美国CDC咨询小组支持为65岁及以上者接种追加剂

美国CDC咨询小组支持为65岁及以上者接种追加剂

文 / 张佳莹

9/23/2021

CDC的一个咨询小组建议，为65岁及以上的美国人和一些有潜在疾病风险的成年人接种辉瑞冠病疫苗追加剂。（法新社）

（早报讯）美国疾病控制和预防中心（CDC）的一个咨询小组周四（23日）建议，为65岁及以上的美国人和一些有潜在疾病风险的成年人接种辉瑞-BioNTech冠病疫苗追加剂。

但该小组拒绝建议为在感染冠病的高风险机构中生活或工作的年轻成年人（包括医护人员）接种追加剂，这可能会缩小美国食品和药物管理局（FDA）在周三发布的紧急使用授权的范围。

疾病预防控制中心免疫实践咨询委员会投票通过的指导方针仍需由该机构负责人瓦伦斯基（Rochelle Walensky）签字批准。这些建议不具有约束力，各州和其他辖区可以无视这些建议，使用其他方法来接种追加剂。

除了美国老年人之外，委员会还建议为所有50岁以上有潜在疾病的成年人，以及一些18至49岁有这些疾病的人，根据他们的个人风险状况接种追加剂。这些疾病包括癌症、糖尿病、某些心脏疾病、慢性肾脏疾病和肺部疾病。这些建议只包括至少在六个月前接种第二剂辉瑞疫苗者。疾病预防控制中心说，这个群体目前大约有2600万人，包括1300万65岁或以上的人。

该小组暂时拒绝为包括医护人员、教师以及无家可归者收容所和监狱的居民等群体提供追加剂，部分原因是实施这样一个提案的难度。

在明尼苏达州卫生部工作的小组成员巴塔对该措施投了反对票，该措施将广泛增加供应。她说，数据还不支持在该群体中接种追加剂。该委员会表示，它可以在以后重新审视该指导意见。

Source

FDA poised to authorize booster shot of Pfizer Covid-19 vaccine

The move is expected to align with the recommendation the agency’s independent vaccine advisers made last week.

By LAUREN GARDNER and ADAM CANCRYN

9/22/2021

A Covid-19 vaccine. | Emily Elconin/Getty Images

The Food and Drug Administration will authorize a booster dose of Pfizer and BioNTech’s Covid-19 vaccine for people 65 and older as soon as Wednesday night, three people familiar with the decision told POLITICO.

The move is expected to align with the recommendation the agency’s independent vaccine advisers made last week, although some details of the agency’s ultimate decision — and the timing — remain unclear. The FDA announcement could slip until Thursday, the sources said.

The FDA vaccine advisory committee on Friday endorsed offering boosters people at high risk of severe disease as well as those 65 and older. In a separate, unofficial vote, the group also backed the notion of offering boosters to people with high on-the-job exposure to Covid-19, such as health workers.

The agency is expected to issue its decision before the Centers for Disease Control and Prevention’s own outside advisers convene a meeting at noon Thursday to further refine how the Pfizer-BioNTech booster should be administered, culminating in a vote to endorse the shot’s use.

The FDA declined to comment. The White House didn’t immediately respond to a request for comment.

The Biden administration had hoped to begin a broader booster rollout this week, after top federal health officials endorsed the idea of offering third does of the Pfizer-BioNTech and Moderna Covid-19 vaccines to most adults on that timetable. But in the weeks after that announcement, scientists in and out of the federal government pushed back against the idea, arguing there was not convincing evidence for the plan.

Two of FDA’s top vaccine regulators decided to retire from the agency, at least in part over disagreements related to the administration’s booster timeline.

FDA’s vaccine advisory panel threw a wrench in the administration’s original booster plans on Friday when its members rejected the notion of fully approving the Pfizer-BioNTech booster for people 16 and older, citing concerns about the quality of existing data on safety and effectiveness. The panel instead endorsed narrower use of the shot.

Source

美FDA专家不推荐全民打第三剂支持65岁以上及重病者施打

文 / 麦可欣

9/17/2021

（早报讯）美国食品和药物管理局（FDA）疫苗咨询委员会周五针对加强剂进行表决，多数专家反对对大众推出加强剂，但支持65岁以上长者和患有严重疾病的高风险群可施打，这对力推加强剂的拜登政府而言是一大打击。

FDA顾问组的意见没有强制力，但FDA通常会遵照其决定。

FDA召集的外部专家顾问周五以16票反对、两票赞成，不推荐为16岁以上大众施打第三剂辉瑞疫苗作为加强剂。多数专家对于辉瑞药厂没有提供充分的加强剂安全数据表失望，也有专家质疑全民打加强剂的必要性。不过专家小组一致同意，可对65岁以上长者和有严重疾病的民众推出加强剂。

