Nuvaxovid

Update: Nuvaxovid is now authorised across the EU. This follows the granting of a conditional marketing authorisation by the European Commission on 20 December 2021. 

EMA has recommended granting a conditional marketing authorisation for Novavax’s COVID-19 vaccine Nuvaxovid (also known as NVX-CoV2373) to prevent COVID-19 in people from 18 years of age. 

Nuvaxovid is the fifth vaccine recommended in the EU for preventing COVID-19. It is a protein-based vaccine and, together with the already authorised vaccines, will support vaccination campaigns in EU Member States during a crucial phase of the pandemic.

After a thorough evaluation, EMA’s human medicines committee (CHMP) concluded by consensus that the data on the vaccine were robust and met the EU criteria for efficacy, safety and quality.

Results from two main clinical trials found that Nuvaxovid was effective at preventing COVID-19 in people from 18 years of age. The studies involved over 45,000 people in total. In the first study, around two thirds of participants received the vaccine and the others were given a placebo (dummy) injection; in the other study, participants were equally split between Nuvaxovid and placebo. People did not know if they had been given Nuvaxovid or placebo.

The first study, conducted in Mexico and the United States, found a 90.4% reduction in the number of symptomatic COVID-19 cases from 7 days after the second dose in people who received Nuvaxovid (14 cases out of 17,312 people) compared with people given placebo (63 out of 8,140 people). This means that the vaccine had a 90.4% efficacy in this study.

The second study conducted in the United Kingdom also showed a similar reduction in the number of symptomatic COVID-19 cases in people who received Nuvaxovid (10 cases out of 7,020 people) compared with people given placebo (96 out of 7,019 people); in this study, the vaccine efficacy was 89.7%.

Taken together, the results of the two studies show a vaccine efficacy for Nuvaxovid of around 90%. The original strain of SARS-CoV-2 and some variants of concern such as Alpha and Beta were the most common viral strains circulating when the studies were ongoing. There is currently limited data on the efficacy of Nuvaxovid against other variants of concern, including Omicron.

The side effects observed with Nuvaxovid in the studies were usually mild or moderate and cleared within a couple of days after vaccination. The most common ones were tenderness or pain at the injection site, tiredness, muscle pain, headache, a general feeling of being unwell, joint pain, and nausea or vomiting.

The safety and effectiveness of the vaccine will continue to be monitored as it is used across the EU, through the EU pharmacovigilance system and additional studies by the company and European authorities.

Where to find more information

The  product information for Nuvaxovid contains information for healthcare professionals, a package leaflet for members of the public and details of conditions of the vaccine’s authorisation.

An assessment report with details of EMA’s evaluation of Nuvaxovid and the full risk management plan will be published shortly. Clinical trial data submitted by the company in the application for marketing authorisation will be published on the Agency’s clinical data website in due course.

More information is available in an overview of the vaccine in lay language, including a description of the vaccine’s benefits and risks and why EMA recommended its authorisation in the EU.

How Nuvaxovid works

Nuvaxovid works by preparing the body to defend itself against COVID-19. The vaccine contains a version of a protein found on the surface of SARS-CoV-2 (the spike protein), which has been produced in the laboratory. It also contains an ‘adjuvant’, a substance to help strengthen the immune responses to the vaccine.

When a person is given the vaccine, their immune system will identify the protein as foreign and produce natural defences — antibodies and T cells — against it. If, later on, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognise the spike protein on the virus and be prepared to attack it. The antibodies and immune cells can protect against COVID-19 by working together to kill the virus, prevent its entry into the body’s cells and destroy infected cells.

Nuvaxovid is given as two injections, usually into the muscle of the upper arm, 3 weeks apart.

Conditional marketing authorisation

The European Commission will now fast-track the decision-making process to grant a decision on the conditional marketing authorisation for Nuvaxovid, allowing this vaccine to be included in vaccination programmes rolled out across the EU.

Conditional marketing authorisation (CMA) is used as the fast-track authorisation procedure to speed up approval of treatments and vaccines during public health emergencies in the EU. CMAs allow authorisation of medicines that fulfil an unmet medical need on the basis of less complete data than normally required. This happens if the benefit of a medicine or vaccine’s immediate availability to patients outweighs the risk inherent in the fact that not all the data are yet available. 

A CMA guarantees that the approved medicine or vaccine meets rigorous EU standards for efficacy, safety and quality and is manufactured in approved, certified facilities in line with high pharmaceutical standards for large-scale production.

Once a CMA has been granted, companies must provide further data from ongoing or new studies within pre-defined deadlines to confirm that the benefits continue to outweigh the risks.

Monitoring the safety of Nuvaxovid

In line with the EU’s safety monitoring plan for COVID-19 vaccines, Nuvaxovid will be closely monitored and subject to several activities that apply specifically to COVID-19 vaccines. Although large numbers of people have received COVID-19 vaccines in clinical trials, certain side effects may only emerge when millions of people are vaccinated.

Companies are required to provide monthly safety reports in addition to the regular updates required by legislation and conduct studies to monitor the safety and effectiveness of the vaccines as they are used by the public. In addition, independent studies of COVID-19 vaccines coordinated by EU authorities will give more information on the vaccine’s long-term safety and benefit in the general population.

These measures will allow regulators to swiftly assess data emerging from a range of different sources and take any necessary regulatory action to protect public health.

Assessment of Nuvaxovid

During the assessment of Nuvaxovid, CHMP had the support of EMA’s safety committee, PRAC, who assessed the risk management plan of Nuvaxovid, and the COVID-19 EMA pandemic task force (COVID-ETF), a group that brings together experts from across the European medicines regulatory network to facilitate rapid and coordinated regulatory action on medicines and vaccines for COVID-19.

More info: 

Nuvaxovid is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older.

Nuvaxovid contains a version of a protein found on the surface of SARS-CoV-2 (the spike protein), which has been produced in the laboratory.

Detailed information about this vaccine is available in the product information, which includes the package leaflet.

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How is Nuvaxovid used?

