<SEC-DOCUMENT>0001776985-22-000064.txt : 20221012
<SEC-HEADER>0001776985-22-000064.hdr.sgml : 20221012
<ACCEPTANCE-DATETIME>20221012171756
ACCESSION NUMBER:		0001776985-22-000064
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		4
CONFORMED PERIOD OF REPORT:	20221012
FILED AS OF DATE:		20221012
DATE AS OF CHANGE:		20221012

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			BioNTech SE
		CENTRAL INDEX KEY:			0001776985
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			2M
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-39081
		FILM NUMBER:		221307455

	BUSINESS ADDRESS:	
		STREET 1:		AN DER GOLDGRUBE 12
		CITY:			MAINZ
		STATE:			2M
		ZIP:			55131
		BUSINESS PHONE:		0049613190847081

	MAIL ADDRESS:	
		STREET 1:		AN DER GOLDGRUBE 12
		CITY:			MAINZ
		STATE:			2M
		ZIP:			55131
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>form6-keuaomiba455x1112oct.htm
<DESCRIPTION>6-K
<TEXT>
<!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN" "http://www.w3.org/TR/html4/loose.dtd"><html><head>
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<title>Document</title></head><body><div id="i0b72c6b69b7048c0a15a5c626ad2afdd_1"></div><div style="min-height:54pt;width:100%"><div><font><br></font></div></div><div style="text-align:center"><font><br></font></div><div style="text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:20pt;font-weight:700;line-height:120%">UNITED STATES</font></div><div style="text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:20pt;font-weight:700;line-height:120%">SECURITIES AND EXCHANGE COMMISSION</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:20pt;font-weight:400;line-height:120%"> </font></div><div style="margin-bottom:12pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:120%">Washington, D.C. 20549</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:120%"> </font></div><div style="margin-bottom:12pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:20pt;font-weight:400;line-height:120%"><br></font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:20pt;font-weight:700;line-height:120%">FORM 6-K</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:20pt;font-weight:400;line-height:120%"> </font></div><div><font><br></font></div><div style="text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:120%">REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a&#8209;16 OR 15d&#8209;16</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:120%"> </font></div><div style="margin-bottom:12pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:120%">UNDER THE SECURITIES EXCHANGE ACT OF 1934</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:120%"> </font></div><div style="margin-bottom:12pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:120%">FOR THE MONTH OF OCTOBER 2022</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:120%"> </font></div><div><font><br></font></div><div style="margin-bottom:12pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:120%">COMMISSION FILE NUMBER 001-39081 </font></div><div style="margin-bottom:12pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:20pt;font-weight:700;line-height:120%">BioNTech SE<br></font><font style="color:#333333;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">(Translation of registrant&#8217;s name into English)</font></div><div style="text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:120%">An der Goldgrube 12</font></div><div style="text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:120%">D-55131 Mainz</font></div><div style="text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:120%">Germany</font></div><div style="margin-bottom:12pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:120%">+49 6131-9084-0<br></font><font style="color:#333333;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">(Address of principal executive offices)</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:400;line-height:120%"> </font></div><div><font><br></font></div><div style="margin-bottom:12pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%">Indicate by check mark whether the registrant files or will file annual reports under cover Form 20&#8209;F or Form 40&#8209;F&#58; Form 20&#8209;F </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:12pt;font-weight:400;line-height:120%">&#9746;</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%"> Form 40&#8209;F </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:12pt;font-weight:400;line-height:120%">&#9744;</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%"> </font></div><div style="margin-bottom:12pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%">Indicate by check mark if the registrant is submitting the Form 6&#8209;K in paper as permitted by Regulation S&#8209;T Rule 101(b)(1)&#58; </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:12pt;font-weight:400;line-height:120%">&#9744;</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%"> </font></div><div style="margin-bottom:12pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%">Indicate by check mark if the registrant is submitting the Form 6&#8209;K in paper as permitted by Regulation S&#8209;T Rule 101(b)(7)&#58; </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:12pt;font-weight:400;line-height:120%">&#9744;</font><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%"> </font></div><div style="text-align:center"><font><br></font></div><div style="height:54pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div><font><br></font></div></div></div><hr style="page-break-after:always"><div style="min-height:54pt;width:100%"><div><font><br></font></div></div><div style="text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:700;line-height:120%">DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K</font></div><div style="text-align:center"><font><br></font></div><div><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:112%">On October 12, 2022, BioNTech SE (the &#8220;Company&#8221;) and Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for a 10-&#181;g booster dose of their Omicron BA.4&#47;BA.5-adapted bivalent COVID-19 vaccine in children 5 through 11 years of age. The press release is attached hereto as Exhibit 99.1.