Pfizer and BioNTech Announce Constructive Topline Outcomes From Pivotal Trial of COVID-19 Vaccine in Youngsters 5 to 11 Years

  • Outcomes are the primary from a pivotal trial of any COVID-19 vaccine in youngsters below 12 years of age

  • In individuals 5 to 11 years of age, the vaccine was protected, nicely tolerated and confirmed strong neutralizing antibody responses

  • Corporations plan to submit these information to the FDA, EMA and different regulatory companies around the globe as quickly as potential

  • Ends in youngsters below 5 years of age are anticipated as quickly as later this yr

NEW YORK AND MAINZ, Germany, September 20, 2021–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) at present introduced outcomes from a Part 2/3 trial exhibiting a good security profile and strong neutralizing antibody responses in youngsters 5 to 11 years of age utilizing a two-dose routine of 10 µg administered 21 days aside, a smaller dose than the 30 µg dose used for folks 12 and older. The antibody responses within the individuals given 10 µg doses have been akin to these recorded in a earlier Pfizer-BioNTech examine in folks 16 to 25 years of age immunized with 30 µg doses. The ten µg dose was fastidiously chosen as the popular dose for security, tolerability and immunogenicity in youngsters 5 to 11 years of age. These are the primary outcomes from a pivotal trial of a COVID-19 vaccine on this age group.

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“Over the previous 9 months, a whole lot of thousands and thousands of individuals ages 12 and older from around the globe have obtained our COVID-19 vaccine. We’re keen to increase the safety afforded by the vaccine to this youthful inhabitants, topic to regulatory authorization, particularly as we monitor the unfold of the Delta variant and the substantial menace it poses to youngsters,” mentioned Albert Bourla, Chairman and Chief Government Officer, Pfizer. “Since July, pediatric instances of COVID-19 have risen by about 240 p.c within the U.S. – underscoring the general public well being want for vaccination. These trial outcomes present a powerful basis for in search of authorization of our vaccine for youngsters 5 to 11 years previous, and we plan to submit them to the FDA and different regulators with urgency.”

“We’re happy to have the ability to submit information to regulatory authorities for this group of school-aged youngsters earlier than the beginning of the winter season,” mentioned Dr. Ugur Sahin, CEO and co-founder of BioNTech. “The protection profile and immunogenicity information in youngsters aged 5 to 11 years vaccinated at a decrease dose are according to these now we have noticed with our vaccine in different older populations at the next dose.”

The info summarized from this Part 2/3 examine, which is enrolling youngsters 6 months to 11 years of age, was for two,268 individuals who have been 5 to 11 years of age and obtained a ten µg dose degree in a two-dose routine. Within the trial, the SARS-CoV-2–neutralizing antibody geometric imply titer (GMT) was 1,197.6 (95% confidence interval [CI, 1106.1, 1296.6]), demonstrating sturdy immune response on this cohort of kids one month after the second dose. This compares nicely (was non-inferior) to the GMT of 1146.5 (95% CI: 1045.5, 1257.2) from individuals ages 16 to 25 years previous, used because the management group for this evaluation and who have been administered a two-dose routine of 30 µg. Additional, the COVID-19 vaccine was nicely tolerated, with unintended effects usually akin to these noticed in individuals 16 to 25 years of age.

Pfizer and BioNTech plan to share these information with the U.S. Meals and Drug Administration (FDA), European Medicines Company (EMA) and different regulators as quickly as potential. For america, the businesses count on to incorporate the info in a near-term submission for Emergency Use Authorization (EUA) as they proceed to build up the security and efficacy information required to file for full FDA approval on this age group. A request to the EMA to replace the EU Conditional Advertising Authorization can be deliberate. Topline readouts for the opposite two age cohorts from the trial – youngsters 2-5 years of age and youngsters 6 months to 2 years of age – are anticipated as quickly because the fourth quarter of this yr.

Pfizer and BioNTech plan to submit information from the complete Part 3 trial for scientific peer-reviewed publication.

Concerning the Part 1/2/3 Trial in Youngsters

The Part 1/2/3 trial initially enrolled as much as 4,500 youngsters ages 6 months to 11 years of age in america, Finland, Poland, and Spain from greater than 90 medical trial websites. It was designed to judge the security, tolerability, and immunogenicity of the Pfizer-BioNTech vaccine on a two-dose schedule (roughly 21 days aside) in three age teams: ages 5 to 11 years; ages 2 to five years; and ages 6 months to 2 years. Primarily based on the Part 1 dose-escalation portion of the trial, youngsters ages 5 to 11 years obtained two-dose schedule of 10 µg every whereas youngsters below age 5 obtained a decrease 3 µg dose for every injection within the Part 2/3 examine. The trial enrolled youngsters with or with out prior proof of SARS-CoV-2 an infection.

