Big Pharma vaccine manufacturer Johnson & Johnson now recommends a second dose of the single dose vaccination. An FDA panel unanimously voted to authorize boosters to all adults
Johnson & Johnson announced the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee’s (VRBPAC) unanimous vote of 19-0, recommending Emergency Use Authorization (EUA) for booster doses of the Johnson & Johnson COVID-19 vaccine in adults aged 18 and up, at least two months following the initial single dose vaccination.
“We want to provide optimal protection against COVID and we know that a booster dose will do that,” Dr. Penny Heaton, global therapeutic area head for vaccines at Janssen Research & Development, told the panel during their virtual meeting.
Almost 9,000 participants in Johnson & Johnson’s clinical trials have received a booster shot, though “safety and effectiveness data” was only submitted on a small part of that number.
The company’s website offers an Emergency Use Authorization fact sheet.
How will additional data on the effectiveness of the vaccine be obtained?
Johnson & Johnson’s official website states, “[S]tudies conducted by the manufacturer or by the U.S. government evaluating effectiveness of the vaccine as used under the EUA”
This means that any Americans who choose to get injected with a second dose of Johnson & Johnson will be participating in a mass clinical trial.
Where will vaccinated information be recorded?
According to J&J, each “state/local jurisdiction’s Immunization Information System (IIS)” will record and store their customer’s health information. This private information will be surveilled to determine vaccination status, and eligibility to participate in societies resources, as the definition of “fully vaccinated” continues to shift.
What are the ingredients inside the Johnson & Johnson coronavirus injections?
The Janssen COVID-19 Vaccine includes the following ingredients:
- recombinant, replication-incompetent adenovirus type 26 expressing the SARS-CoV-2 spike protein
- citric acid monohydrate
- trisodium citrate dihydrate
- 2-hydroxypropyl-β-cyclodextrin (HBCD), polysorbate-80
- sodium chloride
What are the benefits?
The benefits, as described “prevent COVID-19 following a single dose”, however “[t]he duration of protection against COVID-19 is currently unknown.”
Dangers of Johnson & Johnson
Though a laundry list of side effects exist with the adenovirus concoction, the most extreme side effects occur within a small percentage of its participants.
Side effects –
These side effects include:
- Injection site reactions: pain, redness of the skin and swelling
- General side effects: headache, feeling very tired, muscle aches, nausea, and fever
- Swollen lymph nodes
- Unusual feeling in the skin (such as tingling or a crawling feeling) (paresthesia), decreased feeling or sensitivity, especially in the skin (hypoesthesia)
- Persistent ringing in the ears (tinnitus)
- Diarrhea, vomiting
- Shortness of breath
- Difficulty breathing
- Swelling of your face and throat
- A fast heartbeat
- A bad rash all over your body
- Dizziness and weakness
- Shortness of breath
- Chest pain
- Leg swelling
- Persistent abdominal pain
- Severe or persistent headaches or blurred vision
- Easy bruising or tiny blood spots under the skin beyond the site of the injection
- Weakness or tingling sensations, especially in the legs or arms, that’s worsening and spreading to other parts of the body
- Difficulty walking
- Difficulty with facial movements, including speaking, chewing, or swallowing
- Double vision or inability to move eyes
- Difficulty with bladder control or bowel function
“These may not be all the possible side effects of Janssen COVID-19 Vaccine. Serious and unexpected effects may occur. The Janssen COVID-19 Vaccine is still being studied in clinical trials.” reads the EUA fact sheet.
While every side effect and the long term effects of this concoction may be unknown, Johnson & Johnson has taken an extra step to prevent any form of backlash due to potential long term vaccine injury: implementing the CICP.
The Countermeasures Injury Compensation Program (CICP) –
The Countermeasures Injury Compensation Program (CICP) “is a federal program that may help pay for costs of medical care and other specific expenses for certain people who have been seriously injured by certain medicines or vaccines, including this vaccine.”
To protect patients, the CICP offers a one-year health guarantee on the Johnson & Johnson product, from the date of receiving the vaccine.
The CICP was founded in 2010. As of October 1st, 3,649 claims have been filed, and 29 claims have been compensated.
Blood Clot Risk Analysis –
On April 13, 2021 the CDC and the FDA announced a pause in the Johnson & Johnson vaccine after administering more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine throughout the U.S. due to six patients developing Thrombosis with thrombocytopenia syndrome (TTS), serious blood clots, after being injected with the substance.
Why did the pause end?
Johnson & Johnson’s vaccine was reviewed and showed that it’s “known and potential benefits, outweigh its known and potential risks for those recommended to receive it”.
Beyond adenovirus vector viral vaccines, are blood clots common in mRNA vaccines?
Since administering 346 million doses of mRNA COVID-19 vaccines, two confirmed cases of Thrombosis with thrombocytopenia syndrome (TTS), blood clots, have been reported. While this doesn’t mean mRNA injections are side effect free, this data displays evidence against blood clots resulting from mRNA concoctions .
Dr, Fauci –
“This [Janssen] should have been a two-dose vaccine to begin with,” Dr. Fauci proclaimed on ABC News on Oct. 17. “I think it’s very favorable for those who have received the J&J vaccine. I don’t see that as a problem at all.”
Johnson & Johnson –
“Today’s recommendation is based on the totality of evidence, with clinical and real-world data showing that while a single shot offers strong and long-lasting protection against COVID-19, a booster given after the single-dose primary vaccination increases protection, in particular against symptomatic COVID-19,” stated Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson.
“Johnson & Johnson is steadfast in its commitment to protect as many people globally as possible against the continued spread of COVID-19,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “Today’s recommendation by the VRBPAC is another step toward ensuring that those who have received the single-shot Johnson & Johnson vaccine – or will receive it in the future – are provided the opportunity to increase their protection against COVID-19. We look forward to sharing these data with regulatory bodies and advisory groups around the world to address the continued threat of COVID-19.”
Clinical Trial Data
The Company’s EUA amendment submission included results from their Phase 3 Clinical Trial
This clinical trial found a Johnson & Johnson booster dose at two months provided:
- 94% protection against symptomatic (moderate to severe/critical) COVID-19 in the United States
- 100% protection against severe/critical COVID-19, at least 14 days post-booster vaccination.
- 75% protection against symptomatic (moderate to severe/critical) COVID-19 globally
The clinical trial data on booster shots also displayed a,
- 9-fold increase in antibody levels one week after booster was given
- 12-fold increase in antibody levels four weeks after the booster
The submission also included data from the “largest real world study for a COVID-19 vaccine reported to date” U.S. real-world evidence study, conducted from March to July 31, 2021, and recently extended to August 31, 2021.
- 390,000 people who received the Johnson & Johnson COVID-19 vaccine
- 79% effectiveness for COVID related infections
- 81% effectiveness for COVID related hospitalizations.
- 1.52 million unvaccinated people
“Johnson & Johnson remains committed to helping end this pandemic as quickly as possible and is committed to diligently generating and evaluating real-world evidence, as well as evidence from its ongoing clinical trial program.”
The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will discuss the use of boosters and expects further recommendations set for October 21st, 2021.
With more similarities to traditional vaccinations, are viral vector vaccines more dangerous than mRNA technology? Is a risk of blood clot greater than the risk of artificially influencing our natural DNA? (“influencing”, i.e. the forced temporary production of proteins, not a permanent change to DNA)
Are the long term physical effects following the aftermath of a coronavirus infection greater than that of the risk from vector viral vaccines? Who should choose what’s best for you and your family? With an era of medical surveillance on the rise, should personal health decisions be at the discretion of the individual?