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 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
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 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.
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."
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%.
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’s announcement that a preliminary and unpublished analysis shows its experimental coronavirus vaccine is nearly 95 percent effective at preventing illness, including severe cases — gives the United States the prospect that two vaccines could be available on a limited basis by the end of the year.
The article explains why early indications of success for Pfizer's COVID vaccine is also good news for its competitors, many of which base their development efforts on similar mRNA platforms. One impediment (but not a deal breaker) is the need for a cold chain to protect the fragile mRNA molecules.
A very good tutorial comparing traditional vaccine development, manufacturong, and distribution methods and timelines with an accelerated process without compromising safety or ethical integrity
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.
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.”
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.
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.
The study is designed to recruit up to 10,000 participants aged 18 to 84 years, with and without relevant comorbidities, over the coming four to six weeks. It is intended to involve at least 25% of subjects aged above 65 years, and also prioritise groups most impacted by Covid-19, including racial and ethnic minorities.
Trials for the single-dose vaccine will include up to 60,000 adult participants at nearly 215 sites in the US and internationally. While the other vaccine candidates require two doses, Johnson & Johnson's candidate will be studied as a single-dose vaccine, which should expedite results Chief Scientific Officer Dr. Paul Stoffels said on a call with reporters.
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.
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.
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.
Some 170 Covid-19 vaccines are in development around the world, according to the World Health Organization. Now, a handful are starting or nearing the final stage of testing. Depending on the results, some companies say their vaccines could be greenlighted for use as soon as this year.
Dr. Stephen M. Hahn, who has been under pressure from the White House to speed coronavirus treatments, said in a newspaper interview that his agency would be willing to approve a coronavirus vaccine before Phase 3 clinical trials were complete if the agency found it “appropriate” to do so.
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 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.
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.
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.
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
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.
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.
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.
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.
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.
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.
Early results put researchers on track for a shot that could be ready for mass production as soon as September ... A study of 1,077 healthy adults who received the vaccine showed it produced two kinds of immune response that could defend a body against Covid-19 ...
Moderna expects to start the company's largest study yet of its Covid-19 vaccine candidate mRNA-1237 on July 27, according to details released separately on Tuesday. It's expected to be the first in the United States to begin Phase 3 trials
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.
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.
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.
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.
