Following the release of data from phase III trials on 9 November, vaccine makers Pfizer and BioNTech deployed their vaccines under emergency-use rules. The developer of another leading vaccine, Moderna, did the same.
When a vaccine is granted emergency approval, and the vaccine is rushed through, companies might not have enough data to establish long-term outcomes, such as safety. The trial phases for a vaccine typically last for multiple years to establish if the vaccine is truly safe.
This did not happen.
From Johnson & Johnson:
Phase 1 testing marks the first time the vaccine is tested in a small group of adults, usually between 20 to 80 people, to evaluate its safety and measure the immune response it generates.
Phase 2a studies aim to determine the most effective dose, and expand the safety experience with the vaccine.
Phase 4:After a successful Phase 3 trial, vaccine manufacturers submit an application to regulatory bodies such as the European Commission or the U.S. Food and Drug Administration (FDA). At this stage, clinical trial data is reviewed to make sure the vaccine is safe and effective.
The FDA also monitors adverse events that may occur related to receiving the vaccine, including through its Vaccine Adverse Event Reporting System and Phase 4 clinical trials—optional studies pharmaceutical companies may be required to perform after a vaccine is licensed to continue to monitor safety and effectiveness.
The end result: A vaccine for COVID-19 that’s been developed in months, which is something that has been unheard of.
Bill Gates once acknowledged that trials are going to have to be skipped or combined in order to rush the vaccine out. Science is going to have to be “limited” Gates suggested in one interview.
Data from Vaccine Research Facility
An anonymous source at a vaccine research facility provided us with some alarming preliminary data:
Out of our 267 participants 21% exhibited one of these adverse reactions.
• Permanent Paralysis
• Bell’s Palsy
• Cardiac arrest
70% of the 21% that exhibited adverse reactions were women.
These findings are from the initial injection. Reports released from Pfizer and Moderna show that some COVID-19 vaccine trial participants experienced a type of facial paralysis, called Bell’s palsy, in the weeks after vaccination. While rare, Bell’s palsy is a nerve condition that causes partial or complete weakness of one side of the face. The symptoms—like a sagging eyebrow or drooping mouth—come on suddenly, and typically resolve over the course of a few weeks or months. While it’s usually difficult to pinpoint a cause, viral infections can trigger Bell’s palsy.
Data from early trials of several Covid-19 vaccines suggest that consumers will need to be prepared for side effects that could ‘disrupt daily life.’ A senior Pfizer executive told the news outlet Stat that side effects from the company’s vaccine appear to be ‘worse than those of the company’s pneumonia vaccine,’ Prevnar, or typical flu shots.
According to new data released today, as of Feb. 12, 15,923 adverse reactions to COVID vaccines, including 929 deaths, have been reported to the Centers for Disease Control and Prevention’s (CDC) Vaccine Adverse Event Reporting System (VAERS) since Dec. 14, 2020.
VAERS is the primary mechanism in the U.S. for reporting adverse vaccine reactions. Reports submitted to VAERS require further investigation before a determination can be made as to whether the reported adverse event was directly or indirectly caused by the vaccine.
Gene Therapy, Not a Vaccine?
Dr. David Martin, founder and chairman of M-CAM Inc, challenges our presuppositions about the new mRNA Covid-19 vaccines. Quoting the pharmaceutical companies themselves, David suggests that these are not vaccines, but, in actuality, gene therapy. He explains what the vaccines may do to us, what they are promising they can do for us, and how to distinguish the difference.
“It’s not somewhat different. It’s not the same at all. This is a public manipulation of misrepresentation of clinical treatment. It’s not a vaccination. It’s not a prohibiting infection. It’s not a prohibiting transmission device. It’s a means by which your body is conscripted to make the toxin that then allegedly your body somehow gets used to dealing with, but unlike a vaccine, which is to trigger the immune response, this is to trigger the creation of the toxin,” said Doctor Martin.
According to recent data, immunity after infection will likely last for years. The data show that most people who have recovered 8 months after infection still have enough immune cells to fend off the virus and prevent illness. A slow rate of decline in the short term suggests that these cells may persist in the body for a very, very long time.
