(CNN) It almost felt like an episode of “Shark Tank.”
One by one, vaccine developers at a White House roundtable convened by President Donald Trump in early March pitched their product as a viable solution to the coronavirus that was spreading globally and killing Americans.
John Shiver, the head of R&D for Sanofi Pasteur vaccines, said he could have a product ready for the clinic in a year — perhaps a vaccine for the public in as “few as several years.”
Trump seemed uninterested.
“Right. OK. Thank you very much,” he said at the March 2 roundtable, which was captured on C-SPAN.
Next was Lenny Schleifer, the founder and CEO of Regeneron — which aims to conduct clinical trials this summer — who talked of pumping 200,000 doses per month of its therapeutic vaccine from his factory, starting in August, “if all goes well.”
This got Trump’s attention. He leaned over the table and interrupted Schleifer mid-pitch.
“So that process would be faster than John’s?” he said, pointing at Shiver.
“It would be,” Schleifer said, adding that the process could take “weeks to months.”
The only way to top that was to start talking about days, and it’s exactly what the next CEO did.
President Donald Trump leads a meeting with the White House Coronavirus Task Force and pharmaceutical executives in the Cabinet Room of the White House on March 2.
President Donald Trump leads a meeting with the White House Coronavirus Task Force and pharmaceutical executives in the Cabinet Room of the White House on March 2.
Stéphane Bancel of Moderna Inc. glanced across the table at the nation’s top infectious disease expert, Dr. Anthony Fauci, and said he is “very proud to be working with the US government and to have already sent, in only 42 days from the sequence of the virus, our vaccine to Dr. Fauci’s team at the NIH.”
The French-born Bancel went on to say that he needed just “a few months” to start phase two of a three-part clinical trial of the sort that typifies vaccine development. (The entire process often takes more than a decade.)
Trump seemed to tune out everything but the talk of time.
“So you’re talking over the next few months, you think you could have a vaccine?” he asked.
“Correct. Correct,” Bancel said, raising a hand to acknowledge Fauci shifting in his chair across the table. “With phase two,” Bancel clarified, just before Fauci interjected, for Trump’s benefit: “You won’t have a vaccine. You’ll have a vaccine to go into testing.”
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In this day and age, understanding bacteria and viruses and developing vaccines are national security issues. In my view sizable part of every country’s defense budget should be spent in these pursuits rather than making tanks and other weapons.
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Categories: The Muslim Times, Vaccine
Moderna hopes to begin manufacturing its as-yet unapproved coronavirus vaccine “as early as July,” CEO Stephane Bancel told CNBC on Friday.
The biotech company announced earlier Friday a 10-year partnership with Swiss drugmaker Lonza to accelerate production of the experimental vaccine.
“We are hoping with Lonza to start making product for the corona vaccine as early as July,” Bancel said on “Squawk Box.” “Our team is ready to start dosing as soon as we get the green light.”
Moderna is pushing forward with manufacturing the potential vaccine, called mRNA-1273, in hopes that it proves safe for humans and effective against the coronavirus. However, the vaccine candidate remains in a phase 1 trial.
The potential vaccine, which was developed by researchers at Moderna and the National Institutes of Health, became the first candidate to enter a phase 1 human trial in March and full results have not been released. Bancel added that data from the phase 1 trial “looks positive” with regard to safety.
Earlier this week, Moderna announced it has submitted an application to the Food and Drug Administration to move the candidate to a phase 2 trial. The company says a phase 3 trial could begin as soon as fall of 2020.
The NIH said their researchers were able to quickly produce a candidate with Moderna because the two organizations were already partnered, researching “related coronaviruses.”
Moderna, as well as other companies in the race to develop a vaccine for the coronavirus, is ramping up manufacturing ahead of approval so that it can rapidly distribute doses if their candidate proves effective against the virus. Bancel said his team on their own could manufacture about 100 million doses per year, but with the Lonza partnership, they hope to produce about 1 billion doses per year.
“If you can only make a few million vials, it’s not going to be really helping the global public health issue we have,” he said. “Our goal is to make the vaccine available around the world.”
