COVID-19 Vaccine Information

On Friday, Dec. 11, the U.S. Food and Drug Administration (FDA) approved an Emergency Use Authorization (EUA) for the Pfizer and BioNtech COVID-19 vaccine. Doses of the Pfizer vaccine began arriving in Colorado on Monday, Dec. 14 and will continue to be shipped to the state on a rolling basis.

Moderna has also applied for an EUA for its COVID-19 vaccine, which is scheduled to be reviewed by the FDA on Thursday, Dec. 17.

To ensure hospitals are prepared to receive, store, educate, administer, monitor and document the vaccine(s), CHA convened a group of subject matter experts from member hospitals and health systems on Friday, Nov. 20 in order to develop a list of considerations for Colorado hospitals and health systems to work through in advance of the state plan being initiated. Of note, the state has decided that COVID-19 vaccines should be voluntary at this stage.

Return to the CHA COVID-19 resources page

The Colorado Department of Public Health and Environment (CDPHE) and the FDA have large, up-to-date libraries of COVID-19 vaccine resources for health care providers and the general public, as well as extensive FAQ sections. 

Joshua Ewing

Vice President, Legislative Affairs
720.330.6061

FAQs

How many COVID-19 vaccines are currently under development?

As of Nov. 4, four vaccines have begun large-scale (Phase 3) clinical trials in the United States. All but one of the COVID-19 vaccines currently in Phase 3 clinical trials need two shots to be effective. The other COVID-19 vaccine uses one shot. [1]

    • Pfizer/BioNTech submitted an EUA request on Nov. 20. The FDA has scheduled a review panel for Dec. 10.
    • Moderna plans to submit an EUA in the “coming weeks”. [2]
    • Johnson & Johnson initiates second global Phase III clinical trail. [3]
    • Oxford Biomedica focus on completing the Phase II/III clinical trail. [4]

When will hospitals likely see COVID-19 vaccines arrive in Colorado?

COVID-19 vaccines are expected to arrive the week of Dec 12. Pfizer’s vaccine will arrive first, followed by  Moderna. 

What is Operation Warp Speed?

Operation Warp Speed’s goal is to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics and diagnostics (collectively known as countermeasures).[1]

So far, Congress has directed almost $10 billion to this effort through supplemental funding, including the CARES Act. Congress has also appropriated other flexible funding. The almost $10 billion specifically directed includes more than $6.5 billion designated for countermeasure development through BARDA and $3 billion for NIH research.[2] HHS developed a factsheet to explain Operatin Warp Speed and their progress to date available here: Fact Sheet: Explaining Operation Warp Speed | HHS.gov.

What is an Emergency Use Authorization (EUA) and how is it being used to expedite COVID-19 vaccine(s) process?

At least at first, COVID-19 vaccines will used under an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). An EUA is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies like the current COVID-19 pandemic. Under an EUA, the FDA may allow the use of unapproved medical products or unapproved uses of approved medical products in an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved and available alternatives.[3]

Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to the FDA. Once submitted, FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA.[4] More information about EUAs is available here: Emergency Use Authorization for Vaccines Explained | FDA.

If there is limited supply at first, how will the COVID-19 vaccine(s) be distributed?

Despite the worldwide effort to develop safe and effective vaccines against COVID-19 and ramp up production capacity, it is inevitable that initial vaccine supply will be limited. In response to a request from the National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC), the National Academies of Sciences, Engineering, and Medicine (NASEM) formed a committee that will produce a consensus study to assist policymakers in the United States and global health communities in planning for equitable allocation of vaccines against COVID-19. [5] Further, CDC’s Advisory Committee on Immunization Practices (ACIP) is considering four groups to possibly recommend for early COVID-19 vaccination if supply is limited [6]:

    • Health care personnel
    • Workers in essential and critical industries
    • People at high risk for severe COVID-19 illness due to underlying medical conditions
    • People 65 years and older

It is important to note that COVID-19 vaccines may not be available for young children until more studies are completed. [7]

What does the hospital need to do in advance of receiving the vaccine.  

To assist hospitals in preparation for Phase 1 of the Colorado COVID-19 Vaccination Plan, CHA developed a checklist. 

How do hospitals manage the inventory? 

COVID-19 vaccination providers will be required to report COVID-19 vaccine inventory daily using VaccineFinder. Once providers are enrolled in VTrckS, they will be preregistered for a VaccineFinder account and provided instructions via email to submit daily supply information. Jurisdictions may also require that providers submit inventory on hand when placing an order for more vaccines to help inform their allocation decisions. However, the submission of this information into VTrckS is optional. All inventory should be managed in accordance with storage and handling requirements specific to each vaccine. 

Has Colorado made any decisions about who will receive the COVID-19 vaccine first?

Yes. The state of Colorado had designated as part of its Vaccine Distribution Plans that the first to receive the vaccine will be inpatient health care workers, including assisted living facilities. The second group to be outpatient health care workers, including home health and outpatient pharmacists. If there isn’t enough vaccine during the first wave, each facility should determine the best way to distribute it.  

If a Heath Care worker has had COVID-19 and recovered, should they still get vaccinated?   

According to the CDC, there is not enough available information to say if or for how long after infection someone is protected from getting COVID-19 again. Until the Advisory Committee on Immunization Practices makes recommendations to CDC on how to best use COVID-19 vaccines, CDC cannot comment on whether people who had COVID-19 should get a COVID-19 vaccine.   

Is PPE still required after receiving a COVID-19 vaccine?   

Yes. While experts learn more about the protection that COVID-19 vaccines provide under real-life conditions, it will be necessary for everyone to continue using PPE to help stop this pandemic. 

How do I report if a patient has a problem or bad reaction after getting a COVID-19 vaccine? 

The CDC and FDA encourage the public to report possible adverse events to the Vaccine Adverse Event Reporting System (VAERS). This national system collects these data to look for adverse events that are unexpected, appear to happen more often than expected or have unusual patterns of occurrence. Learn about the difference between a vaccine side effect and an adverse event. Reports to VAERS help the CDC monitor the safety of vaccines. Safety is a top priority.

Health care providers will be required to report certain adverse events following vaccination to VAERS. Health care providers also have to adhere to any revised safety reporting requirements according to FDA’s conditions of authorized use throughout the duration of any Emergency Use Authorization; these requirements would be posted on FDA’s website

CDC is also implementing a new smartphone-based tool called v-safe to check-in on people’s health after receiving a COVID-19 vaccine. When patients receive a vaccine, you should distribute a v-safe information sheet telling the patients how to enroll in v-safe. If they enroll, they will receive regular text messages directing you to surveys where they can report any problems or adverse reactions you have after receiving a COVID-19 vaccine.