<SEC-DOCUMENT>0001564590-21-036101.txt : 20210709
<SEC-HEADER>0001564590-21-036101.hdr.sgml : 20210709
<ACCEPTANCE-DATETIME>20210709082919
ACCESSION NUMBER:		0001564590-21-036101
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		4
CONFORMED PERIOD OF REPORT:	20210709
FILED AS OF DATE:		20210709
DATE AS OF CHANGE:		20210709

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:		211081709

	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_20210709.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%;font-size:14pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="color:#000000;font-size:20pt;"><br /></font><font style="font-weight:bold;color:#000000;font-size:20pt;">FORM 6-K</font><font style="color:#000000;font-size:20pt;"> </font></p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:14pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"></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 JULY 2021<font style="font-weight:normal;color:#000000;"> </font></p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:14pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"></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%;font-size:14pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"></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 July9 2021, as part of BioNTech SE (the &#8220;Company&#8221;) and Pfizer Inc. continued efforts to stay ahead of the virus causing COVID-19 and circulating mutations, the companies provided an update on their comprehensive booster strategy. 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;;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: July 9, 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_7.htm"><font style="text-decoration:underline;">Pfizer and BioNTech Provide Update on Booster Program in Light of the Delta-Variant.</font></a></p></td>
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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>bntx-ex991_7.htm
<DESCRIPTION>EX-99.1
<TEXT>
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<p style="text-align:right;margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;font-family:Times New Roman;font-size:11pt;font-style:normal;text-transform:none;font-variant: normal;">Exhibit 99.1</p>
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<p style="text-align:right;margin-bottom:0pt;margin-top:0pt;margin-left:0pt;;text-indent:0pt;;font-family:Arial;font-size:11pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><img src="gjcuzlsal0mz000002.jpg" title="" alt="" style="width:153px;height:62px;"></p></td>
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<p style="margin-bottom:0pt;margin-top:0pt;font-size:11pt;font-family:Calibri;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;text-indent:7.72%;">&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-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 Provide Update on Booster Program in Light of the Delta-Variant</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;">&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 part of Pfizer&#8217;s and BioNTech&#8217;s continued efforts to stay ahead of the virus causing COVID-19 and circulating mutations, the companies are providing an update on their comprehensive booster strategy. </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;">Pfizer and BioNTech have seen encouraging data in the ongoing booster trial of a third dose of the current BNT162b2 vaccine. Initial data from the study demonstrate that a booster dose given 6 months after the second dose has a consistent tolerability profile while eliciting high neutralization titers against the wild type and the Beta variant, which are 5 to 10 times higher than after two primary doses.&#160;The companies expect to publish more definitive data soon as well as in a peer-reviewed journal and plan to submit the data to the FDA, EMA and other regulatory authorities in the coming weeks. In addition, data from a recent <font style="font-style:italic;text-decoration:underline;">Nature</font> paper demonstrate that immune sera obtained shortly after dose 2 of the primary two dose series of BNT162b2 have strong neutralization titers against the Delta variant (B.1.617.2 lineage) in laboratory tests. The companies anticipate that a third dose will boost those antibody titers even higher, similar to how the third dose performs for the Beta variant (B.1.351). Pfizer and BioNTech are conducting preclinical and clinical tests to confirm this hypothesis. </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;">While Pfizer and BioNTech believe a third dose of BNT162b2 has the potential to preserve the highest levels of protective efficacy against all currently tested variants including Delta, the companies are remaining vigilant and are developing an updated version of the Pfizer-BioNTech COVID-19 vaccine that targets the full spike protein of the Delta variant. The first batch of the mRNA for the trial has already been manufactured at BioNTech&#8217;s facility in Mainz, Germany. The Companies anticipate the clinical studies to begin in August, subject to regulatory approvals.</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 seen in real world data released from the Israel Ministry of Health, vaccine efficacy<font style="font-size:12pt;font-family:Times New Roman;"> </font>in preventing both infection and symptomatic disease has declined six months post-vaccination, although efficacy in preventing serious illnesses remains high. Additionally, during this period the Delta variant is becoming the dominate variant in Israel as well as many other countries. These findings are consistent with an ongoing analysis from the Companies&#8217; Phase 3 study. That is why we have said, and we continue to believe that it is likely, based on the totality of the data we have to date, that a third dose may be needed within 6 to 12 months after full vaccination. While protection against severe disease remained high across the full 6 months, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected. Based on the totality of the data they have to date, Pfizer and BioNTech belief that a third dose may be beneficial to maintain highest levels of protection.</p>
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<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;">AUTHORIZED USE IN THE U.S.: </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="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;">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;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Calibri;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</font><font style="font-size:10pt;font-family:Cambria Math;color:#000000;">&#8209;</font><font style="font-size:10pt;font-family:Arial;color:#000000;">BioNTech COVID-19 vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer</font><font style="font-size:10pt;font-family:Cambria Math;color:#000000;">&#8209;</font><font style="font-size:10pt;font-family:Arial;color:#000000;">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;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</font><font style="font-size:10pt;font-family:Cambria Math;color:#000000;">&#8209;</font><font style="font-size:10pt;font-family:Arial;color:#000000;">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;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;">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><font style="font-size:10pt;font-family:Arial;text-decoration:underline;color:#000000;">https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html</font><font style="font-size:10pt;font-family:Arial;color:#000000;">)</font></p></td></tr></table></div>
