{"id":48262,"date":"2022-09-12T18:01:45","date_gmt":"2022-09-12T16:01:45","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/pfizer-and-biontech-receive-positive-chmp-opinion-for-omicron-ba-4-ba-5-adapted-bivalent-covid-19-vaccine-booster-in-european-union\/"},"modified":"2022-09-12T18:01:45","modified_gmt":"2022-09-12T16:01:45","slug":"pfizer-and-biontech-receive-positive-chmp-opinion-for-omicron-ba-4-ba-5-adapted-bivalent-covid-19-vaccine-booster-in-european-union","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/pfizer-and-biontech-receive-positive-chmp-opinion-for-omicron-ba-4-ba-5-adapted-bivalent-covid-19-vaccine-booster-in-european-union\/","title":{"rendered":"Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron BA.4\/BA.5-Adapted Bivalent COVID-19 Vaccine Booster in European Union"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\n<i>CHMP recommendation based on favorable data from Omicron-adapted vaccines<\/i>\n<\/li>\n<li>\n<i>The Omicron BA.4\/BA.5 bivalent COVID-19 booster vaccine combines 15-ug of mRNA encoding the wild-type spike protein of SARS-CoV-2 in the Original Pfizer-BioNTech COVID-19 Vaccines and 15-ug of mRNA encoding the spike protein of the Omicron BA.4\/BA.5 subvariants<\/i>\n<\/li>\n<li>\n<i>Pfizer-BioNTech bivalent Omicron BA.4\/BA.5 COVID-19 vaccine is available to ship immediately, pending European Commission approval, to support EU vaccination campaigns this fall<\/i>\n<\/li>\n<\/ul>\n<p>NEW YORK &amp; MAINZ, Germany&#8211;(BUSINESS WIRE)&#8211;<a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.pfizer.com&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=Pfizer+Inc&amp;index=1&amp;md5=e431fe0b3a3be270d6cfb71429c46374\" rel=\"nofollow noopener\" shape=\"rect\">Pfizer Inc<\/a>. (NYSE: PFE) and <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.biontech.com%2Fint%2Fen%2Fhome.html&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=BioNTech+SE&amp;index=2&amp;md5=d7d2a0da0bcf959fcf1cdc4ebb2ab8eb\" rel=\"nofollow noopener\" shape=\"rect\">BioNTech SE<\/a> (Nasdaq: BNTX) today announced a 30-\u00b5g booster dose of their Omicron BA.4\/BA.5 bivalent-adapted COVID-19 Vaccine (COMIRNATY\u00ae Original\/Omicron BA.4\/BA.5 15\/15 \u00b5g) has been recommended for conditional marketing authorization (cMA) by the European Medicines Agency\u2019s (EMA) Committee for Medicinal Products for Human Use (CHMP) for individuals ages 12 years and older. The European Commission will review the CHMP recommendation and is expected to make a final decision soon.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220909005519\/en\/1045874\/5\/Pfizer_Logo_Color_RGB_APPROVED.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220909005519\/en\/1045874\/21\/Pfizer_Logo_Color_RGB_APPROVED.jpg\"><\/a><\/p>\n<p>\nThe Omicron BA.4\/BA.5-adapted bivalent vaccine contains 15-\u00b5g of mRNA encoding the wild-type spike protein of SARS-CoV-2 in the Original Pfizer-BioNTech COVID-19 Vaccine, and 15-\u00b5g of mRNA encoding the spike protein of the Omicron BA.4\/BA.5 subvariants. Apart from the addition of the mRNA sequence of the BA.4\/BA.5 spike protein, all other components of the vaccine remain unchanged.\n<\/p>\n<p>\n\u201c<!-- no quote -->This recommendation marks another major milestone in the ongoing global fight against COVID-19, bolstering our defenses as we prepare for fall and winter with potential increased exposure to the virus,\u201d said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. \u201c<!-- no quote -->Due to our multifaceted approach helping to address emerging variants and subvariants of concern, public health authorities in the EU will have our bivalent booster options, pending authorization, to facilitate flexible vaccination strategies for maximal coverage across the region.\u201d\n<\/p>\n<p>\n\u201c<!-- no quote -->If the European Commission follows today\u2019s recommendation by the CHMP, EU residents will have access to Omicron-adapted vaccines before the start of the winter season,\u201d said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. \u201c<!