US panel recommends Covid vaccines for youngest children

US panel recommends Covid vaccines for youngest children

A panel of experts convened by the US Food and Drug Administration unanimously recommended Covid-19 vaccines Wednesday for children under five, the final age group awaiting immunization in most countries.

Formal authorizations for Moderna and Pfizer should follow soon, with the first shots in arms expected early next week, just over a year-and-a-half after the first Covid vaccines were greenlighted for the elderly in December 2020.

This recommendation does fill a significant unmet need for a really ignored younger population,” said Michael Nelson, a professor of medicine at the University of Virginia, one of the 21 experts asked to vote for the milestone meeting.

Unlike regulators in other countries, FDA offers livestreams of its internal deliberations and its stamp of approval is considered the global gold standard.

Opening the discussion, senior FDA scientist Peter Marks said that despite studies showing the majority of children have now been infected with the coronavirus, the high rate of hospitalizations among infants, toddlers and young children during last winter´s Omicron wave underscored an urgent need for vaccination.

“We are dealing with an issue where we have to be careful we don´t become numb to the pediatric deaths because of the overwhelming number of older deaths,” he said.

“Every life is important and vaccine-preventable deaths are something we would like to try to do something about.”

The United States has recorded 480 Covid deaths in the 0-4 age group in the pandemic — far higher than even a bad flu season, Marks said.

As of May 2022, there have been 45,000 hospitalizations in that group, nearly a quarter of which required intensive care.

Ahead of the meeting, the FDA posted its independent analyses of the pharmaceutical companies´ vaccines, deeming both safe and effective.

Both vaccines are based on messenger RNA, which delivers genetic code for the coronavirus spike protein to human cells that then grow it on their surface, training the immune system to be ready. The technology is now considered the leading Covid vaccination platform.

Pfizer sought authorization for three doses at three micrograms given to children aged six months through four years, while Moderna asked for the FDA to authorize its vaccine as two doses of a higher 25 micrograms for ages six months through five years.

Both vaccines were tested in trials of thousands of children. They were found to cause similar levels of mild side effects as in older age groups and triggered similar levels of antibodies.

Two doses, or three?

Efficacy against infection was higher for Pfizer, with the company placing it at 80 percent, compared to Moderna´s estimates of 51 percent for children aged six-months to two years old and 37 percent for those aged two to five years.

But the Pfizer figure is based on very few cases and is thus considered preliminary. It also takes three doses to achieve its protection, with the third shot given eight weeks after the second, which is given three weeks after the first.

Moderna´s vaccine should provide strong protection against severe disease after two doses, given four weeks apart, and the company is studying adding a booster that would raise efficacy levels against mild disease.

However, Moderna´s decision to go with a higher dose is associated with higher levels of fevers in reaction to the vaccine compared to Pfizer.

There are some 20 million US children aged four years and under.

Although obesity, neurological disorders and asthma are associated with increased risk of severe disease among young children, it´s not easy to predict severe outcomes.

In fact, 64 percent of hospitalizations in those under five occurred in patients without comorbidities.

Children can also go on to contract multisystem inflammatory syndrome in children (MIS-C), a rare but serious post-viral condition. Some three to six percent can experience long Covid symptoms for more than 12 weeks.

The FDA is expected to soon act on the panel´s recommendation, and the matter will go to the Centers for Disease Control and Prevention for a final say.

White House officials last week said the rollout of 10 million shots at pharmacies and doctors´ offices could begin as soon as June 21.

Imagine Losing 20 Pounds In 14 Days!

Imagine Losing 20 Pounds In 14 Days!

[dropcap]D[/dropcap]on’t act so surprised, Your Highness. You weren’t on any mercy mission this time. Several transmissions were beamed to this ship by Rebel spies. I want to know what happened to the plans they sent you. In my experience, there is no such thing as luck. Partially, but it also obeys your commands. I want to come with you to Alderaan. There’s nothing for me here now. I want to learn the ways of the Force and be a Jedi, like my father before me. The more you tighten your grip, Tarkin, the more star systems will slip through your fingers.

Still, she’s got a lot of spirit. I don’t know, what do you think? What!? I don’t know what you’re talking about. I am a member of the Imperial Senate on a diplomatic mission to Alderaan– What good is a reward if you ain’t around to use it? Besides, attacking that battle station ain’t my idea of courage. It’s more like…suicide.

