Chance (13 Jun 2021)
"Beware - FDA Just Extended The Shelf Life Of The Johnson & Johnson Janssen Covid-19 Vaccine!"


 

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."
 
"Increasing demand has proven difficult.  Almost 52% of people in the United States have received at least one Covid-19 shot, but vaccination rates are falling to new lows."  Going to waste? Hundreds of thousands of doses of Johnson & Johnson COVID-19 vaccine will expire this month 
 
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."

FDA extends expiration dates on Johnson & Johnson vaccine doses
 
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 & Johnsonís 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 & Johnsonís Janssen COVID-19 Vaccine Overview and Safety | CD

Janssen COVID-19 Vaccine EUA Fact Sheet for Recipients and Caregivers 04232021
 
And the FDA still approved this!  

Johnson & Johnson has a goal of one billion doses for the world through 2021 and 100 million doses for the U.S. 
Johnson & Johnson Announces Agreement with U.S. Government for 100 Million Doses of Investigational COVID-19 Vaccine | Johnson & Johnson
 
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
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