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Coronavirus vaccine news

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Moderna Wants to Transform the Body Into a Vaccine-Making Machine
The U.S. company and its German rival BioNTech plan to use RNA as a messenger inside cells to produce an immune reaction. The advance could upend vaccine development long after the pandemic.​
Almost every antiviral vaccine ever sold works in a similar way: A dead or weakened virus, or a piece of one, is introduced into a healthy person. The weakened virus stimulates the immune system to generate antibodies, protecting the person when the real pathogen threatens to infect them.​
Over the decades, this tried-and-true approach has vanquished polio, eradicated smallpox, and reined in chicken pox, measles, and mumps.​
But vaccine production has never been simple or fast. Many flu vaccines are still grown in chicken eggs. Newer approaches draw on genetic engineering to eliminate the need for whole viruses, but their viral proteins are still grown inside live cells.​
The coronavirus vaccines from Moderna Inc., in Cambridge, Mass., and its German rival BioNTech SE propose to immunize people in a radically different way: by harnessing human cells to become miniature vaccine factories in their own right. Instead of virus proteins, the vaccines contain genetic instructions that prompt the body to produce them. Those instructions are carried via messenger RNA, or mRNA.​
Moderna’s mRNA-1273 consists of a strand of mRNA that tells the body to produce the spike protein the coronavirus uses to latch onto human cells. The strand is like one side of a zipper; the “teeth” are a sequence of chemical letters that cells read to produce the 1,273 amino acids that make up the spike protein. If the vaccine works as intended, the body will start producing the proteins soon after injection, prompting the immune system to react and build up protective antibodies against them.​
The great advantages of mRNA vaccines are speed and flexibility. No finicky live cells or hard-to-handle viruses are needed, and the basic chemistry is straightforward. Moderna’s vaccine reached Phase I human trials on March 16, only 63 days after the company began developing it. And at 6:43 a.m. on July 27, the first volunteer in Moderna’s 30,000-person, final-stage efficacy trial in the U.S. received an injection. Less than 12 hours later, BioNTech and its partner, Pfizer Inc., said they, too, were beginning a late-stage trial, a study that will be conducted in the U.S., Brazil, and several other countries. They took advantage of mRNA’s rapid-response capability to create four slightly different vaccines, which they compared in initial trials before selecting the best one for large-scale testing.​
In Phase I trials, both the Moderna and BioNTech-Pfizer vaccines stimulated people’s immune systems to produce antibodies that neutralized the virus in lab experiments, a positive initial sign. “This is a relatively new platform, but it is looking quite good,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said after the results of Moderna’s Phase I trial, sponsored by NIAID, were published. “Neutralizing antibodies are the gold standard of protection.” Moderna, which has worked with NIAID for years, is receiving $955 million from the U.S. government to support its coronavirus trials.​
How well mRNA vaccines will actually prevent Covid-19 remains unknown. No vaccine based on messenger RNA has ever been approved for any disease, or even entered final-stage trials until now, so there’s little published human data to compare how mRNA stacks up against older technologies. And the vaccines have hardly been free of side effects: In Moderna’s Phase I trial, all 15 of the patients who received the median of three dose sizes reported at least one side effect, though none were severe. Three of the 15 patients at the highest dose had temporary severe reactions. That dosage won’t be tested further.​
Still, the accumulating data has some mRNA skeptics warming to the technology. “I don’t see the reason for focusing on mRNA vaccines. I don’t get that,” Peter Jay Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said in an interview in early June. “The old-fashioned vaccines may do a better job.” In late July he said his opinion had shifted based on encouraging monkey and human trial results. Moderna’s vaccine “is showing promise,” he said. “There is enough of a glimmer to warrant continuing its clinical development and progressing to larger clinical trials.”​



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Chinese company says coronavirus vaccine ready by early 2021

