Safety, immunogenicity, and reactogenicity of BNT162b2 and mRNA-1273 COVID-19 vaccines given as fourth-dose boosters following two doses of ChAdOx1 nCoV-19 or BNT162b2 and a third dose of BNT162b2 (COV-BOOST): a multicentre, blinded, phase 2, randomised trial
Open accessAbstract
BACKGROUND: Some high-income countries have deployed fourth doses of COVID-19 vaccines, but the clinical need, effectiveness, timing, and dose of a fourth dose remain uncertain. We aimed to investigate the safety, reactogenicity, and immunogenicity of fourth-dose boosters against COVID-19. METHODS: The COV-BOOST trial is a multicentre, blinded, phase 2, randomised controlled trial of seven COVID-19 vaccines given as third-dose boosters at 18 sites in the UK. This sub-study enrolled participants who had received BNT162b2 (Pfizer-BioNTech) as their third dose in COV-BOOST and randomly assigned them (1:1) to receive a fourth dose of either BNT162b2 (30 μg in 0·30 mL; full dose) or mRNA-1273 (Moderna; 50 μg in 0·25 mL; half dose) via intramuscular injection into the upper arm. The computer-generated randomisation list was created by the study statisticians with random block sizes of two or four. Participants and all study staff not delivering the vaccines were masked to treatment allocation. The coprimary outcomes were safety and reactogenicity, and immunogenicity (anti-spike protein IgG titres by ELISA and cellular immune response by ELISpot). We compared immunogenicity at 28 days after the third dose versus 14 days after the fourth dose and at day 0 versus day 14 relative to the fourth dose. Safety and reactogenicity were assessed in the per-protocol population, which comprised all participants who received a fourth-dose booster regardless of their SARS-CoV-2 serostatus. Immunogenicity was primarily analysed in a modified intention-to-treat population comprising seronegative participants who had received a fourth-dose booster and had available endpoint data. This trial is registered with ISRCTN, 73765130, and is ongoing. FINDINGS: Between Jan 11 and Jan 25, 2022, 166 participants were screened, randomly assigned, and received either full-dose BNT162b2 (n=83) or half-dose mRNA-1273 (n=83) as a fourth dose. The median age of these participants was 70·1 years (IQR 51·6-77·5) and 86 (52%) of 166 participants were female and 80 (48%) were male. The median interval between the third and fourth doses was 208·5 days (IQR 203·3-214·8). Pain was the most common local solicited adverse event and fatigue was the most common systemic solicited adverse event after BNT162b2 or mRNA-1273 booster doses. None of three serious adverse events reported after a fourth dose with BNT162b2 were related to the study vaccine. In the BNT162b2 group, geometric mean anti-spike protein IgG concentration at day 28 after the third dose was 23 325 ELISA laboratory units (ELU)/mL (95% CI 20 030-27 162), which increased to 37 460 ELU/mL (31 996-43 857) at day 14 after the fourth dose, representing a significant fold change (geometric mean 1·59, 95% CI 1·41-1·78). There was a significant increase in geometric mean anti-spike protein IgG concentration from 28 days after the third dose (25 317 ELU/mL, 95% CI 20 996-30 528) to 14 days after a fourth dose of mRNA-1273 (54 936 ELU/mL, 46 826-64 452), with a geometric mean fold change of 2·19 (1·90-2·52). The fold changes in anti-spike protein IgG titres from before (day 0) to after (day 14) the fourth dose were 12·19 (95% CI 10·37-14·32) and 15·90 (12·92-19·58) in the BNT162b2 and mRNA-1273 groups, respectively. T-cell responses were also boosted after the fourth dose (eg, the fold changes for the wild-type variant from before to after the fourth dose were 7·32 [95% CI 3·24-16·54] in the BNT162b2 group and 6·22 [3·90-9·92] in the mRNA-1273 group). INTERPRETATION: Fourth-dose COVID-19 mRNA booster vaccines are well tolerated and boost cellular and humoral immunity. Peak responses after the fourth dose were similar to, and possibly better than, peak responses after the third dose. FUNDING: UK Vaccine Task Force and National Institute for Health Research.
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Plenty of articles have demonstrated the efficacy of two-dose vaccination and additional boosters in reducing mortality and severe cases.
