26.03.21 Ann Intern Med COVID-19 Vaccine: Practical Clinical Considerations. There remain many unknowns about COVID-19 vaccine, but there has been great progress since Annals of Internal Medicine and the American College of Physicians hosted our first COVID-19 vaccine forum in October 2020.
That initial forum described the science, approval process, development of clinical indications, and policy environment of vaccines that were in initial phase 3 trials (1). Subsequent forums in December 2020 and January 2021 addressed promoting vaccine acceptance (2) and distribution (3), respectively. Now only 5 months later, the discussion during our most recent forum on 24 March 2021 centered around questions about the 3 vaccines that have received emergency use approval by the U.S. Food and Drug Administration (FDA) and that are, thankfully, being administered with increasing rapidity in the United States. Are there people who should not receive COVID-19 vaccination? The forum held on 24 March 2021 aimed to address the issues on many clinicians' minds. NYT 31.03.21 Factory Mix-Up Ruins Up to 15 Million J&J Coronavirus Vaccine Doses. WASHINGTON — Workers at a plant in Baltimore manufacturing two coronavirus vaccines accidentally conflated the ingredients several weeks ago, contaminating up to 15 million doses of Johnson & Johnson’s vaccine and forcing regulators to delay authorization of the plant’s production lines.
The plant is run by Emergent BioSolutions, a manufacturing partner to both Johnson & Johnson and AstraZeneca, the British-Swedish company whose vaccine has yet to be authorized for use in the United States. Federal officials attributed the mistake to human error. The mix-up has delayed future shipments of Johnson & Johnson doses in the United States while the Food and Drug Administration investigates what occurred. 01.04.21 Pfizer and BioNTech Confirm High Efficacy and No Serious Safety Concerns Through Up to Six Months Following Second Dose in Updated Topline Analysis of Landmark COVID-19 Vaccine Study.
Analysis of 927 confirmed symptomatic cases of COVID-19 demonstrates BNT162b2 is highly effective with 91.3% vaccine efficacy observed against COVID-19, measured seven days through up to six months after the second doseVaccine was 100% effective in preventing severe disease as defined by the U.S.
Centers for Disease Control and Prevention and 95.3% effective in preventing severe disease as defined by the U.S. Food and Drug Administration Vaccine was 100% effective in preventing COVID-19 cases in South Africa, where the B.1.351 lineage is prevalentVaccine safety now evaluated in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after their second doseThe companies plan to share these results with worldwide regulatory agencies soon NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. 30.03.21 FACME sobre trombosis trombocitopenicas ASTRAZENECA.
Preevid: ¿Existe contraindicación a la vacunación con AstraZeneca de pacientes con antecedentes familiares de trombosis? / Is there a contraindication to vaccination with AstraZeneca in patients with a family history of thrombosis? Pinceladas 20210330. 31.03.21 MPR Oxford AstraZeneca COVID 19 Vaccine Does Not Protect Against B.1.351 SARS CoV 2 Variant. Bmj 22.03.21 AZ vacuna previene 79% de Covid sintom. y 100% Covid grave.
CNN 17.03.21 Coronavirus strains first detected in California are officially ;variants of concern,' CDC says. The variants may be about 20% more transmissible, the CDC said, citing early research.
Some Covid-19 treatments may also be less effective against the strains. Still, the CDC didn't say that vaccines would stop working against them. In laboratory studies, antibodies from vaccinated people do seem to be less effective at neutralizing the strains. 30.03.21 MPR CDC Classifies 2 Coronavirus Strains as 'Variants of Concern' 31.03.21 Vacuna en adolescentes Pfizer. In participants aged 12-15 years old, BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those reported in trial of vaccinated 16-25 year old participants in an earlier analysis, and was well tolerated The companies plan to submit these data to the U.S.
Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as soon as possible to request expansion of the Emergency Use Authorization (EUA) and EU Conditional Marketing Authorization for BNT162b2The companies also provided an update on the Phase 1/2/3 study of BNT162b2 in children aged 6 months to 11 years NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. 29.03.21 JWatch The British SARS CoV 2 Variant of Concern, B.1.1.7, Reveals Its Lethality. 30.03.21 JWatch Outcomes in Solid Organ Transplant Recipients After the First Dose of Either SARS CoV 2 mRNA Vaccine. Jama boyarsky 15.03.21 Vacunas en trasplantados. Mar.21 American Society for Bone and Mineral Research- Guidance on COVID-19 Vaccination and Osteoporosis Management from the ASBMR, AACE, Endocrine Society, ECTS, IOF, and NOF.
