{"id":2107,"date":"2021-08-14T17:39:50","date_gmt":"2021-08-14T17:39:50","guid":{"rendered":"http:\/\/wp.cov19longhaulfoundation.org\/?p=2107"},"modified":"2021-08-14T17:39:50","modified_gmt":"2021-08-14T17:39:50","slug":"reactogenicity-following-receipt-of-mrna-based-covid-19-vaccines","status":"publish","type":"post","link":"https:\/\/cov19longhaulfoundation.org\/?p=2107","title":{"rendered":"Reactogenicity Following Receipt of mRNA-Based COVID-19 Vaccines"},"content":{"rendered":"\n

Authors: Johanna\u00a0Chapin-Bardales,\u00a0PhD, MPH1<\/sup><\/a>;\u00a0Julianne\u00a0Gee,\u00a0MPH1<\/sup><\/a>;\u00a0Tanya\u00a0Myers,\u00a0PhD, MSc1<\/sup><\/a><\/p>\n\n\n\n

In December 2020, 2 mRNA-based COVID-19 vaccines (Pfizer-BioNTech and Moderna) were granted Emergency Use Authorization by the US Food and Drug Administration as 2-dose series and recommended for use by the Advisory Committee on Immunization Practices.1<\/a><\/sup>–3<\/a><\/sup> In late February 2021, the US Food and Drug Administration granted Emergency Use Authorization for a third COVID-19 vaccine, a single-dose adenovirus vector-based vaccine from Janssen (Johnson & Johnson).<\/a><\/p>\n\n\n\n

In clinical trials of the mRNA-based 2-dose vaccines, participants reported local and systemic reactions (reactogenicity).4<\/a><\/sup>,5<\/a><\/sup> Frequently reported reactions included injection site pain, fatigue, and headache; greater reactogenicity was reported following the second dose.4<\/a><\/sup>,5<\/a><\/sup> Continued monitoring of reactogenicity of COVID-19 vaccines outside of clinical trial settings may provide additional information for health care practitioners and the public about transient local and systemic reactions following COVID-19 vaccination.<\/a><\/p>\n\n\n\n

V-safe Active Surveillance System<\/strong><\/p>\n\n\n\n

To facilitate rapid assessment of COVID-19 vaccines, in 2020, the Centers for Disease Control and Prevention (CDC) established v-safe, a new active surveillance system for collecting near\u2013real-time data from COVID-19 vaccine recipients in the US. V-safe participants voluntarily self-enroll and receive periodic smartphone text messages to initiate web-based health surveys from the day of vaccination (day 0) through 12 months after the final dose of a COVID-19 vaccine.6<\/a><\/sup> From day 0 through day 7 after each vaccine dose, participants are asked questions about solicited local and systemic reactions (eg, injection site pain, fatigue, headache). These solicited reactions do not include allergic reactions or anaphylaxis; however, v-safe does allow participants to enter free-text information about their postvaccination experience and asks about adverse health events (eg, received medical care). Medically attended events are followed up on through active telephone outreach; future analyses will address these adverse vaccine experiences. This report describes information on solicited local and systemic reactogenicity reported to v-safe on days 0 to 7 after each dose of vaccine from December 14, 2020, through February 28, 2021. Responses were limited to individuals who were vaccinated by February 21, 2021, to allow a 7-day reporting period after the day of vaccination. Preliminary data from v-safe through January 13, 2021, have been previously reported.7<\/a><\/sup> This activity was reviewed by the CDC and was conducted consistent with applicable federal law and CDC policy (see Additional Information).<\/a><\/p>\n\n\n\n

Self-reported Local and Systemic Reactions Among V-safe Participants<\/strong><\/p>\n\n\n\n

By February 21, 2021, more than 46 million persons received at least 1 dose of an mRNA-based COVID-19 vaccine.8<\/a><\/sup> A total of 3\u202f643\u202f918 persons were enrolled in v-safe and completed at least 1 health survey within 7 days following their first vaccine dose; 1\u202f920\u202f872 v-safe participants reported receiving a second vaccine dose and completed at least 1 daily health survey within 7 days following the second dose. Solicited local and systemic reactions during days 0 to 7 after each dose were assessed.<\/a><\/p>\n\n\n\n

Most v-safe participants reported an injection site reaction (dose 1: 70.0%; dose 2: 75.2%) or a systemic reaction (dose 1: 50.0%; dose 2: 69.4%) during days 0 to 7 after vaccination (Table<\/a>). The most frequently reported solicited local and systemic reactions after the first dose of COVID-19 vaccine were injection site pain (67.8%), fatigue (30.9%), headache (25.9%), and myalgia (19.4%). Reactogenicity was substantially greater after the second dose for both vaccines, particularly for systemic reactions, including fatigue (53.9%), headache (46.7%), myalgia (44.0%), chills (31.3%), fever (29.5%), and joint pain (25.6%).Table. \u00a0Solicited Local and Systemic Reactionsa<\/sup>\u00a0to mRNA-Based COVID-19 Vaccines Reported 0 to 7 Days After Vaccination\u2014Centers for Disease Control and Prevention V-safe Surveillance System, December 14, 2020, to February 28, 2021 View Large<\/a>Download<\/a><\/p>\n\n\n\n

\"Solicited<\/a><\/figure>\n\n\n\n

A greater percentage of participants who received the Moderna vaccine, compared with the Pfizer-BioNTech vaccine, reported reactogenicity; this pattern was more pronounced after the second dose (Table<\/a>). When stratified by age (<65 vs \u226565 years), differences in reactogenicity by vaccine remained consistent with overall findings (data not shown). Local and systemic reactions were less commonly reported by v-safe participants 65 years and older compared with those younger than 65 years, but greater reactogenicity after the second dose was observed for both age groups (eFigure in the\u00a0Supplement<\/a>). For both doses of both vaccines, the percentage of v-safe participants who reported local and systemic reactions was highest on day 1 after vaccination and declined markedly through day 7.<\/p>\n\n\n\n

For More Information: https:\/\/jamanetwork.com\/journals\/jama\/fullarticle\/2778441<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Authors: Johanna\u00a0Chapin-Bardales,\u00a0PhD, MPH1;\u00a0Julianne\u00a0Gee,\u00a0MPH1;\u00a0Tanya\u00a0Myers,\u00a0PhD, MSc1 In December 2020, 2 mRNA-based COVID-19 vaccines (Pfizer-BioNTech and Moderna) were granted Emergency Use Authorization by the US Food and Drug Administration as 2-dose series and […]<\/p>\n","protected":false},"author":2,"featured_media":2108,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[17,761,169,806,823,842,851,862,337,882,941],"tags":[],"class_list":["post-2107","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-anaphylaxis","category-concerns","category-fatigure","category-fever","category-headache-symptoms-covid-19","category-injection-site-pain","category-joint-pain","category-malaise-fatigue","category-mrna","category-myalgia-muscle-pain","category-second-dose"],"_links":{"self":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/2107","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2107"}],"version-history":[{"count":0,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/2107\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/media\/2108"}],"wp:attachment":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2107"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2107"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2107"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}