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"the incidence of anaphylaxis associated with the Pfizer SARS-CoV-2 mRNA vaccine appears to be approximately 10 times as high as the incidence reported with all previous vaccines"
"Systemic symptoms such as fever, fatigue, headache, and muscle and joint pain have also been somewhat more common with the vaccines than with placebo, and most have occurred during the first 24 to 48 hours after vaccination."
"In the phase 1–3 clinical trials of the Pfizer–BioNTech and Moderna mRNA vaccines, potential participants with a history of an allergic reaction to any component of the vaccine were excluded."
"The Pfizer–BioNTech studies also excluded participants with a history of severe allergy associated with any vaccine"
"On December 8, 2020, within 24 hours after the start of the U.K. mass vaccination program for health care workers and elderly adults, the program reported probable cases of anaphylaxis in two women, 40 and 49 years of age, who had known food and drug allergies and were carrying auto-injectable epinephrine."
"On December 15, a 32-year-old female health care worker in Alaska who had no known allergies presented with an anaphylactic reaction within 10 minutes after receiving the first dose of the vaccine."
"Since the index case in Alaska, several more cases of anaphylaxis associated with the Pfizer mRNA vaccine have been reported in the United States after vaccination of almost 2 million health care workers, and the incidence of anaphylaxis associated with the Pfizer SARS-CoV-2 mRNA vaccine appears to be approximately 10 times as high as the incidence reported with all previous vaccines."
"In response to the two cases of anaphylaxis in the United Kingdom, the MHRA issued a pause on vaccination with the Pfizer–BioNTech SARS-CoV-2 mRNA vaccine, to exclude any person with a history of anaphylactic reaction to any food, drug, or vaccine. The Centers for Disease Control and Prevention (CDC) has issued advice pertaining to administration of either the first or the second dose of the Pfizer–BioNTech or Moderna mRNA vaccine, recommending exclusion of any person who has a history of a severe or immediate (within 4 hours) allergic reaction associated with any of the vaccine components, including polyethylene glycol (PEG) and PEG derivatives such as polysorbates."
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The Pfizer-BioNTech COVID-19 Vaccine: Remarkably Effective
These findings demonstrate the startlingly high efficacy of the Pfizer-BioNTech vaccine that may arise from induction of both humoral and cellular responses through the mRNA platform. That nine of the ten severe COVID-19 cases were in the placebo group diminishes concern about potential vaccine-induced disease enhancement. The authors note that the study was not powered to detect adverse effects with incidence <0.01%, but the safety profile appears similar to that of other licensed vaccines. We still need information about the vaccine's safety; its efficacy in children, pregnant women, and immunocompromised individuals; whether it protects against asymptomatic infection and limits contagiousness; and its durability. Still, the introduction of this and other COVID-19 vaccines provides hope that the pandemic's end is on the horizon. On December 11, 2020, the FDA issued emergency use authorization, and two days later the CDC advisory committee on immunization practices provided guidance on the vaccine's use.
EDITOR DISCLOSURES AT TIME OF PUBLICATION
Disclosures for Richard T. Ellison III, MD at time of publication
Consult/Advisory Board Acurx Pharmaceuticals, LLC; Philips Healthcare
Speaker’s Bureau Philips Healthcare
Grant/Research Support Philips Healthcare
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Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient
A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups.
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"The (4th booster) vaccine’s effectiveness lasted from 7 to 30 days after the shot was given"
in the press this paper was references with the following claims:
"The news: The fourth dose of the COVID-19 vaccine from Pfizer and BioNTech reportedly added protection against severe COVID-19 symptoms, hospitalization and death for at least one month in individuals, according to a study from patients in Israel."
The vaccine’s effectiveness lasted from seven to 30 days after the shot was given, according to (this) study, which was published in The New England Journal of Medicine.
The research compared medical records for 182,122 individuals aged 60 and older who got a fourth COVID-19 vaccine dose and 182,122 who got the third dose and not the fourth dose.
What they found: “The results of our real-world study suggest that a fourth vaccine dose is, at least initially, effective against the Omicron variant,” the researchers said, per Reuters. “Additional follow-up will allow further assessment of the protection provided by the fourth dose over time.”
More research: However, a separate study out of Israel — which was also published in the New England Journal of Medicine — found that protection from the fourth shot wanes over time.
Fourth Dose of BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting
BACKGROUND
With large waves of infection driven by the B.1.1.529 (omicron) variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), alongside evidence of waning immunity after the booster dose of coronavirus disease 2019 (Covid-19) vaccine, several countries have begun giving at-risk persons a fourth vaccine dose.
