3,770
 

Sep 15 - New Pfizer data makes case for “booster” shots 6 months after primary doses



ADVERTISEMENT
 
topics gone triple plat - Number 1 spot 3X PLAT

most viewed right now
+18  75
61 replies  @games



section  x1   |  0 bx goons and 1 bystanders Share this on Twitter       Share this on Facebook

section news
  
Top 10 most slapped recently  4 weeks ago '20        #1
926 page views
44 comments


BuiltForThis  topics gone triple plat - Number 1 spot x9
avatar
Props total: 17351 17 K  Slaps total: 30306 30 K
Sep 15 - New Pfizer data makes case for “booster” shots 6 months after primary doses
 

 
The Food and Drug Administration on Wednesday released new data from Pfizer's submitted application to approve booster doses of its Covid-19 vaccine. In it, Pfizer demonstrates what it sees as proof that third shot will be both safe and necessary for most Americans to take, arguing that immunity wanes over time -- regardless of any new variant of concern.

It comes two days ahead of a critical juncture in the COVID-19 vaccine booster approval process: Friday, the Food and Drug Administration's independent advisory committee (VRBPAC) is set to convene to review and discuss the latest data on potential booster doses of the Pfizer vaccine. The committee will be asked to vote on whether a booster dose is safe enough for widespread use -- and whether it's necessary and effective at improving protection levels.

In mid-August, the FDA authorized boosters of Moderna and Pfizer for the roughly 7 million immunocompromised Americans who didn't get an optimal immune response to their initial vaccine doses.

Pfizer/BioNTech, which partnered to develop the nation's first fully approved vaccine, has said it has early data suggesting a booster dose anywhere from six to 12 months after the second dose will help maintain a high level of protection; Pfizer asked the FDA to approve booster doses of its vaccine in late August by submitting an application and data. On Wednesday morning, the FDA made that data public.

While the independent members of the VRBPAC's votes are not binding, the agency takes its recommendations under serious advisement in deciding whether to grant vaccines new authorization or approval. If and when a recommendation does come to green light booster shots, several additional steps must follow before it's time for more Americans to role up their sleeves a third time.

First, the FDA would need to formally amend its current vaccine approval for Pfizer; then the Centers for Disease Control and Prevention's advisory committee (ACIP) will weigh to whom, and when, expanded booster shots should begin. Then, the CDC director must formally sign off on whether to recommend the vaccine to the public, including who it will be recommended for and at what time period. It's expected to be authorized for anyone eight months after their second dose. Authorization for Moderna and Johnson & Johnson may not be far behind.

The new data -- and proximate committee vote -- also come days before the Sept. 20 date set by the White House as the target to begin deploying booster shots for a wider pool of Americans.


The question of whether America's immunity is waning has become an urgent question in recent months with the rise of the delta variant and large pockets of the country still unvaccinated.

FDA acting Commissioner Janet Woodcock and CDC Director Rochelle Walensky -- both White House appointees -- endorsed President Joe Biden's Sept. 20 plan.

However, it has been getting some pushback, with health experts criticizing the Sept. 20 boosters-for-all timeline as premature and prior to any ruling from their advisory groups.

Two top FDA officials who are leaving the agency later this year publicly waded into the booster debate on Monday, splitting from the agency and arguing in a scientific journal that it was too soon to give booster shots to the general public since the vaccines still offer strong protection against serious disease.

One of them is scheduled to attend Friday's VRBPAC discussion.


"The message that boosting might soon be needed, if not justified by robust data and analysis, could adversely affect confidence in vaccines and undermine messaging about the value of primary vaccination," the officials wrote, backed by other worldwide organizations.

For their part, the Biden administration has emphasized that science will lead and federal regulators will have the final say -- and that their call to push out booster shots is motivated by wanting to "stay ahead" of the virus.

"You don't want to find yourself behind playing catch up," Dr. Anthony Fauci said when announcing the plan. "Better stay ahead of it than chasing after it."

visit this link https://abcnews.go.com/Po .. ry?id=80023544

visit this link https://www.fda.gov/media .. 52161/download
+2   



best
worst
44 comments
 

 4 weeks ago '11        #2
Pakchoy 
Props total: 76365 76 K  Slaps total: 1061 1 K
...........

 4 weeks ago '10        #3
Trilluminati GA 
Props total: 38546 38 K  Slaps total: 1572 1 K
Bullsh*t...their own top officials say not so and resigned ..and a PhD virologist


Last edited by Trilluminati GA; 09-15-2021 at 12:20 PM..
+7   

Top 10 most slapped recently  4 weeks ago '20        #4
BuiltForThis  topics gone triple plat - Number 1 spot x9 OP
Props total: 17351 17 K  Slaps total: 30306 30 K
 Trilluminati GA said
Bullsh*t...their own top officials say not so and resigned ..and a virologist

+4   

 4 weeks ago '10        #5
Trilluminati GA 
Props total: 38546 38 K  Slaps total: 1572 1 K
 BuiltForThis said

Greedy money thirsty mfs running out of time
+4   

 4 weeks ago '09        #6
GREAT1NE  topics gone triple plat - Number 1 spot x1
Props total: 13415 13 K  Slaps total: 1915 1 K

+6   

Top 10 most slapped recently  4 weeks ago '20        #7
BuiltForThis  topics gone triple plat - Number 1 spot x9 OP
Props total: 17351 17 K  Slaps total: 30306 30 K
 Trilluminati GA said
Greedy money thirsty mfs running out of time

Follow they science

+1   

 4 weeks ago '06        #8
philly337  topics gone triple plat - Number 1 spot x1
Props total: 51357 51 K  Slaps total: 14788 14 K
Not according to @ and his doctor
+8   

Top 10 most slapped recently  4 weeks ago '20        #9
BuiltForThis  topics gone triple plat - Number 1 spot x9 OP
Props total: 17351 17 K  Slaps total: 30306 30 K
 philly337 said
Not according to @ and his doctor
Looking so forward to when 2 injections takers are labeled “unvaccinated”.

