-- Results are the first from a pivotal trial of any COVID-19 vaccine in 
      children under 12 years of age 
 
   -- In participants 5 to 11 years of age, the vaccine was safe, well 
      tolerated and showed robust neutralizing antibody responses 
 
   -- Companies plan to submit these data to the FDA, EMA and other regulatory 
      agencies around the world as soon as possible 
 
   -- Results in children under 5 years of age are expected as soon as later 
      this year

NEW YORK and MAINZ, Germany, September 20, 2021-- https://www.globenewswire.com/Tracker?data=vORoA1UwZemz5_HQVAgb4_H2nCfKSRIWiykgGBaBAi0XaEDv54Tz9E_td6Cb0Wg8glJNU7t_MdhaIlUpW5VFwQ== Pfizer Inc. (NYSE: PFE, "Pfizer") and https://www.globenewswire.com/Tracker?data=JvNwcYPPqevWX-tCiyMIRIujKpqOQHedmvNfIhEoHNBs5JukbLr51uzviBBxvx7a0qUD1T2_LNAjmJKNavmNfg== BioNTech SE (Nasdaq: BNTX, "BioNTech") today announced results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 ug administered 21 days apart, a smaller dose than the 30 ug dose used for people 12 and older. The antibody responses in the participants given 10 ug doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 ug doses. The 10 ug dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age. These are the first results from a pivotal trial of a COVID-19 vaccine in this age group.

"Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. -- underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency."

"We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season, " said Dr. Ugur Sahin, CEO and co-founder of BioNTech. "The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose."

The data summarized from this Phase 2/3 study, which is enrolling children 6 months to 11 years of age, was for 2,268 participants who were 5 to 11 years of age and received a 10 ug dose level in a two-dose regimen. In the trial, the SARS-CoV-2--neutralizing antibody geometric mean titer (GMT) was 1,197.6 (95% confidence interval [CI, 1106.1, 1296.6]), demonstrating strong immune response in this cohort of children one month after the second dose. This compares well (was non-inferior) to the GMT of 1146.5 (95% CI: 1045.5, 1257.2) from participants ages 16 to 25 years old, used as the control group for this analysis and who were administered a two-dose regimen of 30 ug. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.

Pfizer and BioNTech plan to share these data with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators as soon as possible. For the United States, the companies expect to include the data in a near-term submission for Emergency Use Authorization (EUA) as they continue to accumulate the safety and efficacy data required to file for full FDA approval in this age group. A request to the EMA to update the EU Conditional Marketing Authorization is also planned. Topline readouts for the other two age cohorts from the trial -- children 2-5 years of age and children 6 months to 2 years of age -- are expected as soon as the fourth quarter of this year.

Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication.

About the Phase 1/2/3 Trial in Children

The Phase 1/2/3 trial initially enrolled up to 4,500 children ages 6 months to 11 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. It was designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech vaccine on a two-dose schedule (approximately 21 days apart) in three age groups: ages 5 to 11 years; ages 2 to 5 years; and ages 6 months to 2 years. Based on the Phase 1 dose-escalation portion of the trial, children ages 5 to 11 years received two-dose schedule of 10 ug each while children under age 5 received a lower 3 ug dose for each injection in the Phase 2/3 study. The trial enrolled children with or without prior evidence of SARS-CoV-2 infection.

COMIRNATY, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

U.S. Indication & Authorized Use

COMIRNATY(R) (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. 


   -- It is approved as a 2-dose series for prevention of COVID-19 in 
      individuals 16 years of age and older 
 
   -- It is also authorized under Emergency Use Authorization (EUA) to be 
      administered for emergency use to: 
 
          -- prevent COVID-19 in individuals 12 through 15 years, and 
 
          -- provide a third dose to individuals 12 years of age and older who 
             have been determined to have certain kinds of immunocompromise

The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to: 


   -- prevent COVID-19 in individuals 12 years of age and older, and 
 
   -- provide a third dose to individuals 12 years of age and older who have 
      been determined to have certain kinds of immunocompromise

The FDA-approved COMIRNATY(R) (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. An individual may be offered either COMIRNATY(R) (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.

EUA Statement

This emergency use of the product has not been approved or licensed by FDA, but has been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and 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&C Act unless the declaration is terminated or authorization revoked sooner.

Important Safety Information

Individuals should not get the Pfizer-BioNTech COVID-19 Vaccine if they: 


   -- had a severe allergic reaction after a previous dose of this vaccine 
 
   -- had a severe allergic reaction to any ingredient of this vaccine

Individuals should tell the vaccination provider about all of their medical conditions, including if they: 


   -- have any allergies 
 
   -- have had myocarditis (inflammation of the heart muscle) or pericarditis 
      (inflammation of the lining outside the heart) 
 
   -- have a fever 
 
   -- have a bleeding disorder or are on a blood thinner 
 
   -- are immunocompromised or are on a medicine that affects the immune system 
 
   -- are pregnant, plan to become pregnant, or are breastfeeding 
 
   -- have received another COVID-19 vaccine 
 
   -- have ever fainted in association with an injection

The vaccine may not protect everyone.

Side effects reported with the vaccine include: 


   -- There is a remote chance that the vaccine could cause a severe allergic 
      reaction 
 
          -- A severe allergic reaction would usually occur within a few 
             minutes to one hour after getting a dose of the vaccine. For this 
             reason, vaccination providers may ask individuals to stay at the 
             place where they received the vaccine for monitoring after 
             vaccination 
 
          -- Signs of a severe allergic reaction can include difficulty 
             breathing, swelling of the face and throat, a fast heartbeat, a 
             bad rash all over the body, dizziness, and weakness 
 
          -- If an individual experiences a severe allergic reaction, they 
             should call 9-1-1 or go to the nearest hospital 
 
   -- Myocarditis (inflammation of the heart muscle) and pericarditis 
      (inflammation of the lining outside the heart) have occurred in some 
      people who have received the vaccine. In most of these people, symptoms 
      began within a few days following receipt of the second dose of the 
      vaccine. The chance of having this occur is very low. Individuals should 
      seek medical attention right away if they have any of the following 
      symptoms after receiving the vaccine: 
 
          -- chest pain 
 
          -- shortness of breath 
 
          -- feelings of having a fast-beating, fluttering, or pounding heart 
 
   -- Side effects that have been reported with the vaccine include: 
 
          -- severe allergic reactions; non-severe allergic reactions such as 
             rash, itching, hives, or swelling of the face; myocarditis

(MORE TO FOLLOW) Dow Jones Newswires

September 20, 2021 06:45 ET (10:45 GMT)