Nuvaxovid is given as two injections, usually into the muscle of the upper arm, 3 weeks apart.

Arrangements for the supply of the vaccine will be the responsibility of national authorities. For more information about using Nuvaxovid, see the package leaflet or consult a healthcare professional.

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How does Nuvaxovid work?

Nuvaxovid works by preparing the body to defend itself against COVID-19. It contains a version of the spike protein that has been produced in the laboratory. It also contains an ‘adjuvant’, a substance to help strengthen the immune responses to the vaccine.

When a person is given the vaccine, their immune system will identify the protein in the vaccine as foreign and produce natural defences — antibodies and T cells — against it.

If, later on, the vaccinated person comes into contact with SARS-CoV-2 virus, the immune system will recognise the spike protein on the virus and be prepared to attack it. The antibodies and immune cells can protect against COVID-19 by working together to kill the virus, prevent its entry into the body’s cells and destroy infected cells.

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What benefits of Nuvaxovid have been shown in studies?

Results from two main clinical trials found that Nuvaxovid was effective at preventing COVID-19 in people from 18 years of age. The studies involved over 45,000 people in total. In the first study, around two thirds of participants received the vaccine and the others were given placebo (a dummy injection); in the other study, participants were equally split between Nuvaxovid and placebo. People did not know if they had been given Nuvaxovid or placebo.

The first study, conducted in Mexico and the United States, found a 90.4% reduction in the number of symptomatic COVID-19 cases from 7 days after the second dose in people who received Nuvaxovid (14 cases out of 17,312 people) compared with people given placebo (63 out of 8,140 people). This means that the vaccine had a 90.4% efficacy in this study.

The second study conducted in the United Kingdom also showed a similar reduction in the number of symptomatic COVID-19 cases in people who received Nuvaxovid (10 cases out of 7,020 people) compared with people given placebo (96 out of 7,019 people); in this study, the vaccine efficacy was 89.7%.

Taken together, the results of the two studies show a vaccine efficacy for Nuvaxovid of around 90%. The original strain of SARS-CoV-2 and some variants of concern such as Alpha and Beta were the most common viral strains circulating when the studies were ongoing. There is currently limited data on the efficacy of Nuvaxovid against other variants of concern, including Omicron.

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Can people who have already had COVID-19 be vaccinated with Nuvaxovid?

There were no additional side effects in the people who received Nuvaxovid in the clinical trials and had previously had COVID-19.

There were not enough data from the trial to conclude on how well Nuvaxovid works for people who have already had COVID-19.

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Can Nuvaxovid reduce transmission of the virus from one person to another?

The impact of vaccination with Nuvaxovid on the spread of the SARS-CoV-2 virus in the community is not yet known. It is not yet known how much vaccinated people may still be able to carry and spread the virus.

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How long does protection from Nuvaxovid last?

It is not currently known how long protection given by Nuvaxovid lasts. The people vaccinated in the clinical trials will continue to be followed for up to 2 years to gather more information on the duration of protection.

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Can children be vaccinated with Nuvaxovid?

Nuvaxovid is not currently recommended for people below 18 years of age. EMA has agreed with the company on a plan to trial the vaccine in children at a later stage.

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Can immunocompromised people be vaccinated with Nuvaxovid?

There are limited data on immunocompromised people (people with weakened immune systems). Although immunocompromised people may not respond as well to the vaccine, there are no particular safety concerns. Immunocompromised people can still be vaccinated as they may be at higher risk from COVID-19. 

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Can pregnant or breast-feeding women be vaccinated with Nuvaxovid?

Animal studies do not show any harmful effects in pregnancy, however data on the use of Nuvaxovid during pregnancy are limited. Although there are no studies on breast-feeding, no risk for breast-feeding is expected.

The decision on whether to use the vaccine in pregnant women should be made in close consultation with a healthcare professional after considering the benefits and risks.

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Can people with allergies be vaccinated with Nuvaxovid?

People who already know they have an allergy to one of the components of the vaccine listed in section 6 of the package leaflet should not receive the vaccine.

Cases of anaphylaxis (severe allergic reaction) have occurred in people receiving COVID-19 vaccines. Therefore, as for all vaccines, Nuvaxovid should be given under close medical supervision, with the appropriate medical treatment available. People who have a severe allergic reaction when they are given the first dose of Nuvaxovid should not receive the second dose.

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How well does Nuvaxovid work for people of different ethnicities and genders?

The main trials included people of different ethnicities and genders. Efficacy was maintained across genders and ethnic groups.

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What are the risks associated with Nuvaxovid?

The most common side effects with Nuvaxovid in the trials were usually mild or moderate and got better within a few days after vaccination. These included headache, nausea (feeling sick) or vomiting, muscle and joint pain, tenderness and pain at the injection site, tiredness and feeling unwell. These affected more than 1 in 10 people.

Redness and swelling at the injection site, fever, chills and pain in the limbs occurred in less than 1 in 10 people. Enlarged lymph nodes, high blood pressure, rash, reddening of the skin, itching at the injection site and itchy rash were uncommon side effects (affecting less than 1 in 100 people).

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Why has EMA recommended the authorisation of Nuvaxovid?

Nuvaxovid offers a high level of protection against COVID-19 which is a critical need in the current pandemic. The main trials showed that the vaccine has around 90% efficacy. Most side effects are mild to moderate in severity and are gone within a few days.

The Agency therefore decided that Nuvaxovid’s benefits are greater than its risks and that it can be recommended for authorisation in the EU.

EMA has recommended a conditional marketing authorisation for Nuvaxovid. This means that there is more evidence to come about the vaccine (see below), which the company is required to provide. The Agency will review any new information that becomes available and this overview will be updated as necessary.

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What information is still awaited for Nuvaxovid?

As Nuvaxovid is recommended for a conditional marketing authorisation, the company that markets Nuvaxovid will carry out studies to provide additional assurance on the pharmaceutical quality of the vaccine.

