{"id":275,"date":"2021-03-02T09:59:40","date_gmt":"2021-03-02T15:59:40","guid":{"rendered":"https:\/\/betterpathology.com\/?p=275"},"modified":"2022-09-17T15:55:28","modified_gmt":"2022-09-17T20:55:28","slug":"new-vaccine","status":"publish","type":"post","link":"https:\/\/betterpathology.com\/?p=275","title":{"rendered":"New Vaccine"},"content":{"rendered":"\n

There were a couple of big changes in the COVID vaccine landscape last week.   On Thursday, February 25, the FDA reissued its EUAs for the Pfizer<\/a> and Moderna<\/a> COVID-19 vaccines, revising portions of their original EUA<\/a>s.  On Saturday, February 27, the FDA issued a new EUA for the Janssen COVID-19 vaccine<\/a>, commonly known as the Johnson and Johnson vaccine.  Lots of news, too much for one blog.  Let\u2019s address the important information one bite at a time, starting with the Janssen vaccine.<\/p>\n\n\n\n

Like all other COVID-19 vaccines, the Janssen vaccine has not been approved<\/em> for use by the FDA.  Instead, these vaccines are authorized <\/em>for use in the U.S.  This authorization is based on the FDA\u2019s authority to make unapproved products available during an emergency when \u201cthere are no adequate, approved, and available alternatives<\/a>.\u201d  As stated in the EUA letter issued February 27, 2021, \u201cIt is an investigational vaccine not licensed for any indication<\/a>.\u201d  This means that clinical trails on vaccine safety and effectiveness have not been completed. Expect comprehensive analysis of clinical trials this summer at the earliest.<\/p>\n\n\n\n

However, the Janssen vaccine differs from the other two vaccines in important ways.\u00a0\u00a0First, it is not an\u00a0mRNA vaccine<\/a>.\u00a0\u00a0Rather, it is a recombinant vector vaccine.\u00a0\u00a0This vaccine is made by inserting genetic code for a protein of the target into a harmless virus (the “vector”).\u00a0\u00a0When injected, this harmless virus presents the target proteins to the immune system, causing formation of\u00a0antibodies<\/a>, in this case antibodies to the spike proteins on the SARS-CoV-2 capsule.\u00a0\u00a0This technology is not entirely new.\u00a0 Manufactured (or “recombinant”) genetic code has been used to synthesize proteins for vaccines for nearly a decade. \u00a0Recombinant flu vaccines received FDA approval in 2013.\u00a0\u00a0You may have received a recombinant flu vaccine in recent years.\u00a0The difference between recombinant protein vaccine and viral vector vaccines has to do with where the antigenic proteins are made–either in your body (viral vector) or outside your body (recombinant protein). The harmless virus (the “viral vector”) cannot replicate within your body, so the effect is the same.<\/p>\n\n\n\n

There are more differences. According to data submitted to the FDA, the Janssen vaccine is less effective preventing moderate to severe COVID-19 than the Moderna and Pfizer vaccines.\u00a0\u00a0The Janssen vaccine requires only one doses compared to the two doses required by Moderna and Pfizer.\u00a0\u00a0Storage of the Janssen vaccine is easier to accomplish than the other two. Vaccines features are compared as follows:<\/p>\n\n\n\n

<\/td>Pfizer<\/a><\/td>Moderna<\/a><\/td>Janssen<\/a><\/td><\/tr>
Vaccine Technology<\/td>mRNA<\/strong><\/td>mRNA<\/strong><\/td>Recombinant Vector<\/strong><\/td><\/tr>
FDA Approval<\/td>No<\/strong><\/td>No<\/strong><\/td>No<\/strong><\/td><\/tr>
Effective rate<\/td>95%<\/strong><\/td>95%<\/strong><\/td>66%<\/strong><\/td><\/tr>
Minimum Age<\/td>16 years<\/strong><\/td>18 years<\/strong><\/td>18 years<\/strong><\/td><\/tr>
Doses<\/td>2<\/strong><\/td>2<\/strong><\/td>1<\/strong><\/td><\/tr>
Storage<\/td>-70\u00b0C<\/strong><\/td>-70\u00b0C<\/strong><\/td>Refrigerated<\/strong><\/td><\/tr>
Time between doses<\/td>3 weeks<\/strong><\/td>1 month<\/strong><\/td>Not applicable<\/strong><\/td><\/tr><\/tbody><\/table>
Current comparison among authorized COVID-19 vaccines.<\/figcaption><\/figure>\n\n\n\n

