Clinical development of variant-adapted BNT162b2 COVID-19 vaccines: the early Omicron era

References

• World Health Organization. Tracking SARS-CoV-2 variants 2023 [updated 26 January 2023; cited 2023 03 February]. Available from: https://www.who.int/en/activities/tracking-SARS-CoV-2-variants/
   Google Scholar
• McLean G, Kamil J, Lee B, et al. The impact of evolving SARS-CoV-2 mutations and variants on COVID-19 vaccines. MBio. 2022 Apr 26;13(2):e0297921. doi: 10.1128/mbio.02979-21
   PubMed Web of Science ®Google Scholar
• Viana R, Moyo S, Amoako DG, et al. Rapid epidemic expansion of the SARS-CoV-2 Omicron variant in southern Africa. Nature. 2022;603(7902):679–686. doi: 10.1038/s41586-022-04411-y
   PubMed Web of Science ®Google Scholar
• Kandeel M, Mohamed MEM, Abd El-Lateef HM, et al. Omicron variant genome evolution and phylogenetics. J Med Virol. 2022 Apr;94(4):1627–1632.
   PubMed Web of Science ®Google Scholar
• Martin DP, Lytras S, Lucaci AG, et al. Selection analysis identifies clusters of unusual mutational changes in Omicron lineage BA.1 that likely impact spike function. Mol Biol Evol. 2022 Apr 11;39(4):msac061. doi: 10.1093/molbev/msac061
   PubMed Web of Science ®Google Scholar
• Nishiura H, Ito K, Anzai A, et al. Relative reproduction number of SARS-CoV-2 Omicron (B.1.1.529) compared with Delta variant in South Africa. J Clin Med. 2021;11(1):30. doi: 10.3390/jcm11010030
   PubMed Web of Science ®Google Scholar
• Suzuki R, Yamasoba D, Kimura I, et al. Attenuated fusogenicity and pathogenicity of SARS-CoV-2 Omicron variant. Nature. 2022;603(7902):700–705. doi: 10.1038/s41586-022-04462-1
   PubMed Web of Science ®Google Scholar
• Muik A, Lui BG, Wallisch AK, et al. Neutralization of SARS-CoV-2 Omicron by BNT162b2 mRNA vaccine-elicited human sera. Science. 2022 Feb 11;375(6581):678–680. doi: 10.1126/science.abn7591
   PubMed Web of Science ®Google Scholar
• World Health Organization. Weekly epidemiological update on COVID-19 - 18 May 2023 2023. cited 2023 22 May Available from. https://www.who.int/publications/m/item/weekly-epidemiological-update-on-covid-19—18-may-2023
   Google Scholar
• Tamura T, Ito J, Uriu K, et al. Virological characteristics of the SARS-CoV-2 XBB variant derived from recombination of two Omicron subvariants. bioRxiv. 2022;2022.
   Google Scholar
• World Health Organization. Weekly epidemiological update on COVID-19 - 11 January 2023 2023. updated 16 Jan 2023 Available from. https://www.who.int/publications/m/item/weekly-epidemiological-update-on-covid-19—11-january-2023
   Google Scholar
• Mykytyn AZ, Rissmann M, Kok A, et al. Antigenic cartography of SARS-CoV-2 reveals that Omicron BA.1 and BA.2 are antigenically distinct. Sci Immunol. 2022 Sep 23;7(75):eabq4450. doi: 10.1126/sciimmunol.abq4450
   PubMed Web of Science ®Google Scholar
• CoVariants. CoVariants 2022 [cited 2022 10 Aug]. Available from: https://covariants.org/
   Google Scholar
• Wang Q, Guo Y, Iketani S, et al. Antibody evasion by SARS-CoV-2 Omicron subvariants BA.2.12.1, BA.4 and BA.5. Nature. 2022 Aug;608(7923):603–608.
   PubMed Web of Science ®Google Scholar
• Qu P, Faraone JN, Evans JP, et al. Differential evasion of delta and omicron immunity and enhanced fusogenicity of SARS-CoV-2 omicron BA.4/5 and BA.2.12.1 subvariants. bioRxiv. 2022;2022.
