¿Qué ensayos de la vacuna covid-19 se interrumpieron y cuáles fueron las preocupaciones de seguridad sanitaria?
(Which covid-19 vaccine trials were paused and what were the health safety concerns?)
Primeras 5 respuestas:
-
The phase 1/2 trial was briefly paused after a participant developed neurological symptoms, which were later linked to multiple sclerosis.
-
delaying subject enrollment and operational gaps in most ongoing clinical trials, which in turn has a negative impact on trial programmes and data integrity.
-
prioritizing vaccine trial sites in areas with high expected disease incidence can speed endpoint accrual and shorten trial duration.
-
Applying 'Quick fix' and 'short cuts' can lead to errors with disastrous consequences.
-
The vaccine trials (Stem Cells/DNA/RNA) which were cancelled were not included in this review.
The phase 1/2 trial was briefly paused after a participant developed neurological symptoms, which were later linked to multiple sclerosis.
... include the prophylactic use of paracetamol, which reduced local and systemic reactions to the vaccine. The phase 1/2 trial was briefly paused after a participant developed neurological symptoms, which were later linked to multiple sclerosis. A large phase 3 trial of the AZD1222 vaccine involving 30 000 adults (20 000 ...
Ref: SARS-CoV-2 immunity: review and applications to phase 3 vaccine candidates [Lancet, 2020-10-13]delaying subject enrollment and operational gaps in most ongoing clinical trials, which in turn has a negative impact on trial programmes and data integrity.
... "clinical trial" in PubMed, MEDLINE, Embase, Google scholar and Google electronic databases. Key findings include: delaying subject enrollment and operational gaps in most ongoing clinical trials, which in turn has a negative impact on trial programmes and data integrity. Globally, most sites conducting clinical trials other than COVID-19 are experiencing a delay in timelines ...
Ref: Impact of COVID-19 on clinical trials and clinical research: A systematic review. [Nepal journal of epidemiology, 2020-09-01]prioritizing vaccine trial sites in areas with high expected disease incidence can speed endpoint accrual and shorten trial duration.
... To rapidly evaluate the safety and efficacy of COVID-19 vaccine candidates, prioritizing vaccine trial sites in areas with high expected disease incidence can speed endpoint accrual and shorten trial duration. Mathematical and statistical forecast models can inform the process of site selection, integrating available data sources and facilitating comparisons ...
Ref: Ensemble forecast modeling for the design of COVID-19 vaccine efficacy trials [Vaccine, 2020]Applying 'Quick fix' and 'short cuts' can lead to errors with disastrous consequences.
... tremendous hype around the COVID-19 vaccine, and developers are using every moment to make claims, which remain unverified. However, concerns are raised about a rush to deploy a COVID-19 vaccine. Applying "Quick fix" and "short cuts" can lead to errors with disastrous consequences. ...
Ref: COVID-19 Vaccines: A Race Against Time in the Middle of Death and Devastation! [Vaccine, 2020]The vaccine trials (Stem Cells/DNA/RNA) which were cancelled were not included in this review.
... RNA Vaccines and COVID-19" and "Cell-based therapy with SARS-CoV-2, University/Institutions and COVID-19 research" were used. The vaccine trials (Stem Cells/DNA/RNA) which were cancelled were not included in this review. Similarly, few others like repurposing of drugs, Nano Vaccines, other miscellaneous trials of Herbs, Music ...
Ref: Novel Stem Cells and Nucleic Acid-Based Vaccine Trials Against Viral Outbreak: A Systematic Evaluation During COVID-2019 Pandemic [Indian J Clin Biochem, 2020]Numerous studies and clinical trials on vaccines and drugs for the prevention and treatment of COVID-19 are underway across the world.
... institutions all around the world have been endeavoring to discover a potential treatment for COVID-19. Numerous studies and clinical trials on vaccines and drugs for the prevention and treatment of COVID-19 are underway across the world. However, the uncertainty around the efficacy and safety of various treatment regimens have become one ...
Ref: Safety and Efficacy of Different Therapeutic Interventions on Prevention and Treatment of COVID-19 [J Nepal Health Res Counc, 2020]just 66 days after downloading the genome of SARS-CoV-2,
... COVID-19 vaccines are in development, while scientists at the Coalition for Epidemic Preparedness Innovations (CEPI) have counted 115 Moderna was the first to begin clinical testing of a COVID-19 vaccine, just 66 days after downloading the genome of SARS-CoV-2, ...
Ref: COVID-19 vaccines move toward clinic [C&EN Global Enterprise, 2020]The clinical trials carried out on the already approved drugs for their repurposing for COVID-19 yielded mixed results.
... are identified from the work conducted on previously known viruses, such as SARS-CoV and MERS-CoV. The clinical trials carried out on the already approved drugs for their repurposing for COVID-19 yielded mixed results. Several antiviral drugs, such as remdesivir and favipiravir, have shown promising results in reducing the ...
Ref: Recent Advancements in the Diagnosis, Prevention, and Prospective Drug Therapy of COVID-19 [Front Public Health, 2020-07-10]Delaying Phase II vaccine clinical trials in children will delay our recovery from COVID-19
... underappreciated. Carefully conducted Phase II clinical trials can adequately address potential COVID-19 vaccine safety concerns. Delaying Phase II vaccine clinical trials in children will delay our recovery from COVID-19 and unnecessarily prolong its impact upon children"s education, health and emotional well-being, and equitable access ...
Ref: Warp Speed for COVID-19 Vaccines: Why are Children Stuck in Neutral? [Front Public Health, 2020]Clinical trials at different phases are ongoing across different countries to expedite development of effective drugs and vaccine to overcome the pandemic.
... novel prevention measures. While availability of vaccine for COVID-19 may take time, the disease may be contained through hand hygiene, physical distancing, travel restriction and aggressive steps such as "lockdown". Clinical trials at different phases are ongoing across different countries to expedite development of effective drugs and vaccine to overcome the pandemic. ...
Ref: Covid-19: A Comprehensive Review of a Formidable Foe and the Road Ahead [Front Public Health, 2020]whether that is a complete pause or pause in some activities) and/or adapting their processes.
... establishment of COVID-19 clinical trials and many existing non-COVID-19 studies either being temporarily paused ( whether that is a complete pause or pause in some activities) and/or adapting their processes. Trial managers have played a key role in decision-making, undertaking risk assessments and adapting trial ...