</font></div><div style="text-align:center"><font><br></font></div><div style="margin-bottom:12pt;text-align:justify"><font><br></font></div><div style="margin-bottom:12pt;text-align:justify"><font><br></font></div><div style="height:54pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div><font><br></font></div></div></div><hr style="page-break-after:always"><div style="min-height:54pt;width:100%"><div><font><br></font></div></div><div style="margin-bottom:12pt;text-align:justify"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:700;line-height:120%">SIGNATURE</font></div><div style="margin-bottom:12pt;text-align:justify;text-indent:36pt"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%">Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. </font></div><div style="margin-bottom:6pt"><table style="border-collapse:collapse;display:inline-table;margin-bottom:5pt;vertical-align:text-bottom;width:100.000%"><tr><td style="width:1.0%"></td><td style="width:49.493%"></td><td style="width:0.1%"></td><td style="width:1.0%"></td><td style="width:3.647%"></td><td style="width:0.1%"></td><td style="width:1.0%"></td><td style="width:43.560%"></td><td style="width:0.1%"></td></tr><tr><td colspan="3" style="padding:0 1pt"></td><td colspan="6" style="padding:2px 1pt 2px 1.37pt;text-align:left;vertical-align:bottom"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:700;line-height:125%">BioNTech SE</font></td></tr><tr style="height:13pt"><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td></tr><tr style="height:13pt"><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td></tr><tr><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:2px 1pt 2px 1.37pt;text-align:left;vertical-align:bottom"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:125%">By&#58;</font></td><td colspan="3" style="padding:2px 1pt 2px 1.37pt;text-align:left;vertical-align:bottom"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:125%">&#47;s&#47; Dr. Sierk Poetting</font></td></tr><tr><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="border-top:1pt solid #000000;padding:2px 1pt 2px 1.37pt;text-align:left;vertical-align:bottom"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:125%">Name&#58; Dr. Sierk Poetting</font></td></tr><tr><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:2px 1pt 2px 1.37pt;text-align:left;vertical-align:bottom"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:125%">Title&#58;   Chief Operating Officer</font></td></tr></table></div><div><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%">Date&#58; October 12, 2022 </font></div><div style="margin-bottom:12pt;text-align:center"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:12pt;font-weight:400;line-height:120%"> </font></div><div style="height:54pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div><font><br></font></div></div></div><hr style="page-break-after:always"><div style="min-height:54pt;width:100%"><div><font><br></font></div></div><div style="margin-bottom:12pt;text-align:center"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:700;line-height:120%">EXHIBIT INDEX </font></div><div style="margin-bottom:6pt"><table style="border-collapse:collapse;display:inline-table;margin-bottom:5pt;vertical-align:text-bottom;width:100.000%"><tr><td style="width:1.0%"></td><td style="width:9.895%"></td><td style="width:0.1%"></td><td style="width:1.0%"></td><td style="width:87.905%"></td><td style="width:0.1%"></td></tr><tr style="height:13pt"><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td></tr><tr><td colspan="3" style="padding:2px 1pt 2px 1.37pt;text-align:left;vertical-align:top"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:125%;text-decoration:underline">Exhibit</font></td><td colspan="3" style="padding:2px 1pt 2px 1.37pt;text-align:left;vertical-align:top"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:125%;text-decoration:underline">Description of Exhibit</font></td></tr><tr style="height:13pt"><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td></tr><tr><td colspan="3" style="padding:2px 1pt 2px 1.37pt;text-align:left;vertical-align:top"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:125%">99.1</font></td><td colspan="3" style="padding:2px 1pt;text-align:left;vertical-align:top"><div><font style="color:#0000ff;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%;text-decoration:underline"><a href="ex991euaomiba455-1112oct20.htm" style="color:#0000ff;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%;text-decoration:underline">Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4&#47;BA.5-Adapted Bivalent COVID-19 Vaccine Booster in Children 5 Through 11 Years of Age</a></font></div><div style="padding-left:0.35pt;padding-right:0.35pt;text-align:justify"><font><br></font></div></td></tr><tr style="height:13pt"><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td></tr><tr style="height:13pt"><td colspan="3" style="padding:0 1pt"></td><td colspan="3" style="padding:0 1pt"></td></tr></table></div><div style="text-align:right"><font><br></font></div><div style="text-align:right"><font><br></font></div><div style="margin-bottom:8pt"><font><br></font></div><div style="height:54pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div><font><br></font></div></div></div></body></html>
</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>ex991euaomiba455-1112oct20.htm
<DESCRIPTION>EX-99.1
<TEXT>
<!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN" "http://www.w3.org/TR/html4/loose.dtd"><html><head>
