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美國加強針獲批,可能出現這些副作用

美國加強針獲批,可能出現這些副作用

Sy Mukherjee 2021年08月20日
美國的聯邦衛生官員在很大程度上仍然對新冠疫苗加強劑的副作用持觀望態度。

新冠疫苗加強劑已經在美國成為現實。根據拜登政府于8月18日宣布的一項新的新冠免疫計劃,從9月20日的一周開始,所有尚未接種過輝瑞(Pfizer)或Moderna基于mRNA的第二劑疫苗至少8個月的美國成年人,將可以獲得新冠疫苗增強劑,等待美國食品與藥品管理局(Food and Drug Administration)和美國疾病控制中心(Centers for Disease Control)的監管批準。至于注射了強生(Johnson & Johnson)疫苗的人,相關潛在加強劑的政策仍然在審查中,因為強生的疫苗依賴于另外一種技術,而非mRNA。此前,8月13日,美國食品與藥品管理局和美國疾病控制中心已經為一些完全接種疫苗的美國民眾批準了第一批新冠疫苗增強劑,盡管其針對的是一小部分免疫系統受損的美國民眾。

但在未來幾個月,隨著在技術上有資格獲得第三劑輝瑞或Moderna新冠疫苗的接種人數從老年人擴大到醫護人員,最終擴大到年輕、健康的普通個人,以及越來越多的民眾愿意插隊去接受第三針加強劑——了解新冠疫苗加強劑的副作用是否與我們在第一輪疫苗注射中看到的相同、不同或更嚴重,將變得十分重要。

現在,加強劑的授權甚至還沒有到一周,而且還尚未出現足夠的數據以表明完全接種疫苗的人在第三次注射后可能會有什么副作用。早期指標表明,他們的情況與許多人在最初幾輪疫苗接種后的情況基本一致,但醫學專家對最容易出現非常罕見且相當嚴重的副作用的人群表示擔憂。

不同的人經歷新冠疫苗副作用的形式不同,從疲勞、注射部位手臂疼痛、頭痛、頭暈、注射周圍紅腫到幾天后出現的延遲效應,例如身體各部位的肌肉疼痛(特別是在注射第二劑mRNA疫苗后)、頭暈、惡心、發冷和發燒等等。在難受了幾天之后,這些癥狀往往會消失。根據美國疾病控制中心的說法,這些可能也是加強劑會產生的情況,人們會經歷一些類似于流感的較溫和的副作用。

“關于接受額外劑量疫苗風險的信息有限,額外劑量新冠疫苗在免疫缺陷人群中的安全性、有效性和益處將繼續受評估。”該機構表示,“到目前為止,第三劑mRNA疫苗劑量后報告的反應與前兩次劑量相似:注射部位的疲勞和疼痛是最常見的副作用,且總體上屬于輕到中度。但是,與兩劑疫苗一樣,嚴重的副作用很少,但仍然可能會發生。”

嚴重或延遲的副作用尤其需要關注。據凱撒健康新聞(Kaiser Health News)報道,有證據表明,對于極少數對疫苗有危險反應的人來說(比如心肌炎或心臟腫脹),第二次注射后副作用更為常見。第三劑疫苗是否會擴大這一罕見的結果,或導致在加強劑注射前的免疫過程中就觀察到的血凝塊和過敏反應,目前仍不清楚。但是,美國西北大學范伯格醫學院(Northwestern University Feinberg School of Medicine)的流行病學家和心臟病學家薩迪婭?汗等醫生質疑,額外的劑量是否會使心肌炎的風險更為明顯,尤其是在年輕和健康的人群中,他們可能會產生嚴重的心臟副作用。此外,他們還懷疑加強劑的優點是否值得這些人冒潛在風險。

在接下來的幾周和幾個月里,還有許多關于加強劑副作用的重要考慮有待追蹤,包括接受強生疫苗的1300萬美國民眾。公共衛生官員和監管機構表示,現在就建議強生疫苗接種者接受加強劑還為時過早,因為目前信息還不夠多。而且這種特殊的疫苗從3月才開始供應,這意味著其距離美國政府8個月的疫苗補充窗口期還差幾個月。

“目前還沒有足夠的數據來確定接受強生公司的楊森(Janssen)新冠疫苗的免疫功能低下人群,在額外注射相同疫苗后是否也有更好地抗體反應。”美國疾病控制中心表示。但越來越多的專家一致認為,每個人最終都需要加強劑,包括強生疫苗的接種者。他們擔心強生疫苗與其他新冠疫苗相比之下的有效性,以及對抗新毒株(例如德爾塔變異毒株)的效力。除非強生疫苗獲得更可靠的指導和數據,包括加強劑應該是強生疫苗的第二劑還是輝瑞或Moderna的mRNA疫苗,在此之前,官方無法正式跟蹤這些美國民眾的加強劑副作用。

