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COVID-19 Vaccine FAQs

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Pfizer & Moderna Vaccines FAQ

Vaccine Safety

  • Yes. During the studies done so far, no serious safety concerns have been reported. Safety monitoring will continue throughout the duration of vaccine distribution.
  • There have been reports of anaphylaxis after receiving the Pfizer-BioNTech vaccine outside of clinical trials. 
  • The Phase 3 trials that took place with the vaccines were of similar size and nature to other Phase 3 trials that took place with previous vaccines and medications.
  • The data gathered from the Phase 3 trials will undergo many rounds of reviews by independent experts in multiple areas of science including immunology, statistics, infectious diseases, virology, and vaccinology.
  • Once the company submits its vaccine to the FDA via Emergency Authorization Use, it goes under another round of review by the Vaccine and Related Biologics Product Approval Committee (VRBPAC). This committee then provides advice to the FDA before any decision is made.
  • Once the FDA decides to approve a vaccine, it goes through another round of review by the Advisory Committee on Immunization Practices (ACIP). The ACIP then makes recommendations to the CDC and who should and who shouldn’t get the vaccine.
  • Finally, once a vaccine is approved and individuals are deciding whether to get it, they will also have access to information that summarizes the clinical trial findings, particularly related to any side effects found during the trials and who should or should not get the vaccine.

Vaccine Specific Information

  • Emergency Use Authorization (EUA) submission date: 11-20-2020
  • Date of FDA meeting for EUA approval: 12-10-2020
  • EUA Approval Date: 12-11-2020
  • mRNA vaccine
  • 2 dose vaccine series separated by 21 days 
  • Efficacy rate: 95%
    • ~42,000 participants in the trial who received the second dose of the series as of 11-13-2020
    • 41% of participants were >56 years old
  • Storage recommendations:
    •  -70°C ±10°C for up to 15 days
    • Once the vaccine is thawed, the vaccine vial can be stored for up to 5 days at refrigerated (2 – 8oC) conditions
  • Common adverse effects included fatigue, headache, and muscle aches
  • This vaccine does NOT contain any live virus

Proceed with immunization:

  • Immunocompromising conditions, pregnancy, lactation
  • History of food, pet, insect, venom, environmental, latex, etc. allergies
  • History of allergy to oral medications
  • Non-serious allergy to vaccines or other injectables
  • Family history of anaphylaxis

Precaution to immunization:

  • Moderate/severe acute illness
  • History of severe allergic reactions (e.g. anaphylaxis) to another vaccine or injectable

Contraindication to immunization:

  • History of severe allergic reaction to any component of the vaccine
  • The CDC is continually updating these recommendations. However, at this time, the CDC recommends waiting at least 14 days before receiving any other vaccination (including influenza or shingles) after having received the COVID-19 vaccine. Additionally, if you receive another vaccination first, you should wait at least 14 days before getting the COVID-19 vaccine.
  • If the COVID-19 vaccine is given within 14 days of another vaccine, the COVID-19 vaccine series does not need to be restarted. You may complete the series as scheduled.
  • Emergency Use Authorization submission date: 11-30-2020

  • Date of FDA meeting for approval: 12-17-2020

  • mRNA vaccine
  • 2 dose vaccine series separated by 28 days
  • Efficacy rate: 94.5% 
    • ~30,000 participants in trial, half receiving the vaccine and half receiving placebo and 25,600 participants have received their second dose of the series as of 10-22-2020
    • 196 total people developed COVID-19
      • 185 among placebo group, 30 out of 185 became severely ill
        • 1 death from placebo group
      • 11 among vaccine group, none of which became severely ill
    • ~25% of participants were >65 years old
  • The most common adverse events included pain and redness at the injection site, fatigue, muscle or bone pain, and headache
    • More common with second injection
  • Storage recommendations:
    • -20°C (-4°F), equal to most standard freezer temperatures, for up to 6 months
    • Once the vaccine is thawed, it is stable at standard refrigerated conditions of 2° to 8°C (36° to 46°F) for up to 30 days within the 6-month shelf life
    • Once the vaccine is removed from the refrigerator for administration, it can be kept at room temperature for up to 12 hours
  • This vaccine does NOT contain any live virus

Special Considerations

  • The Pfizer and Moderna vaccine trials excluded women who are pregnant or breastfeeding.
  • There is currently no evidence supporting safety and effectiveness in this population to inform vaccine recommendations.
  • Further considerations and guidance will be issued as more evidence is being discovered and examined. The CDC website has the most up to date guidance and is being continuously updated as new evidence emerges.

