新冠疫苗仍是大家最关心的问题，那么你了解儿童疫苗吗?一起看看美国食品药品监督管理局的介绍。
辉瑞公司正在向儿童疫苗和助推器批准迈进
美国食品药品监督管理局和美国疾病控制与预防中心预计将在辉瑞公司宣布其12岁以下儿童疫苗研究显示有希望的结果的同一周内最终决定辉瑞加强剂量
道格·多诺万/发表于2天前
本周将是一个重要的一周，因为辉瑞公司的新冠疫苗有两项备受期待的进展:加强注射，以及为5岁儿童首次注射疫苗的进展。
美国食品和药物管理局将决定是否接受其咨询委员会的决定，授权辉瑞公司为65岁及以上的老年人和其他已经注射了前两剂疫苗的高危人群注射第三针疫苗。该委员会拒绝了该公司向任何16岁及以上接受最初两剂方案的人注射助推器的要求。拜登总统上个月说，他希望看到这一广泛的策略得到应用。
一旦FDA决定如何执行其委员会的建议，辩论就转移到美国疾病控制中心免疫实践咨询委员会，该委员会将于周三和周四召开会议，决定自己对哪些人应该接受额外剂量的建议。
同时,辉瑞宣布更多的进展与儿童疫苗,释放初步研究结果显示“良好的安全性和健壮的中和抗体反应在5到11岁的儿童使用剂治疗方案10微克每隔21天,小剂量30毫克用于多人12以上。”
为了了解更多最新进展，中心采访了该大学彭博公共卫生学院国际疫苗获取中心执行主任、冠状病毒资源中心疫苗学负责人威廉·莫斯。
FDA是否总是遵循其咨询委员会的建议?
如果FDA给出的建议与其咨询委员会不同，我会感到惊讶。代理机构通常会听从委员会的建议。但这是可能发生的。
本周在食品和药物管理局，疾病预防控制中心的顾问小组和疾病预防控制中心还有更多的争论。CDC不同意FDA的意见也是不寻常的。可能存在一些边缘差异，比如什么样的医护人员或有风险的成年人可能也有资格注射第三针。但到本周末，我们就会知道谁有资格获得第三剂辉瑞的药物。
“接受moderna或强生疫苗的人将没有资格获得辉瑞的助推器。”接受Moderna疫苗的人能得到辉瑞的助推器吗?
不。FDA小组关于加强剂量的决定只适用于已经注射了两剂辉瑞疫苗的人。辉瑞公司申请了第三剂紧急使用授权。它不适用于从Moderna或强生获得疫苗的人。这不是混搭的问题。Moderna尚未申请第三剂疫苗的授权。
为什么不给每个人第三次机会呢?
美国的数据确实表明，疫苗对所有年龄组的严重疾病仍然具有高度的保护作用。第一批接种疫苗的65岁以上人群的人数略有减少。美国的数据并未显示出与以色列数据显示的同样程度的保护缺失。
FDA的疫苗和相关生物产品咨询委员会也同意，医护人员和其他工作场所暴露风险高的人应该被包括在紧急使用助推器授权范围内。辉瑞和Moderna的疫苗已经被批准用于实体器官移植受者和其他免疫缺陷患者的第三次注射。
你认为5岁至11岁的儿童什么时候可以接种疫苗?
辉瑞公司周一发布了一份新闻稿，详细介绍了该疫苗在5岁至11岁儿童身上进行试验的成功结果。这意味着该公司有足够的数据对5至11岁儿童的两剂方案的安全性和免疫原性做出结论。该公司并不关注疫苗的功效，也不关注疫苗抵御疾病的能力;它观察抗体反应，并将它们与老年人的抗体反应进行比较。辉瑞预计将在9月底之前正式向FDA提交数据。我们有望在10月底看到辉瑞公司针对这一年轻群体的疫苗获得授权。
“我们有望在10月底看到辉瑞公司为5- 11岁儿童开发的疫苗获得批准。”辉瑞的儿童疫苗剂量和成人疫苗剂量相同吗?
在试验中，辉瑞进行了剂量递增。该公司开始使用小剂量，然后增加剂量，以检查抗体反应、耐受性或副作用。12岁及以上人群的剂量为30微克。该公司周一宣布的剂量为10微克，是成人剂量的三分之一。这是我们第一次在这个年龄组的儿童中看到这类mRNA疫苗的结果。
辉瑞对儿童和成人使用相同的第一和第二剂间隔时间吗?