COMIRNATY, which relies on BioNTech’s proprietary mRNA know-how, was developed by each BioNTech and Pfizer. BioNTech is the Advertising Authorization Holder in america, the European Union, the UK, Canada and the holder of emergency use authorizations or equivalents in america (collectively with Pfizer) and different international locations. Submissions to pursue regulatory approvals in these international locations the place emergency use authorizations or equal have been initially granted are deliberate.

U.S. Indication & Approved Use

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

  • It’s authorized as a 2-dose sequence for prevention of COVID-19 in people 16 years of age and older

  • It’s also licensed below Emergency Use Authorization (EUA) to be administered for emergency use to:

    • forestall COVID-19 in people 12 by 15 years, and

    • present a 3rd dose to people 12 years of age and older who’ve been decided to have sure sorts of immunocompromise

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

  • forestall COVID-19 in people 12 years of age and older, and

  • present a 3rd dose to people 12 years of age and older who’ve been decided to have sure sorts of immunocompromise

The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the identical formulation and can be utilized interchangeably to offer the COVID-19 vaccination sequence. A person could also be provided both COMIRNATY® (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to forestall coronavirus illness 2019 (COVID-19) attributable to SARS-CoV-2.

EUA Assertion

This emergency use of the product has not been authorized or licensed by FDA, however has been licensed by FDA below an Emergency Use Authorization (EUA) to forestall Coronavirus Illness 2019 (COVID-19) to be used in people 12 years of age and older; and the emergency use of this product is just licensed during the declaration that circumstances exist justifying the authorization of emergency use of the medical product below Part 564(b)(1) of the FD&C Act except the declaration is terminated or authorization revoked sooner.

Essential Security Info

People ought to not get the Pfizer-BioNTech COVID-19 Vaccine in the event that they:

People ought to inform the vaccination supplier about all of their medical situations, together with in the event that they:

  • have any allergy symptoms

  • have had myocarditis (irritation of the center muscle) or pericarditis (irritation of the liner exterior the center)

  • have a fever

  • have a bleeding dysfunction or are on a blood thinner

  • are immunocompromised or are on a medication that impacts the immune system

  • are pregnant, plan to grow to be pregnant, or are breastfeeding

  • have obtained one other COVID-19 vaccine

  • have ever fainted in affiliation with an injection

The vaccine could not defend everybody.

Unwanted effects reported with the vaccine embrace:

  • There’s a distant probability that the vaccine might trigger a extreme allergic response

    • A extreme allergic response would often happen inside a couple of minutes to at least one hour after getting a dose of the vaccine. Because of this, vaccination suppliers could ask people to remain on the place the place they obtained the vaccine for monitoring after vaccination

    • Indicators of a extreme allergic response can embrace problem respiratory, swelling of the face and throat, a quick heartbeat, a foul rash everywhere in the physique, dizziness, and weak spot

    • If a person experiences a extreme allergic response, they need to name 9-1-1 or go to the closest hospital

  • Myocarditis (irritation of the center muscle) and pericarditis (irritation of the liner exterior the center) have occurred in some individuals who have obtained the vaccine. In most of those folks, signs started inside a couple of days following receipt of the second dose of the vaccine. The prospect of getting this happen could be very low. People ought to search medical consideration immediately if they’ve any of the next signs after receiving the vaccine:

  • Unwanted effects which have been reported with the vaccine embrace:

    • extreme allergic reactions; non-severe allergic reactions corresponding to rash, itching, hives, or swelling of the face; myocarditis (irritation of the center muscle); pericarditis (irritation of the liner exterior the center); injection website ache; tiredness; headache; muscle ache; chills; joint ache; fever; injection website swelling; injection website redness; nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); diarrhea; vomiting; arm ache

  • These might not be all of the potential unintended effects of the vaccine. Critical and sudden unintended effects could happen. The vaccine remains to be being studied in medical trials. Name the vaccination supplier or healthcare supplier about bothersome unintended effects or unintended effects that don’t go away.

There isn’t a info on the usage of the vaccine with different vaccines.

Sufferers ought to all the time ask their healthcare suppliers for medical recommendation about adversarial occasions. People are inspired to report unfavourable unintended effects of vaccines to the US Meals and Drug Administration (FDA) and the Facilities for Illness Management and Prevention (CDC). Go to http://www.vaers.hhs.gov or name 1-800-822-7967. As well as, unintended effects will be reported to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.

Please click on right here for full Prescribing Info (16+ years of age). Please click on right here for Reality Sheet for Vaccination Suppliers (12+ years of age).