美国官员和专家近期都在争论加强剂的必要性，拜登政府早在8月宣布，若FDA与美国疾病控制与预防中心（CDC）都批准，最快会在9月20日这周开始推出加强剂。这两个机构随后表示，辉瑞必须提供充分数据，才可能获得批准。

Source

拜登将接种第三剂冠病疫苗

文 / 林煇智

8/19/2021

美国总统拜登说，他和第一夫人吉尔-拜登将接种第三剂冠病疫苗，以提高他们对冠病的免疫力。（路透社）

（早报讯）美国总统拜登和夫人将接种第三剂冠病疫苗。

路透社报道，美国总统拜登说，他和第一夫人吉尔-拜登将接种第三剂冠病疫苗，以提高他们对冠病的免疫力。

拜登在周三（18日）录制并于隔天播放的采访中说：“我们将接种追加剂注射。”

Source

Biden says he and his wife will get COVID booster vaccine- interview

Reuters

8/19/2021

U.S. President Joe Biden and first lady Jill Biden walk from Marine One as they return from Camp David, on the South Lawn at the White House in Washington, U.S., July 18, 2021. REUTERS/Elizabeth Frantz

WASHINGTON, Aug 19 (Reuters) – U.S. President Joe Biden said he and first lady Jill Biden would receive a third dose of the COVID-19 vaccine to boost their immunity, as his administration announced booster shots would be offered to Americans in September.

“We will get the booster shots,” Biden told ABC News in an television interview that aired on Thursday.

His comments were taped on Wednesday as health officials unveiled their plan to make third doses of the approved two-dose COVID-19 vaccines available for U.S. adults starting Sept. 20.

The booster program is being launched even as millions of Americans have yet to adopt initial vaccination and as many around the world are waiting for vaccine supplies.

Biden, 78, noted that he and his wife received their first doses of the Pfizer Inc/BionNSech SE (PFE.N), (22UAy.DE) vaccine back in December, when vaccines were just being rolled out in the United States.

“It’s past time,” he told ABC.

Source

Nearly 100 Positive COVID-19 Tests Linked to Illinois Summer Camp

6/29/2021

QUINCY, Ill. (WGEM/CNN) – Nearly 100 teenagers and staff tested positive for COVID-19 after attending a church camp in rural Illinois.

‘The Crossing Camp’ was held in mid-June in Rushville. While majority of the campers and staff were eligible for the vaccine, Illinois Department of Health officials said few had been inoculated.

The health department said the camp did not require masks indoor. At least one young adult was hospitalized as a result of the outbreak.

Source>>

The Delta variant appears to have tripled to 31% of all US coronavirus cases in just 11 days. It’s more dangerous than other variants and could imperil the country’s recovery.

By Marianne Guenot

6/21/2021

covid vaccine — A medical assistant administering a COVID-19 vaccine dose in Los Angeles. Mario Tama/Getty Image

As of Wednesday, the Delta coronavirus variant may have been responsible for 31% of all coronavirus cases in the US, according to an estimate by the Financial Times.

Previous data from the Centers for Disease Control and Prevention put that share of cases at about 10% as of June 5 and 2.7% on May 22.

The Financial Times estimate, based on available sequencing data, would mean the share of Delta-variant infections in the US tripled in just 11 days.

The CDC has not yet released data on the rate of Delta-variant cases after June 5 in the US.

Dr. Rochelle Walensky, the director of the CDC, warned last week that the Delta variant could soon become dominant in the US.

And on Sunday, the former Food and Drug Administration chief Scott Gottlieb warned that the Delta variant could lead to a surge of cases in the fall even if 75% of eligible Americans were vaccinated by then.

The variant, which was first identified in India and is also called B.1.617.2, appears to be 60% more transmissible than the variant that is now still dominant in the US, the Alpha variant.

Data from the UK, where the Delta variant is thought to make up about 90% of current coronavirus cases, also suggests that the risk of hospitalization is higher for unvaccinated people with this variant.

The Delta variant also appears to more likely to evade the protection given by partial vaccinations.

Research suggests a single shot of the Pfizer-BioNTech or Oxford University-AstraZeneca coronavirus vaccines may give just 33% protection against symptomatic COVID-19 cases with the Delta variant, compared with at least 88% for other variants.

Two doses of the Pfizer-BioNTech or Oxford-AstraZeneca shot have been found to be protective against hospitalization from the variant, however.

It is not clear what protection other vaccines give against this variant.

On Friday, President Joe Biden warned that the Delta variant was “particularly dangerous for young people,” who are less likely to be vaccinated than older adults and are more socially active.

He also urged all Americans to get second doses of vaccines that require them.

As of Monday, 45% of Americans were fully vaccinated and 53% had received one dose, according to data from the CDC. The pace of vaccination, however, has fallen in the past two months.

Source: https://www.businessinsider.com/delta-coronavirus-variant-growing-in-us-could-imperil-recovery-2021-6