COVID-19 Vaccines: What You Need to Know

Emergency Use Authorizations are used by the FDA to authorize medical products more quickly during public health emergencies. The FDA employs strict guidance that needs to be met before a vaccine receives an EUA. For effectiveness, this includes at least a 50% reduction in COVID-19 infection. For safety, this means a strong track record through at least a median of two months of follow-up time.

The vaccine may seem like it was very quick in the discovering, making and studying; however, the research that these vaccines are based on took place many years prior. Indeed, in the last nine to 12 months, scientists worked around the clock to create these vaccines and conduct studies to assure they were safe and effective. All the standard requirements for emergency authorization by the U.S. Food and Drug Administration were met.

In addition to staying home, avoiding large gatherings, wearing masks and keeping your hands clean, vaccines are one extremely significant way to prevent or reduce the severity of COVID-19. There are other types of vaccines being prepared that will be available in the future.

mRNA vaccines do not contain the live SARS-CoV-2 virus and cannot give you COVID-19.

Supply availability for the future is not clear. We are told that the U.S. government has contracts to purchase millions of doses of COVID vaccines; however, there are circumstances that could interrupt the supply chain, such as logistical problems, manufacturing problems, and the like, which are possible but uncertain.

Yes. Please carefully read the information below.

• The Moderna vaccine is for those 18 years and older. The Moderna vaccine should not be given to anyone who has experienced severe allergic reaction to any of the vaccine’s components. The Moderna vaccine includes the following ingredients:
  • a total lipid content of 1.93 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC])
  • 0.31 mg tromethamine, 1.18 mg tromethamine hydrochloride
  •  0.043 mg acetic acid
  • 0.12 mg sodium acetate
  • 43.5 mg sucrose.
• Tell your vaccination provider about all of your medical conditions, including if you:
  • have any allergies
  • have a fever
  • have a bleeding disorder or are on a blood thinner
  • are immunocompromised or are on a medicine that affects your immune system
  • are pregnant or plan to become pregnant
  • are breastfeeding
  • have received another COVID-19 vaccine
• Individuals who had a severe adverse reaction to the first dose should not receive the second dose

Anyone ages 16 years and older is eligible to receive the Pfizer vaccine, and anyone 18 years and older is eligible to receive the Moderna vaccine.

Please sign up at 863.904.1895 or visit https://myLRH.org/vaccineform to indicate your interest in scheduling an appointment for the vaccine through Lakeland Regional Health. The Department of Health in Polk County will not longer be maintaining a web portal for vaccine signups.

Vaccine recipients will complete a COVID-19 Vaccination Consent & Waiver Form before receiving the vaccine.

This Pfizer and Moderna COVID-19 vaccine requires two (2) different inoculations separated by a few weeks. You must receive both injections for the vaccine to work. The second dose serves as a booster. Try to schedule your doses so that you will be around for the second dose. When you get your first dose, you will get a vaccination card to show you when to return for your second dose of the COVID-19 vaccine. Remember to bring your card when you return.

There will be no out of pocket cost for the vaccine for any person in the United States.

Consult the Moderna Vaccine Fact Sheet for Recipients and Caregivers or the Pfizer Vaccine Fact Sheet for Recipients and Caregivers. Side effects that have been reported with the Moderna and Pfizer COVID-19 Vaccine include:

• Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and redness
• General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, and fever

Please allow for 30 to 45 minutes for your appointment. The actual injection takes only about 5 minutes. The screening process prior to receiving your vaccine will take several minutes. Medical teams will monitor each vaccine recipient for at least 15 minutes to observe any adverse reactions.

Tell your vaccination provider about all of your medical conditions, including if you:

• Are pregnant or breastfeeding.
• Have received other vaccinations within two (2) weeks of receiving the COVID-19 Vaccine.
• Have received monoclonal antibody or plasma therapy within the previous 90 days.
• Have a history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine.
• Are allergic to any ingredients in the vaccine.
  • The Moderna COVID-19 Vaccine contains the following ingredients: messenger ribonucleic acid (mRNA), lipids (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose.

Beginning April 5, 2021, those ages 16 years and older are eligible to receive a vaccine. Keep in mind that the majority of children and adolescents experience no symptoms or mild symptoms with COVID-19, though there are children with medical conditions that place them in a high-risk category. Children’s immune systems are very different from adults’ immune systems. Both Pfizer and Moderna are performing vaccine trials in those as young as age 12. If they are successful, the data will go to the U.S. Food and Drug Administration to review.

You should consult a healthcare provider as appropriate, based on your symptoms. If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital. Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away. Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to https://vaers.hhs.gov/reportevent.html. Please include “Moderna COVID-19 Vaccine EUA” in the first line of box #18 of the report form. In addition, you can report side effects to ModernaTX, Inc. at 1-866-MODERNA (1-866-663-3762). You may also be given an option to enroll in v-safe. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information on how to sign up, visit: www.cdc.gov/vsafe.

Projected immunity after the two-dose series is within two weeks after the second dose.

As with many vaccines, these COVID-19 vaccines reduce the severity of symptoms if you contract COVID-19. 95% of vaccine recipients are expected to have mild to no symptoms if they catch COVID-19.

The length of immunity following COVID-19 vaccination is not yet known. Studies are ongoing to determine how long immunity will last after vaccination.

Check out these resources:

• Ask the vaccination provider.
• Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html.
• Visit FDA at https://www.fda.gov/emergency-preparedness-and-response/mcmlegal- regulatory-and-policy-framework/emergency-use-authorization.
• Contact your local or state public health departments.