About Pfizer: Breakthroughs That Change Sufferers’ Lives

At Pfizer, we apply science and our world sources to carry therapies to folks that stretch and considerably enhance their lives. We try to set the usual for high quality, security and worth within the discovery, growth and manufacture of well being care merchandise, together with progressive medicines and vaccines. Every single day, Pfizer colleagues work throughout developed and rising markets to advance wellness, prevention, remedies and cures that problem essentially the most feared ailments of our time. In step with our duty as one of many world’s premier progressive biopharmaceutical corporations, we collaborate with well being care suppliers, governments and native communities to help and increase entry to dependable, reasonably priced well being care around the globe. For greater than 170 years, now we have labored to make a distinction for all who depend on us. We routinely put up info which may be essential to buyers on our web site at www.Pfizer.com. As well as, to be taught extra, please go to us on www.Pfizer.com and observe us on Twitter at @Pfizer and @Pfizer Information, LinkedIn, YouTube and like us on Fb at Fb.com/Pfizer.

Pfizer Disclosure Discover

The knowledge contained on this launch is as of September 20, 2021. Pfizer assumes no obligation to replace forward-looking statements contained on this launch as the results of new info or future occasions or developments.

This launch accommodates forward-looking details about Pfizer’s efforts to fight COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine program and COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (together with potential in youngsters 5 to 11 years of years of age and a examine in youngsters 6 months to five years of age, qualitative assessments of accessible information, potential advantages, expectations for medical trials, the anticipated timing of knowledge readouts, regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and provide) involving substantial dangers and uncertainties that would trigger precise outcomes to vary materially from these expressed or implied by such statements. Dangers and uncertainties embrace, amongst different issues, the uncertainties inherent in analysis and growth, together with the flexibility to fulfill anticipated medical endpoints, graduation and/or completion dates for medical trials, regulatory submission dates, regulatory approval dates and/or launch dates, in addition to dangers related to preclinical and medical information (together with the Part 2/3 information), together with the potential of unfavorable new preclinical, medical or security information and additional analyses of present preclinical, medical or security information; whether or not and when our Part 3 medical trial will exhibit safety from an infection or illness following a booster (third) dose, which is the topic of ongoing examine; the flexibility to provide comparable medical or different outcomes, together with the speed of vaccine effectiveness and security and tolerability profile noticed to this point, in extra analyses of the Part 3 trial and extra research or in bigger, extra various populations following commercialization; the flexibility of BNT162b2 to forestall COVID-19 attributable to rising virus variants; the danger that extra widespread use of the vaccine will result in new details about efficacy, security, or different developments, together with the danger of extra adversarial reactions, a few of which can be severe; the danger that preclinical and medical trial information are topic to differing interpretations and assessments, together with through the peer overview/publication course of, within the scientific group usually, and by regulatory authorities; whether or not and when extra information from the BNT162 mRNA vaccine program will probably be printed in scientific journal publications and, in that case, when and with what modifications and interpretations; whether or not regulatory authorities will probably be glad with the design of and outcomes from these and any future preclinical and medical research; whether or not and when information from BNT162b2 in youthful pediatric populations will probably be submitted to the FDA and different regulatory authorities to request amendments to emergency use or conditional advertising authorizations, whether or not and when functions for a possible booster (third) dose will probably be filed in every other jurisdictions and whether or not and when different biologics license and/or emergency use authorization functions or amendments to any such functions could also be filed particularly jurisdictions for BNT162b2 or every other potential vaccines which will come up from the BNT162 program, and if obtained, whether or not or when such emergency use authorization or licenses will expire or terminate; whether or not and when any functions which may be pending or filed for BNT162b2 (together with the potential amendments to request use in youthful pediatric populations, a possible booster (third) dose or every other requested amendments to the emergency use or conditional advertising authorizations) or different vaccines which will outcome from the BNT162 program could also be authorized by specific regulatory authorities, which is able to rely upon myriad components, together with making a dedication as as to if the vaccine’s advantages outweigh its identified dangers and dedication of the vaccine’s efficacy and, if authorized, whether or not it is going to be commercially profitable; choices by regulatory authorities impacting labeling or advertising, manufacturing processes, security and/or different issues that would have an effect on the supply or industrial potential of a vaccine, together with growth of merchandise or therapies by different corporations; disruptions within the relationships between us and our collaboration companions, medical trial websites or third-party suppliers; the danger that demand for any merchandise could also be diminished or not exist; dangers associated to the supply of uncooked supplies to fabricate a vaccine; challenges associated to our vaccine’s ultra-low temperature formulation, two-dose schedule and attendant storage, distribution and administration necessities, together with dangers associated to storage and dealing with after supply by Pfizer; the danger that we could not have the ability to efficiently develop different vaccine formulations, booster doses or new variant-specific vaccines; the danger that we could not have the ability to create or scale up manufacturing capability on a well timed foundation or preserve entry to logistics or provide channels commensurate with world demand for our vaccine, which might negatively affect our potential to provide the estimated numbers of doses of our vaccine inside the projected time durations as beforehand indicated; whether or not and when extra provide agreements will probably be reached; uncertainties concerning the flexibility to acquire suggestions from vaccine advisory or technical committees and different public well being authorities and uncertainties concerning the industrial affect of any such suggestions; challenges associated to public vaccine confidence or consciousness; uncertainties concerning the affect of COVID-19 on Pfizer’s enterprise, operations and monetary outcomes; and aggressive developments.