   Google Scholar
• Kimura I, Yamasoba D, Tamura T, et al. Virological characteristics of the SARS-CoV-2 Omicron BA.2 subvariants, including BA.4 and BA.5. Cell. 2022 Oct 13;185(21):3992–4007 e16. doi: 10.1016/j.cell.2022.09.018
   PubMed Web of Science ®Google Scholar
• Tegally H, Moir M, Everatt J, et al. Emergence of SARS-CoV-2 Omicron lineages BA.4 and BA.5 in South Africa. Nat Med. 2022 Sep;28(9):1785–1790.
   PubMed Web of Science ®Google Scholar
• Wolter N, Jassat W, Walaza S, et al. Clinical severity of SARS-CoV-2 Omicron BA.4 and BA.5 lineages compared to BA.1 and Delta in South Africa. Nat Commun. 2022 Oct 4;13(1):5860. doi: 10.1038/s41467-022-33614-0
   PubMed Web of Science ®Google Scholar
• Quandt J, Muik A, Salisch N, et al. Omicron BA.1 breakthrough infection drives cross-variant neutralization and memory B cell formation against conserved epitopes. Sci Immunol. 2022 Sep 16;7(75):eabq2427. doi: 10.1126/sciimmunol.abq2427
   PubMed Web of Science ®Google Scholar
• Kurhade C, Zou J, Xia H, et al. Neutralization of Omicron sublineages and Deltacron SARS-CoV-2 by three doses of BNT162b2 vaccine or BA.1 infection. Emerg Microbes Infect. 2022 Dec;11(1):1828–1832.
   PubMed Web of Science ®Google Scholar
• World Health Organization. TAG-VE statement on Omicron sublineages BQ.1 and XBB 2022 [updated 1 Dec 2022]. Available from: https://www.who.int/news/item/27-10-2022-tag-ve-statement-on-omicron-sublineages-bq.1-and-xbb
   Google Scholar
• Qu P, Evans JP, Faraone JN, et al. Enhanced neutralization resistance of SARS-CoV-2 Omicron subvariants BQ.1, BQ.1.1, BA.4.6, BF.7, and BA.2.75.2. Cell Host Microbe. 2022 Nov 22;31(1):9–17.e3. doi: 10.1016/j.chom.2022.11.012
   PubMed Web of Science ®Google Scholar
• Jiang N, Wang L, Hatta M, et al. Bivalent mRNA vaccine improves antibody-mediated neutralization of many SARS-CoV-2 Omicron lineage variants. bioRxiv. 2023:2023.01.08.523127.
   Google Scholar
• Kurhade C, Zou J, Xia H, et al. Low neutralization of SARS-CoV-2 Omicron BA.2.75.2, BQ.1.1 and XBB.1 by parental mRNA vaccine or a BA.5 bivalent booster. Nat Med. 2023 Feb;29(2):344–347.
   PubMedGoogle Scholar
• Andrews N, Stowe J, Kirsebom F, et al. Covid-19 vaccine effectiveness against the omicron (B.1.1.529) variant. N Engl J Med. 2022 Apr 21;386(16):1532–1546. doi: 10.1056/NEJMoa2119451
   PubMed Web of Science ®Google Scholar
• Richterman A, Behrman A, Brennan PJ, et al. Durability of severe acute respiratory syndrome coronavirus 2 messenger RNA booster vaccine protection against omicron among healthcare workers with a vaccine mandate. Clin Infect Dis. 2023 Feb 8;76(3):e319–e326. doi: 10.1093/cid/ciac454
   PubMedGoogle Scholar
• Chemaitelly H, Ayoub HH, AlMukdad S, et al. Duration of mRNA vaccine protection against SARS-CoV-2 Omicron BA.1 and BA.2 subvariants in Qatar. Nat Commun. 2022 Jun 2;13(1):3082. doi: 10.1038/s41467-022-30895-3
   PubMed Web of Science ®Google Scholar
• Lauring AS, Tenforde MW, Chappell JD, et al. Clinical severity of, and effectiveness of mRNA vaccines against, COVID-19 from omicron, delta, and alpha SARS-CoV-2 variants in the United States: prospective observational study. BMJ. 2022 Mar 9;376:e069761. doi: 10.1136/bmj-2021-069761
   PubMedGoogle Scholar
• Collie S, Nayager J, Bamford L, et al. Effectiveness and durability of the BNT162b2 vaccine against Omicron sublineages in South Africa. N Engl J Med. 2022 Oct 6;387(14):1332–1333. doi: 10.1056/NEJMc2210093
   PubMed Web of Science ®Google Scholar
• Stowe J, Andrews N, Kirsebom F, et al. Effectiveness of COVID-19 vaccines against Omicron and Delta hospitalisation, a test negative case-control study. Nat Commun. 2022 Sep 30;13(1):5736. doi: 10.1038/s41467-022-33378-7
   PubMed Web of Science ®Google Scholar
