NO SAFETY CONCERNS OBSERVED WHEN THE ADJUVANTED RECOMBINANT ZOSTER VACCINE (RZV) AND THE COVID-19 MRNA-1273 BOOSTER WERE CO-ADMINISTERED IN ≥50-YEAR-OLDS
Intro: The US CDC recommends that COVID-19 vaccines may be coadministered with other age-appropriate vaccines. There is limited data assessing outcomes, including reactogenicity, on such co-administration. For the first time, we present interim safety data of RZV administered concomitantly or sequen...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2023-05-01
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| Series: | International Journal of Infectious Diseases |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971223002680 |
| _version_ | 1797824583977402368 |
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| author | A. Naficy P. Pirrotta A. Kuxhausen J. Miller B. Leav A. Mwakingwe-Omari |
| author_facet | A. Naficy P. Pirrotta A. Kuxhausen J. Miller B. Leav A. Mwakingwe-Omari |
| author_sort | A. Naficy |
| collection | DOAJ |
| description | Intro: The US CDC recommends that COVID-19 vaccines may be coadministered with other age-appropriate vaccines. There is limited data assessing outcomes, including reactogenicity, on such co-administration. For the first time, we present interim safety data of RZV administered concomitantly or sequentially with an mRNA-1273 booster vaccine. Methods: In this phase 3, randomized, open-label, multi-center study (NCT05047770), adults aged ≥50 years were randomized 1:1 to receive the first RZV dose with mRNA-1273 booster (50 μg) at day 1 and the second RZV dose at week (W)8 (Co-Administration group [Co-Ad]), or mRNA-1273 at day 1, the first RZV dose at W2 and the second RZV dose at W10 (Sequential group [Seq]). Descriptive analyses of solicited/unsolicited adverse events (AEs) with onset within 7/30 days post-mRNA-1273 or first RZV dose, and of serious AEs/potential immune-mediated diseases/AEs of special interest (SAEs/pIMDs/AESIs) reported until database freeze are reviewed. Findings: The exposed set comprised 267 (Co-Ad) and 272 (Seq) participants. In each group, most solicited AEs were mild/moderate in intensity and each with ≤2.5 days median duration, the most frequent were injection site pain, myalgia, and fatigue. Unsolicited (vaccines-related) AEs were reported by 25.0% (2.9%) of participants post-mRNA-1273 in Seq, 25.2% (0.8%) post-RZV in Seq, and 37.1% (3.7%) in Co-Ad. SAEs/pIMDs/AESIs were reported for 6/1/2 participants in Co-Ad and 5/1/3 in Seq. In Seq, one SAE/AESI (pulmonary embolism) and one pIMD/AESI (cutaneous vasculitis) occurred 2 and 9 days postmRNA-1273 (before RZV administration), respectively, and were considered mRNA-1273-related by investigators. In Co-Ad, one AESI (chronic hepatitis) occurred 35 days post-second RZV dose, considered vaccines-related by Sponsor. No fatalities occurred. Conclusion: No safety concerns were identified. The frequency/severity/type of AEs were comparable between groups and consistent with the known safety profile of each vaccine, whether RZV and mRNA-1273 booster were administered concomitantly or sequentially. Co-administration may enhance vaccine coverage rates. Funding: GSK |
| first_indexed | 2024-03-13T10:41:07Z |
| format | Article |
| id | doaj.art-8e31d33707bd4acaaf34d0f7628ef861 |
| institution | Directory Open Access Journal |
| issn | 1201-9712 |
| language | English |
| last_indexed | 2024-03-13T10:41:07Z |
