LI school prom will have different rules for vaxxed and unvaxxed teens

Forget popular kids and dorks — seniors at one Long Island high school dance will be divided by whether they are vaccinated or unvaccinated against COVID-19, The Post has learned...

The school said that, per state and CDC guidelines, kids who are vaccinated will be able to attend maskless — while those who aren’t will need to wear a face covering.

Students will need to show proof of inoculation to attend mask-free, and will be given wristbands to signify they’ve gotten the jab, Dr. Ira Pernick, the school’s principal, said in a video sent to the senior class this week and seen by The Post.

In addition to wearing masks, those who haven’t been vaccinated will need to show proof of a negative COVID-19 test before the party, Pernick said...

“The health and safety of our students, staff and community are the Port Washington School District’s foremost priorities,” Hynes said in a statement. “The district is in close contact with local and state health officials and will continue to regularly monitor any changes in guidance.”

Once again, I'm going to ask my simple question:

How is a vaccine that is only approved for emergency use being mass distributed to younger and younger people as if it is really a general use therapy?

Has the phrase "emergency use authorization" lost its meaning, or was it really the proverbial camel's nose under the tent, intended to get the vaccine into the mainstream by any means necessary, and then treating it as if it had full FDA approval even though it does not?

Wasn't the "emergency use authorization" intended to get the vaccine into the most susceptible and at-risk people who were most likely to contract the virus based on what we knew at the time last December? Haven't recent studies shown that the decline in new cases is now trending more rapidly downward?

Can we honestly now say that we've exited the "emergency" period that started in December when the vaccine was first being rolled out? If so, then shouldn't we rethink the mass distribution of a vaccine that was only authorized for emergency use, and maybe slow down the rush to inject our children with it if the emergency period is behind us?

-PJ

Emergency Use Authorization is one of two emergency access mechanisms to provide new medicines to the public under specific circumstances. It’s not new. The guidelines for it are not new. The process for issuing EUAs is not new. Dozens of new medicines receive an Emergency Use Authorization each and every year; many of them cancer treatments. This is just the first time most people are seeing this designation and few in the general public have any idea what it means at this point.

There are also four expedited pathways for new medicine development: Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review. More information about each of them is here: https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review

A more complete overview of all the programs, including the emergency access mechanisms is here: https://www.fda.gov/media/101333/download

You’ll notice the date on it is April 2016, which is the last revision. This is a routinely used process and just one of many. People seem to think that “FDA approval” is the only way new medicines become available and that it takes a decade. None of that is correct and it never has been.

".... The way this vaccine is being pushed for something highly survivable tells me something evil is going on...."

New York: $5 million lottery ticket prizes

California: $116 million in lottery ticket incentives

Maryland: $2 million in lottery prizes

Ohio: $1 million in lottery jackpots

Oregon: $10,000 to $1 million in lottery prizes

If these vaccines were so safe and efficient, people would be lined up around the block to get their free job.

But instead, because the vaccines are neither safe nor efficient, the government is having to bribe people to get the shots, a strategy meant to address the dramatically decreasing numbers of residents inoculated each day.

I agree. Something evil is afoot.

You still didn't answer the question about whether "emergency use" is meant for general use or for "emergency" use to treat high-risk people?

Is injecting our children a part of the emergency, or just the elderly with comorbidities?

Are the conditions that prompted the need for "emergency use" in December still in effect today?

Do we know more today about what constituted the "emergency" such that, given what we know today, the "emergency use authorization" would still be granted today or other treatments would suffice?

You get the gist of my question... shouldn't "emergency use" be limited to people in emergency situations, that is, people in the highest risk categories?

-PJ

𝘐𝘧 𝘵𝘩𝘦𝘴𝘦 𝘷𝘢𝘤𝘤𝘪𝘯𝘦𝘴 𝘸𝘦𝘳𝘦 𝘴𝘰 𝘴𝘢𝘧𝘦 𝘢𝘯𝘥 𝘦𝘧𝘧𝘪𝘤𝘪𝘦𝘯𝘵, 𝘱𝘦𝘰𝘱𝘭𝘦 𝘸𝘰𝘶𝘭𝘥 𝘣𝘦 𝘭𝘪𝘯𝘦𝘥 𝘶𝘱 𝘢𝘳𝘰𝘶𝘯𝘥 𝘵𝘩𝘦 𝘣𝘭𝘰𝘤𝘬 𝘵𝘰 𝘨𝘦𝘵 𝘵𝘩𝘦𝘪𝘳 𝘧𝘳𝘦𝘦 𝘫𝘰𝘣.