Last month, Moderna announced it received a $483 million contract from the Biomedical Advanced Research and Development Authority to accelerate the development of its vaccine candidate. Shares of Moderna rose more than 15% on the news. The company’s shares were up more than 6% in early trading Friday.
The vaccine uses synthetic messenger RNA to inoculate against the virus. Such treatments help the body immunize against a virus and can potentially be developed and manufactured more quickly than traditional vaccines.
https://www.cnbc.com/2020/05/01/moderna-could-begin-manufacturing-unproven-coronavirus-vaccine-in-july-ceo-says.html
They are part of a phase 1 clinical trial for a COVID-19 vaccine aiming for 45 participants, that was registered and recruiting on 25 February 2020, with the first dose injected on 16 March: on 19 March they had all the people they needed, and closed to recruitment. The NIH Director reported that the vaccine has been tested in animals. The first healthy volunteers come from Seattle in the US – a giant thanks to all of them! On 20 March, a second site for the trial was added the trial’s registry entry: a pediatric hospital in Decatur, Georgia. On 30 March, the registry entry noted the Georgia site was now recruiting, and a third location was added at the NIH’s Clinical Center in Bethesda (not yet recruiting).
This vaccine and trial have gotten going incredibly fast for a disease that only emerged late last year. The trial’s registration entry reports it will test the safety and immune response of various doses of an mRNA-based vaccine (currently called mRNA-1273), following people for a year after the second of the 2 injections they will get. (More details in the NIH Director’s report.)
The trial is sponsored by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). If it makes it through to FDA approval, it would be the first mRNA-based vaccine in use, using genetics to instruct cells to produce antibodies. Being the first means it should face extra scrutiny if it is to get that far. There are other types of vaccine in preclinical development too. (For more about Covid-19 vaccines, see Laura Spinney’s article).
On 18 March, a trial of a different recombinant Covid-19 vaccine was registered. That vaccine is based on adenovirus Type 5 Vector (currently called Ad5-nCoV), and is recruiting 108 adults in China. It’s following up for 6 months, so could have some results before the NIH’s Seattle/Decatur/Bethesda trial. A Phase 2 randomized trial beginning 12 April was subsequently registered for this vaccine. That trial is aiming to enrol 500 participants, in 3 arms: 250 receiving a middle dose, 125 a low dose, and 125 a placebo injection, with 6 months follow-up. There was also a high dose group in the Phase 1 trial. No results have been reported: the manufacturer’s report to the Hong Kong stock exchange says it is proceeding “based on the preliminary safety data of the phase 1 clinical trial”.
Scientists from Oxford University are fast-tracking another adenovirus vector vaccine, called ChAdOx1 nCoV-19 (more details here). They are leap-frogging straight to a Phase 1/Phase 2 trial and hope to beat the 12-18 months estimate till a vaccine is available. On 27 March, they announced they are recruiting participants 510 healthy people, with 260 to be randomized to the vaccine and the other 250 to a saline injection. It will be a 6-month trial, and although they are already recruiting, preclinical animal testing is still going on. If that goes well, then the first-in-human randomized trial will begin: their timetable for that is a few weeks. (Clinical trial register entry here. In a 14 April update, they reported they will be recruiting in Southampton and London as well as Oxford. On 23 April, the first injections in this trial were reported.)
And a fourth. According to the company manufacturing it, the first dose of this trial was given to a healthy volunteer on 6 April 2020. Currently called INO-4800, this one is partly funded by the Gates Foundation, and it builds on previous work on a vaccine for another coronavirus, MERS. This Phase 1 trial aims to recruit 40 people, at 2 sites in the US: Philadelphia and Kansas City, with 6 months follow-up (to November 2020). The clinical trial register entry doesn’t tell you anything about the vaccine itself, but unlike the others, there is a preprint about its development and initial animal tests. It’s a DNA vaccine, delivered through a hand-held device that’s geared to be feasible in at-risk countries globally: trials in China and South Korea are also planned.
