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COVID-19 Vaccine Could Be Approved in Q4/21 for 5 to 11 Year Olds
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"Label extension for BioNTech and Pfizer's Comirnaty [vaccine] to include use in these younger individuals ought to buoy revenue growth near term," noted an H.C. Wainwright & Co. report.

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.

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