You don’t believe in the Force, do you? Obi-Wan is here. The Force is with him. I call it luck. Look, I can take you as far as Anchorhead. You can get a transport there to Mos Eisley or wherever you’re going. What?! The Force is strong with this one. I have you now.

We hire people who want to make the best things in the world. -Steve Jobs

She must have hidden the plans in the escape pod. Send a detachment down to retrieve them, and see to it personally, Commander. [highlight color=”yellow”]There’ll be no one to stop us this time![/highlight] You’re all clear, kid. Let’s blow this thing and go home! Partially, but it also obeys your commands.

  • Dantooine. They’re on Dantooine.
  • He is here.
  • Don’t underestimate the Force.

[tie_full_img]5825871567_4d477202ce_b[/tie_full_img]

I care. So, what do you think of her, Han? A tremor in the Force. The last time I felt it was in the presence of my old master. [highlight color=”blue”]But with the blast shield down,[/highlight] I can’t even see! How am I supposed to fight? Obi-Wan is here. The Force is with him. But with the blast shield down, I can’t even see! How am I supposed to fight? You are a part of the Rebel Alliance and a traitor! Take her away!

[padding right=”5%” left=”5%”]
Still, she’s got a lot of spirit. I don’t know, what do you think? What!? I don’t know what you’re talking about. I am a member of the Imperial Senate on a diplomatic mission to Alderaan– What good is a reward if you ain’t around to use it? Besides, attacking that battle station ain’t my idea of courage. It’s more like…suicide.
You don’t believe in the Force, do you? Obi-Wan is here. The Force is with him. I call it luck. Look, I can take you as far as Anchorhead. You can get a transport there to Mos Eisley or wherever you’re going. What?! The Force is strong with this one. I have you now.

  1. I care. So, what do you think of her, Han?
  2. You mean it controls your actions?
  3. Look, I can take you as far as Anchorhead. You can get a transport there to Mos Eisley or wherever you’re going.
  4. I’m trying not to, kid.

[/padding]

Revenge of the Sith

post-imageI can’t get involved! I’ve got work to do! It’s not that I like the Empire, I hate it, but there’s nothing I can do about it right now. It’s such a long way from here. Leave that to me. Send a distress signal, and inform the Senate that all on board were killed. I’m surprised you had the courage to take the responsibility yourself. No! Alderaan is peaceful. We have no weapons. You can’t possibly…

Your eyes can deceive you. Don’t trust them. He is here. What?! Hokey religions and ancient weapons are no match for a good blaster at your side, kid. I’m trying not to, kid.

I’m trying not to, kid. I have traced the Rebel spies to her. Now she is my only link to finding their secret base. He is here. You are a part of the Rebel Alliance and a traitor! Take her away! Dantooine. They’re on Dantooine.

 

Still, she’s got a lot of spirit. I don’t know, what do you think? What!? I don’t know what you’re talking about. I am a member of the Imperial Senate on a diplomatic mission to Alderaan– What good is a reward if you ain’t around to use it? Besides, attacking that battle station ain’t my idea of courage. It’s more like…suicide.

Hey, Luke! May the Force be with you. Kid, I’ve flown from one side of this galaxy to the other. I’ve seen a lot of strange stuff, but I’ve never seen anything to make me believe there’s one all-powerful Force controlling everything. There’s no mystical energy field that controls my destiny. It’s all a lot of simple tricks and nonsense. Remember, a Jedi can feel the Force flowing through him. He is here. Ye-ha! I have traced the Rebel spies to her. Now she is my only link to finding their secret base.

You don’t believe in the Force, do you? Obi-Wan is here. The Force is with him. I call it luck. Look, I can take you as far as Anchorhead. You can get a transport there to Mos Eisley or wherever you’re going. What?! The Force is strong with this one. I have you now.

 

[tie_full_img]9FybtVFNSEOxogGzIvHJ_IMG_2226[/tie_full_img]

 

[padding right=”5%” left=”5%”]

Hey, Luke! May the Force be with you. Kid, I’ve flown from one side of this galaxy to the other. I’ve seen a lot of strange stuff, but I’ve never seen anything to make me believe there’s one all-powerful Force controlling everything. There’s no mystical energy field that controls my destiny. It’s all a lot of simple tricks and nonsense. Remember, a Jedi can feel the Force flowing through him. He is here. Ye-ha! I have traced the Rebel spies to her. Now she is my only link to finding their secret base.

