GENERAL INFORMATION

Manufacturer: Novavax, Inc.

Number of Shots: 2 doses in the primary series, given 3–8 weeks apart.

People who are moderately or severely immunocompromised should also receive 2 doses, given 3 weeks apart (a 3rd primary dose is not currently authorized).

Booster Shot:  Novavax COVID-19 vaccine is not authorized for use as a booster dose.

Type of Vaccine: Protein subunit

How Given: Shot in the muscle of the upper arm

Does NOT Contain: Eggs, preservatives, latex, metals
See full list of ingredients

Name: NVX-CoV2373

SAFETY DATA SUMMARY

• COVID-19 vaccines have undergone—and continue to undergo—the most intensive safety monitoring in U.S. history. Side effects that happen within 7 days of getting vaccinated are common but are mostly mild and only last a few days. Some people have reactions that affect their ability to do daily activities.
• Side effects throughout the body (such as fever, chills, tiredness, and headache) are more common after the second dose of the vaccine.
• Severe allergic reactions to vaccines are rare but can happen. Cases of myocarditis and pericarditis have been reported in people who received Novavax COVID-19 vaccine.

Learn more about vaccine safety monitoring after a vaccine is authorized or approved for use.

HOW WELL THE VACCINE WORKS

• Vaccines reduce the risk of COVID-19, including the risk of severe illness and death among people who are fully vaccinated.
• COVID-19 vaccines are effective. Clinical trials demonstrate that Novavax COVID-19 reduces the risk of COVID-19, including the risk of severe illness and death. However, studies from other COVID-19 vaccines have shown that protection declines over time especially with the Omicron variant.
• All FDA-approved or authorized COVID-19 vaccines provide substantial protection against COVID-19 hospitalization and death.
• CDC will continue to provide updates as we learn more.

Learn about Novavax’s clinical trial information for people 18 years and older.

NOVAVAX COVID-19 VACCINE INGREDIENTS

COVID-19 vaccine ingredients are considered safe for most people. Nearly all of the ingredients in COVID-19 vaccines are ingredients found in many foods—fats, sugar, and salts. The Novavax COVID-19 vaccine also includes harmless pieces (proteins) of the virus that causes COVID-19; they are pieces of what is often called the spike protein.  After vaccination, the body creates an immune response to these protein pieces. This response helps protect you from getting sick with COVID-19 in the future. After the body produces an immune response, it discards all the vaccine ingredients, just as it would discard any substance that cells no longer need. This process is a part of normal body functioning.

All COVID-19 vaccines are manufactured with as few ingredients as possible and with very small amounts of each ingredient. Each ingredient in the vaccine serves a specific purpose as seen in the table below.

Type of Ingredient	Ingredient	Purpose
Protein	SARS-CoV-2 recombinant spike protein	Causes an immune response that helps protect the body from getting sick with COVID-19 in the future.
Lipids (fats)	Cholesterol Phosphatidylcholine	Work together to help the recombinant spike protein enter cells
Adjuvant	Fraction-A and Fraction-C of Quillaja saponaria Molina extract.	Facilitates activation of the cells of the innate immune system.
Salts, sugar, and acid	Disodium hydrogen phosphate heptahydrate Disodium hydrogen phosphate dihydrate Polysorbate-80 Potassium chloride (common food salt) Potassium dihydrogen phosphate (common food salt) Sodium chloride (basic table salt) Sodium dihydrogen phosphate monohydrate Sodium hydroxide or hydrochloric acid Water	Work together to help keep the vaccine molecules stable while the vaccine is manufactured, shipped, and stored until it is ready to be given to a vaccine recipient.

The vaccine may also contain very small amounts of ingredients from the manufacturing stage, which can be found in the EUA Fact Sheet.

INGREDIENTS THAT ARE NOT USED IN COVID-19 VACCINES

The above table lists ALL ingredients in the Novavax COVID-19 vaccine. There are NO ingredients in this vaccine beyond what is listed in the table. The Novavax COVID-19 vaccine has:

• No preservatives such as thimerosal or mercury or any other preservatives.
• No antibiotics such as sulfonamide or any other antibiotics.
• No medicines or therapeutics such as ivermectin or any other medications.
• No tissues such as aborted fetal cells, gelatin, or any materials from any animal.
• No food proteins such as eggs or egg products, gluten, peanuts, tree nuts, nut products, or any nut byproducts (COVID-19 vaccines are not manufactured in facilities that produce food products).
• No metals such as iron, nickel, cobalt, titanium, rare earth alloys, or any manufactured products like microelectronics, electrodes, carbon nanotubes or other nanostructures, or nanowire semiconductors.
• No latex. The vial stoppers used to hold the vaccine also do not contain latex.

