You and the COVID-19 vaccine.

There are three vaccines that are currently authorized and recommended to prevent COVID-19:

• Pfizer-BioNTech COVID-19 vaccine
• Moderna’s COVID-19 vaccine
• Janssen COVID-19 vaccine

There are multiple COVID-19 vaccines still under development. Phase 3 clinical trials are in progress or are being planned for two additional COVID-19 vaccines in the United States.

Source: CDC: Frequently Asked Questions about COVID-19 Vaccination

UPDATE: April 14, 2021

A decision made by both the United States Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) has paused administration of the single dose Johnson & Johnson vaccine. This move is being made with an abundance of caution because of rare cases of cerebral venous sinus thrombosis in combination with low levels of platelets (thrombocytopenia) specifically in young women. The State of Florida has stopped distribution of the Johnson & Johnson vaccine for now.

The American College of Obstetricians and Gynecologists (ACOG) issued a press release encouraging young women and pregnant women to preferentially receive either the Pfizer or Modena vaccine series. It also mentions that if a patient has already been vaccinated with the Johnson & Johnson vaccine and displays any clinical signs or symptoms of a deep vein thrombosis to not treat with heparin. Please review the statement here.

In the meanwhile, all agencies are encouraging continued vaccination programs with the mRNA vaccines from Pfizer or Moderna. Click here for more information.

 

Johnson & Johnson’s Janssen COVID-19 vaccine is an adenovirus-based vaccine that uses a specific type of adenovirus, called Ad26, to deliver a piece of genetic material that is used to make a spike protein of the virus that causes COVID-19. Adenoviruses are relatively common and the Ad26 adenovirus can cause cold symptoms and pink eye. However, it has been modified for the vaccine so that it cannot replicate in the human body to cause illness. 

After a person receives the vaccine, the body can temporarily make the spike protein, not causing disease, but triggering the immune system to learn to react defensively by producing an immune response against SARS-CoV-2, the virus that causes COVID-19. 

The Janssen COVID-19 vaccine is given as an injection into the muscle as a single dose. It is recommended for people aged 18 years and older.

The most common side effects were pain at the injection site, headache, fatigue, muscle aches, and nausea. Most side effects were reported within 1-2 days after vaccination and were mild to moderate in severity lasting 1-2 days. 

For more information, Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson, has published a fact sheet for recipients and caregivers.

Source: CDC: Janssen COVID-19 Vaccine, FDA: FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

Moderna’s COVID-19 vaccine is a messenger RNA (mRNA) vaccine. mRNA vaccines do not use the live virus that causes COVID-19 and it cannot give someone COVID-19. mRNA vaccines enable cells in the body to make a spike protein that triggers an immune response that produces antibodies. These antibodies are what protect individuals from getting infected by the actual virus.

Moderna’s COVID-19 vaccine is given in the upper arm muscle as a series of 2 shots, 28 days (one month) apart. It is recommended for people aged 18 years and older.

Most common side effects are pain, swelling, and redness in the location of vaccination as well as chills, tiredness, and headache. Side effects can start within a day of receiving the vaccine and could feel like flu symptoms but should subside within a few days. For more information on side effects, see “What are the side effects of the COVID-19 vaccine?” below.

For more information, Moderna has published a fact sheet for recipients and caregivers.

Source: CDC: Information about the Moderna COVID-19 Vaccine, CDC: Understanding mRNA COVID-19 Vaccines

The Pfizer-BioNTech COVID-19 vaccine is a messenger RNA (mRNA) vaccine. mRNA vaccines do not use the live virus that causes COVID-19 and it cannot give someone COVID-19. mRNA vaccines enable cells in the body to make a spike protein that triggers an immune response that produces antibodies. These antibodies are what protect individuals from getting infected by the actual virus.

The Pfizer-BioNTech COVID-19 vaccine is given in the upper arm muscle as a series of 2 shots, 21 days apart. It is recommended for people aged 16 years and older.