| publishDate | 2023-05-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj.art-8e31d33707bd4acaaf34d0f7628ef8612023-05-18T04:38:24ZengElsevierInternational Journal of Infectious Diseases1201-97122023-05-01130S55S56NO SAFETY CONCERNS OBSERVED WHEN THE ADJUVANTED RECOMBINANT ZOSTER VACCINE (RZV) AND THE COVID-19 MRNA-1273 BOOSTER WERE CO-ADMINISTERED IN ≥50-YEAR-OLDSA. Naficy0P. Pirrotta1A. Kuxhausen2J. Miller3B. Leav4A. Mwakingwe-Omari5GSK, Clinical Sciences, Viral Vaccines, Rockville, MD, United States of AmericaGSK, Vaccine Clinical Safety & Pharmacovigilance, Global Safety, Wavre, BelgiumGSK, Biostatistics & Statistical Programming, Clinical Evidence Generation, Rockville, MD, United States of AmericaModerna, Clinical Development, Cambridge, MA, United States of AmericaModerna, Clinical Development, Cambridge, MA, United States of AmericaGSK, Clinical Sciences, Viral Vaccines, Rockville, MD, United States of AmericaIntro: The US CDC recommends that COVID-19 vaccines may be coadministered with other age-appropriate vaccines. There is limited data assessing outcomes, including reactogenicity, on such co-administration. For the first time, we present interim safety data of RZV administered concomitantly or sequentially with an mRNA-1273 booster vaccine. Methods: In this phase 3, randomized, open-label, multi-center study (NCT05047770), adults aged ≥50 years were randomized 1:1 to receive the first RZV dose with mRNA-1273 booster (50 μg) at day 1 and the second RZV dose at week (W)8 (Co-Administration group [Co-Ad]), or mRNA-1273 at day 1, the first RZV dose at W2 and the second RZV dose at W10 (Sequential group [Seq]). Descriptive analyses of solicited/unsolicited adverse events (AEs) with onset within 7/30 days post-mRNA-1273 or first RZV dose, and of serious AEs/potential immune-mediated diseases/AEs of special interest (SAEs/pIMDs/AESIs) reported until database freeze are reviewed. Findings: The exposed set comprised 267 (Co-Ad) and 272 (Seq) participants. In each group, most solicited AEs were mild/moderate in intensity and each with ≤2.5 days median duration, the most frequent were injection site pain, myalgia, and fatigue. Unsolicited (vaccines-related) AEs were reported by 25.0% (2.9%) of participants post-mRNA-1273 in Seq, 25.2% (0.8%) post-RZV in Seq, and 37.1% (3.7%) in Co-Ad. SAEs/pIMDs/AESIs were reported for 6/1/2 participants in Co-Ad and 5/1/3 in Seq. In Seq, one SAE/AESI (pulmonary embolism) and one pIMD/AESI (cutaneous vasculitis) occurred 2 and 9 days postmRNA-1273 (before RZV administration), respectively, and were considered mRNA-1273-related by investigators. In Co-Ad, one AESI (chronic hepatitis) occurred 35 days post-second RZV dose, considered vaccines-related by Sponsor. No fatalities occurred. Conclusion: No safety concerns were identified. The frequency/severity/type of AEs were comparable between groups and consistent with the known safety profile of each vaccine, whether RZV and mRNA-1273 booster were administered concomitantly or sequentially. Co-administration may enhance vaccine coverage rates. Funding: GSKhttp://www.sciencedirect.com/science/article/pii/S1201971223002680 |
| spellingShingle | A. Naficy P. Pirrotta A. Kuxhausen J. Miller B. Leav A. Mwakingwe-Omari NO SAFETY CONCERNS OBSERVED WHEN THE ADJUVANTED RECOMBINANT ZOSTER VACCINE (RZV) AND THE COVID-19 MRNA-1273 BOOSTER WERE CO-ADMINISTERED IN ≥50-YEAR-OLDS International Journal of Infectious Diseases |
| title | NO SAFETY CONCERNS OBSERVED WHEN THE ADJUVANTED RECOMBINANT ZOSTER VACCINE (RZV) AND THE COVID-19 MRNA-1273 BOOSTER WERE CO-ADMINISTERED IN ≥50-YEAR-OLDS |
| title_full | NO SAFETY CONCERNS OBSERVED WHEN THE ADJUVANTED RECOMBINANT ZOSTER VACCINE (RZV) AND THE COVID-19 MRNA-1273 BOOSTER WERE CO-ADMINISTERED IN ≥50-YEAR-OLDS |
| title_fullStr | NO SAFETY CONCERNS OBSERVED WHEN THE ADJUVANTED RECOMBINANT ZOSTER VACCINE (RZV) AND THE COVID-19 MRNA-1273 BOOSTER WERE CO-ADMINISTERED IN ≥50-YEAR-OLDS |
| title_full_unstemmed | NO SAFETY CONCERNS OBSERVED WHEN THE ADJUVANTED RECOMBINANT ZOSTER VACCINE (RZV) AND THE COVID-19 MRNA-1273 BOOSTER WERE CO-ADMINISTERED IN ≥50-YEAR-OLDS |
| title_short | NO SAFETY CONCERNS OBSERVED WHEN THE ADJUVANTED RECOMBINANT ZOSTER VACCINE (RZV) AND THE COVID-19 MRNA-1273 BOOSTER WERE CO-ADMINISTERED IN ≥50-YEAR-OLDS |
| title_sort | no safety concerns observed when the adjuvanted recombinant zoster vaccine rzv and the covid 19 mrna 1273 booster were co administered in ≥50 year olds |
| url | http://www.sciencedirect.com/science/article/pii/S1201971223002680 |
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