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Post by Admin on Jul 2, 2021 19:01:11 GMT
Johnson & Johnson vaccine shows promise against Delta variant, plus COVID-19 back-to-school concerns
#Johnson&Johnson #Deltavariant #coronavirus #backtoschool
Yahoo Finance's Anjalee Khemlani reports the latest news on the Delta variant and the Johnson&Johnson vaccine, Anjalee also spoke with Dr. Paul Offit, Children’s Hospital of Philadelphia (CHOP) director of the Vaccine Education Center about concerns regarding COVID-19 as children get ready to return to school in the fall.
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Post by Admin on Jul 2, 2021 19:47:20 GMT
Johnson & Johnson said its Covid vaccine showed promising signs of protecting against the delta variant of Covid-19 in a small laboratory study. The company said the vaccine triggered a strong immune response in blood samples taken from eight vaccinated people. J&J reported the findings in a news release, not a peer-reviewed study. Dr. Scott Gottlieb, member of the boards of Pfizer and biotech company Illumina and former FDA commissioner, joined "Squawk Box" on Friday to discuss. Johnson & Johnson's COVID-19 vaccine offers strong protection against the delta variant of the coronavirus, the company said Thursday. And the protection appears to last at least eight months. The results follow similar announcements about the Pfizer and Moderna vaccines in the fight against the fast-spreading delta strain. In one small laboratory study, researchers observed what happened to the blood of eight vaccinated individuals when it was exposed to the delta variant. And they found that antibodies and immune system cells in the blood were highly effective at neutralizing the virus. A second study involving 20 patients at Beth Israel Deaconess Medical Center in Boston showed similar results. Johnson & Johnson also noted the vaccine continued to be effective over the eight months it was studied in recipients. Dr. Mathai Mammen, the company's global head of research and development, said the vaccine elicits a "strong neutralizing antibody response that does not wane; rather, we observe an improvement over time."
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Post by Admin on Jul 2, 2021 21:58:33 GMT
The Johnson & Johnson COVID-19 vaccine is highly effective against the highly transmissible delta variant, the company announced on Thursday (July 1). Though the analysis was conducted on only a small number of participants and hasn't yet been peer-reviewed, it suggests that the Johnson & Johnson vaccine, like the Pfizer and Moderna's vaccines, may provide a buffer for the U.S. against the highly transmissible variant. The findings were submitted as two separate studies to the preprint server bioRxiv. The delta variant (B.1.617.2) was first discovered in India in October 2020, and the World Health Organization designated it a "variant of concern" in May 2021, Live Science previously reported. The variant has spread to at least 92 countries and prompted new COVID-19 restrictions in some places. In the U.K., the delta variant now accounts for more than 90% of newly diagnosed cases, and in the U.S., it currently makes up more than 20% of new cases, Live Science reported. Delta is thought to be around 60% more transmissible than the alpha variant, the variant first discovered in the U.K. and the one that is currently dominant in the United States. A recent study conducted by Public Health England found that Pfizer's COVID-19 vaccine was 88% effective against symptomatic disease caused by the delta variant, while AstraZeneca's vaccine was 60% effective against the variant, Live Science reported. Because Moderna's COVID-19 vaccine is very similar to Pfizer's vaccine (they're both mRNA vaccines), experts think it will likely confer a similar amount of protection. But less was known about how protective Johnson & Johnson's vaccine would be against the delta variant. Some experts predicted that the Johnson & Johnson vaccine would confer similar protection against delta as the AstraZeneca vaccine because they use the same platform, according to The New York Times. But the two vaccines have some differences, the major one being that Johnson & Johnson’s vaccine is given in a single dose, whereas AstraZeneca’s is given in two doses. The new data is based on two separate analyses. The first, based on data from eight participants in the company's phase 3 trial, found that the vaccine generated neutralizing antibodies — immune system cells that bind to the virus and inactivate it before it can infect cells — against the delta variant. The second analysis, conducted by researchers at the Beth Israel Deaconess Medical Center in Boston, analyzed data from 20 participants enrolled in an earlier clinical trial testing the vaccine. They found that the Johnson & Johnson vaccine protects people against SARS-CoV-2 for at least eight months and generates "neutralizing antibodies against a range of SARS-CoV-2 variants of concern," including delta, the company wrote. (Protection may persist beyond eight months, but this is the timeframe that researchers have studied so far). The level of neutralizing antibodies increased with time: People had a higher average number of neutralizing antibodies eight months after they were vaccinated compared with 29 days after they were vaccinated, according to the statement. The vaccine also generated immune system cells known as T cells that lasted for over eight months. "Current data for the eight months studied so far show that the single-shot Johnson & Johnson COVID-19 vaccine generates a strong neutralizing antibody response that does not wane; rather, we observe an improvement over time," Dr. Mathai Mammen, the global head of Johnson and Johnson's Janssen Research & Development, said in the statement. "In addition, we observe a persistent and particularly robust, durable cellular immune response." Moderna and Pfizer have previously both announced that their vaccine protects for at least six months, according to CNN. A small new study found that the mRNA vaccines might even provide protection for years if the virus doesn't evolve significantly, Live Science previously reported.
