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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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?
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.
"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.
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.
Ranking of companies in COVID-19 vaccine race, including funding, vaccine technology, clinical trials phase(s), brief synopsis of results, and production plans
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
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?
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.
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
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.
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....
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.
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.
Current as of Sept. 11, 2020: Synopsis of company funding, background on company and vaccine,clinical trial results, trials planned, & any additional company news.
Ranking of companies in COVID-19 vaccine race, including funding, vaccine technology, clinical trials phase(s), brief synopsis of results, and production plans
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
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.
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.
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.
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.
"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.
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.
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.
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.
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.
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.
Two virologists have free-whelling discussion with Dr. Fauci about SARS-CoV-2 tranmission, testing, immunity, pathogenesis, vaccines, and preparedness.
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.
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.
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.
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.
