information.
Compiled by reporters Erin Prater, Mary Shinn, Seth Klamann, Julia Cardi, and Evan Wyloge, with additional information from wire services."
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