Calls grow for FDA to speed authorization of kid Covid-19 vaccines

Politico via MSN ^ | 9/07/21 | Lauren Gardner

[Libloather]

Pressure is mounting on the Food and Drug Administration to authorize Covid-19 vaccines for children under 12 - even though the data needed to support the move is still being collected.

Politicians have joined anxious parents and some public health groups in calling on federal regulators to accelerate their process for authorizing shots for the youngest Americans. They point to a record number of infections among this age group in recent weeks as schools have reopened. These adults want FDA to expedite its review of data from clinical trials in children, especially now that FDA has fully licensed the Pfizer-BioNTech shot for people 16 and older.

“Getting our children vaccinated is critical to giving parents greater peace of mind, but we are being told approval is still months away,” Maryland Gov. Larry Hogan, a Republican, said in a statement late last month urging speedy sign-off on shots for children ages 5 to 11. Others who have asked for a faster timeline include the American Academy of Pediatrics and several members of Congress from both parties.

But those calls are running up against the FDA’s caution and - crucially - a lack of safety and efficacy data. Regulators have already asked vaccine makers to increase the size of their pediatric clinical trials to increase the chances of detecting rare side effects. The first results from one of those studies, Pfizer’s, are not expected until later this month. And top federal health officials have said they don’t expect a vaccine will be available for 5-to-11-year-olds until late fall or winter. Authorization for children as young as six months will come even later.

With cold weather approaching in much of the country, many parents and public health experts see a recipe for disaster.

[Libloather]

Add a pinch of CRT and everything will be just fine.

[ransomnote]

“Pressure is mounting on the Food and Drug Administration to authorize Covid-19 vaccines for children under 12 - even though the data needed to support the move is still being collected.”

WHO is calling for experimenting on children for an illness to which they are not susceptible? Just curious.

I know we’re being told they are flooding the hospitals, but as we don’t have any reason to believe them anymore, and as there is no test that identifies Delta, Mu, Covid etc. from influenza, inquiring minds ask how are they diagnosing these supposed Covid victims? :/
Hey, maybe if they kick loose HCQ/AZ the problem will go away.

[ClearCase_guy]

Bodies of kids are stacking up the street! We better do something super quick.

[EVO X]

Hospitalization rates aren’t much different for children now than during the winter surge. Here is an interactive chart:

https://gis.cdc.gov/grasp/COVIDNet/COVID19_3.html

[PghBaldy]

Of course, since the Feds and the media are nixing any discussion of deaths and injuries from the vaccine, people believe they should vaccinate children. Absolutely evil from the people who say conservatives “only” care about unborn children and liberals care about born children. Nothing could be further from the truth.

[Metrobank]

Beyond irresponsible to foist these shots on kids under 12 with no scientific proof that they aren’t more dangerous to their long health. Parents need to fight back against this push.

[No_Mas_Obama]

And we will. But not gonna lie, knowing the types of people who can’t wait to inject their kids with this stuff, I’m happy for them to make the human sacrifices here.

[Pollard]

[Karma_Sherab]

Flooding the hospitals?

Makes me wonder. I read somewhere where 80 percent of the covid beds were taken in florida. Now, on the surface, that sounds bad.
But, if a hospital has 1000 beds and reserves 100 for covid, then 80 percent is only 80 beds.....a bit different when you see the numbers.

But that doesn't serve the purpose of keeping everyone afraid

[DoodleBob]

Politicians have joined anxious parents and some public health groups in calling on federal regulators to accelerate their process for authorizing shots for the youngest Americans.

This is like asking wine or whiskey makers to accelerate the fermentation process.

Up until this year, an "approved" vaccine was backed by years of clinical trials, largely so the long-term effects and efficacy can be examined. What happens if in month 18 all of your hair falls out? Or your finger nails turn green? Or your blood won't clot? Better call off the approval, OR approve but with a fully informed consumer.

I'm OK with the EUA because at least people were (theoretically) given a caveat emptor warning about the unknown long-run impacts. But this got so politicized that almost any bad side effect reported in the public square was suppressed. Worse yet, the test subjects underpinning the EUA were unmasked and we lost the ability to track them in a regimented, accurate, and punctual data collection effort.

Now they're doing this on kids? I'd like to see the voter registration profile of the parents signing up their kids for these trials.

[MAGAthon]

eventually, no child will be left behind:

7 Sept: UK Daily Mail: Cuba is world’s first country to vaccinate TODDLERS: Children from age of two receive home-grown Covid-19 jabs not recognised by WHO
Cuba on Monday started vaccinating children from the age of two against Covid
Clinical trials for its home-grown Abdala and Soberana jabs found to be safe
Communist nation is aiming to vaccinate all kids before it reopens schools
The Cuban jabs have not undergone international, scientific peer review
By AFP
Countries such as China, the United Arab Emirates and Venezuela have announced they plan to vaccinate younger children, but Cuba is the first to do so.

Chile on Monday approved the Chinese Sinovac vaccines for children between six and 12.

The Cuban vaccines, the first developed in Latin America, have not undergone international, scientific peer review.

They are based on recombinant protein technology — the same used by the United States’ Novavax and France’s Sanofi jabs also awaiting WHO approval...
https://www.dailymail.co.uk/news/article-9965585/Cuba-worlds-country-vaccinate-TODDLERS.html

[Cowman]

Remember. It was the government approved experts that said thalidomide was safe and effective.

[metmom]

Not from the American people.

Notice it’s always politicians who are pressuring others to do what they want to enact?

[ballplayer]

Studies for approval of vaccines for children under 12 are not expected until 2023 ,2024,anything earlier than that will be emergency use authorization because testing WILL NOT HAVE BEEN COMPLETED,in other words your children will be lab rats

[blueplum]

calls from whom?

children and the elderly/frail are the people who are supposed to be protected by herd immunity. Seniors ponied up on social responsibility and are at 80% acquired immunity and can go a little higher. Adults are way behind, and need to catch up so that children under 12 are actually protected.

[minnesota_bound]

Bill Gates to the FDA: Can you guys speed up the authorization of kid Covid-19 vaccines?
I need to make billions more. I do not care about side effects. My kid will not be getting any vaccine.