In addition, independent studies of COVID-19 vaccines coordinated by EU authorities will also give more information on the vaccine’s long-term safety and benefit in the general population.

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What measures are being taken to ensure the safe and effective use of Nuvaxovid?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nuvaxovid have been included in the summary of product characteristics and the package leaflet.

A risk management plan (RMP) for Nuvaxovid is also in place and contains important information about the vaccine’s safety, how to collect further information and how to minimise any potential risks. A summary of the RMP is available.

Safety measures will be implemented for Nuvaxovid in line with the EU safety monitoring plan for COVID-19 vaccines to ensure that new safety information is rapidly collected and analysed. The company that markets Nuvaxovid will provide monthly safety reports.

As for all medicines, data on the use of Nuvaxovid are continuously monitored. Suspected side effects reported with Nuvaxovid are carefully evaluated and any necessary action taken to protect patients.

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Other information about Nuvaxovid

Nuvaxovid was recommended by EMA’s human medicines committee (CHMP) on 20 December 2021 for a conditional marketing authorisation valid throughout the EU. The European Commission will issue a decision shortly.

Detailed recommendations for the use of this product are described in the product information, which will be available in all official European Union languages after a decision on the marketing authorisation has been issued by the European Commission.

Ethics and life’s big questions

Why philosophers have advocated simple living for 2,500 years—and why we ignore them at our peril. The good life is a simple life. Among philosophical ideas about how we should live, this one is a hardy perennial; from Socrates to Thoreau, from the Buddha to Wendell Berry, thinkers have been peddling it for more than two millennia.

And it still has plenty of adherents. Magazines such as Real Simple call out to us from the supermarket checkout; Oprah Winfrey regularly interviews fans of simple living such as Jack Kornfield, a teacher of Buddhist mindfulness; the Slow Movement, which advocates a return to pre-industrial basics, attracts followers across continents.

Through much of human history, frugal simplicity was not a choice but a necessity – and since necessary, it was also deemed a moral virtue. But with the advent of industrial capitalism and a consumer society, a system arose that was committed to relentless growth, and with it grew a population (aka ‘the market’) that was enabled and encouraged to buy lots of stuff that, by traditional standards, was surplus to requirements. As a result, there’s a disconnect between the traditional values we have inherited and the consumerist imperatives instilled in us by contemporary culture.

In pre-modern times, the discrepancy between what the philosophers advised and how people lived was not so great. Wealth provided security, but even for the rich wealth was flimsy protection against misfortunes such as war, famine, disease, injustice, and the disfavour of tyrants. The Stoic philosopher Seneca, one of the richest men in Rome, still ended up being sentenced to death by Nero. As for the vast majority – slaves, serfs, peasants, and labourers – there was virtually no prospect of accumulating even modest wealth.

Before the advent of machine-based agriculture, representative democracy, civil rights, antibiotics, and aspirin, just making it through a long life without too much suffering counted as doing pretty well. Today, though, at least in prosperous societies, people want and expect (and can usually have) a good deal more. Living simply now strikes many people as simply boring.

Yet there seems to be growing interest, especially among millennials, in rediscovering the benefits of simple living. Some of this might reflect a kind of nostalgia for the pre-industrial or pre-consumerist world, and also sympathy for the moral argument that says that living in a simple manner makes you a better person, by building desirable traits such as frugality, resilience, and independence – or a happier person, by promoting peace of mind and good health, and keeping you close to nature.

These are plausible arguments. Yet in spite of the official respect their teachings command, the sages have proved remarkably unpersuasive. Millions of us continue to rush around getting and spending, buying lottery tickets, working long hours, racking up debt, and striving 24/7 to climb the greasy pole. Why is this?

One obvious answer is good old-fashioned hypocrisy. We applaud the frugal philosophy while ignoring its precepts in our day-to-day lives. We praise the simple lifestyle of, say, Pope Francis, seeing it as a sign of his moral integrity, while also hoping for and cheering on economic growth driven, in large part, by a demand for bigger houses, fancier cars, and other luxury goods.

But the problem isn’t just that our practice conflicts with our professed beliefs. Our thinking about simplicity and luxury, frugality and extravagance, is fundamentally inconsistent. We condemn extravagance that is wasteful or tasteless and yet we tout monuments of past extravagance, such as the Forbidden City in Beijing or the palace at Versailles, as highly admirable. The truth is that much of what we call ‘culture’ is fuelled by forms of extravagance.

Somewhat paradoxically, then, the case for living simply was most persuasive when most people had little choice but to live that way. The traditional arguments for simple living in effect rationalise a necessity. But the same arguments have less purchase when the life of frugal simplicity is a choice, one way of living among many. Then the philosophy of frugality becomes a hard sell.

That might be about to change, under the influence of two factors: economics and environmentalism. When recession strikes, as it has done recently (revealing inherent instabilities in an economic system committed to unending growth) millions of people suddenly find themselves in circumstances where frugality once again becomes a necessity, and the value of its associated virtues is rediscovered.

In societies such as the United States, we are currently witnessing a tendency for capitalism to stretch the distance between the ‘have lots’ and the ‘have nots’. These growing inequalities invite a fresh critique of extravagance and waste. When so many people live below the poverty line, there is something unseemly about in-your-face displays of opulence and luxury. Moreover, the lopsided distribution of wealth also represents a lost opportunity. According to Epicurus and the other sages of simplicity, one can live perfectly well, provided certain basic needs are satisfied – a view endorsed in modern times by the psychologist Abraham Maslow’s ‘hierarchy of needs‘. If correct, it’s an argument for using surplus wealth to ensure that everyone has basics such as food, housing, healthcare, education, utilities and public transport – at low cost, rather than allowing it to be funnelled into a few private pockets.

However wise the sages, it would not have occurred to Socrates or Epicurus to argue for the simple life in terms of environmentalism. Two centuries of industrialisation, population growth, and frenzied economic activity has bequeathed us smog; polluted lakes, rivers, and oceans; toxic waste; soil erosion; deforestation; extinction of plant and animal species, and global warming. The philosophy of frugal simplicity expresses values and advocates a lifestyle that might be our best hope for reversing these trends and preserving our planet’s fragile ecosystems.

