<SEC-DOCUMENT>0001564590-21-006795.txt : 20210219
<SEC-HEADER>0001564590-21-006795.hdr.sgml : 20210219
<ACCEPTANCE-DATETIME>20210219083402
ACCESSION NUMBER:		0001564590-21-006795
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		8
CONFORMED PERIOD OF REPORT:	20210219
FILED AS OF DATE:		20210219
DATE AS OF CHANGE:		20210219

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:		21652117

	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_20210219.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="gqir0lscxvqj000001.jpg" title="" alt="" style="width:169px;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="gqir0lscxvqj000002.jpg" title="" alt="" style="width:169px;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 FEBRUARY 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="gqir0lscxvqj000003.jpg" title="" alt="" style="width:169px;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="gqir0lscxvqj000004.jpg" title="" alt="" style="width:169px;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 February 19, 2021, BioNTech SE (the &#8220;Company&#8221;) and Pfizer Inc. announced the submission of new data to the U.S. Food and Drug Administration (FDA) demonstrating the stability of their COVID-19 vaccine when stored at -25&#176;C to -15&#176;C (-13&#176;F to 5&#176;F), temperatures more commonly found in pharmaceutical freezers and refrigerators. 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%;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: February 19, 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;;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;"><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;;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 Submit COVID-19 Vaccine Stability Data at Standard Freezer Temperature to the U.S. FDA.</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-size:11pt;font-family:Times New Roman;">&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 Submit COVID-19 Vaccine Stability Data at Standard Freezer Temperature to the U.S. FDA<font style="color:#000000;"> </font></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-style:italic;font-size:10pt;font-family:Arial;color:#000000;">Proposed U.S. EUA label update would enable the vaccine to be stored at -25&#176;C to -15&#176;C (-13&#176;F to 5&#176;F) for a total of two weeks </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;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-style:italic;font-size:10pt;font-family:Arial;color:#000000;">If approved, new storage option could offer pharmacies and vaccination centers greater flexibility in managing and maintaining vaccine distribution and supply</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-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;">NEW YORK and MAINZ, GERMANY, February 19, 2021 (GLOBE NEWSWIRE)<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) today announced the submission of new data to the U.S. Food and Drug Administration (FDA) demonstrating the stability of their COVID-19 vaccine when stored at <br />-25&#176;C to -15&#176;C (-13&#176;F to 5&#176;F), temperatures more commonly found in pharmaceutical freezers and refrigerators. The data have been submitted to the FDA to support a proposed update to the U.S. Emergency Use Authorization (EUA) Prescribing Information, which would allow for vaccine vials to be stored at these temperatures for a total of two weeks as an alternative or complement to storage in an ultra-low temperature freezer.</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 FDA submission includes stability data generated on batches manufactured over the past nine months of COVID-19 vaccine development, from the batches that supplied the earliest clinical trials through the commercial scale batches currently in production. These data also will be submitted to global regulatory agencies within the next few weeks.</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;We have been continuously performing stability studies to support the production of the vaccine at commercial scale, with the goal of making the vaccine as accessible as possible for healthcare providers and people across the U.S. and around the world,&#8221; said <font style="font-weight:bold;">Albert Bourla, Chairman and Chief Executive Officer, Pfizer. </font>&#8220;We appreciate our ongoing collaboration with the FDA and CDC as we work to ensure our vaccine can be shipped and stored under increasingly flexible conditions. If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply.&#8221;</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;">&#8220;Our top priority was to quickly develop a safe and effective vaccine and make it available to the most vulnerable people in the world in order to save lives. At the same time, we have continuously collected data that could enable storage at around -20&#176;C. The data submitted may facilitate the handling of our vaccine in pharmacies and provide vaccination centers an even greater flexibility,&#8221; said <font style="font-weight:bold;">Ugur Sahin, CEO and Co-founder of BioNTech.</font> &#8220;We will continue to leverage our expertise to develop potential new formulations that could make our vaccine even easier to transport and use.&#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%;font-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Currently, the labels for the Pfizer-BioNTech COVID-19 vaccine, including the EUA label in the U.S., state that the vaccine must be stored in an ultra-cold freezer at temperatures between -80&#186;C and -60&#186;C (-112&#186;F to &#8209;76&#186;F). It can remain stored at these temperatures for up to 6 months. The vaccines are shipped in a specially-designed thermal container that can be used as temporary storage for a total of up to 30 days by refilling with dry ice every five days. Before mixing with a saline diluent, the vaccine may also be refrigerated for up to five days at standard refrigerator temperature, between <font style="Background-color:#FFFFFF;color:#000000;">2&#8304;C and 8&#8304;C (36&#8304;F and 46&#8304;F). If approved, the option to store at -</font>25&#176;C to -15&#176;C (-13&#176;F to 5&#176;F) for two weeks would be in addition to this five-day option to store at standard refrigerator temperature. <font style="Background-color:#FFFFFF;color:#000000;">The vaccine is administered at room temperature by medical staff. </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 additional stability data are obtained, Pfizer and BioNTech anticipate the shelf life and/or expiration date could be extended, and alternate short-term temperature storage may be considered. </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 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 equivalent in the United States, United Kingdom, Canada </font></p>