Joint Guidance on COVID-19 Vaccination and Osteoporosis Management from the American Society for Bone and Mineral Research (ASBMR), American Association of Clinical Endocrinology (AACE), Endocrine Society, European Calcified Tissue Society (ECTS), the International Osteoporosis Foundation (IOF), and the National Osteoporosis Foundation (NOF) The guidance below has been created to assist clinicians in the management of patients with osteoporosis who will receive vaccination against COVID-19.
The current pandemic has necessitated the implementation of strategies that have disrupted medical care for patients with osteoporosis.(1,2) We acknowledge that there is a paucity of data to provide clear guidance. Thus, the below recommendations are based primarily on expert opinion. General Recommendations Osteoporosis per se does not appear to increase the risk for infection with or complications from COVID-19. Evidence Denosumab (Prolia®) 29 03 21 EMA covid 19 vaccine safety update vaxzevria previously covid 19 vaccine astrazeneca 29 march 2021 en. MMWR 29.03.21 RWD Efectividad vaccunas. Studies in Additional Populations. 26.03.21 GSK and Vir Biotechnology announce submission of Emergency Use Authorization request to FDA for VIR-7831 for the early treatment of COVID-19.
Issued: London, UK and San Francisco, US GlaxoSmithKline plc and Vir Biotechnology, Inc. today announced the submission of an application to the U.S.
Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for VIR-7831 (GSK4182136) an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with mild-to-moderate COVID-19 who are at risk for progression to hospitalisation or death. The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation.
Preclinical data suggest VIR-7831 targets a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop. Bmj.18.03.21 Demora en la segunda dosis. 25.03.21 MPR Primary Analysis Shows AstraZeneca's COVID 19 Vaccine 76% Effective. AZD1222 US Phase III primary analysis confirms safety and efficacy. Positive high-level results from the primary analysis of the Phase III trial of AZD1222 in the US have confirmed vaccine efficacy consistent with the pre-specified interim analysis announced on Monday 22 March 2021.
These results have been presented to the independent Data Safety Monitoring Board. The primary analysis is pre-specified in the protocol and will be the basis for a regulatory submission for Emergency Use Authorization to the US Food and Drug Administration in the coming weeks. This primary efficacy analysis included the accrual of 190 symptomatic cases of COVID-19 from the 32,449 trial participants, an additional 49 cases to the previously announced interim analysis. Participants were randomised on a 2:1 ratio between the vaccine and placebo group. The primary endpoint, vaccine efficacy at preventing symptomatic COVID-19 was 76% (confidence interval (CI): 68% to 82%) occurring 15 days or more after receiving two doses given four weeks apart.
NEJM 18.03.21 How Well Does the Oxford AstraZeneca Vaccine Stand Up Against the South African SARS CoV 2 Variant. NEJM Journal Watch 18.03.21 In Previously Infected Persons, Is One Dose of mRNA COVID 19 Vaccine Enough. Medscape 22.03.21 79% eficacia global. AZ 23.03.21 Update following statement by NIAID on AZD1222 US Phase III trial data.
The numbers published yesterday were based on a pre-specified interim analysis with a data cut-off of 17 February.
We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis. We are now completing the validation of the statistical analysis. We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data. We intend to issue results of the primary analysis within 48 hours. AstraZenecaAstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology.
ContactsFor details on how to contact the Investor Relations Team, please click here. 23.03.21 NIAID Statement on AstraZeneca Vaccine. News Release Tuesday, March 23, 2021 Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial.
The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible. MPR 22.03.21 ACAAI Updates Guidance for Allergic Reactions to COVID 19 Vaccines. MPR 22.03.21 Interim Phase 3 Analysis Russian COVID 19 Vaccine Shows 91.6% Efficacy. MPR 22.03.21 Pfizer vaccine eficacia in a nationwide mass vaccination program. AZ 22.03.21 AZ vaccine US Phase III trial met primary efficacy endpoint in preventing COVID-19 at interim analysis.