• Adams K, Rhoads JP, Surie D, et al. Vaccine effectiveness of primary series and booster doses against COVID-19 associated hospital admissions in the United States: living test negative design study. BMJ. 2022 Oct 11;379:e072065. doi: 10.1136/bmj-2022-072065
   PubMedGoogle Scholar
• World Health Organization. Interim statement on the composition of current COVID-19 vaccines 2022 [updated 12 Jul 2022; cited 2022 12 Jul]. Available from: https://www.who.int/news/item/17-06-2022-interim-statement-on–the-composition-of-current-COVID-19-vaccines
   Google Scholar
• Wang Q, Iketani S, Li Z, et al. Alarming antibody evasion properties of rising SARS-CoV-2 BQ and XBB subvariants. Cell. 2023 Jan 19;186(2):279–286 e8. doi: 10.1016/j.cell.2022.12.018
   PubMed Web of Science ®Google Scholar
• Kaku CI, Bergeron AJ, Ahlm C, et al. Recall of preexisting cross-reactive B cell memory after Omicron BA.1 breakthrough infection. Sci Immunol. 2022 Jul 29;7(73):eabq3511. doi: 10.1126/sciimmunol.abq3511
   PubMed Web of Science ®Google Scholar
• Richardson SI, Motlou T, van der Mescht MA, et al. SARS-CoV-2 BA.4 infection triggers more cross-reactive neutralizing antibodies than BA.1. bioRxiv. 2022;2022.07.14.500039.
   Google Scholar
• Muik A, Lui BG, Bacher M, et al. Exposure to BA.4/5 S protein drives neutralization of Omicron BA.1, BA.2, BA.2.12.1, and BA.4/5 in vaccine-experienced humans and mice. Sci Immunol. 2022 Dec 23;7(78):eade9888. doi: 10.1126/sciimmunol.ade9888
   PubMed Web of Science ®Google Scholar
• Pillai S. SARS-CoV-2 vaccination washes away original antigenic sin. Trends Immunol. 2022 Apr;43(4):271–273. doi: 10.1016/j.it.2022.02.009
   PubMed Web of Science ®Google Scholar
• Roltgen K, Nielsen SCA, Silva O, et al. Immune imprinting, breadth of variant recognition, and germinal center response in human SARS-CoV-2 infection and vaccination. Cell. 2022 Mar 17;185(6):1025–1040 e14. doi: 10.1016/j.cell.2022.01.018
   PubMed Web of Science ®Google Scholar
• Vardhana S, Baldo L, Morice WG 2nd, et al. Understanding T cell responses to COVID-19 is essential for informing public health strategies. Sci Immunol. 2022 May 20;7(71):eabo1303. doi: 10.1126/sciimmunol.abo1303
   PubMed Web of Science ®Google Scholar
• Tang J, Zeng C, Cox TM, et al. Respiratory mucosal immunity against SARS-CoV-2 after mRNA vaccination. Sci Immunol. 2022 Oct 28;7(76):eadd4853. doi: 10.1126/sciimmunol.add4853
   PubMed Web of Science ®Google Scholar
• Clinicaltrials.gov. To evaluate the safety, tolerability, efficacy and immunogenicity of BNT162b2 boosting strategies against COVID-19 in participants ≥12 years of age 2022 [updated 2022; cited 2022 3 Oct]. Available from: https://clinicaltrials.gov/ct2/show/NCT04955626
   Google Scholar
• Pfizer, BioNTech. Pfizer/BioNTech COVID-19 Omicron-Modified Vaccine Options 2022 [ cited 03 Oct 2022; Available from: https://www.fda.gov/media/159496/download
   Google Scholar
• Clinicaltrials.gov. A study to learn about new COVID-19 RNA vaccine candidates as a booster dose in COVID-19 vaccine-experienced healthy individuals 2022. [cit 2022 3 Oct]. Available from: https://clinicaltrials.gov/ct2/show/NCT05472038
   Google Scholar
• Muik A, Lui BG, Bacher M, et al. Omicron BA.2 breakthrough infection enhances cross-neutralization of BA.2.12.1 and BA.4/BA.5. Sci Immunol. 2022 Nov 25;7(77):eade2283. doi: 10.1126/sciimmunol.ade2283
   PubMed Web of Science ®Google Scholar
• U.S. Food and Drug Administration. Coronavirus (COVID-19) update: FDA recommends inclusion of Omicron BA.4/5 component for COVID-19 vaccine booster doses 2022 [updated 12 Jul 2022; cited 2022 12 Jul]. Available from: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-recommends-inclusion-omicron-ba45-component-covid-19-vaccine-booster
   Google Scholar