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Post by Admin on Jul 3, 2021 4:17:10 GMT
Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19 List of authors. Jerald Sadoff, M.D., Glenda Gray, M.B., B.Ch., An Vandebosch, Ph.D., Vicky Cárdenas, Ph.D., et al., for the ENSEMBLE Study Group* June 10, 2021 N Engl J Med 2021; 384:2187-2201 DOI: 10.1056/NEJMoa2101544 Abstract BACKGROUND The Ad26.COV2.S vaccine is a recombinant, replication-incompetent human adenovirus type 26 vector encoding full-length severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein in a prefusion-stabilized conformation. METHODS In an international, randomized, double-blind, placebo-controlled, phase 3 trial, we randomly assigned adult participants in a 1:1 ratio to receive a single dose of Ad26.COV2.S (5×1010 viral particles) or placebo. The primary end points were vaccine efficacy against moderate to severe–critical coronavirus disease 2019 (Covid-19) with an onset at least 14 days and at least 28 days after administration among participants in the per-protocol population who had tested negative for SARS-CoV-2. Safety was also assessed. RESULTS The per-protocol population included 19,630 SARS-CoV-2–negative participants who received Ad26.COV2.S and 19,691 who received placebo. Ad26.COV2.S protected against moderate to severe–critical Covid-19 with onset at least 14 days after administration (116 cases in the vaccine group vs. 348 in the placebo group; efficacy, 66.9%; adjusted 95% confidence interval [CI], 59.0 to 73.4) and at least 28 days after administration (66 vs. 193 cases; efficacy, 66.1%; adjusted 95% CI, 55.0 to 74.8). Vaccine efficacy was higher against severe–critical Covid-19 (76.7% [adjusted 95% CI, 54.6 to 89.1] for onset at ≥14 days and 85.4% [adjusted 95% CI, 54.2 to 96.9] for onset at ≥28 days). Despite 86 of 91 cases (94.5%) in South Africa with sequenced virus having the 20H/501Y.V2 variant, vaccine efficacy was 52.0% and 64.0% against moderate to severe–critical Covid-19 with onset at least 14 days and at least 28 days after administration, respectively, and efficacy against severe–critical Covid-19 was 73.1% and 81.7%, respectively. Reactogenicity was higher with Ad26.COV2.S than with placebo but was generally mild to moderate and transient. The incidence of serious adverse events was balanced between the two groups. Three deaths occurred in the vaccine group (none were Covid-19–related), and 16 in the placebo group (5 were Covid-19–related). CONCLUSIONS A single dose of Ad26.COV2.S protected against symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection and was effective against severe–critical disease, including hospitalization and death. Safety appeared to be similar to that in other phase 3 trials of Covid-19 vaccines. (Funded by Janssen Research and Development and others; ENSEMBLE ClinicalTrials.gov number, NCT04505722. opens in new tab.)
