건강과 대안 » 백신 부작용

[돼지독감] 돼지독감 백신, 드물게 신경장애(길렝-바레 증후군 ) 유발

건강과대안 — Wed, 18 Jul 2012 10:15:20 +0000

미국의사협회지 (JAMA) 2012년 7월 11일자에 신증플루(H1N1) 예방접종 후 말초신경 장애를 초래하는 희귀질환인 길렝-바레 증후군이 발생할 수 있다는 보고가 실렸습니다.

캐나다 퀘백주에서 신종플루 백신을 접종받은 440만 명 중에서 25명에서 길렝-바레 증후군이 발생했으며… 100만 명 당 2명 꼴로 이 증상이 나타나는 것으로 추정됩니다.

그렇지만 연구진은 백신접종을 받지 않은 58명에게서도 길렝-바레 증후군이 나타났으며…
백신접종을 받지 않았을 경우의 위험이 길렝-바레 증후군이 발생할 위험보다 크기 때문에
백신접종을 받는 것을 권장하고 있습니다.

H1N1 vaccine may be linked to rare nerve disorder

By Christopher Wanjek

Published July 10, 2012 LiveScience
http://www.foxnews.com/health/2012/07/10/h1n1-vaccine-may-be-linked-to-rare-nerve-disorder/

The H1N1 (swine) flu vaccine was associated with a small but significant risk for developing a rare nervous disorder called Guillain–Barré syndrome (GBS), say doctors in a report detailed in the July 11 issue of the Journal of the American Medical Association (JAMA).

The study, conducted in Quebec rekindles the still-controversial connection between Guillain–Barré syndrome (GBS) and the 1976 swine flu outbreak, which halted that year’s flu vaccination program in the United States. It also raises questions about vaccines for flu strains originating in swine.

This latest analysis, led by Philippe De Wals of Laval University, Quebec City, Canada, followed 4.4 million residents vaccinated against the H1N1 “swine flu” in late 2009. Over the next six months, 25 people who received the vaccine developed GBS. Across the Quebec province, however, another 58 people who were not vaccinated also developed GBS.

De Wals said that, regarding the entire population, the number of GBS cases attributed to the swine flu vaccine was about 2 per 1 million doses, but that the benefits of immunization outweigh the risks.

Vaccine risks and benefits

Health experts have long been nervous to speak about risks associated with vaccines. This is because the vaccine benefits are great and the risks are small, with adverse reactions usually occurring in vulnerable populations, such as those with certain allergies or pre-existing nervous system disorders. [5 Dangerous Vaccination Myths]

Flu vaccines, in particular, save millions of lives. Influenza will kill on average about a half-million people worldwide annually, including up to 40,000 in the United States, according to the U.S. Centers for Disease Control and Prevention (CDC). Flu pandemics will kill millions.

Sometimes vaccine risks are real and high because of a bad batch of drugs. A prime example is the Cutter Incident in 1955, in which the polio vaccine accidentally contained a live virus that infected 40,000 children, leading to 55 cases of paralysis and five deaths. This nearly destroyed the public’s confidence in vaccines at the dawn of polio eradication.

Sometimes, however, reports of vaccine risks turn out to be false and based on fabricated science, such as the link between the measles, mumps and rubella (MMR) vaccine and autism. Measles and also whooping cough have had resurgences as a result of low vaccination rates brought on by this scare.

Thus, many health experts do not readily concede to vaccine risks when confronted with them. And Guillain–Barré syndrome haunts many like a specter.

Tale of two swine

Guillain–Barré syndrome is a serious peripheral nerve disease that can cause partial paralysis, breathing difficulties and death. Most patients recover after several months to a year, although not always fully. GBS is associated with Campylobacter jejuni,the food-borne bacterium, and several viruses; but for most cases, the immediate cause is not known, according to the CDC. [Top 10 Mysterious Diseases]

During the 1976 swine flu outbreak in the United States, health authorities reported an unusually high number of GBS cases, nearly 1,100 — half of which occurred after immunization against the flu. Panic ensued, and the vaccine program ended by December that year.

Doctors debated the connection then, and it took nearly 30 years before the prestigious U.S.-based Institute of Medicine concluded in 2003 that there was a causal relationship and that one extra person out of a million contracted GBS as a result of the vaccination.

The results of the new Quebec study on the 2009 H1N1 flu strain of swine origin are eerily similar to the conclusions drawn from the dozens of studies on the 1976 swine flu outbreak. Is there something about vaccines for flu strains of swine origin that can trigger GBS?

A much larger study published in February 2011 in the New England Journal of Medicine examined nearly 90 million doses of H1N1 vaccine in China and concluded that the answer was no. Doctors there found only 11 cases of Guillain–Barré syndrome, which actually is far lower than the natural rate.