Ref: It is unprecedented: trial management during the COVID-19 pandemic and beyond [Trials, 2020]However, we believe that challenge studies could be set up before the time that most vaccines would be ready for efficacy testing.
... to develop and operationalize challenge studies and we are not suggesting that ongoing development of any vaccines which become ready for phase 3 trials must be paused during this period. However, we believe that challenge studies could be set up before the time that most vaccines would be ready for efficacy testing. ...
Ref: Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure [J Infect Dis, 2020-03-31]Currently, no single effective drug or specific vaccine is available against SARS-CoV-2.
... evaluation studies. Viral isolation is not recommended for routine diagnostic procedures due to safety concerns. Currently, no single effective drug or specific vaccine is available against SARS-CoV-2. Some candidate drugs targeting different levels and stages of human responses against COVID-19 such as ...
Ref: Fighting COVID-19: A quick review of diagnoses, therapies, and vaccines [Biomed J, 2020]The administration of higher dose injections and new enrolment were paused if any criteria for pausing dose escalation were met.
... recruit further participants to receive the middle dose, and then after safety observation for 3 days, the last group of participants were recruited and allocated to receive the high dose. The administration of higher dose injections and new enrolment were paused if any criteria for pausing dose escalation were met. ...
Ref: Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial [Lancet, 2020-05-22]delaying subject enrollment and operational gaps in most ongoing clinical trials, which in turn has a negative impact on trial programmes and data integrity Globally,
... "clinical trial" in PubMed, MEDLINE, Embase, Google scholar and Google electronic databases Key findings include: delaying subject enrollment and operational gaps in most ongoing clinical trials, which in turn has a negative impact on trial programmes and data integrity Globally, most sites conducting clinical trials other than COVID-19 are experiencing a delay in timelines and ...
Ref: Impact of COVID-19 on clinical trials and clinical research: A systematic review [Nepal J Epidemiol, 2020]further clinical trials and large randomized controlled studies are needed to validate the effective role, safety profile, and adverse effects of all the potential drugs.
... it is still unclear which drug can successfully fight against the disease. Therefore, for the better safety of patients with COVID-19, further clinical trials and large randomized controlled studies are needed to validate the effective role, safety profile, and adverse effects of all the potential drugs. Such a measure requires action at the global level. ...
Ref: Anti COVID-19 Drugs: Need for More Clinical Evidence and Global Action [Adv Ther, 2020]In COVID-19, there were a number of trials ongoing assessing the efficacy and safety of hydroxychloroquine.
... signals that may arise for the same drug or drugs with similar mechanisms of action. In COVID-19, there were a number of trials ongoing assessing the efficacy and safety of hydroxychloroquine. The perception of hydroxychloroquine changed quite dramatically of the course of only a few weeks. ...
Ref: Data monitoring committees for clinical trials evaluating treatments of COVID-19 [Adv Ther, 2020-08-20]Clinical trials at different phases are ongoing across different countries to expedite the development of effective drugs and vaccine to overcome the pandemic.
... novel prevention measures. While availability of vaccine for COVID-19 may take time, the disease may be contained through hand hygiene, physical distancing, travel restriction, and aggressive steps such as "lockdown." Clinical trials at different phases are ongoing across different countries to expedite the development of effective drugs and vaccine to overcome the pandemic. ...
Ref: Covid-19: a comprehensive review of a formidable foe and the road ahead [Expert Rev Respir Med, 2020]unnecessarily prolong its impact upon children’s education, health and emotional well-being, and equitable access to opportunities for development and social success.
... Delaying Phase II vaccine clinical trials in children will delay our recovery from COVID-19 and unnecessarily prolong its impact upon children’s education, health and emotional well-being, and equitable access to opportunities for development and social success. Given the potential direct and indirect benefits of pediatric vaccination, implementation of Phase II clinical ...
Ref: Warp Speed for COVID-19 Vaccines: Why are Children Stuck in Neutral? [Clin Infect Dis, 2020-09-18]we shed light on the 16 current approved clinical trials worldwide in search for a COVID-19 vaccine.
... in areas relevant to vaccine design. Using the ClinicalTrials.gov and World Health Organization (WHO) databases, we shed light on the 16 current approved clinical trials worldwide in search for a COVID-19 vaccine. The different vaccine platforms being tested are Bacillus Calmette-Guérin (BCG) vaccines, DNA and RNA-based vaccines, ...
Ref: Vaccine Candidates against Coronavirus Infections. Where Does COVID-19 Stand? [Viruses, 2020]What should happen if a participant tests positive for SARS-CoV-2 during the study?
What should happen if a participant tests positive for SARS-CoV-2 during the study?
Ref: Operationalizing HIV cure-related trials with analytic treatment interruptions during the SARS-CoV-2 pandemic: A collaborative approach [Clin Infect Dis, 2020-08-25]An effective vaccine that completes phase 3 trials having been administered to 20,000 individuals with very few or no serious effects is well worth taking.
... much as anybody could want it. But the data have to be clear and compelling."(21) An effective vaccine that completes phase 3 trials having been administered to 20,000 individuals with very few or no serious effects is well worth taking. J o u r n a l P r e -p r o o f ...
Ref: Theoretical novel COVID-19 vaccination risk of rare and severe adverse events versus COVID-19 mortality [Early Hum Dev, 2020-10-01]Two trials in China testing remdesivir in patients with COVID-19 were terminated early because of insufficient numbers of patients.
... are challenges to ensure that the most useful trials are able to find enough patients. Two trials in China testing remdesivir in patients with COVID-19 were terminated early because of insufficient numbers of patients. The issues here are compounded by geographical and interventional diversity: with investigators in so many ...
Ref: Global clinical trial mobilization for COVID-19: higher, faster, stronger [Drug Discov Today, 2020-08-07]During the outbreak, the urgency for developing candidate vaccines has brought distinct challenges to clinical development.
... COVID-19 has become a global pandemic, and an effective vaccine is needed. During the outbreak, the urgency for developing candidate vaccines has brought distinct challenges to clinical development. An efficacy trial, which measures whether the vaccine reduces the incidence of disease, is ordinarily required to fully ...
Ref: Considerations on the clinical development of COVID-19 vaccine from trial design perspectives. [Human vaccines & immunotherapeutics, 2020-09-29]The results from the phase I trial of the mRNA-1273 vaccine are awaited [13] .
... of mRNA vaccine seem strong, whereas limitations such as the delivery and stability issues related to RNA degradation, and the safety concerns due to immunogenicity hinder its development [29] . The results from the phase I trial of the mRNA-1273 vaccine are awaited [13] . ...
