The COVID-19 Vaccine

Vaccines currently prevent millions of deaths every year from diseases like diphtheria, tetanus, pertussis, measles and influenza. Vaccines work by training and preparing the body’s natural defenses to recognize and fight off the viruses and bacteria they target. If the body is exposed to those disease-causing germs later, the body is immediately ready to destroy them, preventing illness. Vaccines are also critical to the prevention and control of infectious-disease outbreaks.

The Centers for Disease Control and Prevention (CDC) is the national public health institute in the United States under the Department of Health and Human Services. The CDC’s overall responsibility is to address health and safety. 

The CDC is focused on vaccine planning, working closely with health departments and partners to prepare for when a vaccine is available, but they do not have a role in developing COVID-19 vaccines. Learn more about the vaccine planning process by visiting Key Things to Know About COVID-19 Vaccines.

In this unprecedented pandemic, vaccine development is time-dependent, and so scientists and funding have come together to move vaccine candidates through the process for preclinical and clinical assessment, including animal and human trials, under the federal government operation known as Operation Warp Speed, which is a partnership among components of the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Defense to help develop, make, and distribute millions of vaccine doses for COVID-19 as quickly as possible while ensuring that the vaccines are safe and that they work.

This has enabled researchers to advance into phase 3 clinical trials (testing the vaccine on large groups of people to evaluate safety and effectiveness) in six months instead of the typical two years. It is important to note that the scientists are working both quickly and thoughtfully. 
 

COVID-19 can be a minor illness in some or lead to severe disease or even death in previously healthy people. Many treatments and medications are being studied, but there is no cure currently. Prevention is key. Public health officials and medical providers believe that getting a COVID-19 vaccine may help keep you from getting seriously ill even if you do get COVID-19.

The FDA guidance expects that an authorized or approved COVID-19 vaccine would prevent disease or decrease its severity in at least 50 percent of people who are vaccinated. In some cases, COVID-19 vaccines may protect against severe infection, but not necessarily prevent mild or asymptomatic infection. If this is the case, an infected person could still spread the virus. This is why it is expected that even after a vaccine becomes available, people will need to use masks and practice social distancing measures for some time.

A live virus vaccine uses a weakened form of the germ that causes a disease. The vaccines that are expected to be the first to receive EUA from the FDA, do not contain live virus. For information about vaccine types visit: vacines.gov/basics/types. 

The mRNA would not change a person’s DNA.  An mRNA vaccine causes cells to make viral proteins, in this case it is making proteins found in the SARS-CoV-2 virus which is the virus that causes COVID-19. When the proteins are made, they are released from the cell and cells from the immune system recognize them as foreign and attack them, creating an immune response. Since mRNA is active only in a cell’s cytoplasm and DNA is located in the nucleus, mRNA vaccines do not operate in the same part of the cell where DNA is located. 

Information on how to volunteer for a COVID-19 vaccine clinical trial is available on the National Institute of Health website, click Volunteer for COVID-19 Clinical Trials to learn more.

The New Jersey Department of Health collaborated with health care partners and immunization stakeholders to submit a vaccine plan to the CDC in mid-October. This plan encompasses suggested priority groups for vaccination, logistics of vaccine storage and handling, health care provider recruitment, tracking and reporting of immunizations, etc. 

The state is closely following progress on COVID-19 vaccine trials and potential FDA authorized or approved vaccine(s). The NJDOH will provide guidance to hospitals and health care providers regarding the allocation and administration of vaccine in NJ.

Emergency Use Authorization is the legal authority of the U.S. Food and Drug Administration (FDA) to authorize emergency use of an investigational medical product or an unapproved use of an approved medical product to diagnose, treat, or prevent a serious or life-threatening disease. According to the FDA, an EUA is used "to help make medical products available as quickly as possible by allowing unapproved medical products to reach patients in need when there are no adequate, FDA-approved and available alternatives."

When the FDA authorizes emergency use of a medical product, an EUA Fact Sheet for Health Care Providers (in place of a package insert typical of a licensed vaccine) and an EUA Fact Sheet for Recipients (akin to product information for patients or a CDC-provided VIS for a licensed vaccine) must be provided to the health care providers prescribing and/or administering the authorized medical product. The health care providers, in turn, provide the EUA Fact Sheet for Recipients to vaccine recipients or their guardians.