There is another difference.  In its reissued EUA, the FDA has required Pfizer to disclose post-authorization adverse events in its fact sheet to health care providers.  We will discuss that next time.<\/p>\n","protected":false},"excerpt":{"rendered":"

There were a couple of big changes in the COVID vaccine landscape last week.   On Thursday, February 25, the FDA reissued its EUAs for the Pfizer and Moderna COVID-19 vaccines, revising portions of their original EUAs.  On Saturday, February 27, the FDA issued a new EUA for the Janssen COVID-19 vaccine, commonly known as the Johnson and Johnson vaccine.  Lots of news, too […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"nf_dc_page":"","om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[13,3,8],"tags":[],"class_list":["post-275","post","type-post","status-publish","format-standard","hentry","category-13","category-covid-19","category-vaccine"],"jetpack_publicize_connections":[],"jetpack_likes_enabled":true,"jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":1148,"url":"https:\/\/betterpathology.com\/?p=1148","url_meta":{"origin":275,"position":0},"title":"Vaccine Booster Update","author":"Kevin Homer, MD","date":"October 24, 2021","format":false,"excerpt":"The FDA reshaped the vaccine landscape last week, authorizing single boosters for Moderna and Janssen vaccines, and permitting boosters from all vaccine manufacturers regardless of the initial vaccine brand.\u00a0\u00a0\u00a0Here is an updated vaccine chart, incorporating these changes. The changes were discussed at the two-day\u00a0Advisory Committee Meeting on Vaccines and Related\u2026","rel":"","context":"In "2021"","block_context":{"text":"2021","link":"https:\/\/betterpathology.com\/?cat=13"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2021\/10\/Vaccine-Update-2.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2021\/10\/Vaccine-Update-2.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2021\/10\/Vaccine-Update-2.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2021\/10\/Vaccine-Update-2.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2021\/10\/Vaccine-Update-2.png?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2021\/10\/Vaccine-Update-2.png?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":1354,"url":"https:\/\/betterpathology.com\/?p=1354","url_meta":{"origin":275,"position":1},"title":"FDA Limits Janssen EUA","author":"Kevin Homer, MD","date":"May 5, 2022","format":false,"excerpt":"The vaccine landscape changed today.\u00a0\u00a0To keep you up to date, here is a summary of changes and a new vaccine chart. Pfizer New Factsheets for Healthcare Providers have been issued for Pfizer\u00a0Purple,\u00a0Gray, and\u00a0Orange vaccines.\u00a0\u00a0The Pfizer family of vaccines are now authorized for two booster doses, the first of which may\u2026","rel":"","context":"In "Vaccine"","block_context":{"text":"Vaccine","link":"https:\/\/betterpathology.com\/?cat=8"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2022\/05\/Vaccine-Update-May-2022.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2022\/05\/Vaccine-Update-May-2022.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2022\/05\/Vaccine-Update-May-2022.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2022\/05\/Vaccine-Update-May-2022.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2022\/05\/Vaccine-Update-May-2022.png?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2022\/05\/Vaccine-Update-May-2022.png?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":391,"url":"https:\/\/betterpathology.com\/?p=391","url_meta":{"origin":275,"position":2},"title":"A New Vaccine Warning: Guillain-Barr\u00e9 Syndrome","author":"Kevin Homer, MD","date":"July 15, 2021","format":false,"excerpt":"Last week, the FDA added a new statement to the Janssen vaccine\u00a0Factsheet for Healthcare Providers, warning of an increased incidence of Guillain-Barr\u00e9 Syndrome among vaccine recipients. This warning was issued after cases in\u00a0India\u00a0and the\u00a0United Kingdom\u00a0were published in the\u00a0Annals of Neurology.