• International Coalition of Medicines Regulatory Authorities. International Coalition of Medicines Regulatory Authorities SARS-CoV-2 Variant Workshop 2022 [updated 1 Dec 2022]. Available from: https://icmra.info/drupal/en/covid-19/30june2022
   Google Scholar
• U.S. Food and Drug Administration. Emergency use authorization for vaccines to prevent COVID-19: guidance for industry 2022 [cited 2022 12 Jul]. Available from: https://www.fda.gov/media/142749/download
   Google Scholar
• European Medicines Agency. Reflection paper on the regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2 2021 [updated 9 Feb 2023; cited 2021 23 Feb]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-regulatory-requirements-vaccines-intended-provide-protection-against-variant_en.pdf
   Google Scholar
• Winokur P, Gayed J, Fitz-Patrick D, et al. Bivalent Omicron BA.1-Adapted BNT162b2 Booster in Adults Older than 55 Years. N Engl J Med. 2023 Jan 19;388(3):214–227. doi: 10.1056/NEJMoa2213082
   PubMed Web of Science ®Google Scholar
• Barda N, Lustig Y, Indenbaum V, et al. Immunogenicity of Omicron BA.1-adapted BNT162b2 vaccines: randomized trial, 3-month follow-up. Clin Microbiol Infect. 2023 Mar 13;29(7):918–923. doi: 10.1016/j.cmi.2023.03.007
   PubMed Web of Science ®Google Scholar
• BioNTech. Pfizer and BioNTech Announce Updated Clinical Data for Omicron BA.4/BA.5-Adapted Bivalent Booster Demonstrating Substantially Higher Immune Response in Adults Compared to the Original COVID-19 Vaccine 2022 [updated 1 Dec 2022; cited 2023 29 Mar]. Available from: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-updated-clinical-data-omicron
   Google Scholar
• Zou J, Kurhade C, Patel S, et al. Neutralization of BA.4-BA.5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent Vaccine. N Engl J Med. 2023 Mar 2;388(9):854–857. doi: 10.1056/NEJMc2214916
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Comirnaty COVID-19 vaccine. Summary of product characteristics 2022 [cited 2022 Sep 7]. Available from: https://www.ema.europa.eu/en/documents/product-information/comirnaty-epar-product-information_en.pdf
   Google Scholar
• European Medicines Agency. Start of rolling review for adapted Comirnaty COVID-19 vaccine 2022 [updated 26 September 2022; cited 2022 15 June]. Available from: https://www.ema.europa.eu/en/news/start-rolling-review-adapted-comirnaty-covid-19-vaccine
   Google Scholar
• European Medicines Agency. Start of rolling review for adapted Spikevax COVID-19 vaccine 2022 [updated 26 Sep 2022; cited 2022 17 Jun]. Available from: https://www.ema.europa.eu/en/news/start-rolling-review-adapted-spikevax-covid-19-vaccine
   Google Scholar
• European Medicines Agency. Procedural guidance for variant strain(s) update to vaccines intended for protection against Human coronavirus 2022 [updated 9 Feb 2023]. Available from: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedural-guidance-variant-strains-update-vaccines-intended-protection-against-human-coronavirus_en.pdf
   Google Scholar
• European Medicines Agency. Global regulators agree on key principles on adapting vaccines to tackle virus variants 2022 [updated 12 Jul 2022]. Available from: https://www.ema.europa.eu/en/news/global-regulators-agree-key-principles-adapting-vaccines-tackle-virus-variants
   Google Scholar
• U.S. Centers for Disease Control and Prevention. CDC Fall Vaccination Operational Planning Guide – Information for the Fall Vaccine Campaign, Including Upcoming Bivalent COVID-19 Vaccine Booster Doses 2022 [updated 30 Aug 2022; cited 2022 16 Aug]. Available from: https://www.cdc.gov/vaccines/covid-19/downloads/CDC-Fall-Vaccination-Operational-Planning-Guide.pdf
   Google Scholar
