One of the world’s leading vaccine manufacturers has suffered a major setback in its work to produce a Covid-19 vaccine. The problem will push the timeline for deployment of Sanofi Pasteur’s vaccine — if it is approved — from the first half of 2021 into the second half of the year, the company said Friday. The news is not just disappointing for Sanofi and its development partner, GlaxoSmithKline, which is providing an adjuvant used in the vaccine. The companies have contracts with multiple countries, including the United States and Britain, as well as the European Union.
The Sputnik results were based on a study of 19,000 participants 42 days after receiving the first of two doses of the vaccine. Earlier data showed that the vaccine had an approximately 91.4% efficacy 28 days after particpants received the first dose.
AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. The analysis was from the trials in the UK and Brazil and demonstrated efficacy of up to 90% ... One dosing regimen was given at a half dose and demonstrated 90% efficacy, followed by a full dose at least one month apart. Another dosing regimen demonstrated 62% efficacy when given two full doses at least one month apart. The combined analysis showed average efficacy of 70%.
With the efficacy portion of their Covid-19 vaccine trial completed, showing the vaccine to prevent 95% of cases of the disease, the companies said that they plan to submit to the Food and Drug Administration for an emergency use authorization “within days,” and will also submit to regulatory agencies around the globe.
Moderna’s announcement that a preliminary and unpublished analysis shows its experimental coronavirus vaccine is nearly 95 percent effective at preventing illness, including severe cases — gives the United States the prospect that two vaccines could be available on a limited basis by the end of the year.
The article explains why early indications of success for Pfizer's COVID vaccine is also good news for its competitors, many of which base their development efforts on similar mRNA platforms. One impediment (but not a deal breaker) is the need for a cold chain to protect the fragile mRNA molecules.
Pfizer announced stunning early results from its coronavirus vaccine trial, cementing the lead in a frenzied global race that has unfolded at record-breaking speed.
Federal health regulators have decided to allow the resumption of U.S. studies of a leading Covid-19 vaccine candidate from AstraZeneca PLC and the University of Oxford, according to a person familiar with the matter and materials reviewed by The Wall Street Journal.
Major coronavirus virus vaccine trials experience halts because of isolated adverse effects. FDA Commissioner Stephen Hahn, MD affirms, “The system was designed to identify safety issues... but also ultimately to get to the right answer regarding the safety and efficacy of a therapeutic or vaccine.”
[PODCAST] This podcast starts in conversation with Yale vaccine expert Saad Omer discussing how side effects in vaccine trials can cause them to break the blinding (not knowing who has gotten vaccine and who has gotten placebo). Minor side effects such as local injection site reactions are common, but each of the major vaccine trials have had at least one volunteer with a more serious adverse effect.
Sanjay Gupta explores what a DSMB (Data Safety & Monitoring Board) does in getting an inside look at the data from a clinical trial, including ones on vaccines. In a double-blind trial, neither the subjects volunteering for it nor the investigators know who is getting active vaccine or placebo. But the DSMB keeps an eye on safety, adverse events, and even if a vaccine is working so well that a trial should be stopped early.
A document sent to outside researchers running the 60,000-patient clinical trial states that a “pausing rule” has been met, that the online system used to enroll patients in the study has been closed, and that the data and safety monitoring board would be convened. Contacted by STAT, J&J confirmed the study pause, saying it was due to “an unexplained illness in a study participant.” The company declined to provide further details.
Pfizer and Moderna mRNA vaccines have caused transient but severe adverse events (chills, fever, headache, etc) in a few trial participants. mRNA vaccines depend on recipients' cells to make coronavirus antigen, causing antibody formation. Do different recipients' cells make different amounts of antigen, accounting for different adverse events among vaccine recipients?
Just 150 or so of the 30,000 or more subjects enrolled in U.S. trials conducted by Pfizer, AstraZeneca, Moderna and Johnson & Johnson need to be infected and show symptoms to provide the data to assess the vaccines, according to a Wall Street Journal review of researchers’ plans.