To learn more, please visit https://www.cdc.gov/coronavirus/2019-ncov/vaccines/novavax.html.

Learning about how COVID-19 spreads and the factors that can increase or decrease that risk can help you make informed choices.

The questions below are written in past tense to help you assess the likelihood that you were infected when you were around a person with COVID-19. If multiple factors below indicate higher transmission risk, you should follow the steps for what to do if you are exposed.

You can also ask yourself the same questions, but about future interactions with others, to help you decide what prevention actions to take. If multiple factors below indicate higher transmission risk, you should consider adding more prevention actions.

Factors that lower or increase risk of transmission

Length of time: How long were you with the infected person?

Longer exposure time increases the risk of transmission (for example, contact longer than 15 minutes is more likely to result in transmission than two minutes of contact).

Cough or heavy breathing: Was the infected person coughing, singing, shouting, or breathing heavily?

Activities like coughing, singing, shouting, or breathing heavily due to exertion increase the risk of transmission.

Symptoms: Did the infected person have symptoms at the time?

Being around people who are symptomatic increases the risk of transmission.

Masks: Were you or the infected person or both wearing a respirator (for example, N95) or high-quality mask?

If one person was wearing a mask, the risk of transmission is decreased, and if both people were wearing masks, the risk is substantially decreased. Risk is also lower if the mask or respirator is a type that offers greater protection.

Ventilation and filtration: How well-ventilated was the space?

More outdoor air can decrease the risk of transmission. Being outside would be lower exposure risk than being indoors, even with good ventilation and filtration; both of those options would be lower risk than being indoors with poor ventilation or filtration. See the Interactive Home Ventilation Tool.

Distance: How close was the infected person to you?

Being closer to someone who is infected with COVID-19 increases the risk of transmission. Crowded settings can raise your likelihood of being close to someone with COVID-19.

To learn more, please visit https://www.cdc.gov/coronavirus/2019-ncov/your-health/risks-exposure.htm

What You Need to Know

• COVID-19 vaccines are safe and effective and severe reactions after vaccination are rare.
• CDC recommends COVID-19 vaccines for everyone ages 6 months and older, and boosters for everyone 5 years and older, if eligible.
• Millions of people in the United States have received COVID-19 vaccines under the most intense safety monitoring program in U.S. history.
• CDC, the U.S. Food and Drug Administration (FDA), and other federal agencies continue to monitor the safety of all vaccines, including COVID-19 vaccines, by reviewing data reported to the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD).

The benefits of COVID-19 vaccination continue to outweigh any potential risks.

CDC is providing timely updates on the following adverse events of interest:

• Anaphylaxis after COVID-19 vaccination is rare and has occurred at a rate of approximately 5 cases per one million vaccine doses administered. Anaphylaxis, a severe type of allergic reaction, can occur after any kind of vaccination. If it happens, healthcare providers can effectively and immediately treat the reaction. Learn more about COVID-19 vaccines and allergic reactions, including anaphylaxis.

CDC scientists have conducted detailed reviews of cases of anaphylaxis and made the information available to healthcare providers and the public:

• Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine
• Reports of Anaphylaxis After Receipt of mRNA COVID-19 Vaccines in the US—December 14, 2020-January 18, 2021
• Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Moderna COVID-19 Vaccine— United States, December 21, 2020-January 10, 2021
• Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine — United States, December 14-23, 2020
• Thrombosis with thrombocytopenia syndrome (TTS) after J&J/Janssen COVID-19 vaccination is rare and has occurred in approximately 4 cases per one million doses administered. TTS is a rare but serious adverse event that causes blood clots in large blood vessels and low platelets (blood cells that help form clots).

