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.
Operation Warp Speed: Where has the money gone -- $10 billion of it? Public Citizen sues HHS under the Freedom of Information Act for transparency on contracts to major corporations developing coronavirus vaccines.
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.
[PODCAST} A winde-ranging talk among health care researchers including development and testing of a coronavirus spike-encoding mRNA vaccine, and then veering into a review of the Nobel Prize fordiscovery of the hepatitis C virus.
[PODCAST] Why mutations in coronavirus may make a vaccine less effective or even negate its efficacy. And if natural antibodies wane after infection, could some people still be protected against the virus?
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.
Top officials in charge of making sure that a safe and effective Covid-19 vaccine is swiftly delivered to the American people waved caution flags on Tuesday, all but assuring that a shot won’t be widely available by Election Day. The Food and Drug Administration has been working for months to hammer out clear standards for vaccines seeking to be fast-tracked to market. The process has placed the agency at odds with the White House, which has wanted to get a shot approved by the time Americans head to the polls on Nov. 3.
The White House blocks more rigorous FDA standards for emergency use authorization of a coronavirus vaccine, hoping to achieve a (dubious) political win in getting a vaccine approved before Nov. 3. But will an already skeptical public see it as a win, and will they lose continue to lose confidence in the safety or efficacy of suchg a vaccine? A political win (if that) may really be a public health loss.
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.
He who is last may later be first. Expertise in clinical trials, scaling up production on a commercial scale, and distribution of vaccine -- and "substantial muscle memory of doing that" -- may beat first-out-of-the-box.
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.
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.
How did a lead investigator working with one of the major COVID vaccine developers become chair of the FDA's vaccine advisory committee in the first place? Without ascribing any ill intent or motive to her, it just seems very tone deaf. Doesn't the U.S. have enough qualified experts to chair the committee so as not to commit such a blunder?
SARS-CoV-2 is accuulating mutations, with implications for: 1. transmissibility (contagiousness); 2. virulence (severity of disease); 3. susceptibility to a vaccine against the current strain of the virus. Preprint (not peer reviewed) from MedRxiv: https://www.medrxiv.org/content/10.1101/2020.09.22.20199125v1 (PDF of full preprint available)
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.
The Advisory Committee on Immunization Practices may wait until government authorizes specific vaccine or vaccines before voting on prioritization plan for recipients. The group of external medical experts that advises the Centers for Disease Control and Prevention was initially expected to vote at a meeting Tuesday on a plan to give priority to initial doses of any Covid-19 vaccine that passes muster in clinical trials.
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 WHO plan is to vaccinate some people in all countries, not everyone in some countries. Funding will come from middle- and upper-income countries. 170 countries will participate in the distribution plan. The U.S is not one of them. A pandemic by definition is a widespread disease, in this case, a global one.
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.
AstraZeneca PLC’s chief executive said a Covid-19 vaccine it is developing with the University of Oxford could still be ready by the end of the year, despite the company pausing late-stage trials after a participant in the U.K. developed an unexplained illness.
Interview with Dr. Paul Offit, Professor of Pediatrics at Children’s Hospital of Philadelphia, co-inventor of the rotavirus vaccine, and director of the Vaccine Education Center at Children’s Hospital of Philadelphia
A podcast with editors of NEJM covering how COVID-19 vaccines are being developed, discussing a recent setback of one case of a possibe neurological adverse effect, and then talking about vaccine global deployment -- how and to whom first.
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 large, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the U.S. has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom.
"It's just incredible. I think the vaccine supply chain is one of the most mind-bogglingly complex supply chains ever built." -- Johns Hopkins professor of operations management. It will involve which vaccine(s) to use, production, cold chain, the CDC, middle men, decisions on whom to vaccine first, how/where to administer it, storage, shelf life, injection supplies, PPE, record keeping for a second shot, and more.
Several drug makers developing Covid-19 vaccines plan to issue a public pledge not to seek government approval until the shots have proven to be safe and effective, an unusual joint move among rivals that comes as they work to address concerns over a rush to mass vaccination. A draft of the joint statement, still being finalized by companies including Pfizer Inc., Johnson & Johnson and Moderna Inc. and reviewed by The Wall Street Journal, commits to making the safety and well-being of vaccinated people the companies’ priority. The vaccine makers would also pledge to adhere to high scientific and ethical standards in the conduct of clinical studies and in the manufacturing processes.
In separate interviews Thursday with NPR, the chief scientific adviser to the Trump administration's vaccine development effort and the former director of the CDC's office of public health preparedness cautioned that an effective vaccine is likely still months away ... “I'm very optimistic about a vaccine and potentially more than one vaccine," Dr. Ali Khan said. But the notion that one may be ready in October was "super optimistic," he said.