-- no quote -->The bivalent vaccines encode the spike protein of the SARS-CoV-2 wild-type as well as a spike protein of an Omicron subvariant. They aim to provide broader immunization against COVID-19 caused by the current dominant Omicron sublineages and previous variants of concern.\u201d\n<\/p>\n<p>\nToday\u2019s recommendation follows guidance from the EMA, World Health Organization (WHO) and International Coalition of Medicines Regulatory Authorities (ICMRA) to advance bivalent vaccine candidates, with the goal of making an Omicron-adapted vaccine available to European Union (EU) member states as soon as possible. The CHMP recommendation concerning the Omicron BA.4\/BA.5 bivalent COVID-19 vaccine is based on data from Pfizer\u2019s and BioNTech\u2019s Omicron BA.1-adapted bivalent vaccine as well as pre-clinical and manufacturing data from the Omicron BA.4\/BA.5-adapted bivalent vaccine. <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Finvestors.biontech.de%2Fnews-releases%2Fnews-release-details%2Fpfizer-and-biontech-announce-omicron-adapted-covid-19-vaccine%2F&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=Clinical+data&amp;index=3&amp;md5=ea55443f67ab3683ae46f6b27968db8d\" rel=\"nofollow noopener\" shape=\"rect\">Clinical data<\/a> from a Phase 2\/3 trial showed a booster dose of Pfizer and BioNTech\u2019s Omicron BA.1-adapted bivalent vaccine elicited a superior immune response against the Omicron BA.1 subvariant compared to the companies\u2019 current COVID-19 vaccine, with a favorable safety profile. Additionally, pre-clinical data showed a booster dose of the BA.4\/BA.5-adapted bivalent vaccine generated a strong neutralizing antibody response against the Omicron sublineages including BA.1, BA.2, BA.4 and BA.5 subvariants, as well as the original virus, while retaining a favorable safety profile.\n<\/p>\n<p>\nIf an authorization is granted, the Pfizer-BioNTech bivalent Omicron BA.4\/BA.5 COVID-19 vaccine will be available within the coming days to all 27 EU member states supporting the European vaccination campaigns. Local supply may vary based on individual country government requests. In early September, Pfizer and BioNTech were granted a conditional marketing authorization for an Omicron BA.1-adapted bivalent COVID-19 vaccine in the EU. An Omicron-adapted vaccine based on the BA.4\/BA.5 subvariant was also authorized by the U.S. Food and Drug Administration as a booster for ages 12 and older on August 31, 2022. The companies are also planning to file the data with other regulatory authorities in the coming weeks and are planning to submit data to the FDA and the EMA to prepare an application for an Omicron-adapted bivalent vaccine in children younger than 12 years of age.\n<\/p>\n<p>\nThe Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech\u2019s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (COMIRNATY\u00ae) in the United States, the European Union, the United Kingdom, Canada and other countries, 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.\n<\/p>\n<p>\n<b>PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4\/BA.5) AUTHORIZED USES<\/b>\n<\/p>\n<p>\n<b>Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4\/BA.5)<\/b> is FDA-authorized under<b> <\/b>Emergency Use Authorization (EUA) for use in individuals 12 years of age and older as a single booster dose administered at least 2 months after either:\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\ncompletion of primary vaccination with any authorized or approved monovalent* COVID-19 vaccine; or\n<\/li>\n<li>\nreceipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.\n<\/li>\n<\/ul>\n<p>\n*Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus\n<\/p>\n<p>\n<b><span class=\"bwuline\">COMIRNATY<sup>\u00ae<\/sup> (COVID-19 Vaccine, mRNA) INDICATION<br \/>\n<br \/><\/span><\/b>COMIRNATY<b><sup>\u00ae<\/sup><\/b> (COVID-19 Vaccine, mRNA) is a vaccine approved for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.