PMID- 37244809
OWN - NLM
STAT- MEDLINE
DCOM- 20230621
LR  - 20230624
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Print)
IS  - 0264-410X (Linking)
VI  - 41
IP  - 28
DP  - 2023 Jun 23
TI  - Randomized trial to evaluate the safety, tolerability, and immunogenicity of a 
      booster (third dose) of BNT162b2 COVID-19 vaccine coadministered with 20-valent 
      pneumococcal conjugate vaccine in adults >/=65 years old.
PG  - 4190-4198
LID - S0264-410X(23)00520-0 [pii]
LID - 10.1016/j.vaccine.2023.05.002 [doi]
AB  - BACKGROUND: Older adults are at increased risk of adverse outcomes from 
      pneumococcal disease and COVID-19. Vaccination is an established strategy for 
      preventing both illnesses. This study evaluated the safety and immunogenicity of 
      coadministration of the 20-valent pneumococcal conjugate vaccine (PCV20) and a 
      booster (third dose) of BNT162b2 COVID-19 vaccine. METHODS: This phase 3, 
      randomized, double-blind, multicentre study included 570 participants 
      aged >/=65 years randomized 1:1:1 to PCV20 and BNT162b2 coadministered, or PCV20 or 
      BNT162b2 only (administered with saline for blinding). Primary safety endpoints 
      included local reactions, systemic events, adverse events (AEs) and serious AEs 
      (SAEs). Secondary objectives were immunogenicity of PCV20 and BNT162b2 when 
      administered together or separately. RESULTS: Coadministration of PCV20 and 
      BNT162b2 was well tolerated. Local reactions and systemic events were generally 
      mild-moderate; injection-site pain and fatigue were the most frequent local and 
      systemic events, respectively. AE and SAE rates were low and similar across 
      groups. No AEs led to discontinuation; no SAEs were considered 
      vaccination-related. Robust immune responses were observed, with opsonophagocytic 
      activity geometric mean fold rises (GMFRs; from baseline to 1 month) of 2.5-24.5 
      and 2.3-30.6 across PCV20 serotypes in Coadministration and PCV20-only groups, 
      respectively. GMFRs for full-length S-binding IgG of 35.5 and 39.0, and for 
      neutralizing titres against SARS-CoV-2-wild type virus of 58.8 and 65.4, were 
      observed in the Coadministration and BNT162b2-only groups, respectively. 
      CONCLUSIONS: Safety and immunogenicity of coadministered PCV20 and BNT162b2 were 
      similar to those of PCV20 or BNT162b2 administered alone, suggesting that the 2 
      vaccines may be coadministered. TRIAL REGISTRATION: ClinicalTrials.gov, 
      NCT04887948.
CI  - Copyright (c) 2023 Elsevier Ltd. All rights reserved.
FAU - Fitz-Patrick, David
AU  - Fitz-Patrick D
AD  - East-West Medical Research Institute, Honolulu, HI, USA.
FAU - Young, Mariano
AU  - Young M
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA. Electronic 
      address: Mariano.Young-Jr@pfizer.com.
FAU - Yacisin, Kari
AU  - Yacisin K
AD  - Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
FAU - McElwee, Kathleen
AU  - McElwee K
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
FAU - Belanger, Todd
AU  - Belanger T
AD  - Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
FAU - Belanger, Kelly
AU  - Belanger K
AD  - Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
FAU - Peng, Yahong
AU  - Peng Y
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
FAU - Lee, Dung-Yang
AU  - Lee DY
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
FAU - Gruber, William C
AU  - Gruber WC
AD  - Vaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
FAU - Scott, Daniel A
AU  - Scott DA
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
FAU - Watson, Wendy
AU  - Watson W
AD  - Vaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT04887948
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20230508
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (BNT162 Vaccine)
RN  - 0 (COVID-19 Vaccines)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Pneumococcal Vaccines)
RN  - 0 (Vaccines, Conjugate)
SB  - IM
MH  - Aged
MH  - Humans
MH  - Antibodies, Bacterial
MH  - BNT162 Vaccine
MH  - *COVID-19/prevention & control
MH  - *COVID-19 Vaccines/adverse effects
MH  - Double-Blind Method
MH  - Immunogenicity, Vaccine
MH  - Immunoglobulin G
MH  - *Pneumococcal Infections
MH  - Pneumococcal Vaccines
MH  - SARS-CoV-2
MH  - Vaccines, Conjugate
PMC - PMC10165018
OTO - NOTNLM
OT  - 20-valent pneumococcal conjugate vaccine
OT  - COVID-19
OT  - Coadministration
OT  - SARS-CoV-2
OT  - Streptococcus pneumoniae
COIS- Declaration of Competing Interest The authors declare the following financial 
      interests/personal relationships which may be considered as potential competing 
      interests: MY, KY, KM, TB, KB, YP, DYL, WCG, DAS, and WW are employees of Pfizer 
      Inc and may hold stock or stock options. DF-P reports receiving grant support 
      from Pfizer, Moderna, and AstraZeneca.
EDAT- 2023/05/28 01:07
MHDA- 2023/06/21 06:42
PMCR- 2023/05/08
CRDT- 2023/05/27 21:59
PHST- 2023/02/01 00:00 [received]
PHST- 2023/04/19 00:00 [revised]
PHST- 2023/05/01 00:00 [accepted]
PHST- 2023/06/21 06:42 [medline]
PHST- 2023/05/28 01:07 [pubmed]
PHST- 2023/05/27 21:59 [entrez]
PHST- 2023/05/08 00:00 [pmc-release]
AID - S0264-410X(23)00520-0 [pii]
AID - 10.1016/j.vaccine.2023.05.002 [doi]
PST - ppublish
SO  - Vaccine. 2023 Jun 23;41(28):4190-4198. doi: 10.1016/j.vaccine.2023.05.002. Epub 
      2023 May 8.