Berlin — Regulators authorized AstraZeneca's coronavirus vaccine for use in adults throughout the European Union on Friday, amid criticism the bloc is not moving fast enough to vaccinate its population. The European Medicines Agency (EMA) licensed the vaccine to be used in people 18 and over, though concerns had been raised this week that not enough data exist to prove it works in older people.
The small biotech firm Novavax, once considered a dark horse in the COVID-19 vaccine race, announced today its candidate delivered high efficacy—89.3%—in a pivotal trial in the United Kingdom where a new, highly transmissible variant of the pandemic coronavirus accounted for more than half of the cases in people in the trial. But interim results from a Novavax trial that ran separately in South Africa, in which a different, troubling variant of SARS-CoV-2 accounted for most infections, were sobering.
Johnson & Johnson said Friday that its one-dose coronavirus vaccine was 66% effective overall in protecting against Covid-19. The vaccine, however, appeared to be less potent against other variants. The level of protection varied by region, J&J said, with the vaccine demonstrating 66% effectiveness overall, 72% in the United States, 66% in Latin America and 57% in South Africa after four weeks.
Probably the biggest news from Moderna was that they are going to begin to develop booster immunizations specifically for variant COVID-19 (SARS-CoV-2) viruses. The booster can be used with any vaccine. They can do this easily because, unlike other vaccines, they can simply change the sequence of the RNA and swap it out or add it to the current vaccine. This will allow them to change the vaccine in response to changes in the virus within weeks rather than years without further testing.
Merck & Co said on Monday it would stop development of its two COVID-19 vaccines and focus pandemic research on treatments, with initial data on an experimental oral antiviral expected by the end of March. In early trials, both vaccines generated immune responses that were inferior to those seen in people who had recovered from COVID-19 as well as those reported for other COVID-19 vaccines, the company said.
The Oxford-AstraZeneca vaccine has been approved for use in the UK, with the first doses due to be given on Monday amid rising coronavirus cases. The UK has ordered 100 million doses - enough to vaccinate 50 million people. This would cover the entire population when combined with the full order of the Pfizer-BioNTech jab, Health Secretary Matt Hancock said.
The coronavirus vaccine being developed by AstraZeneca and the University of Oxford is expected to be approved for use in the U.K. in coming days. The Financial Times reported Sunday that government officials confirmed that the Medicines and Healthcare products Regulatory Agency would imminently approve the vaccine, saying the announcement could come as soon as Tuesday. .
Covid-19 continues to ravage the United States, even as a second coronavirus vaccine received a vote of recommendation from a committee at the US Centers for Disease Control and Prevention. The CDC's Advisory Committee on Immunization and Practices (ACIP) voted Saturday to recommend Moderna's vaccine candidate for people 18 and older, following the US Food and Drug Administration's decision a day earlier to authorize the vaccine for emergency use
“Allergic reactions to vaccines are rare but...not unheard of, and they’re seen for most vaccines,” says Jason Schwartz, an assistant professor of health policy at the Yale School of Public Health and co-chair of the Connecticut COVID-19 Vaccine Advisory Group’s Science Subcommittee. While these events need to be taken seriously and investigated, he says, “I wouldn’t anticipate [them], based on what we know right now, substantially changing or slowing the rollout of these vaccines.”
Come Saturday, the U.S. will likely have two Covid-19 vaccines. The FDA’s advisory committee on vaccines voted unanimously Thursday — with one abstention — to recommend an emergency use authorization for Moderna’s mRNA-based Covid-19 shot, setting the agency up to likely issue the EUA on Friday. The agency does not have to listen to the committee but usually does.
The Food and Drug Administration released a detailed analysis Tuesday morning of the COVID-19 vaccine from drugmaker Moderna that supports the authorization of the company's vaccine for emergency use. The FDA's briefing document along with one from Moderna were posted two days before a group of experts will convene to advise the agency on whether to grant the vaccine emergency authorization for use, or EUA, during the pandemic.
