(2) Fact Sheet for Healthcare Provider Administering Vaccine (Vaccine Providers); Emergency Use Authorization (EUA) of the Moderna COVIS-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19). FDA, December 2020.
https://www.modernatx.com/covid1 ... sheet-providers.pdf
Quote
(a) "SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS * * * The Moderna COVID-19 Vaccine is a suspension for intramuscular injection administered as a series of two doses (0.5 mL each) 1 month apart." page
(b) "DOSAGE AND ADMINISTRATION
Storage and Handling
Do not store on dry ice or below -40ºC (-40ºF).
Vials can be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use.
Unpunctured vials may be stored between 8° to 25°C (46° to 77°F) for up to 12 hours.
Do not refreeze once thawed." pages 1-2.
(c) "END SHORT VERSION FACT SHEET
Long Version (Full EUA Prescribing Information) Begins On Next Page" page 7
(d) "4 CONTRAINDICATIONS
Do not administer the Moderna COVID-19 Vaccine to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine [see Description (13)].
5 WARNINGS AND PRECAUTIONS
5.1 Management of Acute Allergic Reactions
Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the Moderna COVID-19 Vaccine.
Monitor Moderna COVID-19 vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines
(https://www.cdc.gov/vaccines/covid-19/)." at pages 9-10.
(e) "13 DESCRIPTION
Moderna COVID-19 Vaccine is provided as a white to off-white suspension for intramuscular injection. Each 0.5 mL dose of Moderna COVID-19 Vaccine contains 100 mcg of nucleoside-modified messenger RNA (mRNA) encoding the pre-fusion stabilized Spike glycoprotein (S) of
SARS-CoV-2 virus.
Each dose of the Moderna COVID-19 Vaccine contains the following ingredients: a total lipid content of 1.93 mg (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), 0.31 mg tromethamine, 1.18 mg tromethamine hydrochloride, 0.043 mg acetic acid, 0.12 mg sodium acetate, and 43.5 mg sucrose.
Moderna COVID-19 Vaccine does not contain a preservative.
The vial stoppers are not made with natural rubber latex.
14 CLINICAL PHARMACOLOGY
14.1 Mechanism of Action
The nucleoside-modified mRNA in the Moderna COVID-19 Vaccine is formulated in lipid particles, which enable delivery of the nucleoside-modified mRNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits an immune response to the S antigen, which protects against COVID-19." at pages 18-19.
Note:
(a) The URL contains two parts:
(i) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) Emergency Use Authorization (EUA) of the Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19), followed by
(ii) Full Emergency Use Authorization (EUA) Prescribing Information.
FDA has exactly the same of the two in its website.
https://www.fda.gov/media/144637/download
Thus the Moderna apparently reproduced the same from FDA, or Moderna content was pre-approved by FDA.
For the same vaccine, compared to Note (a)(i) above FDA has a separate "Fact Sheet for Recipients [ie, persons to be vaccinated] and Caregivers."
(b) Moderna, Inc (2010- ; based in Cambridge, Massachusetts -- within walking distance from MIT) has the second COVID-19 vaccine approved by FDA (on Dec 18, 2020). The first and only commercial product of Moderna, the vaccine (mRNA-1273) is made up of single-stranded messenger RNA (mRNA) in a lipid particle. Repeat:
(i) In nature as well as in this vaccine, mRNA is single-stranded (whereas DNA is double-stranded helix) -- this, along with that of Pfizer/ BioNTech, is the first mRNA vaccine in the world. For centuries, killed or weakened viruses have been used; then viral coat protein(s) --with genetic material of the virus -- are used. This time, mRNA for a single viral protein (S) is used, so that human cells may produce the viral protein INSIDE the body, to generate immune response to that viral protein.
(ii) Further the vehicle is lipid particles (that contain the mRNA at issue) that will automatically fuse with cells once injected (the vaccine can not go through mouth, because digestive system will destroy it, the vaccine), in contrast to the commonplace viral protein coat (in part because mRNA contains information for just about one protein, hence no room for protein coat).
(c)
(i) Boston Doctor Who Had Allergic Reaction to Moderna Vaccine Describes Experience. NBC (Boston), Dec 28 (Monday), 2020
https://www.nbcboston.com/news/c ... experience/2266946/
("Within moments of receiving the first dose of the vaccine on Thursday [Dec 24, 2020], Dr Hossein Sadrzadeh of Boston Medical Center [a teaching hospital of Boston University School of Medicine] said his heart began racing. 'My blood pressure was really down, so this is the time that I knew that this was anaphylactic shock,' Sadrzadeh told NBC10 Boston [10 is channel 10] and NECN [New England Cable News, a subscription-based cable service owned by NBC]. 'My heart rate is up, I'm sweating so my blood pressure is really down. I've had this before so I had my EpiPen and I administered myself.' * * * Sadrzadeh, who has a severe shellfish allergy, was taken to the emergency department * * * Sadrzadeh is the first person to have a known allergic reaction to Moderna's coronavirus vaccine, according to The New York Times. Other vaccines now in use have also been known to cause allergic reactions in rare cases, however. More than 35,000 people [Massachusetts population: 6.9m (2019) estimate)] have gotten the vaccine in Massachusetts as of Tuesday, according to the state's new dashboard. * * * Just over 1 million people in the US had received their first dose of a coronavirus vaccine as of Wednesday morning, according to the CDC, and only a handful of reactions to them had qualified as anaphylaxis, a severe and potentially life-threatening allergic reaction. * * * It's unclear why some people are experiencing allergic reactions after getting the shots. Fatigue, headaches and muscle pain have been noted as the most common side effects from Moderna's vaccine, according to the Food and Drug Administration")
(ii) I am a biologist by training. Looking at the ingredients of the vaccine -- see quotation (b) -- nothing in theory should cause allergy. In allergy, an antigen (ie, allergen) binds to immunoglobulin E (IgE) on the surface of mast cell, which the releases histamine (which causes all symptoms of an allergy). Anaphylactic shock is an extreme form of allergy. With massive release of histamine.
(d) "to allow expression of the SARS-CoV-2 S antigen"
(i) Severe acute respiratory syndrome coronavirus 2
https://en.wikipedia.org/wiki/Se ... drome_coronavirus_2
(abbreviation: SARS-CoV-2; section 2 Virology, section 2.4 Structural biology: "SARS-CoV-2 has four structural proteins, known as the S (spike) * * * [see illustration]")
Because vaccines from Pfizer/BioNTech and Moderna are mRNA in lipid particles, AND or intramuscular injection. I do not know why the former needs special storage conditions.
(ii) To sum up, COVID-19 is a disease, which is caused by the virus SARS-CoV-2.
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发表于 12-28-2020 16:30:47
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