COVID-19 Vaccine

What role do COVID-19 vaccinations play in helping to curb the pandemic?

COVID-19 vaccination will help protect ourselves, our families, and our communities from the disease and save lives. Vaccines can both prevent and reduce the severity of disease. Vaccines provide immunity without the serious risks associated with getting infected naturally. Wearing masks and physical distancing help reduce the chance of being exposed to the virus or spreading it to others, but these measures are not enough.

The COVID-19 vaccines are designed to work with our immune systems so the body is ready to fight the virus if we are exposed to it. When enough people in a community get vaccinated against COVID- 19, immunity rates in our communities substantially increase, which reduces the spread of the virus.

Are the COVID-19 vaccines safe?

Yes. COVID-19 vaccines have been evaluated in tens of thousands of individuals who volunteered to participate in clinical trials. These clinical trials met the same rigorous standards set for all vaccines by the Food and Drug Administration (FDA).

The information from these clinical trials allowed the FDA to determine that the newly authorized COVID-19 vaccines meet its safety and effectiveness standards. Based on these findings, the FDA has made the vaccines available for use in the United States under what is known as an Emergency Use Authorization (EUA).

The Centers for Disease Control and Prevention (CDC) and the FDA is continuing to monitor the safety of the vaccines now that they are in use.

How effective will the vaccines be for disease prevention?

The COVID-19 vaccines currently authorized for use were found to be highly effective in preventing COVID-19 in clinical trials.

For example, in Phase 3 trials, the Pfizer vaccine showed a 95% efficacy rate seven days after the second dose. The Moderna vaccine showed a 94% efficacy rate 14 days after the second dose.

These results for both vaccines were consistent across gender, age, race, and ethnicity.

How do COVID-19 mRNA vaccines (Pfizer and Moderna) work?

The vaccines contain synthetic mRNA, which is genetic information used to make the SARS-CoV-2 spike protein. The spike protein is the part of the virus that attaches to human cells. The spike protein alone cannot cause COVID-19.

Once the spike protein is created, it causes the immune system to make antibodies against the virus. These antibodies can then provide protection if a person comes into contact with the virus.

Since the vaccine does not contain any virus, it is not possible to spread COVID-19 from receiving the vaccine. The mRNA does not enter the center of the human cell where DNA is made (the nucleus); so, it cannot alter the genetic material of the cell (DNA). The mRNA is rapidly broken down, making the chance for long-term side effects less likely. The mRNA vaccines do not have the ability to cause cancer.

Learn more here: https://www.cdc.gov/vaccines/covid-19/downloads/healthcare-professionals- mRNA.pdf

Can I get COVID-19 from a vaccine?

No. None of the COVID-19 vaccines currently authorized for use or in development in the United States use the live virus that causes COVID-19.

What many people experience as a result of receiving the vaccine are not side effects, but rather the body’s immune system responding to the COVID-19 vaccine. Both COVID-19 mRNA vaccines (Pfizer and Moderna) work with your immune system so it will be ready to fight the virus if you are exposed. The most common immune responses are short-term injection site pain, swelling or redness, tiredness, headache, muscle pain, joint pain, chills or fever.

It usually takes a few weeks for the body to build immunity after receiving the second dose of the vaccine. That means it is possible for an individual to be infected with the virus that causes COVID-19 if exposed just before or just after vaccination. The vaccine itself does not cause infection. Similarly, the vaccine cannot cause you to have a positive COVID-19 test.

What is an Emergency Use Authorization (EUA)?

During a public health emergency, the FDA can use a process called “Emergency Use Authorization” (EUA). This process allows the use of medical products that are not yet approved to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met.

Several additional COVID-19 vaccines are currently being developed and tested for their safety and effectiveness in clinical trials (efficacy). Once vaccine manufacturers submit for authorization, the FDA evaluates the EUA request and determines whether they are safe and effective, taking scientific evidence into account. For a vaccine to receive an EUA, the FDA must determine if the vaccine’s benefits outweigh its risks based on data from rigorous clinical trial(s).