The findings are consistent with encouraging evidence emerging from other labs. Researchers at the University of Washington, led by the immunologist Marion Pepper, had earlier shown that certain “memory” cells that were produced following infection with the coronavirus persist for at least three months in the body.
For older people the vaccine may be the best option, but for most individuals natural infection seems to be the safest immunity method. Especially considering the fact that according to all available data, the virus itself has an infection fatality rate that is either equivalent to, or far less than the influenza for most age groups.
Many Americans Don’t Want It, Including Healthcare Workers
According to Pew Research, only about half of U.S. adults say they would definitely or probably get a vaccine to prevent COVID-19 if it were available today. Nearly as many (49%) say they definitely or probably would not get vaccinated. Intent to get a COVID-19 vaccine has fallen from 72% in May, a 21 percentage point drop.
Black Americans remain among the groups that have the least confidence in the vaccine, according to a study from the Kaiser Family Foundation.
The Kaiser study found that 35% of Black Americans would probably or definitely not get the vaccine if it was determined to be safe by scientists and widely available for free.
Dr. Joseph Varon, chief of critical care at Houston’s United Memorial Medical Center, described that over 50% of his nurses do not want to get vaccinated.
“Yesterday I had a – not a fight, but I had a friendly argument with more than 50% of my nurses in my unit telling me that they would not get the vaccine,” he told Morning Edition.
Because of this, the Hospital chain is attempting to incentivize employees by offering them an extra $500 in pay to get the vaccine.
Private companies are also offering incentives for customers who receive the vaccine.
Elon Musk recently revealed that he will not get a coronavirus vaccine when they’re available because he’s ‘not at risk’ and defends keeping his Tesla factories up and running amid the pandemic.
When asked ‘Will you get a vaccine? What will you do with your own family?’ he curtly replied, ‘No, I’m not at risk for COVID. Nor are my kids.’
He slammed lockdowns that unfolded across the country as a grave mistake.
‘I mean this is a hot button issue where rationality takes a back seat. In the grand scheme of things what we have something with a very low mortality rate and high contagion,’ he said.
‘Essentially the right thing to do would be to not have done a lockdown for the whole country but to have anyone that who is at risk quarantine until the storm passes,’ he added.
Even Mark Zuckerberg is Reluctant to Take the Vaccine
Despite his company’s policy of removing “anti-vax misinformation,” in a leaked video provided to Project Veritas, Mark Zuckerberg expressed that he was reluctant to take the vaccine because it was an MRNA vaccine that was rushed through.
Military Members Don’t Want It
Thousands of U.S. service members are refusing or putting off the COVID-19 vaccine as frustrated commanders scramble to knock down internet rumors and find the right pitch that will persuade troops to get the shot.
Some units are seeing as few as one-third agree to take the vaccine. Military leaders have identified one potential convincer: an imminent deployment. Navy sailors on ships heading out to sea last week, were choosing to take the shot at rates exceeding 80% to 90%.
Their resistance also comes as troops are deploying to administer shots at vaccination centers around the US, and as leaders look to American forces to influence the rest of the nation.
“We’re still struggling with what is the messaging and how do we influence people to opt in for the vaccine,” said Brig. Gen. Edward Bailey, the surgeon for Army Forces Command. He explained that in some units just 30% have agreed to take the vaccine, while others are between 50% and 70%.
Adverse Reaction in Healthcare Workers
In December, two health care workers in Alaska suffered adverse reactions minutes after receiving Pfizer’s COVID-19 vaccine.
One of the healthcare workers was a middle-aged female with no history of allergies who had an allergic reaction that included flushing and shortness of breath within minutes of receiving the first of Pfizer’s two-dose vaccine on Tuesday.
She was rushed to Bartlett Hospital after the incident.
The woman experienced an anaphylactic reaction that required hospitalization and monitoring, and will not be receiving the second dose of the vaccine, officials said during a press briefing on Wednesday. She took a Benadryl to relieve the symptoms but it did not work and was rushed to the hospital.