The study is designed to recruit up to 10,000 participants aged 18 to 84 years, with and without relevant comorbidities, over the coming four to six weeks. It is intended to involve at least 25% of subjects aged above 65 years, and also prioritise groups most impacted by Covid-19, including racial and ethnic minorities.
Trials for the single-dose vaccine will include up to 60,000 adult participants at nearly 215 sites in the US and internationally. While the other vaccine candidates require two doses, Johnson & Johnson's candidate will be studied as a single-dose vaccine, which should expedite results Chief Scientific Officer Dr. Paul Stoffels said on a call with reporters.
Will vaccine trials answer the most important question: Will the vaccines prevent moderate and severe COVID disease? The trials look only at mild disease as the endpoint. And nothing will be known abouut their efficacy in children, adolescents, and pregnant women because these populations are excluded from trials.
With very little information about the one recent serious adverse effect in the AstraZeneca vaccine trial, NIH scientists are circumspect regarding the safey of the vaccine -- not to say that it may not be safe, but they need more information before being assured that the trial should proceed in the U.S.
Current as of Sept. 11, 2020: Synopsis of company funding, background on company and vaccine,clinical trial results, trials planned, & any additional company news.
A concise explanation of how COVID vaccine trials are conducted, how a vaccine would be judged effective, and potential downsides to putting out a vaccine too soon.
Phase 3 trial in U.S. should show how this population reacts to vaccine. Since the trial primary endpoint is event-driven (sufficient number of infections), completion of the trial depends on the level of viral transmission.
Some 170 Covid-19 vaccines are in development around the world, according to the World Health Organization. Now, a handful are starting or nearing the final stage of testing. Depending on the results, some companies say their vaccines could be greenlighted for use as soon as this year.
Dr. Stephen M. Hahn, who has been under pressure from the White House to speed coronavirus treatments, said in a newspaper interview that his agency would be willing to approve a coronavirus vaccine before Phase 3 clinical trials were complete if the agency found it “appropriate” to do so.
Moderna Inc. said Wednesday its experimental coronavirus vaccine induced immune responses in people aged 56 years and older that were comparable to those seen in younger adults in a small study, a promising sign for a vulnerable age group. The 20 subjects received the dose level of the Moderna vaccine that has been advanced to a late-stage, Phase 3 study.
Excellent, inciteful compilation of and commentary on reports regarding natural and vaccine-induced immunity to SARS-CoV-2 in not-too-technical language (with links to reports)
Infographic: The U.S. Department of Defense, a participant in Operation Warp Speed to develop a vaccine against COVID-19, outlines an ambitious timeline to deliver 300 million doses of a safe and effective vaccine by January 1, 2021.
A vaccine approved based on administering it to 76 volunteers? More mainstream vaccine developers are planning phase 3 trials involving ~30,000. But no Russian trial results or protocols for phase 3 trials have been published.
Novavax on Monday announced it would proceed with Phase 2 clinical trials to determine if its coronavirus vaccine candidate showed positive results for patients. Its move to begin the second phase of study comes just weeks after reporting that its vaccine showed promising signs in early trials.
With sustained widespread contagion, a deep bench of immunization experts, a robust medical manufacturing infrastructure and thousands of vaccine trial volunteers, Brazil has emerged as a potentially vital player in the global scramble to end the pandemic. Three of the most promising and advanced vaccine studies in the world are relying on scientists and volunteers in Brazil.
Ranking of companies in COVID-19 vaccine race, including funding, vaccine technology, clinical trials phase(s), brief synopsis of results, and production plans
READY, FIRE, AIM! Russian vaccine gets approval as phase 3 trials start only this week. "I know that it works quite effectively, it forms a stable immunity." -- Putin. (Is that like "a very stable genius"?) Antibodies are one thing, but poven prevention of disease is the important criterion. Political pressure to rush approval could sully other vaccines if testing goes south.
The country’s regulators became the first in the world to approve a possible vaccine against the virus, despite warnings from the global authorities against cutting corners.
