billwanhua
本站元老
- 注册
- 2005-07-07
- 消息
- 16,725
- 荣誉分数
- 5,490
- 声望点数
- 373
智利研究显示接种两剂科兴疫苗后预防有症状感染的有效率为56%，分别接种科兴、辉瑞、阿斯利康作为第三针加强剂后，有效率分别提升至80.2%、90%和93%。研究还显示，接种两剂科兴疫苗后预防住院的有效率为84%，分别接种科兴、辉瑞、阿斯利康作为第三针加强剂后，有效率分别提升至88%、87%和96.3%。
Az 好像第三针不错
Az 好像第三针不错
当初的一念之仁，一次脑子清楚的判断，如今回报了。
- 主题发起人 贵圈
- 开始时间
- 注册
- 2003-04-13
- 消息
- 241,022
- 荣誉分数
- 37,876
- 声望点数
- 1,393
我那是在说已经打过疫苗的成年人。
贵圈
政府都对党
- 注册
- 2014-10-21
- 消息
- 32,811
- 荣誉分数
- 6,153
- 声望点数
- 373
然！
- 注册
- 2005-11-23
- 消息
- 30,291
- 荣誉分数
- 7,455
- 声望点数
- 373
1 hr 56 min ago
FDA vaccine advisers are meeting now to consider Moderna Covid-19 boosters
From CNN’s Jamie Gumbrecht
Vaccine advisers to the US Food and Drug Administration are meeting this morning to discuss whether to authorize boosters of Moderna’s coronavirus vaccine for some adults.
It’s the first portion of a two-day Vaccines and Related Biological Products Advisory Committee meeting that will also include a vote on boosters for the Johnson & Johnson vaccine and a presentation on mix-and-match vaccines.
Thursday’s agenda focuses on Moderna boosters, and includes a presentation by Moderna, and another by the FDA, which will provide its assessment of Moderna’s booster data.
Moderna is requesting authorization for a 50-microgram booster dose – half the size of the 100-microgram doses used in the primary series of the two-dose vaccine – at least six months after the second dose, and only for certain groups: people age 65 and older; people ages 18 to 64 who are at high risk of severe Covid-19; and people ages 18 to 64 whose exposure to the coronavirus in their settings or jobs put them at risk for Covid-19 complications or severe illness
Moderna’s request mirrors the groups authorized to receive a booster dose of Pfizer’s mRNA vaccine. Third doses of the Moderna and Pfizer Covid-19 vaccines are already authorized for some immunocompromised people.
On Thursday, the committee will hear from Dr. Peter Marks, the director of FDA’s Center for Biologics Evaluation and Research who recently took over as acting director of the agency’s Office of Vaccines Research and Review as two of its senior leaders prepared to depart the agency.
Israeli researchers will also brief VRBPAC on booster data from there; most people in Israel received the Pfizer Covid-19, and boosters for vaccinated people began weeks before the United States authorized Pfizer boosters. The presenters, Dr. Sharon Alroy-Preiss, director of public health services at Israel's Ministry of Health and Ron Milo, a professor at Israel's Weizmann Institute, spoke in support of Pfizer's booster application last month.
The meeting, which will be streamed online, is scheduled to last until 4:45 p.m. ET. A two-hour period for discussion and voting is scheduled to begin at
2:45 p.m. ET.
More on the process: The FDA’s committee of independent advisers typically discusses and makes recommendations to the agency around vaccine authorizations and approvals, and the agency then makes the final decision about whether to OK a vaccine. If the FDA gives emergency use authorization to Moderna boosters, vaccine advisers to the US Centers for Disease Control and Prevention will meet to discuss which groups to recommend them to. Typically, shots can be administered once the CDC director signs off on the recommendation.
The CDC’s Advisory Committee on Immunization Practices is already scheduled to meet to discuss boosters from 10 a.m. to 5 p.m. ET Oct. 20 to 21.
3 hr 20 min ago
Moderna has asked the FDA to authorize a half-size booster dose for some people. Here's why.
From CNN’s Jamie GumbrechtIn documents released ahead of a key meeting of the US Food and Drug Administration’s vaccine advisers, Moderna urged the agency to authorize a 50-microgram booster dose of its Covid-19 vaccine.
