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CLINICAL TRIALS

CURRENT

Sanofi suffers major setback in development of a Covid-19 vaccine

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.

, STAT News

Russia says data on Sputnik Covid vaccine shows 95% efficacy

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.

, The Guardian

AstraZeneca’s COVID-19 Vaccine Boasts Strong Results with Up to 90% Efficacy

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%.

, Biospace

Four reasons for encouragement based on Pfizer’s Covid-19 vaccine results

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. 

, STAT New

Listen: A risk for Covid-19 vaccine trials, disappointing data on intermittent fasting, & Trump’s new take on pharma

[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.

, STAT Readout Loud podcast (Oct. 1)

The Secretive and Essential Work to Find a Vaccine

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.

, CNN

Johnson & Johnson Covid-19 vaccine study paused due to unexplained illness in participant

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. 

, STAT News

HEALTH AND SCIENCECoronavirus vaccine trial participants report day-long exhaustion, fever and headaches — but say it’s worth it

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?

, CNBC

Covid-19 Vaccine Trials Need Only a Fraction of People to Get Sick

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.

, Wall Street Journal

Novavax launches Phase III trial of Covid-19 vaccine in UK

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.

, Clinical Trials Arena

Johnson & Johnson's coronavirus vaccine is fourth to begin Phase 3 trials in the United States

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.

, CNN

These Coronavirus Trials Don’t Answer the One Question We Need to Know

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.

, The New York Times

NIH ‘Very Concerned’ About Serious Side Effect in Coronavirus Vaccine Trial

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. 

, Kaiser Health News

AstraZeneca starts 30K-subject U.S. phase 3 COVID-19 vaccine trial

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. 

, Fierce Biotech

Covid-19 Vaccines: What’s Coming and When?

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.

, Wall Street Journal

F.D.A. Chief Highlights Circumstances for Early Vaccine Approval

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.

, New York Times

Moderna Says Covid-19 Vaccine Shows Signs of Working in Older Adults

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.

, Wall Street Journal

Encouraging News About Coronavirus Immunity

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)

, In the Pipeline by Derek Lowe

Operation Warp Speed Accelerated Vaccine Process

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.

, U.S. Department of Defense

Novavax coronavirus vaccine candidate begins Phase 2 trials

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. 

, The Hill

COVID-19 vaccine tracker

Candidate vaccines by sponsor, trial phase, institution, & funding as of 13 August (click green "Study Design & Details" box to see those items)

, Regulatory Affairs Professionals Society (RAPS)

Coronavirus Crisis Has Made Brazil an Ideal Vaccine Laboratory

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.

, New York Times

Putin says Russia has approved 'world first' Covid-19 vaccine. But questions over its safety remain

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.

, CNN

Covid-19 Vaccine Trials Have a Problem: Minority Groups Don’t Trust Them

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.

, Wall Street Journal

Single-shot COVID-19 vaccine proves successful with primates

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.

, Harvard Gazette

Vaccines may arrive in record time, but the virus has been faster

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

, Harvard Gazette

FDA Insight: Vaccines for COVID-19, Part 2

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.

, U.S> Food and Drug Administration

Pandemic vaccine trials: expedite, but don’t rush

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.

, Research Ethics

Encouraging results from phase 1/2 COVID-19 vaccine trials

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 ...

, The Lancet

Coronavirus vaccines latest updates

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.

, The Indian Express

'At War Time Speed', China Leads COVID-19 Vaccine Race

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.

, Reuters

Coronavirus Vaccine Enters Human Testing in U.S.

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.

, Wall Street Journal

RESULTS

Moderna to seek FDA emergency use authorization based on further trial results

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.

, NPR

AstraZeneca’s very strange data release around their COVID-19 vaccine

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. 

, Pandemic Pondering Blog

Moderna’s COVID-19 vaccine triggers immune response in older adults

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.

, Fierce Biotech

COVID-19 vaccine tracker

Candidate vaccines by sponsor, trial phase, institution, & funding as of 13 August (click green "Study Design & Details" box to see those items)

, Regulatory Affairs Professionals Society (RAPS)

Pfizer reports strong T-cell response to COVID-19 vaccine

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.

, Fierce Biotech

ENROLLING

Warp Speed for COVID-19 Vaccines: Why are Children Stuck in Neutral?

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.

, Clinical Infectious Diseases

Pfizer's Latest Stealthy Move Could Help It Win the Coronavirus Vaccine Race

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. 

, The Motley Fool

AstraZeneca starts 30K-subject U.S. phase 3 COVID-19 vaccine trial

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. 

, Fierce Biotech

NIH launches clinical trials network to test COVID-19 vaccines and other prevention tools

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.

, National Institute of Health press release

Here's how to volunteer for a Covid-19 vaccine trial

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.

, CNN