So, one debate will continue: whether there is a small but real link between swine flu vaccines and GBS. But few if any reputable doctors will argue that the flu vaccine is dangerous or not worthwhile for most people, from infants to the elderly. In fact, a study published in the same issue of JAMA finds the H1N1 vaccine is safe for pregnant women.

Read more: http://www.foxnews.com/health/2012/07/10/h1n1-vaccine-may-be-linked-to-rare-nerve-disorder/#ixzz20vfrSEOn

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[국내사례] 신종 인플루엔자(H1N1) 예방 접종 후 발생한 길렝 바레 증후군 1례
Journal of The Korean Child Neurology Society 2010 ; 18(1) : 108-111

[구제역] 경기도 구제역 백신 부작용 의심신고 118건

건강과대안 — Sat, 29 Jan 2011 16:42:14 +0000

경기도 구제역 백신 부작용 의심신고 118건

출처 : 연합뉴스 2011/01/28 09:47
http://www.yonhapnews.co.kr/economy/2011/01/28/0302000000AKR20110128062200061.HTML?template=4685

(수원=연합뉴스) 김광호 기자 = 지난달 25일 구제역 백신 접종 이후 27일까지 경기도내에서 모두 118건의 부작용 의심 사례가 신고됐다.

   28일 도에 따르면 부작용 의심 사례는 백신 접종 후 소와 돼지의 유산 또는 사산, 새끼돼지 및 송아지의 폐사 등이다.

   도 재난안전대책본부는 의심 사례의 상당수는 송아지에서 나타나고 있다고 설명한 뒤 현재 일선 시.군에서 의심 신고 사례가 백신 부작용인지 여부를 정밀 조사하고 있다고 밝혔다.

   신고된 사례를 보면 지난 22일 남양주시 수동면 한 농가에서 어미소가 새끼를 유산했고, 하루 앞선 21일에는 화성시 비봉면 농가에서 송아지 1마리가 백신 접종후 폐사했다.

   또 지난 12일에는 안산시 부곡동 한 농가에서 임신 3개월의 소가 유산하기도 했다.

   도내에서는 지금까지 소 47만5천여마리, 돼지 106만4천여마리가 구제역 백신을 접종받은 가운데 이날부터 2차 접종에 들어갔다.

   도 대책본부 관계자는 “구제역 백신은 젤 형태로 돼 있어 체내에 주입 후 통증으로 스트레스를 받을 수 있다”며 “백신 부작용으로 확인되면 해당 농가는 적절한 보상을 받게 된다”고 밝혔다.

   kwang@yna.co.kr

[돼지독감] WHO, 백신 접종후 사망 30건 검사 결과 “안전”

건강과대안 — Fri, 20 Nov 2009 10:20:08 +0000

Safety of pandemic vaccines

Pandemic (H1N1) 2009 briefing note 16

출처 : http://www.who.int/csr/disease/swineflu/notes/briefing_20091119/en/index.html

19 NOVEMBER 2009 | GENEVA — To date, WHO has received vaccination information from 16 of around 40 countries conducting national H1N1 pandemic vaccine campaigns. Based on information in these 16 countries, WHO estimates that around 80 million doses of pandemic vaccine have been distributed and around 65 million people have been vaccinated. National immunization campaigns began in Australia and the People’s Republic of China in late September.

Vaccination campaigns currently under way to protect populations from pandemic influenza are among the largest in the history of several countries, and numbers are growing daily. Given this scale of vaccine administration, at least some rare adverse reactions, not detectable during even large clinical trials, could occur, underscoring the need for rigorous monitoring of safety. Results to date are encouraging.

Common side effects

As anticipated, side effects commonly reported include swelling, redness, or pain at the injection site, which usually resolves spontaneously a short time after vaccination.

Fever, headache, fatigue, and muscle aches, occurring shortly after vaccine administration, have also been reported, though with less frequency. These symptoms also resolve spontaneously, usually within 48 hours. In addition, a variety of allergic reactions has been observed. The frequency of these reactions is well within the expected range.

Guillain-Barre syndrome

To date, fewer than ten suspected cases of Guillain-Barre syndrome have been reported in people who have received vaccine. These numbers are in line with normal background rates of this illness, as reported in a recent study. Nonetheless, all such cases are being investigated to determine whether these are randomly occurring events or if they might be associated with vaccination.

WHO has received no reports of fatal outcomes among suspected or confirmed cases of Guillain-Barre syndrome detected since vaccination campaigns began. All cases have recovered. WHO recommends continued active monitoring for Guillain-Barre syndrome.

Investigations of deaths

A small number of deaths have occurred in people who have been vaccinated. All such deaths, reported to WHO, have been promptly investigated. Although some investigations are ongoing, results of completed investigations reported to WHO have ruled out a direct link to pandemic vaccine as the cause of death.