Oh God, my uncle. How am I ever gonna explain this? Look, I ain’t in this for your revolution, and I’m not in it for you, Princess. I expect to be well paid. I’m in it for the money. A tremor in the Force. The last time I felt it was in the presence of my old master.

All right. Well, take care of yourself, Han. [highlight color=”orange”]I guess that’s what you’re best at,[/highlight] ain’t it? Alderaan? I’m not going to Alderaan. I’ve got to go home. It’s late, I’m in for it as it is. The plans you refer to will soon be back in our hands.
[/padding]

 

WOW, Nice photo !
WOW, Nice photo !

I need your help, Luke. She needs your help. I’m getting too old for this sort of thing. Oh God, my uncle. How am I ever gonna explain this? Hey, Luke! May the Force be with you. No! Alderaan is peaceful. We have no weapons. You can’t possibly… As you wish. Look, I can take you as far as Anchorhead. You can get a transport there to Mos Eisley or wherever you’re going.

I suggest you try it again, Luke. This time, let go your conscious self and act on instinct. Dantooine. They’re on Dantooine. You’re all clear, kid. Let’s blow this thing and go home! I’m surprised you had the courage to take the responsibility yourself. I’m trying not to, kid.

I care. So, what do you think of her, Han? Don’t underestimate the Force. I don’t know what you’re talking about. I am a member of the Imperial Senate on a diplomatic mission to Alderaan– I have traced the Rebel spies to her. Now she is my only link to finding their secret base.

You’re all clear, kid. [highlight color=”green”]Let’s blow this thing and go home![/highlight] But with the blast shield down, I can’t even see! How am I supposed to fight? Alderaan? I’m not going to Alderaan. I’ve got to go home. It’s late, I’m in for it as it is.

10 Reasons To Start Your Own, Profitable Website!

10 Reasons To Start Your Own, Profitable Website!

[dropcap]D[/dropcap]on’t act so surprised, Your Highness. You weren’t on any mercy mission this time. Several transmissions were beamed to this ship by Rebel spies. I want to know what happened to the plans they sent you. In my experience, there is no such thing as luck. Partially, but it also obeys your commands. I want to come with you to Alderaan. There’s nothing for me here now. I want to learn the ways of the Force and be a Jedi, like my father before me. The more you tighten your grip, Tarkin, the more star systems will slip through your fingers.

Still, she’s got a lot of spirit. I don’t know, what do you think? What!? I don’t know what you’re talking about. I am a member of the Imperial Senate on a diplomatic mission to Alderaan– What good is a reward if you ain’t around to use it? Besides, attacking that battle station ain’t my idea of courage. It’s more like…suicide.

You don’t believe in the Force, do you? Obi-Wan is here. The Force is with him. I call it luck. Look, I can take you as far as Anchorhead. You can get a transport there to Mos Eisley or wherever you’re going. What?! The Force is strong with this one. I have you now.

We hire people who want to make the best things in the world. -Steve Jobs

She must have hidden the plans in the escape pod. Send a detachment down to retrieve them, and see to it personally, Commander. [highlight color=”yellow”]There’ll be no one to stop us this time![/highlight] You’re all clear, kid. Let’s blow this thing and go home! Partially, but it also obeys your commands.

  • Dantooine. They’re on Dantooine.
  • He is here.
  • Don’t underestimate the Force.

[tie_full_img]5825871567_4d477202ce_b[/tie_full_img]

I care. So, what do you think of her, Han? A tremor in the Force. The last time I felt it was in the presence of my old master. [highlight color=”blue”]But with the blast shield down,[/highlight] I can’t even see! How am I supposed to fight? Obi-Wan is here. The Force is with him. But with the blast shield down, I can’t even see! How am I supposed to fight? You are a part of the Rebel Alliance and a traitor! Take her away!

[padding right=”5%” left=”5%”]
Still, she’s got a lot of spirit. I don’t know, what do you think? What!? I don’t know what you’re talking about. I am a member of the Imperial Senate on a diplomatic mission to Alderaan– What good is a reward if you ain’t around to use it? Besides, attacking that battle station ain’t my idea of courage. It’s more like…suicide.
You don’t believe in the Force, do you? Obi-Wan is here. The Force is with him. I call it luck. Look, I can take you as far as Anchorhead. You can get a transport there to Mos Eisley or wherever you’re going. What?! The Force is strong with this one. I have you now.

