全球领先疫苗,39支疫苗进入3期实验,10月13日,德国法国放弃两款mRNA疫苗,转为研发新一代疫苗和加强剂。中国两款疫苗进入第三期试验。

8 hr 27 min ago
US federal agency invests in needle-free vaccine technologies
From CNN's Maggie Fox

The US federal government said Wednesday it’s investing nearly $2.5 million in efforts to create a needle-free coronavirus vaccine.

The Biomedical Advanced Research and Development Authority (BARDA) announced four small grants to groups trying to make either oral vaccines against coronavirus, or patches that could painlessly deliver a vaccine.
“The novel routes of administration they are developing could reduce the dependence on needles and syringes that are used to deliver vaccine via intramuscular injection. Instead, a wearable skin patch or oral option for vaccines may support rapid, large-scale immunization while reducing the strain on the manufacturing supply chain,” BARDA said in a statement.
The four new technologies are also "shelf-stable" -- unlike current coronavirus vaccine candidates, they don’t have to be kept under special conditions or temperatures, making them easier to store and deliver.

The four groups:
  • Michigan-based Esperovax is working on vaccines people could take in capsules. They received $600,000 from BARDA.
  • The University of Connecticut already has a microneedle patch that can deliver pneumonia vaccines. They are now testing a coronavirus vaccine in animals. BARDA gave them $430,000.
  • Vaxess Technologies spun out of research done at Tufts University and MIT. Its patch releases a vaccine over time. BARDA gave them $749,000.
  • California-based biotech startup Verndari is creating a fast-production, sugar-based microneedle patch. BARDA awarded them $700,000.
 
现场照:首支昆虫细胞生产的重组蛋白新冠疫苗开始注射
文章来源: 红星新闻 于 2020-08-29 09:33:30 - 新闻取自各大新闻媒体,新闻内容并不代表本网立场!
(被阅读 9304 次)

8月29日,红星新闻记者从四川大学华西医院获悉,上午9点,四川大学华西医院重组新型冠状病毒肺炎疫苗(Sf9细胞)第一支疫苗注入志愿者体中。

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据四川大学华西医院生物治疗国家重点实验室主任、魏于全院士介绍,本次重组蛋白新冠疫苗于8月21日获国家药监局临床试验批文。该疫苗将新冠病毒的基因引入昆虫细胞生产出高质量的重组疫苗蛋白并进行精致纯化,易于大规模生产并投入市场。该科研成果已于7月29日在国际著名的Nature杂志发表。目前,所有受试者感觉良好,没有出现不良反应。

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红星新闻记者 于遵素 图据华西医院

 
2 hr 51 min ago
Canadian Prime Minister says he will not rush vaccine approval
From CNN’s Paula Newton


Justin Trudeau, Canada's prime minister, waits to speak at the National Research Council of Canada Royalmount Human Health Therapeutics Research Centre facility in Montreal on Monday, Aug. 31.

Justin Trudeau, Canada's prime minister, waits to speak at the National Research Council of Canada Royalmount Human Health Therapeutics Research Centre facility in Montreal on Monday, Aug. 31. Andrej Ivanov/Bloomberg/Getty Images

Canadian Prime Minister Justin Trudeau says his government will not give in to pressure and rush vaccine approval, despite what some other countries are doing.

“Canada will always put the safety of Canadians first and foremost and that’s true on vaccines on it is on everything else,” said Trudeau during a press conference Monday in Montreal.

Trudeau pointed out that the Canadian government has been under pressure for months to approve testing methods and therapeutic drugs on a more rapid timetable but that Health Canada has refused to do so citing safety and efficacy concerns.

“We will not see testing protocols approved until they are safe for Canadians. We will not move forward on a vaccine until we are confident it is safe for Canadians. Other countries will make their own decisions and have already in regards to testing,” he said.

Some more context: Monday the Canadian government announced new agreements with Johnson & Johnson and Novavax, adding to agreements with Pfizer and Moderna to reserve millions of doses of experimental COVID‑19 vaccines. Canadian officials say they are in negotiations to secure other vaccines so that a ‘diverse portfolio’ of vaccine candidates is developed over the next few months.

Canadian officials say they do not expect a viable vaccine to be distributed until early next year at the earliest.

Trudeau also announced nearly $100 million in funding for a new biomanufacturing facility in Montreal in order to increase vaccine manufacturing to about 2 million doses per month by next year. This is intended to help Canada to domestically produce enough doses of an eventual vaccine.
 
Third virus vaccine reaches major hurdle: Final US testing

AstraZeneca announced Monday its vaccine candidate has entered the final testing stage in the U.S.

