The Centers for Disease Control and Prevention (CDC), along with the FDA and other federal partners, will use established safety systems to conduct heightened safety monitoring of COVID- 19 vaccines, and U.S. Food and Drug Administration (FDA) will only issue an Emergency Use Authorization (EUA) if a vaccine has demonstrated clear and compelling effectiveness in a large phase 3 clinical trial. The CDC and the FDA are monitoring COVID-19 vaccine safety post-EUA and post-licensure, as vaccines continue to be administered publicly.

Patients will not be charged for this vaccine. If you have insurance, we may bill your insurance company to cover the cost of administering. However, there are no out-of-pocket costs.

Pfizer’s vaccine requires two shots in the vaccine series. The second shot –is given 19-22 days - after the first one. Moderna’s vaccine also requires two shots in the vaccine series. The second shot is given – 26-30 days – after the first one. If you receive the Pfizer or Moderna vaccine, you will be asked to schedule your appointment for your second shot at your first appointment. The second shot will be given at the same vaccination site that you received the first one.

J&J Janssen’s vaccine only requires one dose.

Delay in completing the vaccine series means that you will likely remain vulnerable to COVID-19 infection. You will not get the boost in immunity until you receive the second shot. However, you should reschedule your second dose at the earliest opportunity (but no doses need to be repeated).

Hackensack Meridian Health administers all three vaccine types (Pfizer, Moderna and J&J Janssen) depending on availability of supply. All three vaccines are very effective against preventing symptomatic or severe COVID infections.

Vaccine supplies are limited as we are dependent upon receiving it from state and federal partners. Hackensack Meridian Health manages its supply to ensure the second booster shot is available.

We continue to work through the distribution plan as additional supply is provided.

Yes. It’s important for everyone to continue using all the tools available to us to help stop this pandemic, like covering your mouth and nose with a mask, washing hands often, and staying at least 6 feet away from others. Experts need to understand more about the protection that COVID-19 vaccines provide before deciding to change those recommendations.

If you are not feeling well, it is recommended that you wait until you are feeling better to get the vaccine. If you have scheduled an appointment to receive the vaccine and are not feeling well on the day of vaccination, it is best to reschedule the vaccine.

It is recommended you wait two weeks from the time of your flu shot to receive the vaccine.

There is a potential for injection site reactions (redness, swelling and pain) as well as fever, fatigue, headache, chills, vomiting, diarrhea, muscle pain and/or joint pain. These are common reactions seen with other vaccines. There may be other reactions that are not currently known. If you experience common side effects from the vaccine it is still necessary to receive the second dose for the vaccine to be effective.

We are happy to report that with more than 25,000 people vaccinated as of Jan. 15, there has been no reports of serious side effects.

If you experience symptoms where you got the shot:

• Apply a clean, cool, wet washcloth over the area.
• Use or exercise your arm.

You may also experience other common symptoms related to the vaccine. This includes:

• Fatigue
• Headache
• Muscle pain
• Joint pain
• Chills

If you have only these symptoms and NO FEVER, take acetaminophen (Tylenol) or a non- steroidal (like ibuprofen, Motrin or Advil). Your symptoms will typically improve in 24-48 hours. If they do not improve or you have any questions or concerns, contact your health care provider.

The CDC and FDA have a robust safety monitoring system in place as public vaccination begins. Through v-safe, use your smartphone to tell CDC about any side effects after getting the COVID- 19 vaccine. You will also get reminders for your second dose. Learn more here: www.cdc.gov/vsafe.

You are also encouraged to report possible side effects to the Vaccine Adverse Event Reporting System (VAERS), https://vaers.hhs.gov/reportevent.html.

If you experience common side effects from the vaccine, it still is necessary to receive the second dose for the vaccine to be effective.

You should contact your primary care physician.

If you have had a COVID-19 infection in the past, or if you are currently infected with COVID-19, you should wait to get vaccinated until after your illness has resolved and after you meet criteria to discontinue isolation. There is no need to wait 90 days. Vaccination will be offered regardless of history of prior symptomatic or asymptomatic COVID-19 infection. Data from clinical trials suggest vaccination is safe and likely effective in those with a history of COVID-19 infection.

If you have had a COVID-19 infection in the past, or if you are currently infected with COVID-19, you should wait to get vaccinated until after your illness has resolved and after you meet criteria to discontinue isolation. There is no need to wait 90 days. Vaccination will be offered regardless of history of prior symptomatic or asymptomatic COVID-19 infection. Data from clinical trials suggest vaccination is safe and likely effective in those with a history of COVID-19 infection.

There is currently no data on safety or efficacy of COVID-19 vaccination in those who received monoclonal antibodies or convalescent plasma as part of COVID-19 treatment. Vaccination should be deferred for at least 90 days to avoid interference of the treatment with vaccine-induced immune responses.

Vaccination should be deferred until the quarantine period has ended to avoid exposing health care personnel or others during the vaccination visit.

Vaccines may be administered to those with underlying medical conditions who have no contraindications to vaccination. Clinical trials demonstrate similar safety and efficacy profiles in those with underlying medical conditions, including those that place them at increased risk for severe COVID-19, compared to those without comorbidities.

