FDA Approves COVID Vaccines for Kids Under 5 美FDA批准5歲以下幼童 可接種新冠疫苗

The Food and Drug Administration's vaccine advisers gave a thumbs-up to vaccines from Moderna and Pfizer for children under 5 years of age. The outside experts voted unanimously that the benefits of the shots outweigh any risks for children under 5. That's roughly 18 million youngsters. The Centers for Disease Control and Prevention will decide on a formal recommendation after its own advisers meet Saturday. If the CDC signs off, shots could be available as soon as next week.


Christina Vert, US FDA Designated Federal Officer: “And we have here 21 yes votes. This is a unanimous vote and there are zero no votes and zero abstain.”

An expert panel convened by the U.S. Food and Drug Administration voted unanimously on June 15 to authorize the use of the Moderna and Pfizer-BNT COVID-19 vaccines on children under the age of five. A representative from Pfizer said that a 3-microgram dosage offered 80 percent protection for children aged six months to five years. Fever and fatigue were the most common side effects. Meanwhile, the Moderna vaccine is one-fourth the dosage of the adult vaccine.

Dr. Jacqueline Miller, Moderna Executive: “As children under four have had the greatest increase in their risk of hospitalization due to COVID-19 during the Omicron surge, initiating this vaccination series now is vital to start protecting children this summer.”

The U.S. has around 18 million children under the age of five. The U.S.' Centers for Disease Control and Prevention will make the final decision. The vaccination of this age group at pharmacies or medical institutions may begin as early as June 21. However, experts warn that two doses of the Moderna vaccine only provide about 40 percent protection, so both vaccine producers are studying the effectiveness of a third dose.

Dr. Doran Fink, US FDA Expert Panel Member: “We do feel very confident that the evidentiary standard for benefit for EUA has been met here. But I think, you know, in terms of what the efficacy is after a third dose and whether an additional dose beyond that would be needed is going to require a little bit more data.”

On June 15, Chief Medical Advisor to the President of the United States Anthony Fauci tested positive for COVID-19. A statement issued by the National Institutes of Health said the 81-year-old Fauci, who is fully vaccinated and has been boosted twice, tested positive in a rapid test and has mild symptoms. He has not been in contact with U.S. President Joe Biden or other senior officials recently.

 

 


美國FDA官員沃特:「有21票贊成,這是一致的投票,沒有人棄權或反對。」

美國FDA專家小組成員,15號投票一致贊成,批准5歲以下兒童,接種輝瑞和莫德納疫苗;輝瑞專家代表指出,在6個月到5歲的兒童,施打3微克劑量疫苗,能達到80%的防護力,發燒和疲勞是常見副作用,莫德納則施打成人的1/4劑量。

莫德納疫苗專家代表伯恩斯坦博士:「在Omicron病例激增期間,4歲以下兒童因為新冠病毒,住院的風險增加最多,因此現在啟動疫苗注射,對今夏保護兒童至關重要。」

目前美國約有1800萬名5歲以下兒童符合資格,FDA專家小組建議接種疫苗後,接下來將交由美國CDC做最後決定;預計最快下週、6月21號就能在藥房或醫療院所,施打幼兒疫苗。不過專家也指出,兩劑莫德納疫苗的保護力僅約四成左右,因此兩家疫苗廠都在研究,第三劑疫苗的效果。

FDA顧問委員會成員芬克博士:「我們確實極具信心,這已經達到EUA獲益的實證標準,但我認為,就第三劑施打後產生的效果,以及是否有需要,將需要更多的數據來支持。」

不過白宮首席防疫顧問佛奇,15號傳出確診的消息;美國國家衛生研究院發表聲明指出,現年81歲的佛奇,因為快篩陽才得知自己確診新冠病毒。他已經打過兩劑新冠疫苗追加劑,目前症狀輕微,最近也沒有接觸總統拜登和其他高級官員。

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