Ref: An Evidence Based Perspective on mRNA-SARS-CoV-2 Vaccine Development [Med Sci Monit, 2020-05-05]Vaccines, such as inactivated vaccines, nucleic acid-based vaccines, and vector vaccines, have already entered clinical trials.
... considerable efforts have been put into developing effective and safe drugs and vaccines against SARS-CoV-2. Vaccines, such as inactivated vaccines, nucleic acid-based vaccines, and vector vaccines, have already entered clinical trials. In this review, we provide an overview of the experimental and clinical data obtained from ...
Ref: A systematic review of SARS-CoV-2 vaccine candidates [Signal Transduct Target Ther, 2020]During early trials with inactivated RSV vaccine, the vaccine did not prevent infection, 80% of those infected required hospitalization and two children died [4] .
... results in increased disease severity if the subject is later infected by the natural virus. During early trials with inactivated RSV vaccine, the vaccine did not prevent infection, 80% of those infected required hospitalization and two children died [4] . Lung pathology in patients showed an unexpected inflammatory response with both neutrophils and eosinophils, evidence ...
Ref: Consensus Summary Report for CEPI/BC March 12-13, 2020 Meeting: Assessment of Risk of Disease Enhancement with COVID-19 Vaccines [Vaccine, 2020-05-25]To date, there are no approved antiviral drugs or vaccines against this transmissible disease.
... Coronavirus disease 2019 (COVID-19) is a major public health concern currently. To date, there are no approved antiviral drugs or vaccines against this transmissible disease. This report sheds light on available information for a better understanding of clinical trials and pharmacotherapy related to COVID-19. ...
Ref: Current updates on the European and WHO registered clinical trials of coronavirus disease 2019 (COVID-19) [Biomed. j. (Mumbai.Online), 2020]Multiple ongoing clinical trials are currently focusing on pharmacologic therapy, including repurposed and investigational drugs to treat active COVID-19 in adults.
... Multiple ongoing clinical trials are currently focusing on pharmacologic therapy, including repurposed and investigational drugs to treat active COVID-19 in adults. Therapies that have been studied so far target specific viral components or a specific phase in the infective process. Chloroquine, hydroxychloroquine, camostat mesylate, and arbidol interfere with viral receptor attachment ...
Ref: COVID-19: A Review of Emerging Preventative Vaccines and Treatment Strategies [Cureus, 2020-05-20]By 2021, efficacy and safety data from clinical trials are expected, and potentially a vaccine will be available for those most at risk.
... and the pace of vaccine development has been highly accelerated to meet the urgent need. By 2021, efficacy and safety data from clinical trials are expected, and potentially a vaccine will be available for those most at risk. This review focuses on the ongoing SARS-CoV-2 vaccine development efforts with emphasis on the nonclinical ...
Ref: Review of Current Vaccine Development Strategies to Prevent Coronavirus Disease 2019 (COVID-19) [Toxicol Pathol, 2020]It is difficult to state at this time the safety and efficacy of the vaccines in development until Phase 3 clinical trial data are examined properly.
... since the disease is still evolving and there is no effective treatment for the disease. It is difficult to state at this time the safety and efficacy of the vaccines in development until Phase 3 clinical trial data are examined properly. It is still debatable whether neutralizing antibody is sufficient and what is the critical level ...
Ref: Vaccine Against Covid-19 Disease – Present Status of Development [Indian J Pediatr, 2020-09-03]An effective vaccine is needed to halt the spread of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic.
... An effective vaccine is needed to halt the spread of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic. Recently, we reported safety, tolerability and antibody response data from an ongoing placebo-controlled, observer-blinded phase 1/2 coronavirus disease 2019 (COVID-19) vaccine trial with BNT162b1, a lipid nanoparticle (LNP) formulated nucleoside-modified ...
Ref: COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T-cell responses. [Nature, 2020-09-30]We excluded the 2014 polio PHEIC because existing polio vaccines were available.
... in 2019), Zika (1 February 2016 [12] ), and COVID-19 (30 January 2020 [13] ). We excluded the 2014 polio PHEIC because existing polio vaccines were available. We searched for all interventional trials for these diseases, including Phase I to Phase IV ...
Ref: Global clinical trial mobilization for COVID-19: higher, faster, stronger [Drug Discov Today, 2020-08-07]A number of new clinical trials are currently in progress to test the efficacy and safety of various approved drugs.
... as improvement in the clinical condition and reduction in the duration of treatment are concerned. A number of new clinical trials are currently in progress to test the efficacy and safety of various approved drugs. This review focuses on recent advancements in the field of development of diagnostic tests, vaccines, ...
Ref: cord_uid 0yp5qa8m Recent Advancements in the Diagnosis, Preventi... 0yp5qa8m Recent Advancements in the Diagnosis, Preventi... Name: title, dtype: object [Drug Discov Today, cord_uid 0yp5qa8m 2020 0yp5qa8m 2020 Name: publish_time, dtype: object]Nation-wide containment efforts including lock-down of non-essential services and facilities are taking a toll on the academic and clinical arena.
... Kingdom (2) , United States (3) and countries that have invested heavily in biomedical sciences. Nation-wide containment efforts including lock-down of non-essential services and facilities are taking a toll on the academic and clinical arena. However, the real immediate impact of these restrictions has been most acutely felt primarily by ...
Ref: Safeguarding Non-COVID-19 Research: Looking Up from Ground Zero [Arch Med Res, 2020-05-30]No proven effective antiviral therapy or vaccine currently exists, and supportive care remains to be the cornerstone treatment.
... highly pathogenic and transmissible CoV that is presently plaguing the global human population and economy. No proven effective antiviral therapy or vaccine currently exists, and supportive care remains to be the cornerstone treatment. Through previous lessons learned from SARS-CoV-1 and MERS-CoV studies, scientific groups worldwide have rapidly expanded ...
Ref: A review on sars-cov-2 virology, pathophysiology, animal models, and anti-viral interventions [Pathogens, 2020]These trials would involve the deliberate exposure of relatively few young, healthy volunteers to SARS-CoV-2.
... (SARS-CoV-2), some have proposed accelerating SARS-CoV-2 vaccine development through controlled human infection (or "challenge") trials. These trials would involve the deliberate exposure of relatively few young, healthy volunteers to SARS-CoV-2. We defend this proposal against the charge that there is still too much uncertainty surrounding ...