The Food and Drug Administration on Friday issued an emergency authorization for a Covid-19 vaccine developed by Pfizer and its German partner, BioNTech, a seminal moment in the effort to curb a pandemic that has so far infected an estimated 16 million people and killed nearly 300,000 in the United States. “While not an FDA approval, today’s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.
The Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee has voted in favor of granting Emergency Use Authorization (EUA) to Pfizer and BioNTech’s mRNA-based vaccine BNT162b2 for the prevention of coronavirus disease 2019 (COVID-19). The panel voted 17 to 4 in favor of the vaccine for the prevention of COVID-19 in individuals 16 years of age and older.
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.
Pfizer’s Covid-19 vaccine passed a critical milestone on Thursday when a panel of experts formally recommended that the Food and Drug Administration authorize the vaccine. The agency is likely to do so within days, giving health care workers and nursing home residents first priority to begin receiving the first shots early next week.
The FDA today released its internal review of the Pfizer/BioNTech request for emergency use approval of their COVID-19 vaccine. The document reveals that the vaccine met all efficacy and safety milestones set by the agency and strongly suggests the vaccine will be approved by the review committee. Remarkably, no major surprises or concerns were identified. This is unusual for such a large and comprehensive (44,000 people) data set. However, there were a few insights that had not previously been made known. Most make the data, if anything, more compelling.
The Food and Drug Administration has confirmed the safety and efficacy of Pfizer’s coronavirus vaccine candidate. The review also found evidence that the vaccine — which is given in two doses, three weeks apart — began to protect people after the first dose. The announcement came hours after Britain started administering the same vaccine, becoming the first Western nation to begin a mass effort to inoculate people against the coronavirus.
Stock analyst Bernstein predicts even 5th place market finisher J&J will have blockbuster sales of its SARS-CoV-2 vaccine, reaping $3 billion for the year. All told, the top five vaccine COVID vaccine marketers are predicted to bring in $40 billion.
Over the next six months there will be enough coronavirus vaccine produced to immunize every American, Operation Warp Speed chief Moncef Slaoui is predicting.“Hopefully, by the middle of the year, I hope most Americans will have been immunized,” Slaoui, head of the Trump administration’s vaccine initiative, said at a Post Live event yesterday. “If enough people are immunized, we should have this pandemic under control in the second half of 2021.”
The UK has become the first country in the world to approve the Pfizer/BioNTech coronavirus vaccine, paving the way for mass vaccination. The first doses are already on their way to the UK, with 800,000 due in the coming days, Pfizer said.
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.
CDC director Robert Redfield told "The Daily Briefing" that a vaccine would initially be made available "in a hierarchical way" with priority going to "nursing home residents and then some combination of health care providers and individuals at high risk for a poor outcome."
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.
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.
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%.
An industrial and systems engineer explains how a vaccine will get from a manufacturer into your arm: the cold chain, facilities capable of handling it, information systems for tracking product and vaccine recipients, and policy decisions, including equity.
Pfizer and its German partner BioNTech announced they plan to file Friday for emergency authorization of their coronavirus vaccine, a landmark moment and a signal that a powerful tool to help control the pandemic could begin to be available by mid- to late December. The filing will move the race to its next, deliberative phase — a weeks-long process in which the Food and Drug Administration scrutinizes the data and determine if the vaccine is safe and effective.
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 said they can manufacture 20 million doses before the end of this year and at least 500 million doses in 2021 ... If both the Pfizer and Moderna vaccines are authorized, that would give the US 40 million doses before January.
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.
(Review articles) A good technical exploration of the potential mechanisms of immune responses in the elderly and how they may affect development and use of SARS-CoV-2 vaccines in this population with the possibility of "damned if you do, damned if you don't" scenarios.
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.
A very good tutorial comparing traditional vaccine development, manufacturong, and distribution methods and timelines with an accelerated process without compromising safety or ethical integrity
In this study, willingness to get a vaccine depended on several factors, including the number of cases as well as people's perceived risk of an infection's lethality. But then there is this: "... and our findings suggest a relationship between willingness to vaccinate and political ideology."