Most common side effects are pain, swelling, and redness in the location of vaccination as well as chills, tiredness, and headache. Side effects can start within a day of receiving the vaccine and could feel like flu symptoms but should subside within a few days. For more information on side effects, see “What are the side effects of the COVID-19 vaccine?” below.

For more information, Pfizer-BioNTech has published a fact sheet for recipients and caregivers.

Source: CDC- Information about the Pfizer-BioNTech COVID-19 Vaccine, Understanding mRNA COVID-19 Vaccines

When infected with a virus, the immune system fights the infection using white or immune cells that are found in our blood. There are different types of white blood cells, such as macrophages, B-lymphocytes, and T-lymphocytes, that all help fight infection. The first time a person is infected with the virus that causes COVID-19, it can take several days or weeks for their immune system to get over the infection. However, the immune system will remember how to protect the body against that disease in the future. After infection, T-lymphocytes, or memory cells, remain in the body and will quickly go into action if the body were to encounter the same virus again. When the antigens of the familiar virus are detected, B-lymphocytes produce antibodies to attack them.

mRNA COVID-19 vaccines assist in developing immunity to the virus that causes COVID-19 without actually having to get the illness.

Source: CDC: CDC: Understanding mRNA COVID-19 Vaccines, Understanding How COVID-19 Vaccines Work

Viral vector vaccines use a modified version of a different virus (known as the vector) to deliver important cellular instructions. Viral vector COVID-19 vaccines do not use a vector of the virus that causes COVID-19 but rather a different, harmless adenovirus, Ad26, instead. 

The vector enters the cells in the body and uses the cell to produce a harmless piece of the virus that causes COVID-19, known as a spike protein, that is only found on the surface of the virus that causes COVID-19. Once the cell displays the spike protein on its surface, the immune system recognizes it doesn’t belong, triggering the immune system to begin producing antibodies and activating other immune cells to fight what is thought to be an infection. In the end, our body and immune system will have learned how to protect against future infection from the virus that causes COVID-19 without ever risking the serious consequences of getting sick with COVID-19.

Viral vector COVID-19 vaccines cannot give someone COVID-19 or other infections from the virus used as the vaccine’s vector. 

While there are different types of vaccines that work in different ways to offer protection, all vaccines leave the body with a supply of “memory” T-lymphocytes and B-lymphocytes that will remember how to fight against that virus in the future.  

Source: CDC: Understanding Viral Vector COVID-19 Vaccines, CDC: Understanding How COVID-19 Vaccines Work

No. mRNA vaccines do not use the live virus that causes COVID-19 and it cannot give someone COVID-19.

Source: CDC: Understanding How COVID-19 Vaccines Work, CDC: Understanding mRNA COVID-19 Vaccines

No. The viral vector used in the Janssen COVID-19 vaccine does not contain the virus that causes COVID-19. Rather, the adenovirus called Ad26 is used as the vector to produce a harmless piece of the virus that causes COVID-19. Viral vector vaccines cannot cause infection with COVID-19 or with the virus that was used as the vaccine vector. 

Source: CDC: Understanding Viral Vector COVID-19 Vaccines, CDC: Understanding How COVID-19 Vaccines Work

For the Moderna COVID-19 vaccine, vaccination is a 2 shot series, 28 days (one month) apart.

For the Pfizer-BioNTech COVID-19 vaccine, vaccination is a 2 shot series, 21 days apart.

For the Janssen COVID-19 vaccine, vaccination is a single dose.

Source: CDC: Information about the Moderna COVID-19 Vaccine, CDC: Information about the Pfizer-BioNTech COVID-19 Vaccine, CDC: Janssen COVID-19 Vaccine 

COVID-19 vaccine doses that have been purchased with U.S. taxpayer dollars will be given at no cost.
Vaccination providers can charge an administration fee for administering the shot to someone. This vaccine administration fee can be reimbursed by patients’ public or private insurance companies or by the Health Resources and Services Administration’s Provider Relief Fund for uninsured patients.

