Issue Brief COVID-19 Comparison Last Updated: Sept. 7, 2021

This past year, three COVID-19 produced by /BioNTech, , and , Inc. were granted Emergency Use Authorization (EUA) by FDA. A comparison of key details for each vaccine can be found below, which has evolved over time. This list is not exhaustive. For further details, please see the FDA documents for Pfizer/BioNTech, Moderna, and Janssen (J&J).

New Updates On Aug. 23, FDA fully licensed the Pfizer/BioNTech product, marketed as Comirnaty, for persons aged 16 years and older.

Key Updates Coadministration of Vaccine Following an emergency Advisory Committee on Practices (ACIP) meeting on May 12, 2021, CDC revised vaccine administration guidance indicating that COVID-19 vaccines can be co-administered with other vaccines without regard to timing. Coadministration information is summarized in CDC’s Interim Clinical Considerations guidance.

Variants In December 2020, the B.1.617.2 variant, or Delta variant, was first identified in India, and quickly became the dominant variant in over 98 countries, including the . COVID-19 vaccines remain effective against the Delta variant. However, studies have shown that rates are lower against the Delta variant compared to the original strain.

In late July 2021, CDC published a report evaluating outbreaks of SARS-CoV-2 associated with large public gatherings in Barnstable County, Massachusetts and found 74% of reported COVID-19 cases were breakthrough – with 90% of infections caused by the Delta variant – that occurred in people who were fully vaccinated with two doses of Pfizer/BioNTech or Moderna, or one of the J&J vaccine. This information prompted CDC to recommend the use of masks in indoor public spaces, regardless of status, in areas where COVID-19 is high.

In addition to the Delta variant, CDC and WHO continue to monitor other variants of interest, including the B.1.621 variant, or Mu variant. Pfizer is currently conducting Mu variant vaccine effectiveness studies.

Side Effects Since April 2021, FDA has investigated uncommon but severe side effects associated with the COVID-19 vaccines. The mRNA vaccines (Pfizer/BioNTech and Moderna) were found to have a suggested increased risk of myocarditis and pericarditis. The J&J vaccine was found to have a suggested increased risk of thrombosis with thrombocytopenia syndrome and Guillain-Barré Syndrome. All events were found to be uncommon, and the vaccine’s benefits continue to outweigh the additional risks found.

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Pregnant and Lactating Women Preliminary data from FDA and CDC safety systems have not identified any safety concerns among pregnant or lactating women. Additionally, completed data from studies show no issues. Pregnant/lactating people should discuss the risks and benefits with their provider. Additionally, the American College of Obstetricians and Gynecologist, the Society for Maternal-Fetal , and CDC now recommend that all pregnant and lactating women should be vaccinated against COVID-19 in response to growing evidence of safe and effective use of COVID-19 vaccines during pregnancy and breastfeeding.

Immunocompromised Individuals On Aug. 12, FDA authorized the use of an additional vaccine dose for mRNA vaccines’ Pfizer/BioNTech and Moderna for certain immunocompromised individuals. ACIP met on Aug. 13 to discuss further clinical recommendations for moderately to severely immunocompromised individuals. You can find more information on CDC’s recommendations for who should receive an additional dose on its website.