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<title>Document</title></head><body><div id="idada4c21d0e04c3bbcdda34ed7a5141b_1"></div><div style="min-height:120.83pt;width:100%"><div style="text-align:right"><font style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:11pt;font-weight:700;line-height:120%">Exhibit 99.1</font></div><div><font><br></font></div><div style="margin-bottom:6pt"><table style="border-collapse:collapse;display:inline-table;margin-bottom:5pt;vertical-align:text-bottom;width:100.000%"><tr><td style="width:1.0%"></td><td style="width:49.560%"></td><td style="width:0.1%"></td><td style="width:1.0%"></td><td style="width:48.240%"></td><td style="width:0.1%"></td></tr><tr style="height:56pt"><td colspan="3" style="padding:0 1pt"><div style="padding-left:2.75pt;padding-right:2.75pt"><img alt="image_0.jpg" src="image_0.jpg" style="height:26px;margin-bottom:5pt;vertical-align:text-bottom;width:240px"></div></td><td colspan="3" style="padding:0 1pt"><div style="padding-left:2.75pt;padding-right:2.75pt;text-align:right"><img alt="image_1.jpg" src="image_1.jpg" style="height:62px;margin-bottom:5pt;vertical-align:text-bottom;width:153px"></div></td></tr></table></div><div><font style="color:#000000;font-family:'Calibri',sans-serif;font-size:11pt;font-weight:400;line-height:120%">&#160;&#160;&#160;&#160;</font></div></div><div style="text-align:center"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:14pt;font-weight:700;line-height:115%">Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4&#47;BA.5-Adapted Bivalent COVID-19 Vaccine Booster in Children 5 Through 11 Years of Age</font></div><div style="text-align:center"><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">NEW YORK, USA and MAINZ, GERMANY, October 12, 2022 </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8212; Pfizer Inc. (NYSE&#58; PFE, &#8220;Pfizer&#8221;) and BioNTech SE (Nasdaq&#58; BNTX, &#8220;BioNTech&#8221;) today announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for a 10-&#181;g booster dose of their Omicron BA.4&#47;BA.5-adapted bivalent COVID-19 vaccine in children 5 through 11 years of age. Pending recommendation from the Centers for Disease Control and Prevention (CDC), 10-&#181;g doses will be shipped immediately.</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8220;As families across the country take part in fall festivities and plan for the upcoming holiday season, we aim to provide school-aged children with additional protection against the Omicron BA.4&#47;BA.5 subvariants, which continue to account for more than 80% of cases in the U.S.,&#8221; said </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">Albert Bourla, Chairman and Chief Executive Officer, Pfizer</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">. &#8220;Anticipating this need, we manufactured millions of booster doses, which will be made available, pending CDC recommendation, to help families stay up to date with COVID-19 vaccinations.&#8221;</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8220;This milestone is important to be able to provide access to variant-adapted vaccines to a broader population,&#8221; said </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">. &#8220;In addition, we have started a clinical trial to evaluate the adapted vaccine based on the BA.4 and BA.5 subvariants in children six months through 11 years of age aiming to offer all age groups the opportunity to immunize against Omicron variants and subvariants.&#8221;</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">The authorization of the bivalent COVID-19 vaccine for children 5 through 11 years of age is supported by safety and immunogenicity data from Pfizer and BioNTech&#8217;s 30-&#181;g Omicron BA.1-adapted bivalent vaccine, non-clinical and manufacturing data from the companies&#8217; 10-&#181;g Omicron BA.4&#47;BA.5-adapted bivalent vaccine, and pre-clinical data from the 30-&#181;g Omicron BA.4&#47;BA.5-adapted bivalent vaccine. Clinical data from a Phase 2&#47;3 trial showed a booster dose of Pfizer and BioNTech&#8217;s 30-&#181;g Omicron BA.1-adapted bivalent vaccine elicited a superior immune response against the Omicron BA.1 subvariant compared to the companies&#8217; original COVID-19 vaccine, with a favorable safety profile. Additionally, pre-clinical data showed a booster dose of the 30-&#181;g BA.4&#47;BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against the Omicron BA.1, BA.2, BA.4 and BA.5 subvariants, as well as the original virus.</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">The companies will supply the original and bivalent vaccines under their existing supply agreement with the U.S. government. Booster vaccinations for individuals 5 through 11 years of age are anticipated to start subject to and after the CDC endorses a potential recommendation. Pfizer and BioNTech will begin shipping bivalent doses as directed by the U.S. government. Eligible U.S. residents will continue to receive the vaccine for free, consistent with the U.S. government&#8217;s commitment to free access to COVID-19 vaccines.</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">Pfizer and BioNTech have submitted an application to the European Medicines Agency (EMA) requesting a variation of the companies&#8217; marketing authorization in the European Union to include a 10-&#181;g booster dose of Omicron BA.4&#47;BA.5-adapted bivalent COVID-19 vaccine in this age group. Similar applications are planned for submission with regulatory authorities around the world in the coming weeks.