“As plenty of articles have demonstrated the efficacy of two-dose vaccination and additional boosters in reducing mortality and severe cases [13,14,35-37]”
From Protective effect of COVID-19 vaccination against long COVID syndrome: A systematic review and meta-analysis (2023) · cites this paper as [36]
The Discussion (page unavailable) reports observational evidence of increased protection against severe illness after a fourth-dose booster. This trial measured immune responses rather than mortality or severe-case outcomes, and the cited passages do not establish that two-dose vaccination reduces either outcome. The claim therefore extends beyond what this source supports. (LLM, conf=0.86)
Experimental — accuracy not yet measuredFor some COVID-19 vaccines, heterologous boosting improves the magnitude and breadth of the immune response compared with homologous boosters; however, for mRNA vaccines, a homologous mRNA booster is usually superior to a heterologous non-mRNA booster.
“For some COVID-19 vaccines, heterologous boosting has been shown to improve both the magnitude and the breadth of the immune response when compared with homologous boosters; 7,21,22 however, this has not been the case for mRNA vaccines, for which the response to a homologous mRNA booster is usually superior to the response to a heterologous non-mRNA booster.[10][11][12]”
From Immunogenicity and safety of a booster dose of a self-amplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, non-inferiority trial (2024) · cites this paper as [21]
Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredBooster vaccines seem promising both in preventing infection and severe progression.
“Since booster vaccines seem promising both in preventing infection and severe progression [35-37]”
From Protective effect of COVID-19 vaccination against long COVID syndrome: A systematic review and meta-analysis (2023) · cites this paper as [36]
Both ARCT-154 and BNT162b2 were well tolerated with mainly mild-to-moderate solicited adverse events, similar to those reported in previous studies of mRNA vaccine boosters.
“Both ARCT-154 and BNT162b2 were well tolerated with mainly mild-tomoderate solicited adverse events, similar to those reported in previous studies of mRNA vaccine boosters.21,22”
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BioNTech/Pfizer (BNT162b2) COVID-19 mRNA vaccine: manufacturing, immunogenicity, efficacy and safety
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Global landscape of COVID-19 research: a visualization analysis of randomized clinical trials
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Discovery platforms for RNA therapeutics
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Advancing ORFV‐Based Therapeutics to the Clinical Stage
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Boosting capacity of a fourth dose BNT162b2 in cancer patients
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Immunology of SARS-CoV-2 infection and vaccination
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Antibody response in elderly vaccinated four times with an mRNA anti-COVID-19 vaccine
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The Ambivalence of Post COVID-19 Vaccination Responses in Humans
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McLeod, C., Dymock, M., Flanagan, K. L., Plebanski, M., Marshall, H. S., Estcourt, M. J., Tjiam, M. C., Blyth, C. C., Subbarao, K., Mordant, F. L., et al. (2024) · Journal of Infection · doi:10.1016/j.jinf.2024.106286 · Cited by 6 · see citing works
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Farias, J. P., Andreata‐Santos, R., Brito, R. D. D. S., Souza, M. S., Fogaça, M. M. C., Pinheiro, J. R., da Cruz, E. F., Liang, W., Simões, R. D. C., Luiz, W. B., et al. (2023) · Microbiology Spectrum · doi:10.1128/spectrum.02857-23 · Cited by 7 · see citing works
