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- Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2023
- FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on June 15, 2023, to discuss and make recommendations for SARS-CoV-2 strain(s) for updated COVID-19 vaccines for use in the United States beginning in the fall of 2023. For the 2023-2024 formulation of the COVID-19 vaccines for use in the U.S. beginning in the fall of 2023, the committee unanimously voted that the vaccine composition be updated to a monovalent COVID-19 vaccine with an XBB-lineage of the Omicron variant. Following discussion of the evidence, the committee expressed a preference for XBB.1.5. During this meeting, the advisory committee was informed of the manufacturing timelines, they reviewed the available data on the circulation of SARS-CoV-2 virus variants, current vaccine effectiveness, human immunogenicity data of current vaccines against recently circulating virus variants, the antigenic characterization of circulating virus variants, animal immunogenicity data generated by new candidate vaccines expressing or containing updated spike components, and preliminary human immunogenicity data generated by one XBB.1.5 candidate vaccine. Based on the totality of the evidence, FDA has advised manufacturers who will be updating their COVID-19 vaccines, that they should develop vaccines with a monovalent XBB 1.5 composition.
- Prevention of COVID-19 Following a Single Intramuscular Administration of Adintrevimab: Results From a Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial (EVADE)
- The prevention of COVID-19 in vulnerable populations is a global health priority. EVADE was a phase 2/3 multicenter, double-blind, randomized, placebo-controlled trial of adintrevimab, an extended–half-life monoclonal antibody, for post-exposure (PEP) and pre-exposure prophylaxis (PrEP) of symptomatic COVID-19. Eligible participants (vaccine-naïve, aged ≥12 years) were randomized 1:1 to receive a single 300-mg intramuscular injection of adintrevimab or placebo. Primary efficacy endpoints were reverse-transcription polymerase chain reaction (RT-PCR)-confirmed symptomatic COVID-19 through day 28 in the PEP cohort (RT-PCR-negative at baseline) and through month 3 in the PrEP cohort (RT-PCR-negative and seronegative at baseline) among participants randomized before emergence of the SARS-CoV-2 Omicron variant (30 November 2021). Safety was assessed through 6 months. Between 27 April 2021, and 11 January 2022, 2582 participants were randomized. In the primary efficacy analysis, RT-PCR-confirmed symptomatic COVID-19 occurred in 3/175 (1.7%) vs 12/176 (6.8%) adintrevimab- and placebo-treated PEP participants, respectively (74.9% relative risk reduction [RRR]; standardized risk difference –5.0%; 95% CI, –8.87 to –1.08; P=.0123), and in 12/752 (1.6%) vs 40/728 (5.5%) adintrevimab- and placebo-treated PrEP participants, respectively (71.0% RRR; standardized risk difference –3.9%; 95% CI, –5.75 to –2.01; P<.0001). In a prespecified exploratory analysis of 428 PrEP participants randomized after emergence of Omicron, adintrevimab reduced RT-PCR-confirmed symptomatic COVID-19 by 40.6% (standardized risk difference −8.4%; 95% CI, −15.35 to −1.46; nominal P=.0177) vs placebo. Adintrevimab was well tolerated with no serious drug-related adverse events reported. A single intramuscular injection of adintrevimab provided prophylactic efficacy against COVID-19 due to susceptible variants without safety concerns.