Ref: Why continuing uncertainties are no reason to postpone challenge trials for coronavirus vaccines [J. med. ethics, 2020]The ongoing clinical trials both with respect to drug repurposing and vaccines are summarized along with a brief description.
... and amino quinolones and their probable role in suppressing SARS-CoV-2 with reference to case studies. The ongoing clinical trials both with respect to drug repurposing and vaccines are summarized along with a brief description. The recent advancements and future perspective of ongoing research for therapy and detection of SARS-CoV-2 ...
Ref: Potential therapeutic targets for combating SARS-CoV-2: Drug repurposing, clinical trials and recent advancements [Life Sci, 2020]They include standard of care for any viral illness, antivirals, anti-inflammatory and immune altering medications.
... in Pakistan and 13 in India. Overall, 940 trials are related to medicines and/or interventions. They include standard of care for any viral illness, antivirals, anti-inflammatory and immune altering medications. Two out of 10 vaccine trials are novel vaccines. It is knowledgeable and resourceful to ...
Ref: cord_uid u26mqu1n Comprehensive overview of COVID-19 clinical tr... u26mqu1n Comprehensive overview of COVID-19 clinical tr... u26mqu1n Comprehensive overview of COVID-19 clinical tr... Name: title, dtype: object [Life Sci, cord_uid u26mqu1n 2020 u26mqu1n 2020 u26mqu1n 2020 Name: publish_time, dtype: object]COVID-19 vaccine trials must be careful to minimize economic coercion that might occur through incentives that inequitably drive participation among economically marginalized people.
... income, being female, perception of likely COVID-19 infection during the pandemic, and COVID-19 prosocial behaviors. COVID-19 vaccine trials must be careful to minimize economic coercion that might occur through incentives that inequitably drive participation among economically marginalized people. Gender-specific communication about trials participation may be needed. As participants tend to view research as ...
Ref: Interest in COVID-19 vaccine trials participation among young adults in China: Willingness, reasons for hesitancy, and demographic and psychosocial determinants [medRxiv, 2020-07-14]The AMP studies have not been impacted by COVID-19, and results from the AMP studies are expected in fall of 2020.
... in women in Southern Africa and MSM and transgender persons in the Americas [13] . The AMP studies have not been impacted by COVID-19, and results from the AMP studies are expected in fall of 2020. If protection is observed in the AMP trials, an important correlate for future vaccine studies ...
Ref: The search for an HIV vaccine, the journey continues [J Int AIDS Soc, 2020-05-16]As of 20 April 2020, there were 5 candidate vaccines in clinical evaluation and a further 71 candidate vaccines in preclinical evaluation [17] .
... As of 20 April 2020, there were 5 candidate vaccines in clinical evaluation and a further 71 candidate vaccines in preclinical evaluation [17] . These candidates are being trialed in Asia, North America, and Europe. If novel candidate vaccines are not tested in African settings, the continent has to bank on efficacious vaccines developed ...
Ref: The Case for Why Africa Should Host COVID-19 Candidate Vaccine Trials [J Infect Dis, 2020-06-03]After a rapid process of vaccine development, the use of COVID-19 vaccine can be mainstreamed among people to prevent the disease.
... of recombinant DNA technology will be a source of inspiration to people for further studies. After a rapid process of vaccine development, the use of COVID-19 vaccine can be mainstreamed among people to prevent the disease. As a result of these practices, the evaluation of which vaccine will be more safe, ...
Ref: How close are we to a COVID-19 vaccine? [J. Pure Appl. Microbiol., 2020]The first RSV vaccine, based on formalin-inactivated RSV (FI-RSV), entered a clinical trial in 1965,
... for coronavirus vaccines to avoid repeating the tragic failure of the RSV vaccine 28 . The first RSV vaccine, based on formalin-inactivated RSV (FI-RSV), entered a clinical trial in 1965, a time when several other inactivated or attenuated virus-based vaccines had already been successfully developed, ...
Ref: Learning from the past: development of safe and effective COVID-19 vaccines [Nat Rev Microbiol, 2020-10-16]We encourage the continuous clinical studies and post-marketing evaluation of vaccines, including the novel corona virus-19 vaccines,
... post-marketing evaluation of various vaccines, it was extremely useful to support vaccine licensing and market use. We encourage the continuous clinical studies and post-marketing evaluation of vaccines, including the novel corona virus-19 vaccines, to provide technical support for the population use, under the situation of COVID-19 pandemic. ...
Ref: [Conduct vaccines clinical trials and optimize the immunization strategies]. [Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine], 2020-09-06]human challenge trials and production capacity in COVID-19 vaccine development.
... is an unprecedented need to produce and distribute enough safe and effective vaccines to individuals globally. Here, we discuss the challenges in several aspects including the vaccine safety, vaccine efficacy, human challenge trials and production capacity in COVID-19 vaccine development. ...
Ref: Challenges in the development of a vaccine against COVID-19 [Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine], 2020]Currently, there are many vaccines undergoing clinical trials.
... formaldehyde, UV light or ß-propiolactone are being deployed for the preparation of inactivated virus vaccine. Currently, there are many vaccines undergoing clinical trials. Even though mRNA and DNA vaccines are being designed and moved into clinical trials, these ...
Ref: Coronavirus Disease (COVID-19): Current Status and Prospects for Drug and Vaccine Development [Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine], 2020]The first phase 3 trials have started in July 2020.
... in clinical testing. The first results are encouraging, but in order to properly assess the merits of the different vaccines, we must wait for the results of phase 3 trials. The first phase 3 trials have started in July 2020. ...
Ref: [SARS coronavirus-2 vaccines: options and state-of-the-art]. [Nederlands tijdschrift voor geneeskunde, 2020-09-03]writing of protocols, ethics and site approvals, database design, data capture and randomisation schedules, statistical analysis plans, and safety monitoring.
... 1-2 months, multiple clinical trials had been launched, including securing funding and investigational product supply, writing of protocols, ethics and site approvals, database design, data capture and randomisation schedules, statistical analysis plans, and safety monitoring. All of this was achieved in the midst of an evolving pandemic that was overwhelming ...
Ref: Clinical trials for the prevention and treatment of COVID‐19: current state of play [Med J Aust, 2020-06-27]In pandemic situation, however, the entire process of vaccine development including clinical trials gets shortened and may be fast tracked to 15-18 mo time.