An additional description of dangers and uncertainties will be present in Pfizer’s Annual Report on Type 10-Okay for the fiscal yr ended December 31, 2020 and in its subsequent studies on Type 10-Q, together with within the sections thereof captioned “Threat Elements” and “Ahead-Trying Info and Elements That Could Have an effect on Future Outcomes”, in addition to in its subsequent studies on Type 8-Okay, all of that are filed with the U.S. Securities and Alternate Fee and out there at www.sec.gov and www.pfizer.com.

About BioNTech

Biopharmaceutical New Applied sciences is a subsequent technology immunotherapy firm pioneering novel therapies for most cancers and different severe ailments. The Firm exploits a big selection of computational discovery and therapeutic drug platforms for the speedy growth of novel biopharmaceuticals. Its broad portfolio of oncology product candidates contains individualized and off-the-shelf mRNA-based therapies, progressive chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, focused most cancers antibodies and small molecules. Primarily based on its deep experience in mRNA vaccine growth and in-house manufacturing capabilities, BioNTech and its collaborators are creating a number of mRNA vaccine candidates for a variety of infectious ailments alongside its various oncology pipeline. BioNTech has established a broad set of relationships with a number of world pharmaceutical collaborators, together with Genmab, Sanofi, Bayer Animal Well being, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For extra info, please go to www.BioNTech.de.

BioNTech Ahead-looking Statements

This press launch accommodates “forward-looking statements” of BioNTech inside the which means of the Non-public Securities Litigation Reform Act of 1995. These forward-looking statements could embrace, however might not be restricted to, statements regarding: BioNTech’s efforts to fight COVID-19; the collaboration between BioNTech and Pfizer together with this system to develop a COVID-19 vaccine and COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (together with potential in youngsters 5 to 11 years of years of age and an ongoing examine in youngsters 6 months to five years of age, a BLA to help potential full FDA approval of BNT162b2 in people 12 by 15 years, qualitative assessments of accessible information, potential advantages, expectations for medical trials, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and provide); our expectations concerning the potential traits of BNT162b2 in our medical trials and/or in industrial use primarily based on information observations to this point; the flexibility of BNT162b2 to forestall COVID-19 attributable to rising virus variants; the anticipated time level for extra readouts on efficacy information of BNT162b2 in our medical trials; the character of the medical information, which is topic to ongoing peer overview, regulatory overview and market interpretation; the timing for submission of knowledge for, or receipt of, any advertising approval or Emergency Use Authorization; our contemplated delivery and storage plan, together with our estimated product shelf life at varied temperatures; and the flexibility of BioNTech to provide the portions of BNT162 to help medical growth and market demand, together with our manufacturing estimates for 2021. Any forward-looking statements on this press launch are primarily based on BioNTech present expectations and beliefs of future occasions, and are topic to quite a few dangers and uncertainties that would trigger precise outcomes to vary materially and adversely from these set forth in or implied by such forward-looking statements. These dangers and uncertainties embrace, however usually are not restricted to: the flexibility to fulfill the pre-defined endpoints in medical trials; competitors to create a vaccine for COVID-19; the flexibility to provide comparable medical or different outcomes, together with our acknowledged price of vaccine effectiveness and security and tolerability profile noticed to this point, within the the rest of the trial or in bigger, extra various populations upon commercialization; the flexibility to successfully scale our productions capabilities; and different potential difficulties.

For a dialogue of those and different dangers and uncertainties, see BioNTech’s Annual Report as Type 20-F for the Yr Ended December 31, 2020, filed with the SEC on March 30, 2021, which is accessible on the SEC’s web site at www.sec.gov. All info on this press launch is as of the date of the discharge, and BioNTech undertakes no obligation to replace this info except required by legislation.

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Contacts

Pfizer:
Media Relations
Amy Rose
+1 (212) 733-7410
[email protected]

Investor Relations
Christopher Stevo
+1 (212) 733-0437
[email protected]

BioNTech:
Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513
[email protected]

Investor Relations
Sylke Maas, Ph.D.
+49 (0)6131 9084 1074
[email protected]

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