The fifth was the first German trial. It received approval to start a Phase 1/Phase 2 trial on 20 April. This is a 2-part dose-escalation trial with parallel cohorts in 196 people, testing 4 RNA vaccines called BNT162 a1, b1, b2, and c2. It will be run in multiple sites in Germany, and further studies are planned in the USA and China. (Clinical trial register entry.)
Also on 20 April, another Phase 1/Phase 2 trial was registered. This inactivated SARS-CoV-2 vaccine is unnamed, and is being run in Xuzhou, China (Jiangsu province). The Phase 1 trial aims to recruit 144 people, and the Phase 2 trial aims for 600, randomized to the candidate vaccine or placebo. (A preprint on this vaccine’s preclinical phase was posted on 19 April.)
The first Canadian vaccine trial is planned to get underway at 2 universities in British Columbia on 30 April. This is for an oral vaccine, named bacTRL-Spike, which uses SARS-CoV-2 DNA on a bacterial medium. It’s a Phase 1 trial with 84 planned participants, randomized to either the vaccine or the bacterial medium alone. (Clinical trial register entry.)
On 28 April, there was a call for participants in Perth, Australia, for a Phase 1 trial of a vaccine called Covid-19 S-Trimer. This vaccine uses antibodies from people who have recovered from Covid-19.
A Phase 1 trial is scheduled to start on 15 May in Brisbane, Australia, for a nanoparticle vaccine called SARS-CoV-2 rS. (Clinical trial register entry.) It will aim for 131 people, testing the vaccine with and without a trademarked adjuvant, versus a placebo (saline) injection. It might test a second vaccine, too.
First-in-human vaccine trials
Let’s go back to the beginning. The preclinical phase involves all the work that goes on in laboratories to develop a vaccine. A phase 1 clinical trial is a small, first-in-human test of a drug or device, testing safety and response in carefully selected people who are believed to be at relatively low risk of being harmed. For example, the Seattle trial’s registry entry lists 15 criteria you have to meet to be included, and 25 reasons you could be excluded even if you meet them.
A phase 1 trial can show if a vaccine could work, but it’s just a start: it’s not enough to test its benefits or harms in the general community. The graph below is from the NIH. It shows where these trials fit into the process in the US, but the process is similar in other parts of the world. You need phase 3 trials to get a vaccine or other drug approved.
A chart showing preclinical to clinical trial phases up to and after drug approval – click the image to go to text explanation
These days, phase 1 trials are often done by commercial organizations. The healthy people who volunteer for them are far more likely to be on a low income or unemployed than the general population. That’s according to a study of 1,194 people in one company’s drug trials in Belgium, Singapore, and the US (Grady 2017), and Chen’s study points to other signs of this as well. That means financial pressure might be pressing people into doing it: they might really need the payment they get for participating in these trials.
Ethicist Carl Elliott wrote an article in The New Yorker called “Guinea-Pigging” in 2007, saying that trials in the private sector have “created a new dynamic. The relationship between testers and test subjects has become, more nakedly than ever, a business transaction”.
That isn’t the case for this first Covid-19 vaccine trial. It is being run by the non-commercial Kaiser Permanente Washington Health Research Institute, open to people living or working in Seattle. Participants in the trial will reportedly receive $100 for each of up to 11 visits. The people who step up will be joining a long history of people shouldering a serious load for the rest of us. Let’s take a quick look at some tales of first-in-human vaccine tests – starting with the most famous and mythologized case, smallpox. Most of the popularized story about it is wrong.
Earnest Board’s painting of Edward Jenner vaccinating James Phipps
Here’s the legend that grew around this: Jenner got the idea for using cowpox to vaccinate because milkmaids had beautiful skin untouched by smallpox. He picked out his gardener’s son to be the first person experimented on with this hypothesis, and then infected him with smallpox to see if it worked. None of that is true. And the real story is far more interesting.