That dose is half the size of the 100-microgram doses used in the primary series of the two-dose vaccine. The company says this booster dose increases protection against the coronavirus while helping to keep the worldwide Covid-19 vaccine supply higher.
The documents were released ahead of the meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee this week that will consider booster doses of the Moderna and Johnson & Johnson Covid-19 vaccines. The FDA previously authorized boosters of Pfizer’s Covid-19 vaccine for some adults.
Moderna is requesting authorization for a 50-microgram booster dose at least six months after the second dose for certain groups: people age 65 and older; people ages 18 to 64 who are at high risk of severe Covid-19; and people ages 18 to 64 whose exposure to the coronavirus in their settings or jobs put them at risk for Covid-19 complications or severe illness.
Antibodies have been shown to wane several months after people complete their Moderna or Pfizer vaccine series, but protection against severe disease and death remain strong after two doses. However, Moderna says, trial data and real-world evidence “support interventions to restore or enhance” antibodies that have waned over time.
“Clinical trial data breakthrough infections as well as real world evidence of reduced effectiveness against the Delta variant indicate that a booster dose of mRNA-1273 for those vaccinated more than 6 months previously could be beneficial to restore antibody titers to higher than post-dose 2 levels and reduce the number of breakthrough cases particularly against (variants of concern),” Moderna said in its briefing document.
Efficacy against symptomatic Covid-19 wasn’t evaluated among booster dose recipients, the FDA analysis notes.
Moderna’s authorization request includes results from a study of 171 people who received the authorized 100-microgram doses of Moderna’s vaccine and a 50-microgram booster dose at least six months later – a smaller group than the more than 300 who were studied ahead of Pfizer’s booster authorization request. It also included safety data from additional Moderna trial participants.
There was a higher rate of swollen lymph nodes after the booster dose when compared with the second dose in the primary series, but safety data didn’t otherwise show increased frequency or severity of reactions after a booster dose, the FDA’s analysis said. It notes that trials conducted before authorization might not be large enough to fully understand uncommon, potentially serious adverse reactions.
“It is currently not known if there will be an increased risk of myocarditis/pericarditis or other adverse reactions after a booster dose of the Moderna COVID-19 Vaccine,” the FDA’s analysis says. “These risks and associated uncertainties have to be considered when assessing benefit and risk.” The two-dose mRNA Covid-19 vaccines made by Moderna and Pfizer have been linked to rare cases of heart inflammation, particularly among younger men. Studies have found the cases are generally mild.
ottawa_tj
不知名会员
- 注册
- 2015-02-22
- 消息
- 14,647
- 荣誉分数
- 4,626
- 声望点数
- 373
U.S. FDA staff says Moderna did not meet all criteria for COVID-19 boosters
Scientists at the U.S. Food and Drug Administration said on Tuesday that Moderna Inc had not met all of the agency's criteria to support use of booster doses of its COVID-19 vaccine, possibly because the efficacy of the shot's first two doses has remained strong.www.reuters.com
英文差可怕啊！
- 注册
- 2005-11-23
- 消息
- 30,291
- 荣誉分数
- 7,455
- 声望点数
- 373
2 hr 18 min ago
The Food and Drug Administration and the Centers for Disease Control and Prevention are reviewing data on Moderna and Johnson & Johnson boosters this week, and a final decision is expected in the next couple of weeks, President Biden said.
"If they authorize the boosters, which will be strictly made based on the science, this will mean all three vaccines will be available for boosters," he told Americans.
"Already more than one out of three eligible seniors have gotten their third shot — the booster. And we're going to continue to provide that additional protection to seniors and others as we head into the holidays. These boosters are free, available and convenient to get," he added.
Biden: Final decision on Johnson & Johnson and Moderna boosters is expected in the next couple of weeks
From CNN's Aditi SangalThe Food and Drug Administration and the Centers for Disease Control and Prevention are reviewing data on Moderna and Johnson & Johnson boosters this week, and a final decision is expected in the next couple of weeks, President Biden said.
"If they authorize the boosters, which will be strictly made based on the science, this will mean all three vaccines will be available for boosters," he told Americans.
"Already more than one out of three eligible seniors have gotten their third shot — the booster. And we're going to continue to provide that additional protection to seniors and others as we head into the holidays. These boosters are free, available and convenient to get," he added.