 

  • There is no statement from either Pfizer or Moderna on whether their vaccines will interfere with any particular medication.
  • The ACIP will provide recommendations on who should receive the vaccine once the vaccine is approved and all evidence is reviewed.
  • Both studies included female participants on birth control.
  • Both studies included those with chronic lung disease, heart disease, diabetes, liver disease and HIV infection.
  • Pfizer vaccine trial excluded individuals who receive treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids.
  • Allergic reactions can follow any vaccination, but rarely occur in about 1 in 450,000 vaccinations that do not contain gelatin or egg protein.
  • Generally, penicillins or cephalosporins are not used in vaccines due to their ability to cause severe allergic reactions.
  • Although neither of the companies released a full list of components that are in their vaccines.

There are no specific recommendations regarding shellfish allergies and the COVID-19 vaccine.

  • Unless there is a contraindication to vaccination, completing the series is recommended even if post-vaccination symptoms develop.
  • Both doses are necessary for protection (single dose efficacy has not been evaluated).

Vaccine Roll-out & Timing

  • Phase 1a: Healthcare personnel and residents of long-term care facilities
  • Phase 1b: Essential workers
  • Phase 1c: Adults with high risk medical conditions and adults age 65+
  • Phase 2: Teachers, school staff members, childcare workers and people working in the food supply chain
  • Phase 3: Children and adults ages 30 and younger
  • Phase 4: Everyone else living in the United States
  • Pfizer-BioNTech: 3 weeks (21 days) after the first dose
  • Moderna: 1 month (28 days) after the first dose
  • The second dose should be administered as close as possible to the intervals above. However, if for some reason this is not feasible, the CDC recommends that the second dose of both vaccines may be given up to 6 weeks after the first dose. 

    • There is limited data on the efficacy of these vaccines beyond this window. 
    • If the second dose is received past these intervals, the series does not need to be restarted.

The Advisory Committee of Immunization Practice voted that these two populations should be the first to receive the vaccine.

What is in the vaccine(s) and how does it work?

While there are some vaccines being tested that may use a live virus, the vaccines that are near the end of development (Moderna, Pfizer, AstraZeneca, or Johnson & Johnson) do not use the live form of the virus.

  • mRNA vaccine contains a small part of the genetic code for the SARS-CoV-2 spike protein.
  • This mRNA enters the cells of the body and encodes for the spike protein seen on the surface of the coronavirus.
  • Since spike protein is a foreign object, our body recognizes it as foreign and produces antibodies against it.
  • Then, if an individual would encounter the virus, a vaccinated individual would already have pre-formed antibodies to fight off COVID-19.
  • It is worth noting that the mRNA does not enter the cell’s nucleus and does not affect the person’s genetic makeup.

No, these vaccines being tested do not contain microchips. This idea has developed from misinformation spread online.

General

  • Being vaccinated will decrease your risk of contracting and getting sick from the COVID-19 virus like the influenza vaccine decreases your risk of contracting the flu virus.
  • The benefit of receiving the vaccine far exceeds the risks of contracting COVID-19 and potentially having serious, life-threatening or life-long complications.
  • Getting vaccinated will help stop the pandemic in combination with following CDC’s guidelines.

No, the proteins will not make you sick. You may experience side effects from the vaccine.

Yes, it is possible to experience side effects from these vaccines much like the annual influenza vaccine or any other vaccination. These side effects can range from a sore arm to feeling warm or muscle aches. These are signs that an immune response is building in your body and are completely normal. Experiencing these side effects does not mean you have a mild form of the virus.

All but one of the vaccines that are currently in Phase 3 Trials will require the use of two vaccinations to gain the full effect.

  • Yes. Previous COVID-19 infection is not considered a contraindication to receiving the vaccine. Antibody testing is not necessary or recommended prior to receiving the COVID-19 vaccination per CDC guidance.
  • Healthcare workers who tested positive for COVID-19 within the previous 90 days have a choice to delay receiving the vaccine until near the end of the 90 days to allow other healthcare workers to get vaccinated first. There is evidence suggesting reinfection of COVID-19 is not common 90 days post initial infection.
  • No, the COVID vaccine will not cause you to test positive for a viral test.
  • You may test positive if the test is measuring antibodies. This is the desired result of the vaccine. The goal of vaccination is for your body to produce antibodies to be ready to fight COVID-19 once you are exposed.

Yes, it is recommended that even if you receive the vaccine that you should still follow all the guidelines set by the CDC. This is because it will take time to immunize the entire country to the point where there is no concern of transmission.