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Post by Admin on Jul 3, 2021 6:20:54 GMT
Since emerging in December 2019, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has caused high morbidity and mortality, with new variants rapidly spreading.1-4 Vaccines to prevent coronavirus disease 2019 (Covid-19) have been developed with unprecedented speed.5,6
The Ad26.COV2.S vaccine comprises a recombinant, replication-incompetent human adenovirus type 26 (Ad26) vector7 encoding a full-length, membrane-bound SARS-CoV-2 spike protein in a prefusion-stabilized conformation.8,9 Other Ad26-based vaccines, including an approved Ebola vaccine, are safe and have induced durable immune responses.8,10-13 Ad26.COV2.S induced durable protection at low doses in preclinical SARS-CoV-2 challenge studies,8,14 and initial clinical data showed that a single dose at 5×1010 viral particles was safe and induced excellent humoral and cellular immune responses.9 Ad26.COV2.S can be stored for up to 2 years in a standard freezer and up to 3 months at refrigerator temperatures, which simplifies transport, storage, and use in a pandemic.
We are conducting an ongoing phase 3 trial (ENSEMBLE) to evaluate the safety and efficacy of a single dose of Ad26.COV2.S at 5×1010 viral particles for the prevention of Covid-19 and SARS-CoV-2 infection in adults. Here, we report the results of the primary analyses.
Methods
TRIAL DESIGN AND OVERSIGHT We are conducting this ongoing, 2-year, multicenter, randomized, double-blind, placebo-controlled, phase 3, pivotal trial in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States. All the participants provided written informed consent. The trial adheres to the principles of the Declaration of Helsinki and to the Good Clinical Practice guidelines of the International Council for Harmonisation. The protocol (available with the full text of this article at NEJM.org) and amendments were approved by institutional review boards according to local regulations. An unblinded independent data and safety monitoring board continuously monitors safety, including monitoring for vaccine-associated enhanced respiratory disease.
The trial is a collaboration between the sponsor, Janssen Research and Development, which is an affiliate of Janssen Vaccines and Prevention and part of the Janssen pharmaceutical companies of Johnson & Johnson, and the Operation Warp Speed Covid-19 Rapid Response Team (which includes the Biomedical Advanced Research and Development Authority, the National Institutes of Health, the Covid-19 Prevention Trials Network, and the Department of Defense). The trial was designed and conducted, and the data analysis and data interpretation were performed, by the sponsor and collaborators. Trial-site investigators collected and contributed to the interpretation of the data. All the data were available to the authors, who vouch for the accuracy and completeness of the data and for the fidelity of the trial to the protocol. Medical writers who were funded by the sponsor assisted in drafting the manuscript.
TRIAL PARTICIPANTS Stages 1a and 2a of the trial were conducted in parallel and included 2000 adults 18 to 59 years of age and 60 years of age or older, respectively, who were in good or stable health and did not have coexisting conditions that have been associated with an increased risk of severe Covid-19. After a 3-day safety review by the data and safety monitoring board, stages 1b and 2b were initiated. Those stages additionally included adults of the same respective age ranges who had stable and well-controlled coexisting conditions. The eligibility criteria are provided in the Supplementary Methods section in the Supplementary Appendix, available at NEJM.org. Participants were not excluded on the basis of SARS-CoV-2 infection or serostatus.
PROCEDURES Details of the trial procedures are provided in the Supplementary Methods section. Participants were randomly assigned in a 1:1 ratio, with the use of randomly permuted blocks, to receive either Ad26.COV2.S or saline placebo. Randomization was conducted with an interactive Web-response system and stratified according to trial site, age group, and the presence or absence of coexisting conditions that have been associated with an increased risk of severe Covid-19.
Vaccine or placebo was administered on day 1. Ad26.COV2.S was supplied in single-use vials at a concentration of 1×1011 viral particles per milliliter and was administered at a dose of 5×1010 viral particles as a single intramuscular injection (0.5 ml) by a health care worker who was unaware of the group assignment.