\n<\/p>\n<p>\n<b>AUTHORIZED USES<br \/>\n<br \/><\/b><b>Primary Series<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\na third primary series dose to individuals 12 years of age and older who have certain kinds of immunocompromise\n<\/li>\n<\/ul>\n<p>\n<b><span class=\"bwuline\">Pfizer-BioNTech COVID-19 Vaccine<\/span><\/b>\n<\/p>\n<p>\n<b>INDICATION<br \/>\n<br \/><\/b>Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for use in individuals 6 months and older to provide:\n<\/p>\n<p>\n<b>AUTHORIZED USES<br \/>\n<br \/><\/b><b>Primary Series<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\na 3-dose primary series to individuals 6 months through 4 years of age\n<\/li>\n<li>\na 2-dose primary series to individuals 5 years through 11 years of age\n<\/li>\n<li>\na third primary series dose to individuals 5 years through 11 years of age with certain kinds of immunocompromise\n<\/li>\n<\/ul>\n<p>\n<b>Booster<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\na single booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine\n<\/li>\n<\/ul>\n<p>\n<b>Emergency Use Authorization<br \/>\n<br \/><\/b>Emergency uses of the vaccines 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:\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nindividuals 6 months of age and older (Pfizer-BioNTech COVID-19 Vaccine)\n<\/li>\n<li>\nindividuals 12 years of age and older (Pfizer-BioNTech COVID-19 Vaccine, Bivalent)\n<\/li>\n<\/ul>\n<p>\nThe 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&amp;C Act unless the declaration is terminated or authorization revoked sooner.\n<\/p>\n<p>\n<b><span class=\"bwuline\">IMPORTANT SAFETY INFORMATION<\/span><\/b>\n<\/p>\n<p>\n<b>Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4\/BA.5), COMIRNATY<sup>\u00ae<\/sup> (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine<\/b>\n<\/p>\n<p>\n<b>Tell your vaccination provider about all of your medical conditions, including if you:<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nhave any allergies\n<\/li>\n<li>\nhave had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)\n<\/li>\n<li>\nhave a fever\n<\/li>\n<li>\nhave a bleeding disorder or are on a blood thinner\n<\/li>\n<li>\nare immunocompromised or are on a medicine that affects the immune system\n<\/li>\n<li>\nare pregnant, plan to become pregnant, or are breastfeeding\n<\/li>\n<li>\nhave received another COVID-19 vaccine\n<\/li>\n<li>\nhave ever fainted in association with an injection\n<\/li>\n<li>\nCOMIRNATY\u00ae (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4\/BA.5) may not protect all vaccine recipients.\n<\/li>\n<li>\nYou should not receive Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4\/BA.5) if you have had a severe allergic reaction to after a previous dose of COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID 19 Vaccine or had a severe allergic reaction to any ingredient in these vaccines\n<\/li>\n<li>\nThere is a remote chance that Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4\/BA.5) could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. If you experience a severe allergic reaction, call 9-1-1 or go to the nearest hospital\n<\/li>\n<\/ul>\n<p>\n<b>Seek medical attention right away if you have any of the following symptoms:<\/b>\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\ndifficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness\n<\/li>\n<li>\nMyocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received COMIRNATY\u00ae (COVID-19 vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine. The observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males, and the observed risk is highest in males 12 through 17 years of age. In most of these people, symptoms began within the first week following receipt of the second primary series dose or first booster dose, with most booster doses administered at least 5 months after completing primary vaccination. The chance of having this occur is very low.