  • At first, there may be a limited supply of vaccine, but experts expect there to be enough vaccine for everyone by mid-2021.
  • The U.S. government is working closely with vaccine manufacturers to ensure the U.S. population can be vaccinated as quickly as possible.
  • Currently there are projected to be no more than 20,000,000 vaccine doses produced by the end of 2020.
  • Herd immunity is a concept used in public health to describe a situation in which the more people in a community immune to a particular pathogen, the fewer people available for that pathogen to infect.
  • We rely on herd immunity for viruses, such as measles, rubella, polio, and chickenpox, among others.
  • However, herd immunity through natural infection is dangerous with COVID-19 because:
    • The disease is more fatal than a virus like influenza
    • We don’t know who will become severely ill if infected
    • If too many people get sick at the same time, we will overwhelm medical resources
    • We don’t know everything we need to know about how long immunity lasts following infection; we don’t understand the long-lasting effects of infection; and we have limited treatments at this stage (although we are learning more every day)
  • For COVID-19, herd immunity can only be introduced through vaccination.
  • An EUA may be approved by the FDA during a public health emergency to allow availability of medical products that may be helpful to the situation.
  • Criteria that must be met for an EUA to be issued:
    • Used for a serious or life-threatening disease or condition
    • The product is believed to be effective in the emergency based off of the current scientific evidence 
    • Potential benefits outweigh the potential risks of the product
    • There is no adequate FDA-approved alternative available 

There is no information on whether or not you should receive the vaccine if you are not feeling well at this time. 

  • mRNA COVID-19 vaccines are not interchangeable. It is very important to make sure the same vaccine product is given for both the first and second dose.
  • However, the CDC states that “in exceptional situations in which the first-dose vaccine product is unknown or unavailable, any mRNA COVID-19 vaccine product may be administered at a minimal interval of 28 days between doses of different products to complete the vaccination series”.

Johnson & Johnson (Janssen) Vaccine FAQ

Emergency Use Authorization submission date: 2-4-2021

Date of FDA meeting for approval: 2-26-2021

Emergency Use Authorization Approval Date: 2-27-2021

  • Single dose (0.5 mL) viral vector vaccine
  • Efficacy rate: 72% in the United States and 66% effective overall at preventing moderate to severe COVID-19, 28 days after vaccination
    • 43,783 participants, 34% of population over the age of 60
    • 468 developed symptomatic cases of COVID-19
  • Common adverse events include: injection site pain, headache, fatigue, muscle pain, and nausea
    • One report of anaphylaxis in a clinical trial in South Africa

Storage Recommendations:

  • Unpunctured, multi-dose vials should be stored at 2°C to 8°C (36° to 46°F) and protect from light. 
    • Do not store frozen
  • Unpunctured vials should be stored at 9°C to 25°C (47° to 77°F) for up to 12 hours
  • Vaccine initially stored frozen by manufacturer, then shipped at 2°C to 8°C (36° to 46°F).
    • If vaccine is frozen upon receipt, thaw at 2°C to 8°C (36° to 46°F).
    • If needed immediately, thaw at room temperature 25°C (77°F).
      • A carton of 10 vials will take about 2 hours to thaw
      • An individual vial will take about 1 hour to thaw
  • After first puncture, hold the vial between 2°C to 8°C (36° to 46°F) for up to 6 hours or at room temperature for up to 2 hours

 

  • Viral vectors use a modified version from a different virus to deliver information to cells. The viral vector COVID-19 vaccine uses a different, harmless virus to enter cells in the body in order to produce the spike protein of the COVID-19 virus. This spike protein is harmless
  • Similar to the mRNA vaccines effects, our cells present the spike protein on its surface so that our immune system recognizes this foreign protein and can start producing antibodies against it

 

  • There is currently insufficient data to determine whether there are vaccine-associated risks in those who are pregnant or breastfeeding.
  • However, the CDC states that if you are pregnant you may choose to be vaccinated as there is no evidence that the antibodies formed from COVID-19 vaccination can cause any problem with pregnancy. The CDC is continually updating its guidance on COVID-19 vaccination

 

Individuals with a known history of severe allergic reaction to any components of the Janssen COVID-19 vaccine are contraindicated.

There is no data available regarding the use of the Janssen COVID-19 vaccine to complete another vaccination series.

 

There is currently no data available regarding the use of this vaccine with other vaccines.

 

Resources & References

  • Dooling K, McClung N, Chamberland M, et al. The Advisory Committee on Immunization Practices’ Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine — United States, 2020. MMWR Morb Mortal Wkly Rep. ePub: 3 December 2020. 
  • Common Ingredients in U.S. Licensed Vaccines. U.S. Food & Drug Administration. Published 04/30/2018.
    • https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/common-ingredients-us-licensed-vaccines

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