<SEC-DOCUMENT>0001564590-21-026265.txt : 20210511
<SEC-HEADER>0001564590-21-026265.hdr.sgml : 20210511
<ACCEPTANCE-DATETIME>20210511061252
ACCESSION NUMBER:		0001564590-21-026265
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		8
CONFORMED PERIOD OF REPORT:	20210511
FILED AS OF DATE:		20210511
DATE AS OF CHANGE:		20210511

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:		21909525

	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>bntx-6k_20210511.htm
<DESCRIPTION>6-K
<TEXT>
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<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-weight:bold;;font-size:20pt;">&nbsp;</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:20pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">UNITED STATES</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:20pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">SECURITIES AND EXCHANGE COMMISSION<font style="font-weight:normal;"> </font></p>
<p style="text-align:center;margin-bottom:12pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:11pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Washington, D.C. 20549<font style="font-weight:normal;color:#000000;"> </font></p>
<p style="text-align:center;margin-bottom:12pt;margin-top:0pt;text-indent:0%;color:#000000;font-size:20pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><img src="gryljaqf0t3d000001.jpg" title="" alt="" style="width:168px;height:0px;"><br /><font style="font-weight:bold;">FORM 6-K</font> </p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;color:#000000;font-family:Times New Roman;font-size:12pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><img src="gryljaqf0t3d000002.jpg" title="" alt="" style="width:168px;height:0px;"></p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:11pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a&#8209;16 OR 15d&#8209;16<font style="font-weight:normal;color:#000000;"> </font></p>
<p style="text-align:center;margin-bottom:12pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:11pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">UNDER THE SECURITIES EXCHANGE ACT OF 1934<font style="font-weight:normal;color:#000000;"> </font></p>
<p style="text-align:center;margin-bottom:12pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:11pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">FOR THE MONTH OF MAY 2021<font style="font-weight:normal;color:#000000;"> </font></p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;color:#000000;font-family:Times New Roman;font-size:12pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><img src="gryljaqf0t3d000003.jpg" title="" alt="" style="width:168px;height:0px;"></p>
<p style="text-align:center;margin-bottom:12pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:11pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">COMMISSION FILE NUMBER 001-39081 </p>
<p style="text-align:center;margin-bottom:12pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:20pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">BioNTech SE<br /><font style="color:#333333;font-size:10pt;font-weight:normal;">(Translation of registrant&#8217;s name into English)</font></p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:11pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">An der Goldgrube 12</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:11pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">D-55131 Mainz</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:11pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Germany</p>
<p style="text-align:center;margin-bottom:12pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:11pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">+49 6131-9084-0<br /><font style="color:#333333;font-size:10pt;font-weight:normal;">(Address of principal executive offices)</font><font style="font-weight:normal;color:#000000;"> </font></p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;color:#000000;font-family:Times New Roman;font-size:12pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><img src="gryljaqf0t3d000004.jpg" title="" alt="" style="width:168px;height:0px;"></p>
<p style="margin-bottom:12pt;margin-top:0pt;text-indent:0%;color:#000000;font-family:Times New Roman;font-size:12pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Indicate by check mark whether the registrant files or will file annual reports under cover Form 20&#8209;F or Form 40&#8209;F:<font style="color:#000000;"> </font>Form 20&#8209;F <font style="font-family:Segoe UI Symbol;">&#9746;</font> Form 40&#8209;F <font style="font-family:Segoe UI Symbol;">&#9744;</font><font style="color:#000000;"> </font></p>
<p style="margin-bottom:12pt;margin-top:0pt;text-indent:0%;color:#000000;font-family:Times New Roman;font-size:12pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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):<font style="color:#000000;"> </font><font style="font-family:Segoe UI Symbol;">&#9744;</font> </p>
<p style="margin-bottom:12pt;margin-top:0pt;text-indent:0%;color:#000000;font-family:Times New Roman;font-size:12pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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)<font style="color:#000000;">: </font><font style="font-family:Segoe UI Symbol;">&#9744;</font> </p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;color:#000000;font-size:11pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><br /></p>
<hr style="page-break-after:always;width:100%;">
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;color:#000000;font-size:11pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="font-weight:bold;font-size:12pt;">DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K</font></p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:12pt;margin-top:0pt;text-indent:0%;color:#000000;font-family:Times New Roman;font-size:12pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On May 11, 2021, BioNTech SE (the &#8220;Company&#8221;) and Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for their COVID-19 vaccine to include individuals 12 to 15 years of age. The press release is attached hereto as Exhibit 99.1.</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;;font-size:14pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:12pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:12pt;margin-top:0pt;text-indent:0%;color:#000000;font-size:11pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><br /></p>
<hr style="page-break-after:always;width:100%;">
<p style="text-align:justify;margin-bottom:12pt;margin-top:0pt;color:#000000;font-size:11pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="font-weight:bold;font-size:12pt;">SIGNATURE</font></p>