Many people are still unconvinced by this. But if our current methods of making, getting, spending, and discarding prove unsustainable, then there could come a time – and it might come quite soon – when we are forced towards simplicity. In which case, a venerable tradition will turn out to contain the philosophy of the future.

Emrys Westacott is a professor of philosophy at Alfred University in New York. The Wisdom of Frugality (2016) by Emrys Westacott is published via Princeton University Press. 

https://press.princeton.edu/books/hardcover/9780691155081/the-wisdom-of-frugality 

Stanični imunitet

Mnogi prijatelji HCOIE portala postavljaju isto pitanje vezano za imunitet kod onih koji su preboljeli i onih koji su cijepljeni, dosta pitanja vezana su i za memorijske stanice. Postoje dva glavna mehanizma imunosti unutar adaptivnog imunološkog sustava – humoralni i stanični.

Humoralni imunitet se također naziva imunitet posredovan antitijelima. Uz pomoć pomoćnih T stanica, B stanice će se diferencirati u plazma B stanice koje mogu proizvesti antitijela protiv specifičnog antigena. Humoralni imunološki sustav se bavi antigenima iz patogena koji slobodno cirkuliraju ili izvan zaraženih stanica. Protutijela koja proizvode B stanice vezat će se za antigene, neutralizirajući ih ili uzrokujući lizu (otapanje ili uništavanje stanica lizinom) ili fagocitozu.

Stanična imunost javlja se unutar inficiranih stanica i posredovana je T limfocitima. Antigeni patogena su izraženi na površini stanice ili na stanici koja predstavlja antigen. Pomoćne T stanice oslobađaju citokine koji pomažu aktiviranim T stanicama da se vežu na kompleks MHC-antigena zaraženih stanica i diferenciraju T stanicu u citotoksičnu T stanicu. 

Nakon infekcije virusom SARS-CoV-2 ili cijepljenja dolazi do reakcije imunosnog sustava organizma koja dovodi do stvaranja specifičnih stanica zvanih limfociti. Limfociti su stanice koje cirkuliraju putem krvi i obavljaju svoje specifične funkcije u svrhu obrane organizma od virusa. Postoji velik broj limfocita, ali ih dijelimo u dvije osnovne skupine: limfocite T i limfocite B. Limfociti B su stanice koje stvaraju antitijela, a ona specifično prepoznaju virus te se na njega vežu, neutraliziraju ga i sprečavaju ulazak virusa u naše zdrave stanice. Ako virus ipak uspije dospjeti u naše zdrave stanice, u njima započinje replikacija virusne nasljedne upute te virusnih proteina i stvaranje novih virusnih čestica. Takve patološki promijenjene, bolesne stanice (prethodno fagocitirane od strane antigen predočnih stanica) mogu prepoznati naši limfociti T, koji u svojim granulama sadrže brojne citotoksične tvari, a na površini specifične stanične receptore. Stanični receptori limfocita T imaju sposobnost naše bolesne stanice potaknuti na programiranu staničnu smrt, čime stanica u kojoj se virus nalazi odumire te je spriječeno daljnje umnažanje virusa. Limfociti T čine prvu liniju naše stanične imunosti koja je naziv dobila upravo po tome što je posredovana stanicama - limfocitima T, a ne antitijelima.

Dio limfocita T i limfocita B nakon preboljene infekcije ili cijepljenja ima sposobnost pretvorbe u stanicu sa specifičnom funkcijom koju nazivamo memorijska stanica. Memorijske stanice imaju sposobnost pamćenja virusnih dijelova kako bi se aktivirale u trenutku kada organizam dođe u ponovni doticaj s virusom. Takve stanice višestruko ubrzavaju stvaranje aktivnih limfocita T koji će prepoznati bolesne stanice inficirane virusom i uništiti ih. Također, memorijske stanice ubrzavaju stvaranje limfocita B, koji će produkcijom antitijela neutralizirati slobodne virusne čestice u krvi. Tajna dugovječnosti stanične imunosti upravo je u memorijskim stanicama, a istraživanje objavljeno u jednom od najcitiranijih svjetskih časopisa - Nature otkriva da je stanična imunost na virusni antigen N trajala čak 17 godina u pacijenata nakon infekcije SARS-om 2003. godine.

Sva cjepiva koja su sada na tržištu zasnivaju se na prezentaciji virusnog antigena S našem imunosnom sustavu kako bi naše stanice mogle prepoznati spike (S) protein virusa i pravodobno reagirati tijekom ulaska virusa u naš organizam. S druge strane, tijekom infekcije virusom SARS-CoV-2 dolazi do razgradnje cijele virusne čestice, obrade većeg broja različitih virusnih antigena uključujući i antigen S te naš imunosni sustav stvara zaštitu protiv svih virusnih komponenti. Istraživanja koja su u tijeku pokazuju da je razina imunosne reakcije na S protein virusa podjednaka u cijepljenih i onih koji su preboljeli covid-19.

Humoralni imunitet i imunitet posredovan stanicama dvije su vrste adaptivnog imunološkog odgovora koji omogućavaju ljudskom tijelu da se ciljano brani od štetnih agenasa kao što su bakterije, virusi i toksini. Iako postoji određeno preklapanje između ovih krakova imunološkog odgovora - oba se oslanjaju na funkcije limfoidnih stanica - postoje i neke važne razlike. Može se steći humoralni imunitet na određenu infekciju ili bolest ako se daje s protutijelima od nekoga tko je prethodno bio izložen istoj infekciji, zaobilazeći humoralni odgovor. Međutim, imunost posredovana antitijelima uključuje skup molekularnih komponenti i procesa koji se razlikuju od imunosti posredovane stanicama. U ovom članku definiramo humoralnu imunost i stanični imunitet, raspravljajući o različitim imunološkim procesima, svrhama i važnim tipovima stanica.

