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Biotech Co. Advances COVID-19 Vaccines Toward Approval

May 2, 2022 ( Newswire) They include booster vaccines for different age groups of children and an Omicron-targeting booster for adults, noted an H.C. Wainwright & Co. report.

BioNTech SE (BNTX:NASDAQ) has been asked by the U.S. Food and Drug Administration (FDA) to provide additional data regarding its emergency use application (EUA) for administering COMIRNATY to children aged 6 months to 4 years, reported H.C. Wainwright & Co. analyst Robert Burns in an April 29 research note.

BioNTech’s EUA specifically requested approval of the first two COMIRNATY doses (3 micrograms each) of three for this pediatric age group. COMIRNATY is a COVID-19 vaccine that BioNTech and Pfizer are advancing together.

In response to the EUA, the FDA noted it would like to see “additional information about the ongoing evaluation of a third dose” before making a decision. Accordingly, the partnering companies are expected to submit, without delay, data on a third dose, given at least eight weeks after the second one.

“We believe that COMIRNATY should ultimately be granted EUA by the FDA in this age group,” Burns wrote.

Also, full trial results for the use of COMIRNATY in 2- to 5-year-old children should be released by mid-2022, added Burns.

In other news, BioNTech and Pfizer recently submitted a separate EUA to the FDA for use of a 10 microgram COMIRNATY booster dose in children aged 5 through 11 years, wrote Burns. In the coming weeks, the two firms will submit similar approval requests to the European Medicines Agency and other vaccine regulating agencies.

Burns also pointed out that BioNTech and Pfizer are advancing a COVID Omicron-specific vaccine through the clinic, too. An initial data readout is expected also by midyear. With this product, BioNTech and Pfizer are close behind Moderna in bringing such a vaccine to market.

Moderna’s booster, mRNA-1273.211, demonstrated better initial results than its previous iteration, mRNA-1273, Burns noted. Recently released data showed mRNA-1273.211 to be superior after one month against SARS-CoV-2 and the Beta, Delta, and Omicron variants, and superior after six months against SARS-CoV-2, Beta, and Omicron.

Finally, Burns warned that COVID-19 vaccination numbers are dropping worldwide and the trend could continue.

“We anticipate that changing views towards the COVID-19 public health problem may negatively impact vaccine demand in the coming months,” the analyst wrote.

H.C. Wainwright has a Buy rating and a 12-month price target of $298 per share on BioNTech. In comparison, its current share price is less than half of that, at around $143.40.


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Disclosures for H.C. Wainwright & Co., LLC, BioNTech SE, April 29, 2022

This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules. If you have received it by mistake, please let us know by e-mail reply to and delete it from your system; you may not copy this message or disclose its contents to anyone. The integrity and security of this message cannot be guaranteed on the Internet. H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Robert Burns and Raghuram Selvaraju, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. A research analyst of the firm and/or the research analyst’s household has a financial interest in and own the securities of BioNTech SE (including, without limitation, any option, right, warrant, future, long or short position). As of March 31, 2022 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of BioNTech SE. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report. The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The Firm or its affiliates did not receive compensation from BioNTech SE for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in BioNTech SE as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request. H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report. H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report. H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice. Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.

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