The COVID vaccine… a ‘treatment’ that alters a person’s DNA, for a virus that has a 99% recovery rate… may not be as safe as you think.
In addition to some very strong ‘side effects’ from the second dose, a few people have developed Bell’s palsy, but the spontaneous development of that paralysis is not being connected to the vaccine.
The Pfizer–BioNTech coronavirus vaccine is both safe and effective, according to the U.S. Food and Drug Administration. In a report released Tuesday morning, the FDA indicated that it could greenlight the country’s first Covid-19 inoculation within days.
If Pfizer’s shot is granted an emergency use authorization, or EUA, the immunizations — which are administered in two doses about three weeks apart — could start as soon as next week.
Many people are now wondering whether this will be just like getting the flu vaccine.
The short answer is: No, not really.
One Pfizer trial participant told CNBC that after the second shot, he woke up with chills, shaking so hard he cracked a tooth. “It hurt to even just lay in my bed sheet,” he said.
Others experienced headaches and fatigue.
The FDA said that while side effects of the Pfizer vaccine are common, there are “no specific safety concerns identified that would preclude issuance of an EUA.”
The Pfizer vaccine is one of four U.S.-backed candidates in phase three trials. Next up is one from U.S. biotech firm Moderna, which has also submitted its EUA application.
When trial participant Yasir Batalvi first read Moderna’s 22-page consent form warning of side effects ranging from nothing at all to death, he felt pretty worried, he told CNBC.
“You have to keep in mind, I joined the trial when we didn’t know it was going to be a safe vaccine,” said Batalvi, a recent college graduate living in Boston.
The 24-year-old said that when he got the first injection in mid-October, it felt just like a flu shot. “I experienced stiffness and pain in my left arm where I had gotten the shot, but it was mild,” he explained. “By that evening, I didn’t want to move my arm above my shoulder, but it was localized, and it disappeared by the next day.”
The second dose was a different story.
“After the injection, I had the same side effects as the first: localized pain and stiffness, but it was a little bit worse. My arm got sore faster, and by the time I got home, I started feeling fatigued and like anyone would feel if they were coming down with the flu,” said Batalvi.
More significant symptoms presented that evening. “I developed a low-grade fever and had chills,” he said. “That evening was rough.”
After a restless night, he called the study doctors, who reassured him it was a normal reaction and no cause for concern. By that afternoon, Batalvi said, he felt like himself again.
Moderna stopped testing the highest dose of its vaccine during the trial because of the number of reports of severe adverse reactions.
As for any long-term effects, Batalvi isn’t giving it much thought. “I’m not too concerned,” he said. “We know from vaccination trials that any adverse events mostly show up in the first couple of months.”
How an mRNA vaccine works
Front-runners Pfizer and Moderna built their candidates with a new kind of technology that’s never before been licensed in the U.S.
Messenger RNA vaccines, called mRNA for short, aren’t like your normal flu vaccine. Typically, a vaccine puts a weakened or inactivated virus into our bodies to trigger an immune response, which then produces antibodies. Those antibodies are what ultimately protect us from getting infected if we ever encounter the real thing.
An mRNA vaccine, on the other hand, is essentially just a piece of genetic code that contains instructions for our body. The mRNA tells our cells to make a protein — the same protein that is the spike on top of the actual coronavirus. This is what triggers the immune response in these types of vaccines.
[Basically, it ALTERS YOUR DNA!]
So even though some trial participants reported Covid-like symptoms, it is impossible to contract the coronavirus from the vaccine, because the mRNA vaccines that Pfizer and Moderna are making don’t use the live virus.
The Daily Mail reported:
Food and Drug Administration (FDA) regulators said there wasn’t any clear way that the vaccine caused Bell’s palsy, but warned that doctors should watch for the alarming side effect and Pfizer should continue to keep tab on how many people it strikes.
No one knows what exactly causes Bell’s palsy, which resolves on its own most of the time.
This isn’t the first time it’s been linked to vaccines, but scientists have ultimately ruled that shots did not trigger Bell’s in all but one case – a Swiss flu vaccine that was sold during the 2001-2002 flu season there, then promptly taken off the market.
So far, the FDA said that the number of Bell’s palsy cases seen in the Pfizer vaccine trial was ‘consistent with the background frequency of reported Bell’s palsy in the vaccine group that is consistent with the expected background rate in the general population, and there is no clear basis upon which to conclude a causal relationship at this time,’ but will keep a close watch on future cases.
Four people who received the real shot in Pfizer’s trial of its coronavirus vaccine developed a form of temporary facial paralysis known as Bell’s policy, new data from the firm and the FDA published ahead of regulators’ Thursday approval meeting revealed. Pictured: a UK trial participant gets Pfizer’s coronavirus vaccine
Bell’s palsy typically resolves on its own but can cause one side of the face to droop rather alarmingly for weeks. It’s exact cause is unknown but it’s more common among pregnant women, people with diabetes and those with upper respiratory infections
The four cases of Bell’s palsy were the only side effect that the FDA saw as ‘imbalanced’ with more occurring in the vaccine group than the placebo group, and fewer than 0.5 percent of the trial participants had serious side effects.
Among the four people who developed Bell’s palsy, one saw facial paralysis or weakness within three days after they received the shot. As a respiratory infection, it’s possible that COVID-19 itself could be a risk factor for Bell’s palsy. Facial palsy was reported in three Brazilian COVID-19 patients, at least one person in China, a pregnant woman in Portugal, and in a number of Indian patients.
Enough concern has been expressed that scientists have conducted a number of studies to try to work out if these shots really could cause temporary palsy.