Jačina stanične imunosti je individualna karakteristika koja se zasniva na velikom broju faktora uključujući i genetsku podlogu pojedinca. Trenutno ne možemo predvidjeti kakva će biti reakcija na virus u pojedine osobe niti znamo koja je to razina stanične imunosti koja nas štiti od zaraze ili teškog oblika bolesti. Međutim, recentna znanstvena literatura objavljena u vodećem medicinskom časopisu Lancet navodi izrazito nisku pojavnost reinfekcije u osoba koje su preboljele i stvorile staničnu imunost na virus SARS-CoV-2. Humoralna imunost omogućuje neutralizaciju virusnih čestica u krvi i sprečava njihov ulazak u stanice, dok stanična imunost prepoznaje inficirane stanice, uništava ih i time zaustavlja daljnje širenje virusa. Svaki rezultat testa interpretira se individualno u kontekstu kliničke slike pacijenta, njegovih komorbiditeta, razine stanične i humoralne imunosti te prema potrebi i genetske analize. 

Ova tablica nije vezana uz temu ali je dobro da je proučite. 

Trajanje stanične imunosti još se ne može sa sigurnošću odrediti, ali istraživanja bazirana na ljudima koji su preboljeli SARS 2003. ukazuju da stanični imunosni odgovor, zahvaljujući memorijskim stanicama, može potrajati i do dva desetljeća. Trenutna pandemija traje prekratko da bismo mogli odrediti koliko će točno trajati stanična imunost na SARS-CoV-2, no Shrestha i kolege iz američke Klinike Cleveland u radu koji je retrospektivno analizirao populaciju SAD-a, i to 52.238 osoba među kojima i njih 1359 koji su preboljeli covid-19 i nisu cijepljeni, potvrđuje da ni jedna od 1359 osoba nije ponovno oboljela od covida-19. S druge strane, prije dva dana Lancet Infect Dis u preglednom članku navodi i studiju objavljenu u Clin Infect Dis, rađenu na 9119 osoba koje su preboljele covid-19 i koja potvrđuje da je samo 0,7 posto osoba imalo ponovnu infekciju SARS-CoV-2 (reinfekcija). Ti su rezultati potpuno u skladu s upravo objavljenom studijom u JAMA Internal Medicine na 1579 osoba u kojoj su analizirani oboljeli od covida-19 tijekom prvog vala bolesti u Italiji, a od kojih je samo pet osoba (0,31 posto) ponovno oboljelo od covida-19, dok je samo jedna ponovno oboljela osoba hospitalizirana. O zaštićenosti od zaraze ovisi nekoliko čimbenika, a među kojima su i stanična i humoralna imunost koje čine temeljnu obranu našeg imunosnog sustava. Među čimbenike o kojima ovisi hoće li se pojedina osoba zaraziti svakako spadaju i količina virusa unesenog u organizam, trajanje kontakta s inficiranom osobom, kao i sposobnost naše prirodne mehaničke zaštite - mukozne barijere koja oblaže nos, usnu šupljinu i unutrašnjost dišnih puteva.

Nakon preboljenja infekcije SARS-CoV-2 razvija se stanična imunost na različite virusne antigene, što znači da se naš imunosni sustav može boriti prepoznajući različite dijelove virusa. Ako s vremenom dođe do promjena u virusnim antigenima, stanična imunost može prepoznati druge komponente i tako aktivirati obranu protiv virusa. Zanimljivo je da su istraživanja pokazala da na pojedine virusne antigene postoji križna reaktivnost te tako stanična imunost protiv virusnog proteina N u osoba koje su 2003. preboljele SARS može križno reagirati i prepoznati protein N virusa SARS-CoV-2.

Stanična imunost nastaje kao reakcija na gotovo sve infektivne bolesti te se razvija i prilikom infekcije drugim virusima i mikroorganizmima. S obzirom na dugotrajnost stanične imunosne memorije te s obzirom na mogućnost križne reaktivnosti, stanična imunost izuzetno je značajna komponenta našeg imunosnog sustava. Nedavno objavljena znanstvena studija u američkom medicinskom časopisu JAMA navodi zabrinutost zbog pojave probojnih infekcija nakon cijepljenja protiv SARS-CoV-2 virusa te ističu nepouzdanost razine titra antitijela kao zaštite od zaraze virusom SARS-CoV-2. Za razliku od antitijela čiji titar ubrzano pada s vremenom, trenutna saznanja ukazuju na dugotrajnost stanične imunosti i njezinu važnu ulogu u održavanju imunosne zaštite. 

Reference:

F.S. Dhabhar, in Encyclopedia of Stress (Second Edition), 2007

J. Descotes, in Encyclopedia of Toxicology (Third Edition), 2014

E. Diane Williamson, in Vaccines for Biodefense and Emerging and Neglected Diseases, 2009

Linda Kidd, Edward B. Breitschwerdt, in Canine and Feline Infectious Diseases, 2014

A.J. Zajac, L.E. Harrington, in Reference Module in Biomedical Sciences, 2014

GUSTAVO PACHECO-LÓPEZ, ... MANFRED SCHEDLOWSKI, in Psychoneuroimmunology (Fourth Edition), 2007

N.V. Bhagavan, Chung-Eun Ha, in Essentials of Medical Biochemistry, 2011

Tom R. Phillips, in Encyclopedia of Immunology (Second Edition), 1998

Global Future

A terrifying coalition of big business and big tech is so confident and brazen they are promising the public “you will own nothing, and you will be happy” in an advertising campaign for a global reset.

The Great Reset is a proposal set out by the World Economic Forum for a new globalized fiscal system that would allow the world to effectively tackle the so-called climate crisis.

Zeljko Serdar from CCRES said the plan intends to use the “tools of oppression” implemented during the pandemic, such as lockdowns and forced business closures as well as other measures destroying private property rights, to combat the coronavirus to achieve climate outcomes.

“I've spoken before about the insidious phrases which sound like common sense but is in fact just one of several slogans for the Great reset, another being the Orwellian phrase the fourth industrial revolution. This is as serious and as dangerous a threat to our prosperity and freedom as we have faced in decades”.