\n<\/li>\n<\/ul>\n<p>\nSide effects that have been reported with these vaccines include:\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nSevere allergic reactions\n<\/li>\n<li>\nNon-severe allergic reactions such as rash, itching, hives, or swelling of the face\n<\/li>\n<li>\nMyocarditis (inflammation of the heart muscle)\n<\/li>\n<li>\nPericarditis (inflammation of the lining outside the heart)\n<\/li>\n<li>\nInjection site pain\n<\/li>\n<li>\nTiredness\n<\/li>\n<li>\nHeadache\n<\/li>\n<li>\nMuscle pain\n<\/li>\n<li>\nChills\n<\/li>\n<li>\nJoint pain\n<\/li>\n<li>\nFever\n<\/li>\n<li>\nInjection site swelling\n<\/li>\n<li>\nInjection site redness\n<\/li>\n<li>\nNausea\n<\/li>\n<li>\nFeeling unwell\n<\/li>\n<li>\nSwollen lymph nodes (lymphadenopathy)\n<\/li>\n<li>\nDecreased appetite\n<\/li>\n<li>\nDiarrhea\n<\/li>\n<li>\nVomiting\n<\/li>\n<li>\nArm pain\n<\/li>\n<li>\nFainting in association with injection of the vaccine\n<\/li>\n<li>\nUnusual and persistent irritability\n<\/li>\n<li>\nUnusual and persistent poor feeding\n<\/li>\n<li>\nUnusual and persistent fatigue or lack of energy\n<\/li>\n<li>\nUnusual and persistent cool, pale skin\n<\/li>\n<\/ul>\n<p>\nThese may not be all the possible side effects of the vaccine. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nIndividuals should always ask their healthcare providers for medical advice about adverse events. Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1\u2010800\u2010822\u20107967 or report online to <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.vaers.hhs.gov%2Freportevent.html&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=www.vaers.hhs.gov%2Freportevent.html&amp;index=4&amp;md5=6a35ecbe72e1ac2f50144cf1eb0feb96\" rel=\"nofollow noopener\" shape=\"rect\">www.vaers.hhs.gov\/reportevent.html<\/a>. In addition, individuals can report side effects to Pfizer Inc. at <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.pfizersafetyreporting.com%2F&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=www.pfizersafetyreporting.com&amp;index=5&amp;md5=7c41d9adc7700e6acca8a007c8776dac\" rel=\"nofollow noopener\" shape=\"rect\">www.pfizersafetyreporting.com<\/a> or by calling 1-800-438-1985\n<\/li>\n<\/ul>\n<p>\n<b>Click for Fact Sheets and Prescribing Information for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4\/BA.5):<br \/>\n<br \/><\/b><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F153716%2Fdownload&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=EUA+Fact+Sheet+for+Recipients+and+Caregivers+%2812+years+of+age+and+older%29&amp;index=6&amp;md5=fb13dd4b299c8373e5bcd733cf95b5eb\" rel=\"nofollow noopener\" shape=\"rect\">EUA Fact Sheet for Recipients and Caregivers (12 years of age and older)<\/a><br \/><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F161327%2Fdownload&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=EUA+Fact+Sheet+for+Vaccination+Providers+%2812+Years+%26amp%3B+Up%29%2C+BIVALENT+%28Original+and+Omicron+BA.4%2FBA.5%29%2C+DO+NOT+DILUTE%2C+Gray+Cap&amp;index=7&amp;md5=da49bc0d53bda3df9f7dd68b3c5d8180\" rel=\"nofollow noopener\" shape=\"rect\">EUA Fact Sheet for Vaccination Providers (12 Years &amp; Up), BIVALENT (Original and Omicron BA.4\/BA.5), DO NOT DILUTE, Gray Cap<\/a>\n<\/p>\n<p>\n<b>Click for Fact Sheets and Prescribing Information for individuals 5 years of age and older:<br \/>\n<br \/><\/b><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Flabeling.pfizer.com%2FShowLabeling.aspx%3Fid%3D17228%26format%3Dpdf&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=Recipients+and+Caregivers+Fact+Sheet+%286+months+through+4+years+of+age%29&amp;index=8&amp;md5=81a080c7bec76d02288ca5a6d6ae3219\" rel=\"nofollow noopener\" shape=\"rect\">Recipients and Caregivers Fact Sheet (6 months through 4 years of age)<\/a><br \/><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Flabeling.pfizer.com%2FShowLabeling.aspx%3Fid%3D16074%26format%3Dpdf&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=Recipients+and+Caregivers+Fact+Sheet+%285+through+11+years+of+age%29&amp;index=9&amp;md5=a93c75bd47bd20307113ad5421937022\" rel=\"nofollow noopener\" shape=\"rect\">Recipients and Caregivers Fact Sheet (5 through 11 years of age)<\/a><br \/><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Flabeling.pfizer.com%2FShowLabeling.aspx%3Fid%3D14472%26format%3Dpdf&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=Recipients+and+Caregivers+Fact+Sheet+%2812+years+of+age+and+older%29&amp;index=10&amp;md5=503deace635dd7d39b23201a1523d266\" rel=\"nofollow