• World Health Organization. Interim statement on decision-making considerations for the use of variant updated COVID-19 vaccines 2022 [updated 05 October 2022; cited 2022 5 October]. Available from: https://www.who.int/news/item/17-06-2022-interim-statement-on-decision-making-considerations-for-the-use-of-variant-updated-covid-19-vaccines
   Google Scholar
• World Health Organization. Interim Statement on COVID-19 vaccines in the context of the circulation of the Omicron SARS-CoV-2 Variant from the WHO Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) 2022 [updated 14 Jan 2022]. Available from: https://www.who.int/news/item/11-01-2022-interim-statement-on-covid-19-vaccines-in-the-context-of-the-circulation-of-the-omicron-sars-cov-2-variant-from-the-who-technical-advisory-group-on-covid-19-vaccine-composition
   Google Scholar
• BioNTech. Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron BA.1-Adapted Bivalent COVID-19 Vaccine Booster in European Union 2022 [cited 2022 3 October]. Available from: https://investors.biontech.de/news-releases/news-release-details/pfizer-and-biontech-receive-positive-chmp-opinion-omicron-ba1
   Google Scholar
• European Centre for Disease Prevention and Control, European Medicines Agency. ECDC-EMA statement on booster vaccination with Omicron adapted bivalent COVID-19 vaccines 2022 [updated 05 October 2022; cited 2022 5 October]. Available from: https://www.ema.europa.eu/en/documents/public-statement/ecdc-ema-statement-booster-vaccination-omicron-adapted-bivalent-covid-19-vaccines_-0.pdf
   Google Scholar
• Medicines and Healthcare products Regulatory Agency. Decision: regulatory approval of Pfizer/BioNTech bivalent Original/Omicron booster vaccine 2022 [cited 2022 5 Oct]. Available from: https://www.gov.uk/government/publications/regulatory-approval-of-pfizerbiontech-bivalent-originalomicron-booster-vaccine
   Google Scholar
• BioNTech. Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine 2022 [Updated 05 October 2022]. Available from: https://investors.biontech.de/news-releases/news-release-details/pfizer-and-biontech-submit-application-us-fda-emergency-use
   Google Scholar
• U.S. Food and Drug Administration. Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose 2022 [updated 26 September 2022; cited 2022 26 September]. Available from: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use
   Google Scholar
• BioNTech. Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster in Children 5 Through 11 Years of Age 2022 [updated 2 Dec 2022]. Available from: https://investors.biontech.de/news-releases/news-release-details/pfizer-and-biontech-receive-us-fda-emergency-use-authorization-1
   Google Scholar
• U.S. Food & Drug Administration. Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups 2022 [cited 2022 12 Jul]. Available from: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-bivalent-covid-19-vaccines
   Google Scholar
• BioNTech. Pfizer and BioNTech Complete Submission to European Medicines Agency for Omicron BA.4/BA.5 Adapted Bivalent Vaccine 2022 [updated 5 Oct 2022]. Available from: https://investors.biontech.de/news-releases/news-release-details/pfizer-and-biontech-complete-submission-european-medicines-0
   Google Scholar
• European Medicines Agency. Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11 2021 [3 Sep 2022]. Available from: https://www.ema.europa.eu/en/news/comirnaty-covid-19-vaccine-ema-recommends-approval-children-aged-5-11
   Google Scholar
• European Medicines Agency. Comirnaty 2022 [updated 8 Nov 2022; cited 2022 8 Nov]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty
   Google Scholar
• U.S. Food and Drug Administration. Coronavirus (COVID-19) Update: FDA Authorizes Bivalent Pfizer-BioNTech COVID-19 Vaccine as Booster Dose for Certain Children 6 Months through 4 Years of Age2023 [cited. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-bivalent-pfizer-biontech-covid-19-vaccine-booster-dose