Comirnaty (Pfizer/BioNTech) Moderna Vaccine J&J Vaccine Vaccine Target • Full BLA license approved • EUA authorized for • EUA authorized for Population for people aged 16 and people aged 18 and people aged 18 and older. older. older. • EUA authorized for people aged 12 and older. Vaccine • data • Clinical trial data • Clinical trial data Efficacy demonstrated vaccine demonstrated vaccine demonstrated vaccine efficacy was 95.0% against efficacy was 94.1% efficacy was 66.3% at Disclaimer: symptomatic, laboratory- against symptomatic, least 14 days after vaccine confirmed COVID-19 in laboratory-confirmed vaccination against effectiveness people ages 16 years and COVID-19 following symptomatic, data is older without evidence of receipt of two doses of laboratory-confirmed emerging – previous SARS-CoV-2 Moderna COVID-19 COVID-19 in persons much of this following receipt vaccine. without evidence of information is of two doses of • The COVID-19 vaccines previous SARS-CoV-2 from clinical Pfizer/BioNTech COVID-19 authorized in the United infection; 93.1% for the trials and may vaccine. In adolescents States are highly prevention of COVID-19- be outdated. ages 12–15 years, efficacy effective at preventing associated CDC is was 100% in the clinical severe and hospitalization; and 75% currently trial. death, including against against all-cause death. conducting • The COVID-19 vaccines the Delta variant. But • The COVID-19 vaccines studies on authorized in the United they are not 100% authorized in the United vaccine States are highly effective effective, and some fully States are highly effectiveness, at preventing severe vaccinated people will effective at preventing which can be disease and death, become infected (called severe disease and found here. including against the Delta a breakthrough death, including against variant. But they are not infection) and the Delta variant. But 100% effective, and some experience illness. For they are not 100% fully vaccinated people will such people, the vaccine effective, and some fully become infected (called a still provides strong vaccinated people will ) protection against become infected (called and experience illness. For serious illness and a breakthrough

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Comirnaty (Pfizer/BioNTech) Moderna Vaccine J&J Vaccine Vaccine such people, the vaccine death. infection) and still provides strong experience illness. For protection against serious such people, the vaccine illness and death. still provides strong protection against serious illness and death. Vaccine Pfizer/BioNTech Factsheet and Moderna Administration Janssen Administration Administration Package Insert Factsheet Factsheet • Two shots are required, • Two shots are required, • One shot is required. three weeks apart. Each one month apart. Each Each dose contains 0.5 dose contains 0.3mL of dose 0.5mL of vaccine. mL of vaccine. vaccine. • The vaccine is ready to • The vaccine is ready to • The vaccine must be administer. administer. No dilution diluted with saline before • The vaccine is supplied required. it is injected. in two multiple-dose vial • There are five doses per • After dilution, one vial presentations. A vial. Once punctured, contains six doses. Vial multiple-dose vial vials can be stored in a labels and cartons may containing a maximum refrigerator (36 °F to 46 state that after dilution, a of 11 doses: range 10-11 °F) for up to six hours or vial contains five doses. doses (0.5 mL each) and up to two hours at room The information found in a multiple-dose vial temperature (77 °F). the updated EUA factsheet containing a maximum supersedes the number of of 15 doses: range 13-15 doses stated on vial labels doses (0.5 mL each). It and cartons. Undiluted can be stored in a vials can be stored in a refrigerator (36°F to refrigerator for up to one 46°F) for 30 days and at month (30 days). Once it is room temperature (46°F thawed, it must be used to 77°F) for 24 hours. within two hours. Diluted After the first dose has vials can be stored been withdrawn, the fil between 35°F to 77°F for should be held at 36°F to up to six hours. 77°F and discarded • Certain moderately to within 12 hours) severely • Certain moderately to immunocompromised severely persons can receive an immunocompromised additional (or third) dose persons can receive an of the vaccine at least 28 additional (or third) dose days after the initial of the vaccine at least 28 primary two-dose series of days after the initial the same vaccine. primary two-dose series of the same vaccine.

Possible Side • The benefits of vaccine • The benefits of vaccine • The benefits of vaccine outweigh the risks; outweigh the risks; outweigh the risks;

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Comirnaty (Pfizer/BioNTech) Moderna Vaccine J&J Vaccine Vaccine Effects however, side effects have however, side effects however, side effects been reported. Common have been reported. have been reported. side effects include at Common side effects Common side effects the site, include pain at the include pain at the tiredness, headache, injection site, tiredness, injection site, headache, muscle pain, chills, headache, muscle pain, fatigue, muscle aches, pain, and fever. chills, joint pain, swollen and nausea. • Other side effects include lymph nodes in the • Other side effects severe allergic reactions, same arm as the include severe allergic non-severe allergic injection, nausea and reactions, clots reactions, myocarditis, vomiting, and fever with low level of pericarditis, injection site • Side effects that have , and Guillain swelling, injection site been reported post Barre Syndrome. redness, nausea, feeling authorization include unwell, swollen lymph severe allergic reactions, nodes, diarrhea, vomiting, myocarditis, and and arm pain. pericarditis.

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