noopener\" shape=\"rect\">Recipients and Caregivers Fact Sheet (12 years of age and older)<\/a><br \/><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Flabeling.pfizer.com%2FShowLabeling.aspx%3Fid%3D15623%26format%3Dpdf&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=COMIRNATY%26%23174%3B+Full+Prescribing+Information+%2812+years+of+age+and+older%29%2C+DILUTE+BEFORE+USE%2C+Purple+Cap&amp;index=11&amp;md5=39b35e99f0eaaba6be13c6fad17647a3\" rel=\"nofollow noopener\" shape=\"rect\">COMIRNATY\u00ae Full Prescribing Information (12 years of age and older), DILUTE BEFORE USE, Purple Cap<\/a><br \/><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Flabeling.pfizer.com%2FShowLabeling.aspx%3Fid%3D16351%26format%3Dpdf&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=COMIRNATY%26%23174%3B+Full+Prescribing+Information+%2812+years+of+age+and+older%29%2C+DO+NOT+DILUTE%2C+Gray+Cap&amp;index=12&amp;md5=33ab51e77c3a7930052edec143bb9dfd\" rel=\"nofollow noopener\" shape=\"rect\">COMIRNATY\u00ae Full Prescribing Information (12 years of age and older), DO NOT DILUTE, Gray Cap<\/a><br \/><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Flabeling.pfizer.com%2FShowLabeling.aspx%3Fid%3D17227%26format%3Dpdf&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=EUA+Fact+Sheet+for+Vaccination+Providers+%286+months+through+4+years+of+age%29%2C+DILUTE+BEFORE+USE%2C+Maroon+Cap&amp;index=13&amp;md5=079874641af13277504c3c6f22bd05a4\" rel=\"nofollow noopener\" shape=\"rect\">EUA Fact Sheet for Vaccination Providers (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap<\/a><br \/><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Flabeling.pfizer.com%2FShowLabeling.aspx%3Fid%3D16073%26format%3Dpdf&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=EUA+Fact+Sheet+for+Vaccination+Providers+%285+through+11+years+of+age%29%2C+DILUTE+BEFORE+USE%2C+Orange+Cap&amp;index=14&amp;md5=5628f8fc3e7430e6db820e7ed8d81c99\" rel=\"nofollow noopener\" shape=\"rect\">EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap<\/a><br \/><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Flabeling.pfizer.com%2FShowLabeling.aspx%3Fid%3D14471%26format%3Dpdf&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=EUA+Fact+Sheet+for+Vaccination+Providers+%2812+years+of+age+and+older%29%2C+DILUTE+BEFORE+USE%2C+Purple+Cap&amp;index=15&amp;md5=5972da43607faeaffc62bd0102c6c0c0\" rel=\"nofollow noopener\" shape=\"rect\">EUA Fact Sheet for Vaccination Providers (12 years of age and older), DILUTE BEFORE USE, Purple Cap<\/a><br \/><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Flabeling.pfizer.com%2FShowLabeling.aspx%3Fid%3D16072%26format%3Dpdf&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=EUA+Fact+Sheet+for+Vaccination+Providers+%2812+years+of+age+and+older%29%2C+DO+NOT+DILUTE%2C+Gray+Cap&amp;index=16&amp;md5=ad8f3f4b87bd2ac756d28ed0e16c54b9\" rel=\"nofollow noopener\" shape=\"rect\">EUA Fact Sheet for Vaccination Providers (12 years of age and older), DO NOT DILUTE, Gray Cap<\/a>\n<\/p>\n<p>\n<b>About Pfizer: Breakthroughs That Change Patients\u2019 Lives<br \/>\n<br \/><\/b>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&#8217;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 <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.pfizer.com%2F&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=www.Pfizer.com&amp;index=17&amp;md5=d0d260a94981f33beb9eb3d11cc68eae\" rel=\"nofollow noopener\" shape=\"rect\">www.Pfizer.com<\/a>. In addition, to learn more, please visit us on <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.pfizer.com%2F&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=www.Pfizer.com&amp;index=18&amp;md5=31781ff4844ff9434e7a9b29c24e5bdb\" rel=\"nofollow noopener\" shape=\"rect\">www.Pfizer.com<\/a> and follow us on Twitter at <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftwitter.com%2Fpfizer&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=%40Pfizer&amp;index=19&amp;md5=a9e37c32e13a71a508b6cc57d1b29f3d\" rel=\"nofollow