Additional information on EUAs: https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency- use-authorization-vaccines-explained

How does the FDA Assess Safety and Effectiveness of a COVID-19 Vaccine Submitted for Emergency Use Authorization (EUA)?

COVID-19 vaccines are undergoing a rigorous development process that includes tens of thousands of study participants to gather required safety and efficacy data, in the same way as many other currently approved vaccines. The FDA evaluates the information submitted by a vaccine manufacturer and uses
all available tools and information, including records reviews, site visits, and previous manufacturing compliance history.

For an EUA to be issued, the FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine.

Link: https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines- explained

Which COVID-19 vaccines have been authorized for use by the FDA?

At this time, there are two COVID-19 vaccines authorized for use by the FDA. 

The Pfizer-BioNTech mRNA COVID-19 vaccine received FDA authorization December 11, 2020 for individuals ages 16 an older. It is a 2-dose vaccination series, given intramuscularly, recommended at least 3 weeks apart. For the full FDA statement on the authorization of this vaccine:

https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19

The Moderna mRNA COVID-19 vaccine received FDA authorization December 18, 2020 for individuals 18 and older. It is a 2-dose vaccination series, given intramuscularly, recommended at least 1 month apart. 

For the full FDA statement on the authorization of this vaccine: https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid

Why have vaccines been developed so quickly?

The vaccine process has happened faster because vaccine research and development, clinical trials, manufacturing, and plans for distribution have occurred at the same time. This method removed delays that occur when these processes are carried out one after the other. Steps to ensure safety were NOT eliminated.

What can individuals do to protect themselves and others until COVID-19 vaccines are more widely available?

It is vital that each person uses all tools available to stop the pandemic. Tools include:​

• wearing masks/face coverings properly,
• washing hands with warm water and soap for at least 20 seconds (or rubbing hands with at

• least 60% alcohol-based hand sanitizer when soap/water is not available),

• staying at least 6 feet away from others,

• avoiding indoor gatherings as possible, and

• getting vaccinated against COVID-19.

  
  

Why do we need a vaccine if we can take other COVID-19 precautions, like masking and physical distancing, to slow or prevent the spread?

It is vital that each person uses all tools available to stop the pandemic. Vaccines work with the immune system and allow a strengthened response to the virus if exposure occurs.

Other steps, like covering the mouth and nose with masks/face coverings worn properly, washing hands, and staying at least 6 feet away from others, help reduce chances of exposure to the virus or spreading it to others.

How do West Virginians sign up to get registered?

COVID-19 vaccine appointments are now coordinated through a centralized statewide system. All West Virginians 16 years of age and older are encouraged to pre-register for COVID-19 vaccination by creating a WV COVID-19 Vaccine Registration System account at vaccinate.wv.gov or by calling the WV COVID-19 Vaccine Info Line at 1-833-734-0965.

Pre-registering allows West Virginians to receive updates on COVID-19 vaccine availability and to get contacted with a vaccination appointment when available to you as limited supplies allow. More information is available at vaccinate.wv.gov.

Should I take COVID-19 vaccines if I have a significant history of allergic reactions?

This section addresses contraindications and precautions to mRNA COVID-19 vaccines. Individuals with allergy questions or concerns should consult a health care provider. Disclose any allergies to medical staff prior to vaccination.

While rare, anaphylactic reactions have been reported following vaccination with mRNA COVID-19 vaccines. Although investigations are ongoing, persons with a history of an immediate allergic reaction (of any severity) to an mRNA COVID-19 vaccine or any of its components might be at greater risk for severe reaction upon taking additional doses. For the purposes of this guidance, an immediate allergic reaction to a vaccine or medication is defined as any hypersensitivity-related signs or symptoms such as hives (urticaria); swelling around the face, lips, and tongue (angioedema); wheezing or other respiratory distress; or anaphylaxis that occur within four hours following getting the vaccine.

Recommendations for contraindications and precautions are described below and summarized in the figure from CDC at the end of this question section. The following recommendations may change as further information becomes available.


Contraindication to vaccination:

Contraindications are conditions or factors that would be a reason to not get vaccination due to harm. (Individuals with a contraindication should not get the COVID-19 vaccine.)