In China, for example, where more than 11 million doses of pandemic vaccine have been administered, health authorities have informed WHO of 15 cases of severe side effects and two deaths that occurred following vaccination. Thorough investigation of these deaths, including a review of autopsy results, determined that underlying medical conditions were the cause of death, and not the vaccine.

Safety profile of different vaccines

Campaigns are using nonadjuvanted inactivated vaccines, adjuvanted inactivated vaccines, and live attenuated vaccines. No differences in the safety profile of severe adverse events among different vaccines have been detected to date.

Although intense monitoring of vaccine safety continues, all data compiled to date indicate that pandemic vaccines match the excellent safety profile of seasonal influenza vaccines, which have been used for more than 60 years.

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WHO “신종플루 백신에 의한 사망 아직 없었다”

백신 접종후 사망 30건 검사 결과 “안전”

출처 : 연합뉴스 2009/11/19 23:34 송고

(제네바=연합뉴스) 맹찬형 특파원 = 세계보건기구(WHO)는 19일 인플루엔자 A［H1N1］(신종플루) 백신을 접종받은 후 사망한 30명에 대해 검사를 실시했으나, 현재까지 백신과 사망 원인 사이에 직접적인 연관성은 드러나지 않았다고 밝혔다.

   WHO 백신연구 책임자인 마리-폴 키니 박사는 이날 “일부 조사가 아직 진행 중이긴 하지만, 현재까지 조사가 완료돼 WHO에 보고된 결과들에 따르면 신종플루 백신이 사망 원인이 된 경우는 없었다”고 밝혔다고 AFP통신이 보도했다.

   키니 박사에 따르면 백신 접종 후 사망 사례는 16개 나라에서 접종이 이뤄진 6천500만 회분의 백신 중에서 극히 일부로, 1만 회분에 1건 꼴로 역효과가 나타나고, 보고된 역효과 100건 가운데 사망 등으로 상황이 악화되는 경우는 5건 정도다.

   키니 박사는 “지금까지 보고로 보면 신종플루 백신은 계절성 인플루엔자 백신 만큼이나 안전하다”고 말했다.

   mangels@yna.co.kr

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WHO plays down ‘swine flu vaccination deaths’

Thu Nov 19, 8:59 am ET

GENEVA (AFP) – The World Health Organisation said on Thursday that checks on many of the 30 deaths recorded following mass pandemic flu vaccinations had so far ruled out a direct link to the vaccines.

“Although some investigations are still ongoing, results of completed investigations reported to WHO have ruled out that the pandemic vaccine is a cause of death,” said Marie-Paule Kieny, the WHO’s director for vaccine research, she added.

The fatalities made up a minute fraction of at least 65 million doses of swine flu vaccines which have been administered, said the WHO, citing data from 16 countries.

For every 10,000 doses of vaccines administered, only one report of adverse effect had been logged.

Of every 100 reports of adverse effects, five are serious cases such as death, added Kieny.

“The reports so far confirmed that the pandemic vaccine is as safe as the seasonal flu vaccine,” she said.

Vaccination programmes have been rolled out across some 40 countries, and the WHO is planning to start delivering vaccines at the end of November to poorer countries.

Kieny acknowledged that there was a “few days’ delay” in delivery of these vaccines to some 95 countries, but added that they should get the drugs over the next three months.

The A(H1N1) pandemic has claimed over 6,250 lives since the virus was first uncovered in April.

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[돼지독감] WHO reports mild adverse effects in China swine flu jabs

건강과대안 — Wed, 07 Oct 2009 13:42:21 +0000

WHO reports mild adverse effects in China swine flu jabs

출처 : AFP통신 Tue Oct 6, 12:08 pm ET

GENEVA (AFP) – The World Health Organisation said Tuesday that four people in China had reportedly suffered mild “adverse” effects after being vaccinated against swine flu.

WHO spokesman Gregory Hartl told journalists that such occurrences among a sample of 39,000 people vaccinated were expected and must not put people off being immunised against A(H1N1) swine flu.

“In the case of China we are seeing reports — we do not have first hand confirmation yet — that out of 39,000 people vaccinated apparently four people have had adverse events,” he said.

“Those adverse events have all been mild, if I’m not mistaken things like muscle cramps and headaches,” he added.

“Adverse events are fully to be expected, especially these mild types,” he underlined ahead of forthcoming mass swine flu vaccination campaigns in the United States and in Europe.

The vaccines approved so far had been used in seasonal formulation for years and have been among the safest vaccines known to exist, Hartl explained.

“The most important tool we have to fight this pandemic is the vaccine,” he added, insisting on its importance for health workers.

China began mass vaccinations against swine flu on September 21 in Beijing, making it one of the first nations to start inoculating its population against the virus.

The most populous nation in the world has been at the forefront of international efforts to produce an A(H1N1) influenza vaccine, with at least five companies receiving government approval for the work.