- The prevention of COVID-19 in vulnerable populations is a global health priority. EVADE was a phase 2/3 multicenter, double-blind, randomized, placebo-controlled trial of adintrevimab, an extended–half-life monoclonal antibody, for post-exposure (PEP) and pre-exposure prophylaxis (PrEP) of symptomatic COVID-19. Eligible participants (vaccine-naïve, aged ≥12 years) were randomized 1:1 to receive a single 300-mg intramuscular injection of adintrevimab or placebo. Primary efficacy endpoints were reverse-transcription polymerase chain reaction (RT-PCR)-confirmed symptomatic COVID-19 through day 28 in the PEP cohort (RT-PCR-negative at baseline) and through month 3 in the PrEP cohort (RT-PCR-negative and seronegative at baseline) among participants randomized before emergence of the SARS-CoV-2 Omicron variant (30 November 2021). Safety was assessed through 6 months. Between 27 April 2021, and 11 January 2022, 2582 participants were randomized. In the primary efficacy analysis, RT-PCR-confirmed symptomatic COVID-19 occurred in 3/175 (1.7%) vs 12/176 (6.8%) adintrevimab- and placebo-treated PEP participants, respectively (74.9% relative risk reduction [RRR]; standardized risk difference –5.0%; 95% CI, –8.87 to –1.08; P=.0123), and in 12/752 (1.6%) vs 40/728 (5.5%) adintrevimab- and placebo-treated PrEP participants, respectively (71.0% RRR; standardized risk difference –3.9%; 95% CI, –5.75 to –2.01; P<.0001). In a prespecified exploratory analysis of 428 PrEP participants randomized after emergence of Omicron, adintrevimab reduced RT-PCR-confirmed symptomatic COVID-19 by 40.6% (standardized risk difference −8.4%; 95% CI, −15.35 to −1.46; nominal P=.0177) vs placebo. Adintrevimab was well tolerated with no serious drug-related adverse events reported. A single intramuscular injection of adintrevimab provided prophylactic efficacy against COVID-19 due to susceptible variants without safety concerns.
- Real-World Effectiveness of Nirmatrelvir/Ritonavir on Coronavirus Disease 2019 (COVID-19)–Associated Hospitalization Prevention: A Population-based Cohort Study in the Province of Quebec, Canada.
- Nirmatrelvir/ritonavir has shown to reduce COVID-19 hospitalization and death before Omicron, but updated real-world evidence studies are needed. This study aimed to assess whether nirmatrelvir/ritonavir reduces the risk of COVID-19–associated hospitalization among high-risk outpatients. A retrospective cohort study of outpatients with SARS-CoV-2 between March 15 and 15 October 2022, using data from the Quebec clinico-administrative databases. Outpatients treated with nirmatrelvir/ritonavir were compared with infected ones not receiving nirmatrelvir/ritonavir using propensity-score matching. Relative risk (RR) of COVID-19–associated hospitalization within 30 days was assessed using a Poisson regression. A total of 8402 treated outpatients were matched to controls. Regardless of vaccination status, nirmatrelvir/ritonavir treatment was associated with a 69% reduced RR of hospitalization (RR: .31; 95% CI: .28; .36; number needed to treat [NNT] = 13). The effect was more pronounced in outpatients with incomplete primary vaccination (RR: .04; 95% CI: .03; .06; NNT = 8), while no benefit was found in those with a complete primary vaccination (RR: .93; 95% CI: .78; 1.08). Subgroups analysis among high-risk outpatients with a complete primary vaccination showed that nirmatrelvir/ritonavir treatment was associated with a significant decrease in the RR of hospitalization in severely immunocompromised outpatients (RR: .66; 95% CI: .50; .89; NNT = 16) and in high-risk outpatients aged ≥70 years (RR: .50; 95% CI: .34; .74; NNT = 10) when the last dose of the vaccine was received at least 6 months ago. Nirmatrelvir/ritonavir reduces the risk of COVID-19–associated hospitalization among incompletely vaccinated high-risk outpatients and among some subgroups of completely vaccinated high-risk outpatients.