CDC considers a history of the following to be a contraindication to vaccination with both the Pfizer- BioNTech and Moderna COVID-19 vaccines:

1. Severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or any of its components

2. Immediate allergic reaction* (within 4 hours) of any severity to a previous dose of an mRNA COVID-19 vaccine or any of its components (including polyethylene glycol [PEG])

3. Immediate allergic reaction* (within 4 hours) of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)*

*As noted above: For the purposes of this guidance, an immediate allergic reaction to a vaccine or medication is defined as any hypersensitivity-related signs or symptoms such as hives (urticaria); swelling around the face, lips, and tongue (angioedema); wheezing or other respiratory distress; or anaphylaxis that occur within four hours following getting the vaccine.

Persons with an immediate allergic reaction to the first dose of an mRNA COVID-19 vaccine should NOT receive additional doses of either of the mRNA COVID-19 vaccines. Providers should attempt to determine whether reactions reported following vaccination are consistent with immediate allergic reactions versus other types of reactions commonly observed following vaccination, such as passing out (a vasovagal reaction) or post-vaccination side effects—which are not contraindications to receiving the second vaccine dose (see the figure at the bottom of this question section).


The following fact sheets contain additional information about who should not receive the vaccine.

Pfizer-BioNTech Fact Sheet for Vaccine Recipients and Caregivers:
https://www.fda.gov/media/144414/download

Moderna Fact Sheet for Vaccine Recipients and Caregivers:
https://www.fda.gov/media/144638/download

The following vaccines ingredients list is available from:
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-12/slides-12-19/06-COVID- Mbaeyi.pdf

Precaution to vaccination:

Precautions are conditions or factors that would be a reason to consult with a health care provider before proceeding with vaccination. Vaccine providers should observe these patients for 30 minutes after vaccination to monitor for the development of immediate adverse reactions.

No contraindication or precaution:

There are allergies that do not constitute a contraindication or precaution to vaccination, including:

• History of food, pet, insect, venom, environmental/seasonal, latex, or other allergies not related to vaccines or injectable therapies

• History of allergy to oral medications (including the oral equivalent of an injectable medication)

• Family history of anaphylaxis

• Any other history of anaphylaxis that is not related to a vaccine or injectable therapy

For rare instances when individuals experience immediate allergic reactions, appropriate medical treatments are available (and are mandatory on site) to manage the symptoms.

Clinical considerations are available here: https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/anaphylaxis-management.html

Figure is available at: https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html

Are children and adolescents recommended to receive COVID-19 mRNA (Pfizer and Moderna) vaccines?

Children/adolescents under age 16.

COVID-19 vaccines are not recommended for children/teens under age 16 (Pfizer) or under age 18 (Moderna) at this time. In early clinical trials for various COVID-19 vaccines, only adults who were not pregnant participated. Older children (12 and up) were added in later trials. However, clinical trials continue to expand and include other groups, so these recommendations may change in the future.

Adolescents age 16 and older.

Individuals aged 16-17 years are eligible to receive the Pfizer-BioNTech COVID-19 vaccines (but not the Moderna COVID-19 vaccine at this time). No safety concerns were identified in this group during Pfizer- BioNTech COVID-19 clinical trials. Although vaccine safety and efficacy data in this age group are somewhat limited, there is no medical reason to believe that responses from this group would be different from those who are 18 years of age and older. Adolescents aged 16-17 years who are part of a group recommended to receive a COVID-19 vaccine may be vaccinated with the Pfizer-BioNTech vaccine.

Full clinical guidance is available here: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html

Should I take the vaccine if I am pregnant?

Based on current knowledge, experts believe that mRNA vaccines are unlikely to pose a risk for people who are pregnant. Currently, however, there are no data on the safety and efficacy of COVID-19 vaccines in pregnant women. Yet, people who are pregnant and become infected with COVID-19 can have an increased risk of severe illness or negative pregnancy outcomes, such as preterm birth. Reputable sources, such as the American College of Obstetricians and Gynecologists, have advised that the benefit of vaccination may outweigh the risk of severe COVID-19 disease. For this reason, if a person who is pregnant is part of a group who is recommended to receive a COVID-19 vaccine, they may choose to be vaccinated. A discussion with a health care provider can help make an informed decision. Although a conversation with a healthcare provider may be helpful, it is not required prior to vaccination.

