COVID-19 Vaccine (Pfizer-BioNTech) - Revision history

Rossdonaldson1: /* References */

2024-02-07T18:32:39Z

References

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	==References==		==References==
	<references/>		<references/>

	[[Category:Pharmacology]]		[[Category:Pharmacology]]

	~~[[Category:COVID-19]]~~

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External Links

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	==External Links==		==External Links==
	[https://www.fda.gov/media/144245/download Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Briefing Document- FDA]		*[https://www.fda.gov/media/144245/download Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Briefing Document- FDA]

	==References==		==References==

Rossdonaldson1: /* See Also */

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References

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	<references/>		<references/>
	[[Category:Pharmacology]]		[[Category:Pharmacology]]

			[[Category:COVID-19]]

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Pregnancy Rating

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	==Special Populations==		==Special Populations==
	===[[Drug pregnancy categories\|Pregnancy Rating]]===		===[[Drug pregnancy categories\|Pregnancy Rating]]===
	It is unclear as to the effect of the vaccine in pregnant women, as Pregnancy was an exclusion criteria from the phase 3 clinical trial for this vaccine. <ref>FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine, https://www.fda.gov/media/144245/download, December, 2020. Accessed 21 December 2020 </ref>		It is unclear as to the effect of the vaccine in pregnant women, as Pregnancy was an exclusion criteria from the phase 3 clinical trial for this vaccine.<ref>FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine, https://www.fda.gov/media/144245/download, December, 2020. Accessed 21 December 2020</ref>

	===Lactation risk===		===Lactation risk===

Jmf300: /* Background */

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Background

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	The Pfizer-BioNTech COVID-19 vaccine is an mRNA based vaccine which is approved in the United States to prevent symptomatic [[COVID-19]] infection. The Pfizer-BioNTech was the first COVID-19 vaccine to be approved for distribution in the United States, and it was granted Emergency Use Authorization by the United States Food and Drug Administration (FDA) on 11 December 2020.		The Pfizer-BioNTech COVID-19 vaccine is an mRNA based vaccine which is approved in the United States to prevent symptomatic [[COVID-19]] infection. The Pfizer-BioNTech was the first COVID-19 vaccine to be approved for distribution in the United States, and it was granted Emergency Use Authorization by the United States Food and Drug Administration (FDA) on 11 December 2020.

	The approved dosing regimen is two doses, 30 μg each, administered 21 days apart. The vaccine is approved for individuals 16 years of age and older.		The approved vaccine dosing regimen is an intramuscular injection given as two doses, 30 μg each, administered 21 days apart. The vaccine is approved for individuals 16 years of age and older.

	The vaccine is intended to prevent the COVID-19 illness, which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The Pfizer-BioNTech vaccine targets the SARS-CoV-2 spike glycoprotein (S).<ref>FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine, https://www.fda.gov/media/144245/download, December, 2020. Accessed 21 December 2020</ref>		The vaccine is intended to prevent the COVID-19 illness, which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The Pfizer-BioNTech vaccine targets the SARS-CoV-2 spike glycoprotein (S).<ref>FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine, https://www.fda.gov/media/144245/download, December, 2020. Accessed 21 December 2020</ref>

Jmf300 at 17:35, 21 December 2020

2020-12-21T17:35:58Z

← Older revision		Revision as of 17:35, 21 December 2020
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	The approved dosing regimen is two doses, 30 μg each, administered 21 days apart. The vaccine is approved for individuals 16 years of age and older.		The approved dosing regimen is two doses, 30 μg each, administered 21 days apart. The vaccine is approved for individuals 16 years of age and older.

	The vaccine is intended to prevent the COVID-19 illness, which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The Pfizer-BioNTech vaccine targets the SARS-CoV-2 spike glycoprotein (S).		The vaccine is intended to prevent the COVID-19 illness, which is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The Pfizer-BioNTech vaccine targets the SARS-CoV-2 spike glycoprotein (S).<ref>FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine, https://www.fda.gov/media/144245/download, December, 2020. Accessed 21 December 2020</ref>

	==Clinical Features==		==Clinical Features==
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	==Adult Dosing==		==Adult Dosing==
			The adult dosing of the vaccine is 2 doses of 30 μg each, administered 21 days apart.

	==Pediatric Dosing==		==Pediatric Dosing==
			The Pfizer-BioNTech COVID-19 vaccines has only been approved for individuals aged 16+. However, the dosing in individuals aged 16 and 17 is the same as the adult dosing of the vaccines.

	==Special Populations==		==Special Populations==
	===[[Drug pregnancy categories\|Pregnancy Rating]]===		===[[Drug pregnancy categories\|Pregnancy Rating]]===
	*		It is unclear as to the effect of the vaccine in pregnant women, as Pregnancy was an exclusion criteria from the phase 3 clinical trial for this vaccine. <ref>FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine, https://www.fda.gov/media/144245/download, December, 2020. Accessed 21 December 2020 </ref>

	===Lactation risk===		===Lactation risk===
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	==References==		==References==
	<references/>		<references/>
	~~FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine, https://www.fda.gov/media/144245/download, December, 2020. Accessed 21 December 2020~~


	[[Category:Pharmacology]]		[[Category:Pharmacology]]

Jmf300: /* See Also */

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Jmf300: /* See Also */

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Jmf300: /* References */

2020-12-21T17:20:28Z

References

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	==References==		==References==
	<references/>		<references/>
	FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine, [https://www.fda.gov/media/144245/download], December, 2020. Accessed 21 December 2020		FDA Briefing Document, Pfizer-BioNTech COVID-19 Vaccine, https://www.fda.gov/media/144245/download, December, 2020. Accessed 21 December 2020


	[[Category:Pharmacology]]		[[Category:Pharmacology]]

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	==See Also==		==See Also==
	* [[COVID-19]]		{{Special:Prefixindex/COVID-19 \|hideredirects=1}}
	* [[COVID-19_Vacccines\|~~COVID-19 Vaccines]]~~
	* [[COVID-19 Vaccine (Moderna)]]

	==External Links==		==External Links==

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	==See Also==		==See Also==
	[[COVID-19}}		* [[COVID-19]]
	[[COVID-19 Vaccines]]		* [[COVID-19_Vacccines\|COVID-19 Vaccines]]
	[[COVID-19 Vaccine (Moderna)]]		* [[COVID-19 Vaccine (Moderna)]]

	==External Links==		==External Links==

← Older revision		Revision as of 17:22, 21 December 2020
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	==See Also==		==See Also==
			[[COVID-19}}
			[[COVID-19 Vaccines]]
			[[COVID-19 Vaccine (Moderna)]]

	==External Links==		==External Links==