noopener\" shape=\"rect\">@Pfizer<\/a> and <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftwitter.com%2Fpfizer_news&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=%40Pfizer+News&amp;index=20&amp;md5=2989bd9380bb388dbcb6d687f3f568ed\" rel=\"nofollow noopener\" shape=\"rect\">@Pfizer News<\/a>, <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fpfizer&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=21&amp;md5=0ec2767c5b1a9ad81aebf52bab53d9e5\" rel=\"nofollow noopener\" shape=\"rect\">LinkedIn<\/a>, <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.youtube.com%2Fpfizer&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=YouTube&amp;index=22&amp;md5=61323500854def5a9a172eda80556e6a\" rel=\"nofollow noopener\" shape=\"rect\">YouTube<\/a> and like us on Facebook at <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.facebook.com%2FPfizer%2F&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=Facebook.com%2FPfizer&amp;index=23&amp;md5=97f441f0333b882224adf61f2b10f095\" rel=\"nofollow noopener\" shape=\"rect\">Facebook.com\/Pfizer<\/a>.\n<\/p>\n<p>\n<b>Pfizer Disclosure Notice<br \/>\n<br \/><\/b>The information contained in this release is as of September 12, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.\n<\/p>\n<p>\nThis release contains forward-looking information about Pfizer\u2019s efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including an Omicron-adapted bivalent vaccine candidate, based on the BA.4\/BA.5 subvariants, and an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 subvariant,\u00a0 including a submission pending with EMA for an Omicron-adapted bivalent vaccine candidate, based on the BA.4\/BA.5 subvariants, planned regulatory submissions, qualitative assessments of available data, potential benefits, expectations for clinical trials, potential regulatory submissions, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and\/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and\/or launch dates, as well as risks associated with preclinical and clinical data (including Phase 1\/2\/3 or Phase 4 data), including the data discussed in this release for BNT162b2, any monovalent, bivalent or variant-adapted vaccine candidates or any other vaccine candidate in the BNT162 program in any of our studies in pediatrics, adolescents, or adults or real world evidence, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies, in real world data studies or in larger, more diverse populations following commercialization; the ability of BNT162b2, any monovalent, bivalent or variant-adapted vaccine candidates or any future vaccine to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review\/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when submissions to request emergency use or conditional marketing authorizations for BNT162b2 in additional populations, for a potential booster dose for BNT162b2, any monovalent or bivalent vaccine candidates or any potential future vaccines (including potential future annual boosters or re-vaccination), and\/or other biologics license and\/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2, any monovalent or bivalent vaccine candidates or any other potential vaccines that may arise from the BNT162 program, including a potential variant-based, higher dose, or bivalent vaccine, and if obtained, whether or when such emergency use authorizations or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including any requested amendments to the emergency use or conditional marketing authorizations), any monovalent or bivalent vaccine candidates (including the submissions pending with the EMA for an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.4\/BA.5 subvariants, and an Omicron-adapted bivalent COVID-19 vaccine candidate, based on the BA.1 subvariant), or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine\u2019s benefits outweigh its known risks and determination of the vaccine\u2019s efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and\/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist which may lead to reduced revenues or excess inventory; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine\u2019s formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based or next generation vaccines; the risk that we may not be able to maintain or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; uncertainties regarding the impact of COVID-19 on Pfizer\u2019s business, operations and financial results; and competitive developments.