Source: CDC: Frequently Asked Questions about COVID-19 Vaccination

Yes. Due to the severe health risks associated with COVID-19 and possibility for reinfection, the vaccine should be offered even if you already had COVID-19. You are not required to have an antibody test before being vaccinated.

Currently, it is not known how long protection will last after recovering from COVID-19. Natural immunity, immunity that is gained from having an infection, varies by person and early evidence suggests natural immunity may not last very long.

Anyone currently infected with COVID-19 should wait to receive the vaccine until after their illness has resolved and after they no longer have to isolate.

Source: CDC: Facts about COVID-19 Vaccines

Due to demand of the vaccine, state and local governments are managing access and distribution points primarily to ensure the most vulnerable populations have priority. At some point soon, vaccines will have broader distribution points, including primary care physicians and perhaps other medical specialties such as pediatrics and obstetrics and gynecology. In order to optimize distribution, state government requires practices to register in order to receive and begin vaccinations. It is expected that most TopLine MD Alliance affiliated practices will be able to provide the vaccine once available.

While the CDC continues to provides recommendations on who should have access to the COVID-19 vaccine first, each state has its own plan on deciding who will be vaccinated first and how they will be able to access the vaccines. Your local health department will be able to provide more information on COVID-19 vaccination in your area.

During public health emergencies, like the current coronavirus (COVID-19) outbreak, there is often an urgent need for products to diagnose, treat, or prevent a medical threat. In cases of these emergencies, the Food and Drug Administration (FDA) can issue an Emergency Use Authorization (EUA) that provides more timely access to drugs, diagnostic testing, or other critical medical products, like vaccines, when there are no available options.

EUA does not require emergency products to follow the full approval process as there may not be available time to gather enough evidence for full FDA approval. Under EUA, the FDA quickly evaluates options using available evidence to balance any known risks and potential benefits of releasing the product to the public during the emergency.

Source: FDA: Emergency Use Authorization

Yes. After receiving authorization from the FDA, the Advisory Committee on Immunization Practices (ACIP) reviews each vaccine’s available data and clinical trial information before making recommendations. They consider:

• Who receives each vaccine (age, race, ethnicity, underlying medical conditions)
• How different groups respond to the vaccine
• Side effects of each vaccine

After considering the above, the ACIP votes on whether to recommend the vaccine and who should be offered a COVID-19 vaccine first when supplies are limited.
For more information on how recommendations are determined, see “When access to vaccines is limited, how are recommendations determined?” below.

Source: CDC: How CDC is Making COVID-19 Vaccine Recommendations

The CDC continues to provide recommendations to federal, state, and local governments about who should be vaccinated first due to the U.S.’s limited supply of the COVID-19 vaccine. Recommendations from the CDC are based on the ACIP’s recommendations and are made with goals in mind:

• Decreasing death and serious disease as much as possible
• Preserve functioning of society
• Reducing the extra burden COVID-19 is having on people already facing disparities

While the CDC makes recommendations on who should have access to the COVID-19 vaccine first, each state has its own plan on deciding who will be vaccinated first and how they will be able to access the vaccines. Your local health department will be able to provide more information on COVID-19 vaccination in your area.

Source: CDC: When Vaccine is Limited, Who Should Get Vaccinated First?

All persons 18 years of age and older are eligible to receive the vaccine in Florida. As of Monday, April 5, all Florida residents shall be eligible to receive any COVID-19 vaccine as prescribed by the Food and Drug Administration.

Persons under the age of 18: The Pfizer vaccine is authorized for persons 12 and up. The Moderna and Janssen (Johnson and Johnson) vaccines are authorized for persons age 18 and up. All individuals under the age of 18 receiving a vaccine must be accompanied by a guardian and complete the COVID-19 vaccine screening and consent form found here.

