Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico.

BACKGROUND: NVX-CoV2373 is an adjuvanted, recombinant spike protein nanoparticle vaccine that was shown to have clinical efficacy for the prevention of coronavirus disease 2019 (Covid-19) in phase 2b-3 trials in the United Kingdom and South Africa, but its efficacy had not yet been tested in North America. METHODS: We conducted a phase 3, randomized, observer-blinded, placebo-controlled trial in the United States and Mexico during the first half of 2021 to evaluate the efficacy and safety of NVX-CoV2373 in adults (≥18 years of age) who had not had severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Participants were randomly assigned in a 2:1 ratio to receive two doses of NVX-CoV2373 or placebo 21 days apart. The primary objective was to determine vaccine efficacy against reverse-transcriptase-polymerase-chain-reaction-confirmed Covid-19 occurring at least 7 days after the second dose. Vaccine efficacy against moderate-to-severe disease and against different variants was also assessed. RESULTS: Of the 29,949 participants who underwent randomization between December 27, 2020, and February 18, 2021, a total of 29,582 (median age, 47 years; 12.6% ≥65 years of age) received at least one dose: 19,714 received vaccine and 9868 placebo. Over a period of 3 months, 77 cases of Covid-19 were noted - 14 among vaccine recipients and 63 among placebo recipients (vaccine efficacy, 90.4%; 95% confidence interval [CI], 82.9 to 94.6; P<0.001). Ten moderate and 4 severe cases occurred, all in placebo recipients, yielding vaccine efficacy against moderate-to-severe disease of 100% (95% CI, 87.0 to 100). Most sequenced viral genomes (48 of 61, 79%) were variants of concern or interest - largely B.1.1.7 (alpha) (31 of the 35 genomes for variants of concern, 89%). Vaccine efficacy against any variant of concern or interest was 92.6% (95% CI, 83.6 to 96.7). Reactogenicity was mostly mild to moderate and transient but was more frequent among NVX-CoV2373 recipients than among placebo recipients and was more frequent after the second dose than after the first dose. CONCLUSIONS: NVX-CoV2373 was safe and effective for the prevention of Covid-19. Most breakthrough cases were caused by contemporary variant strains. (Funded by Novavax and others; PREVENT-19 ClinicalTrials.gov number, NCT04611802.).

Humoral Immunogenicity of the mRNA-1273 Vaccine in the Phase 3 Coronavirus Efficacy (COVE) Trial.

BACKGROUND: Messenger RNA (mRNA)-1273 vaccine demonstrated 93.2% efficacy against coronavirus disease 2019 (COVID-19) in the Coronavirus Efficacy (COVE) trial. The humoral immunogenicity results are now reported. METHODS: Participants received 2 mRNA-1273 (100 µg) or placebo injections, 28 days apart. Immune responses were evaluated in a prespecified, randomly selected per-protocol immunogenicity population (n = 272 placebo; n = 1185 mRNA-1273). Serum binding antibodies (bAbs) and neutralizing antibodies (nAbs) to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-spike protein were assessed at days 1, 29, and 57 by baseline SARS-CoV-2-negative (n = 1197) and SARS-CoV-2-positive (n = 260) status, age, and sex. RESULTS: SARS-CoV-2-negative vaccinees had bAb geometric mean AU/mL levels of 35 753 at day 29 that increased to 316 448 at day 57 and nAb inhibitory dilution 50% titers of 55 at day 29 that rose to 1081 at day 57. In SARS-CoV-2-positive vacinees, the first mRNA-1273 injection elicited bAb and nAb levels that were 11-fold (410 049) and 27-fold (1479) higher than in SARS-CoV-2-negative vaccinees, respectively, and were comparable to levels after 2 injections in uninfected participants. Findings were generally consistent by age and sex. CONCLUSIONS: mRNA-1273 elicited robust serologic immune responses across age, sex, and SARS-CoV-2 status, consistent with its high COVID-19 efficacy. Higher immune responses in those previously infected support a booster-type effect. Clinical Trials Registration. NCT04470427.

Rapid assessment of avoidable blindness: Prevalence of blindness, visual impairment and diabetes in nuevo leon, Mexico 2014.

PURPOSE: To estimate the prevalence of blindness, visual impairment, diabetes mellitus, and diabetic retinopathy in patients aged 50 years and older in the State of Nuevo León, Mexico. METHODS: Ninety-one clusters of 60 people aged 50+ were selected randomly and a rapid assessment of avoidable blindness (RAAB) was conducted. Participants had their visual acuity and cause of visual impairment assessed, underwent a random glucose test and fundoscopy under mydriasis if they had diabetes. The diabetic retinopathy (DR) degree was classified according to the Scottish diabetic retinopathy grading scheme. RESULTS: From the sample 5,055 (92.6%) people were examined. The blindness prevalence was 1.7% (95% Confidence Interval: 1.3-2.1%). Cataract (32.6%), DR (29.1%) and glaucoma (16.3%) were the leading causes of blindness. The prevalence of severe, moderate, and early visual impairment was 1.0%, 5.1%, and 7.7%, respectively. Among respondents, 31% had diabetes and 8.1% of them was not diagnosed prior to the study. Of all participants with diabetes, 50% had glucose levels of 200 mg/dl or higher and 15.7% had sight-threatening diabetic retinopathy. CONCLUSIONS: Besides strengthening of cataract intervention activities, more ophthalmic services for diabetic retinopathy and glaucoma control are needed in Nuevo León to provide timely intervention to prevent blindness.

Corneal compensation of presbyopia: PresbyLASIK: an updated review.

ABSTRACT: The main purpose of this review is to compare and analyze the results of the main PresbyLASIK approaches; central and peripheral. SUMMARY: A comprehensive research was conducted in PUBMED using keywords like "presbyopia correction", "PresbyLASIK", "Corneal multifocality", "Laser blended vision". We reviewed the PresbyLASIK technique, uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), uncorrected near visual acuity (UNVA), and corrected near visual acuity (CNVA), and compared the differences between the techniques.