<p style="text-align:justify;margin-bottom:12pt;margin-top:0pt;text-indent:7.14%;color:#000000;font-family:Times New Roman;font-size:12pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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 style="color:#000000;"> </font></p>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-weight:bold;color:#000000;font-family:Times New Roman;font-size:12pt;font-style:normal;text-transform:none;font-variant: normal;">BioNTech SE</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:12pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">By:</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:12pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">/s/ Dr. Sierk Poetting</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:12pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Name: Dr. Sierk Poetting</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:12pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Title:&nbsp;&nbsp; Chief Financial Officer</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;color:#000000;font-family:Times New Roman;font-size:12pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Date: May 11, 2021 </p>
<p style="text-align:center;margin-bottom:12pt;margin-top:0pt;text-indent:0%;color:#000000;font-size:11pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><br /></p>
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<p style="text-align:center;margin-bottom:12pt;margin-top:0pt;color:#000000;font-size:11pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="font-weight:bold;font-size:12pt;">EXHIBIT INDEX </font></p>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:12pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">Exhibit</font></p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:12pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">Description of Exhibit</font></p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;">&nbsp;</p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;color:#000000;font-family:Times New Roman;font-size:12pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">99.1</p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Times New Roman;font-size:12pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><a href="bntx-ex991_6.htm"><font style="text-decoration:underline;">Pfizer and BioNTech Receive First U.S. Authorization for Emergency Use of COVID-19 Vaccine in Adolescents.</font></a></p></td>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>bntx-ex991_6.htm
<DESCRIPTION>EX-99.1
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-weight:bold;;font-size:14pt;"><a name="_Hlk44485827"></a>&nbsp;</p>
<p style="text-align:center;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:14pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;">Pfizer and BioNTech Receive First U.S. Authorization for Emergency Use of COVID-19 Vaccine in Adolescents<font style="font-style:italic;font-weight:normal;"><br /></font></p>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#000000;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#FFFFFF;color:#000000;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#8226;</font></p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#000000;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Calibri Light;font-size:11pt;"><font style="Background-color:#FFFFFF;text-decoration:none;"></font><font style="color:#000000;"></font><font style="font-style:italic;font-size:10pt;font-family:Arial;color:#000000;">In a Phase 3 trial, the</font><font style="font-style:italic;Background-color:#FFFFFF;font-size:10pt;font-family:Arial;"> vaccine was 100% effective and generally well tolerated in participants aged 12 to 15 years </font></p></td></tr></table></div>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#000000;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#FFFFFF;color:#000000;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#8226;</font></p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#000000;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Calibri Light;font-size:11pt;"><font style="Background-color:#FFFFFF;text-decoration:none;"></font><font style="color:#000000;"></font><font style="font-style:italic;font-size:10pt;font-family:Arial;color:#000000;">Data also submitted to European Medicines Agency (EMA) and other global regulators, with additional authorizations expected in coming weeks </font></p></td></tr></table></div>
<p style="text-align:justify;margin-top:0pt;margin-bottom:0pt;margin-left:7.69%;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;">NEW YORK and MAINZ, GERMANY, May 11, 2021<font style="font-weight:normal;"> &#8212; </font><font style="text-decoration:underline;font-weight:normal;">Pfizer Inc.</font><font style="font-weight:normal;"> (NYSE: PFE) and </font><font style="text-decoration:underline;font-weight:normal;">BioNTech SE</font><font style="font-weight:normal;"> (Nasdaq: BNTX) announced today that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for their COVID-19 vaccine to include individuals 12 to 15 years of age. This is the first COVID-19 vaccine authorized in the U.S. for use in this age group.</font></p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#8220;Today&#8217;s expansion of our EUA represents a significant step forward in helping the U.S. government broaden its vaccination program and help protect adolescents before the start of the next school year,&#8221; said <font style="font-weight:bold;">Albert Bourla, Chairman and Chief Executive Officer, Pfizer</font>. &#8220;We are grateful to all of our clinical trial volunteers and their families, whose courage helped make this milestone possible. Together, we hope to help bring a sense of normalcy back to young people across the country and around the world.&#8221;<font style="font-weight:bold;color:#FF0000;"> </font></p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-weight:bold;;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;color:#000000;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="Background-color:#FFFFFF;">The FDA based its decision on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years. Topline results from this trial, </font><font style="Background-color:#FFFFFF;text-decoration:underline;">announced</font><font style="Background-color:#FFFFFF;"> on March 31, 2021, showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and robust antibody responses. In the trial, the vaccine was also generally well tolerated. Participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.