Although pregnant and breastfeeding women did not participate in the Pfizer-BioNTech or Moderna COVID-19 vaccine clinical trials, the Food and Drug Administration noted during emergency use authorization that these women may opt in for immunization, if they choose.

According to the American College of Obstetricians and Gynecologists, it is expected the safety of the vaccine in pregnant women would be similar to that observed in non-pregnant women. If you are pregnant or breastfeeding, speak with your physician to determine what’s best for you.

The FDA has determined that the Pfizer-BioNTech and Moderna COVID-19 vaccines are safe and effective, based on rigorous clinical trials, and no evidence has suggested that problems with fertility is even a consideration. Other types of vaccines also don’t impact fertility.

You should not get the Pfizer-BioNTech COVID-19, Moderna or J&J Janssen vaccine if you:

• had a severe allergic reaction after a previous dose of this vaccine;
• had a severe allergic reaction to any ingredient of the vaccine

The Pfizer-BioNTech was approved for use in those 12 years and older; the Moderna and J&J Janssen vaccine was approved for use in those 18 years and older. These vaccines are currently being evaluated in younger age groups.

• mRNA: Many vaccines work by putting inactivated or weakened germs into our bodies that trigger an immune response and build natural antibodies against the virus. mRNA vaccines are different. mRNA technology teaches our cells how to make a protein that prevents infection.
• Viral vector: Viral vector vaccines use inactivated or weakened virus to trigger an immune response and build natural antibodies against the virus. Note: The J&J vaccine does not contain any live COVID virus.

All three vaccines are highly effective against COVID-19. Importantly, they are very effective against preventing someone from getting seriously ill, requiring hospitalization or dying from COVID-19.

No. The available vaccines do not contain live COVID virus.

Hackensack Meridian Health recommends the following resources for questions and more information about the COVID-19 vaccine:

https://www.cdc.gov/vaccines/covid-19/index.html

https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid- 19/covid-19-vaccines

https://nj.gov/health/cd/topics/covid2019_vaccination.shtml

The most important step is to get vaccinated by any of the three available vaccines. Vaccines are distributed by the state and federal government and still are in limited supply.  Vaccination sites cannot request a particular vaccine.  Patients will be given the vaccine available at the site.

• Don't forget to eat and drink prior to your vaccine. There's no need to fast.

• Per the CDC, it is not recommended you take over-the-counter medicine – such as ibuprofen, aspirin or acetaminophen – before vaccination for the purpose of trying to prevent vaccine-related side effects.

• Per the CDC, it is also not recommended to take antihistamines before getting a COVID-19 vaccine to try to prevent allergic reactions.

• If you have any questions about medications, please speak with your healthcare provider.

The CDC and FDA made the recommendation to resume use of the J&J COVID-19 vaccine following a thorough review of available data that shows the vaccine’s known and potential benefits outweigh the risk of the potential rare blood clotting disorder that led to the pause.

For two weeks after receiving the vaccine, you should be on the lookout for the following possible symptoms:

• Shortness of breath,

• Chest pain,

• Leg swelling,

• Persistent abdominal pain,

• Severe or persistent headaches or blurred vision,

• Easy bruising or tiny blood spots under the skin beyond the site of the injection.

If you develop one or more of these symptoms after receiving the J&J COVID-19 vaccine, seek

medical care immediately.

• Why was there a temporary pause in the administration of the J&J COVID-19 vaccine?

COVID-19 vaccines have undergone and continue to undergo what the CDC describes as the most intensive safety monitoring in U.S. history. The early detection and reporting of the rare adverse events involving blood clots with low platelets and the subsequent decision to temporarily pause administration of the J&J vaccine serve to illustrate that the safety monitoring process is working.

Per the CDC, as of April 23, 2021, more than 8 million doses of the J&J COVID-19 vaccine had been given in the United States; experts reviewing safety reports for this vaccine found 15 reports of women who got this vaccine and later developed the serious condition that involves blood clots with low platelets.

Effective April 23, 2021, the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) recommended use of the Johnson & Johnson Janssen COVID-19 vaccine after a temporary pause. Following this recommendation, providers across the state, including HMH, have resumed administration of the one-shot J&J vaccine. The CDC and FDA made the recommendation to resume use following a thorough review of available data that shows the vaccine’s known and potential benefits outweigh the risk of the potential rare blood clotting disorder that led to the pause. More generally, it remains clear that any risk associated with COVID-19 vaccination is less than the risk associated with a COVID-19 infection.

Early clinical trials largely focused on adult participants. Now, researchers are studying the vaccine in younger children. Pfizer-BioNTech recently completed a vaccination trial on patients aged 12-15 and found the younger group’s immune response was “as good as” the immune response of older participants. Both Pfizer-BioNTech and Moderna are currently studying the vaccine in children as young as six months old.

Parents should be vaccinated against COVID-19, both to protect themselves and their children. Everyone should continue to wear masks and practice social distancing and handwashing to model best behavior for their children that are too young to get the currently available vaccines.