</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">A Phase 1&#47;2&#47;3 pediatric study is currently underway to evaluate different dosing regimens and dose levels of the Omicron BA.4&#47;BA.5-adapted bivalent COVID-19 vaccine across age groups. </font></div><div style="height:59.84pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div style="text-align:center"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:9pt;font-weight:400;line-height:120%">1</font></div><div><font><br></font></div></div></div><hr style="page-break-after:always"><div style="min-height:120.83pt;width:100%"><div><font><br></font></div></div><div><font><br></font></div><div style="text-align:justify"><font style="background-color:#ffffff;color:#0a0a0a;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech&#8217;s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (COMIRNATY</font><font style="color:#0a0a0a;font-family:'Arial',sans-serif;font-size:7.15pt;font-weight:400;line-height:112%;position:relative;top:-3.85pt;vertical-align:baseline">&#174;</font><font style="background-color:#ffffff;color:#0a0a0a;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%;text-decoration:underline">U.S. INDICATION &#38; AUTHORIZED USE</font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%"> </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">Pfizer-BioNTech Covid-19 Vaccine, Bivalent (Original And Omicron BA.4&#47;BA.5) </font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">AUTHORIZED USE</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%"> </font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4&#47;BA.5) is FDA-authorized under</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%"> </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">Emergency Use Authorization (EUA) for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either&#58;</font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">completion of primary vaccination with any authorized or approved monovalent* COVID-19 vaccine&#59; or</font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. </font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">*Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus </font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">COMIRNATY</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:7.15pt;font-weight:700;line-height:112%;position:relative;top:-3.85pt;vertical-align:baseline">&#174;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%"> (COVID-19 Vaccine, mRNA) </font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">INDICATION</font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">COMIRNATY</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:7.15pt;font-weight:700;line-height:112%;position:relative;top:-3.85pt;vertical-align:baseline">&#174;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%"> (COVID-19 Vaccine, mRNA) is a vaccine approved for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. </font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">AUTHORIZED USE</font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">COMIRNATY</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:7.15pt;font-weight:700;line-height:112%;position:relative;top:-3.85pt;vertical-align:baseline">&#174;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%"> (COVID-19 Vaccine, mRNA) is FDA-authorized under Emergency Use Authorization (EUA) to provide&#58;</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">Primary Series</font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">a third primary series dose to individuals 12 years of age and older who have certain kinds of immunocompromise</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">Pfizer-BioNTech Covid-19 Vaccine </font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">AUTHORIZED USES</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%"> </font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">Pfizer-BioNTech COVID-19 Vaccine is FDA</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%"> </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">authorized under Emergency Use Authorization (EUA) for use in individuals 6 months and older to provide&#58;</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">Primary Series</font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">a 3-dose primary series to individuals 6 months through 4 years of age</font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">a 2-dose primary series to individuals 5 years through 11 years of age</font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">a third primary series dose to individuals 5 years through 11 years of age with certain kinds of immunocompromise</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">EMERGENCY USE AUTHORIZATION</font></div><div style="height:59.84pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div style="text-align:right"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">2</font></div><div><font><br></font></div></div></div><hr style="page-break-after:always"><div style="min-height:120.83pt;width:100%"><div><font><br></font></div></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">Emergency uses of the vaccines have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&#38;C Act unless the declaration is terminated or authorization revoked sooner.</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">IMPORTANT SAFETY INFORMATION</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4&#47;BA.5), COMIRNATY</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:7.15pt;font-weight:700;line-height:112%;position:relative;top:-3.85pt;vertical-align:baseline">&#174;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%"> (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">Tell your vaccination provider about all of your medical conditions, including if you&#58;</font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">have any allergies</font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)</font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">have a fever</font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">have a bleeding disorder or are on a blood thinner</font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">are immunocompromised or are on a medicine that affects the immune system</font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">are pregnant, plan to become pregnant, or are breastfeeding</font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">have received another COVID-19 vaccine</font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">have ever fainted in association with an injection</font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">The vaccine may not protect everyone.  </font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:106%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:106%;padding-left:14.15pt">You should not get COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent if you have had a severe allergic reaction after a previous dose of COMIRNATY or the Pfizer-BioNTech COVID-19 Vaccine or any ingredient in these vaccines</font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">There is a remote chance that these vaccines could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. If you experience a severe allergic reaction, call 9-1-1 or go to the nearest hospital</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">Seek medical attention right away if you have any of the following symptoms&#58; </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness</font></div><div><font><br></font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received COMIRNATY&#174; (COVID-19 vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine. The observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males, and the observed risk is highest in males 12 through 17 years of age. In most of these people, symptoms began within a few days following receipt of the second dose of vaccine. The chance of having this occur is very low</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">Side effects that have been reported with these vaccines include&#58; </font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Severe allergic reactions </font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Non-severe allergic reactions such as rash, itching, hives, or swelling of the face </font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Myocarditis (inflammation of the heart muscle) </font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Pericarditis (inflammation of the lining outside the heart) </font></div><div style="height:59.84pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div style="text-align:right"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">3</font></div><div><font><br></font></div></div></div><hr style="page-break-after:always"><div style="min-height:120.83pt;width:100%"><div><font><br></font></div></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Injection site pain </font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Tiredness </font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Headache </font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Muscle pain </font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Chills </font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Joint pain </font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Fever </font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Injection site swelling </font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Injection site redness </font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Nausea </font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Feeling unwell </font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Swollen lymph nodes (lymphadenopathy) </font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Decreased appetite </font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Diarrhea </font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Vomiting </font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Arm pain </font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Fainting in association with injection of the vaccine </font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Unusual and persistent irritability</font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Unusual and persistent poor feeding</font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Unusual and persistent fatigue or lack of energy</font></div><div style="padding-left:36pt;text-align:justify;text-indent:-18pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">&#8226;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%;padding-left:14.15pt">Unusual and persistent cool, pale skin</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">These may not be all the possible side effects of the vaccine. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">Individuals should always ask their healthcare providers for medical advice about adverse events. Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1&#8208;800&#8208;822&#8208;7967 or report online to www.vaers.hhs.gov&#47;reportevent.html. In addition, individuals can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:107%">COMIRNATY&#174; Full Prescribing Information and EUA Fact Sheets for Vaccination Providers and Recipients and Caregivers Fact Sheets&#58; </font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:107%">EUA Fact Sheet for Vaccination Providers (12 Years &#38; Up), BIVALENT (Original and Omicron BA.4&#47;BA.5), DO NOT DILUTE, Gray Cap</font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">EUA Fact Sheet for Vaccination Providers (5 through 11 Years), BIVALENT (Original and Omicron BA.4&#47;BA.5), DO NOT DILUTE, Orange Cap </font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">COMIRNATY&#174; Full Prescribing Information (12 years of age and older), DO NOT DILUTE, Gray Cap</font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">EUA