A review of reports indicates a causal relationship between the J&J/Janssen COVID-19 vaccine and TTS. CDC scientists have conducted detailed reviews of TTS cases and made the information available to healthcare providers and the public:

• US Case Reports of Cerebral Venous Sinus Thrombosis With Thrombocytopenia After Ad26.COV2.S Vaccination, March 2 to April 21, 2021
• Case Series of Thrombosis with Thrombocytopenia Syndrome following COVID-19 vaccination—United States, December 2020–August 2021
• Updates on Thrombosis with Thrombocytopenia Syndrome (TTS) [1.3 MB, 39 Pages]
• Guillain-Barré Syndrome (GBS) in people who have received the J&J/Janssen COVID-19 vaccine is rare. GBS is a rare disorder where the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis. GBS has largely been reported in men ages 50 years and older.

Based on a recent analysis of data from the Vaccine Safety Datalink, the rate of GBS within the first 21 days following J&J/Janssen COVID-19 vaccination was found to be 21 times higher than after Pfizer-BioNTech or Moderna (mRNA COVID-19 vaccines). After the first 42 days, the rate of GBS was 11 times higher following J&J/Janssen COVID-19 vaccination. The analysis found no increased risk of GBS after Pfizer-BioNTech or Moderna (mRNA COVID-19 vaccines). CDC and FDA will continue to monitor for and evaluate reports of GBS occurring after COVID-19 vaccination and will share more information as it becomes available.

• Myocarditis and pericarditis after COVID-19 vaccination are rare. Myocarditis is inflammation of the heart muscle, and pericarditis is inflammation of the outer lining of the heart. Most patients with myocarditis or pericarditis after COVID-19 vaccination responded well to medicine and rest and felt better quickly. Most cases have been reported after receiving Pfizer-BioNTech or Moderna (mRNA COVID-19 vaccines), particularly in male adolescents and young adults.

A review of vaccine safety data in VAERS from December 2020–August 2021 found a small but increased risk of myocarditis after mRNA COVID-19 vaccines. Over 350 million mRNA vaccines were given during the study period and CDC scientists found that rates of myocarditis were highest following the second dose of an mRNA vaccine among males in the following age groups:

• 12–15 years (70.7 cases per one million doses of Pfizer-BioNTech)
• 16–17 years (105.9 cases per one million doses of Pfizer-BioNTech)
• 18–24 years (52.4 cases and 56.3 cases per million doses of Pfizer-BioNTech and Moderna, respectively)

Multiple studies and reviews of data from vaccine safety monitoring systems continue to show that vaccines are safe. As a result, the agency will refocus enhanced surveillance and safety monitoring efforts toward children and adolescents.

As of July 28, 2022, there have been 1,010 preliminary reports in VAERS among people younger than age 18 years under review for potential cases of myocarditis and pericarditis. Of these, 258 remain under review. Through confirmation of symptoms and diagnostics by provider interview or review of medical records, 665 reports have been verified to meet CDC’s working case definition for myocarditis. See below for counts of verified reports of myocarditis by age group.

5-11 years: 22 verified reports of myocarditis after 20,404,074 doses administered

12-15 years: 346 verified reports of myocarditis after 24,198,309 doses administered

16-17 years: 297 verified reports of myocarditis after 13,326,016 doses administered

As the COVID-19 vaccines are authorized for younger children, CDC and FDA will continue to monitor for and evaluate reports of myocarditis and pericarditis after COVID-19 vaccination and will share more information as it becomes available. Learn more about myocarditis and pericarditis, including clinical considerations, after mRNA COVID-19 vaccination.

• Reports of death after COVID-19 vaccination are rare. FDA requires healthcare providers to report any death after COVID-19 vaccination to VAERS, even if it’s unclear whether the vaccine was the cause. Reports of adverse events to VAERS following vaccination, including deaths, do not necessarily mean that a vaccine caused a health problem. More than 603 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through July 27, 2022. During this time, VAERS received 15,700 preliminary reports of death (0.0026%) among people who received a COVID-19 vaccine. CDC and FDA clinicians review reports of death to VAERS including death certificates, autopsy, and medical records.

Continued monitoring has identified nine deaths causally associated with J&J/Janssen COVID-19 vaccination. CDC and FDA continue to review reports of death following COVID-19 vaccination and update information as it becomes available.

To learn more, please visit https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html