Steinhubl, S. R., Sekaric, J., Gendy, M., Guo, H., Ward, M. P., Goergen, C. J., Anderson, J. L., Amin, S., Wilson, D. A., Paramithiotis, E., et al. (2025) · Communications Medicine · doi:10.1038/s43856-025-00840-8 · Cited by 6 · see citing works
Effectiveness of COVID-19 vaccination in healthcare workers in Shiga Prefecture, Japan
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Hausinger, R. I., Bachmann, Q., Crone-Rawe, T., Hannane, N., Monsef, I., Haller, B., Heemann, U. W., Skoetz, N., Kreuzberger, N., & Schmaderer, C. (2023) · Vaccines · doi:10.3390/vaccines11040863 · Cited by 5 · see citing works
Chappell, K. J., Mordant, F. L., Amarilla, A. A., Modhiran, N., Liang, B., Li, Z., Wijesundara, D. K., Lackenby, J. A., Griffin, P. M., Bennet, J. K., et al. (2023) · EBioMedicine · doi:10.1016/j.ebiom.2023.104842 · Cited by 6 · see citing works
Ntanasis‐Stathopoulos, I., Karalis, V. D., Sklirou, A. D., Gavriatopoulou, M., Alexopoulos, H., Malandrakis, P., Trougakos, I. P., Dimopoulos, M. A., & Terpos, E. (2022) · HemaSphere · doi:10.1097/hs9.0000000000000747 · Cited by 6 · see citing works
Chatzilena, A., Hyams, C. J., Challen, R., Marlow, R. D., King, J., Adegbite, D., Kinney, J., Clout, M., Maskell, N. A., Oliver, J., et al. (2023) · medRxiv · doi:10.1101/2023.03.16.23287360 · Cited by 6 · see citing works
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Bejko, D., Ernst, C., Vergison, A., Stranges, S., Zeegers, M. P., & Mossong, J. (2024) · Vaccine · doi:10.1016/j.vaccine.2024.05.059 · Cited by 5 · see citing works
Kang, J., Lee, J., Huh, K. H., Joo, D. J., Lee, J. G., Kim, H. Y., Lee, M., Jung, I., Kim, M. Y., Kim, S., et al. (2022) · Journal of Clinical Virology · doi:10.1016/j.jcv.2022.105374 · Cited by 5 · see citing works
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Airway and Systemic Immune Responses Following the Third COVID-19 Vaccination in COPD Patients
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Lorent, D., Nowak, R., Figlerowicz, M., Handschuh, L., & Zmora, P. (2024) · Vaccines · doi:10.3390/vaccines12050475 · Cited by 5 · see citing works
Mungmunpuntipantip, R., & Wiwanitkit, V. (2022) · PubMed Central · Cited by 4 · see citing works
Janani, L., Munro, A. P. S., Wright, A., Aley, P. K., Babbage, G., Baxter, D. N., Bawa, T., Bibi, S., Bula, M., Cathie, K., et al. (2025) · Journal of Infection · doi:10.1016/j.jinf.2025.106576 · Cited by 4 · see citing works
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- Authors
- Munro, A. P. S., Feng, S., Janani, L., Cornelius, V., Aley, P. K., Babbage, G., Baxter, D., Bula, M., Cathie, K., Chatterjee, K., Dodd, K., Enever, Y., Qureshi, E., Goodman, A. L., Green, C. A., Harndahl, L., Haughney, J., Hicks, A., van der Klaauw, A. A., Kanji, N., Libri, V., Llewelyn, M. J., McGregor, A. C., Maallah, M., Minassian, A. M., Moore, P., Mughal, M., Mujadidi, Y. F., Holliday, K., Osanlou, O., Osanlou, R., Owens, D. R., Pacurar, M., Palfreeman, A., Pan, D., Rampling, T., Regan, K., Saich, S., Bawa, T., Saralaya, D., Sharma, S., Sheridan, R., Thomson, E. C., Todd, S., Twelves, C., Read, R. C., Charlton, S., Hallis, B., Ramsay, M., Andrews, N., Lambe, T., Nguyen-Van-Tam, J. S., Snape, M. D., Liu, X., Faust, S. N., Munro, A. P. S., Feng, S., Janani, L., Cornelius, V., Aley, P. K., Babbage, G., Baxter, D., Bula, M., Cathie, K., Chatterjee, K., Dodd, K., Enever, Y., Qureshi, E., Goodman, A. L., Green, C. A., Harndahl, L., Haughney, J., Hicks, A., van der