By Lauran Neergaard , Carla K. Johnson | Associated Press

A handful of the dozens of experimental COVID-19 vaccines in human testing have reached the last and biggest hurdle: looking for the needed proof that they work as a U.S. advisory panel suggested Tuesday a way to ration the first limited doses once a vaccine wins approval.

AstraZeneca announced Monday its vaccine candidate has entered the final testing stage in the U.S. The Cambridge, England-based company said the study will involve up to 30,000 adults from various racial, ethnic and geographic groups.

Two other vaccine candidates began final testing in tens of thousands of people in the U.S. this summer. One was created by the National Institutes of Health and manufactured by Moderna Inc., and the other developed by Pfizer Inc. and Germany’s BioNTech.

“To have just one vaccine enter the final stage of trials eight months after discovering a virus would be a remarkable achievement; to have three at that point with more on the way is extraordinary,” Health and Human Services Secretary Alex Azar said in a statement.

FILE - In this Aug. 14, 2020, file photo, laboratory technicians work at the mAbxience biopharmaceutical company on an experimental coronavirus vaccine developed by Oxford University and the laboratory AstraZeneca in Garin, Argentina. AstraZeneca announced Monday, Aug. 31, its vaccine candidate has entered the final testing stage in the U.S. (AP)


FILE - In this Aug. 14, 2020, file photo, laboratory technicians work at the mAbxience biopharmaceutical company on an experimental coronavirus vaccine developed by Oxford University and the laboratory AstraZeneca in Garin, Argentina. AstraZeneca announced Monday, Aug. 31, its vaccine candidate has entered the final testing stage in the U.S. (AP)

NIH Director Francis Collins tweeted that his agency "is supporting several vaccine trials since more than one may be needed. We have all hands on deck."
AstraZeneca said development of the vaccine, known as AZD1222, is moving ahead globally with late-stage trials in the U.K., Brazil and South Africa. Further trials are planned in Japan and Russia. The potential vaccine was invented by the University of Oxford and an associated company, Vaccitech.

Meanwhile, a U.S. advisory panel released a draft plan Tuesday for how to ration the first doses of vaccine. The National Academies of Sciences, Engineering and Medicine proposed giving the first vaccine doses — initial supplies are expected to be limited to up to 15 million people — to high-risk health care workers and first responders.

Next, older residents of nursing homes and other crowded facilities and people of all ages with health conditions that put them at significant danger would be given priority. In following waves of vaccination, teachers, other school staff, workers in essential industries, and people living in homeless shelters, group homes, prisons and other facilities would get the shots.

Healthy children, young adults and everyone else would not get the first vaccinations, but would be able to get them once supplies increase.

The panel of experts described “a moral imperative” to lessen the heavy disease burden of COVID-19 on Blacks, Hispanics, Native Americans and Alaska Natives, and suggested state and local authorities could target vulnerable neighborhoods using data from the Centers for Disease Control and Prevention.
The National Academies will solicit public comments on the plan through Friday.

There’s a good reason so many COVID-19 vaccines are in development.

“The first vaccines that come out are probably not going to be the best vaccines,” Dr. Nicole Lurie, who helped lead pandemic planning under the Obama administration, said at a University of Minnesota vaccine symposium.

There’s no guarantee that any of the leading candidates will pan out — and the bar is higher than for COVID-19 treatments, because these vaccines will be given to healthy people. Final testing, experts stress, must be in large numbers of people to know if they’re safe enough for mass vaccinations.

Third coronavirus vaccine candidate reaches final testing phase

They’re made in a wide variety of ways, each with pros and cons. One problem: Most of the leading candidates are being tested with two doses, which lengthens the time required to get an answer — and, if one works, to fully vaccinate people.

Another: They’re all shots. Vaccine experts are closely watching development of some nasal-spray alternatives that just might begin the first step of human testing later this year — late to the race, but possibly advantageous against a virus that sneaks into the airways.

For now, here’s a scorecard of vaccines that already have begun or are getting close to final-stage tests:

The Moderna and Pfizer candidates began Phase 3 testing in late July.

Neither uses the actual coronavirus. Instead, they’re made with the genetic code for the aptly named “spike” protein that coats the surface of the coronavirus. Inject the vaccine containing that code, called mRNA, and the body’s cells will make some harmless spike protein — just enough for the immune system to respond, priming it to react if it later encounters the real virus.

These mRNA vaccines are easier and faster to make than traditional vaccines, but it’s a new and unproven technology.

