Is it ok to ask about the ramping up of vaccine side effects stories?

[SparklingJam]

I’m generally pro vaccines, but I’m starting to question the effects of the covid jab, and wonder if it’s possible to have a discussion about it. Apologies if this has been done to death, or isn’t an accepted topic.

I’ve been seeing more information about deaths of young men, how the vaccine isn’t very effective against covid, and hearing all about dreadful side effects, to the point where some people won’t have the jab because they “know” they’ll die.

I can fully accept that there are side effects, but the talk of increased deaths (apparently 1300 excess deaths per week, coupled with videos of supposed undertakers saying they are 50-100% busier now) is making me question things and worry.

Having said that, in my extended circle of friends, family and colleagues, I know many people who are mostly vaccinated, and apart from a day or 5 of feeling fluey they all have no side effects and haven’t died.
At the same time through the same extended group, I know a couple who have died of covid and several who still have long covid which has disabled them to varying degrees.

It would be logical to think that the excess deaths are a catch up to lock down and lack of hospital treatment, plus the current issues many have with seeing a gp or calling an ambulance, but I am assured by certain people that the excess deaths are solely due to the vaccine.

What the actual fuck are you on about?

Full FDA Approval of a COVID-19 Vaccine: What You Should Know

Updated on February 14, 2022

The Pfizer/BioNTech and Moderna COVID-19 vaccines have received full approval by the Food and Drug Administration (FDA).

Do you ever tire of being wrong? And the correct term is EUA (emergency use authorization), not EMA.

But you offered to share it?!

When people call your bluff, you come up with a million and one reasons as to why you possibly can't.

If I had genuine evidence vaccination was harmful, I would be explicity informing as many people as possible, with verifed sources linked, not making vague and elusive hints.

And it really wouldn't be of any benefit to those who have already been vaccinated.
Ah right - because they're all going to drop dead and there's nothing they can do? Ridiculous.

That is ABSOLUTELY WRONG. The head of Pfizer put a document up the other day. you might want to read it.

@Samarie123

I think you need to ask yourself that question…

Are you going to link any of these "documents" you keep referring to?

Again - where did you get this document?

Why do you have access to it, but no scientists of clinicians do?

Albert Bourla linked a document that reads:
Emergency Use Authorization
Emergency uses of Pfizer-BioNTech COVID-19 Vaccine, Bivalent have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 5 years and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

Now do some of you ever tire of being wrong?

The irony....

That statement refers to the bivalent boosters (the clue being that "bivalent booster" is included in the statement).

@bronzepig
which is what people are being offered now, correct?

Yup - not sure anyone has ever denied that they're under this type of authorisation?

so, the irony is ???

The were all in EUA when people started taking them right at the very beginning!

This is getting ridiculous. This is not the grand reveal you think it is.

Yes they were. The original vaccines are not under emergency use approval anymore, which is what you claimed, and why posters corrected you.

That the PP asked "are you ever tired of being wrong", whilst being wrong, and being someone who has continually posted fake claims for the past two years.

Again, you are just revealing you don't understand what you're talking about.

Post-authorization long-term follow up happens for all vaccines and drugs.

There was a recent analysis published on the HPV vaccine which was approved over a decade ago.

@hangryyhippo
but they were not wrong. the current shots being offered, i.e. bivalent, are under EUA, as were CV vaccines when they were rolled out globally.

Vaccines need to be trialled for years not bloody days and the new one on 8 mice? Please do your research and stop believing all the nonsense from VERY well paid ''professionals'''

God - the old ‘do your own research line”. Is there a conspiracy theorists bingo card??

Here's What the FDA's Full Approval of the Pfizer & Moderna COVID-19 Vaccines Mean for You

Feb. 14, 2022 - Katie McCallum

On Aug. 23, 2021, the FDA granted full approval to the Pfizer COVID-19 vaccine. Next, on Jan. 31, 2022, the agency granted full approval to the Moderna COVID-19 vaccine.

"These vaccines were initially granted emergency use authorization (EUA), which allowed them to be distributed in a timely manner during this devastating pandemic," explains Dr. H. Dirk Sostman, chief academic officer of Houston Methodist.