聯邦衛生官員在很大程度上仍然對新冠疫苗加強劑的副作用持觀望態度。他們表示,過去一周的行動表明,加強劑的潛在好處可能超過其風險。但是,如果你選擇接種加強劑,為了獲得額外的保護而不得不忍受幾天的昏昏沉沉和手臂疼痛,也請你不要感到驚訝。(財富中文網)

編譯:楊二一

新冠疫苗加強劑已經在美國成為現實。根據拜登政府于8月18日宣布的一項新的新冠免疫計劃,從9月20日的一周開始,所有尚未接種過輝瑞(Pfizer)或Moderna基于mRNA的第二劑疫苗至少8個月的美國成年人,將可以獲得新冠疫苗增強劑,等待美國食品與藥品管理局(Food and Drug Administration)和美國疾病控制中心(Centers for Disease Control)的監管批準。至于注射了強生(Johnson & Johnson)疫苗的人,相關潛在加強劑的政策仍然在審查中,因為強生的疫苗依賴于另外一種技術,而非mRNA。此前,8月13日,美國食品與藥品管理局和美國疾病控制中心已經為一些完全接種疫苗的美國民眾批準了第一批新冠疫苗增強劑,盡管其針對的是一小部分免疫系統受損的美國民眾。

但在未來幾個月,隨著在技術上有資格獲得第三劑輝瑞或Moderna新冠疫苗的接種人數從老年人擴大到醫護人員,最終擴大到年輕、健康的普通個人,以及越來越多的民眾愿意插隊去接受第三針加強劑——了解新冠疫苗加強劑的副作用是否與我們在第一輪疫苗注射中看到的相同、不同或更嚴重,將變得十分重要。

現在,加強劑的授權甚至還沒有到一周,而且還尚未出現足夠的數據以表明完全接種疫苗的人在第三次注射后可能會有什么副作用。早期指標表明,他們的情況與許多人在最初幾輪疫苗接種后的情況基本一致,但醫學專家對最容易出現非常罕見且相當嚴重的副作用的人群表示擔憂。

不同的人經歷新冠疫苗副作用的形式不同,從疲勞、注射部位手臂疼痛、頭痛、頭暈、注射周圍紅腫到幾天后出現的延遲效應,例如身體各部位的肌肉疼痛(特別是在注射第二劑mRNA疫苗后)、頭暈、惡心、發冷和發燒等等。在難受了幾天之后,這些癥狀往往會消失。根據美國疾病控制中心的說法,這些可能也是加強劑會產生的情況,人們會經歷一些類似于流感的較溫和的副作用。

“關于接受額外劑量疫苗風險的信息有限,額外劑量新冠疫苗在免疫缺陷人群中的安全性、有效性和益處將繼續受評估。”該機構表示,“到目前為止,第三劑mRNA疫苗劑量后報告的反應與前兩次劑量相似:注射部位的疲勞和疼痛是最常見的副作用,且總體上屬于輕到中度。但是,與兩劑疫苗一樣,嚴重的副作用很少,但仍然可能會發生。”

嚴重或延遲的副作用尤其需要關注。據凱撒健康新聞(Kaiser Health News)報道,有證據表明,對于極少數對疫苗有危險反應的人來說(比如心肌炎或心臟腫脹),第二次注射后副作用更為常見。第三劑疫苗是否會擴大這一罕見的結果,或導致在加強劑注射前的免疫過程中就觀察到的血凝塊和過敏反應,目前仍不清楚。但是,美國西北大學范伯格醫學院(Northwestern University Feinberg School of Medicine)的流行病學家和心臟病學家薩迪婭?汗等醫生質疑,額外的劑量是否會使心肌炎的風險更為明顯,尤其是在年輕和健康的人群中,他們可能會產生嚴重的心臟副作用。此外,他們還懷疑加強劑的優點是否值得這些人冒潛在風險。

在接下來的幾周和幾個月里,還有許多關于加強劑副作用的重要考慮有待追蹤,包括接受強生疫苗的1300萬美國民眾。公共衛生官員和監管機構表示,現在就建議強生疫苗接種者接受加強劑還為時過早,因為目前信息還不夠多。而且這種特殊的疫苗從3月才開始供應,這意味著其距離美國政府8個月的疫苗補充窗口期還差幾個月。

“目前還沒有足夠的數據來確定接受強生公司的楊森(Janssen)新冠疫苗的免疫功能低下人群,在額外注射相同疫苗后是否也有更好地抗體反應。”美國疾病控制中心表示。但越來越多的專家一致認為,每個人最終都需要加強劑,包括強生疫苗的接種者。他們擔心強生疫苗與其他新冠疫苗相比之下的有效性,以及對抗新毒株(例如德爾塔變異毒株)的效力。除非強生疫苗獲得更可靠的指導和數據,包括加強劑應該是強生疫苗的第二劑還是輝瑞或Moderna的mRNA疫苗,在此之前,官方無法正式跟蹤這些美國民眾的加強劑副作用。

