Posted on 12/10/2020 3:19:18 PM PST by BeauBo
A U.S. government advisory panel endorsed widespread use of Pfizer’s coronavirus vaccine Thursday, putting the country just one step away from launching an epic vaccination campaign against the outbreak that has killed close to 300,000 Americans.
Shots could begin within days, depending on how quickly the Food and Drug Administration signs off, as expected, on the expert committee’s recommendation...
Pfizer has said it will have about 25 million doses of the two-shot vaccine for the U.S. by the end of December. But initial supplies will be limited and reserved primarily for health care workers and nursing home residents, with other vulnerable groups next in line...
The FDA next week will review a second vaccine, from Moderna and the National Institutes of Health, that appears about as protective as Pfizer-BioNTech’s shot. A third candidate, from Johnson & Johnson, which would require just one dose, is working its way through the pipeline. Behind that is a candidate from AstraZeneca and Oxford University
All eyes now turn to the FDA staff scientists who will make the final decision on whether to greenlight use of the Pfizer-BioNTech vaccine. Regulators not only in Britain but in Canada have already approved it for use in their countries, and President Donald Trump and White House officials have complained for weeks about the pace of FDA’s careful review.
FDA’s vaccine director Dr. Peter Marks said ahead of the expert meeting that a decision would come within “days to a week.”
(Excerpt) Read more at apnews.com ...
UK already warning don’t take this if you have allergy problems.
Biggest surprise since Reagan’s reelection. Now watch the deaths really zoom.
My fear, widespread death or disability. It’s crazy to pump anything in your body without some understanding of the potential adverse long term consequences.
I cannot find and specificity as to whether this means previous allergies or reactions to prior vaccines or allergies in general such as a peanut allergy or other allergic reaction.
General problems with allergies.
I’ll look for the video.. i watched it yesterday
Surprised the AP didn’t refer to it as Biden’s Vaccine.
“I cannot find and specificity as to whether this means previous allergies or reactions to prior vaccines or allergies in general such as a peanut allergy or other allergic reaction.”
This concern was just raised after the UK began their immunization program, days ago, so little it has not been fully examined yet.
I believe they (UK) are cautioning anyone who is prescribed an epi-pen for a severe allergy, against getting the vaccine, until they look into it further.
It was not an issue in the Phase 1, 2, or 3 trials this year, with tens of thousands of participants.
It will likely become clearer next week, if there is anything to this, as the UK and Canada drive on immunizing.
Food OR Vaccine allergies
coming soon
fake vaccine for the elite
Is this the one that’s causing Bell’s Palsey in folks?
Thank you. My daughter has a shellfish allergy and carries an EpiPen.
“A U.S. Panel”.......No thanks and fvk you very much.
Your welcome.... i have another video for you to watch...
This one concerns a re-purposed drug that FDA is ignoring in favor of these crazy vaccines.
Like Hydrocortisone, this is an anti-viral drug we’ve had for a long time which apparently decimates Covid-19.
This is a long time Doctor on the front lines begging for approval of something he knows works.
https://www.youtube.com/watch?v=Tq8SXOBy-4w
Oh.. i forgot to mention the drug name... “Ivermectin”
The public is being misinformed. Just this evening announcements are being made that the FDA is about to “approve” the Pfizer vaccine.
What they are going to approve is an Emergency Use Authorization (EUA).
Below is some of the information found in the FDA Report:
https://www.fda.gov/media/144245/download
Vaccines and Related Biological Products Advisory Committee Meeting
December 10, 2020
FDA Briefing Document
Pfizer-BioNTech COVID-19 Vaccine
“In the event an EUA is issued for this product, it would still be considered unapproved and it
would be under further investigation (under an Investigational New Drug Application) until it is
licensed under a Biologics License Application (BLA).
Licensure of a COVID-19 vaccine will be
based on review of additional manufacturing, efficacy, and safety data, providing greater
assurance of the comparability of licensed product to product tested in the clinical trials, greater
assurance of safety based on larger numbers of vaccine recipients who have been followed for
a longer period of time,”
” Female study participants of childbearing potential were screened for pregnancy prior to each vaccination, with a positive test resulting in exclusion or discontinuation from study vaccination...Unsolicited AEs related to pregnancy include spontaneous abortion and retained products of conception, both in the placebo group. Pregnancy outcomes are otherwise unknown at this time.”
(FDA mandates three more 30 month studies- does not notify population that they will be guinea pigs)
“Sponsor studies will include completion of long-term follow-up from ongoing clinical trials as well
as the following three planned active surveillance studies. Of note, the Sponsor will submit plans
for a clinical study to assess safety and immunogenicity in pregnant women and has proposed
active surveillance studies designed to monitor vaccination during pregnancy within populations expected to receive the vaccine under EUA.
• Study Protocol Number C4591008. The Sponsor proposes to survey 20,000 U.S. health
care workers enrolled in the COVID-19 HERO registry as well as health care workers in
certain participating health care facilities about adverse events of special interest, and
other clinically significant events of interest after vaccination with the Pfizer-BioNTech
COVID-19 Vaccine. Incidence rates of these events in this cohort will be compared to
expected rates. The respondents would receive follow-up surveys for a 30-month period.
• Study Protocol Number C4591011. This study is an active safety surveillance evaluation
conducted within the Department of Defense Health System Databases using data
derived from electronic health records and medical service claims among covered U.S.
military and their families. Rates of safety events of interest in vaccinated participants
will be compared to unvaccinated comparators. The study will be conducted for 30
months.
• Study Protocol Number C4591012. This study is an active surveillance study for adverse
events of special interest and other clinically significant events associated with the
Pfizer-BioNTech COVID-19 Vaccine using the Veteran’s Health Administration electronic
medical record database. Vaccinated participants will be compared to unvaccinated
participants or to recipients of seasonal influenza vaccine. The study will be conducted
for 30 months.
Currently, the primary objective of all three proposed studies above is descriptive, and the list of
adverse events in the studies has not been finalized. FDA will provide feedback on these
studies after further review.
Following authorization of the vaccine, use in large numbers of individuals may reveal
additional, potentially less frequent and/or more serious adverse events not detected in the trial
safety population of nearly 44,000 participants over the period of follow up at this time. Active
and passive safety surveillance will continue during the post authorization period to detect new safety signals.
(The fact that this is an experimental vaccine should be disclosed to those who choose to take it and along with this admission of long term health risk.)
“...risk of vaccine-enhanced disease over time, potentially associated with waning immunity, remains unknown and needs to be evaluated further in ongoing clinical trials and in observational studies...”
According to another report, the concern is based on two cases of severe anaphylaxis in people in the UK who received the vaccine.
It might have been coincidence unrelated to the vaccine, or some very special cases.
Probably best to err on the side of caution, until more is known. It should not be long before we know more however, as the vaccine will soon roll out to millions of people - the biggest vaccination program ever.
Phizer is on track to deliver 25 million doses this month, and 2-3 times as much next month. Moderna is likely to be approved next week, and have a similar production schedule. If there is a pattern of acute reactions, it should surface quickly.
Why is it taking so long. Didn’t Pfizer summit 2-3 weeks ago?
Why is it taking so long. Didn’t Pfizer summit 2-3 weeks ago?
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