Pfizer and BioNTech Receive Expanded U.S. Emergency Use Authorization for an Additional COVID-19 Vaccine Booster in Individuals Aged 50 Years and Older

  •  FDA also authorizes second booster dose for individuals 12 years of age and older who have certain kinds of immunocompromise
  • Second booster dose is intended to offer increased protection against severe disease and hospitalization for individuals who are most vulnerable

NEW YORK, NY, USA & MAINZ, Germany I March 29, 2022 IPfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) has expanded the emergency use of their COVID-19 vaccine to include a second booster dose in adults ages 50 years and older who have previously received a first booster of any authorized COVID-19 vaccine. The FDA also has authorized a second booster dose for individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and who have received a first booster dose of any authorized COVID-19 vaccine. The additional booster is to be administered at least four months after the first booster and is the same formulation and strength as prior Pfizer-BioNTech COVID-19 vaccine doses.

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The expanded EUA is based on the totality of scientific evidence shared by the companies including immunogenicity data from an ongoing, open-label study in 154 healthcare workers 18 years of age and older at a single center in Israel who received two booster doses during a period when Omicron was the predominant variant. Among these individuals, approximately 11-fold increases in geometric mean neutralizing antibody titers against wild-type virus, and Delta and Omicron variants, respectively, were reported at two weeks after the second booster as compared to 5 months after the first booster dose.1 No new safety concerns were noted among study participants.1 The companies also shared with the FDA data from the U.S. and elsewhere showing a decline in vaccine effectiveness against COVID-19 3 to 6 months after the initial booster,2-6 and evidence from Israel that an additional booster dose can improve protection against severe disease and death. 7-9

Together, these data demonstrate the public health need in the most vulnerable individuals and suggest that an additional booster dose of the Pfizer-BioNTech COVID-19 Vaccine administered at least four months after the initial booster may restore antibody levels,1 improve protection in older people,7-9 and provide a similar safety profile to that of previous doses.1 These emerging data underscore the importance of considering an additional booster dose for all individuals included in this EUA.

The Pfizer-BioNTech COVID-19 Vaccine was previously authorized under EUA as a single booster administered to individuals aged 12 and older who have completed the primary vaccination series with the Pfizer-BioNTech COVID-19 Vaccine, as well as to individuals aged 18 and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The second booster authorized today for those age 50 years and older is meant to extend high levels of protection against COVID-19 for the most vulnerable populations in advance of potential future waves.

The Pfizer-BioNTech COVID-19 Vaccine, 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

HOW IS THE VACCINE GIVEN?

The vaccine will be given as an injection into the muscle.

Primary Series:

In individuals 5 years of age and older, the vaccine is administered as a 2-dose series, 3 weeks apart. In individuals 5 years of age and older, a third primary series dose may be administered at least 28 days after the second dose to individuals who are determined to have certain kinds of immunocompromise.

Booster Dose:

  • A first booster dose of the vaccine may be administered at least 5 months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) to individuals 12 years of age and older
  • A first booster dose of the vaccine may be administered to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. Individuals should check with their healthcare provider regarding timing of the booster dose
  • A second booster dose may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any of authorized COVID-19 vaccine.
  • A second booster dose of the vaccine may be administered at least 4 months after receipt of a first booster dose of any authorized COVID-19 vaccine to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise.

WHAT IS THE INDICATION AND AUTHORIZED USE?

The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably. Although they may be manufactured in different facilities, the products offer the same safety and effectiveness.

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

  • a 2-dose primary series to individuals 5 years of age and older
  • a third primary series dose to individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise
  • a single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
  • a single booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
  • a second booster dose may be administered to individuals 50 years of age and older who have received a first booster dose of any authorized COVID-19 vaccine; and
  • a second booster dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and who have received a first booster dose of any authorized COVID-19 vaccine.

COMIRNATY® (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 EUA to provide:
    • a 2-dose primary series to individuals 12 through 15 years of age
    • a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
    • a single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
    • a single booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
    • a second booster dose may be administered to individuals 50 years of age and older who have received a first booster dose of any authorized COVID-19 vaccine; and
    • a second booster dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and who have received a first booster dose of any authorized COVID-19 vaccine.

EUA Statement

Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 5 years of age and older. The emergency uses are 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. Please see EUA Fact Sheet at www.cvdvaccine-us.com

Click for

Fact Sheets and Prescribing Information for individuals 12 years of age and older

Full Prescribing Information (16 years of age and older) DILUTE BEFORE USE, purple cap

Full Prescribing Information (16 years of age and older) DO NOT DILUTE, gray cap

EUA Fact Sheet for Vaccination Providers (12 years of age and older), Purple Cap

EUA Fact Sheet for Vaccination Providers (12 years of age and older), Gray Cap

Recipients and Caregivers Fact Sheet (12 years of age and older)

Fact Sheets for individuals 5 through 11 years of age

EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), Orange Cap

Recipients and Caregivers Fact Sheet (5 through 11 years of age)

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer

About BioNTech

Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de

  1. Regev-Yochay G, Gonen T, Gilboa M, et al. Efficacy of a Fourth Dose of Covid-19 mRNA Vaccine against Omicron. https://www.nejm.org/doi/full/10.1056/NEJMc2202542. Published online March 16, 2022. doi: 10.1056/NEJMc2202542
  2. COVID-19 vaccine surveillance report – Week 9. UK Health Security Agency. Published March 17, 2022. Accessed March 16, 2022. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1058464/Vaccine-surveillance-report-week-9.pdfAndrews N, Stowe J, Kirsebom F, et al. Covid-19 Vaccine Effectiveness against the Omicron (B.1.1.529) Variant. https://doi.org/101056/NEJMoa2119451. Published online March 2, 2022. doi:10.1056/NEJMOA2119451
  3. Tartof SY, Slezak JM, Puzniak L, et al. BNT162b2 (Pfizer–Biontech) mRNA COVID-19 Vaccine Against Omicron-Related Hospital and Emergency Department Admission in a Large US Health System: A Test-Negative Design. SSRN Electronic Journal. Published online January 20, 2022. doi:10.2139/SSRN.4011905
  4. Chemaitelly H, Ayoub HH, Almukdad S, et al. Duration of protection of BNT162b2 and mRNA-1273 COVID-19 vaccines against symptomatic SARS-CoV-2 Omicron infection in Qatar. medRxiv. Published online February 8, 2022:2022.02.07.22270568. doi:10.1101/2022.02.07.22270568
  5. Ferdinands JM, Rao S, Dixon BE, et al. Waning 2-Dose and 3-Dose Effectiveness of mRNA Vaccines Against COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults During Periods of Delta and Omicron Variant Predominance - VISION Network, 10 States, August 2021-January 2022. MMWR Morbidity and mortality weekly report. 2022;71(7):255-263. doi:10.15585/MMWR.MM7107E2
  6. Bar-On YM, Goldberg Y, Mandel M, et al. Protection by 4th dose of BNT162b2 against Omicron in Israel. medRxiv. Published online February 1, 2022:2022.02.01.22270232. doi:10.1101/2022.02.01.22270232
  7. Gazit S et al. Relative Effectiveness of Four Doses Compared to Three Doses of the BNT162b2 Vaccine in Israel. medRXiv. Published online March 24, 2022:2022.03.24.22272835. doi:10.1101/2022.03.24.22272835
  8. Arbel et al. Second Booster Vaccine and Covid-19 Mortality in Adults 60 to 100 Years Old \. 24514bba-2c9d-4add-9d8f-321f610ed199.pdf ()

SOURCE: Pfizer

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