"Now, the FDA has taken a step beyond EUA and granted full approval to these vaccines," says Dr. Sostman.

Specifically, Pfizer is fully approved for the prevention of COVID-19 in people 16 years of age and older, and Moderna is fully approved for people 18 years of age and older.

Each vaccine will continue to be available under its EUAs for:

Teens who are between 12 to 15 years of age (Pfizer)

Younger children between 5 to 11 years of age (Pfizer)

Certain people as a third dose or booster shot (Pfizer and Moderna)

Additionally, the Johnson & Johnson COVID-19 vaccine will still be offered under its EUAs.

"Full FDA approval of these vaccines is significant because it firmly reinforces what we already knew: The COVID-19 vaccines are safe and effective," adds Dr. Sostman. "We are hopeful that full approval will give people additional confidence to get vaccinated."

Still, you might not be totally sure what "full approval" truly means — in general, as well as for you more specifically.
Full approval reinforces that the vaccine is safe and effective

"After hundreds of million vaccinations and reviewing nine months of data and information — not just from clinical trials, but large-scale vaccination efforts, too — the FDA has determined that the benefits of these vaccines continue to significantly outweigh the risk of getting COVID-19," says Dr. Sostman.

Before granting full approval, the FDA keeps its eye on a few things, including:

Long-term effects and the potential for rare adverse events to arise

How vaccine "efficacy" translates into real-world effectiveness

Manufacturing quality control and consistency

One adverse event identified was the very small risk of experiencing an allergic reaction after receiving the vaccine. This didn't mean the vaccine was unsafe for most people, though. It simply changed how the vaccine is administered (people are monitored for 15 minutes after their shot) — and made this risk clearly known to those who are allergic to any of the vaccine's ingredients.

"For instance, vaccine distributors now knew they needed to ask about severe allergies before administering the vaccine," says Dr. Sostman.

Additionally, large-scale vaccination data helped inform how effective the vaccine is in the real world — bolstering the benefit of vaccination.

"Even with the more infectious omicron variant, both vaccines continue to provide strong protection against severe disease and hospitalization," says Dr. Sostman.
Full approval may help ease vaccine hesitancy

More than 200 million Americans have received at least one dose of COVID-19 vaccine.

Still, others have remained hesitant.

"We're hopeful that full approval provides these people with the confidence needed to get vaccinated as soon as possible. COVID-19 has taken more than 900,000 lives in the U.S. alone and vaccination is the best tool we have to protect against more death," says Dr. Sostman.

The FDA's message is clear: The Pfizer and Moderna COVID-19 vaccines meet the high standards for safety, effectiveness and manufacturing quality the agency requires of an approved product.

"If you're not yet vaccinated, now is the time. And if you have questions about the vaccines, I cannot stress enough how important it is to turn to a trusted health expert for guidance, rather than to social media that is full of myths and misinformation," adds Dr. Sostman.

For instance, your primary care doctor can help you understand how the vaccines work, the side effects that may occur and the benefits of vaccination. He or she can also provide tips on how to deal with vaccine anxiety and decision-making.
Full approval means a few more behind-the-scenes things

While it may not mean much to you right now, full approval means Pfizer and Moderna are now free to market the vaccines and continue to offer them beyond the pandemic.

Pfizer's COVID-19 vaccine will now also go by the name of Comirnaty and can be marketed to people 16+ for the prevention of COVID-19. Moderna's vaccine can now be marketed by the name of Spikevax to people 18+.

Full approval also means that the Pfizer and Moderna COVID-19 vaccines can now be prescribed "off label."

"What this means is that you and your health care provider can use the vaccine in a way that's not approved by the FDA," says Dr. Sostman.

An example of that right now would be as a booster shot in someone who's not quite eligible yet, for one reason or another.

This is very common with many FDA-approved medications that are used by physicians and patients outside of the FDA guidelines. But do keep in mind: If you and your health care provider make the decision to use one of these vaccines off label, know that FDA has not determined that this specific use is safe and effective.

Next Steps:

Here we go!