Klaauw, A. A., Kanji, N., Libri, V., Llewelyn, M. J., McGregor, A. C., Minassian, A. M., Moore, P., Mughal, M., Mujadidi, Y. F., Holliday, K., Osanlou, O., Osanlou, R., Owens, D. R., Pacurar, M., Palfreeman, A., Pan, D., Rampling, T., Regan, K., Saich, S., Bawa, T., Saralaya, D., Sharma, S., Sheridan, R., Maallah, M., Thomson, E. C., Todd, S., Twelves, C., Read, R. C., Charlton, S., Hallis, B., Ramsay, M., Andrews, N., Lambe, T., Nguyen-Van-Tam, J. S., Snape, M. D., Liu, X., Faust, S. N., Riordan, A., Ustianowski, A., Rogers, C., Katechia, K., Cooper, A., Freedman, A., Hughes, R., Grundy, L., Tudor Jones, L., Harrison, E., Snashall, E., Mallon, L., Burton, K., Storton, K., Munusamy, M., Tandy, B., Egbo, A., Cox, S., Ahmed, N. N., Shenoy, A., Bousfield, R., Wixted, D., Gutteridge, H., Mansfield, B., Herbert, C., Murira, J., Calderwood, J., Barker, D., Brandon, J., Tulloch, H., Colquhoun, S., Thorp, H., Radford, H., Evans, J., Baker, H., Thorpe, J., Batham, S., Hailstone, J., Phillips, R., Kumar, D., Westwell, F., Sturdy, A., Barcella, L., Soussi, N., Mpelembue, M., Raj, S., Sharma, R., Corrah, T., John, L., Whittington, A., Roche, S., Wagstaff, L., Farrier, A., Bisnauthsing, K., Abeywickrama, M., Spence, N., Packham, A., Serafimova, T., Aslam, S., McGreevy, C., Borca, A., DeLosSantosDominguez, P., Palmer, E., Broadhead, S., Farooqi, S., Piper, J., Weighell, R., Pickup, L., Shamtally, D., Domingo, J., Kourampa, E., Hale, C., Gibney, J., Stackpoole, M., Rashid-Gardner, Z., Lyon, R., McDonnell, C., Cole, C., Stewart, A., McMillan, G., Savage, M., Beckett, H., Moorbey, C., Desai, A., Brown, C., Naker, K., Gokani, K., Trinham, C., Sabine, C., Moore, S., Hurdover, S., Justice, E., Stone, M., Plested, E., Ferreira Da Silva, C., White, R., Robinson, H., Turnbull, I., Morshead, G., Drake-Brockman, R., Smith, C., Li, G., Kasanyinga, M., Clutterbuck, E. A., Bibi, S., Singh, M., Champaneri, T., Irwin, M., Khan, M., Kownacka, A., Nabunjo, M., Osuji, C., Hladkiwskyj, J., Galvin, D., Patel, G., Grierson, J., Males, S., Askoolam, K., Barry, J., Mouland, J., Longhurst, B., Moon, M., Giddins, B., Pereira Dias Alves, C., Richmond, L., Minnis, C., Baryschpolec, S., Elliott, S., Fox, L., Graham, V., Baker, N., Godwin, K., Buttigieg, K., Knight, C., Brown, P., Lall, P., Shaik, I., Chiplin, E., Brunt, E., Leung, S., Allen, L., Thomas, S., Fraser, S., Choi, B., Gouriet, J., Perkins, J., Gowland, A., Macdonald, J., Seenan, J. P., Starinskij, I., Seaton, A., Peters, E., Singh, S., Gardside, B., Bonnaud, A., Davies, C., Gordon, E., Keenan, S., Hall, J., Wilkins, S., Tasker, S., James, R., Seath, I., Littlewood, K., Newman, J., Boubriak, I., Suggitt, D., Haydock, H., Bennett, S., Woodyatt, W., Hughes, K., Bell, J., Coughlan, T., van Welsenes, D., Kamal, M., Cooper, C., Tunstall, S., Ronan, N., Cutts, R., Dare, T., Yim, Y. T. N., Whittley, S., Hamal, S., Ricamara, M., Adams, K., Baker, H., Driver, K., Turner, N., Rawlins, T., Roy, S., Merida-Morillas, M., Sakagami, Y., Andrews, A., Goncalvescordeiro, L., Stokes, M., Ambihapathy, W., Spencer, J., Parungao, N., Berry, L., Cullinane, J., Presland, L., Ross Russell, A., Warren, S., Baker, J., Oliver, A., Buadi, A., Lee, K., Haskell, L., Romani, R., Bentley, I., Whitbred, T., Fowler, S., Gavin, J., Magee, A., Watson, T., Nightingale, K., Marius, P., Summerton, E., Locke, E., Honey, T., Lingwood, A., de la Haye, A., Elliott, R. S., Underwood, K., King, M., Davies-Dear, S., Horsfall, E., Chalwin, O., Burton, H., Edwards, C. J., Welham, B., Appleby, K., Dineen, E., Garrahy, S., Hall, F., Ladikou, E., Mullan, D., Hansen, D., Campbell, M., Dos Santos, F., Lakeman, N., Branney, D., Vamplew, L., Hogan, A., Frankham, J., Wiselka, M., Vail, D., Wenn, V., Renals, V., Ellis, K., Lewis-Taylor, J., Habash-Bailey, H., Magan, J., & Hardy, A.
