[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.