BEIJING — A Chinese pharmaceutical company said Thursday the coronavirus vaccine it is developing should be ready by early 2021 for distribution worldwide, including the United States.​
Yin Weidong, the CEO of SinoVac, vowed to apply to the U.S. Food and Drug Administration to sell CoronaVac in the United States if it passes its third and final round of testing in humans. Yin said he personally has been given the experimental vaccine.​
"At the very beginning, our strategy was designed for China and for Wuhan. Soon after that in June and July we adjusted our strategy, that is to face the world," Yin said, referring to the Chinese city were the virus first emerged.​
"Our goal is to provide the vaccine to the world including the U.S., EU and others," Yin said.​
Stringent regulations in the U.S., European Union, Japan and Australia have historically blocked the sale of Chinese vaccines. But Yin said that could change.​
SinoVac is developing one of China's top four vaccine candidates along with state-owned SinoPharm, which has two in development, and military-affiliated private firm CanSino.​
More than 24,000 people are currently participating in clinical trials of CoronaVac in Brazil, Turkey, and Indonesia, with additional trials scheduled for Bangladesh and possibly Chile, Yin said. SinoVac chose those countries because they all had serious outbreaks, large populations and limited research and development capacity, he said.​
SinoVac is also starting to test small doses of CoronaVac on children and the elderly in China after noticing rising numbers of cases globally among those two groups.​
Yin said the company would prioritize distribution of the vaccine to countries hosting human trials of CoronaVac.​
While the vaccine has not yet passed the phase 3 clinical trials, a globally accepted standard, SinoVac has already injected thousands of people in China under an emergency use provision.​
Yin said he was one of the first to receive the experimental vaccine months ago along with researchers after phase one and two of human trials showed no serious adverse effects. He said that self-injecting showed his support for CoronaVac.​


 
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Why so many people are hopeful about an mRNA coronavirus vaccine


The whole world is watching — including investors and public health specialists — as more than 30 biotech and pharmaceutical companies race to develop a safe Covid-19 vaccine.​
But there’s a big question lingering over the process: How do we balance safety with speed?​
The process is moving quickly with several vaccine candidates entering late stage trials in a matter of months. Pfizer and biotech Moderna are two of the companies the White House has chosen to fast track through the FDA’s regulatory process. Both companies are attempting to use messenger RNA, or mRNA, to produce their vaccines, a technology that has never before received regulatory approval.​



 

Knobby22

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Still, no vaccine, what a surprise, believers are like flat earthers, deny the science.
You mean Trump. He said just today it is weeks away. Don't think anyone else did, especially on this thread.
 
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Johnson & Johnson pauses COVID-19 vaccine trial after participant experiences unexplained illness


Johnson & Johnson says it has temporarily paused its COVID-19 vaccine candidate clinical trials due to an unexplained illness in a study participant, delaying one of the highest-profile efforts to contain the global pandemic.​
The participant's illness is being reviewed and evaluated by an independent data and safety monitoring board as well as the company's clinical and safety physicians, the company said.​
J&J, which reports quarterly financial results on Tuesday, said that such pauses are normal in big trials, which can include tens of thousands of people. It said the "study pause" in giving doses of the vaccine candidate was different from a "regulatory hold" required by health authorities. The current case is a pause.​
However, J&J's move follows a similar one by AstraZeneca Plc. In September, AstraZeneca paused late-stage trials of its experimental coronavirus vaccine, developed with the University of Oxford, due to an unexplained illness in a UK study participant.​
While trials in the UK, Brazil, South Africa and India have resumed, the US trial is still on hold pending a regulatory review.​


 
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India's first coronavirus vaccine: Here is everything we know
about its development