... pace resulting in almost breakthrough in vaccine development by several research institutions and vaccine manufacturers. In pandemic situation, however, the entire process of vaccine development including clinical trials gets shortened and may be fast tracked to 15-18 mo time. It is expected that there shall be simultaneous marketing of several vaccines by the beginning ...
Ref: Vaccine Against Covid-19 Disease - Present Status of Development [Indian J Pediatr, 2020]The National Institutes of Health is conducting a Phase 1 clinical trial to evaluate for a potential vaccine and the recipients have started to receive the investigational vaccine.
... the hospital. In addition, there are no vaccines available to protect our at-risk healthcare workers. The National Institutes of Health is conducting a Phase 1 clinical trial to evaluate for a potential vaccine and the recipients have started to receive the investigational vaccine. 2 We present a brief overview of the potential prophylactic and treatment agents under investigation, ...
Ref: cord_uid ltu9vd1n Brief Summary of Potential SARS-CoV-2 Prophyla... ltu9vd1n Brief Summary of Potential SARS-CoV-2 Prophyla... Name: title, dtype: object [Indian J Pediatr, cord_uid ltu9vd1n 2020 ltu9vd1n 2020 Name: publish_time, dtype: object]Two hundred and eighty four studies are actively recruiting adults and children with confirmed COVID-19,
... summarize few of the pivotal ones in this paper, including those specific to oncology population Two hundred and eighty four studies are actively recruiting adults and children with confirmed COVID-19, including 25 are early-phase I/phase I, 72 phase II, 58 phase III, 12 phase IV, ...
Ref: COVID-19 Clinical Research [J Cell Signal, 2020]Eyal et al have discussed challenge studies [1] to accelerate the assessment of vaccine effectiveness.
... effective treatments and vaccines for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are urgently needed. Eyal et al have discussed challenge studies [1] to accelerate the assessment of vaccine effectiveness. In a challenge study, all participants are vaccinated with placebo or with the test vaccine ...
Ref: Large Simple Double-Blind Randomized Trials for the Rapid Assessment of the Effectiveness of COVID-19 Vaccines [J Infect Dis, 2020-08-26]The association of rotavirus vaccines with intussusception in children was only detected following licensure and deployment of these vaccines.
... multiple regions concurrently with vaccine deployment is critical both for evaluating the real-world effectiveness of a new vaccine against SARS-CoV-2, but also for monitoring its safety in so-call "post-marketing" surveillance. The association of rotavirus vaccines with intussusception in children was only detected following licensure and deployment of these vaccines. ...
Ref: Vaccines for COVID-19: the current state of play [Paediatr Respir Rev, 2020-06-18]There are three inactivated whole-virus vaccines against SARS-CoV-2 reached phase 1/2 clinical trial.
... There are three inactivated whole-virus vaccines against SARS-CoV-2 reached phase 1/2 clinical trial. These phase 1/2 clinical trials are done by the Beijing Institute of Biological Products (ChiCTR2000032459), Sinovac (NCT04352608) and Wuhan Institute of Biological Products (ChiCTR2000031809) (20). ...
Ref: A review on Promising vaccine development progress for COVID-19 disease [Vacunas, 2020-06-13]There has been an unprecedented rapid response by vaccine developers with now over one hundred vaccine candidates in development and at least six having reached clinical trials.
... morbidity and mortality of Coronavirus Disease 2019 (COVID-19) disease and ease the major economic impact. There has been an unprecedented rapid response by vaccine developers with now over one hundred vaccine candidates in development and at least six having reached clinical trials. However, a major challenge during rapid development is to avoid safety issues both by thoughtful ...
Ref: Consensus summary report for CEPI/BC March 12-13, 2020 meeting: Assessment of risk of disease enhancement with COVID-19 vaccines [Vaccine, 2020]So far, optimized supportive care remains the best practice against COVID-19.
... has been the imperative task in the battle against SARS-CoV-2. While clinical trials have been launched for several candidate vaccines, research on COVID-19 vaccines is still at an early stage. So far, optimized supportive care remains the best practice against COVID-19. ...
Ref: Current status of treatment options, clinical trials, and vaccine development for SARS-CoV-2 infection [J. Pure Appl. Microbiol., 2020]On March 16th, 2020, the first trial of COVID-19 vaccine candidate was launched in record speed.
... the infections. The scope of the impact of the COVID-19 pandemic on humanitarianism and the economy is also prompting the assessment of the next-generation vaccine technology platform through new paradigms. On March 16th, 2020, the first trial of COVID-19 vaccine candidate was launched in record speed. ...
Ref: Recent insights for the emerging COVID-19: drug discovery, therapeutic options and vaccine development [Asian J Pharm Sci, 2020-07-04]As of May 15, the WHO has filed 110 candidate vaccines in the preclinical evaluation and eight candidate vaccines in clinical evaluation [30] .
... priority. At present, there are no approved vaccines for SARS-CoV-2, a growing number of global public and private institutions have joined the efforts to develop vaccines against SARS-CoV-2 [29] . As of May 15, the WHO has filed 110 candidate vaccines in the preclinical evaluation and eight candidate vaccines in clinical evaluation [30] . ...
Ref: Profiles of COVID-19 clinical trials in the Chinese Clinical Trial Registry [Emerging microbes & infections, 2020-07-22]The proposed stopping boundaries are assessed in a simulation study motivated by clinical trials in COVID-19.
... monitoring clinical trials of treatments for COVID-19 are considered. Some recommendations are made regarding the presentation of the data, stopping rules for safety monitoring and the use of external data. The proposed stopping boundaries are assessed in a simulation study motivated by clinical trials in COVID-19. ...
Ref: Data monitoring committees for clinical trials evaluating treatments of COVID-19. [Contemporary clinical trials, 2020-09-19]While clinical trials have been launched for several candidate vaccines, research on COVID-19 vaccines is still at an early stage.
... in the clinical use to treat COVID-19. Vaccine development has been the imperative task in the battle against SARS-CoV-2. While clinical trials have been launched for several candidate vaccines, research on COVID-19 vaccines is still at an early stage. So far, optimized supportive care remains the best practice against COVID-19. ...
Ref: Current status of treatment options, clinical trials, and vaccine development for SARS-CoV-2 infection [J. Pure Appl. Microbiol., 2020]A phase 2 trial of this adenovirus type-5 (Ad5)-vectored COVID-19 vaccine was conducted in Wuhan, China.