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.
AstraZeneca is working to secure capacity to meet what could be a 3 billion-dose demand for its COVID-19 vaccine front-runner, paying Oxford Biomedica $20 million to reserve 1,000 liters of production capacity for its AZD1222 vaccine for at least 18 months with an optional 18-month extension, thereby expanding on an initial pact for just one year and 200 liters of capacity.
The Trump administration said it will not join Covax, a global effort to develop, manufacture and equitably distribute a coronavirus vaccine, in part because the World Health Organization is involved, with potential implications for U.S. and global public health as well as the global economy.
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.
These vaccines, using modified adenovirus type 5 (Ad5) viral vectors, could potentially have limited efficacy. Many adenoviruses commonly circulate in the population to cause the common cold. Thus, many people may have immunity to Ad5, eliminating the vector carrying the SARS-CoV-2 genes before it could insert its payload into cells. A group at McMaster University is developing an inhaled Ad5 COVID vaccine, "theorizing it could circumvent pre-existing immunity issues." But isn't the respiratory tract exactly where a cold virus would induce immunity?
The IDSA urges the FDA to approve and license any vaccine based on completed phase 3 trials and not through an Emergency Use Authorization. However, if the FDA issues an EUA, the IDSA urges it to use both internal and independent external experts to review full safety and efficacy data.
Development and approval of one or more COVID-19 vaccines are only the first steps. Then the logistics begin: production & distribution of the vaccines, supplies for administering doses, PPE, and human issues of getting people to show up for two doses.
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.
The deadline is fast approaching for less wealthy countries to commit to purchasing COVID vaccines through the COVAX facility when available, now that wealthy countries (US, UK, Japan, Canada, Australia, and others) have already signed bilateral contracts with manufacturers to buy millions of doses for themselves.
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.
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.
A very technical paper showing that a secretory IgA monoclonal antibody (the kind of antibody secreted from mucosal surfaces, such as in the lungs) bound with higher affinity and neutralized SARS-CoV-2 better than did an IgG monoclonal (IgG is typically found in blood). SInce the virus typically enters the body through the lungs, one implication of the paper is whether vaccines to induce IgA should be developed (& possibly administered via inhalation?).
Ezekiel Emanuel, MD, PhD, of the University of Pennsylvania's Perelman School of Medicine, Department of Medical Ethics and Health Policy, discusses logistics, policy, & ethis of COVID vaccine distribution (at 15:28-25:58; Recorded August 19, 2020)
Ezekiel Emanuel, chair of Medical Ethics & Health Policy at the University of Pennsylvania, believes a COVID vaccine will need to be given to people who have the highest risk of transmitting the virus, who are not necessarily front-line health care workers.
Roche will help manufacture and distribute Regeneron’s promising Covid-19 antibody medicine, more than tripling expected supply. Regeneron’s drug is in clinical trials as a treatment for sick patients and to temporarily prevent new infections in people at high risk of catching the virus.
To achieve so-called herd immunity scientists have suggested that perhaps 70 percent of a given population must be immune, through vaccination or because they survived the infection. Now some researchers are wrestling with a hopeful possibility that the threshold is likely to be much lower: just 50 percent, perhaps even less.
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.
U.S. officials organizing the fight against the pandemic have been under pressure from advocacy groups such as 1 Day Sooner and others that see challenge trials as a way to speed up tests of a COVID-19 vaccine. Most vaccine trials rely on inadvertent infection, which can take time to occur.
One of the most promising therapies uses “medicinal signaling cells,” or MSCs, which are found on blood vessels throughout the body. Early trials show signaling cells eliminate the virus, calm the immune response and repair tissue damage.
Rushing vaccine testing won't help anyone if the public doesn't have confidence in the end product. And regardless of how fast a vaccine is tested and approved, it will take time for sufficent numbers of people to be immunized, more time for protective immunity to develop, and more time for herd immunity.
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.
Even if the most optimistic projections hold true and a Covid-19 vaccine is cleared for U.S. use in November, the vast majority of Americans won’t be able to get the shots until spring or summer next year at the earliest.
The company’s experimental vaccine is currently in early-stage human trials and is expected to begin late-stage human trials in September. The deal gives the U.S. the option to order an additional 200 million doses. The U.S. had previously awarded J&J $456 million to develop its vaccine earlier this year. J&J said its goal is to supply more than 1 billion doses globally through 2021
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.
T cells from blood samples stored since before SARS-CoV-2 react to current epitopes - T cells presumably induced by past coronavirus (CV) exposures. So it appears CV-specific T cells have some longevity, with implications for making vaccines that induce T cell immunity.