Welcome to the year 2030. Welcome to my city - or should I say, "our city." I don't own anything. I don't own a car. I don't own a house. I don't own any appliances or any clothes.

It might seem odd to you, but it makes perfect sense for us in this city. Everything you considered a product, has now become a service. We have access to transportation, accommodation, food and all the things we need in our daily lives. One by one all these things became free, so it ended up not making sense for us to own much.

First communication became digitized and free to everyone. Then, when clean energy became free, things started to move quickly. Transportation dropped dramatically in price. It made no sense for us to own cars anymore because we could call a driverless vehicle or a flying car for longer journeys within minutes. We started transporting ourselves in a much more organized and coordinated way when public transport became easier, quicker, and more convenient than the car. Now I can hardly believe that we accepted congestion and traffic jams, not to mention the air pollution from combustion engines. What were we thinking?

Sometimes I use my bike when I go to see some of my friends. I enjoy the exercise and the ride. It kind of gets the soul to come along on the journey. Funny how some things seem never seem to lose their excitement: walking, biking, cooking, drawing, and growing plants. It makes perfect sense and reminds us of how our culture emerged out of a close relationship with nature.

In our city, we don't pay any rent, because someone else is using our free space whenever we do not need it. My living room is used for business meetings when I am not there.

Once in a while, I will choose to cook for myself. It is easy - the necessary kitchen equipment is delivered to my door within minutes. Since transport became free, we stopped having all those things stuffed into our homes. Why keep a pasta maker and a crepe cooker crammed into our cupboards? We can just order them when we need them.

This also made the breakthrough of the circular economy easier. When products are turned into services, no one has an interest in things with a short life span. Everything is designed for durability, repairability, and recyclability. The materials are flowing more quickly in our economy and can be transformed into new products pretty easily. Environmental problems seem far away since we only use clean energy and clean production methods. The air is clean, the water is clean and nobody would dare to touch the protected areas of nature because they constitute such value to our well-being. In the cities, we have plenty of green space and plants and trees all over. I still do not understand why in the past we filled all free spots in the city with concrete.

Shopping? I can't really remember what that is. For most of us, it has been turned into choosing things to use. Sometimes I find this fun, and sometimes I just want the algorithm to do it for me. It knows my taste better than I do by now.

When AI and robots took over so much of our work, we suddenly had time to eat well, sleep well and spend time with other people. The concept of rush hour makes no sense any more since the work that we do can be done at any time. I don't really know if I would call it to work anymore. It is more like thinking-time, creation-time, and development-time.

For a while, everything was turned into entertainment and people did not want to bother themselves with difficult issues. It was only at the last minute that we found out how to use all these new technologies for better purposes than just killing time.

My biggest concern is all the people who do not live in our city. Those we lost on the way. Those who decided that it became too much, all this technology. Those who felt obsolete and useless when robots and AI took over big parts of our jobs. Those who got upset with the political system and turned against it. They live different kinds of lives outside of the city. Some have formed little self-supplying communities. Others just stayed in the empty and abandoned houses in small 19th century villages.

Once in a while, I get annoyed about the fact that I have no real privacy. Nowhere I can go and not be registered. I know that, somewhere, everything I do, think and dream of is recorded. I just hope that nobody will use it against me.

All in all, it is a good life. Much better than the path we were on, where it became so clear that we could not continue with the same model of growth. We had all these terrible things happening: lifestyle diseases, climate change, the refugee crisis, environmental degradation, completely congested cities, water pollution, air pollution, social unrest, and unemployment. We lost way too many people before we realized that we could do things differently.

This blog post was written ahead of the World Economic Forum Annual Meeting of the Global Future Councils. Thank you for your interest in the World Economic Forum, the International Organization for Public-Private Cooperation.

Family Farming Platform

 

Family farming is the most common operational farming model in Europe – representing 97 percent of the European Union’s (EU) 12 million farms. Thus it is of great importance in the EU. It covers a diverse range of situations, including farms of all sizes. While there are obvious differences across regions and countries of the world when it comes to family farming, there is also much common ground. Below some of the key challenges and opportunities for family farms across the EU are identified, together with the policy solutions introduced in the EU to address them. The new 2014-2020 Common Agricultural Policy (CAP) that was agreed in 2013 offers a robust policy to maintain the rich diversity of family farms in the European agricultural sector and to ensure sustainability. The CAP continues to provide support to farmers through direct payments and measures to support agricultural, environmental and territorial development under the rural development programs. Some of these measures are of particular relevance for family farming. 

Under the new direct payment regime, Member States now have the possibility to establish a simplified scheme for small farmers under which they will be able to receive annual direct support ranging from €500 to €1,250. They will be subject to reduced administrative formalities, and exempted from certain environmental obligations. Member States can also choose to pay a redistributive payment – a top-up to support small and middle-sized farms. Furthermore, a scheme will specifically address the challenge of generation renewal by giving farmers up to the age of 40 an additional top-up payment for up to five years. As part of the market measures, the reform also contains measures to enhance producers’ organizations. Under the rural development elements of the CAP, the modified European Agricultural Fund for Rural Development (EAFRD) also enables spending on a raft of proven measures to strengthen the sustainability of smaller family farms through regional or national rural development programs. These measures include support for training and advice, economic improvements (such as physical investments, business development), cooperation to overcome small-scale disadvantages (such as setting up producer groups, jointly developing short supply chains, new technologies), and compensation for environmental commitments (such as voluntarily improved environmental or organic farming standards).