There are recommendations for people who have had allergic reactions to other vaccines. If you have had allergic reactions to any ingredients found in the COVID-19 vaccines or in a vaccine for another disease, regardless of severity, you should ask your TopLine MD affiliated physician if you should receive the COVID-19 vaccine. Your physician will help you with deciding if the COVID-19 vaccine is safe for you.

Source: CDC: Vaccines and Allergic Reactions

UPDATE: April 14, 2021

The American College of Obstetricians and Gynecologists (ACOG) issued a press release encouraging young women and pregnant women to preferentially receive either the Pfizer or Modena vaccine series. It also mentions that if a patient has already been vaccinated with the Johnson & Johnson vaccine and displays any clinical signs or symptoms of a deep vein thrombosis to not treat with heparin. Please review the statement here.

 

The Advisory Committee on Immunization Practices (ACIP) recommends that people who are part of the recommended groups (see “Who is recommended to get the COVID-19 vaccine?”) and women who are pregnant can choose to be vaccinated. As the COVID-19 vaccines do not contain live virus, experts believe the vaccines are likely to be safe when used during pregnancy, based on what is known about how the vaccines are made. However, since there has been no testing with the COVID-19 vaccines and women who are pregnant, researchers are not aware of any known risks.

There is data that shows pregnant people with COVID-19 have an increased risk of severe illness. Pregnant women with COVID-19 may also be at an increased risk of adverse pregnancy outcome, such as preterm birth, when compared with pregnant women without COVID-19.

If you are pregnant and have questions on receiving the COVID-19 vaccine, talk with your TopLine MD affiliated obstetrician-gynecologist (ob-gyn) or provider to help you make an informed decision. Your providers can discuss your risk of getting COVID-19 and assess risks for severe illness if you were to get sick.

For more information, you can find additional vaccine advice for pregnant or breastfeeding women composed by the Society for Maternal-Fetal Medicine or you can read Vaccination Considerations for People who are Pregnant or Breastfeeding from the CDC. 

For general information on COVID-19 vaccines, read How do we know the COVID-19 vaccines are safe and effective? One expert explains from the American College of Obstetrics and Gynecology (ACOG)

Source: ACOG: Coronavirus (COVID-19), Pregnancy, and Breastfeeding: A Message for Patients, ACOG: How do we know the COVID-19 vaccines are safe and effective? One expert explains, CDC: COVID-19 Vaccines and Allergic Reactions, CDC: Vaccination Considerations for People who are Pregnant or Breastfeeding, Society for Maternal Fetal Medicine: Vaccine Advice if You Are Pregnant or Breastfeeding

Yes. The American College of Obstetricians and Gynecologists (ACOG) recommends that breastfeeding women receive the COVID-19 vaccine. Because the COVID-19 vaccine does not contain live virus, mRNA vaccines are not thought to be a risk to breastfeeding infants or on milk production/excretion. The CDC recommends that people who are breastfeeding can choose to be vaccinated.

For more information, you can read additional vaccine advice for pregnant or breastfeeding women composed by the Society for Maternal Fetal Medicine or you can read Vaccination Considerations for People who are Pregnant or Breastfeeding from the CDC.

Source: ACOG: Coronavirus (COVID-19), Pregnancy, and Breastfeeding: A Message for Patients, Society for Maternal Fetal Medicine: Vaccine Advice if You Are Pregnant or Breastfeeding, CDC: Vaccination Considerations for People who are Pregnant or Breastfeeding

Appointments may be required and vaccine availablilty will vary at each vaccine location. It is recommended that you contact the vaccine location to find out more information on appointment requirements and vaccine availability beforehand. Through the Florida Department of Health, you can find a vaccine location that is near you.