The whole world is waiting eagerly for an effective vaccine to fight the coronavirus pandemic. It has not only claimed lives, but also impacted people, both physically and mentally. There are more than 170 vaccines in progress right now, but closer home we have our hopes pinned on India’s first vaccine called Covaxin.​
Under normal circumstances, researchers and scientists take years before formulating and releasing a vaccine, however, the global impact of COVID on humankind has pressed a ‘forward’ button on all vaccines, where it is safe to expect a vaccine in the next 4-5 months (within a span of 12-18 months).​
Covaxin, the vaccine candidate developed by Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR) is in Phase 2 clinical trial in the country. And now the makers have sought approval from drug regulators to start the third phase clinical trial. As per reports, the Drugs Controller General of India (DGCI) has asked Bharat Biotech to submit "complete safety and immunogenicity data of the phase II trial" and some clarifications before proceeding for the next stage.​
The results of their animal-based trial of the vaccine were found to be favourable. "The vaccine candidate was found to generate robust immune responses. Thus, preventing infection and disease in the primates upon high amounts of exposure to live SARS-CoV-2 virus."​
The vaccine candidate has been tested in 12 hospitals across India, where volunteers between the ages of 18 and 55 participated in the trial. These volunteers had no co-morbidities. The places where the trial took place include Hyderabad, Delhi, Goa, Rohtak, Patna, Kancheepuram and Bhubaneswar, among other places.​


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IFocus

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Hopefully (long shot) one of the new tech vaccines works that would be a game changer.
 
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Pfizer to seek vaccine approval in November


US drugmaker will seek go-ahead for emergency use after reaching 'safety milestone'​

WASHINGTON" The US pharmaceutical giant Pfizer expects to file for emergency use authorisation for its Covid-19 vaccine in late November, around two weeks after the Nov 3 US presidential election, it said on Friday.

The company said it hopes to move ahead with the vaccine after safety data is available in the third week of November, immediately lifting the company's shares two percent in the US.

"So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorisation Use in the US soon after the safety milestone is achieved in the third week of November," the company's chairman and CEO Albert Bourla said in an open letter.

The announcement means the United States could have two vaccines ready by the end of the year, with the Massachussetts biotech firm Moderna aiming for Nov 25 to seek authorisation.

The Food and Drug Administration (FDA), which authorises pharmaceuticals for distribution in the US, asked vaccine developers last week to spend two months monitoring for serious side effects after the second dose is given to trial participants.

The FDA will require the vaccine to prove effective and safe, while Pfizer will have to demonstrate it is capable of producing large-scale production. Pfizer is partnering with the German company BioNTech on the research.

Pfizer and Moderna, both with funding assistance from the US government, launched Phase 3 of their clinical trials at the end of July, and both have started production of doses. They aim to be in a position to deliver tens of millions of doses to the US by the end of the year.

Bourla said the Pfizer trial, involving 30,000 participants, might produce results on the vaccine's efficacy within the next two weeks.

"I've said before, we are operating at the speed of science. This means we may know whether or not our vaccine is effective by the end of October," he said.​


 
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Johns Hopkins Researchers Identify Immune System Pathway That
May Stop COVID-19 Infection



SARS-COV-2-Virus-Particles-on-Cell-777x668.jpg



Blocking Immune System Pathway May Stop COVID-19 Infection, Prevent Severe Organ Damage