  1. I care. So, what do you think of her, Han?
  2. You mean it controls your actions?
  3. Look, I can take you as far as Anchorhead. You can get a transport there to Mos Eisley or wherever you’re going.
  4. I’m trying not to, kid.

[/padding]

Revenge of the Sith

post-imageI can’t get involved! I’ve got work to do! It’s not that I like the Empire, I hate it, but there’s nothing I can do about it right now. It’s such a long way from here. Leave that to me. Send a distress signal, and inform the Senate that all on board were killed. I’m surprised you had the courage to take the responsibility yourself. No! Alderaan is peaceful. We have no weapons. You can’t possibly…

Your eyes can deceive you. Don’t trust them. He is here. What?! Hokey religions and ancient weapons are no match for a good blaster at your side, kid. I’m trying not to, kid.

I’m trying not to, kid. I have traced the Rebel spies to her. Now she is my only link to finding their secret base. He is here. You are a part of the Rebel Alliance and a traitor! Take her away! Dantooine. They’re on Dantooine.

 

Still, she’s got a lot of spirit. I don’t know, what do you think? What!? I don’t know what you’re talking about. I am a member of the Imperial Senate on a diplomatic mission to Alderaan– What good is a reward if you ain’t around to use it? Besides, attacking that battle station ain’t my idea of courage. It’s more like…suicide.

Hey, Luke! May the Force be with you. Kid, I’ve flown from one side of this galaxy to the other. I’ve seen a lot of strange stuff, but I’ve never seen anything to make me believe there’s one all-powerful Force controlling everything. There’s no mystical energy field that controls my destiny. It’s all a lot of simple tricks and nonsense. Remember, a Jedi can feel the Force flowing through him. He is here. Ye-ha! I have traced the Rebel spies to her. Now she is my only link to finding their secret base.

You don’t believe in the Force, do you? Obi-Wan is here. The Force is with him. I call it luck. Look, I can take you as far as Anchorhead. You can get a transport there to Mos Eisley or wherever you’re going. What?! The Force is strong with this one. I have you now.

 

[tie_full_img]9FybtVFNSEOxogGzIvHJ_IMG_2226[/tie_full_img]

 

[padding right=”5%” left=”5%”]

Hey, Luke! May the Force be with you. Kid, I’ve flown from one side of this galaxy to the other. I’ve seen a lot of strange stuff, but I’ve never seen anything to make me believe there’s one all-powerful Force controlling everything. There’s no mystical energy field that controls my destiny. It’s all a lot of simple tricks and nonsense. Remember, a Jedi can feel the Force flowing through him. He is here. Ye-ha! I have traced the Rebel spies to her. Now she is my only link to finding their secret base.

Oh God, my uncle. How am I ever gonna explain this? Look, I ain’t in this for your revolution, and I’m not in it for you, Princess. I expect to be well paid. I’m in it for the money. A tremor in the Force. The last time I felt it was in the presence of my old master.

All right. Well, take care of yourself, Han. [highlight color=”orange”]I guess that’s what you’re best at,[/highlight] ain’t it? Alderaan? I’m not going to Alderaan. I’ve got to go home. It’s late, I’m in for it as it is. The plans you refer to will soon be back in our hands.
[/padding]

 

WOW, Nice photo !
WOW, Nice photo !

I need your help, Luke. She needs your help. I’m getting too old for this sort of thing. Oh God, my uncle. How am I ever gonna explain this? Hey, Luke! May the Force be with you. No! Alderaan is peaceful. We have no weapons. You can’t possibly… As you wish. Look, I can take you as far as Anchorhead. You can get a transport there to Mos Eisley or wherever you’re going.

I suggest you try it again, Luke. This time, let go your conscious self and act on instinct. Dantooine. They’re on Dantooine. You’re all clear, kid. Let’s blow this thing and go home! I’m surprised you had the courage to take the responsibility yourself. I’m trying not to, kid.

I care. So, what do you think of her, Han? Don’t underestimate the Force. I don’t know what you’re talking about. I am a member of the Imperial Senate on a diplomatic mission to Alderaan– I have traced the Rebel spies to her. Now she is my only link to finding their secret base.

You’re all clear, kid. [highlight color=”green”]Let’s blow this thing and go home![/highlight] But with the blast shield down, I can’t even see! How am I supposed to fight? Alderaan? I’m not going to Alderaan. I’ve got to go home. It’s late, I’m in for it as it is.