I saw orders come through for Prevnar 20. I can’t find FDA approval, only the approved application. Is this the same game as the Covid vaccine or am I missing something?
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Hi fren, see the Supporting Documents section (Downloadable Documents)
There is an approval for the Biologics Licence Application (BLA) June 10 2021
This June 10 2021 Approval corrects error in June 8 2021 Approval.
https://www.fda.gov/media/150021/download This sparked my concern. It looks like it got accelerated approval and has post-marketing studies to complete by 2027. 2027?
I didnt look at what you've posted, im short on time, however I can tell you that Post-marketing studies are known as stage 4 clinical trials that are ongoing after a a product is approved for use in humans. They usually go on for years after a product is approved to see if there are any long term negative consequences of a product that were not caught in the earlier clinical trials. They are normal.
Ok, thank you. I’m just so nervous and have little trust these days.
Hi fren, I just had a quick search. You may already have this FDA information.
https://www.fda.gov/vaccines-blood-biologics/vaccines/prevnar-20
We could do a bit more digging on this.
I saw this, but as a nurses, do we have to educate that it has not yet completed clinical trials? I feel if this isn’t documented we have legal problems. It’s not cut and dry as it should be leading me to suspect deceit.
I agree, this needs more investigation. It looks like it's approved (these days, does that really mean anything? Especially as it's manufactured by a Pfizer subsidy)
On that approval document, it indicates it will be delivered in conjunction with the influenza vaccine.
This really needs further investigation. After the debacle with the Covid Vaccines, it really generates a feeling of great uneasiness.
Especially when pneumonia might be best dealt with by other means, other than a vaccine.
I'm not in the medical profession. As a nurse, are you aware of problems with previous Pneumococcal Vaccines?
Not specifically, except if the original pneumococcal vaccine, Prevnar 13 and Prevnar 23 are not enough, is 20 more worthy of accelerated approval? Are we seeking autoimmune responses?
Not being in the medical profession, but after these last 3 years, I'm a bit wary of stuff like this.
I don't know if it's possible, (I'm in Australia) but I wonder if it would be possible to contact Dr Pierre Cory at Frontline Covid Critical Care (FLCCC) Also Dr Paul Marik.
Both Dr Kory and Dr Marik are very senior ER Doctors specialising in Pulmonary care.
This would be right up their alley. You probably have the FLCCC information but if you don't, just search FLCCC and you will find the information on how to get in contact.
Near the bottom of the FLCCC site there is contact information.
I wish you all the best. This really needs specialist information.
Thank you.