In a Sept. 29 research note, H.C. Wainwright & Co. analyst Robert Burns reported that in seeking approval of their Comirnaty COVID-19 vaccine for 5 to 11 year olds, BioNTech SE (BNTX:NASDAQ) and partner Pfizer submitted to the U.S. Food and Drug Administration (FDA) new trial data on this age group.
"Broad-based vaccination of children and teenagers is likely to be a crucial element of achieving herd immunity."
Last month, the FDA approved Comirnaty, previously called the Pfizer-BioNTech COVID-19 vaccine, for individuals 16 years old and up.
H.C. Wainwright expects that in Q4/21 the FDA will grant emergency use authorization of the vaccine in this young population.
Submitted data are from the Phase 2/3 trial that evaluated a Comirnaty (BNT162b2) regimen of two doses of 10 micrograms given 21 days apart in children 5 to 11 years of age.
Release of the full Phase 3 results are expected soon.
"From our vantage point, broad-based vaccination of children and teenagers is likely to be a crucial element of achieving herd immunity, and label extension for Comirnaty to include use in these younger individuals ought to buoy revenue growth near term," Burns wrote.
H.C. Wainwright has a Neutral rating and a $330 per share 12-month price target on BioNTech, the current share price of which is about $276.52.
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Disclosures from BioNTech SE (BNTX), H.C. Wainwright, Sept. 29, 2021.
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 August 31, 2021 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.
