Virus

A second potential COVID-19 vaccine, backed by Bill and Melinda Gates, is entering human testing

Darrell Etherington@etherington / 9:44 pm CEST • April 6, 2020

A new COVID-19 vaccine candidate is entering Phase 1 clinical human testing today, after the U.S. Food and Drug Administration (FDA) accepted an application from Inovio Pharmaceuticals under the regulator’s Investigational New Drug program. Inovio plans to inject its first volunteer test subject with the INO-4800 DNA vaccine candidate it has developed, following promising results from preclinical studies performed on animals that did indicate increased immune response.

The Inovio DNA vaccine candidate works by injecting a specifically engineered plasmid (a small, independent genetic structure) into a patient so that their cells can produce a desired, targeted antibody to fight off a specific infection. DNA vaccines, while available and approved for a variety of animal infections in veterinary medicine, have not yet been approved for human use.

That said, Inovio’s work isn’t starting from scratch: The company previously completed a Phase 1 study for a DNA vaccine candidate for Middle East Respiratory Syndrome (MERS), where it showed promising results and a high level of antibodies produced in subjects that persisted for an extended period of time.

Inovio has been able to scale up quickly, developing and producing “thousands of doses” of INO-4800 in just a few short weeks in order to support its Phase 1 and Phase 2 trials. The company has done so in part thanks to backing from the Bill and Melinda Gates Foundation, as well as funding from other nonprofits and organizations. If clinical trials are successful, Inovio says it will be able to have up to one million doses of the vaccine ready by the end of the year, for use both in additional trials and for potential emergency use pending authorization.

This is the second vaccine to undertake Phase 1 clinical testing on human subjects: Moderna began its trial in mid-March. Inovio’s trial will be made up of 40 volunteers, all healthy adults selected via screening conducted at either Philadelphia’s Perelman School of Medicine at the University of Pennsylvania, or the Center for Pharmaceutical Research in Kansas City. It’ll span the next several weeks, and the company expects data around the immune responses from test subjects, as well as info pertaining to the safety of the treatment for humans, to be available by late this summer.

Any broad clearance or approval for use is still likely at least a year to 18 months away, but the pace with which human trials are beginning is still exceptional, so hopefully we won’t have to wait too much longer than that.

Dr Sarfaraz Munshi
Urgent Care Lead
MBBS BSC MRCGP

Sue Elliott
Interim Director of Quality, Governance and Nursing

When Sarfaraz Munshi posted a video on Whatsapp to show breathing techniques to his mother who had coronavirus symptoms, he had no idea that it would also help JK Rowling.

Dr Munshi, 36, was surprised when the author tweeted a link to the video to her 14.5 million followers and wrote: “I'm fully recovered & [this] technique helped a lot.”

Please watch this doc from Queens Hospital explain how to relieve respiratory symptoms. For last 2 weeks I've had all symptoms of C19 (tho haven't been tested) & did this on doc husband's advice. I'm fully recovered & technique helped a lot.https://t.co/xo8AansUvc via @YouTube

— J.K. Rowling (@jk_rowling) April 6, 2020

This is a very helpful video making the rounds about breathing techniques. My wife tried this and it does help.https://t.co/E3RfYEjtCx

— Mr #WeNeedToWorkTogether (@MrRemain) April 7, 2020

For anyone out there with coronavirus, I have been doing these breathing exercises and they help a lot. Be well. https://t.co/xbubtr5xxg

— Amee Vanderpool (@girlsreallyrule) April 7, 2020

Marius Lăcătuș wrote:ovo isto dobio veceras od drugara koji je kovid pozitivan u danskoj, smorio sam se kao foka jer je cancer surviver u pitanju medjutim isto mi je rekao, radio vezbice i OK je, nije dobio upalu pluca. ne zna tacno koliko dugo ima virus, veruje da je zena prelezala pre njega. neki ce ga se setiti po dokumentarcima koje je snimao na balkanu - doug aubrey, "see you in another war"

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Jyrki Juhani Järvilehto wrote:

