COVID-19 Vaccine Planning

The FDA regulates vaccines. Vaccines undergo a rigorous review of laboratory and clinical data to ensure the safety and effectiveness of these products. Approved vaccines may also be required to undergo additional studies to further evaluate the vaccine and often to address specific questions about the vaccine's safety, effectiveness, or possible side effects. The FDA is expediting clinical trials for vaccines by providing timely advice to and interactions with vaccine developers. The FDA is also supporting product development and scaling up of manufacturing capacity for high priority vaccines for COVID-19.

As with most vaccines, studies will need to be conducted in children and in pregnant women, but these studies are often done after the vaccine has been shown to work and be safe in healthy adults. Given the current circumstances, the Food and Drug Administration (FDA) has encouraged vaccine manufacturers to consider including pregnant women in the current studies. Children will most likely be studied after one or more vaccines are approved. 

At first, there may be a limited supply of COVID-19 vaccine(s). Operation Warp Speed will work to get those first vaccine doses out once a vaccine is authorized or approved and recommended, rather than waiting until there are enough vaccines for everyone. However, it is important that the initial vaccines are given to people in a fair, ethical, and transparent way. The goal is for everyone to be able to easily get a COVID-19 vaccine as soon as large quantities are available. Whether it’s at their doctor’s office, retail pharmacy, hospital, or federally qualified health center, several thousand vaccination providers will be available so no one will have to travel far to be vaccinated.

Vaccines will be available when they are demonstrated to be safe and effective in large phase 3 clinical trials, have been approved by the FDA, and have been manufactured and distributed to places where people can be vaccinated. The United States government and others have heavily invested in building the manufacturing capacity to produce large numbers of vaccine doses before the findings of the phase 3 trials are available. This accelerated development does not imply short-cuts or that safety, scientific or ethical integrity are compromised.

If you are interested in stocking and administering the COVID-19 vaccine and meet the requirements below, please fill out this survey https://www.surveymonkey.com/r/9VLNBGB

• You are enrolled in NV WEBIZ.
• You have a stand-alone freezer and a stand-alone refrigerator with digital temperature monitoring devices for vaccine storage.

If a facility needs a data logger, they should include their request in the REDCap enrollment survey.

Yes, but only if the site also has the means to administer the 975 minimum doses required for a direct shipment.

Yes. Facilities will be able to request how much of their allocation they want for each shipment. Hospitals and facilities will be able to receive multiple shipments of vaccines to avoid creating even more strain on an already low health care provider workforce.

Although COVID-19 vaccine manufacturing and distribution is an ever-changing event, we are currently planning for an early December vaccine distribution for hospitals.

All but one of the COVID-19 vaccines currently in phase 3 clinical trials in the United States use two doses. The other COVID-19 vaccine uses one dose. When giving two doses, they are usually given one or two months apart. We will need to wait for the results of the clinical trials to have more information about how many doses will be needed. 

Independent advisory committees to the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) review vaccine safety and effectiveness data before any vaccine is approved or allowed for distribution under Emergency Use Authorization. Vaccines will not be released for use until deemed safe and effective by these committees. In order to speed up the distribution process, Operation Warp Speed is manufacturing vaccines while they are in clinical trials with the intention of throwing them away if the vaccine is not deemed safe and effective at the conclusion of the clinical trial. 

COVID-19 vaccines will not contain microchips. This idea is based on a false narrative and misinformation campaign being waged online. 

No. There is no evidence the vaccines would alter any part of your genomic DNA. These vaccines are “mRNA” vaccines, which use a fragment of genetic material from the virus rather than a weakened or killed version of the virus, to produce an immune response

Under the CARES Act, health insurance, insurers and plans are required to cover any ACIP recommended COVID-19 preventive service, including vaccines, without cost sharing from both in and out-of-network providers during the course of the public health emergency (PHE). As a condition of receiving free COVID-19 vaccines from the federal government, providers will be prohibited from charging consumers for administration of the vaccine. For individuals who are uninsured, providers will be able to be reimbursed for administering the COVID-19 vaccine to individuals without insurance through the Provider Relief Fund, administered by the Health Resources and Services Administration (HRSA).

No. A COVID-19 vaccine administration will NEVER yield a positive COVID PCR test result, regardless if a patient has a low-grade fever or not. The vaccine makes the muscle cells produce the spike protein and antibodies are formed to the spike protein. For a test to be positive, there must be viral RNA in the nose. The vaccine does not cause that.

Once vaccine vials have been pulled out of their Ultra-Cold Storage Units, they are viable for up to 5 days in refrigerators. The ultra-cold vaccine, Pfizer product, vials cannot be refrozen. They must only be thawed out with the intention of using them within 5 days of removal from the ultra-cold freezer. Once a vial has been diluted it must be used within 6 hours

Vaccination data should ideally be reported within 24 hours, but no later than 72 hours.