有趣的是，辉瑞公司对12岁以下儿童和老年人使用相同的间隔21天的第一次和第二次注射。与Moderna的比赛间隔是四周。
Moderna的数据显示，其保护性或有效性高于辉瑞的疫苗。一些科学家推测，Moderna的两种剂量之间的四周间隔可能是部分原因。Moderna的用量也高得多，为100微克。
辉瑞公司坚持儿童的三周间隔，公司可能没有任何改变间隔的依据。这可能是最安全的一步了。但也有可能间隔时间越长越好，因为这给了免疫系统重置和反应的时间。最初的试验使用较短的间隔，部分原因是他们想更快地完成试验。
如果只允许65岁以上人群接种，是否会让更多疫苗进入海外市场?
包括世界卫生组织在内的许多组织认为，像美国这样的富裕国家不应该向全体人口提供助推器。如果美国向免疫功能低下的人或65岁以上的人提供第三剂疫苗，他们支持美国是公平的。在决定为65岁及以上人群提供助推器后，美国可能会宣布支持向疫苗接种率低的国家捐赠和提供疫苗的全球努力。
发布在健康，声音+意见
标记威廉·莫斯，新冠疫苗，助推器
附上原文，以供参考，拒绝转载，侵权必删：
PFIZER MOVES TOWARD BOOSTER APPROVAL AND VACCINE FOR CHILDREN
The FDA and CDC are expected to finalize their decisions about Pfizer booster doses in the same week the company announced that studies of its vaccine for children under 12 show promising results
Doug Donovan / Published 2 days ago
It's shaping up to be a big week for news on two eagerly awaited developments involving Pfizer's COVID-19 vaccine: Booster shots and progress toward its first doses for children as young as 5.
The Food and Drug Administration is set to decide whether to accept its advisory committee's decision to authorize a third shot of Pfizer's vaccine for people 65 and older and other high-risk individuals who have already received the first two doses. The committee rejected the company's request to administer boosters to anyone 16 and over who had received the initial-two dose regimen—a broad strategy President Biden said last month he had wanted to see utilized.
Once the FDA decides how to proceed with its committee's recommendation, the debate moves to the U.S. Centers for Disease Control's Advisory Committee on Immunization Practices, which is scheduled to meet Wednesday and Thursday to determine its own recommendations on who should receive an additional dose.
Meanwhile, Pfizer announced more progress with its children's vaccine, releasing initial study results showing "a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen 10 micrograms administered 21 days apart, a smaller dose than the 30 micrograms used for people 12 and older."
To find out more about the lasted developments, the Hub spoke to Willliam Moss, executive director of the International Vaccine Access Center at the university's Bloomberg School of Public Health and vaccinology lead for the Coronavirus Resource Center.
Does the FDA always follow its advisory committee's recommendations?
I would be surprised if the FDA came out with a different recommendation than its advisory committee. The agency usually follows the committee's advice. But that could happen.
There is still more debate to be had this week within the FDA, the CDC's advisory panel, and the CDC. It would also be unusual for the CDC not to agree with the FDA. There could be some differences at the margins such as what type of health care workers or at-risk adults might also be eligible for the third shot. But by the end of this week we should know who is eligible for a third dose of Pfizer.
"PEOPLE WHO RECEIVED THE MODERNA OR JOHNSON & JOHNSON VACCINES WILL NOT BE ELIGIBLE FOR THE PFIZER BOOSTER."Will Moderna vaccine recipients be able to get the Pfizer booster?
No. This FDA panel's decision on booster doses only applies to people who have gotten two doses of the Pfizer vaccine. Pfizer applied for Emergency Use Authorization for the third dose. It won't apply to people who received the vaccine from Moderna or Johnson & Johnson. This isn't about mixing and matching. Moderna has not yet applied for authorization of a third dose of its vaccines.
Why not offer the third shot to everyone?
The U.S. data really suggests that the vaccines remain highly protective against severe disease across all age groups. There was a slight reduction in those older than 65 years old who were the first to be vaccinated. The U.S. data is not showing the same degree of loss of protection that Israeli data has indicated.
The FDA's Vaccines and Related Biological Products Advisory Committee did also agree that health care workers and others at a high risk of workplace exposure should be included in the Emergency Use Authorization for boosters. Both the Pfizer and Moderna vaccines are already approved for third shots for solid organ transplant recipients and others who are similarly immunocompromised.
When would you expect a vaccine to be available for children between 5 and 11?