\n<\/p>\n<p>\nA further description of risks and uncertainties can be found in Pfizer\u2019s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned \u201cRisk Factors\u201d and \u201c<!-- no quote -->Forward-Looking Information and Factors That May Affect Future Results\u201d, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DRnYjuX1qNnk63wnFRI2njqkWCUtSvj6x_99MqPLwYIXuudw4effilg2LyEquwqm-7QGJ6tM6dhKt8Yb6iY-5gw%3D%3D&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=www.sec.gov&amp;index=24&amp;md5=a7da6cd7a50546109fabe655e0d87f89\" rel=\"nofollow noopener\" shape=\"rect\">www.sec.gov<\/a> and <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DRnYjuX1qNnk63wnFRI2njhMtuWVC6S5kOg8JnuFHwPyIzH1O7AiSzrr-wECJd2hrMZ7668ALHee8mVEXVNXWFA%3D%3D&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=www.pfizer.com&amp;index=25&amp;md5=02753f6ab106976f7485c7610c38aacf\" rel=\"nofollow noopener\" shape=\"rect\">www.pfizer.com<\/a>.\n<\/p>\n<p>\n<b>About BioNTech<br \/>\n<br \/><\/b>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, bispecific immune checkpoint 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, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.BioNTech.com&amp;esheet=52881654&amp;newsitemid=20220909005519&amp;lan=en-US&amp;anchor=www.BioNTech.com&amp;index=26&amp;md5=dd7aee34a8a3799159d0d62d00475589\" rel=\"nofollow noopener\" shape=\"rect\">www.BioNTech.com<\/a>.\n<\/p>\n<p>\n<strong>BioNTech Forward-looking Statements<br \/>\n<br \/><\/strong>This press release contains \u201cforward-looking statements\u201d of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech\u2019s efforts to combat COVID-19; the collaboration between BioNTech and Pfizer including the program to develop a COVID-19 vaccine and COMIRNATY (COVID-19 vaccine, mRNA) (BNT162b2) (including an Omicron-adapted bivalent COVID-19 vaccine candidates based on the BA.1 and BA.4\/BA.5 subvariants, planned regulatory submissions, qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply); our expectations regarding the potential characteristics of BNT162b2, any monovalent or bivalent vaccine candidates or any future vaccine, in our clinical trials and\/or in commercial use based on data observations to date; the ability of BNT162b2, any monovalent or bivalent vaccine candidates or any future vaccine, to prevent COVID-19 caused by emerging virus variants; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and\/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and\/or launch dates, as well as risks associated with preclinical and clinical data (including Phase 1\/2\/3 or Phase 4 data), including the data discussed in this release for BNT162b2, any monovalent or bivalent vaccine candidates or any other vaccine candidate in BNT162 program in any of our studies in pediatrics, adolescents, or adults or real world evidence, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the expected time point for additional readouts on efficacy data of BNT162b2, any monovalent or bivalent vaccine candidates or any future vaccine, in our clinical trials; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; the ability of BioNTech to supply the quantities of BNT162, any monovalent or bivalent vaccine candidates or any future vaccine, to support clinical development and market demand, including our production estimates for 2022; that demand for any products may be reduced or no longer exist which may lead to reduced revenues or excess inventory; the availability of raw materials to manufacture a vaccine; our vaccine\u2019s formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the ability to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based vaccines; the ability to maintain or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; and uncertainties regarding the impact of COVID-19 on BioNTech\u2019s trials, business and general operations.