When FDA authorizes a vaccine for use under an EUA, providers and public health entities involved in vaccine administration are legally required to provide the FDA-authorized EUA Fact Sheet for Recipients to individuals receiving vaccine or their guardians, similar to VIS’s that are also required by law for certain licensed vaccines. The EUA Fact Sheet for Recipients, like the VIS, explains the benefits and risks associated with the vaccine. But unlike a VIS, the EUA fact sheet also provides vaccine product-specific information, including the vaccine’s authorized use, dose/dose-series, and known information or experience with the vaccine from clinical trials that support issuance of the EUA by FDA. 
Providers can provide the EUA Fact Sheet for Recipients (or VIS if/when the COVID-19 vaccine is licensed) in a variety of ways, including hard copy, online, video, or other electronic means of dissemination.

The FDA applies the same stringent review process to all vaccines regardless of manufacturer. FDA approval or authorization of a vaccine means that the agency has determined, based on substantial evidence and a stringent review process, the vaccine is safe and effective for its intended use. Pfizer’s and Moderna’s vaccines – the first two vaccines that are likely to receive EUA – have both been shown to be at least 94 percent effective and they have the same mechanism of action.

The safety of COVID-19 vaccines is a top priority. Vaccine makers continue to follow strict protocols for monitoring the safety and efficiency of the vaccines, as well as any side effects that vaccine recipients experienced during the clinical trial phase. They have been transparent with the data which shows these vaccines are highly effective in protecting against COVID-19.

Most vaccines only need to reach 50% efficacy for FDA approval. After two doses, the Pfizer vaccine has an efficacy rate of 95% with no serious safety concerns based on clinical trials with more than 43,000 people. The Moderna vaccine has an efficacy rate of 94% with no serious safety concerns. The efficacy rate means that there was at least a 94% reduction in contracting COVID-19 for the clinical trial participants who received the vaccine versus those who received a placebo.

For detailed information, visit Ensuring COVID-19 Vaccine Safety in the US.

As with other vaccines, some people experience side effects consistent with immune responses. It is normal to have some arm soreness at the injection site and some people experience additional side effects such as fatigue, fever, muscle pain, chills, or headache. Taking ibuprofen or acetaminophen (if it is safe for you to do so) before you get the vaccine may help to alleviate the side effects, which typically go away within a day or less. What remains is protection against COVID-19.

Additional data will determine how long that protection lasts and whether an annual vaccination will be required. But the evidence is clear that the risks from contracting COVID are greater than the possible risks from receiving the vaccine.

If you are not feeling well, it is recommended that you wait until you are feeling better to get the vaccine. 

In early clinical trials for various COVID-19 vaccines, only non-pregnant adults participated. For this reason, the vaccine will not be available for use in pregnant women when it first becomes available. However, clinical trials continue to expand those recruited to participate. Based on data from the expanded clinical trials, groups recommended to receive the vaccines could change in the future. 

Yes, Inspira Health is offering the Pfizer-BioNTech vaccine to children ages 5 and up.

Appointments are recommended for Inspira employees to receive the vaccine and those being vaccinated will be required to observe their scheduled appointment.

You will need to bring your mobile phone; your employee ID; a government ID; and your insurance card. You will also need to wear a mask consistent with our current protective measures.

You will arrive at the scheduled clinic site, check-in to confirm your employee registration form, then you will receive the COVID-19 vaccine. You will be monitored for 15 minutes on-site after receipt of the vaccine and will then be able to schedule the 2nd COVID-19 vaccine dose for 21 days later. After the appointment, you will be provided with a COVID-19 vaccination card and vaccine EUA fact sheet. The appointment will take approximately 30 minutes, including the 15-minute observation period.

Yes. Vaccines may boost your immune system so it is ready to fight the virus if you are exposed, but it is not yet fully understood whether vaccinated people might still be able to transmit the virus. Initially, we will not have enough vaccine globally to vaccinate everyone who wants the vaccine, and the virus will still be transmitted in the environment. 

Receiving the vaccine will have no effect on your work assignments.

All are welcomed to direct questions to our COVID vaccine email: COVIDvax@ihn.org.  

Healthcare workers are being vaccinated by health care facilities to insure vaccine availability and all necessary tracking and documentation.  Pharmacy chains such as CVS and Walgreens will be working with the Long Term Care providers to provide vaccinations to staff and residents of those facilities.  It is unknown just yet when vaccines will be available to pharmacies for the general public.

No, Inspira currently only offers the Pfizer vaccine. 

Yes, at least one vaccine (Pfizer) requires ultra-cold storage conditions and Inspira has purchased two freezers capable of storing vaccine down to -80 degrees Celsius. The CDC is working on ways to support ultra-cold chain vaccine storage and handling needs. Information will be shared once it becomes available. 

There are numerous vaccination sites within NJ. Use the NJ Vaccine Appointment Finder to find vaccination sites with available appointments. 