The AstraZeneca US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation. MPR 19.03.21 Pediatric Trial Evaluating Moderna’s COVID 19 Vaccine Begins. RSG Medidas para evitar EM en la vacunación Covid 19. 22.03.21 Hemos Leído Vacunación masiva contra el SARS-CoV-2: una necesidad mundial. Leemos en el último NEJM una reflexión sobre la gestión de la vacunación masiva que se está llevando a cabo en los “países afortunados” que reciben vacunas contra el SARS-CoV-2 para proteger a su población.
Aunque la velocidad del desarrollo y evaluación de estas vacunas ha superado con creces las expectativas del mundo científico, el despliegue inicial de su distribución mundial se ha ralentizado (e incluso paralizado temporalmente), por lo que debemos estar preparados y tener un buen plan de vacunación masiva, para cuando realmente lleguen todas las unidades de vacunas prometidas por los laboratorios farmacéuticos. En un principio, se anunció que se iban a aprovechar los sitios de atención médica comunitarios existentes para administrar las vacunas, es decir, los Centros de Salud. Sin embargo, el uso de estos espacios no es suficiente para lograr una vacunación lo suficientemente rápida como para detener la pandemia. Si te gustó, puedes compartirlo... MPR 17.03.21 Partial Pfizer COVID 19 Vaccination 63% Effective MPR. 17.03.21 WHO Interim recommendations for the use of the Janssen Ad26.COV2.S (COVID-19) vaccine: interim guidance, 17 March 2021.
Jama edara 19.03.2021 Ac neutralizantes tras infección y vacunación. MPR 19.03.21 Novavax COVID 19 Vaccine Highly Effective in Clinical Trials. 15.03.21 MPR Novavax COVID 19 Vaccine Highly Effective in Clinical Trials. 17.03.21 jama rubin 2021 Vacunas y Covid cuándo la inmunidad es suficiente. MPR 17.03.21 Challenges of Global COVID 19 Vaccinations Production, Affordability, Allocation, and Deployment. COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets. EMA’s safety committee, PRAC, concluded its preliminary review of a signal of blood clots in people vaccinated with COVID-19 Vaccine AstraZeneca at its extraordinary meeting of 18 March 2021.
The Committee confirmed that: the benefits of the vaccine in combating the still widespread threat of COVID-19 (which itself results in clotting problems and may be fatal) continue to outweigh the risk of side effects;the vaccine is not associated with an increase in the overall risk of blood clots (thromboembolic events) in those who receive it;there is no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites;however, the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e. low levels of blood platelets (elements in the blood that help it to clot) with or without bleeding, including rare cases of clots in the vessels draining blood from the brain (CVST). Information for patients More about the medicine. 16 03 21 Nota AZ PreguntasyRespuestas MINISTERIO DE SANIDAD. 16 03 21 Nota AZ Eventos InfoProfesionales MINISTERIO DE SANIDAD. MPR 11.03.21 Real World Data Demonstrate Effectiveness of Pfizer BioNTech COVID 19 Vaccine.
Jama adhikari 08.02.2021 Vacuna Covid en embarazo y lactancia. Nejm16.03.21 Cepa sudafricana y vacuna AZ. NI AEMPS 15 21 AEMPS balance AstraZeneca 12 3 2021. 14.03.21 AZ -Update on the safety of COVID-19 Vaccine AstraZeneca. Following a recent concern raised around thrombotic events, AstraZeneca would like to offer its reassurance on the safety of its COVID-19 vaccine based on clear scientific evidence. Safety is of paramount importance and the Company is continually monitoring the safety of its vaccine.
A careful review of all available safety data of more than 17 million people vaccinated in the European Union (EU) and UK with COVID-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country. So far across the EU and UK, there have been 15 events of DVT and 22 events of pulmonary embolism reported among those given the vaccine, based on the number of cases the Company has received as of 8 March. This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines.