Researchers and companies developing Covid-19 vaccines are taking new steps to tackle a longtime challenge: People who need the vaccines most urgently, including Blacks and Latinos, are least likely to participate in clinical trials to determine whether they work safely.
Novavax Inc. said Tuesday its experimental coronavirus vaccine induced promising immune responses and was generally well-tolerated in healthy adults in the first human study of the shot. Results support larger test of 30,000 people in fall.
A single-shot vaccine for COVID-19 has proven successful in tests on primates and could begin phase 3 trials as early as September. The results of the tests on the vaccine, developed at Beth Israel Deaconess Medical Center in collaboration with Johnson & Johnson, showed that it promoted creation of protective antibodies and built on the team’s previous results. It is published in the journal Nature.
Johnson & Johnson has started a Phase I/IIa clinical trial to assess the safety, reactogenicity, and immunogenicity of Ad26.COV2.S in more than 1,000 healthy volunteers aged 18 to 55 years, and those aged 65 years and above in the U.S and belgium.
Scientists have created candidate vaccines with astonishing speed, compressing scientific efforts that usually take years into months. But the leader of a key drug trial said Tuesday that the blistering research pace has nonetheless been too slow to catch the coronavirus
Podcast and transcript: FDA's Dr. Peter Marks explains Operation Warp Speed and how it intends to speed up COVID-19 vaccine development without sacrificing assurances of safety and efficacy.
Pfizer and its German partner BioNTech SE dosed their first U.S. patient in a late-stage trial Monday, and they could be ready to seek approval from regulators as early as October.
The article argues for adherence to existing structures for drug/vaccine development in the quest for a SARS-CoV-2 vaccine. "...consent is not suficient for the justification of additional risk," the author asserts.
Good technical overview and deep-dive into previous studies, current status, and future possibilities for SARS-CoV-2 vaccines. The article covers immunotherapeutic approaches, many vaccine technologies, vaccines in development, plus challenges for development.
Oxford vaccine (AZD1222) induced T cell as well as antibody immunity, but subjects were no older than 55. How well will it work in seniors, a very vulnerable population?
The trial is expected to enroll about 30,000 adult volunteers and evaluates the safety of the Moderna/NIH vaccine and whether it can prevent symptomatic Covid-19 after two doses, among other outcomes.
The results of two early phase COVID-19 vaccine trials are reported, one from investigators at the Jenner Institute at Oxford University (Oxford, UK), with support from AstraZeneca, and the second from investigators supported by CanSino Biologics in Wuhan, China. Both groups used an adenoviral vector, and both report the vaccine achieving humoral responses ...
Of the 21 vaccine candidates listed by the WHO in clinical trial stages, the vaccine candidates by Chinese company Sinovac, China National Pharmaceutical Group (Sinopharm) and Oxford University-AstraZeneca are undergoing Phase III tests ,,, GlaxoSmithKline (GSK), which is already working with Sanofi on a shot, has partnered with Canadian biopharmaceutical firm Medicago to develop and manufacture a plant-based adjuvanted Covid-19 vaccine candidate.
SEOUL/SINGAPORE (Reuters) - China is forging ahead in the race to develop a vaccine to help control the COVID-19 pandemic, with Sinovac Biotech's experimental vaccine set to become the country's second and the world's third to enter final stage testing later this month.
Researchers at the New York University Grossman School of Medicine in Manhattan and the University of Maryland School of Medicine in Baltimore said Tuesday they began injecting people with the first of four vaccine candidates from Pfizer and Germany’s BioNTech.
Moderna released new data Monday morning that strengthens the case for its COVID-19 vaccine. It concludes the vaccine is 94 percent effective – and strongly protects against serious illness. Based on these latest findings, the company plans to submit an application for emergency use authorization to the Food and Drug Administration today.
At first, I was confused since some of the press releases state that it was 90% effective, others stated it was 60% effective, and yet other press releases came up with an average of 70% effective. These were supposed to be the results from a single clinical trial! Remarkably, this was only the start of the confusion on this vaccine’s data.