Pfizer issued a press release on Monday detailing successful results for the vaccine it has been conducting trials on with children from 5 to 11 years old. This means the company has enough data for drawing conclusions about the safety and the immunogenicity of the two-dose regimen for children 5 to 11 years old. The company is not looking at efficacy, or how well the vaccine protects against disease; it's looking at antibody responses and comparing them to the antibody responses in older people. Pfizer will likely submit its data officially to the FDA by the end of September. We could expect to see authorization of a Pfizer vaccine for this younger age group by the end of October.
"WE COULD EXPECT TO SEE AUTHORIZATION OF A PFIZER VACCINE FOR THE 5-TO-11-YEAR-OLD AGE GROUP BY THE END OF OCTOBER."Is the Pfizer vaccine dose for children the same as the vaccine dose for adults?
In its trials Pfizer conducted a dose escalation. The company started with a small dose and increased it to examine antibody response as well as tolerability or side effects. The dose for people 12 and over is 30 micrograms. The dose the company announced Monday was 10 micrograms, a third of the adult dose. This is the first time we are seeing results for these type of mRNA vaccines in children of this age group.
Did Pfizer use the same interval between the first and second doses for children as with adults?
What's interesting is that Pfizer did use the same interval of 21 days between its first and second doses for children under 12 as they did for older people. The interval with Moderna is four weeks.
Moderna's data has been showing higher protection or efficacy than the Pfizer vaccines. And some scientists have speculated that Moderna's four-week interval between its two doses could be part of the reason. Moderna also uses a much higher dosage of 100 micrograms.
Pfizer stuck to the three-week interval for children and the company may not have any basis for changing the interval. It was probably the safest move to make. But it could be that a longer interval is better because it gives the immune system time to reset and respond. The original trials used the shorter intervals in part because they wanted to get the trials done faster.
Will authorization of boosters only for people over 65 make more vaccines available for overseas?
The position from many, including the World Health Organization, is that the richer nations like the United States should not be providing boosters to their entire populations. They've been fair to support the United States if it offers third doses to immunocompromised people or those over 65. A decision on boosters for those 65 and over may likely be followed by an announcement about the U.S. support for the global effort to donate and deliver vaccines to nations with low vaccination rates.
Posted in Health, Voices+Opinion
Tagged william moss, covid-19 vaccine, boosters
Source of articles：https://hub.jhu.edu/
Author：Doug Donovan
辉瑞公司正在向儿童疫苗和助推器批准迈进
美国食品药品监督管理局和美国疾病控制与预防中心预计将在辉瑞公司宣布其12岁以下儿童疫苗研究显示有希望的结果的同一周内最终决定辉瑞加强剂量
道格·多诺万/发表于2天前
本周将是一个重要的一周，因为辉瑞公司的新冠疫苗有两项备受期待的进展:加强注射，以及为5岁儿童首次注射疫苗的进展。
美国食品和药物管理局将决定是否接受其咨询委员会的决定，授权辉瑞公司为65岁及以上的老年人和其他已经注射了前两剂疫苗的高危人群注射第三针疫苗。该委员会拒绝了该公司向任何16岁及以上接受最初两剂方案的人注射助推器的要求。拜登总统上个月说，他希望看到这一广泛的策略得到应用。
一旦FDA决定如何执行其委员会的建议，辩论就转移到美国疾病控制中心免疫实践咨询委员会，该委员会将于周三和周四召开会议，决定自己对哪些人应该接受额外剂量的建议。
同时,辉瑞宣布更多的进展与儿童疫苗,释放初步研究结果显示“良好的安全性和健壮的中和抗体反应在5到11岁的儿童使用剂治疗方案10微克每隔21天,小剂量30毫克用于多人12以上。”
为了了解更多最新进展，中心采访了该大学彭博公共卫生学院国际疫苗获取中心执行主任、冠状病毒资源中心疫苗学负责人威廉·莫斯。
FDA是否总是遵循其咨询委员会的建议?
如果FDA给出的建议与其咨询委员会不同，我会感到惊讶。代理机构通常会听从委员会的建议。但这是可能发生的。
本周在食品和药物管理局，疾病预防控制中心的顾问小组和疾病预防控制中心还有更多的争论。CDC不同意FDA的意见也是不寻常的。可能存在一些边缘差异，比如什么样的医护人员或有风险的成年人可能也有资格注射第三针。但到本周末，我们就会知道谁有资格获得第三剂辉瑞的药物。
“接受moderna或强生疫苗的人将没有资格获得辉瑞的助推器。”接受Moderna疫苗的人能得到辉瑞的助推器吗?