<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-size:10pt;font-family:Arial;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="color:#000000;">and other countries in advance of a planned application for full marketing authorizations in these countries.</font></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;">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 16 years of age and older.</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) for use in individuals 16 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.com</font>. </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;">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;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 (e.g., 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-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- 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/</font><font style="font-size:10pt;font-family:Arial;color:#000000;">). </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-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-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;">Severe allergic reactions, including anaphylaxis, have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination 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;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.</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;">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;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>
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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 at http s://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967. The reports should include the words "Pfizer-BioNTech COVID-19 Vaccine EUA" in the description section of the report.</font></p></td></tr></table></div>
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<table border="0" cellspacing="0" cellpadding="0"  style="border-collapse:collapse; width:100%;">
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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;">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: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>
<hr style="page-break-after:always;width:100%;">
<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;">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>.&nbsp;&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 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 150 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:#0563C1;">www.Pfizer.com</font>. In addition, to learn more, please visit us on <font style="text-decoration:underline;color:#0563C1;">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-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;"><br />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 February 19, 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 a proposed label update to the U.S. EUA Prescribing Information which would enable the vaccine to be stored at -25&#176;C to -15&#176;C (-13&#176;F to 5&#176;F), standard freezer temperature, for a total of two weeks, qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply), 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 in vitro and Phase 3 data), including the possibility of unfavorable 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 upon 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;<font style="font-style:italic;"> </font>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 proposed update to the U.S. EUA Prescribing Information may be approved; 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 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 a potential Biologics License Application in the U.S.) 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 </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</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="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;">determination of the vaccine&#8217;s efficacy and, if approved, 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 or third-party suppliers; 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 technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; 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, 2019 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;www.sec.gov&#160;and&#160;www.pfizer.com.</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-weight:bold;font-size:10pt;font-family:Arial;font-style:normal;text-transform:none;font-variant: normal;"><br />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 regarding a COVID-19 vaccine; our expectations regarding the potential characteristics of BNT162b2 in our Phase 2/3 trial 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 trial data of BNT162b2 in our Phase 2/3 trial; 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 or potential label change; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures including the data submitted to FDA; whether and when the proposed update to the U.S. EUA Prescribing Information may be approved; 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 BioNTech; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and, if approved, market demand, including our production estimate for 2021. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and </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="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;">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 Quarterly Report for the Three and Nine Months Ended September 30, 2020, filed as Exhibit 99.2 to its Current Report on Form 6-K filed with the SEC on November 10, 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-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-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="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-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;">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: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:8pt;margin-top:0pt;margin-left:7.94%;text-indent:0%;font-size:11pt;font-family:Times New Roman;">&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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