</font></p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">As a next step following today&#8217;s FDA decision, the U.S. Centers for Disease Control and Prevention&#8217;s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss recommendations for use of the Pfizer-BioNTech COVID-19 Vaccine in adolescents 12 to 15 years of age based on the amended EUA.</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">&#8220;Since securing the EUA in December for individuals 16 years and older, we have been working tirelessly to get our COVID-19 vaccine authorized around the world so that governments can provide it to as many people as possible,&#8221; said <font style="font-weight:bold;">Ugur Sahin, M.D., CEO and Co-founder of BioNTech</font>. &#8220;Our work is not yet complete, as we continue our research into the use of our vaccine in pediatric populations. Our goal is to submit data for pre-school and school-age children in September.&#8221;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;color:#000000;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="Background-color:#FFFFFF;">Pfizer and BioNTech have submitted the data in adolescents 12 to 15 years of age for scientific peer review for potential publication. The data also have been submitted to other regulators around the world, including the European Medicines Agency (EMA).</font></p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-weight:bold;;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">In addition, the pediatric study evaluating the safety and efficacy of the Pfizer-BioNTech COVID-19 vaccine in children 6 months to 11 years of age is ongoing. Pfizer and BioNTech expect to have definitive readouts, and subject to the data generated, submit for an EUA or a variation to Conditional Marketing Authorizations for two cohorts, including children 2-5 years of age and 5-11 years of age, in September. The readout and submission for the cohort of children 6 months to 2 years of age are expected in the fourth quarter.</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Pfizer-BioNTech COVID-19 vaccine<font style="color:#000000;">, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalents in the United States (together with </font></p>
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="color:#000000;">Pfizer), United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries.</font></p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for use in individuals 12 years of age and older. The emergency use of this product is 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&amp;C Act unless the declaration is terminated or authorization revoked sooner. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Full EUA Prescribing Information available at <font style="text-decoration:underline;">www.cvdvaccine-us.com</font>.</p>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;">AUTHORIZED USE IN THE U.S.: </p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-weight:bold;;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Pfizer-BioNTech COVID19 vaccine is authorized for use under an Emergency Use Authorization (EUA) 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.</p>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;"><a name="_Hlk70588515"></a><a name="_Hlk70588515"></a>IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION: </p>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#8226;</font></p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Calibri Light;font-size:11pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;"></font><font style="font-size:10pt;font-family:Arial;color:#000000;">Do not administer Pfizer-BioNTech COVID-19 vaccine to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 vaccine </font></p></td></tr></table></div>
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<p style="text-align:justify;margin-top:0pt;margin-bottom:0pt;font-weight:normal;font-style:normal;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#8226;</font></p></td>
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<p style="text-align:justify;margin-top:0pt;margin-bottom:0pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Calibri Light;font-size:11pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;"></font><font style="font-size:10pt;font-family:Arial;color:#000000;">Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 vaccine</font></p></td></tr></table></div>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;margin-left:3.81%;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Monitor Pfizer-BioNTech COVID-19 vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (<font style="text-decoration:underline;">https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html</font>)</p>
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<p style="text-align:left;Background-color:#F0F0F0;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#5B5B5B;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#5B5B5B;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#8226;</font></p></td>
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<p style="text-align:left;Background-color:#F0F0F0;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#5B5B5B;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Calibri Light;font-size:11pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;"></font><font style="font-size:10pt;font-family:Arial;">Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting</font></p></td></tr></table></div>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#8226;</font></p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Calibri Light;font-size:11pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;"></font><font style="font-size:10pt;font-family:Arial;color:#000000;">Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 vaccine </font></p></td></tr></table></div>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#8226;</font></p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Calibri Light;font-size:11pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;"></font><font style="font-size:10pt;font-family:Arial;color:#000000;">The Pfizer-BioNTech COVID-19 vaccine may not protect all vaccine recipients </font></p></td></tr></table></div>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#8226;</font></p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Calibri Light;font-size:11pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;"></font><font style="font-size:10pt;font-family:Arial;color:#000000;">In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%)&nbsp;&nbsp;</font></p></td></tr></table></div>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#8226;</font></p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Calibri Light;font-size:11pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;"></font><font style="font-size:10pt;font-family:Arial;color:#000000;">In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever&#160;(24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%)</font></p></td></tr></table></div>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#8226;</font></p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Calibri Light;font-size:11pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;"></font><font style="font-size:10pt;font-family:Arial;color:#000000;">Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions, diarrhea, vomiting, and pain in extremity (arm) have been reported following administration of the Pfizer-BioNTech COVID-19 vaccine outside of clinical trials. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 vaccine</font></p></td></tr></table></div>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#8226;</font></p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Calibri Light;font-size:11pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;"></font><font style="font-size:10pt;font-family:Arial;color:#000000;">Available data on Pfizer-BioNTech COVID-19 vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy&nbsp;&nbsp;</font></p></td></tr></table></div>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#8226;</font></p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Calibri Light;font-size:11pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;"></font><font style="font-size:10pt;font-family:Arial;color:#000000;">Data are not available to assess the effects of Pfizer-BioNTech COVID-19 vaccine on the breastfed infant or on milk production/excretion </font></p></td></tr></table></div>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#8226;</font></p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Calibri Light;font-size:11pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;"></font><font style="font-size:10pt;font-family:Arial;color:#000000;">There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 vaccine should receive a second dose of Pfizer-BioNTech COVID-19 vaccine to complete the vaccination series </font></p></td></tr></table></div>
<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-family:Calibri;font-size:11pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">2</a></p>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#8226;</font></p></td>
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<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Calibri Light;font-size:11pt;"><font style="text-decoration:none;Background-color:#auto;font-size:10pt;font-family:'Times New Roman';"></font><font style="color:#000000;"></font><font style="font-size:10pt;font-family:Arial;color:#000000;">Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS call 1-800-822-7967. The reports should include the words &#8220;Pfizer-BioNTech COVID-19 Vaccine EUA&#8221; in the description section of the report </font></p></td></tr></table></div>
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<p style="text-align:justify;margin-top:0pt;margin-bottom:0pt;font-weight:normal;font-style:normal;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"><font style="font-weight:normal;font-style:normal;text-decoration:none;Background-color:#auto;color:#auto;font-size:10pt;font-family:'Times New Roman';text-transform:none;font-variant: normal;letter-spacing:0pt;"></font><font style="font-size:10pt;font-family:'Times New Roman'">&#8226;</font></p></td>
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<p style="text-align:justify;margin-top:0pt;margin-bottom:0pt;font-weight:normal;font-style:normal;color:#auto;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Calibri Light;font-size:11pt;"><font style="Background-color:#auto;text-decoration:none;"></font><font style="color:#000000;"></font><font style="font-size:10pt;font-family:Arial;color:#000000;">Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 vaccine Administration Under Emergency Use Authorization</font></p></td></tr></table></div>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Before administration of Pfizer-BioNTech COVID-19 vaccine, please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at <font style="text-decoration:underline;">www.cvdvaccine-us.com</font>.</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;">About Pfizer: Breakthroughs That Change Patients&#8217; Lives</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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 <font style="text-decoration:underline;color:#0000FF;">www.Pfizer.com</font>. In addition, to learn more, please visit us on <font style="text-decoration:underline;color:#0000FF;">www.Pfizer.com</font> and follow us on Twitter at <font style="text-decoration:underline;">@Pfizer</font> and <font style="text-decoration:underline;">@Pfizer News</font>, <font style="text-decoration:underline;">LinkedIn</font>, <font style="text-decoration:underline;">YouTube</font> and like us on Facebook at <font style="text-decoration:underline;">Facebook.com/Pfizer</font>.</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-weight:bold;;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;">Pfizer Disclosure Notice </p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><a name="_Hlk54352787"></a>The information contained in this release is as of May <font style="font-weight:bold;">11</font>, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><a name="_Hlk64379077"></a>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 BNT162 mRNA vaccine program and the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) (including qualitative assessments of available data, potential benefits, expectations for clinical trials, the potential of BNT162b2 for adolescents 12 to 15 years of age, evaluation of BNT162b2 in children 6 months to 11 years old, anticipated timing of 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/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including the topline data outlined in this release), including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data (including the topline data outlined in this release); 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 or in larger, more diverse populations following commercialization; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; 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; the risk that preclinical and clinical trial data (including the topline data outlined in this release) are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program (including the topline data outlined in this release) will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when a Biologics License Application for BNT162b2 may be filed in the U.S. and whether and when other biologics license and/or emergency use authorization applications or amendments to any such applications may be </p>
