Mary Wilson
Well-known member
January 25, 2023
DOI: 10.1056/NEJMc2214916
TO THE EDITOR:
Since its emergence in November 2021, the B.1.1.529 (omicron) variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has continued to evolve into sublineages.[SUP]1[/SUP] To mitigate the omicron pandemic, in late August and early September 2022, the Food and Drug Administration and the European Medicines Agency authorized emergency use of the BNT162b2 bivalent vaccine (Pfizer–BioNTech) that targets both the omicron BA.4–BA.5 spike (BA.4 and BA.5 encode an identical spike protein) and the ancestral wild-type (D614G) spike of SARS-CoV-2. The vaccine was subsequently authorized for use in many countries worldwide.
New omicron sublineages, including those that have descended from BA.2 and BA.4–BA.5, have emerged. These sublineages include BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1. Although early epidemiologic data suggest these new sublineages have not led to increased disease severity, they have accumulated additional spike mutations that could further evade vaccine-elicited antibody neutralization, infection-elicited antibody neutralization, or both.[SUP]2-4[/SUP] Here, we compare the neutralization activity against these omicron sublineages in persons who had received three doses of BNT162b2 vaccine and then received a fourth dose of either the original BNT162b2 vaccine or the bivalent BA.4–BA.5 booster.
Participants were older than 55 years of age and had received three 30-μg doses of BNT162b2 vaccine and either a fourth monovalent booster dose of BNT162b2 vaccine (30 μg) approximately 6.6 months after the third dose (in the C4591031 clinical trial[SUP]5[/SUP]) or the bivalent vaccine (15 μg of messenger RNA [mRNA] directed against the ancestral strain of SARS-CoV-2 and 15 μg of mRNA directed against BA.4–BA.5) approximately 11 months after the third dose (in the C4591044 clinical trial; ClinicalTrials.gov number, NCT05472038. opens in new tab). The protocols are available with the full text of this letter at NEJM.org. All the participants provided written informed consent.
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Protocol
Protocol for: 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. DOI: 10.1056/NEJMc2214916
This trial protocol has been provided by the authors to give readers additional information about the work.
https://www.nejm.org/doi/suppl/10.10...6_protocol.pdf
DOI: 10.1056/NEJMc2214916
TO THE EDITOR:
Since its emergence in November 2021, the B.1.1.529 (omicron) variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has continued to evolve into sublineages.[SUP]1[/SUP] To mitigate the omicron pandemic, in late August and early September 2022, the Food and Drug Administration and the European Medicines Agency authorized emergency use of the BNT162b2 bivalent vaccine (Pfizer–BioNTech) that targets both the omicron BA.4–BA.5 spike (BA.4 and BA.5 encode an identical spike protein) and the ancestral wild-type (D614G) spike of SARS-CoV-2. The vaccine was subsequently authorized for use in many countries worldwide.
New omicron sublineages, including those that have descended from BA.2 and BA.4–BA.5, have emerged. These sublineages include BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1. Although early epidemiologic data suggest these new sublineages have not led to increased disease severity, they have accumulated additional spike mutations that could further evade vaccine-elicited antibody neutralization, infection-elicited antibody neutralization, or both.[SUP]2-4[/SUP] Here, we compare the neutralization activity against these omicron sublineages in persons who had received three doses of BNT162b2 vaccine and then received a fourth dose of either the original BNT162b2 vaccine or the bivalent BA.4–BA.5 booster.
Participants were older than 55 years of age and had received three 30-μg doses of BNT162b2 vaccine and either a fourth monovalent booster dose of BNT162b2 vaccine (30 μg) approximately 6.6 months after the third dose (in the C4591031 clinical trial[SUP]5[/SUP]) or the bivalent vaccine (15 μg of messenger RNA [mRNA] directed against the ancestral strain of SARS-CoV-2 and 15 μg of mRNA directed against BA.4–BA.5) approximately 11 months after the third dose (in the C4591044 clinical trial; ClinicalTrials.gov number, NCT05472038. opens in new tab). The protocols are available with the full text of this letter at NEJM.org. All the participants provided written informed consent.
__________________________________________________ __
Protocol
Protocol for: 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. DOI: 10.1056/NEJMc2214916
This trial protocol has been provided by the authors to give readers additional information about the work.
https://www.nejm.org/doi/suppl/10.10...6_protocol.pdf
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