- Affiliations
- UK Health Security Agency (GB)
- University of Leeds (GB)
- NHS Greater Glasgow and Clyde (GB)
- University Hospital Southampton NHS Foundation Trust (GB)
- University Hospitals Birmingham NHS Foundation Trust (GB)
- St Thomas' Hospital (GB)
- University Hospitals Sussex NHS Foundation Trust (GB)
- Bradford Teaching Hospitals NHS Foundation Trust (GB)
- University of Nottingham (GB)
- University of Oxford (GB)
- Cambridge University Hospitals NHS Foundation Trust (GB)
- Imperial College London (GB)
- Royal Devon & Exeter NHS Foundation Trust (GB)
- University of Leicester (GB)
- Broadgreen Hospital (GB)
- ORCID
- Riordan, Andrew
- Ustianowski, Andrew
- Rogers, Chris
- Cooper, Alison
- Bousfield, Rachel
- Murira, Jennifer
- Batham, Sally
- Kumar, Dileep
- Sharma, Rajni
- Farrier, Adam
- Bisnauthsing, Karen
- Spence, Niamh
- Packham, Alice
- Serafimova, Teona
- Domingo, Jason
- Desai, Amisha
- Naker, Kush
- Gokani, Karishma
- Plested, Emma
- Robinson, Hannah
- Turnbull, Iain
- Li, Grace
- Kasanyinga, Mwila
- Clutterbuck, Elizabeth A
- Bibi, Sagida
- Singh, Michael
- Graham, Victoria
- Baker, Natalie
- Buttigieg, Karen
- Leung, Stephanie
- Allen, Lauren
- Perkins, Jonathan
- Macdonald, Jonathan
- Seenan, John Paul
- Starinskij, Igor
- Hall, Jane
- Suggitt, Debbie
- Yim, Yee Ting Nicole
- Adams, Kirsty
- Baker, Holly
- Driver, Kimberley
- Turner, Nicola
- Roy, Subarna
- Oliver, Abigail
- Locke, Emily
- Edwards, Christopher J
- Welham, Benjamin
- Ladikou, Eleni
- Hansen, Daniel
- Campbell, Marion
- Wiselka, Martin
- Venue
- The Lancet Infectious Diseases
- Publisher
- Elsevier BV
- Published
- 2022-08
- Volume
- 22
- Issue
- 8
- Pages
- 1131-1141
- ISSN
- 1473-3099 (ISSN-L)
- PMC
- PMC9084623
- OpenAlex
- W4229458272
- Cited by
- 175
- References
- 14
- Citations by year
- 2026: 13 · 2025: 23 · 2024: 44 · 2023: 62 · 2022: 33
- FWCI
- 19.80
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- The Lancet Infectious Diseases (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Repository@Nottingham (University of Nottingham) (publishedVersion, cc-by)
- University of Birmingham Research Portal (University of Birmingham) (publishedVersion, cc-by)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion, cc-by-sa)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
- ePrints Soton (University of Southampton) (acceptedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Figshare (submittedVersion, cc-by)
- Royal Devon and Exeter Research Repository (Royal Devon and Exeter) (submittedVersion, cc-by)
- Bangor University Research Portal (Bangor University) (submittedVersion, cc-by)
- Spiral (Imperial College London) (submittedVersion, other-oa)
- Apollo (University of Cambridge) (submittedVersion)
- Apollo
- Funders
- NIHR Biomedical Research Centre, Royal Marsden NHS Foundation Trust/Institute of Cancer Research
- National Institute for Health and Care Research
- Public Health England
- Wellcome Trust (210755/Z/18/Z)
- University Hospital Southampton NHS Foundation Trust (BNT162b2)
- Government of the United Kingdom
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Social Sciences › Health › Vaccine Coverage and Hesitancy
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Keywords
- COVID-19 vaccines, BNT162b2, mRNA-1273, ChAdOx1 nCoV-19 vaccine, immunogenicity, reactogenicity, vaccine safety, anti-spike IgG, cell-mediated immunity, SARS-CoV-2
- MeSH terms
- Immunogenicity, Vaccine, COVID-19, SARS-CoV-2, COVID-19 Vaccines, BNT162 Vaccine, 2019-nCoV Vaccine mRNA-1273, ChAdOx1 nCoV-19, Aged, Antibodies, Viral, Female, Humans, Immunoglobulin G, Male, Middle Aged
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