While the world waits eagerly for a safe and effective vaccine to prevent infections from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus behind the COVID-19 pandemic, researchers also are focusing on better understanding how SARS-CoV-2 attacks the body in the search for other means of stopping its devastating impact. The key to one possibility — blocking a protein that enables the virus to turn the immune system against healthy cells — has been identified in a recent study by a team of Johns Hopkins Medicine researchers.​
Based on their findings, the researchers believe that inhibiting the protein, known as factor D, also will curtail the potentially deadly inflammatory reactions that many patients have to the virus.​
Making the discovery even more exciting is that there may already be drugs in development and testing for other diseases that can do the required blocking.​
The study was published recently in the journal Blood.​
Scientists already know that spike proteins on the surface of the SARS-CoV-2 virus — making the pathogen look like the spiny ball from a medieval mace — are the means by which it attaches to cells targeted for infection. To do this, the spikes first grab hold of heparan sulfate, a large, complex sugar molecule found on the surface of cells in the lungs, blood vessels and smooth muscle making up most organs. Facilitated by its initial binding with heparan sulfate, SARS-CoV-2 then uses another cell-surface component, the protein known as angiotensin-converting enzyme 2 (ACE2), as its doorway into the attacked cell.​
The Johns Hopkins Medicine team discovered that when SARS-CoV-2 ties up heparan sulfate, it prevents factor H from using the sugar molecule to bind with cells. Factor H’s normal function is to regulate the chemical signals that trigger inflammation and keep the immune system from harming healthy cells. Without this protection, cells in the lungs, heart, kidneys and other organs can be destroyed by the defense mechanism nature intended to safeguard them.​
“Previous research has suggested that along with tying up heparan sulfate, SARS-CoV-2 activates a cascading series of biological reactions — what we call the alternative pathway of complement, or APC — that can lead to inflammation and cell destruction if misdirected by the immune system at healthy organs,” says study senior author Robert Brodsky, M.D., director of the hematology division at the Johns Hopkins University School of Medicine. “The goal of our study was to discover how the virus activates this pathway and to find a way to inhibit it before the damage happens.”​
The APC is one of three chain reaction processes involving the splitting and combining of more than 20 different proteins — known as complement proteins — that usually gets activated when bacteria or viruses invade the body. The end product of this complement cascade, a structure called membrane attack complex (MAC), forms on the surface of the invader and causes its destruction, either by creating holes in bacterial membranes or disrupting a virus’ outer envelope. However, MACs also can arise on the membranes of healthy cells. Fortunately, humans have a number of complement proteins, including factor H, that regulate the APC, keep it in check and therefore, protect normal cells from damage by MACs.​
In a series of experiments, Brodsky and his colleagues used normal human blood serum and three subunits of the SARS-CoV-2 spike protein to discover exactly how the virus activates the APC, hijacks the immune system and endangers normal cells. They discovered that two of the subunits, called S1 and S2, are the components that bind the virus to heparan sulfate — setting off the APC cascade and blocking factor H from connecting with the sugar — and in turn, disabling the complement regulation by which factor H deters a misdirected immune response.​
In turn, the researchers say, the resulting immune system response to chemicals released by the lysing of killed cells could be responsible for the organ damage and failures seen in severe cases of COVID-19.​
Most notably, Brodsky says, the research team found by blocking another complement protein, known as factor D, which works immediately upstream in the pathway from factor H, they were able to stop the destructive chain of events triggered by SARS-CoV-2.​


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Further to post #70

Coronavirus vaccine rolls off production line in Belgium

A coronavirus vaccine on track for the new year is rolling off the production line.​
Pfizer has manufactured hundreds of doses of the drug in Belgium.​
It comes as Astra Zeneca, the company behind the vaccine Australia is aligned with, says the jab could be available as soon as Christmas.​
However, Pfizer's CEO announced on Friday in the US, it cannot request emergency authorisation of its COVID-19 vaccine before the third week of November - and that's if everything goes well.​
Despite President Donald Trump's repeated promises of a vaccine before Election Day, scientists have been cautioning that it's unlikely data showing a leading shot actually works would come until November or December.​
Another leading US contender, Moderna Inc, previously announced the earliest it could seek authorization of its own vaccine would be November 25.​
Pfizer CEO Albert Bourla has long said it's possible testing might reveal by the end of October if his company's vaccine actually protects against the coronavirus.​
But in Friday's announcement, he made clear that effectiveness is only part of the equation.​
The vaccine also must be proven safe. And to qualify for an "emergency use authorization," any COVID-19 vaccine must track at least half the participants in large-scale studies for two months after their second dose, the time period in which side effects are likely to appear.​
Mr Bourla estimated Pfizer's 44,000-person study will reach that milestone in the third week of November.​
"We are operating at the speed of science," he wrote in a letter posted to the company's website.​
The vaccine made by Pfizer and its German partner BioNTech are among several leading candidates in final testing.​
Even if a vaccine emerges by year's end, only limited doses will be available right away.​
The US government is deciding who would be first in line, almost certainly health care workers, and estimates there may be enough for​
widespread vaccinations in the spring.​