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.
Most vaccine development data will go through Fauci before it reaches the FDA for vaccine approval, except for Pfizer's data. The NIAID will determine if the data is ready for prime time.
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] It's a new ball game for vaccine development based on genetic technologies. This video explains the principles underlying the leading DNA, mRNA, and viral vector vaccines.
[PODCAST] The FDA's Peter Marks, MD, PhD talks with JAMA Editor Howard Bauchner, MD on vaccine progress as of Oct. 5 and prospects for pre-election interference in the FDA approval process.
[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.
Win one for science and rationality: The FDA prevails over White House effort to block FDA guidance on stricter requirements for coronavirus vaccine approval
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.
A Black pastor with a doctorate in community health and a long career in government health care uses Biblical story telling to overcome vaccine skepticism among his congregants.
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.
Bill Gates highlights several missteps in the federal government's reposnse to the COVID-19 pandemic: "You know, this has been a mismanaged situation every step of the way," Gates told STAT News.
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.
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.
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.
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.
Two bioethicists explore the ethics, legal aspects, and what knowledge may be gained or lost when scientists self-administer untested products developed as COVID-19 vaccines.
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.
Despite positive early results from Moderna's mRNA vaccine, SVB Leerink analysts favor antigen subunit vaccines with an adjuvant as their favorite approach among the COVID-19 vaccines in development.
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.
Is a vaccine the only way to return to normal after COVID-19? New research into the virus suggests not — that the infection rate may drop to tiny levels before then.
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?).
The emergency-use authorization, expected Sunday, would come after preliminary studies supported the benefits of the antibody-rich plasma taken from recovered Covid-19 patients
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.
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)
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.
The HHS said the contract, which includes an option to distribute vaccines in the event of a pandemic, was awarded to McKesson as part of a competitive bidding process in 2016.
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.
Ranking of companies in COVID-19 vaccine race, including funding, vaccine technology, clinical trials phase(s), brief synopsis of results, and production plans
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.
New U.S. government award up to $1.525 billion for 100 million doses. Option granted to U.S. government to purchase up to an additional 400 million doses
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.
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.
Chinese drugmaker Kangtai aims to make at least 100 million doses of experimental new coronavirus vaccine for domestic use by year’s end and at least 200 million by the end of 2021.
Caveats and considerations in the rush to develop/approve SARS-CoV-2 vaccine: early vaccine efficacy; efficacy in vulnerable populations; "A weakly effective vaccine can do more harm than good."
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.
The world’s largest vaccine producer, the Serum Institute, announced a plan to make hundreds of millions of doses of an unproven inoculation. It’s a gamble with a huge upside. And huge risks.
Reuters, citing anonymous sources, said Russia's first potential vaccine would be approved by regulators this month. However, some experts are concerned at Russia's fast-track approach.
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
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 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.
An overview of classic vaccine technologies and next-generation vaccine platforms, which will accelerate COVID-19 vaccine development and development of vaccines to future infectious threats.
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.
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?
Two virologists have free-whelling discussion with Dr. Fauci about SARS-CoV-2 tranmission, testing, immunity, pathogenesis, vaccines, and preparedness.
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.
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.
Hackers from Russia's intelligence services are attempting to steal coronavirus vaccine research from the United States, Canada and the United Kingdom, officials said Thursday.
Novavax just received the Trump administration’s largest vaccine contract. In the Maryland company’s 33-year history, it has never brought a vaccine to market.
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.
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.
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.
Developing a COVID-19 vaccine in record time will be tough. Producing enough to end the pandemic will be the biggest medical manufacturing feat in history.
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.
Moderna Inc., one of the leaders among U.S. companies developing experimental vaccines against the coronavirus, entered a pact with Lonza Group AG aimed at manufacturing 1 billion doses a year.
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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