Source: Florida Department of Health: COVID-19 Vaccines in Florida  

On March 3, 2021, Governor DeSantis expanded the groups of those who are able to receive the COVID-19 vaccine to the following eligible groups:

• Long-term care facility residents and staff
• Persons 65 years of age and older
• Persons under 65 deemed extremely vulnerable
• Health care personnel with direct patient contact
• K-12 school employees 50 years of age and older
• Sworn law enforcement officers 50 years of age and older
• Firefighters 50 years of age and older

Any licensed physician can deem a patient “medically vulnerable” so long as they have a professional doctor/patient relationship.  The CDC recommends that patients with particular conditions under the age of 65 should be given vaccine priority.  

Once a patient has been determined to be eligible to receive the vaccine, they will need to bring a copy of a completed form to a vaccination site where the vaccine is administered. 

Patients younger than 65 deemed medically vulnerable must go to a site offering vaccination administration by a physician, nurse practitioner or licensed pharmacist rather than to a mass vaccination site, where the vaccines are administered by licensed practice nurses and registered nurses.  

If you meet any of the above requirements, please call your TopLine MD Alliance affiliated physician to formally request a form to be completed by your physician stating that you are eligible. Please note, that it may take a few business days to complete and you should not make a vaccination appointment until you have the completed form in hand.

Source: CDC: People with Certain Medical Conditions  

Currently eligible Florida residents can save their place in line to receive a COVID-19 vaccine by pre-registering through myvaccine.fl.gov. 

If you are not yet eligible, you can sign up on myvaccine.fl.gov to receive email updates to learn when you will be eligible.

Source: MyVaccine.FL.GOV: Pre-Register Now for the COVID-19 Vaccine

After receiving the vaccine, vaccination sites have a recovery section where people are asked to wait 15 minutes for additional monitoring.
You may experience some side effects, which are normal signs that your body is working to build protection against COVID-19. While these side effects may impact certain daily activities, they should go away in just a few days.

With the Janssen COVID-19 vaccine, you will need a single dose in order to receive full vaccination

With the Moderna and Pfizer-BioNTech COVID-19 vaccines, you will need 2 shots in order for them to be effective. Even if you experience side effects from the first shot, you should still receive the second shot or dose, unless you are instructed by your physician to not receive the second shot. COVID-19 vaccines that require 2 shots may not provide protection for up to two weeks after you receive your second shot. After any vaccination, it takes time for the body to build protection.

For more information on side effects, you can print out this handout from the CDC What to Expect after Getting a COVID-19 Vaccine- Handout and see “What are the side effects of the COVID-19 vaccine” below.

Source: CDC: What to Expect after Getting a COVID-19 Vaccine

Pain and swelling on the arm that you received the COVID-19 vaccine shot are common side effects as well as fever, chills, tiredness, muscle pain, nausea, and headache.
If you are experiencing pain or discomfort, talk to your TopLine MD affiliated physician about using over-the-counter medications, such as ibuprofen or acetaminophen, to help manage. You can also try other methods to alleviate pain from the vaccination site by applying a (clean) cool, wet washcloth or exercising the arm. To help reduce discomfort from fever, you should ensure you drink plenty of water or fluids and dress lightly.

Source: CDC: What to Expect after Getting a COVID-19 Vaccine

Most cases of discomfort from fever or pain from the vaccination site are normal and to be expected after receiving the vaccine. If the redness or tenderness where you received the vaccine increases after 24 hours and/or if your side effects do not appear to be subsiding after a few days, you should contact your TopLine MD affiliated physician. If you do not have a primary care physician, it is important to consider selecting a primary provider when seeking routine care or annual exams.

If you think you are having a severe allergic reaction after receiving the COVID-19 vaccine and have left the vaccination site, seek immediate medical attention by calling 911.

For more information on allergic reactions to the COVID-19 vaccine, see “What do I do if I have an allergic reaction to a COVID-19 vaccine?”

Source: CDC: What to Expect after Getting a COVID-19 Vaccine

There are two types of allergic reactions: a non-severe allergic reaction and a severe allergic reaction.

