Covid-19: Razvoj vakcine, imunitet i primena medikamenata

[Dzudi]

5 hours ago, Filozof manijak said:

Hajmo malo da se misaono igramo, koju bi ste preuranjenu vakcinu protiv covida primili, američku ili rusku? 

 

Potpuno mi je svejedno odakle dolazi. Važno je da dođe, da bude bez ozbiljnijih nuspojava i da krene vakcinacija. 

[trustno1]

7 hours ago, Filozof manijak said:

Hajmo malo da se misaono igramo, koju bi ste preuranjenu vakcinu protiv covida primili, američku ili rusku? 

 

Dobro pitanje. Američku. S tim što bi me tištalo da li je moj organizam ipak bolje prilagodjen za vakcinu koju su sastavila naša slovenska braća nego ovi anglo-saksonci, otkud ja znam šta je suština anglo-saksonskog bića. Jeste da su Amerikanci transparentniji, moralniji i legalniji ali ipak biće je biće.

[trustno1]

8 hours ago, Jozef K. said:

Stara stvar. Kod nas je to deksazon i daje se najtežim pacijentima. U protokolu lečenja se nalazi.

 

Mislim da su tek sada izašli rezultati zvaničnih istraživanja koja potvrdjuju učinkovitost.

[trustno1]

Nego, sad i ovi pišu o kolektivnom imunitetu ističući da se procene naučnika kreću od 10% do 80% zaraženih za dostizanje KI! Meni je to stvarno zanimljivo.

 

Njujork je bio pokošen u martu, sada je delimično otvoren već nekoliko nedelja a brojevi nisu skočili (kuc u drvo). Da li je to zbog poštovanja mera ili zbog imuniteta ili mešano - nobody knows. Možda će najveći test biti otvaranje škola - koje bi za sada trebalo da bude 21. septembra.

 

https://www.technologyreview.com/2020/08/11/1006366/immunity-slowing-down-coronavirus-parts-us/?utm_medium=tr_social&utm_campaign=site_visitor.unpaid.engagement&utm_source=Twitter#Echobox=1599066625

[pasha]

 

 

[precog]

https://en.m.wikipedia.org/wiki/Randomized_controlled_trial

[precog]

Pharma Companies Plan Joint Pledge on Vaccine Safety

Spoiler

 

The statement is meant to reassure the public that the companies will not seek a premature approval of vaccines under pressure from the Trump administration.

 

pisem sa telefona, jebe me linkovanje.

Edited September 5, 2020 by precog

[vememah]

3. faza ispitivanja dve kineske vakcine delom će se odvijati i u Srbiji.

 

 

[vememah]

Quote

 

EXCLUSIVE

AstraZeneca Covid-19 vaccine study put on hold due to suspected adverse reaction in participant in the U.K.

By REBECCA ROBBINS @rebeccadrobbins, ADAM FEUERSTEIN @adamfeuerstein, and HELEN BRANSWELL @HelenBranswell

SEPTEMBER 8, 2020

A large, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the U.S. has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom.

A spokesperson for AstraZeneca, a frontrunner in the race for a Covid-19 vaccine, said in a statement that the company’s “standard review process triggered a pause to vaccination to allow review of safety data.” 

It was not immediately clear who placed the hold on the trial, though it is possible it was placed voluntarily by AstraZeneca and not ordered by any regulatory agency. The nature of the adverse reaction and when it happened were also not immediately known, though the participant is expected to recover, according to an individual familiar with the matter. 

The spokesperson described the pause as “a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.” The spokesperson also said that the company is “working to expedite the review of the single event to minimize any potential impact on the trial timeline.”

An individual familiar with the development said researchers had been told the hold was placed on the trial out of “an abundance of caution.” A second individual familiar with the matter, who also spoke on condition of anonymity, said the finding is having an impact on other AstraZeneca vaccine trials underway — as well as on the clinical trials being conducted by other vaccine manufacturers.

Clinical holds are not uncommon, and it’s unclear how long AstraZeneca’s might last. But the progress of the company’s trial — and those of all Covid-19 vaccines in development — are being closely watched given the pressing need for new ways to curb the global pandemic. There are currently nine vaccine candidates in Phase 3 trials. AstraZeneca’s is the first Phase 3 Covid-19 vaccine trial known to have been put on hold.

Researchers running other trials are now looking for similar cases of adverse reactions by combing through databases reviewed by a so-called Data and Safety Monitoring Board, the second person said.

AstraZeneca only began its Phase 3 trial in the U.S. in late August. The U.S. trial is currently taking place at 62 sites across the country, according to clinicaltrials.gov, a government registry, though some have not yet started enrolling participants. Phase 2/3 trials were previously started in the U.K., Brazil, and South Africa.