Marius Lăcătuș wrote:ovo isto dobio veceras od drugara koji je kovid pozitivan u danskoj, smorio sam se kao foka jer je cancer surviver u pitanju medjutim isto mi je rekao, radio vezbice i OK je, nije dobio upalu pluca. ne zna tacno koliko dugo ima virus, veruje da je zena prelezala pre njega. neki ce ga se setiti po dokumentarcima koje je snimao na balkanu - doug aubrey, "see you in another war"

Jel imao ranije operaciju ili nesto?

rumbeando wrote:Londonski lekar pokazuje vežbe disanja koje smanjuju simptome koronavirusa i pomažu očuvanju pluća:

Ferenc Puskás wrote:Austrijanci navodno uradili istraživanje na uzorku 1200 osoba, i to zdravstveno osoblje, socijalni radnici i prodavači u trgovinama, 0,5 % prokuženosti. Kaže ovdje neki expert, ne vjeruje u tezu o velikom broju asimptomatičnih.

rumbeando wrote:Londonski lekar pokazuje vežbe disanja koje smanjuju simptome koronavirusa i pomažu očuvanju pluća:

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The green vice-chancellor Werner Kogler pointed out the result of a test, with which the number of unreported cases of Corona patients should be investigated. According to this, there is only a "relatively low rate of infestation". Of more than 2000 people tested throughout Austria, less than one percent were infected.

Extrapolated to the country, this would currently be around 88,000 people, with 12,008 cases confirmed yesterday. Kogler therefore warned against carelessness: "So there is a danger that everything will start all over again". There is also the fear that everything could still go wrong despite the stage success.

“All ideas of herd immunity have been clearly refuted by this sample,” said Kurz, adding that tens of thousands of deaths have been prevented due to the early restrictions.

Luxembourg. Blood tests on 1500 citizens in the Grand Duchy are supposed to give first hints about the infestation.

According to Berlin virologist Christian Drosten, it takes about 10 days for antibodies to form after a person is infected with the novel coronavirus.

A blood test can then determine whether or not a patient has developed antibodies, “regardless of whether they had a severe, mild, or completely unnoticed infection,” Drosten said in an NDR podcast last week.

Even those who have had a completely unnoticed infection will test positive for the antibody.

Knowledge of a past infection is also important to give people with existing immune protection the “green light” to return to work and ease social distancing.

Germany is currently considering so-called "immunity passports" which would allow people to return to a normal life sooner - or even volunteer to help coronavirus patients due to the lower risk that they face.

The [UK] government bought three-and-a-half million antibody tests, but has not yet found one that is reliable enough to use.
...
So far, antibody tests have not proved to be as reliable [as the diagnostic tests].

Health Secretary Matt Hancock said last week that 15 of the most promising antibody tests had been tested, but none was good enough.

Prof John Newton, who is overseeing testing, told The Times that tests bought from China had been able to identify antibodies in patients who had been seriously ill with coronavirus, but didn't pick up the milder cases.

https://www.bbc.co.uk/news/health-51943612

The sensitivity (hit rate of correctly positive results, note) and specificity (hit rate of correctly negative results, note) of these tests is currently mostly below 90 percent.

"The low specificity is a problem. If you take samples from a hundred healthy people, even with a high specificity of 98 percent, you can expect two false positive results. The people concerned were not sick or confronted with the virus at all," said the laboratory physician. In view of the currently low rate of infestation of the Austrian population with SARS-CoV-2, which is still present, the use of antibody tests as area tests does not seem to be reasonable.

Marius Lăcătuș wrote:jel jazavac opasan?

radiátor wrote:Austrijanci su radili testove na prisustvo antitela ili na prisustvo virusa? Koliko sam skapirao, nema dovoljno pouzdanih testova na prisustvo antitela...

Halászlé wrote:Ma da, to je sve jasnije. Nije ovo grip. Ako je puštanje gripa u zajednicu ekvivalent usvajanja nervoznog uličnog psa, ovo je usvajanje jazavca i pume.