Jama boyarsky 15.03.2021 Vacuna mRNA en trasplantados. 12.03.21 MPR Bahrat Biotech Inactivated Vaccine COVID 19 Vaccine Enhances Immune Response, Phase 1 Results. MPR 11.03.21 Psoriasis Task Force Says Take the First Available COVID 19 Vaccine. 11.03.21 WHO adds Janssen vaccine to list of safe and effective emergency tools against COVID-19. The World Health Organization (WHO) today listed the COVID-19 vaccine Ad26.COV2.S, developed by Janssen (Johnson & Johnson), for emergency use in all countries and for COVAX roll-out. The decision comes on the back of the European Medicines Agency (EMA) authorization, which was announced yesterday. “Every new, safe and effective tool against COVID-19 is another step closer to controlling the pandemic,” said WHO Director-General, Dr Tedros Adhanom Ghebreyesus.
“But the hope offered by these tools will not materialize unless they are made available to all people in all countries. 14.03 The Guardian Netherlands joins Ireland in vaccine suspension over blood clot concerns. The Netherlands has joined Ireland in suspending use of the Oxford/AstraZeneca coronavirus vaccine as a precautionary measure following further reports of blood clots in people who have received it, this time from Norway. Announcing the move late on Sunday, the Dutch health ministry said there was no proof yet of a direct link between the vaccine and reports of possible side-effects from Norway and Denmark and it had not recorded any cases in the Netherlands. The government said it would now wait for an investigation by the European Medicines Agency (EMA). “We can’t allow any doubts about the vaccine,” Dutch health minister Hugo de Jonge said.
“We have to make sure everything is right, so it is wise to pause for now.” Earlier that day, Ireland’s deputy chief medical officer, Dr Ronan Glynn, said the country’s advisory body on vaccines had recommended that deployment of the AstraZeneca jab should be “temporarily deferred” with immediate effect. EMA 11.03.21 COVID-19 Vaccine AstraZeneca: PRAC investigating cases of thromboembolic events - vaccine’s benefits currently still outweigh risks - Update. EMA is aware that the Danish Health Authority has paused its vaccination campaign with COVID-19 Vaccine AstraZeneca. This was decided as a precautionary measure while a full investigation is ongoing into reports of blood clots in people who received the vaccine, including one case in Denmark where a person died.
MPR 15.03.21 Tocilizumab más redemsivir. Bmj.10.03.21 EMA data leak inestabilidad vacuna mRNA. Bmj.02.03.21 primera dosis vacuna Pf y AZ reduce ingresos por Covid. Bmj.09.03.21 Booster Dosis de recuerdo en otoño. Medscap 09.03.21 COVID Positive After Two Vaccine Doses? What It Means. Authors. Jama stephenson 11.03.2021 Inmunogenicidad vvacuna Janssen. AEMPS 11.03.21 La EMA recomienda la autorización de la cuarta vacuna frente a la COVID-19 - Agencia Española de Medicamentos y Productos Sanitarios. Fecha de publicación: 11 de marzo de 2021 Categoría: la AEMPS, Medicamentos de Uso Humano, Vacunas, COVID-19 Referencia: AEMPS, 14/2021 La vacuna desarrollada por Janssen previene la enfermedad causada por SARS-CoV-2 en personas a partir de 18 añosEl CHMP, formado por expertos de las autoridades competentes, entre ellas la AEMPS, ha completado su evaluación científica concluyendo por consenso que dispone de datos suficientemente sólidos sobre la calidad, seguridad y eficacia de esta vacunaSe trata de la única de las cuatro vacunas autorizadas que se administrará en una única dosisLa Comisión Europea será ahora la encargada de otorgar esta autorización de comercialización condicional para que pueda distribuirse en todos los Estados miembro de la UE La Agencia Europea del Medicamento (EMA, por sus siglas en inglés) ha recomendado que se otorgue una autorización de comercialización condicional a la vacuna frente a la COVID-19 desarrollada por Janssen (una compañía de Johnson&Johnson).