... and can elicit a rapid immunity reaction. Horton stated, "These results represent an important milestone." A phase 2 trial of this adenovirus type-5 (Ad5)-vectored COVID-19 vaccine was conducted in Wuhan, China. A total of 508 eligible participants aged 18-83 years were randomly assigned to vaccine or ...
Ref: Challenges in the development of a vaccine against COVID-19 [Engineering (Beijing), 2020-09-14]Most vaccine developments have taken place in Asia, using a viral vector method.
... intervention characteristics, the design used, and the local or global center partnerships created are highlighted. Most vaccine developments have taken place in Asia, using a viral vector method. Two purified inactivated SARS-CoV-2 vaccine candidates, an mRNA-based vaccine mRNA1273, and the chimpanzee adenoviral vaccine ...
Ref: Current clinical trials protocols and the global effort for immunization against sars-cov-2 [Vaccines, 2020]to decrease pressure on healthcare infrastructure, the situation is not the same for clinical trials in patient populations.
... volunteer clinical trials, except first-in-human COVID-19 vaccine trials, are being paused for subject safety and to decrease pressure on healthcare infrastructure, the situation is not the same for clinical trials in patient populations. The decision to stop treatment with an investigational agent in phase II/III trials in settings ...
Ref: Challenges in Drug Development Posed by the COVID‐19 Pandemic: An Opportunity for Clinical Pharmacology [Clin Pharmacol Ther, 2020-05-28]This report summarizes the evidence presented and provides considerations for safety assessment of COVID-19 vaccine candidates in accelerated vaccine development.
... vaccine immunology and coronaviruses to consider what vaccine designs could reduce safety concerns and how animal models and immunological assessments in early clinical trials can help to assess the risk. This report summarizes the evidence presented and provides considerations for safety assessment of COVID-19 vaccine candidates in accelerated vaccine development. ...
Ref: Consensus summary report for CEPI/BC March 12-13, 2020 meeting: Assessment of risk of disease enhancement with COVID-19 vaccines [Vaccine, 2020]There are already an estimated 374 phase 3 or 4 coronavirus randomized trials planned, ongoing, or completed across the world (4).
... There are already an estimated 374 phase 3 or 4 coronavirus randomized trials planned, ongoing, or completed across the world (4). Approximately two thirds of them have target enrollments below 1000 persons, a sample size that is likely to be insufficient to identify many benefits, such as reduced mortality. Trials are ...
Ref: COVID-19 Clinical Trials: A Teachable Moment for Improving Our Research Infrastructure and Relevance [Ann Intern Med, 2020-06-16]At the conclusion of the Phase 1 trial, the safety and immunogenicity data are reviewed and presented to the FDA for approval to advance to Phase 2 studies.
... 1 studies evaluating SARS-CoV-2 vaccines have also included individuals >65 years of age to assess safety and immunogenicity in this population, which is at greater risk for severe COVID-19 disease. At the conclusion of the Phase 1 trial, the safety and immunogenicity data are reviewed and presented to the FDA for approval to advance to Phase 2 studies. ...
Ref: Anticipating SARS-CoV-2 Vaccine Testing, Licensure, and Recommendations for Use [J Pediatr, 2020-06-19]The phase 3 trial was paused after a vaccine recipient developed symptoms consistent with transverse myelitis.
... vaccine recipients and 10 000 controls) began in August, 2020, in multiple worldwide locations (table). The phase 3 trial was paused after a vaccine recipient developed symptoms consistent with transverse myelitis. Although the UK trial resumed shortly after the pause, as of Oct 5, 2020, the ...
Ref: SARS-CoV-2 immunity: review and applications to phase 3 vaccine candidates [Lancet, 2020-10-13]The conduct of clinical trials has become increasingly complicated in the era of COVID-19, significantly restricting access of clinical trials to oncology patients.
... treatment trials revealed a correlation between trial enrollment and 5-year cancer-specific survival rates (4) . The conduct of clinical trials has become increasingly complicated in the era of COVID-19, significantly restricting access of clinical trials to oncology patients. Underlying factors include the desire to limit patient contact to decrease SARS-CoV-2 exposure, research personnel ...
Ref: Oncology Treatment in the Era of COVID‐19: We Cannot Afford to Hit the Pause Button [Clin Pharmacol Ther, 2020-06-02]due to the suspected adverse event in a person receiving the vaccine in the United Kingdom, the clinical trials have been temporarily paused.
... in UK by September 2020. Jenner Institute, Oxford, UK is a leader in this effort and launched a Phase III clinical trial of more than 6000 people in May. However, due to the suspected adverse event in a person receiving the vaccine in the United Kingdom, the clinical trials have been temporarily paused. ...
Ref: Cardiovascular Complications Associated with COVID-19 and Potential Therapeutic Strategies [Int J Mol Sci, 2020-09-16]Efficacy and longer-term adverse event assessment will require phase 3 trials.
Efficacy and longer-term adverse event assessment will require phase 3 trials. Trial Registration: Chinese Clinical Trial Registry Identifier: ChiCTR2000031809.
Ref: Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes: Interim Analysis of 2 Randomized Clinical Trials [JAMA, 2020]Such a stance risks stigmatizing COVID-19 vaccine trials in Africa and depriving Africa of critical research.
... World Health Organization Director General has declared that Africa will not host COVID-19 vaccine trials. Such a stance risks stigmatizing COVID-19 vaccine trials in Africa and depriving Africa of critical research. To the contrary, there is a critical need for Africa to host COVID-19 vaccine trials ...
Ref: The Case for Why Africa Should Host COVID-19 Candidate Vaccine Trials [J Infect Dis, 2020]COVID-19 human challenge trials would be inappropriate for some low and middle income settings which lack adequate critical care and rehabilitation services.
... to a study participant, that setting should not host a COVID-19 vaccine human challenge trial. COVID-19 human challenge trials would be inappropriate for some low and middle income settings which lack adequate critical care and rehabilitation services. For instance, at least 10 African countries lack even a single ventilator while dozens more ...
Ref: COVID-19 vaccine trials: Duty of care and standard of prevention considerations [Vaccine, 2020-10-09]The vaccine costs in this discussion are the potential adverse health effects from a cOVId-19 vaccine, particularly for the mid-and long-term.
... The vaccine costs in this discussion are the potential adverse health effects from a cOVId-19 vaccine, particularly for the mid-and long-term. For a vaccine with high levels of uncertainty as to the projected costs, a high risk factor is required. For the tradeoff to justify moving forward, a very high level ...