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?
Sanofi and GlaxoSmithKline will get up to $2.1 billion from the U.S. government to help test, manufacture, and, potentially deliver their experimental shot. The companies expect to begin a Phase 1/2 study of their candidate in September, followed quickly by a Phase 3 trial before the end of the year.
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
The article focuses on identifying "key ethical, empirical, and methodological gaps, related to COVID-19 vaccine uptake, that require urgent attention by both researchers and funders" -- gaps that it says exist in Operation Warp Speed. "If we build it, they will come" is probably not a valid assumption. Or as Jonathan Mann, former head of the WHO global AIDS program, once said about a potential AIDS vaccine, a vaccine in a bottle on a shelf will do no one any good.
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.
How public health officials may use Youtube videos to increase awareness and interest in COVID-19 vaccine, demonstrate to the public the safety and effectiveness of the vaccine(s), and make informed decisions about vaccine uptake.
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.
Preprint (not peer reviewed): Memory (CD8+) T cells from COVID-19 convalescent patients recognized various viral epitopes among the 29 epitopes identified. But only 3 of the recognized epitopes were part of the spike protein, suggesting that vaccines ought to elicit broader CD8+ T cell responses than to just spike protein.
As manufacturers around the world race to develop Covid-19 vaccines, a parallel effort has begun to figure out who in the United States should get them first — and how those doses should be distributed.
Top vaccine makers predict a vaccine or vaccines may be available as early as the beginning of 2021 and at least two pledged doses will be free or low-cost for all Americans. Speaking before a House subcommittee Tuesday, executives from AstraZeneca, Johnson & Johnson, Merck, Moderna and Pfizer said their goal is to have effective vaccines available as soon as possible while following all safety and regulatory guidelines.
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 ...
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 ...
Almost daily, President Trump and leaders worldwide say they are racing to develop a coronavirus vaccine, in perhaps the most urgent mission in the history of medical science. But the repeated assurances of near-miraculous speed are exacerbating a problem that has largely been overlooked and one that public health experts say must be addressed now: persuading people to actually get the shot.
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
Those decades of research into HIV have taught scientists an enormous amount about the immune system, honed vaccine technologies now being repurposed against the coronavirus and created a worldwide infrastructure of clinical trial networks that can be pivoted from HIV to the pathogen that causes the disease covid-19.
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.
U.S. health officials and drugmakers expect to start producing potential coronavirus vaccine doses by the end of the summer, a senior administration official said Monday ... He said they are already buying equipment, securing the manufacturing sites and, in some cases, acquiring the raw materials.
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.
More research emerged this week in potential support of using the tuberculosis vaccine Bacillus Calmette-Guerin (BCG) as a tool in the fight against coronavirus. Researchers found that countries where many people have been given the vaccine have had less mortality from Covid-19.
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.
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.
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.
Novavax has been awarded $1.6 billion by the federal government to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX‑CoV2373, Novavax’ COVID-19 vaccine candidate, as early as late 2020.
The COVID-19 outbreak in the United States will continue to "get worse before it gets better," but the situation might improve as clinicians gain a better understanding of how to treat the virus in the absence of a vaccine or a cure, experts said Tuesday.
Dr. Anthony Fauci says he would "settle" for a Covid-19 vaccine that is 70% to 75% effective, but that this incomplete protection, coupled with the fact that many Americans say they will not get a coronavirus vaccine, makes it "unlikely" that the US will achieve sufficient levels of immunity to quell the outbreak.
Less than half of the population would need to be immune to COVID-19 to develop "herd immunity" to the virus, according to an analysis published Tuesday by the journal Science.The modeling study found that herd immunity potentially could be achieved with about 43 percent of the population being immune, as opposed to the 60 percent estimate derived from previous models.
Health experts are worried about whether coronavirus vaccines under development will adequately protect the elderly, sparking efforts to make sure there are shots that can help the vulnerable group....
Drugmakers in the U.S., Europe, China, and elsewhere are pushing ahead to test and manufacture vaccines against the new coronavirus, hoping to distribute billions of shots once they have proven to work safely. Yet hampering the ramp-up, industry officials said, is a shortage of vials and the special glass they are made from.
There’s a good chance the coronavirus will never go away. Even after a vaccine is discovered and deployed, the coronavirus will likely remain for decades to come, circulating among the world’s population. Experts call such diseases endemic — stubbornly resisting efforts to stamp them out. Think measles, HIV, chickenpox.
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.
But if there was any time to fast-track a vaccine, it is now. So Times Opinion asked vaccine experts how we could condense the timeline and get a vaccine in the next few months instead of years.Here’s how we might achieve the impossible.
, New York Times
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