- Coronavirus Disease 2019 Convalescent Plasma Outpatient Therapy to Prevent Outpatient Hospitalization: A Meta-Analysis of Individual Participant Data From 5 Randomized Trials
- Outpatient monoclonal antibodies are no longer effective and antiviral treatments for coronavirus disease 2019 (COVID-19) disease remain largely unavailable in many countries worldwide. Although treatment with COVID-19 convalescent plasma (CCP) is promising, clinical trials among outpatients have shown mixed results. Researchers conducted an individual participant data meta-analysis from outpatient trials to assess the overall risk reduction for all-cause hospitalizations by day 28 in transfused participants. Relevant trials were identified by searching Medline, Embase, medRxiv, World Health Organization COVID-19 Research Database, Cochrane Library, and Web of Science from January 2020 to September 2022. Five included studies from 4 countries enrolled and transfused 2620 adult patients. Comorbidities were present in 1795 (69%). The virus neutralizing antibody dilutional titer levels ranged from 8 to 14 580 in diverse assays. One hundred sixty of 1315 (12.2%) control patients were hospitalized, versus 111 of 1305 (8.5%) CCP-treated patients, yielding a 3.7% (95% confidence interval [CI], 1.3%–6.0%; P = .001) absolute risk reduction and 30.1% relative risk reduction for all-cause hospitalization. The hospitalization reduction was greatest in those with both early transfusion and high titer with a 7.6% absolute risk reduction (95% CI, 4.0%–11.1%; P = .0001) accompanied by at 51.4% relative risk reduction. No significant reduction in hospitalization was seen with treatment >5 days after symptom onset or in those receiving CCP with antibody titers below the median titer. Among outpatients with COVID-19, treatment with CCP reduced the rate of all-cause hospitalization and may be most effective when given within 5 days of symptom onset and when antibody titer is higher.
- Outpatient monoclonal antibodies are no longer effective and antiviral treatments for coronavirus disease 2019 (COVID-19) disease remain largely unavailable in many countries worldwide. Although treatment with COVID-19 convalescent plasma (CCP) is promising, clinical trials among outpatients have shown mixed results. Researchers conducted an individual participant data meta-analysis from outpatient trials to assess the overall risk reduction for all-cause hospitalizations by day 28 in transfused participants. Relevant trials were identified by searching Medline, Embase, medRxiv, World Health Organization COVID-19 Research Database, Cochrane Library, and Web of Science from January 2020 to September 2022. Five included studies from 4 countries enrolled and transfused 2620 adult patients. Comorbidities were present in 1795 (69%). The virus neutralizing antibody dilutional titer levels ranged from 8 to 14 580 in diverse assays. One hundred sixty of 1315 (12.2%) control patients were hospitalized, versus 111 of 1305 (8.5%) CCP-treated patients, yielding a 3.7% (95% confidence interval [CI], 1.3%–6.0%; P = .001) absolute risk reduction and 30.1% relative risk reduction for all-cause hospitalization. The hospitalization reduction was greatest in those with both early transfusion and high titer with a 7.6% absolute risk reduction (95% CI, 4.0%–11.1%; P = .0001) accompanied by at 51.4% relative risk reduction. No significant reduction in hospitalization was seen with treatment >5 days after symptom onset or in those receiving CCP with antibody titers below the median titer. Among outpatients with COVID-19, treatment with CCP reduced the rate of all-cause hospitalization and may be most effective when given within 5 days of symptom onset and when antibody titer is higher.
- Association of Culturable-Virus Detection and Household Transmission of SARS-CoV-2, California and Tennessee, 2020–2022
- From 2 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) household transmission studies (enrolling April 2020 to January 2022) with rapid enrollment and specimen collection for 14 days, 61% (43/70) of primary cases had culturable virus detected ≥6 days post-onset. Risk of secondary infection among household contacts tended to be greater when primary cases had culturable virus detected after onset. Regardless of duration of culturable virus, most secondary infections (70%, 28/40) had serial intervals <6 days, suggesting early transmission. These data examine viral culture as a proxy for infectiousness, reaffirm the need for rapid control measures after infection, and highlight the potential for prolonged infectiousness (≥6 days) in many individuals.
Situation Dashboards
World Health Organization (WHO)
Novel Coronavirus (COVID-19) Situation from World Health Organization (WHO)
Johns Hopkins University (JHU)
Coronavirus COVID-19 Global Cases by the Center for Systems Science and Engineering (CSSE) at JHU
COVID-19 in US and Canada
1Point3Acres Real-Time Coronavirus (COVID-19) Updates in US and Canada with Credible Sources
Genomic Epidemiology COVID-19
Genomic Epidemiology of (COVID-19) Maintained by the Nextstrain team, enabled by data from GISAID.
