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Covid-19: Razvoj vakcine, imunitet i primena medikamenata


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The European Medicines Authority (EMA) will most likely not be able to approve the COVID-19 vaccine developed by drug maker AstraZeneca and the University of Oxford in January, the watchdog’s Deputy Executive Director Noel Wathion said.

“They have not even filed an application with us yet”, Wathion said in an interview with Belgian newspaper Het Nieuwsblad published on Tuesday.

European regulators have only received some information about the vaccine, Wathion said.

“Not even enough to warrant a conditional marketing licence”, he said. “We need additional data about the quality of the vaccine. And after that, the company has to formally apply.”

This made it “improbable” that an approval could already be granted next month, Wathion said.


Edited by vememah
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kao sto smo i pretpostavili, seklerova teorija o manjoj unetoj kolicini virusa pri nosenju maske, koja samim tim dovodi do blazih simptoma, nije bas nesto urezano u kamenu i apsolutno prihvaceno:



We caution against incorporating hypotheses about masks functioning as effective “variolation” — a notion that was advanced by Gandhi and Rutherford in the Journal (online September 8)1 — into public health messaging without considering the implications and nuances. The term “variolation” should be avoided because it is inaccurate with respect to coronaviruses, and it describes an obsolete and risky practice that was used for the iatrogenic inoculation of smallpox. There is insufficient evidence to support the claim that masks reduce the infectious dose of SARS-CoV-2 and the severity of Covid-19, much less that their use can induce protective immunity. Substantial knowledge gaps must be addressed before claims are made about the efficacy of face masks in reducing morbidity or eliciting immune responses.

Masks are used primarily to reduce SARS-CoV-2 transmission rather than reduce the dose of infectious particles or mitigate the severity of Covid-19. The suggestion that masks offer an alternative to vaccination without evidence that the benefits outweigh the great risks implicitly encourages reckless behavior. With the lack of a vaccine, nonpharmaceutical interventions continue to be the best preventive tools.2,3 Transparent, contextualized messaging and embracing uncertainty are essential while science moves forward. Currently, there are too many research gaps to conclude that masks offer benefits beyond reducing transmission risk. We should not advocate for these benefits without fully comprehending the risks.


Edited by Aleksija
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sto se tice nove varijante virusa, jos uvek su u fazi utvrdjivanja sta je sve drugacije - zaraznost svakako jeste. ono sto se otvara kao problem jeste da ako dominantna postane varijanta sa vecim r0, onda raste i procenat imunizovanih (bilo vakcinacijom, bilo zarazavanjem) neophodan za kolektivni imunitet - negde se sad pominje i do 90% :(

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jos uvek su u fazi ispitivanja, nadajmo se da ce vakcinacija ici uporedo ili brze nego sirenje nove varijante (i da ce delovati na mutaciju, kao sto se ocekuje). ili da mozda i nisu u pravu. ali moram priznati da me sad vec brinu ove vesti, pre 7-8 dana je delovalo malo bolje.

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Instant View: UK approves AstraZeneca/Oxford COVID-19 vaccine

(Reuters) - Britain on Wednesday became the first country in the world to approve a coronavirus vaccine developed by AstraZeneca and Oxford University as it battles a winter surge driven by a new, highly contagious variant of the virus.



“It is a bad message that disorients citizens ... the EMA declared the data insufficient and MHRA granted approval. While there is no doubt about the safety of the vaccine, the efficacy is unclear and too many errors and announcements have complicated the interpretation of the data.”


“Scientists don’t use terms like ‘game-changer’ lightly, but that’s what this is. Currently, the virus is once again proving that it can devastate by outrunning even our most draconian efforts to break transmission by limiting contact.

“To get out of this debacle there is no alternative to having a significant majority of the population carrying a high level of neutralising antibodies. With today’s announcement, that comes within our grasp.

“I await the modelling, but I suspect this will speed things by several months. An immune population by the spring starts to look feasible.”



“This is a moment to celebrate British innovation - not only are we responsible for discovering the first treatment to reduce mortality for COVID-19, this vaccine will be made available to some of the poorest regions of the world at a low cost, helping protect countless people from this awful disease.