不。FDA小组关于加强剂量的决定只适用于已经注射了两剂辉瑞疫苗的人。辉瑞公司申请了第三剂紧急使用授权。它不适用于从Moderna或强生获得疫苗的人。这不是混搭的问题。Moderna尚未申请第三剂疫苗的授权。
为什么不给每个人第三次机会呢?
美国的数据确实表明，疫苗对所有年龄组的严重疾病仍然具有高度的保护作用。第一批接种疫苗的65岁以上人群的人数略有减少。美国的数据并未显示出与以色列数据显示的同样程度的保护缺失。
FDA的疫苗和相关生物产品咨询委员会也同意，医护人员和其他工作场所暴露风险高的人应该被包括在紧急使用助推器授权范围内。辉瑞和Moderna的疫苗已经被批准用于实体器官移植受者和其他免疫缺陷患者的第三次注射。
你认为5岁至11岁的儿童什么时候可以接种疫苗?
辉瑞公司周一发布了一份新闻稿，详细介绍了该疫苗在5岁至11岁儿童身上进行试验的成功结果。这意味着该公司有足够的数据对5至11岁儿童的两剂方案的安全性和免疫原性做出结论。该公司并不关注疫苗的功效，也不关注疫苗抵御疾病的能力;它观察抗体反应，并将它们与老年人的抗体反应进行比较。辉瑞预计将在9月底之前正式向FDA提交数据。我们有望在10月底看到辉瑞公司针对这一年轻群体的疫苗获得授权。
“我们有望在10月底看到辉瑞公司为5- 11岁儿童开发的疫苗获得批准。”辉瑞的儿童疫苗剂量和成人疫苗剂量相同吗?
在试验中，辉瑞进行了剂量递增。该公司开始使用小剂量，然后增加剂量，以检查抗体反应、耐受性或副作用。12岁及以上人群的剂量为30微克。该公司周一宣布的剂量为10微克，是成人剂量的三分之一。这是我们第一次在这个年龄组的儿童中看到这类mRNA疫苗的结果。
辉瑞对儿童和成人使用相同的第一和第二剂间隔时间吗?
有趣的是，辉瑞公司对12岁以下儿童和老年人使用相同的间隔21天的第一次和第二次注射。与Moderna的比赛间隔是四周。
Moderna的数据显示，其保护性或有效性高于辉瑞的疫苗。一些科学家推测，Moderna的两种剂量之间的四周间隔可能是部分原因。Moderna的用量也高得多，为100微克。
辉瑞公司坚持儿童的三周间隔，公司可能没有任何改变间隔的依据。这可能是最安全的一步了。但也有可能间隔时间越长越好，因为这给了免疫系统重置和反应的时间。最初的试验使用较短的间隔，部分原因是他们想更快地完成试验。
如果只允许65岁以上人群接种，是否会让更多疫苗进入海外市场?
包括世界卫生组织在内的许多组织认为，像美国这样的富裕国家不应该向全体人口提供助推器。如果美国向免疫功能低下的人或65岁以上的人提供第三剂疫苗，他们支持美国是公平的。在决定为65岁及以上人群提供助推器后，美国可能会宣布支持向疫苗接种率低的国家捐赠和提供疫苗的全球努力。
发布在健康，声音+意见
标记威廉·莫斯，新冠疫苗，助推器
附上原文，以供参考，拒绝转载，侵权必删：
PFIZER MOVES TOWARD BOOSTER APPROVAL AND VACCINE FOR CHILDREN
The FDA and CDC are expected to finalize their decisions about Pfizer booster doses in the same week the company announced that studies of its vaccine for children under 12 show promising results
Doug Donovan / Published 2 days ago
It's shaping up to be a big week for news on two eagerly awaited developments involving Pfizer's COVID-19 vaccine: Booster shots and progress toward its first doses for children as young as 5.
The Food and Drug Administration is set to decide whether to accept its advisory committee's decision to authorize a third shot of Pfizer's vaccine for people 65 and older and other high-risk individuals who have already received the first two doses. The committee rejected the company's request to administer boosters to anyone 16 and over who had received the initial-two dose regimen—a broad strategy President Biden said last month he had wanted to see utilized.
Once the FDA decides how to proceed with its committee's recommendation, the debate moves to the U.S. Centers for Disease Control's Advisory Committee on Immunization Practices, which is scheduled to meet Wednesday and Thursday to determine its own recommendations on who should receive an additional dose.