Nejm10.03.21 Inmunidad en pac con antedecentes de Covid tras primera dosis. MPR 09.03.21 SIDA y COVID grave. CDC 08.03.21 Interim Public Health Recommendations for Fully Vaccinated People. Visits or small gatherings likely represent minimal risk to fully vaccinated people. Medium or large-sized gatherings and those including unvaccinated people from multiple households increase the risk of SARS-CoV-2 transmission. Though the risk of disease may be minimal to the fully vaccinated person themselves, they should be mindful of their potential risk of transmitting the virus to others if they become infected, especially if they are visiting with unvaccinated people at increased risk for severe illness from COVID-19 or who have unvaccinated people at increased risk for severe disease in their own households.
Fully vaccinated people should not visit or attend a gathering if they have tested positive for COVID-19 in the prior 10 days or are experiencing COVID-19 symptoms, regardless of vaccination status of the other people at the gathering. Visits between fully vaccinated people. Dr. B – Standby list for leftover COVID vaccines. Jama blumenthal 08.03.21 Alergia a vacunas mRNA. Jama blumenthal 08.03.21 RAM agudas a vacunas mRNA. MPR 05.03.21 ACR Releases COVID 19 Vaccine Clinical Guidance for Patients With Rheumatic and Musculoskeletal Diseases Infectious Disease Advisor. Medscape 04.03.21 Comparación 9 vacunas. Medscape 05.03.21 Vacuna con 1 sola dosis. Jama saadat 01.03.21 Ac tras primera dosis de vacuna en pacientes con historia de Covid. Bmj.02.03.21 Vacunas y variantes.
CDC 03.03 Interim Clinical Considerations for Use of COVID-19 Vaccines. Summary of recent changes (last updated March 3, 2021): 04.03 Variantes Covid. Jama moore 04.03 2021 Vacunas y variantes. MPR 02.03 COVID 19 Vaccine Efficacy After First Dose Pfizer, Moderna, AstraZeneca. Nejm03,03,21 Preferencias individuales con las vacunas. Coronavirus (COVID-19) Update: Vaccines and Immunity. MMWR 02.03.21 The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Janssen COVID-19 Vaccine. Vacunas covid pacientes MERIDA. Early effectiveness of COVID vaccines con 1 sola dosis preprint. Jama 01.03.21 livingston Vacuna de J&J. Jama saadat 01.03.2021 Ac tras la primera dosis de vacuna.
03.03. Janssen Single Shot COVID 19 Vaccine Gets Emergency Use Authorization. MPR 01.03 Janssen's Single Shot COVID 19 Vaccine Gets Emergency Use Authorization. FDA 27.02.21 Issues Emergency Use Authorization for Third COVID-19 Vaccine. For Immediate Release: February 27, 2021. 28.02.21 CDC Media Statement from CDC Director on Signing the Advisory Committee on Immunization Practices’ Recommendation to Use Janssen’s COVID-19 Vaccine in People 18 and Older. Today, I signed CDC’s Advisory Committee on Immunization Practices’ (ACIP) recommendation that endorsed the safety and effectiveness of Janssen (Johnson & Johnson)’s COVID-19 vaccine and its use in people age 18 and older. This official CDC recommendation — which follows Saturday’s FDA decisionexternal icon to authorize emergency use of the vaccine — is another milestone toward an end to the pandemic.
MPR 19.02.21 Pfizer BioNTech COVID 19 Vaccine Trial in Pregnant Women Begins; New Storage Data Submitted to FDA. MPR 25.02. Moderna Outlines Strategy to Address SARS CoV 2 Variants; Ships Variant Booster to NIH for Testing. JAMA creech 26.02.21 Vacunas rev. 25.02 MPR COVID 19 Vaccine Efficacy After First Dose Pfizer, Moderna, AstraZeneca. Pfizer 25.02. Nuevo estudio dosis booster vacuna eficacia variantes. MPR 23.02.21 CDC Report Shows No Evidence of Unexpected Adverse Events With COVID 19 Vaccines. MPR 24.02.21 Pfizer BioNTech COVID 19 Vaccine Trial in Pregnant Women Begins; New Storage Data Submitted to FDA. FarmaAPCOVID19 20210225 Vacuna AstraZeneca. FarmaAP 20210225 Anafilaxia Adultos CS.
Nejm 24.02 Estudio RWD vacuna Pfizer. FDA 26.92 Eficacia vacuna J&J. Jama shimabukuro 21.02.21 Anafilaxia vacuna Covid.