Should I take the vaccine if I am breastfeeding?

If someone who is breastfeeding is part of a group who is recommended to receive a COVID-19 vaccine, they may choose to be vaccinated. Currently, there is no data on the safety and efficacy of COVID-19 vaccines in breastfeeding women as they were excluded from clinical trials. However, the CDC has stated that since the mRNA vaccine does not contain live virus, it is not thought to be a risk to breastfeeding infants. A discussion with a health care provider can help to make an informed decision. Although a conversation with a healthcare provider may be helpful, it is not required prior to vaccination.

Are the mRNA vaccines safe for people who want to become pregnant?

There is no evidence the COVID-19 vaccine affects fertility. People who are trying to become pregnant or who are pregnant and for whom the vaccine is recommended may choose to be vaccinated. A discussion with a health care provider can help to make an informed decision.

More information from the American Society for Reproductive Medicine is available here: https://www.asrm.org/news-and-publications/news-and-research/press-releases-and-bulletins/asrm- issues-statement-on-covid-19-vaccines-joins-other-obgyn-groups-on-community-wide-statement/

Should I take the vaccine if I am immunocompromised?

Currently, there is no data on the safety and efficacy of COVID-19 vaccines in immunocompromised people. However, persons with immunocompromising conditions or who take immunosuppressive medications or therapies might be at increased risk for severe disease if they get COVID-19. Therefore, the CDC recommends these individuals receive the COVID-19 vaccine. Immunocompromised individuals should discuss this with a healthcare provider. It is important to note that the mRNA vaccines do not contain live virus; so, it is not possible to develop COVID-19 from vaccination.

Are COVID-19 vaccines safe for people with autoimmune disease?

Experts say there is no reason to believe that the currently approved mRNA COVID-19 vaccines will be unsafe for people with autoimmune disease. Additionally, authorized mRNA vaccines are expected to be safe for immunocompromised patients and those on immunosuppressant drugs. However, it is yet unconfirmed whether immunosuppressant medications or unchecked disease activity may reduce vaccine effectiveness. Persons with autoimmune conditions who have no contraindications to vaccination may receive an mRNA COVID-19 vaccine. A discussion with a health care provider can help to make an informed decision.

Should I take the vaccine if I’ve had Guillain-Barré syndrome?

To date, no cases of Guillain-Barré syndrome (GBS) have been reported following vaccination among participants in the mRNA COVID-19 vaccines clinical trials. With few exceptions, Advisory Committee on Immunization Practices (ACIP) general best practice guidelines for immunization does not include history of GBS as a contraindication or precaution to vaccination. Persons with a history of GBS may receive an mRNA COVID-19 vaccine unless they have a contraindication to vaccination. Any occurrence of GBS following mRNA COVID-19 vaccination should be reported to VAERS.


Should I take the vaccine if I have a history of Bell’s palsy?

Cases of Bell’s palsy were reported following vaccination in participants in both the Pfizer-BioNTech and Moderna COVID-19 vaccines’ clinical trials. However, the FDA does not consider these to be above the frequency expected in the general population and has not concluded that these cases were causally related to vaccination. The FDA and CDC will continue to monitor the vaccines’ safety. In the absence of such evidence, persons with a history of Bell’s palsy may receive an mRNA COVID-19 vaccine unless they have a contraindication to vaccination. Any occurrence of Bell’s palsy following mRNA COVID-19 vaccination should be reported to VAERS.

Should I take the vaccine if I have had convalescent plasma or monoclonal antibody?

The Advisory Committee on Immunization Practices (ACIP) recommends that vaccination should be deferred until 90 days after receiving convalescent plasma or monoclonal antibodies. Currently, there are no data on the safety and efficacy of COVID-19 vaccines in people who received convalescent plasma or monoclonal antibody therapy. This is to avoid interference of these treatments with vaccine- induced immune responses. The risks and benefits of vaccination based upon the underlying risk factors, including living in a nursing home, could be considered. A discussion with a health care provider can help make an informed decision.