TROJAN HORSE VACCINES

Britain’s Oxford University and AstraZeneca are making what scientists call a “viral vector” vaccine but a good analogy is the Trojan horse. The shots are made with a harmless virus — a cold virus that normally infects chimpanzees — that carries the spike protein’s genetic material into the body. Once again, the body produces some spike protein and primes the immune system, but it, too, is a fairly new technology.

Two possible competitors are made with different human cold viruses.

Shots made by Johnson & Johnson began initial human studies in late July. The company plans to begin Phase 3 testing in September in as many as 60,000 people in the U.S. and elsewhere.

China’s government authorized emergency use of CanSino Biologics’ adenovirus shots in the military ahead of any final testing.

‘KILLED’ VACCINES

Making vaccines by growing a disease-causing virus and then killing it is a tried-and-true approach — it’s the way Jonas Salk’s famed polio shots were made. China has three so-called “inactivated” vaccine candidates against COVID-19 made this way.

Sinovac has final studies of its candidate underway in Brazil and Indonesia. Competitor SinoPharm has announced plans for final testing in some other countries.

Safely brewing and then killing the virus takes longer than newer technologies. But inactivated vaccines give the body a sneak peek at the germ itself rather than just that single spike protein.

PROTEIN VACCINES

Novavax makes “protein subunit” vaccines, growing harmless copies of the coronavirus spike protein in the laboratory and packaging them into virus-sized nanoparticles.

There are protein-based vaccines against other diseases, so it’s not as novel a technology as some of its competitors. But it only recently finished its first-step study; the U.S. government’s Operation Warp Speed aims for advanced testing later in the fall.

AP journalist Danica Kirka in London contributed to this report.

 
A closer look at the vaccines Canada is betting on to stem the spread of COVID-19
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Ottawa has signed deals for millions of doses from 4 companies, and a 5th is close


Emily Chung · CBC News · Posted: Sep 02, 2020 4:00 AM ET | Last Updated: 8 hours ago

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The first patient enrolled in Pfizer's COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore receives an injection in May. Pfizer's vaccine candidate is one of four that Canada has announced deals to reserve. (University of Maryland School of Medicine via The Associated Press)

Canada has announced that it has signed deals with four U.S. companies to reserve millions of doses of COVID-19 vaccines under development in an effort to make sure Canadians are at "the front of the line" when a vaccine becomes available.

The federal government announced agreements with Moderna and Pfizer/BioNTech on Aug. 5 and with Novavax and Janssen, a subsidiary of Johnson & Johnson, earlier this week.

It also said it's close to a deal with AstraZeneca, based in the United Kingdom.

All of the companies have received funding from the U.S. government's Operation Warp Speed, which is investing billions of dollars to fast-track the development of promising vaccine candidates.

Canada will receive 20 million to 76 million doses of each vaccine, should any of them successfully make it through clinical trials and be approved by Health Canada.

The federal government has announced deals to buy millions of potential COVID-19 vaccine doses from two American drug companies, on top of its existing deal with two other U.S. firms. The government is aggressively looking for backup plans after its deal with a Chinese company CanSino fell apart recently. 2:06
They're among more than 150 vaccine candidates under development around the world.

While they have shown promising results in small-scale, early-stage clinical trials, even those most advanced candidates have only recently begun Phase 3 clinical trials to determine their effectiveness in preventing COVID-19, and there is no guarantee any of them will make it to market. That's the crucial large-scale human trial that must demonstrate that the vaccine prevents the disease, and it's the final stage before approval by government.

"What we don't know, of course, is which vaccines are going to be effective," Dr. Michael Gardam, medical director of infection prevention and control at Toronto's Women's College Hospital, said in an interview with CBC's As It Happens.

"We don't know which company ultimately is going to have the best vaccine and the safest vaccine."
Gardam said the deals represent different types of vaccine from four different manufacturers. The federal government, he said, is "just kind of playing the field ... to make sure they have a reasonable chance that one of these will be successful."

Here's a closer look at the four candidates.

Janssen Pharmaceutical Companies (Johnson & Johnson)

Headquarters: Raritan, N.J., U.S.

Type: Non-replicating viral vector

Doses reserved: Up to 38 million

Phase of development: Phase 1/2a trial started in July

How it works: This vaccine, made by a Johnson & Johnson subsidiary, is a new type of vaccine called a non-replicating viral vector. Unlike traditional vaccines made from viruses or parts of viruses, this vaccine uses only a piece of coronavirus DNA. The DNA contains instructions for making a coronavirus protein so that the human body can produce it and learn to recognize it.

The protein targeted by most COVID-19 vaccines, including this one, is called the spike protein or S-protein. It's found on the outer surface of coronaviruses and is used by the virus to bind to and enter human cells.