“It is a tribute to the incredible UK scientists at Oxford University and AstraZeneca, whose breakthrough will help to save lives around the world. I want to thank every single person who has been part of this British success story.

“While it is a time to be hopeful, it is so vital everyone continues to play their part to drive down infections.”

EMA = regulator za lekove EU
MHRA = britanski regulator za lekove
Edited by vememah
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Argentinska iskustva s ruskom vakcinom:



Argentina reported 317 adverse cases in those vaccinated with Sputnik V


The Ministry of Health informed this Friday that 317 adverse events have been reported after the application of 32,013 doses of Sputnik V vaccine, in the first two days of the national vaccination campaign against covid-19 that Argentina started last Tuesday.

These adverse events have been reported until 23.59 local time last December 30th to the Integrated Health Information System of Argentina (SIISA), according to the first vaccine safety surveillance report published today by the Ministry of Health.

"44.2% of the reported ESAVIs (adverse events) correspond to people with fever, headache and/or myalgia initiated 6 to 8 hours after the vaccination," he explained.

These events are related to the Sputnik V vaccine, added the report, which details that within the expected reactions, the following can occur: pain at the injection site, hyperemia, swelling. 

And that within the systemic reactions, the following can occur: short-lived flu-like syndrome that starts within 24 to 48 hours (characterized by chills, fever, arthralgia, myalgia, asthenia, general malaise, headache) or less frequent gastrointestinal symptoms (nausea, dyspepsia, decreased appetite). 

"These reactions have an average duration of 24 hours," he explained.

Argentina began last Tuesday the process of simultaneous vaccination throughout the country, with the batch of 300,000 doses of the Russian vaccine Sputnik V received on Thursday of the previous week, which is applied to health personnel.

The report published today informed that 18 of the 24 jurisdictions of the country have reported adverse events to SIISA.

"99.3% of the reported events were mild and moderate, not requiring hospitalization and evolving with full recovery," he added.


With some mistrust due to the lack of public dissemination of scientific information on the Russian vaccine, Sputnik V, Argentina applied the first dose, which should be completed after 21 days with the second component.

The target population at this stage is health personnel of large urban agglomerations, health personnel of closed intensive care units and laboratory personnel, who handle the virus to make diagnoses.

Argentina has committed 51 million doses, according to the contracts the country signed with AstraZeneca for 22.4 million doses, with the Russian Investment Fund for 20 million doses of Sputnik V vaccine and through the World Health Organization's COVAX Mechanism for 9 million doses. In addition, the country continues to negotiate to acquire vaccines from Pfizer, Sinovac and Sinopharm laboratories.

Today the only vaccine available is the first dose of the Russian vaccine. The President, Alberto Fernandez, has said that Russia will deliver the second 300,000 doses in the first days of January, at the end of January 4 million of the first dose and 1 million of the second, and in February the remaining amount to finish vaccinating 10 million people.

The intention is to continue in a next phase with vaccination of adults over 70 years of age; then adults between 60 and 69 years of age; the armed forces, security and prison services; teachers; and then other strategic populations.



(engleski prevod by Deepl)


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Vaccine won’t work against South Africa coronavirus variant, worry UK scientists

By The Africa Report, Monday, 4 January 2021 11:52

New variants in the Covid-19 coronavirus from the UK and South Africa have caused renewed global concern in recent weeks. But UK scientists now fear that it is the South African strain that causes the greatest risk, as it may be impervious to the various vaccines that have been developed, including those of Pfizer and Moderna.

The concerns were relayed to UK broadcaster ITV by unnamed advisers to the UK government.

Matt Hancock, the UK minister for health, has said that he was ‘incredibly worried’ about the new South African variant, calling it a “very significant problem”.

Scientists say the new variants in both South Africa and the UK have mutations on a key protein that helps the virus enter other cells.

John Bell, regius professor of medicine at University of Oxford, told Times Radio that there was a “big question mark” over whether vaccines would work on the South African variant, and that “It might take a month or six weeks to get a new vaccine”.


Edited by vememah
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