Should I take the vaccine if I have dermal fillers (e.g., face/lip enhancements)?

It is possible, although infrequent, for persons who have received dermal fillers to develop swelling at or near the site of filler injection (usually face or lips) following administration of a dose of an mRNA COVID-19 vaccine. This appears to be temporary and can resolve with medical treatment, including corticosteroid therapy. The mRNA COVID-19 vaccines may be administered to persons who have received injectable dermal fillers (and who have no contraindications to vaccination). Anyone with a dermal filler who experiences swelling at or near the site of the filler injection should contact a healthcare provider for evaluation.

Should I take the vaccine if I already had COVID-19 and recovered?

Data from clinical trials indicate that mRNA COVID-19 vaccines are safe in persons with evidence of a prior SARS-CoV-2 infection. Vaccination should be offered to individuals regardless of history of COVID-19 (symptomatic or asymptomatic). The length of immunity after recovering from COVID-19 disease is unknown; early studies show that immunity after disease recovery is not long lasting and rare cases of reinfection have been reported.

Testing specifically to determine whether a person has active or prior COVID-19 infection is not recommended solely for the purpose of vaccine decision-making.

How long after recovering from COVID-19 should I take the vaccine?

While there is no recommended minimum interval between infection and vaccination, current evidence suggests that the risk of COVID-19 reinfection is low within 90 days after initial infection, but risk may increase with time due to waning immunity. Thus vaccination could be deferred during that timeframe; however, given initially limited supply of vaccines, it is not certain when another opportunity for vaccination will be available.

Should I take the vaccine if I currently am infected with COVID-19?

No. Those infected should wait until they have recovered from the acute illness (if the person had symptoms) and criteria have been met for them to end their isolation. This waiting period is essential to avoid exposing healthcare personnel (HCP) or other persons during the vaccination visit. Getting the vaccine while infected is not expected to harm you, but leaving isolation will put others in danger of getting COVID-19. This recommendation applies to persons who get COVID-19 before receiving any vaccine doses as well as those who get COVID-19 after the first dose but before taking the second dose.

Should I get the vaccine if I am in quarantine?

Individuals in a community or outpatient setting should defer vaccination until quarantine period has ended to avoid exposing healthcare personnel (HCP) or other persons during the vaccination visit.

Residents of congregate healthcare settings (e.g., long-term care facilities) may be vaccinated, as this likely would not result in any additional exposures. HCP are already in close contact with residents and should employ appropriate infection prevention and control procedures.

Residents of other congregate settings (e.g., correctional facilities, homeless shelters, residential settings) may be vaccinated, in order to avoid delays and missed opportunities for vaccination. Where possible, precautions should be taken to limit mixing of these individuals with other residents or non- essential staff.

How long after the flu shot or other vaccines do I have to wait to take the COVID-19 vaccine?

Given the lack of data on the safety and efficacy of mRNA COVID-19 vaccines administered simultaneously with other vaccines, the vaccine series should routinely be administered alone, with a minimum interval of 14 days before or after administration with any other vaccine. However, mRNA COVID-19 and other vaccines may be administered within a shorter period in situations where the benefits of vaccination are deemed to outweigh the potential unknown risks of vaccine co- administration (e.g., tetanus toxoid-containing vaccination as part of wound management, measles or hepatitis A vaccination during an outbreak) or to avoid barriers or delays to mRNA COVID-19 vaccination (e.g., in long-term care facility residents or healthcare personnel who received influenza or other vaccinations prior to/upon admission or onboarding). If mRNA COVID-19 vaccines are administered within 14 days of another vaccine, doses do not need to be repeated for either vaccine.

Should premedication be given prior to vaccination?

Taking medications such as acetaminophen or ibuprofen before receiving the vaccine to try to prevent symptoms like fever or pain is not recommended at this time. This is because there is not enough information on how pain-relieving medications will impact immune responses. These medications may be taken after receiving the vaccine for the treatment of symptoms.