In this case, the DNA with instructions for making the spike protein is carried into the body by a common cold virus called an adenovirus. The adenovirus has been genetically modified so it can't replicate itself in the human body. However, because it's a virus, it may generate a stronger immune response than the DNA alone and helps get the DNA into human cells, where the spike protein can be produced. One disadvantage of this type of vaccine is that some people may have immunity to some adenoviruses from catching colds, which may make the vaccine less effective.

Viral vector vaccines haven't been approved for widespread use in humans, but 12 are in use for diseases in livestock.

Where it's at: The company reported in July that its vaccine protected monkeys against the virus after a single shot. The company started a human Phase 1/2a trial in July in Belgium and the U.S, and it announced this week it is starting a Phase 2 trial in Spain, the Netherlands and Germany. It says it will conduct Phase 3 trials in Argentina, Brazil, Chile, Colombia and Mexico.

"We just need to have as many sticks in the fire as possible," says infectious disease specialist Dr. Isaac Bogoch. 3:00

Moderna

Headquarters: Cambridge, Mass., U.S.

Type: mRNA

Doses reserved: Up to 56 million

Phase of development: Phase 3 clinical trial started in July

How it works: Moderna's vaccine candidate is made from messenger RNA, a type of genetic material. Messenger RNA, or mRNA, is used by cells to translate instructions found in DNA to make proteins. In this case, the instructions tell a human cell how to make a stabilized version of the spike protein for SARS-CoV2. That introduces the protein into the body so immune cells can learn to recognize it and produce antibodies against it.

The mRNA is encapsulated in a lipid nanoparticle for injection into the body. The LNP "container" protects it from being degraded by enzymes and helps it enter cells, Moderna says.

The mRNA itself also generates an immune response. While mRNA vaccines have been under development and widely tested for many years, none have ever been approved for widespread human use.

Where it's at: Moderna launched the first Phase 3 clinical trial in the U.S. in July, and hopes to enrol 30,000 volunteers. The company reported in May that the vaccine produced protective antibodies in a small group of healthy volunteers, and the study showed the vaccine was safe. However, three people in an early-stage trial reportedly had severe or "systemic" adverse reactions, such as high fevers, to a high dose of the vaccine.

Human challenge trials could make finding a COVID-19 vaccine faster, but the controversial approach involves exposing volunteers to the virus to see if a potential vaccine works. The National’s Andrew Chang finds out more about this process and the people volunteering to be test subjects. 9:01

Novavax

Headquarters: Gaithersburg, Md., U.S.

Vaccine type: Protein subunit

Doses reserved: 76 million

Phase of development: Phase 1/2 clinical trial started in May

How it works: Novavax's vaccine is the most traditional of the ones reserved by the federal government. The vaccine is made from nanoparticles of a key protein from the coronavirus that causes COVID-19. When the protein particles are injected into the body with an adjuvant — a compound that enhances the body's immune response — the body learns to recognize and fight off the virus.

"That is a tried and true way of producing vaccines and of creating immunity," Dr. Barry Pakes, a professor at the Centre for Vaccine Preventable Diseases at the University of Toronto's Dalla Lana School of Public Health, told CBC News Network.

It's similar to vaccines already on the market, such as the hepatitis B vaccine.

Novavax makes the protein by putting the genetic sequence for the protein into a virus that infects insect cells, causing them to make large quantities of protein. The protein has some small genetic modifications compared with the one found on the real virus to help it maintain a rigid shape and make it easier for the body to bind to and recognize.

Protein subunit vaccines don't elicit as strong an immune response as whole virus vaccines, so they often include an adjuvant. Novavax uses a proprietary adjuvant called Matrix-M, which is based on a type of compound found in many plants called a saponin. The company says it boosts the body's immune response and generates a bigger immune response with a lower dose.

Where it's at: Novavax reports in a study preprint (not yet peer-reviewed) that in Phase 1 clinical trials, its protein and adjuvant stimulate high levels of neutralizing antibodies — higher than those in people who have had a natural infection — with few side effects. It's currently running a combined Phase 1 and 2 trial.

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Vials used by pharmacists to prepare syringes used on the first day of a first-stage safety study clinical trial of a potential vaccine for COVID-19 are shown in March. (Ted S. Warren/The Associated Press)

Pfizer/BioNTech

Headquarters: New York, N.Y., U.S./Mainz, Germany

Type: mRNA

Doses reserved: At least 20 million

Phase of development: Phase 2/3 clinical trial started in July

How it works: Pfizer and BioNTech's mRNA vaccine is quite similar to Moderna's. It's an mRNA sequence for a stabilized spike protein. Like Moderna's vaccine, it's delivered in a lipid nanoparticle container.