No, informed consent is not a federal requirement. An Emergency Use Authorization (EUA) vaccine recipient fact sheet will be available online, and providers are required to provide those to vaccine recipients prior to vaccine administration. 

Minors (under 18 years old) must bring a form of ID that shows their date of birth (i.e. driver’s license/permit, passport, birth certificate, etc.). Additionally, minors must be accompanied by a parent/guardian who is authorized to sign an informed consent for the minor's vaccination.

Clinical trials for the COVID-19 vaccines did not include testing safety of getting the flu vaccine on the same day. Once COVID-19 vaccine(s) are authorized or approved by FDA, CDC will provide administration guidance. Inspira employees and providers should have already received their influenza vaccination for this flu season.

No, the COVID-19 vaccine does not take the place of the pneumonia vaccine or the flu vaccine. It is a good idea to be up to date on pneumonia and flu vaccines in addition to COVID-19. 

Staff will be wearing a procedure mask, face and eye protection, gown and gloves. The staff will also perform hand hygiene before and after administering the vaccine. This is the PPE recommended by the CDC and additional guidance will be provided as needed when COVID-19 vaccine is available. 

For information on PPE for health care workers, see Using Personal Protective Equipment.

It usually takes about one to two weeks for immunity to develop following vaccination, but the specific timeline for any coronavirus vaccine will depend to some extent on which type of vaccine it is. 

Yes, you should still be vaccinated. There is not enough information currently available to say if or for how long after infection someone is protected from getting COVID-19 again; this is called natural immunity. Early evidence suggests natural immunity from COVID-19 may not last very long, but more studies are needed to better understand this. Until we have a vaccine available and know more about natural immunity to COVID-19, the CDC cannot comment on whether people who had COVID-19 should get a COVID-19 vaccine. Once a vaccine has been authorized or approved, ACIP will make recommendations to CDC on who should get a COVID-19 vaccine.

The New Jersey Immunization Information System (NJIIS), operating since 1997, is the statewide immunization information system (IIS) serving as the official repository of immunizations administered to individuals in the state of New Jersey. NJIIS is a free, confidential, population-based online system that collects and consolidates immunization information to provide an accurate immunization assessment for individuals in the state of New Jersey, as well as assists communities in assessing their immunization coverage and identifying pockets of need. For more information on NJIIS, please visit the New Jersey Immunization Information System.

If you are NOT an NJIIS user or facility, you will be required to register with NJIIS by completing the COVID-19 Facility Preregistration Enrollment Form.

If you are a currently an active NJIIS provider, you do not need to complete the COVID-19 Preregistration Enrollment Form. The Program will message out instructions once COVID-19 vaccines ordering and training is available.

Yes, the CDC’s provider agreement form will need to be completed in order for a provider to order the COVID-19 vaccine. The COVID-19 Vaccine Enrollment is available for sites currently registered in NJIIS. Providers interested in participating in the COVID-19 vaccination program should complete the CDC COVID-19 Provider Agreement that is available electronically through NJIIS. When you log into NJIIS, the COVID-19 Vaccine Enrollment will be on the landing page. 

To assist sites with completing the enrollment and to have technical assistance questions answered, the Vaccine Preventable Disease Program will hold weekly office hours. You can register for office hours on the NJIIS COVID-19 enrollment page.

The COVID-19 vaccine will be distributed by the federal government at no cost to enrolled COVID-19 vaccination providers. More information will be shared as soon as it is available. 

Yes, providers can bill for an office visit when administering COVID-19 vaccine if the visit meets the criteria for office visit coding under a recipient’s plan.

Yes, vaccine providers will be able to charge an administration fee. However, participating vaccine providers must administer COVID-19 vaccine regardless of the vaccine recipient’s ability to pay COVID-19 vaccine administration fees or coverage status, as stated in the CDC Provider Agreement. Vaccine providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient. For uninsured patients, the vaccine provider can seek reimbursement for an administration fee from the HRSA Provider Relief Fund.

Data may be entered manually. Once a staff member has completed the COVID-19 training, they will be able to log into NJIIS, with their username and password, to manually enter COVID-19 doses into NJIIS. If you have an Electronic Health Record (EHR) and wish to establish an interface with NJIIS, please complete the Interface Enrollment Request Form. NJIIS can receive immunization data directly from a provider’s office EHR system via HL7 version 2.5.1 standard messaging protocol. The time it takes to establish an interface will vary based on issues with data submissions, errors in formatting of the messages.

Yes. Funds from 317 and PPHF would be the easiest funds to use. Awardees may also reach out to Preparedness and/or Strategic National Stockpile to determine if funds/equipment are available through alternative channels.