There is a need to promote innovation within family farms, taking into account their diversity, the different natural conditions under which they operate, and their varying degrees of technological development. There are a number of obstacles to the uptake of innovation that need to be addressed: lack of access to knowledge, insufficient information flow, weak exchange of research results, and too little responsiveness to the needs of farmers. The revised CAP is ready to support innovation, whether it is led by individuals, public sector organizations, or enterprises. A fully-fledged EU innovation package is available for the agrifood sector, comprising the new rural development policy, the Europe 2020 Flagship Initiative on the Innovation Union, Horizon 2020, and the European Innovation Partnership: Agricultural productivity and sustainability. This combination of policy measures aims to encourage researchers, farmers, advisors, and other agricultural sector stakeholders to cooperate more actively. In particular, it is hoped that a more direct and systematic exchange between farming and science will accelerate the speed of technological transfer and innovation.

Agricultural cooperatives can help family farms to overcome the scale constraints inherent to smallholdings while enabling small farmers to respond more effectively to changing market demands. Participating farmers also have more power and control over production than through contract farming, making food security less vulnerable. The increased access cooperatives provide to resources, information tools and services encourages members to increase their levels of food production, while reducing transaction costs, improving quality, and creating jobs. The CAP has supported producer cooperation working through the Common Market Organisation of products, which has enabled improved coordination of specific supply chains. The CAP provides a reinforced framework for producers and other organizations, as well as support for the setting up of producer groups. These should facilitate producer cooperation by granting legal certainty, financial support, and economic advantages to willing farmers. There are also new opportunities through the European Innovation Partnership Operational Groups that can enable new and existing cooperatives to explore and develop their own working practices and penetrate new markets.

Local food supply chains make it easier for customers to identify the origin of their purchases, and they are often willing to pay a premium for fresher and healthier options. By strengthening the relationship between consumers and local farmers, such supply chains promote local family enterprises and boost regional identity. The organization of food chains is a priority in the 2014- 2020 rural development policy. The EAFRD-funded measures aim to help family farmers to sell their products directly to consumers or at least to become involved in short supply chains and to better integrate family farms into distribution channels by providing support for quality schemes, adding value to agricultural products, promotion in local markets and short supply chains,  producer groups, and inter-branch organizations. In addition, the LEADER approach will continue to provide Local Action Groups with the grounds they need to support innovative and experimental approaches to stimulate direct sales and the development of local food markets, where foreseen as part of the Local Development Strategy.

Family farming has survived in Europe over centuries, re-emerging from crises, wars, and natural disasters, adjusting to changing economic fortunes, and, in some countries, to dramatic changes in a political context. This has never been a smooth and painless process, as many small farmers have disappeared over decades to give way to more efficient and competitive farms, able to adopt new inputs and technologies. It is beyond doubt that family farming will survive and will continue to be dominant in EU agriculture as far as the number of farms is concerned and that traditional smaller-scale family farming will continue to be the core of agriculture in many regions. With the majority of the EU’s farms being family farms, discussion about innovative approaches to the promotion and sustainability of the family farming model is certain to continue. The CAP’s role in addressing the challenges set out above and the new ones which will arise, not least as a result of climate change, will be key to assuring the future of the family farming sector, and with it the preservation of the EU’s rural communities and their local economies, traditions and agricultural practices.

Nipah virus

 

• Nipah virus infection in humans causes a range of clinical presentations, from asymptomatic infection (subclinical) to acute respiratory infection and fatal encephalitis.
• The case fatality rate is estimated at 40% to 75%. This rate can vary by outbreak depending on local capabilities for epidemiological surveillance and clinical management.
• Nipah virus can be transmitted to humans from animals (such as bats or pigs), or contaminated foods and can also be transmitted directly from human-to-human.
• Fruit bats of the Pteropodidae family are the natural host of Nipah virus.
• There is no treatment or vaccine available for either people or animals. The primary treatment for humans is supportive care.
• The 2018 annual review of the WHO R&D Blueprint list of priority diseases indicates that there is an urgent need for accelerated research and development for the Nipah virus.

 

 

Nipah virus (NiV) is a zoonotic virus (it is transmitted from animals to humans) and can also be transmitted through contaminated food or directly between people. In infected people, it causes a range of illnesses from asymptomatic (subclinical) infection to acute respiratory illness and fatal encephalitis. The virus can also cause severe disease in animals such as pigs, resulting in significant economic losses for farmers.  

Although Nipah virus has caused only a few known outbreaks in Asia, it infects a wide range of animals and causes severe disease and death in people, making it a public health concern.

Past Outbreaks 

Nipah virus was first recognized in 1999 during an outbreak among pig farmers in, Malaysia. No new outbreaks have been reported in Malaysia since 1999. 

It was also recognized in Bangladesh in 2001, and nearly annual outbreaks have occurred in that country since. The disease has also been identified periodically in eastern India.

Other regions may be at risk for infection, as evidence of the virus has been found in the known natural reservoir (Pteropus bat species) and several other bat species in a number of countries, including Cambodia, Ghana, Indonesia, Madagascar, the Philippines, and Thailand.

Transmission

During the first recognized outbreak in Malaysia, which also affected Singapore, most human infections resulted from direct contact with sick pigs or their contaminated tissues. Transmission is thought to have occurred via unprotected exposure to secretions from the pigs, or unprotected contact with the tissue of a sick animal.

In subsequent outbreaks in Bangladesh and India, consumption of fruits or fruit products (such as raw date palm juice) contaminated with urine or saliva from infected fruit bats was the most likely source of infection.

There are currently no studies on viral persistence in bodily fluids or the environment including fruits.

Human-to-human transmission of Nipah virus has also been reported among family and care givers of infected patients.

During the later outbreaks in Bangladesh and India, Nipah virus spread directly from human-to-human through close contact with people's secretions and excretions. In Siliguri, India in 2001, transmission of the virus was also reported within a health-care setting, where 75% of cases occurred among hospital staff or visitors. From 2001 to 2008, around half of reported cases in Bangladesh were due to human-to-human transmission through providing care to infected patients.

Signs and symptoms

Human infections range from asymptomatic infection to acute respiratory infection (mild, severe), and fatal encephalitis.

Infected people initially develop symptoms including fever, headaches, myalgia (muscle pain), vomiting and sore throat. This can be followed by dizziness, drowsiness, altered consciousness, and neurological signs that indicate acute encephalitis. Some people can also experience atypical pneumonia and severe respiratory problems, including acute respiratory distress. Encephalitis and seizures occur in severe cases, progressing to coma within 24 to 48 hours. 