Where it's at: Pfizer and BioNTech tested two different mRNA sequences for Phase 1. It reported in a study posted online that has not yet been peer-reviewed that both vaccines generated higher levels of neutralizing antibodies than found in the blood of someone who had had a natural COVID-19 infection.

However, the spike protein sequence generated fewer side effects, especially in older adults, so that's the focus of a combined Phase 2 and 3 trial.

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(CBC News)

 
最后编辑:
美英的两种疫苗的二期结果不理想,现在也是死马当活马医,进入到三期。
 
3 hr 43 min ago
First clinical trial results from Russia's Covid-19 vaccine published in The Lancet medical journal
From CNN's Zahra Ullah and Matthew Chance in Moscow

Employees are seen at Russia's biotech company BIOCAD, which is working on a coronavirus vaccine.

Employees are seen at Russia's biotech company BIOCAD, which is working on a coronavirus vaccine. Olga Maltseva/AFP/Getty Images

The first peer-reviewed results of Phase 1 and Phase 2 clinical trials of Russia’s coronavirus vaccine, which is named Sputnik-V, have been published in the medical journal The Lancet on Friday.

Results from the two 42-day trials – which each included 38 healthy adults – “have a good safety profile with no serious adverse events” among participants, The Lancet said in a press release, noting that the vaccine-induced antibody responses in all participants.

Russia faced criticism last month when it announced the world's first approved coronavirus vaccine for public use, even before Phase 3 trials are completed.
Russia also faced skepticism over how quickly the vaccine was registered and the initial lack of scientific data around the clinical trials.

Naor Bar-Zeev, deputy director of the International Vaccine Access Center at Johns Hopkins University said in a linked comment that the studies are “encouraging but small,” according to The Lancet. Bar-Zeev was not involved in the Russian study, but peer reviewed it.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund (RDIF) funding the vaccine development said the trial results confirm the "high safety and efficacy" of the vaccine, adding in a statement Friday that the results are "a powerful response to sceptics who unreasonably criticized the Russian vaccine."
 
3 hr 16 min ago
Russia’s Covid-19 vaccine generated an immune response, study says
From CNN Health’s Elizabeth Cohen and Naomi Thomas

A Covid-19 vaccine developed and tested in Russia generated neutralizing antibodies in dozens of study subjects, and while the vaccine often caused side effects such as fever, those side effects were mostly mild, according to data published Friday in the medical journal The Lancet.

In the phase one and two studies, all 76 study participants developed antibodies to the virus that causes Covid-19, according to the report.

The levels of neutralizing antibody response were similar to the immune response that people had after naturally recovering from Covid-19, according to the study.

The researchers also looked at responses from T cells, another component of the immune system.

“[Outcomes from] the trial also suggest the vaccines also produce a T cell response within 28 days,” the researchers wrote.

Remember: Scientists not involved in the study said while the results are a positive sign, only larger, phase three trials can confirm whether the vaccine actually prevents illness with Covid-19.

“The data on the Russian vaccine studies reported in the Lancet are encouraging,” said Brendan Wren, professor of microbial pathogenesis, London School of Hygiene and Tropical Medicine.

In the study, half of the participants developed fevers and 42% developed headaches. In addition, about 28% experienced weakness and 24% had joint pain.
The article did not say how long these side effects lasted but said “most adverse events were mild.”

The vaccine was registered in Russia in August, before it had gone through large-scale trials. The researchers at the Gamaleya National Research Centre for Epidemiology and Microbiology in Russia received approval on August 26 to do a phase three trial, which is expected to have 40,000 volunteers, according to a press release from The Lancet. The researchers are already distributing the vaccine to high-risk groups, according to Kirill Dmietriev, head of the Russian Direct Investment Fund (RDIF), which is financing Russian vaccine research.

Gamaleya is using adenoviruses in their Covid-19 vaccines; this is the same type of approach used in the vaccine developed by University of Oxford and AstraZeneca. The adenovirus delivers genetic material for the spike protein that sits atop the virus the causes Covid-19, and that genetic material is designed to generate an immune response to the virus that causes Covid-19.

Adenoviruses can cause a variety of symptoms, including the common cold. The researchers manipulate the virus so it will not replicate and cause illness.
The Gamaleya vaccine is given in two doses, and each dose used a different adenovirus vector.

“Using two different viruses gives a theoretical advantage,” said Dr. Paul Offit, a vaccinologist at the University of Pennsylvania.
 
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