<p style="text-align:center;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-size:9pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">1</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;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;">Reports of adverse events following use of the Pfizer-BioNTech COVID-19 Vaccine under EUA suggest increased risks of myocarditis and pericarditis, particularly following the second dose. The decision to administer the Pfizer-BioNTech COVID-19 Vaccine to an individual with a history of myocarditis or pericarditis should take into account the individual&#8217;s clinical circumstances. </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;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;">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;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</font><font style="font-size:10pt;font-family:Cambria Math;color:#000000;">&#8209;</font><font style="font-size:10pt;font-family:Arial;color:#000000;">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;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</font><font style="font-size:10pt;font-family:Cambria Math;color:#000000;">&#8209;</font><font style="font-size:10pt;font-family:Arial;color:#000000;">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;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%)</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;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 (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;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;">Following administration of the Pfizer-BioNTech COVID-19 Vaccine, the following have been reported outside of clinical trials: </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;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;">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;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Calibri;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</font><font style="font-size:10pt;font-family:Cambria Math;color:#000000;">&#8209;</font><font style="font-size:10pt;font-family:Arial;color:#000000;">BioNTech COVID-19 vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy</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;text-transform:none;font-variant: normal;letter-spacing:0pt;font-family:Calibri;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</font><font style="font-size:10pt;font-family:Cambria Math;color:#000000;">&#8209;</font><font style="font-size:10pt;font-family:Arial;color:#000000;">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;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</font><font style="font-size:10pt;font-family:Cambria Math;color:#000000;">&#8209;</font><font style="font-size:10pt;font-family:Arial;color:#000000;">BioNTech COVID</font><font style="font-size:10pt;font-family:Cambria Math;color:#000000;">&#8209;</font><font style="font-size:10pt;font-family:Arial;color:#000000;">19 vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer</font><font style="font-size:10pt;font-family:Cambria Math;color:#000000;">&#8209;</font><font style="font-size:10pt;font-family:Arial;color:#000000;">BioNTech COVID-19 vaccine should receive a second dose of Pfizer</font><font style="font-size:10pt;font-family:Cambria Math;color:#000000;">&#8209;</font><font style="font-size:10pt;font-family:Arial;color:#000000;">BioNTech COVID-19 vaccine to complete the vaccination series</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;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 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-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;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>
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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;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;">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><font style="font-size:10pt;font-family:Arial;text-decoration:underline;color:#000000;">www.cvdvaccine-us.com</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-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 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;">The information contained in this release is as of July 8, 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;">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, potential booster and variant specific vaccines, the 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, </p>
<p style="text-align:right;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">2</a></p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:11pt;font-family:Times New Roman;">&nbsp;</p>
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<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;">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 Phase 3 data), including the possibility of </font><font style="font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">unfavorable</font><font style="font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; 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 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 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 the rolling submission of a Biologics License Application for BNT162b2 in the U.S. (the BLA) </font><font style="font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">will be accepted for review a</font><font style="font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">nd whether and when other biologics license and/or emergency use authorization applications or amendments to any such applications may be 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 the BLA 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, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting </font><font style="font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">labeling</font><font style="font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> 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; the risk that demand for any products may be reduced or no longer exist; 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, booster doses or new variant-specific vaccines; 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; 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 <font style="text-decoration:underline;">www.sec.gov</font><font style="text-decoration:none;"> </font>and <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-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 </p>
<p style="text-align:right;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">3</a></p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:11pt;font-family:Times New Roman;">&nbsp;</p>
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<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;">collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, </font><font style="font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Genevant</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;">Fosun</font><font style="font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"> Pharma, and Pfizer. For more information, please visit </font><font style="text-decoration:underline;">www.BioNTech.de</font><font style="font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">.</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;">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 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 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; the risk that demand for any products may be reduced or no longer exist; the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimates for 2021; and challenges related to public vaccine confidence or awareness. 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.</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 <font style="text-decoration:underline;">www.sec.gov</font>. 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-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-size:10pt;font-family:Arial;font-weight:normal;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="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;">+1 (212) 733-7410</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;"><font style="text-decoration:underline;">Amy.Rose@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-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Investor 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;">Chuck Triano</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;">+1 (212) 733-3901</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;"><font style="text-decoration:underline;">Charles.E.Triano@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;">BioNTech Contacts:</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;">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;">Jasmina Alatovic</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;">+49 (0)6131 9084 1513 </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;"><font style="text-decoration:underline;">Media@biontech.de</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;">Investor 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;">Sylke Maas, Ph.D.</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;">+49 (0)6131 9084 1074</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;"><font style="text-decoration:underline;">Investors@biontech.de</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:right;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">4</a></p>
<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:11pt;font-family:Times New Roman;">&nbsp;</p>
<hr style="page-break-after:always;width:100%;">
<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;text-indent:0%;font-family:Times New Roman;font-size:10pt;">&nbsp;</p>
<p style="text-align:right;margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-size:10pt;font-family:Arial;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-size:11pt;font-family:Times New Roman;">&nbsp;</p></body>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