Meanwhile, Pfizer announced more progress with its children's vaccine, releasing initial study results showing "a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen 10 micrograms administered 21 days apart, a smaller dose than the 30 micrograms used for people 12 and older."
To find out more about the lasted developments, the Hub spoke to Willliam Moss, executive director of the International Vaccine Access Center at the university's Bloomberg School of Public Health and vaccinology lead for the Coronavirus Resource Center.
Does the FDA always follow its advisory committee's recommendations?
I would be surprised if the FDA came out with a different recommendation than its advisory committee. The agency usually follows the committee's advice. But that could happen.
There is still more debate to be had this week within the FDA, the CDC's advisory panel, and the CDC. It would also be unusual for the CDC not to agree with the FDA. There could be some differences at the margins such as what type of health care workers or at-risk adults might also be eligible for the third shot. But by the end of this week we should know who is eligible for a third dose of Pfizer.
"PEOPLE WHO RECEIVED THE MODERNA OR JOHNSON & JOHNSON VACCINES WILL NOT BE ELIGIBLE FOR THE PFIZER BOOSTER."Will Moderna vaccine recipients be able to get the Pfizer booster?
No. This FDA panel's decision on booster doses only applies to people who have gotten two doses of the Pfizer vaccine. Pfizer applied for Emergency Use Authorization for the third dose. It won't apply to people who received the vaccine from Moderna or Johnson & Johnson. This isn't about mixing and matching. Moderna has not yet applied for authorization of a third dose of its vaccines.
Why not offer the third shot to everyone?
The U.S. data really suggests that the vaccines remain highly protective against severe disease across all age groups. There was a slight reduction in those older than 65 years old who were the first to be vaccinated. The U.S. data is not showing the same degree of loss of protection that Israeli data has indicated.
The FDA's Vaccines and Related Biological Products Advisory Committee did also agree that health care workers and others at a high risk of workplace exposure should be included in the Emergency Use Authorization for boosters. Both the Pfizer and Moderna vaccines are already approved for third shots for solid organ transplant recipients and others who are similarly immunocompromised.
When would you expect a vaccine to be available for children between 5 and 11?
Pfizer issued a press release on Monday detailing successful results for the vaccine it has been conducting trials on with children from 5 to 11 years old. This means the company has enough data for drawing conclusions about the safety and the immunogenicity of the two-dose regimen for children 5 to 11 years old. The company is not looking at efficacy, or how well the vaccine protects against disease; it's looking at antibody responses and comparing them to the antibody responses in older people. Pfizer will likely submit its data officially to the FDA by the end of September. We could expect to see authorization of a Pfizer vaccine for this younger age group by the end of October.
"WE COULD EXPECT TO SEE AUTHORIZATION OF A PFIZER VACCINE FOR THE 5-TO-11-YEAR-OLD AGE GROUP BY THE END OF OCTOBER."Is the Pfizer vaccine dose for children the same as the vaccine dose for adults?
In its trials Pfizer conducted a dose escalation. The company started with a small dose and increased it to examine antibody response as well as tolerability or side effects. The dose for people 12 and over is 30 micrograms. The dose the company announced Monday was 10 micrograms, a third of the adult dose. This is the first time we are seeing results for these type of mRNA vaccines in children of this age group.
Did Pfizer use the same interval between the first and second doses for children as with adults?
What's interesting is that Pfizer did use the same interval of 21 days between its first and second doses for children under 12 as they did for older people. The interval with Moderna is four weeks.
Moderna's data has been showing higher protection or efficacy than the Pfizer vaccines. And some scientists have speculated that Moderna's four-week interval between its two doses could be part of the reason. Moderna also uses a much higher dosage of 100 micrograms.
Pfizer stuck to the three-week interval for children and the company may not have any basis for changing the interval. It was probably the safest move to make. But it could be that a longer interval is better because it gives the immune system time to reset and respond. The original trials used the shorter intervals in part because they wanted to get the trials done faster.
Will authorization of boosters only for people over 65 make more vaccines available for overseas?
The position from many, including the World Health Organization, is that the richer nations like the United States should not be providing boosters to their entire populations. They've been fair to support the United States if it offers third doses to immunocompromised people or those over 65. A decision on boosters for those 65 and over may likely be followed by an announcement about the U.S. support for the global effort to donate and deliver vaccines to nations with low vaccination rates.
Posted in Health, Voices+Opinion
Tagged william moss, covid-19 vaccine, boosters
Source of articles：https://hub.jhu.edu/
Author：Doug Donovan
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