<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-family:Calibri;font-size:11pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">3</p>
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including a potential Biologics License Application in the U.S. or any requested amendments to the emergency use or conditional marketing authorizations) 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</font><font style="font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">, </font><font style="font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">if approved</font><font style="font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">,</font><font style="font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; </font><font style="font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">the risk that demand for any products may be reduced or no longer exist</font><font style="font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine&#8217;s ultra-low temperature formulation, two-dose schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations; the risk that we may not be able to create 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; whether and when additional supply agreements will be reached; 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; challenges related to public vaccine confidence or awareness;&nbsp;&nbsp;uncertainties regarding the impact of COVID-19 on Pfizer&#8217;s business, operations and financial results; and competitive developments.</font></p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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, 2020 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&#160;<font style="text-decoration:underline;">www.sec.gov</font> and&#160;<font style="text-decoration:underline;">www.pfizer.com</font>.</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;">About BioNTech </p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and 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, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit <font style="text-decoration:underline;">www.BioNTech.de</font>.</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-weight:bold;;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;">BioNTech Forward-looking Statements </p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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: BioNTech&#8217;s efforts to combat COVID-19; the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine (including a potential second booster dose of BNT162b2 and/or a potential booster dose of a variation of BNT162b2 having a modified mRNA sequence); the potential of BNT162b2 for adolescents 12 to 15 years of age, evaluation of BNT162b2 in children 6 months to 11 years old, anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply; our expectations regarding the potential characteristics of BNT162b2 in our clinical trials and/or in commercial use based on data observations to date; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the expected time point for additional readouts on efficacy data of BNT162b2 in our clinical trials; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for </p>
<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-family:Calibri;font-size:11pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">4</a></p>
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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; </font><font style="font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">the risk that demand for any products may be reduced or no longer exist</font><font style="font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">; the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimates for 2021; and </font><font style="color:#000000;">challenges related to public vaccine confidence or awareness. </font><font style="font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Any forward-looking statements in this press release are based on BioNTech&#8217;s 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: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; 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; the ability to effectively scale our productions capabilities; and other potential difficulties.</font></p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">For a discussion of these and other risks and uncertainties, see BioNTech&#8217;s Annual Report on Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, which is available on the SEC&#8217;s website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law. </p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;">Pfizer Contacts:</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-weight:bold;;font-size:10pt;">&nbsp;</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;">Media Relations</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Amy Rose</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">+1 (212) 733-7410</p>
<p style="text-align:justify;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:normal;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">Amy.Rose@pfizer.com</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;">Investor Relations</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Chuck Triano</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">+1 (212) 733-3901</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">Charles.E.Triano@Pfizer.com</font></p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;">BioNTech Contacts:</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-weight:bold;;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;">Media Relations</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Jasmina Alatovic</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">+49 (0)6131 9084 1513 </p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">Media@biontech.de</font> </p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;">Investor Relations</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Sylke Maas, Ph.D.</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">+49 (0)6131 9084 1074</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="text-decoration:underline;">Investors@biontech.de</font> </p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-family:Calibri;font-size:11pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">5</a></p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:11pt;">&nbsp;</p></body>
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