Ref: COVID-19 vaccine safety [Int J Mol Med, 2020-09-18]There are few phase 3 randomized double-blind placebo controlled trials on the way to investigate the safety and efficacy of remdesivir.
... no published studies that substantiate its activity in vivo until the time of this review. There are few phase 3 randomized double-blind placebo controlled trials on the way to investigate the safety and efficacy of remdesivir. Of which, one completed double blind, placebo controlled trial showed that remdesivir showed faster time ...
Ref: Available Evidence and Ongoing Clinical Trials of Remdesivir: Could It Be a Promising Therapeutic Option for COVID-19? [Front. Pharmacol., 2020]We aimed to determine the proportion of people who intend to get vaccinated against COVID-19 in France or to participate in a vaccine clinical trial.
... INTRODUCTION: The world is facing the COVID-19 pandemic. The development of a vaccine is challenging. We aimed to determine the proportion of people who intend to get vaccinated against COVID-19 in France or to participate in a vaccine clinical trial. METHODS: We conducted an anonymous on-line survey from the 26th of March to the 20th ...
Ref: Intention to participate in a COVID-19 vaccine clinical trial and to get vaccinated against COVID-19 in France during the pandemic [Vaccine, 2020]EXPERT OPINION No drugs and vaccines have been proven to be particularly effective against SARS-CoV-2 up to now.
... treatment regimens based on condition of patients, diseases and drugs as well as concomitant medications. EXPERT OPINION No drugs and vaccines have been proven to be particularly effective against SARS-CoV-2 up to now. The recommended comprehensive medication therapy strategies have already displayed favorable effect in the fight against ...
Ref: Medication therapy strategies for the coronavirus disease 2019 (COVID-19): recent progress and challenges. [Expert review of clinical pharmacology, 2020-08-04]Although some early-stage clinical trials and studies on these drugs and vaccines have shown positive results, definitive and conclusive results are yet to be obtained.
... therapy. Likewise, vaccines against SARS-CoV-2 are being developed and tested, including mRNA, non-replicating viral vector, DNA, protein subunit candidate vaccines, etc. Although some early-stage clinical trials and studies on these drugs and vaccines have shown positive results, definitive and conclusive results are yet to be obtained. Keywords: COVID-19; antiviral drugs; COVID-19 treatment; COVID-19 vaccine; SARS-CoV-2. ...
Ref: Safety and Efficacy of Different Therapeutic Interventions on Prevention and Treatment of COVID-19 [J Nepal Health Res Counc, 2020]Multiple vaccine candidates are under development, but no vaccine is currently available.
... and the resulting disease, coronavirus disease 2019 (Covid-19), have spread to millions of persons worldwide. Multiple vaccine candidates are under development, but no vaccine is currently available. Interim safety and immunogenicity data about the vaccine candidate BNT162b1 in younger adults have been ...
Ref: Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates. [The New England journal of medicine, 2020-10-14]Although there were five Phase I human vaccine trials against SARS and MERS,
... researchers have been trying to draw lessons from previous outbreaks to find a potential cure. Although there were five Phase I human vaccine trials against SARS and MERS, the lack of data in humans provided us with limited benchmarks that could help us ...
Ref: Vaccine Candidates against Coronavirus Infections. Where Does COVID-19 Stand? [Viruses, 2020]We focus on vaccine development in the UK and vaccines that have entered clinical trials around the world.
... unprecedented pace across the world. Here we review the different platforms employed to develop vaccines, the standard timelines of development and how they can be condensed in a pandemic situation. We focus on vaccine development in the UK and vaccines that have entered clinical trials around the world. ...
Ref: The early landscape of coronavirus disease 2019 vaccine development in the UK and rest of the world [Immunology, 2020]Vaccine hesitancy was associated with refusal for participation in a COVID-19 vaccine clinical trial.
... perceived risk were associated with potential acceptance to participate in a COVID-19 vaccine clinical trial. Vaccine hesitancy was associated with refusal for participation in a COVID-19 vaccine clinical trial. CONCLUSIONS: Nearly 75% and 48% of the survey respondents were respectively likely to accept vaccination ...
Ref: Intention to participate in a COVID-19 vaccine clinical trial and to get vaccinated against COVID-19 in France during the pandemic [Vaccine, 2020]The FDA has given emergency approval for remdesivir use in patients with severe COVID-19 [16] .
... The FDA has given emergency approval for remdesivir use in patients with severe COVID-19 [16] . A preliminary report analyzed data from a small cohort of patients who received at least one dose of remdesivir on a compassionate basis, which showed improvement in 68% percent of ...
Ref: COVID-19: An Update Regarding the Quest for Finding an Effective Cure [Cureus, 2020-07-05]An unprecedented research effort and global coordination has resulted in a rapid development of vaccine candidates and initiation of trials.
... a COVID-19 vaccine is likely the most effective approach to sustainably controlling the COVID-19 pandemic. An unprecedented research effort and global coordination has resulted in a rapid development of vaccine candidates and initiation of trials. Here, we review vaccine types, and progress with 10 vaccine candidates against SARS-CoV-2 - the ...
Ref: Vaccines for COVID-19: The current state of play [Paediatr Respir Rev, 2020]Several COVID-19-vaccines are under way, some of which have recently entered phase III trials.
... for a vaccine to provide effective herd immunity for everyone"s lives to return to normal. Several COVID-19-vaccines are under way, some of which have recently entered phase III trials. Meanwhile, an age-old treatment in daily urologic practice may find a novel role in the ...
Ref: Novel use of an old compound? Urologist-led BCG-vaccine trials in the prevention of COVID-19. [BJU international, 2020-10-09]An efficacy trial, which measures whether the vaccine reduces the incidence of disease, is ordinarily required to fully evaluate vaccine efficacy.
... the outbreak, the urgency for developing candidate vaccines has brought distinct challenges to clinical development. An efficacy trial, which measures whether the vaccine reduces the incidence of disease, is ordinarily required to fully evaluate vaccine efficacy. However, emergency use may be possible if promising immunogenicity results are observed. A ring vaccination ...
Ref: Considerations on the clinical development of COVID-19 vaccine from trial design perspectives. [Human vaccines & immunotherapeutics, 2020-09-29]To hasten COVID-19 vaccine development, it has been suggested that the final stage could be replaced with a human challenge trial (HCT).