<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Pfizer:<\/b><br \/>Media Relations<br \/>\n<br \/>+1 (212) 733-7410<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;&#x61;&#105;&#x6c;&#116;&#x6f;&#58;&#x50;&#102;&#x69;&#122;&#x65;&#114;&#x4d;&#101;&#x64;&#105;&#x61;&#82;&#x65;&#108;&#x61;&#116;&#x69;&#111;&#x6e;&#115;&#x40;&#112;&#x66;&#105;&#x7a;&#101;&#x72;&#46;&#x63;&#111;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">Pfi&#122;&#101;&#114;&#x4d;&#x65;&#x64;&#x69;&#x61;&#x52;ela&#116;&#105;&#111;&#110;&#x73;&#x40;&#x70;&#x66;&#x69;&#x7a;er&#46;&#99;&#111;&#109;<\/a>\n<\/p>\n<p>\nInvestor Relations<br \/>\n<br \/>+1 (212) 733-4848<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;a&#x69;l&#x74;o&#x3a;I&#x52;&#64;&#x70;&#102;&#x69;&#122;&#x65;&#114;&#46;&#99;o&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">IR&#64;p&#102;&#105;&#122;&#101;&#114;&#46;&#99;&#x6f;&#x6d;<\/a>\n<\/p>\n<p>\n<b>BioNTech:<\/b><br \/>Media Relations<br \/>\n<br \/>Jasmina Alatovic<br \/>\n<br \/>+49 (0)6131 9084 1513<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#97;i&#x6c;&#116;o&#x3a;&#x4d;&#101;&#x64;&#x69;&#97;&#64;&#x62;&#105;o&#x6e;&#x74;&#101;&#x63;&#x68;&#46;d&#x65;\" rel=\"nofollow noopener\" shape=\"rect\">&#77;&#x65;&#100;&#x69;a&#x40;b&#105;&#x6f;&#110;&#x74;e&#x63;h&#46;&#x64;&#101;<\/a>\n<\/p>\n<p>\nInvestor Relations<br \/>\n<br \/>Sylke Maas, Ph.D.<br \/>\n<br \/>+49 (0)6131 9084 1074<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;a&#x69;l&#x74;&#111;&#x3a;&#73;n&#x76;e&#x73;&#116;&#x6f;&#114;&#x73;&#64;b&#x69;o&#x6e;&#116;&#x65;&#99;&#x68;&#x2e;d&#x65;\" rel=\"nofollow noopener\" shape=\"rect\">&#73;&#x6e;&#x76;&#101;&#x73;&#x74;&#111;&#x72;&#x73;&#64;&#x62;&#x69;&#111;&#x6e;&#x74;&#101;&#x63;&#x68;&#46;&#x64;&#x65;<\/a>\n<\/p>\n<p> <a href=\"http:\/\/www.businesswire.com\/news\/home\/20220909005519\/en\/Pfizer-and-BioNTech-Receive-Positive-CHMP-Opinion-for-Omicron-BA.4BA.5-Adapted-Bivalent-COVID-19-Vaccine-Booster-in-European-Union\/?feedref=Zd8jjkgYuzBwDixoAdXmJgT1albrG1Eq4mAeVP392103_ypKzv-7ah0oHKWbnuHnevRMp3sIgu8q3wq1OF24lT93qbEzrwa15HGbLqMObxZM7XiMhduiSeKMTNDLRqI_doMC3CVAuyHo5cJ7XfDuvA==\"> Read full story here <\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>CHMP recommendation based on favorable data from Omicron-adapted vaccines The Omicron BA.4\/BA.5 bivalent COVID-19 booster vaccine combines 15-ug of mRNA encoding the wild-type spike protein of SARS-CoV-2 in the Original Pfizer-BioNTech COVID-19 Vaccines and 15-ug of mRNA encoding the spike protein of the Omicron BA.4\/BA.5 subvariants Pfizer-BioNTech bivalent Omicron BA.4\/BA.5 COVID-19 vaccine is available to &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/pfizer-and-biontech-receive-positive-chmp-opinion-for-omicron-ba-4-ba-5-adapted-bivalent-covid-19-vaccine-booster-in-european-union\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-48262","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron BA.4\/BA.5-Adapted Bivalent COVID-19 Vaccine Booster in European Union - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/pfizer-and-biontech-receive-positive-chmp-opinion-for-omicron-ba-4-ba-5-adapted-bivalent-covid-19-vaccine-booster-in-european-union\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron BA.4\/BA.5-Adapted Bivalent COVID-19 Vaccine Booster in European Union - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"CHMP recommendation based on favorable data from Omicron-adapted vaccines The Omicron BA.4\/BA.5 bivalent COVID-19 booster vaccine combines 15-ug of mRNA encoding the wild-type spike protein of SARS-CoV-2 in the Original Pfizer-BioNTech COVID-19 Vaccines and 15-ug of mRNA encoding the spike protein of the Omicron BA.4\/BA.5 subvariants Pfizer-BioNTech bivalent Omicron BA.4\/BA.5 COVID-19 vaccine is available to ... 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