Hello John and Doves,
The FDA has just
extended the shelf life of the Johnson & Johnson
Covid-19 Janssen vaccine from the manufacturer's
determined 3 months to 4 1/2 months.
Because
J&J was later than Pfizer and Moderna in getting a
vaccine approved by the FDA (February 27) and there was
an 11 day pause starting on April 13 due to blood
clots...there is now a surplus per state of vaccines -
hundreds of thousands of
these 'already bought and paid for' vaccines are set to
expire soon.
When J&J
applied for FDA approval their request included the
shelf life of the vaccine - in this case it was three
months refrigerated at 36 to 46 degrees or two
years if frozen at minus 4 degrees.
This vaccine is
different from the Pfizer and Moderna mRNA vaccines in
that it uses a viral vector - an adenovirus - whose genome
contains coronavirus genes that code for the SARS-CoV-2
spike protein. After injection, this adenovirus
enters human cells - these cells read the genetic
instructions and put the spike protein on their own
surface...the immune system sees these new proteins and
makes antibodies against these. So when the person
comes in contact with the SARS-CoV-2 virus it will already
have antibodies ready to attack it.
To date 10 million doses
of J&J vaccine have never been given - only about half
have even been delivered. The U.S. government has already
paid for all of these vaccines.
Arizona has some 100,000
doses set to expire on June 23. Ohio has 200,000
expiring on June 24. Arkansas has 93,271 set to
expire - more on June 23 and the rest on July 4. And
the list goes on.
"You've got
three choices," said John Grabenstein, a
former Merck executive and former director of US
Department of Defense military immunization program.
"You increase demand (make people take these) and
use the doses up, you extend the expiration date, or
your throw them away."
Extending the date would
require J&J to do more testing on each lot produced -
this takes time and J&J doesn't have the proper amount
of time to do this. They didn't have 'the proper
amount of time' to test this from the get go! The
expiration dates are fast approaching.
So, people involved are
looking at increasing 'test subjects' - like passing the
vaccines on to Mexico or donating them
internationally. However, this takes time - the
vaccine will expire before they can be gathered up and
shipped. And many countries aren't set up to deliver
tens of thousands of doses to their people before the set
expiration dates.
So the only real option
of the three is 'extend the shelf life'.
Every state has VERY
strict Covid-19 vaccine procedures to follow - including
"Proper storage and handling procedures. Vaccine
receiving procedures. Vaccine relocation
procedures in the event of a power or equipment
failure. Response procedures for when vaccines are
stored out of temperature range." And monitoring
temperatures in vaccine storage unites, administering
vaccines, and transporting vaccines - all must follow
set SOPs. All of this is closely regulated by
states. And it's based on the vaccine
manufacturer's information.
https://www.mass.gov/doc/guidelines-for-compliance-with-federal-vaccine-administration-requirements/download
download
The above
article "Going to waste?" was published on June
10. And the below
article came out of June 10.
Surprise! The FDA
has fixed the problem! This news came out on June 10
- shortly after numerous states noted the expiration date
problem. The FDA moved quickly to solve this
problem.
The FDA has "extended
the expiration date on millions of doses of it Covid-19
vaccine by an extra six weeks." How convenient!
J&J said Thursday
(June 10) that "a Food and Drug Administration review
concluded the shots remain safe and effective up to 4 1/2
months. The announcement comes after state officials
warned that many unused doses in storage would expire
before the end of the month."
"Expiration
dates for vaccines are determined based on data the
manufacturer submits to regulators proving how
long the shots stay at the right strength."
The article goes on to
report that the FDA "extended the period to 4 1/2 months
based on data from ongoing studies assessing the vaccine's
stability.
"As
vaccinations have slowed it's become clear the U.S. is
unlikely to meet President Joe Biden's goal target to
have 70 percent of American adults partially vaccinated
by July 4."
"The extension
will help maintain vaccine supplies even as the rate of
new injections continues to slip....The country
averaged about 800,000 new injections per day last
week....Government officials have turned to a growing
number of incentives to encourage shots - from paid time
off to $1 million lottery prizes."
How much do you want to
bet that the pressure on the FDA to give Biden his '70% of
Americans vaccinated by July 4' was the motivating factor
in extending this date past the manufacturer determined 3
months? This is an experimental vaccine with VERY
short clinical testing to start with! J&J
started its clinical trials on people, Phase 3, on
September 23 - and only had full enrollment of 45,000
adults for their Covid-19 vaccine in December 2020!!
They submitted it for approval on February 4, 2021.
And it was FDA approved on February 27! Do the
math. When did they even have time to look at side
effects past a month or two?
5
Facts About Johnson & Johnson’s Investigational
Janssen COVID-19 Vaccine Candidate
Yet, J&J reports that
their vaccine results were FDA approved under the Emergency Use Authorization based
on an "ongoing clinical trial, 21,895 individuals 18 years
of age and older.." (quote from above article on
J&J website) What happened to the rest of the
45,000 adults?? This was a global clinical trial -
not just the U.S. So this vaccine was released to
the public based on 21,895 test subjects?! Their
additional studies only followed 3,000 participants for 11
weeks and 1,000 participants for 15 weeks to see how the
efficacy of the vaccine held out! What? This
is basically a handful of people. So they had what, maybe four
months max to look at efficacy and side effects!
That's unbelievable!
They even reported the
side effects: "blood clots involving blood vessels
in the brain, abdomen, and legs along with love levels of
platelets have occurred in some people who have received
the Janssen Covid-10 Vaccine. In people who
developed these blood clots and low levels of platelets,
symptoms began approximately one to two-weeks following
vaccination. Most people who developed these blood
clots and low level platelets were females ages 18 through
49 years." What?
They reported that "the
Janssen Covid-19 Vaccine has been shown to prevent
Covid-19 following a single dose." This makes one
think - you won't get Covid if you take this. Yet, the CDC
reports this vaccine "was 66.3% effective in clinical
trials at preventing laboratory-confirmed illness in
people..." What? 50% is the pass/no pass line
for approving a vaccine.
Johnson
& Johnson’s Janssen COVID-19 Vaccine Overview and
Safety | CD
And the FDA still approved
this!
This vaccine has been
associated with blood clots and low platelet counts - it's
production was even paused due to these concerns - but the
FDA determined that it was fine to continue usage.
This vaccine is a single
dose and had been approved by the FDA for people 18 years
of age and older under an Emergency Use Authorization.
Multiple questions arise
about this vaccine - expiration date of 3 month was set
due to testing by the company...now suddenly, the company
discovers the vaccine is stable to 4 1/2 months. Did they
do more clinical trials on people? No. Will
the adenovirus they created with the Covid-19 new genes
mutate into something else? Will it still make the
spike protein or something else? The vaccine is very
labile - the manufacturer knows this.
There has not
been time to re-test this vaccine clinically.
It's experimental. The only testing being done
is on the American population now.
The only reason the FDA
has done this, imo, is they need this vaccine to reach
Biden's magic number of 200 million Americans vaccinated
by July 4!
Be aware of the Johnson
& Johnson vaccine - the FDA has extended the
expiration date because THEY need the vaccine to meet
THEIR goal!
The FDA is not our
friend.
Pray for the peace of
Jerusalem!
Maranatha!
Chance
.