... safe vaccine. Vaccine development usually takes many years as it goes through several different phases. To hasten COVID-19 vaccine development, it has been suggested that the final stage could be replaced with a human challenge trial (HCT). Volunteers would be intentionally infected with SARS-CoV-2 to see how the vaccine candidate works. To ...
Ref: COVID-19 human challenge trials – what research ethics committees need to consider [Res. Ethics, 2020]Previous respiratory syncytial virus and dengue virus vaccine studies revealed human clinical safety risks related to ADE, resulting in failed vaccine trials.
... and other respiratory viruses suggest that anti-SARS-CoV-2 antibodies could exacerbate COVID-19 through antibody-dependent enhancement (ADE). Previous respiratory syncytial virus and dengue virus vaccine studies revealed human clinical safety risks related to ADE, resulting in failed vaccine trials. Here, we describe key ADE mechanisms and discuss mitigation strategies for SARS-CoV-2 vaccines and therapies ...
Ref: Antibody-dependent enhancement and SARS-CoV-2 vaccines and therapies. [Nature microbiology, 2020-09-09]Some recommendations are made regarding the presentation of the data, stopping rules for safety monitoring and the use of external data.
... adaptive designs. Furthermore, statistical aspects of monitoring clinical trials of treatments for COVID-19 are considered. Some recommendations are made regarding the presentation of the data, stopping rules for safety monitoring and the use of external data. The proposed stopping boundaries are assessed in a simulation study motivated by clinical trials in ...
Ref: Data monitoring committees for clinical trials evaluating treatments of COVID-19. [Contemporary clinical trials, 2020-09-19]The development of a vaccine is challenging.
... INTRODUCTION: The world is facing the COVID-19 pandemic. The development of a vaccine is challenging. We aimed to determine the proportion of people who intend to get vaccinated against COVID-19 in France or to participate in a ...
Ref: Intention to participate in a COVID-19 vaccine clinical trial and to get vaccinated against COVID-19 in France during the pandemic [Vaccine, 2020]There are 160 candidate vaccines under clinical trials across the world using different molecular targets and techniques.
... intense global efforts are directed towards development of vaccines to halt the COVID-19 virus pandemic. There are 160 candidate vaccines under clinical trials across the world using different molecular targets and techniques. This race for the vaccine has several challenges and ethical issues like compressed timelines, generation ...
Ref: Expedited COVID-19 vaccine trials: a rat-race with challenges and ethical issues [Pan Afr Med J, 2020]“stopping would be of grave consequence” to participants So study teams have bought and shipped protective equipment to personnel at clinical trial sites,
... trials, some of which have paused during the pandemic But for other studies, he says, “stopping would be of grave consequence” to participants So study teams have bought and shipped protective equipment to personnel at clinical trial sites, secured special permits where necessary for trial participants to leave their homes for medical visits, ...
Ref: Clinical trials press on for conditions other than COVID-19. Will the pandemic’s effects sneak into their data? [Science, 2020]Lilly will continue clinical trials for people who are already enrolled “
... will delay the start of most new studies and pause enrollment in most ongoing ones Lilly will continue clinical trials for people who are already enrolled “ By delaying most new study starts and pausing enrollment of new patients or healthy volunteers ...
Ref: COVID-19 to delay clinical trials [C&EN Global Enterprise, 2020]Controlled human challenge trials of SARS-CoV-2 vaccine candidates could accelerate the testing and potential rollout of efficacious vaccines.
... Controlled human challenge trials of SARS-CoV-2 vaccine candidates could accelerate the testing and potential rollout of efficacious vaccines. By replacing conventional phase 3 testing of vaccine candidates, such trials may subtract many months from the licensure process, making efficacious vaccines available more quickly. Obviously, challenging volunteers with this ...
Ref: Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure [J Infect Dis, 2020]The several ongoing clinical trials on SARS-CoV-2 vaccines do not fall within the scope of this article.
... progress, which demands a harmonized approach of the scientific community. This article aims to provide a critical overview of the clinical trials exploring candidate drugs for potential treatment for COVID-19. The several ongoing clinical trials on SARS-CoV-2 vaccines do not fall within the scope of this article. ...
Ref: COVID‐19Clinical trials: quality matters more than quantity [Allergy, 2020-05-20]Applying ‘Quick fix’ and ‘short cuts’ can lead to errors with disastrous consequences.
... tremendous hype around the COVID-19 vaccine and developers are using every moment to make claims, which remain unverified. However, concerns are raised about a rush to deploy a COVID-19 vaccine. Applying ‘Quick fix’ and ‘short cuts’ can lead to errors with disastrous consequences. ...
Ref: COVID-19 vaccines: A race against time in the middle of death and devastation! [J Clin Exp Hepatol, 2020-06-10]the covid-19 vaccine will be successfully developed, and the COVID-19 pandemic will eventually be controlled.
... of this novel virus, vaccine development for COVID-19 seems to be very challenging. However, with the accumulation of more knowledge about the virus and the efforts of global scientific cooperation, the covid-19 vaccine will be successfully developed, and the COVID-19 pandemic will eventually be controlled. ...
Ref: Frontiers in the COVID-19 vaccines development [Exp Hematol Oncol, 2020-09-03]The FDA has recently issued a guidance document on COVID-19 vaccines.
... and preferred characteristics -the ideal vaccine will have the features outlined in Table 1 . The FDA has recently issued a guidance document on COVID-19 vaccines. 48 This document is primarily focused on regulatory requirements and key considerations for licensure data ...
Ref: SARS-CoV-2 Vaccine Development: Current Status [Mayo Clin Proc, 2020-07-30]a staggering number of vaccines (over 200) had started pre-clinical development of which 39 had entered clinical trials,
... of 2019 there has been an explosion of vaccine development. By the 1st September 2020, a staggering number of vaccines (over 200) had started pre-clinical development of which 39 had entered clinical trials, including some approaches that have not previously been licensed for human vaccines. Vaccines have been ...
Ref: Vaccines for COVID-19. [Clinical and experimental immunology, 2020-09-15]Clinical trials during pandemics of infections face complex challenges of putting scientific and ethical principles into practice.
... pandemic of COVID-19 is a serious unmet medical need requiring clinical research into effective therapies. Clinical trials during pandemics of infections face complex challenges of putting scientific and ethical principles into practice. Some of these issues - selection of investigational product and participants, study design, assessment of ...
Ref: Clinical trials during the COVID-19 pandemic: Challenges of putting scientific and ethical principles into practice [Perspect. Clin. Res., 2020]