聯邦衛生官員在很大程度上仍然對新冠疫苗加強劑的副作用持觀望態度。他們表示,過去一周的行動表明,加強劑的潛在好處可能超過其風險。但是,如果你選擇接種加強劑,為了獲得額外的保護而不得不忍受幾天的昏昏沉沉和手臂疼痛,也請你不要感到驚訝。(財富中文網)

編譯:楊二一

COVID vaccine boosters are now a reality in America. Under a new Biden administration coronavirus immunization plan announced Aug. 18, COVID-19 boosters would be made available to all fully vaccinated U.S. adults who are at least eight months out from getting their second dose of Pfizer's or Moderna's mRNA-based jabs beginning the week of Sept. 20, pending regulatory blessings from the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC). The policy regarding potential boosters for those who received one dose of Johnson & Johnson's shot, which relies on a different kind of technology, is still under review. The FDA and CDC already green-lit the first batch of COVID booster shots for some fully vaccinated Americans on Aug. 13, albeit for a tiny slice of the American populace who have compromised immune systems.

But as the number of vaccinated people technically eligible to get a third dose of Pfizer's or Moderna's two-dose COVID vaccines swells in the coming months from the elderly to health care workers and eventually to young, healthy individuals—or as more people become willing to jump the line and get themselves a booster early like more than 1 million Americans already have—it will be important to keep track of whether or not COVID boosters have the same, different, or more severe side effects than what we've seen with the initial round of shots.

Booster shots haven't even been authorized for a full week, and there's not much data yet on what side effects fully vaccinated people could experience with a third dose. The early indicators suggest they're largely in line with what many experienced after their initial rounds of vaccination, but medical experts have some concerns about those most at risk for very rare but serious side effects.

Different people experience COVID vaccine side effects differently, and they run the gamut from fatigue, arm pain at the injection site, headache, dizziness, and redness and swelling around the injection to delayed effects that present a few days later, like muscle pain in various body parts (particularly after the second dose of an mRNA vaccine), loopiness, nausea, chills, and fever. Those symptoms tend to go away within a day or two but can be unpleasant for those few days. That could be the case for booster doses, too, with people experiencing some milder side effects that resemble the flu, according to the CDC.

"There is limited information about the risks of receiving an additional dose of vaccine, and the safety, efficacy, and benefit of additional doses of COVID-19 vaccine in immunocompromised people continues to be evaluated," per the agency. "So far, reactions reported after the third mRNA dose were similar to that of the two-dose series: fatigue and pain at injection site were the most commonly reported side effects, and overall, most symptoms were mild to moderate. However, as with the two-dose series, serious side effects are rare, but may occur."

Serious or delayed side effects will be particularly important to keep an eye on. There is some evidence that for the very small number of people who experience dangerous reactions to the vaccines such as myocarditis, or heart swelling, the side effect was more common after a second dose, Kaiser Health News reports. Whether or not a third dose could amplify that rare outcome or cause blood clots and allergic reactions that have been observed in some during the pre-booster immunization process is still unknown. But physicians such as Northwestern University Feinberg School of Medicine epidemiologist and cardiologist Sadiya Khan question whether the myocarditis risk specifically could become more pronounced with additional doses, especially among younger and healthier people who could develop the serious cardiac side effect, and whether a booster's benefit is worth the potential risk for those individuals.

There are still many important considerations about booster side effects left to track in coming weeks and months, including for the 13 million Americans who received Johnson & Johnson's COVID vaccine. Public health officials and regulators say it's too early to advise J&J shot recipients on what to do about a booster because there isn't enough information yet. And that particular vaccine has been available only since March, which means it falls a few months short of the administration's eight month post-vaccination window for a booster.

"There is not enough data at this time to determine whether immunocompromised people who received the Johnson & Johnson’s Janssen COVID-19 vaccine also have an improved antibody response following an additional dose of the same vaccine," per the CDC. But there is growing expert consensus that everyone will eventually need a booster dose, including J&J recipients who have concerns about its effectiveness compared to other COVID vaccines and potency against new coronavirus strains like the Delta variant. It won't be possible to officially track booster side effects for these Americans until there's more solid guidance and data around the J&J vaccine, including whether a booster should be a second dose of the Johnson & Johnson product or one of Pfizer's or Moderna's mRNA jabs.

Federal health officials largely remain in wait-and-see mode on COVID booster side effects and have signaled the potential benefits of boosters likely outweigh their risks through the past week's actions. But if you are someone who qualifies for an additional shot, don't be surprised if you have to deal with a few days of grogginess and arm pain in exchange for the added protection.

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