Before Jenner in 1796, Benjamin Jesty may have been first in England in 1774, then Peter Platt in Germany in 1791. Back then, people inoculated children with actual smallpox – that had happened to Jenner himself when he was 8. Arthur Boyle has written the story of what really happened with Jenner and Phipps on the James Lind Library. It wasn’t a single “Eureka!” moment. Others in his professional circle had already considered and more or less dismissed the cowpox hypothesis. Jenner stuck with it, though. Boyle writes:
It took Edward Jenner twenty-five years to unravel the mess. The problem lay in the definition of ‘cowpox’. There were at least three diseases that produced ulcers on the teats of cows and only one of these was caused by the cowpox virus: ‘this for a while damped, but did not extinguish my ardour’. Jenner’s remarkable achievement is that he spent all that time untangling true cowpox from spurious cowpox and defining its unequivocal appearances. He learned how to recognise ‘milker’s nodes’ a painful bacterial infection on the fingers, which lacked the typical erosive ulcer of cowpox, and he could differentiate between cowpox and staphylococcal infections of the udder because the damage caused by staphylococcal bacteria spread beyond the teats. Eventually he learned how to recognise cases of true cowpox and could confirm that they really were resistant to inoculation. Jenner had also had a second insight that his colleagues had not appreciated. Inoculated cowpox would be much less severe than natural cowpox, just as inoculated smallpox was less dangerous than naturally acquired disease.
He didn’t seek James Phipps out: Phipps’ father asked Jenner to inoculate him. Boyle again:
Although Jenner had never ‘vaccinated’ anyone before he had good reason to believe that the procedure might work based on numerous patients of his who had proved resistant to inoculation after having cowpox. All he was doing was attempting to see whether artificial cowpox worked as well as natural cowpox, just as artificial inoculated smallpox protected against natural smallpox. After vaccinating Phipps he was be inoculated in the usual way. If cowpox had failed, he would just have a normal mild inoculation response; if it worked nothing would happen. Jenner was following up his experimental treatment with the ‘gold standard’ method of protecting the child. Since inoculation was a well-established and largely safe procedure that was widely used in England, there was no ethical issue with that part of the experiment. Inoculation would have been viewed as a necessary part of growing up for a child receiving parish support. Since cowpox was never fatal and had few systemic effects, there were unlikely to be any unexpected complications apart from failure to immunize. Even in the hyper health-and-safety conscious twenty-first century this experiment would have been given ethical approval.
https://blogs.plos.org/absolutely-maybe/2020/03/16/first-in-human-covid-19-vaccines-tales-of-phase-1-clinical-trials-past/
Yes, we need a leader and hopefully God guides Our President to decide what is the right for the people who really need HELPS—
Lets pray to God who control every things in this world.
The US has seen foreign spy agencies carry out reconnaissance of research into a coronavirus vaccine, a senior US intelligence official has told the BBC.
Bill Evanina, director of the National Counterintelligence and Security Center, said the US government had warned medical research organisations of the risks.
But he would not say whether there had been confirmed cases of stolen data.
UK security sources says they have also seen similar activity.
Warp speed
An international race is on to find a vaccine for Covid-19.
Researchers, companies and governments are all involved. And their efforts are simultaneously being protected by domestic spy agencies, while being targeted by foreign ones.
Mr Evanina’s organisation provides advice on countering the work of foreign intelligence agencies to the US government, businesses and academia.
“We have been working with our industry and government folk here very closely to ensure they are protecting all the research and data as best they can,” he said.
“We have every expectation that foreign intelligence services, to include the Chinese Communist Party, will attempt to obtain what we are making here.”
https://www.bbc.com/news/technology-52490432
What sort of progress is being made?
Research is happening at breakneck speed. About 80 groups around the world are researching vaccines and some are now entering clinical trials.
The first human trial for a vaccine was announced last month by scientists in Seattle. Unusually, they are skipping any animal research to test its safety or effectiveness
In Oxford, the first human trial in Europe has started with more than 800 recruits – half will receive the Covid-19 vaccine and the rest a control vaccine which protects against meningitis but not coronavirus
Pharmaceutical giants Sanofi and GSK have teamed up to develop a vaccine
Australian scientists have begun injecting ferrets with two potential vaccines. It is the first comprehensive pre-clinical trial involving animals, and the researchers hope to test humans by the end of April
However, no-one know how effective any of these vaccines will be.
https://www.bbc.com/news/health-51665497