Participants reported Covid-19 symptoms electronically using the Symptoms of Infection with Coronavirus-19 questionnaire (methods described in Fig. S1 in the Supplementary Appendix). Participants and trial staff obtained nasal swabs, which were tested with the use of a Food and Drug Administration (FDA) Emergency Use Authorization reverse-transcriptase–polymerase-chain-reaction (RT-PCR) assay for SARS-CoV-2 at a local laboratory and subsequently confirmed centrally (m-2000 SARS-CoV-2 real-time RT-PCR, Abbott). Seropositivity for SARS-CoV-2 was evaluated by means of a SARS-CoV-2 nucleocapsid (N) immunoassay (Elecsys, Roche) at trial entry and on days 29 and 71. Assays were performed according to the manufacturers’ protocols.
Primary and key secondary efficacy evaluations were based on centrally confirmed cases of Covid-19. Owing to the high incidence of Covid-19 and the time taken for central confirmation, not all cases had been centrally confirmed at the time of the primary analysis. A supplementary analysis of RT-PCR–positive cases from all sources, whether centrally confirmed or not, was therefore performed for subgroups, hospitalizations, and deaths.
SAFETY ASSESSMENTS Serious adverse events and adverse events leading to withdrawal from the trial are being recorded throughout the trial. In a safety subpopulation comprising approximately 6000 participants (see below), data on solicited local and systemic adverse events were recorded in an electronic diary for 7 days after administration and unsolicited adverse events for 28 days after administration.
EFFICACY ASSESSMENTS The two primary end points were the efficacy of the Ad26.COV2.S vaccine against the first occurrence of centrally confirmed moderate to severe–critical Covid-19 with an onset at least 14 days after administration and at least 28 days after administration in the per-protocol population (see below). All the potential cases of severe–critical Covid-19 and cases of moderate Covid-19 with at least three signs or symptoms were classified as being severe–critical by an independent Clinical Severity Adjudication Committee whose members were unaware of the group assignments. This committee adjudicated cases on the basis of clinical judgment (e.g., a single low oxygen-saturation measurement was not classified as indicating severe Covid-19 unless other clinical findings were consistent with a severe classification). The case definitions for Covid-19 and the protocol-defined secondary and exploratory end points are described in the Supplementary Appendix.
STATISTICAL ANALYSIS The full analysis set included all the participants who underwent randomization and received a dose of trial vaccine or placebo. The per-protocol population comprised participants who received a dose of trial vaccine or placebo, were seronegative or had an unknown serostatus at the time that the vaccine or placebo was administered, and had no protocol deviations that were likely to affect vaccine efficacy. Participants who were RT-PCR–positive between days 1 and 14 or between days 1 and 28 were excluded from the analysis of cases with an onset at least 14 days after administration and at least 28 days after administration, respectively. The per-protocol population was the main population for the efficacy analyses. Safety analyses were conducted in the full analysis set, including the safety subpopulation.
The null hypothesis was that the efficacy of Ad26.COV2.S would be no higher than 30% for each primary end point, as evaluated with a truncated sequential probability ratio test15,16 at a one-sided significance level of 0.025. The sample size was reduced from 60,000 to approximately 40,000 on the basis of the high incidence of Covid-19 during the trial. The primary analysis was triggered on a positive recommendation from the data and safety monitoring board, after the FDA-specified median 8-week follow-up was reached and prespecified data requirements were met.
If the null hypothesis was rejected for both primary end points, secondary objectives were evaluated against a null hypothesis that used a lower limit of vaccine efficacy of more than 0% with prespecified multiplicity adjustments for familywise type I error control (Fig. S2). Exact Poisson regression17 was used for the analysis of vaccine efficacy and the associated confidence interval calculations, with accounting for follow-up time. The cumulative incidence over time was estimated with the use of Kaplan–Meier methods to evaluate the onset of vaccine efficacy and vaccine efficacy over time. Participants had their data censored at the end of their follow-up.
The frequency of serious adverse events was tabulated in the full analysis set. The frequency and severity of solicited and unsolicited adverse events were tabulated in the safety subpopulation.
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