For non-severe allergic reactions, you may experience hives, swelling, and wheezing (respiratory distress) within 4 hours of receiving the COVID-19 vaccine. This is also known as an immediate allergic reaction. If you have experienced an immediate allergic reaction to any ingredients found in an mRNA COVID-19 vaccine, regardless of severity, the CDC recommends that you should not get either of the available mRNA COVID-19 vaccines. If you experience an immediate allergic reaction after receiving the first dose of an mRNA COVID-19 vaccine, you should not receive the second dose. You can discuss your options further with your TopLine MD affiliated physician who may refer you to an allergist and immunologist.

For severe allergic reactions, there are reports that some people have experienced anaphylaxis after they received the COVID-19 vaccine. An allergic reaction is considered to be severe when a person needs to be treated with epinephrine or if they must seek immediate medical attention at a hospital. If you have experienced a severe allergic reaction to any ingredients found in an mRNA COVID-19 vaccine, you should not get either of the available mRNA COVID-19 vaccines. If you experience a severe allergic reaction after receiving the first dose of an mRNA COVID-19 vaccine, you should not receive the second dose. You can discuss your options further with your TopLine MD affiliated physician who may refer you to an allergist and immunologist.

Source: CDC: COVID-19 Vaccines and Allergic Reactions

If you have experienced an immediate or severe allergic reaction to any ingredient that is found in an mRNA COVID-19 vaccine, you should not get either of the available mRNA COVID-19 vaccines. If you had an immediate or severe allergic reaction after receiving the first dose of an mRNA COVID-19 vaccine, you should not receive the second dose. You can discuss your options further with your TopLine MD affiliated physician who can provide additional guidance or care. If you do not have a primary care physician, it is important to consider selecting a primary provider when seeking routine care or annual exams.

If you have experienced a severe allergic reaction after receiving the COVID-19 vaccine, you may consider seeking immediate medical attention by going to the hospital or calling 911 if you have already left the vaccination site. You should let your vaccination provider know about your severe allergic reaction and they will send a report to the Vaccine Adverse Even Reporting System (VAERS), a national system that collects reports on the adverse events that happen after vaccination.

Source: CDC: COVID-19 Vaccines and Allergic Reactions

If you have been vaccinated and have been exposed to someone with suspected or confirmed COVID-19, you are not required to quarantine if you meet all of the following criteria:

• Are fully vaccinated (i.e., 2 or more weeks following receipt of the second dose in a 2-dose series, or 2 or more weeks following receipt of one dose of a single-dose vaccine)
• Are within 3 months following receipt of the last dose in the series
• Have remained asymptomatic since the current COVID-19 exposure

If you do not meet all 3 criteria above, you should follow the current quarantine guidance after exposure to someone with suspected or confirmed COVID-19.

Source: CDC: Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States 

Current recommendations state fully vaccinated people (i.e., 2 or more weeks following receipt of the second dose in a 2-dose series, or 2 or more weeks following receipt of one dose of a single-dose vaccine) can visit with other fully vaccinated people indoors without wearing masks or physical distancing. Additionally, you can visit with unvaccinated people from a single household who are at low risk for severe COVID-19 disease indoors without wearing masks or physical distancing. 

Fully vaccinated people should continue to:

• Take precautions in public like wearing a well-fitted mask and physical distancing

• Wear masks, practice physical distancing, and adhere to other prevention measures when visiting with unvaccinated people who are at increased risk for severe COVID-19 disease or who have an unvaccinated household member who is at increased risk for severe COVID-19 disease

• Wear masks, maintain physical distance, and practice other prevention measures when visiting with unvaccinated people from multiple households

• Avoid medium- and large-sized in-person gatherings

• Get tested if experiencing COVID-19 symptoms

• Follow guidance issued by individual employers

• Follow CDC and health department travel requirements and recommendations

Source: CDC: Interim Public Health Recommendations for Fully Vaccinated People