There are a number of different reactions that can qualify as suspected serious adverse reactions, symptoms that require hospitalization, life-threatening illness and even death. It was also not immediately clear which clinical trial the adverse reaction occurred in, though a clear possibility is the Phase 2/3 trial underway in the U.K.

While it’s still unclear how severe and rare the adverse event may be, the finding could impact how quickly efficacy data from the U.K. trial will be available. Those data are considered integral to any bid to seek an emergency use authorization for the vaccine from the U.S. Food and Drug Administration — and potentially jeopardize President Trump’s efforts to fast-track a vaccine ahead of the November election.

A Phase 1/2 study published in July reported that about 60% of 1,000 participants given the vaccine experienced side effects. All of the side effects, which included fever, headaches, muscle pain, and injection site reactions, were deemed mild or moderate. All of the side effects reported also subsided during the course of the study. 

The vaccine  — known as AZD1222 — uses an adenovirus that carries a gene for one of the proteins in SARS-CoV-2, the virus that causes Covid-19. The adenovirus is designed to induce the immune system to generate a protective response against SARS-2. The platform has not been used in an approved vaccine, but has been tested in experimental vaccines against other viruses, including the Ebola virus. 

The Phase 3 trial in the U.S. aims to enroll about 30,000 participants at 80 sites across the country, according to a release last week from the National Institutes of Health. 

It was not immediately clear what steps were being taken at study sites across the U.S. in response to the hold. Clinical holds in ongoing studies often involve a pause in recruiting new participants and dosing existing ones, unless it’s deemed in the interest of participant safety to continue dosing.

In the statement from AstraZeneca, the company spokesperson noted that “in large trials illnesses will happen by chance but must be independently reviewed to check this carefully.” The spokesperson also said the company is “committed to the safety of our participants and the highest standards of conduct in our trials.”

 

https://www.statnews.com/2020/09/08/astrazeneca-covid-19-vaccine-study-put-on-hold-due-to-suspected-adverse-reaction-in-participant-in-the-u-k/

[precog]

lose vesti, nadam se da je izolovana reakcija zbog specificnosti pacijenta.

[Arkadija]

Ovo je ozbiljan udarac za vakcinu do 2021.

[borris_]

Jeste losa vijest ali ovo se desava kada radis ovakva ispitivanja.

Ne treba zaboraviti da je neko normalno vrijeme da se dobije vakcina oko dvije godine i da se sa ovom vakcinom sve to ubrzalo.

[precog]

naravno, nego su/smo se svi nadali da ce biti sve ok i da cemo da krenemo da se vakcinisemo u prvoj polovini sledece godine.

[Filozof manijak]

Pa može i tada, ako se pristane na kinesku vakcinu 

[vememah]

Quote

 

A person familiar with the situation, who spoke on the condition of anonymity, said that the participant who experienced the suspected adverse reaction had been enrolled in a Phase 2/3 trial based in the United Kingdom. The individual also said that a volunteer in the U.K. trial had received a diagnosis of transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections. However, the timing of this diagnosis, and whether it was directly linked to AstraZeneca’s vaccine, is still unknown.

Transverse myelitis can result from a number of causes that set off the body’s inflammatory responses, including viral infections, said Dr. Gabriella Garcia, a neurologist at Yale New Haven Hospital. But, she added, the condition is often treatable with steroids.

AstraZeneca declined to comment on the location of the participant and did not confirm the diagnosis of transverse myelitis. “The event is being investigated by an independent committee, and it is too early to conclude the specific diagnosis,” the company said.

 

https://www.nytimes.com/2020/09/08/health/coronavirus-astrazeneca-vaccine-safety.html

 

Quote

Transverse myelitis ( TM ) is a rare neurological condition in which the spinal cord is inflamed.
...
TM is characterized by weakness and numbness of the limbs, deficits in sensation and motor skills, dysfunctional urethral and anal sphincter activities, and dysfunction of the autonomic nervous system that can lead to episodes of high blood pressure. Signs and symptoms vary according to the affected level of the spinal cord.

https://en.wikipedia.org/wiki/Transverse_myelitis

 

Quote

 

AstraZeneca’s CEO, Pascal Soriot, said the woman who suffered the suspected adverse effect is recovering and is expected to leave hospital today.

Mr Soriot added that the trials had also been paused in July after a different participant experienced neurological symptoms. However, these were proven to be unrelated to the vaccine and the individual was diagnosed with multiple sclerosis. 

 

https://www.nytimes.com/2020/09/08/health/coronavirus-astrazeneca-vaccine-safety.html

Edited September 9, 2020 by vememah