The incubation period (interval from infection to the onset of symptoms) is believed to range from 4 to 14 days. However, an incubation period as long as 45 days has been reported.

Most people who survive acute encephalitis make a full recovery, but long term neurologic conditions have been reported in survivors.  Approximately 20% of patients are left with residual neurological consequences such as seizure disorder and personality changes. A small number of people who recover subsequently relapse or develop delayed onset encephalitis.

The case fatality rate is estimated at 40% to 75%. This rate can vary by outbreak depending on local capabilities for epidemiological surveillance and clinical management.

Diagnosis

Initial signs and symptoms of Nipah virus infection are nonspecific, and the diagnosis is often not suspected at the time of presentation.  This can hinder accurate diagnosis and creates challenges in outbreak detection, effective and timely infection control measures, and outbreak response activities. 

In addition, the quality, quantity, type, timing of clinical sample collection and the time needed to transfer samples to the laboratory can affect the accuracy of laboratory results.

Nipah virus infection can be diagnosed with clinical history during the acute and convalescent phase of the disease. The main tests used are real time polymerase chain reaction (RT-PCR) from bodily fluids and antibody detection via enzyme-linked immunosorbent assay (ELISA). 

Other tests used include polymerase chain reaction (PCR) assay, and virus isolation by cell culture.

Treatment

There are currently no drugs or vaccines specific for Nipah virus infection although WHO has identified Nipah as a priority disease for the WHO Research and Development Blueprint.  Intensive supportive care is recommended to treat severe respiratory and neurologic complications.

Natural host: fruit bats

Fruit bats of the family Pteropodidae – particularly species belonging to the Pteropus genus – are the natural hosts for Nipah virus. There is no apparent disease in fruit bats.

It is assumed that the geographic distribution of Henipaviruses overlaps with that of Pteropus category. This hypothesis was reinforced with the evidence of Henipavirus infection in Pteropus bats from Australia, Bangladesh, Cambodia, China, India, Indonesia, Madagascar, Malaysia, Papua New Guinea, Thailand and Timor-Leste.

African fruit bats of the genus Eidolon, family Pteropodidae, were found positive for antibodies against Nipah and Hendra viruses, indicating that these viruses might be present within the geographic distribution of Pteropodidae bats in Africa.

Nipah virus in domestic animals

Outbreaks of the Nipah virus in pigs and other domestic animals such as horses, goats, sheep, cats and dogs were first reported during the initial Malaysian outbreak in 1999.

The virus is highly contagious in pigs. Pigs are infectious during the incubation period, which lasts from 4 to 14 days.

An infected pig can exhibit no symptoms, but some develop acute feverish illness, labored breathing, and neurological symptoms such as trembling, twitching and muscle spasms. Generally, mortality is low except in young piglets. These symptoms are not dramatically different from other respiratory and neurological illnesses of pigs. Nipah virus should be suspected if pigs also have an unusual barking cough or if human cases of encephalitis are present.

For more information of Nipah in animals, see the Food and Agriculture Organization of the United Nations webpage on Nipah and the World Organization for Animal Health (OIE) webpage on Nipah.

Prevention

Controlling Nipah virus in pigs

Currently, there are no vaccines available against Nipah virus. Based on the experience gained during the outbreak of Nipah involving pig farms in 1999, routine and thorough cleaning and disinfection of pig farms with appropriate detergents may be effective in preventing infection.

If an outbreak is suspected, the animal premises should be quarantined immediately.  Culling of infected animals – with close supervision of burial or incineration of carcasses – may be necessary to reduce the risk of transmission to people. Restricting or banning the movement of animals from infected farms to other areas can reduce the spread of the disease.

As Nipah virus outbreaks have involved pigs and/or fruit bats, establishing an animal health/wildlife surveillance system, using a One Health approach, to detect Nipah cases is essential in providing early warning for veterinary and human public health authorities.

Reducing the risk of infection in people

In the absence of a vaccine, the only way to reduce or prevent infection in people is by raising awareness of the risk factors and educating people about the measures they can take to reduce exposure to  the Nipah virus.

Public health educational messages should focus on:

• Reducing the risk of bat-to-human transmission.
  Efforts to prevent transmission should first focus on decreasing bat access to date palm sap and other fresh food products. Keeping bats away from sap collection sites with protective coverings (such as bamboo sap skirts) may be helpful. Freshly collected date palm juice should be boiled, and fruits should be thoroughly washed and peeled before consumption. Fruits with sign of bat bites should be discarded.
• Reducing the risk of animal-to-human transmission.
  Gloves and other protective clothing should be worn while handling sick animals or their tissues, and during slaughtering and culling procedures. As much as possible, people should avoid being in contact with infected pigs. In endemic areas, when establishing new pig farms, considerations should be given to presence of fruit bats in the area and in general, pig feed and pig shed should be protected against bats when feasible.
• Reducing the risk of human-to-human transmission.
  Close unprotected physical contact with Nipah virus-infected people should be avoided. Regular hand washing should be carried out after caring for or visiting sick people.

Controlling infection in health-care settings

Health-care workers caring for patients with suspected or confirmed infection, or handling specimens from them, should implement standard infection control precautions at all times

As human-to-human transmission has been reported, in particular in health-care settings, contact and droplet precautions should be used in addition to standard precautions. Airborne precautions may be required in certain circumstances.

Samples taken from people and animals with suspected Nipah virus infection should be handled by trained staff working in suitably equipped laboratories.

WHO response

WHO is supporting affected and at risk countries with technical guidance on how to manage outbreaks of Nipah virus and on how to prevent their occurrence.

The risk of international transmission via fruits or fruit products (such as raw date palm juice) contaminated with urine or saliva from infected fruit bats can be prevented by washing them thoroughly and peeling them before consumption. Fruit with signs of bat bites should be discarded.