I was going to consider getting it after a year, but something doesn’t feel right. Part of it is seeing this vaccine developed in such a short time, part of it is the insistence of others upon getting it. The company I work for revised their mask, and time off policies in regards to covid. As of next Tuesday 6/1 all new hires must be vaccinated, and as of 7/1 only fully vaccinated employees may take of their masks and eschew social distancing (contrary to Governor Whitmer’s lifting of the mask mandate on that date). It should also be noted that the temperature monitoring stations near a couple of the entry points will remain up indefinitely.

I agree. Something evil is afoot.

An associate told me yesterday told he got the Pfizer vaccine. I responded that one of us would probably be dead within 5 years. All I got in response was a nervous laugh, and a quick change of subject. I had another that I thought would never buckle tell me he was "coerced" in to getting the poke. He told me that I should "play the game" and get it as well, if it meant keeping my job. I have a feeling that most "vaccinated" people are beginning to realize that there there is something strange about it all. A bit of congestive dissonance is starting to set in; hence their increased desire for all to be "vaccinated".

Me, I'm not taking it; moral objections. While I don't relish the thought of dieing, on this issue, I'm at peace with the possibility. Now here's a question that people that say the "vaccines" should be mandatory need to start asking. Are they ready to die for that stance?

"You still didn't answer the question about whether "emergency use" is meant for general use or for "emergency" use to treat high-risk people?"

An Emergency Use Authorization specifies the parameters for that specific medicine's authorized audience. It can be related to specific groups of people - such as an age group - or it can be specific to those suffering from a particular condition, like a particular type of cancer. The EUA specifies the parameters of who exactly that medicine is authorized for.

"Is injecting our children a part of the emergency, or just the elderly with comorbidities?"

The EUA merely makes the medicine it's issued for available for the particular group or groups covered by the EUA. Nobody is forcing children, the elderly, or anyone else to get vaccinated. The EUA gets issued based on the groups covered by clinical trials. Pfizer originally covered ages 16 and older in their trials, so their EUA covered everyone ages 16 and older. Moderna's clinical trials only included those 18 and older, so their EUA reflected that. Subsequent clinical trials to new groups of people can be used to expand the scope of the EUA, as was done here.

The law which created the Emergency Use Authorization states that an EUA is appropriate when the Secretary of HHS declares that it is. It was President Trump's Secretary of HHS that declared it was appropriate to issue EUAs for COVID-19 vaccines, citing the ongoing pandemic.

"Are the conditions that prompted the need for "emergency use" in December still in effect today?"

The pandemic is ongoing, so yes, they are. An apparent decrease in cases and deaths doesn't suddenly mean everything is over anymore than a lack of shots fired for 20 minutes on one battlefield means the entire war is over. Ultimately, none of that matters. EUAs aren't just for national emergencies. EUAs are issued dozens of times a year in cases where the Secretary of HHS determines it's appropriate based on criteria in the Public Readiness and Emergency Preparedness Act of 2005.

"Do we know more today about what constituted the "emergency" such that, given what we know today, the "emergency use authorization" would still be granted today or other treatments would suffice?"

That's really up to the Secretary of HHS, per the 2005 PREP Act.

"You get the gist of my question... shouldn't "emergency use" be limited to people in emergency situations, that is, people in the highest risk categories?"

I understand where you're coming from, but the law is written to provide the Secretary of HHS with wide latitude to make these judgement calls. 16 and 17 year olds were already included in the December Pfizer EUA. The only change is that new clinical trials demonstrated safety and efficacy in a younger group, so the EUA was expanded to include those who've had successful clinical trial results.

If you're looking for an end to the EUAs, the most likely scenario for that is when full FDA approval is given to one or more of the vaccines currently under EUA. That should happen by the end of this summer for Pfizer and Moderna, since both are being given Priority Review (FDA reviews and provides a response within 6 months). Given the strength of both their clinical trial data and the real world data, it's extremely likely both will gain full FDA approval. The question at that point is whether J&J can maintain an EUA with two fully approved vaccines available on the open market.

I understand where you're coming from, but the law is written to provide the Secretary of HHS with wide latitude to make these judgement calls.

Thanks.

So what's your opinion? You seem very knowledgeable about the subject, but you're just posting boilerplate. Do you think children should be vaccinated at this point, given what we know and what we are still being surprised by?

It seems to me that the wider we expand the use of the vaccines down to less at-risk people, the more we are exposed to these side-effects. Do you have a sense of where the line is between "needing" the vaccine and socially "pushing" the vaccine?

-PJ

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