\u00a0\u00a0Although the warning only applies to the Janssen vaccine, at least\u2026","rel":"","context":"In "2021"","block_context":{"text":"2021","link":"https:\/\/betterpathology.com\/?cat=13"},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":1097,"url":"https:\/\/betterpathology.com\/?p=1097","url_meta":{"origin":275,"position":3},"title":"Deception","author":"Kevin Homer, MD","date":"September 28, 2021","format":false,"excerpt":"Misconceptions about COVID Vaccines are fueling vaccine mandates.\u00a0\u00a0The CDC has contributed to these misconceptions by its recent statements and actions.\u00a0\u00a0Trusted institutions and processes are now corrupted by a political agenda that has licensed vaccine mandates.\u00a0\u00a0Next will be vaccine passports and social credit scores, resulting in the loss of human rights.\u2026","rel":"","context":"In "2021"","block_context":{"text":"2021","link":"https:\/\/betterpathology.com\/?cat=13"},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":301,"url":"https:\/\/betterpathology.com\/?p=301","url_meta":{"origin":275,"position":4},"title":"Anaphylaxis","author":"Kevin Homer, MD","date":"April 3, 2021","format":false,"excerpt":"In the\u00a0revised EUA\u00a0issued for its COVID vaccine on February 25, 2021, the FDA required Pfizer to updated its \u201cFact Sheet for Healthcare Providers\u201d to include post-authorization adverse effects. As a result, Pfizer\u2019s fact sheet now states, \u201cSevere allergic reactions,\u00a0including anaphylaxis\u00a0[emphasis added], and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema)\u2026","rel":"","context":"In "2021"","block_context":{"text":"2021","link":"https:\/\/betterpathology.com\/?cat=13"},"img":{"alt_text":"","src":"","width":0,"height":0},"classes":[]},{"id":1184,"url":"https:\/\/betterpathology.com\/?p=1184","url_meta":{"origin":275,"position":5},"title":"Boosters for All","author":"Kevin Homer, MD","date":"November 20, 2021","format":false,"excerpt":"Yesterday, the FDA revised the Factsheets for Providers Administering Pfizer BioNTech (both\u00a0Purple\u00a0and\u00a0Gray) and\u00a0Moderna\u00a0COVID-19 Vaccines, permitting boosters of these unapproved products to Americans 18 years of age and older because of an ongoing emergency.\u00a0\u00a0The FDA took this action without reconvening the Vaccines and Related Biological Products Advisory Committee, a panel of\u2026","rel":"","context":"In "2021"","block_context":{"text":"2021","link":"https:\/\/betterpathology.com\/?cat=13"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2021\/11\/Boosters-for-All.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2021\/11\/Boosters-for-All.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2021\/11\/Boosters-for-All.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2021\/11\/Boosters-for-All.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2021\/11\/Boosters-for-All.png?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/betterpathology.com\/wp-content\/uploads\/2021\/11\/Boosters-for-All.png?resize=1400%2C800&ssl=1 4x"},"classes":[]}],"jetpack_featured_media_url":"","_links":{"self":[{"href":"https:\/\/betterpathology.com\/index.php?rest_route=\/wp\/v2\/posts\/275","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/betterpathology.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/betterpathology.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/betterpathology.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/betterpathology.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=275"}],"version-history":[{"count":2,"href":"https:\/\/betterpathology.com\/index.php?rest_route=\/wp\/v2\/posts\/275\/revisions"}],"predecessor-version":[{"id":295,"href":"https:\/\/betterpathology.com\/index.php?rest_route=\/wp\/v2\/posts\/275\/revisions\/295"}],"wp:attachment":[{"href":"https:\/\/betterpathology.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=275"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/betterpathology.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=275"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/betterpathology.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=275"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}