我以前给大家科普过，根据FDA的批准信，FDA正式批准的COMIRNATY其实跟EUA版本的Pfizer-BioNTech COVID-19 Vaccine没有任何区别，但是legally distinct。现在有更多关于COMIRNATY的信息出来了。 FDA刚发布的COMIRNATY insert prescribing info里专门有一段警告心肌炎副作用 ----------------- WARNINGS AND PRECAUTIONS ------------ • Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. (5.2) • Syncope (fainting) may occur in association with administration of injectable vaccines, including COMIRNATY. Procedures should be in place to avoid injury from fainting. (5.4) The FDA states the risk exists in males under the age of 40 and is highest among young men 12 through 17 years of age. The warning points out that there is currently no information on the likely long-term consequences of this condition. Yet, it says that “most individuals have had resolution of symptoms with conservative management.” https://www.fda.gov/media/151707/download CDC承认心肌炎只跟mRNA疫苗有关（说JJ疫苗没有类似事件reports) https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html
唯一让我惊讶的是根据NIH revised (Oct. 29, 2021) label information for the Pfizer-BioNTech COVID-19 vaccine implies that EUA is in place for not just the Pfizer-BioNTech “vaccine,” but for the COMIRNATY shot as well。COMIRNATY的EUA是for certain uses(不知道这certain uses 是指的啥） ”This EUA for the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.” https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=908ecbe7-2f1b-42dd-94bf-f917ec3c5af8&type=display
FDA刚发布的COMIRNATY insert prescribing info里专门有一段警告心肌炎副作用
----------------- WARNINGS AND PRECAUTIONS ------------ • Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. (5.2) • Syncope (fainting) may occur in association with administration of injectable vaccines, including COMIRNATY. Procedures should be in place to avoid injury from fainting. (5.4)
The FDA states the risk exists in males under the age of 40 and is highest among young men 12 through 17 years of age. The warning points out that there is currently no information on the likely long-term consequences of this condition. Yet, it says that “most individuals have had resolution of symptoms with conservative management.”
https://www.fda.gov/media/151707/download
CDC承认心肌炎只跟mRNA疫苗有关（说JJ疫苗没有类似事件reports) https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html
跟我之前的预料相同，EUA的针剂不打完辉瑞不会生产有COMIRNATY标签的针剂。
https://www.nlm.nih.gov/pubs/techbull/so21/brief/so21_rxnorm_october_release.html
唯一让我惊讶的是根据NIH revised (Oct. 29, 2021) label information for the Pfizer-BioNTech COVID-19 vaccine implies that EUA is in place for not just the Pfizer-BioNTech “vaccine,” but for the COMIRNATY shot as well。COMIRNATY的EUA是for certain uses(不知道这certain uses 是指的啥）
”This EUA for the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.”
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=908ecbe7-2f1b-42dd-94bf-f917ec3c5af8&type=display
以上所有美国政府的官方链接来自于此新闻 https://uncoverdc.com/2021/11/23/the-comirnaty-package-insert/