   Google Scholar
• U.S. Food and Drug Administration. Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals 2023 cited. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-second-booster-dose-two-covid-19-vaccines-older-and
   Google Scholar
• World Health Organization. SAGE updates COVID-19 vaccination guidance 2023 cited. https://www.who.int/news/item/28-03-2023-sage-updates-covid-19-vaccination-guidance
   Google Scholar
• European Medicines Agency. ETF statement on the use of the EMA approved bivalent original/Omicron BA.4-5 mRNA vaccines for primary series 2022 [cited 2022 7 Dec]. Available from: https://www.ema.europa.eu/en/documents/other/etf-statement-use-ema-approved-bivalent-original/omicron-ba4-5-mrna-vaccines-primary-series_en.pdf
   Google Scholar
• U.S. Food and Drug Administration. Coronavirus (COVID-19) Update: FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines 2023 cited. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-changes-simplify-use-bivalent-mrna-covid-19-vaccines
   Google Scholar
• World Health Organization. Statement on the antigen composition of COVID-19 vaccines 2023 cited. https://www.who.int/news/item/18-05-2023-statement-on-the-antigen-composition-of-covid-19-vaccines
   Google Scholar
• U.S. Centers for Disease Control and Prevention. Rates of COVID-19 Cases and Deaths by Vaccination Status 2023 cited. https://covid.cdc.gov/covid-data-tracker/#rates-by-vaccine-status
   Google Scholar
• Lin DY, Xu Y, Gu Y, et al. Durability of Bivalent Boosters against Omicron Subvariants. N Engl J Med. 2023 Apr 12;388(19):1818–1820. doi: 10.1056/NEJMc2302462
   PubMed Web of Science ®Google Scholar
• Poukka E, Goebeler S, Nohynek H, et al. Bivalent booster effectiveness against severe COVID-19 outcomes in Finland, September 2022 — January 2023. medRxiv. 2023;2023.
   Google Scholar
• Arbel R, Peretz A, Sergienko R, et al. Effectiveness of a bivalent mRNA vaccine booster dose to prevent severe COVID-19 outcomes: a retrospective cohort study. Lancet Infect Dis. 2023 Apr 13. doi: 10.1016/S1473-3099(23)00122-6
   Web of Science ®Google Scholar
• Uraki R, Ito M, Kiso M, et al. Antiviral and bivalent vaccine efficacy against an omicron XBB.1.5 isolate. Lancet Infect Dis. 2023 Feb 8;23(4):402–403. doi: 10.1016/S1473-3099(23)00070-1
   PubMedGoogle Scholar
• Uraki R, Ito M, Kiso M, et al. Efficacy of antivirals and bivalent mRNA vaccines against SARS-CoV-2 isolate CH.1.1. Lancet Infect Dis. 2023 Mar 7;23(5):525–526. doi: 10.1016/S1473-3099(23)00132-9
   PubMed Web of Science ®Google Scholar
• Branche AR, Rouphael NG, Losada C, et al. Immunogenicity of the BA.1 and BA.4/BA.5 SARS-CoV-2 Bivalent Boosts: Preliminary Results from the COVAIL Randomized Clinical Trial. Clin Infect Dis. 2023 Apr 10. doi: 10.1093/cid/ciad209
   Web of Science ®Google Scholar
• Traut CC, Blankson JN. Bivalent mRNA vaccine-elicited SARS-CoV-2 specific T cells recognise the omicron XBB sublineage. Lancet Microbe. 2023 Mar 24;4(6):e388. doi: 10.1016/S2666-5247(23)00105-2
   PubMedGoogle Scholar
• Link-Gelles R, Ciesla AA, Roper LE, et al. Early Estimates of Bivalent mRNA Booster Dose Vaccine Effectiveness in Preventing Symptomatic SARS-CoV-2 Infection Attributable to Omicron BA.5- and XBB/XBB.1.5-Related Sublineages Among Immunocompetent Adults - Increasing Community Access to Testing Program, United States, December 2022-January 2023. MMWR Morb Mortal Wkly Rep. 2023 Feb 3;72(5):119–124. doi: 10.15585/mmwr.mm7205e1
   PubMed Web of Science ®Google Scholar
• Andersson NW, Thiesson EM, Baum U, et al. Comparative effectiveness of the bivalent BA.4-5 and BA.1 mRNA-booster vaccines in the Nordic countries. medRxiv. 2023;2023.