+7   

 4 weeks ago '05        #10
Daddy Black 
Props total: 14611 14 K  Slaps total: 1286 1 K
These mafu*kas lyin hard af how people can’t see that.
+4   

 4 weeks ago '05        #11
POSITIVITY  topics gone triple plat - Number 1 spot x59
Props total: 100780 100 K  Slaps total: 60479 60 K
Two shots a year? That’s not bad
-7   

 4 weeks ago '05        #12
POSITIVITY  topics gone triple plat - Number 1 spot x59
Props total: 100780 100 K  Slaps total: 60479 60 K
 BuiltForThis said
Looking so forward to when 2 injections takers are labeled “unvaccinated”.

Lol at “looking forward” u dweeb

Top 10 most slapped recently  4 weeks ago '20        #13
BuiltForThis  topics gone triple plat - Number 1 spot x9 OP
Props total: 17351 17 K  Slaps total: 30306 30 K
 EMPATHY said
Lol at “looking forward” u dweeb


Around 4th / 5th EUA injections y’all Wuhan injection takers gone turn on each other

There’s already a 3rd vs 2nd dispute going on.

.

 4 weeks ago '15        #14
Still Numskull 
Props total: 22330 22 K  Slaps total: 5587 5 K
So the fully vaccinated aren't actually fully vaccinated.


It works just need more of it
+10   

Top 10 most slapped recently  4 weeks ago '20        #15
blackpillblack 
Props total: 12916 12 K  Slaps total: 5728 5 K
For the high risk and immune compromised the efficacy of the vaccine wanes after six months.
+1   

 4 weeks ago '14        #16
strungout  topics gone triple plat - Number 1 spot x5
Props total: 151538 151 K  Slaps total: 34904 34 K
I'm perfectly fine with taking booster

You crazy , if you not fine with it
-5   

 4 weeks ago '06        #17
Storchaveli  topics gone triple plat - Number 1 spot x5
Props total: 28103 28 K  Slaps total: 6764 6 K
Fine with a booster too. Doubt OP has even been to the dentist on time. You think he cares about his health when hundreds of MILLIONS of people have shown these vaccines are safe (and fully approved) now?
-4   

 4 weeks ago '14        #18
Sense Maker  topics gone triple plat - Number 1 spot x1
Props total: 22709 22 K  Slaps total: 4346 4 K


 4 weeks ago '04        #19
abstractq 
Props total: 27214 27 K  Slaps total: 4826 4 K
180 million people vaccinated without issue and bozo OP still worried about a shot

lmao. . .
-5   

Top 10 most slapped recently  4 weeks ago '20        #20
BuiltForThis  topics gone triple plat - Number 1 spot x9 OP
Props total: 17351 17 K  Slaps total: 30306 30 K
 Storchaveli said
Fine with a booster too. Doubt OP has even been to the dentist on time. You think he cares about his health when hundreds of MILLIONS of people have shown these vaccines are safe (and fully approved) now?

@
Y’all don’t even know what booster means.
-2   

Top 10 most slapped recently  4 weeks ago '20        #21
blackpillblack 
Props total: 12916 12 K  Slaps total: 5728 5 K
 strungout said
I'm perfectly fine with taking booster

You crazy , if you not fine with it
Bruh I just left from visiting fam in the covid icu .. take the booster

 4 weeks ago '15        #22
Still Numskull 
Props total: 22330 22 K  Slaps total: 5587 5 K


+9   

 4 weeks ago '16        #23
Homer Pimpson 
Props total: 34813 34 K  Slaps total: 7233 7 K
 EMPATHY said
Two shots a year? That’s not bad
+3   

 4 weeks ago '07        #24
joshdogg26  topics gone triple plat - Number 1 spot x1
Props total: 25133 25 K  Slaps total: 2968 2 K
there is not a medical consensus on the necessity of boosters at this time, so we'll wait. it does look like prevention of infection does wane over time but prevention of hospitalization and serious symptoms hold strong, so there's little need for a booster.


-1   

Top 10 most slapped recently  4 weeks ago '20        #25
BuiltForThis  topics gone triple plat - Number 1 spot x9 OP
Props total: 17351 17 K  Slaps total: 30306 30 K
 joshdogg26 said
there is not a medical consensus on the necessity of boosters at this time, so we'll wait. it does look like prevention of infection does wane over time but prevention of hospitalization and serious symptoms hold strong, so there's little need for a booster.



EUA approval on the 20th of September is all that matters.

Y’all 2 injections bout 2 be void




Sign me up
 
 

yesterday...


most viewed right now
+304online now  34
Video inside My Man Can't Be a Security Guard No More After This....
178 comments
1 day ago
@wild'ish
most viewed right now
+35online now  25
[Fat Loss] The 10 most Underrated foods for fat loss (and staying lean)
47 comments
2 days ago
@misc
most viewed right now
+99online now  21
Video inside When y'all both notice red flags!!
77 comments
24 hours ago
@wild'ish
most viewed right now
online now  17
Video inside HALLOWEEN k*llS (2021) | US Premiere
56 comments
18 hours ago
@movies
back to top
register register Follow BX @ Twitter search BX privacyprivacy