With the efficacy portion of their Covid-19 vaccine trial completed, showing the vaccine to prevent 95% of cases of the disease, the companies said that they plan to submit to the Food and Drug Administration for an emergency use authorization “within days,” and will also submit to regulatory agencies around the globe.
Current as of Sept. 11, 2020: Synopsis of company funding, background on company and vaccine,clinical trial results, trials planned, & any additional company news.
Moderna's mRNA-1273 COVID-19 vaccine induced what they called "robust" neutralizing antibody responses in older adults (56-70 and >71 yrs). Antibody levels were 2-3 times higher than those seen in patients after they recovered from COVID-19. It is unknown if these neutralizing antibodies will protect people from SARS-CoV-2 infection.
Ranking of companies in COVID-19 vaccine race, including funding, vaccine technology, clinical trials phase(s), brief synopsis of results, and production plans
Good technical overview and deep-dive into previous studies, current status, and future possibilities for SARS-CoV-2 vaccines. The article covers immunotherapeutic approaches, many vaccine technologies, vaccines in development, plus challenges for development.
Oxford vaccine (AZD1222) induced T cell as well as antibody immunity, but subjects were no older than 55. How well will it work in seniors, a very vulnerable population?
Pfizer and BioNTech have shared (PDF) phase 1/2 data suggesting their COVID-19 vaccine triggers stronger CD8 T-cell responses than Moderna’s rival candidate. Four-fifths of subjects who received BNT162b1 had vaccine-induced CD8 T-cell responses and researchers classed most of the responses as strong.
Early results put researchers on track for a shot that could be ready for mass production as soon as September ... A study of 1,077 healthy adults who received the vaccine showed it produced two kinds of immune response that could defend a body against Covid-19 ...
Moderna expects to start the company's largest study yet of its Covid-19 vaccine candidate mRNA-1237 on July 27, according to details released separately on Tuesday. It's expected to be the first in the United States to begin Phase 3 trials
A Maryland man believes he may be one of the first people to be successfully vaccinated against the coronavirus after participating in a trial that has reported promising early results in producing antibodies, according to reports.
Many underlying issues need to be addressed to be able to recruit diverse communities for vaccine trials, including whether those communities will have access to a vaccine once approved, aversion to hospitals, and lack of insurance in case of needed medical care resulting from an experimental vaccine.
Emory University pediatrician Dr. Evan Anderson argues that delaying vaccine trials in children will hamper their education, health, and emotional well being as well as prolong the pandemic. "... the role of children in SARS-CoV-2 transmission has clearly been underappreciated," he writes.
Current as of Sept. 11, 2020: Synopsis of company funding, background on company and vaccine,clinical trial results, trials planned, & any additional company news.
With multiple SARS-CoV-2 vaccines in testing, Pfizer may be betting that positioning itself to prevail in the long run will be a better strategy than necessarily being first to market. With multiple vaccine candiates in its portfolio, one may emerge later as more efficacious than what comes first.
A concise explanation of how COVID vaccine trials are conducted, how a vaccine would be judged effective, and potential downsides to putting out a vaccine too soon.
Phase 3 trial in U.S. should show how this population reacts to vaccine. Since the trial primary endpoint is event-driven (sufficient number of infections), completion of the trial depends on the level of viral transmission.
On the verge of Phase 3 testing: Moderna and others set to test for efficacy. Questions remain: Antibodies (and cellular iimmunity) are only a surrogate measure for the critcally important outcome of preventing COVID-19 disease. Will there be protection, and how long might it last?
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has established a new clinical trials network that aims to enroll thousands of volunteers in large-scale clinical trials testing a variety of investigational vaccines and monoclonal antibodies intended to protect people from COVID-19.
If you want to be one of the first to receive an experimental vaccine for Covid-19, now's your chance. Wednesday, a new website -- coronaviruspreventionnetwork.org -- went live allowing people in the United States to register to take part in clinical trials for vaccines.
Vaccine researchers are trying new tacks in an unprecedented effort to recruit the tens of thousands of healthy volunteers needed to finish testing coronavirus shots in late stages of development.