   Google Scholar
• Surie D, DeCuir J, Zhu Y, et al. Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID-19-Associated Hospitalization Among Immunocompetent Adults Aged >/=65 Years - IVY Network, 18 States, September 8-November 30, 2022. MMWR Morb Mortal Wkly Rep. 2022 Dec 30;71(5152):1625–1630. doi: 10.15585/mmwr.mm715152e2
   PubMedGoogle Scholar
• Tenforde MW, Weber ZA, Natarajan K, et al. Early Estimates of Bivalent mRNA Vaccine Effectiveness in Preventing COVID-19-Associated Emergency Department or Urgent Care Encounters and Hospitalizations Among Immunocompetent Adults - VISION Network, Nine States, September-November 2022. MMWR Morb Mortal Wkly Rep. 2023 Mar 17;71(53):1637–1646. doi: 10.15585/mmwr.mm7153a1
   PubMedGoogle Scholar
• Fabiani M, Mateo-Urdiales A, Sacco C, et al. Protection against severe COVID-19 after second booster dose of adapted bivalent (original/Omicron BA.4-5) mRNA vaccine in persons >/= 60 years, by time since infection, Italy, 12 September to 11 December 2022. Euro Surveill. 2023 Feb;28(8). doi: 10.2807/1560-7917.ES.2023.28.8.2300105
   PubMedGoogle Scholar
• Lin DY, Xu Y, Gu Y, et al. Effectiveness of Bivalent Boosters against Severe Omicron Infection. N Engl J Med. 2023 Feb 23;388(8):764–766. doi: 10.1056/NEJMc2215471
   PubMed Web of Science ®Google Scholar
• Stirrup O, Shrotri M, Adams NL, et al. Effectiveness of successive booster vaccine doses against SARS-CoV-2 related mortality in residents of Long-Term Care Facilities in the VIVALDI study. medRxiv. 2023;2023.
   Google Scholar
• Chatzilena A, Hyams C, Challen R, et al. Relative vaccine effectiveness (rVE) of mRNA COVID-19 boosters in the UK vaccination programme, during the Spring-Summer (monovalent vaccine) and Autumn-Winter 2022 (bivalent vaccine) booster campaigns: a prospective test negative case-control study. medRxiv. 2023;2023.
   Google Scholar
• Britton A. COVID-19 vaccine effectiveness updates 2023 [Cited. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2023-02/slides-02-24/COVID-07-Britton-508.pdf
   Google Scholar
• Kalinke U, Barouch DH, Rizzi R, et al. Clinical development and approval of COVID-19 vaccines. Expert Rev Vaccines. 2022 May;21(5):609–619.
   PubMed Web of Science ®Google Scholar
• Vaccines and Related Biological Products Advisory Committee. Vaccines and Related Biological Products Advisory Committee Meeting January 26, 2023. [updated 16 Feb 2023; cited 2023 29 Mar]. Available from: https://www.fda.gov/media/165307/download
   Google Scholar
• Reuters. EU regulator expects eventually to introduce annual COVID shots 2023 [updated 6 Mar 2023; cited 2023 29 Mar]. Available from: https://www.reuters.com/world/europe/eu-drugs-regulator-expects-implement-annual-covid-shots-2023-02-15/
   Google Scholar
• BioNTech. Pfizer and BioNTech continue to advance COVID-19 vaccine strategy: new clinical trial started with next-generation vaccine candidates with improved spike protein design 2022 [cited 2022 5 Oct]. Available from: https://investors.biontech.de/de/news-releases/news-release-details/pfizer-und-biontech-treiben-covid-19-impfstoffstrategie-weiter
   Google Scholar
• World Health Organization. Advancing the development of pan-sarbecovirus vaccines - Next steps 2022 [updated 1 Dec 2022]. Available from: https://www.who.int/publications/m/item/advancing-the-development-of-pan-sarbecovirus-vaccines—next-steps
   Google Scholar
• Zhou J, Liu Z, Zhang G, et al. Development of variant-proof severe acute respiratory syndrome coronavirus 2, pan-sarbecovirus, and pan-beta-coronavirus vaccines. J Med Virol. 2023 Jan;95(1):e28172. doi: 10.1002/jmv.28172.
   PubMed Web of Science ®Google Scholar
• BioNTech. Pfizer and BioNTech Advance Next-Generation COVID-19 Vaccine Strategy with Study Start of Candidate Aimed at Enhancing Breadth of T cell Responses and Duration of Protection 2022 [updated 2 Dec 2022; cited 2023 29 Mar]. Available from: https://investors.biontech.de/news-releases/news-release-details/pfizer-and-biontech-advance-next-generation-covid-19-vaccine
   Google Scholar