 
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Moderna CEO reportedly expects coronavirus vaccine
interim results in November



Key Points

  • Moderna CEO Stéphane Bancel expects interim results from its Covid-19 vaccine trial in November, The Wall Street Journal reported.

  • Bancel also told the Journal the U.S Food and Drug Administration could give an emergency use authorization before the end of the year.


Moderna Chief Executive Officer Stéphane Bancel expects interim results from its Covid-19 vaccine trial in November and said the U.S government could give an emergency use nod in December, The Wall Street Journal reported on Monday.​
Speaking at the newspaper’s annual Tech Live conference, Bancel also said sufficient interim results from the study takes longer to get and that the government’s permission to use the vaccine may not come until next year.​
The first interim analysis of the vaccine’s efficacy will happen when 53 people in the entire study get symptomatic Covid-19, the report said.​
“That first analysis is likely to occur in November, but it’s hard to predict exactly which week because it depends on the cases, the number of people getting sick,” the report quoted Bancel as saying.​
Bancel had told Financial Times last month that Moderna would not be ready to apply for emergency use of its Covid-19 vaccine before Nov. 25 at the earliest.​
Bancel also highlighted that a ramping up of production is a challenge. “If one ingredient is missing, we cannot make the vaccine,” as per the Journal’s report.​
Moderna is on track to produce 20 million doses of its experimental vaccine by the end of the year, the company had said last month, adding that 25,296 participants had enrolled out of a planned 30,000 in its late-stage study.​
Drugmakers are racing to develop a Covid-19 vaccine, with more than 150 potential vaccines being developed and tested globally.​
Besides Moderna, Pfizer, and AstraZeneca, among others, are front-runners to develop the vaccine.​



 
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'China's potential vaccines show no adverse reaction’


Health official says China has 13 vaccine candidates, 4 of them administered on ‘emergency basis’


China claimed on Tuesday that its experimental vaccines for protection against COVID-19 have shown “no adverse reaction."​
“So far, none of those who have received the ‘emergency use’ vaccine have shown severe adverse reactions," Zheng Zhongwei, a top official at China’s National Health Commission, was quoted as saying by the state-run Global Times newspaper.​
Pharma giants in many countries have resisted the idea of taking a shortcut in rolling out an antigen for the novel virus.​
China and Russia, however, have started vaccinating a select group of people with experimental shots, prompting a debate on risks of administering untested treatments on the public.​
Zheng said the country has 13 vaccine candidates entering clinical trials, including four in Phase III trials.​
“Sixty thousand volunteers have received four experimental vaccines... the difficulty now is in carrying out the trials as China's epidemic has been brought under control,” he said.​
The official added that the emergency use of vaccines in China is “in line with the relevant laws concerning drug and vaccine development, which goes through a rigorous scientific argumentation process and approval process."​
“Some Chinese who went abroad received their vaccinations voluntarily... so far, none of them have reported adverse side effects,” he said, adding that the price of Chinese COVID-19 vaccines “will certainly be within a scope that the public can accept."​
Earlier this month, China joined Covax, an international initiative to distribute COVID-19 vaccines to countries worldwide. Some 172 states except the US, Russia and a few others, are participating in the program led by the World Health Organization, the GAVI vaccine alliance, and the Coalition for Epidemic Preparedness Innovations.​
More than 100 coronavirus vaccines are in development across the world to ease the global crisis.​
The disease has infected more than 40 million people and killed 1.1 million in 189 countries, according to the latest figures by US-based John Hopkins University.​



 
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