Fact Sheet for Vaccination Providers (12 years of age and older), DO NOT DILUTE, Gray Cap</font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">EUA Fact Sheet for Vaccination Providers (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap</font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap</font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:107%">EUA Fact Sheet for Recipients and Caregivers (12 years of age and older)</font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">EUA Fact Sheet for Recipients and Caregivers (5 through 11 years of age)</font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">EUA Fact Sheet for Recipients and Caregivers (6 months through 4 years of age)</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">About Pfizer&#58; Breakthroughs That Change Patients&#8217; Lives</font></div><div style="height:59.84pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div style="text-align:right"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">4</font></div><div><font><br></font></div></div></div><hr style="page-break-after:always"><div style="min-height:120.83pt;width:100%"><div><font><br></font></div></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on and follow us on Twitter at &#64;Pfizer and &#64;Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com&#47;Pfizer.</font></div><div><font><br></font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">Pfizer Disclosure Notice </font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">The information contained in this release is as of October 12, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">This release contains forward-looking information about Pfizer&#8217;s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including an EUA in the U.S. and a submission pending with the EMA for an Omicron BA.4&#47;BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age, exploration of use in additional pediatric populations and a Phase 1&#47;2&#47;3 study in children aged 6 months through 11 years of age, qualitative assessments of available data, potential benefits, expectations for clinical trials, potential regulatory submissions, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and&#47;or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and&#47;or launch dates, as well as risks associated with preclinical and clinical data (including Phase 1&#47;2&#47;3 or Phase 4 data), including the data discussed in this release for BNT162b2, any monovalent, bivalent or variant-adapted vaccine candidates or any other vaccine candidate in the BNT162 program in any of our studies in pediatrics, adolescents, or adults or real world evidence, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data&#59; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies, in real world data studies or in larger, more diverse populations following commercialization&#59; the ability of BNT162b2, any monovalent, bivalent or variant-adapted vaccine candidates or any future vaccine to prevent COVID-19 caused by emerging virus variants&#59; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious&#59; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review&#47;publication process, in the scientific community generally, and by regulatory authorities&#59; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations&#59; whether regulatory authorities will be satisfied with the design of and results from these and any future </font></div><div style="height:59.84pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div style="text-align:right"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">5</font></div><div><font><br></font></div></div></div><hr style="page-break-after:always"><div style="min-height:120.83pt;width:100%"><div><font><br></font></div></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">preclinical and clinical studies&#59; whether and when submissions to request emergency use or conditional marketing authorizations for BNT162b2 in additional populations, for a potential booster dose for BNT162b2, any monovalent or bivalent vaccine candidates or any potential future vaccines (including potential future annual boosters or re-vaccination), and&#47;or other biologics license and&#47;or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2, any monovalent or bivalent vaccine candidates or any other potential vaccines that may arise from the BNT162 program, including a potential variant-based, higher dose, or bivalent vaccine, and if obtained, whether or when such emergency use authorizations or licenses will expire or terminate&#59; whether and when any applications that may be pending or filed for BNT162b2 (including any requested amendments to the emergency use or conditional marketing authorizations), any monovalent or bivalent vaccine candidates (including the submissions to the EMA for an Omicron BA.4&#47;BA.5-adapted bivalent COVID-19 vaccine candidate), or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine&#8217;s benefits outweigh its known risks and determination of the vaccine&#8217;s efficacy and, if approved, whether it will be commercially successful&#59; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and&#47;or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies&#59; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers&#59; the risk that demand for any products may be reduced or no longer exist which may lead to reduced revenues or excess inventory&#59; risks related to the availability of raw materials to manufacture a vaccine&#59; challenges related to our vaccine&#8217;s formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer&#59; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based or next generation vaccines&#59; the risk that we may not be able to maintain or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated&#59; whether and when additional supply agreements will be reached&#59; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations&#59; challenges related to public vaccine confidence or awareness&#59; uncertainties regarding the impact of COVID-19 on Pfizer&#8217;s business, operations and financial results&#59; and competitive developments.