Kristi Simmonds is an RN who loves her job, loves her friends and family, loves her clients, and loves her life. She decided to receive the COVID vaccine, in hopes of protecting her family, her clients, and to make a statement to her fellow coworkers that this vaccine is safe. Unfortunately, she was very wrong.
She received the Moderna COVID vaccine on Tuesday, January 19th, and by Thursday, January 21st, she was in her local hospital having a severe allergic reaction, where her throat and tongue swelled up to the point of her having trouble breathing (which has been very common in both types of the vaccine). After a round of prednisone and Benadryl, she was sent home and told to continue the Benadryl until the swelling subsided. After four days of rest, she was able to finally get back to work on Tuesday, January 26th. Other than feeling a little more tired than usual, she did a full days worth of work, drove home, and began her normal bedtime routine around 9pm. And that’s when her world changed.
She started having uncontrollable muscle movements, body convulsions, and extreme pain all over her body. After finally getting her in their vehicle, her husband drove her to our local emergency room, where she had to be lifted out of her vehicle and placed in a wheelchair to be taken inside, because she had no control over her arms or legs. After doing blood work and a urinalysis (and after finding out that she had had the COVID vaccine), she was told she was having a panic attack, and discharged. Believing the blood work and urinalysis was wrong (she was given a copy of her results, and could read them, being an RN), and that she was incorrectly diagnosed and discharged, she left, and went to another emergency room the same night. Unfortunately, she was again sent home, saying the symptoms she was experiencing were not an emergency, and to follow up with her primary care doctor. The following day, she spoke to her primary care doctor, who had her come in immediately, and upon initial inspection knew that this was no panic attack, and it was indeed an emergency.
On the morning of January 19th, Kristi woke up a happy, healthy 40-year-old woman, headed to her job with plans of getting a vaccine to help ease the tension and prove it was safe. As of right now, we do not know if these symptoms she’s having are permanent, or will cause permanent damage to her body/nervous system. We believe, as well as her primary care doctor, that these symptoms are directly related to the Moderna COVID vaccine she received.
On Friday, a Virginia minister died shortly after she received a coronavirus vaccination, authorities said.
Drene Keyes, 58, received her Pfizer vaccine at a clinic in Warsaw, which is about 80 miles north of Newport News, before falling ill, Warsaw police Chief Joan Kent told NBC News.
Officials said they did not know the cause of death, or any underlying conditions Keyes might have had that could have contributed to her death.
Health authorities are investigating the case of a Florida doctor who died from an unusually severe blood disorder 16 days after receiving the Pfizer coronavirus vaccine.
Dr. Gregory Michael, a 56-year-old obstetrician and gynecologist in Miami Beach, received the vaccine at Mount Sinai Medical Center on Dec. 18 and died 16 days later from a brain hemorrhage, his wife, Heidi Neckelmann, wrote in a Facebook post.
Doctors in Norway have been asked to conduct more thorough evaluations of very frail elderly patients in line to receive the Pfizer-BioNTech vaccine, following the reported deaths, the prestigious British Medical Journal (BMJ) reported.
Elderly NYC Man
The man, who was in his 70s, reportedly fell as he left Manhattan’s Jacob Javits Convention Center just 25 minutes after receiving his shot, New York State Health Commissioner Dr. Howard Zucker said in a statement.
On-site security and first responders raced to his side within seconds, but the man, who has not yet been named, was pronounced dead at a local hospital shortly afterward.
Forced Vaccination for Everyone
Although many companies are stopping short of , they have the for most workers under recently passed federal employment guidelines.
Airlines, trade organizations and destinations are beginning to weigh in on what the best vaccination policy (if any) for travelers might be, and how requirements would need to be standardized in order to be effective.
Employers can require employees to get immunized with the coronavirus vaccine, with some accommodation exceptions. In new guidance released, the Employment Opportunity Commission said employers can require that employees get vaccinated as a condition of going to work. However, they must be prepared to exempt employees with disabilities and religious objections.