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Posted on 12/11/2020 8:03:23 AM PST by BeauBo
The FDA has informed Pfizer it intends "to proceed towards an authorization" of the manufacturer's Covid-19 vaccine, the US Health and Human Services Secretary told ABC on Friday morning...
The statement comes a day after an FDA panel recommended the agency grant an emergency use authorization for the Pfizer-BioNTech coronavirus vaccine.
Other key steps remain, but if those hurdles are cleared, the first vaccinations in the US could happen as early as Monday or Tuesday, HHS Secretary Alex Azar told ABC's George Stephanopoulos.
"Just a little bit ago, the FDA informed Pfizer that they do intend to proceed toward an authorization for their vaccine," Azar told ABC.
"We're looking at 20 million Americans being vaccinated just in the next coming weeks (and) up to 50 million total by the end of January," he told ABC. "We believe we could have 100 million actual vaccinations in arm by the end of February."
(Excerpt) Read more at cnn.com ...
So reasonably, lockdowns should be going away for good, in March (plus or minus a month, by location).
The first quarter of 2021 should get all the really high risk people, and many essential workers. The second quarter of 2021 should be widespread availability of the vaccine for the bulk of low risk people.
There is also the growing evidence of Ivermectin as a very effective treatment - a cure.
will they ‘authorize’ against facial paralysis,
hyperautoimmune reactions, iatrogenic unknowns,
sterility, positive HIV tests, induced cancer,
uncontrollable DNA changes, and more?
or even obtain INFORMED CONSENT vis a vis the above?
did they every authorize HCQ?
Even though I am at risk, and care for a sick elderly mother, I would rather wait. Of course, the media will block any discussion of harmful effects...
There’s quite a few effective ways to fight this, but they don’t want that, it doesn’t play into their goals.
Are they going to approve any of the other vaccines other than Pfizer?
[Even though I am at risk, and care for a sick elderly mother, I would rather wait.]
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“There is also the growing evidence of Ivermectin as a very effective treatment - a cure.”
Also as a way to prevent the virus.
“did they every authorize HCQ?”
HCQ remains an approved drug, that can be prescribed for off-label uses, like COVID-19. There was a partial approval of its use specifically for COVID (I think an emergency use authorization), that was later retracted. It is up to individual physicians to decide if they will use it, without official top cover.
HCQ now seems to be overshadowed by Ivermectin though, for treating or preventing COVID. Strong testimony to the Senate this week, by a very credible group of scientists, proposed that Ivermectin is a reliable cure for COVID-19.
“will they ‘authorize’ against facial paralysis,
hyperautoimmune reactions...?”
The Bell’s Palsy (facial paralysis) was noted in four cases, of the over 40,000 in the phase 3 trial, but were assessed by the review panel to not be caused by the vaccine. The hyperautoimmune reactions was noted in two cases of the UK’s mass vaccination program, that started Tuesday. They are designated to be specifically monitored going forward.
The Bell’s Palsy is a temporary side effect (normally, and so far in those four cases), but the hyperautoimmune reactions are potentially life threatening, so the UK has recommended that anyone prescribed an epi-pen for severe allergic reactions, refrain from taking the vaccine, except for those supervised in a continued study of this sub-population.
The vaccine has no history. Period...
Millions of approved drugs have been taken off the market. The big one I remember is Thalidomide. And it was such a minor drug.
“Are they going to approve any of the other vaccines other than Pfizer?”
Moderna is up next, probably next week, or the week after.
They use the same mRNA technology as the Phizer/BioNTech vaccine, and have reported similarly high effectiveness (like 95%). It does not need to be stored at as cold of a temperature, as the Phizer vaccine (-4 F, instead of -94 F).
Moderna is also already on contract under the Defense Production Act, for 100 million doses, and already in full scale production.
The next two vaccines (Johnson & Johnson, and Astra Zeneca/Oxford) are likely to come up for approval in January or February.
One candidate (of eight), the Glaxo Smith Kline/Sanofi vaccine, is looking like a failed experiment, with effectiveness under 50%. But because of the redundant investments made by Operation Warp Speed (and the rest of the world pursuing more than 100 candidates), plenty of successful candidates are coming down the pipeline.
It is the biggest vaccination program in human history. You will be hearing more about it in the coming weeks and months, as they try to line up enough arms for the coming tsunami of vaccine.
Moderna will be approved 12-17. Astra Zenica/Oxford has hit a speed bump.
“Even though I am at risk, and care for a sick elderly mother, I would rather wait.”
Full scale trials were conducted (over 40,000 in Phase 3), and monitoring is in place for the millions that will soon be receiving this vaccine. We may reach a rate of a million vaccinations per day next month. So any yet undetected problems stand a good chance of being uncovered quickly.
But the Ivermectin is an interesting option, if God Forbid, an at risk family member were to contract COVID-19, before you feel comfortable with the vaccine.
I just want ALL federal and state politicians and department leaders, and their spouses, children and parents, to be the first to get the vaccine. Well documented.
Then wait xx days for side-effects monitoring, and publish their results, before going public with it.
“I just want ALL federal and state politicians and department leaders, and their spouses, children and parents, to be the first to get the vaccine.”
If they live, the vaccine is safe.
If they die, the people are safe.
The FDA Report for your consideration.
It will still actually be an “unapproved drug”.
This is nothing more than a massive clinical trial and they have no idea about the longer term side effects.
What they are going to approve is an Emergency Use Authorization (EUA).
Below is just 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...”
So, there ya go.
Those seem like prudent monitoring efforts, to continue collecting follow up data for 30 months, from those accessible populations (20K health care workers, the Military and Veterans Affairs health care systems).
The Military and VA have a public health mission for epidemic control/response, so this is a standing capability that they should have in place, and which should be exercised.
The FDA has informed Pfizer it intends “to proceed towards an authorization” of the manufacturer’s Covid-19 vaccine
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To me, that’s BUREAUCRATESE for “WE’RE TAKING OUR SWEET TIME TO SHOW HOW IMPORTANT AND POWERFUL WE ARE”.
I’ll be damned... the FDA just approved the EUA for the Pfizer vaccine. I guess they took President Trump’s “threat” seriously!
There is NOBODY like Trump!
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