</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">A further description of risks and uncertainties can be found in Pfizer&#8217;s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned &#8220;Risk Factors&#8221; and &#8220;Forward-Looking Information and Factors That May Affect Future Results&#8221;, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.govand www.pfizer.com.</font></div><div><font><br></font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:700;line-height:112%">About BioNTech</font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bispecific immune checkpoint modulators, targeted cancer antibodies and </font></div><div style="height:59.84pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div style="text-align:right"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">6</font></div><div><font><br></font></div></div></div><hr style="page-break-after:always"><div style="min-height:120.83pt;width:100%"><div><font><br></font></div></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.com.</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">BioNTech Forward-looking Statements</font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">This press release contains &#8220;forward-looking statements&#8221; of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning&#58; BioNTech&#8217;s efforts to combat COVID-19&#59; the collaboration between BioNTech and Pfizer including the program to develop a COVID-19 vaccine and COMIRNATY (COVID-19 vaccine, mRNA) (BNT162b2)  (including emergency use authorization in the U.S. for persons 5 years of age and older of an Omicron-adapted COVID-19 bivalent vaccine based on the BA.4&#47;BA.5 subvariant and planned regulatory submissions, an Omicron BA.4&#47;BA.5-adapted bivalent COVID-19 vaccine candidate, qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply)&#59; our expectations regarding the potential characteristics of BNT162b2, any monovalent or bivalent vaccine candidates or any future vaccine, in our clinical trials and&#47;or in commercial use based on data observations to date&#59; the ability of BNT162b2, any monovalent or bivalent vaccine candidates or any future vaccine, to prevent COVID-19 caused by emerging virus variants&#59; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and&#47;or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and&#47;or launch dates, as well as risks associated with preclinical and clinical data (including Phase 1&#47;2&#47;3 or Phase 4 data), including the data discussed in this release for BNT162b2, any monovalent or bivalent vaccine candidates or any other vaccine candidate in BNT162 program in any of our studies in pediatrics, adolescents, or adults or real world evidence, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data&#59; the expected time point for additional readouts on efficacy data of BNT162b2, any monovalent or bivalent vaccine candidates or any future vaccine, in our clinical trials&#59; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious&#59; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation&#59; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization&#59; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures&#59; the ability of BioNTech to supply the quantities of BNT162, any monovalent or bivalent vaccine candidates or any future vaccine, to support clinical development and market demand, including our production estimates for 2022&#59; that demand for any products may be reduced or no longer exist which may lead to reduced revenues or excess inventory&#59; the availability of raw materials to manufacture a vaccine&#59; our vaccine&#8217;s formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer&#59; the ability to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based vaccines&#59; the ability to maintain or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated&#59; whether and when additional supply agreements will be reached&#59; the ability to obtain recommendations </font></div><div style="height:59.84pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div style="text-align:right"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">7</font></div><div><font><br></font></div></div></div><hr style="page-break-after:always"><div style="min-height:120.83pt;width:100%"><div><font><br></font></div></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations&#59; challenges related to public vaccine confidence or awareness&#59; and uncertainties regarding the impact of COVID-19 on BioNTech&#8217;s trials, business and general operations. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to&#58; the ability to meet the pre-defined endpoints in clinical trials&#59; competition to create a vaccine for COVID-19&#59; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization&#59; the ability to effectively scale our productions capabilities&#59; and other potential difficulties.</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">For a discussion of these and other risks and uncertainties, see BioNTech&#8217;s Quarterly Report as Form 6-K for the quarter ended June 30, 2022, filed with the SEC on August 8, 2022, which is available on the SEC&#8217;s website at </font><font style="color:#0000ff;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">www.sec.gov</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:11pt;font-weight:400;line-height:112%">. 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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