METHODS
To evaluate the early effectiveness of a fourth dose of the BNT162b2 vaccine for the prevention of Covid-19–related outcomes, we analyzed data recorded by the largest health care organization in Israel from January 3 to February 18, 2022. We evaluated the relative effectiveness of a fourth vaccine dose as compared with that of a third dose given at least 4 months earlier among persons 60 years of age or older. We compared outcomes in persons who had received a fourth dose with those in persons who had not, individually matching persons from these two groups with respect to multiple sociodemographic and clinical variables. A sensitivity analysis was performed with the use of parametric Poisson regression.
RESULTS
The primary analysis included 182,122 matched pairs. Relative vaccine effectiveness in days 7 to 30 after the fourth dose was estimated to be 45% (95% confidence interval [CI], 44 to 47) against polymerase-chain-reaction–confirmed SARS-CoV-2 infection, 55% (95% CI, 53 to 58) against symptomatic Covid-19, 68% (95% CI, 59 to 74) against Covid-19–related hospitalization, 62% (95% CI, 50 to 74) against severe Covid-19, and 74% (95% CI, 50 to 90) against Covid-19–related death. The corresponding estimates in days 14 to 30 after the fourth dose were 52% (95% CI, 49 to 54), 61% (95% CI, 58 to 64), 72% (95% CI, 63 to 79), 64% (95% CI, 48 to 77), and 76% (95% CI, 48 to 91). In days 7 to 30 after a fourth vaccine dose, the difference in the absolute risk (three doses vs. four doses) was 180.1 cases per 100,000 persons (95% CI, 142.8 to 211.9) for Covid-19–related hospitalization and 68.8 cases per 100,000 persons (95% CI, 48.5 to 91.9) for severe Covid-19. In sensitivity analyses, estimates of relative effectiveness against documented infection were similar to those in the primary analysis.
CONCLUSIONS
A fourth dose of the BNT162b2 vaccine was effective in reducing the short-term risk of Covid-19–related outcomes among persons who had received a third dose at least 4 months earlier. (Funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.)
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Pfizer’s vaccine application for India turned down -"The committee noted that incidents of palsy, anaphylaxis and other SAE’s have been reported during post marketing and the causality of the events with the vaccine is being investigated. Further, the firm has not proposed any plan to generate safety and immunogenicity data in Indian population," stated the minutes.
An expert body under India’s apex drug regulator has recommended against granting approval to Pfizer’s Covid-19 vaccine under emergency circumstances in the country, prompting the American drug giant to withdraw its request.
"After detailed deliberation, the committee has not recommended for grant of permission for emergency use in the country at this stage," stated minutes of the SEC's meeting dated February 3.
This was due to concerns over certain Serious Adverse Events (SAEs) and the fact that additional safety information had not been generated from local trials in the country.
"The committee noted that incidents of palsy, anaphylaxis and other SAE’s have been reported during post marketing and the causality of the events with the vaccine is being investigated. Further, the firm has not proposed any plan to generate safety and immunogenicity data in Indian population," stated the minutes.
Pfizer has decided to withdraw its application until it can generate the additional information required by the Indian regulator.
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Gloucester resident dies from anaphylaxis within hours of receiving Pfizer vaccine. People who have had an allergic reaction to polyethylene glycol or polysorbate are advised to not get the Pfizer or Moderna vaccines, according to the state health department.
Drene Keyes, 58, died after getting a first dose of the Pfizer-Biontech vaccine Saturday in the town of Warsaw. Keyes waited 15 minutes after the shot to be observed by health care providers on site, but soon after experienced vomiting and trouble breathing. She was taken to VCU Tappahannock Hospital, where she died.
Avula said he learned about her death immediately. The case is under investigation by the Office of the Chief Medical Examiner and the U.S. Centers for Disease Control and Prevention.
Rare instances of anaphylaxis, or severe allergic reactions requiring hospitalization or the use of an EpiPen, have been reported for the COVID-19 vaccines. But so far, the CDC hasn’t identified any cases in which a vaccine caused a person’s death.
Keyes’ daughter, Lisa Jones, said she was told the state won’t do a full autopsy “due to public health concerns.” The medical examiner’s office did not return requests for information on the case from The Virginian-Pilot on Thursday.
A doctor at the vaccination site saw she was struggling to breathe and gave her an epinephrine shot in the leg, Jones said. She also received oxygen, and another shot of epinephrine in her arm. When she didn’t improve, she was taken to the hospital.
"They tried to remove fluid from her lungs. They called it 'flash pulmonary edema,' and doctors told me that it can be caused by anaphylaxis," said Jones. "The doctor told me that often during anaphylaxis, chemicals are released inside of a person's body and can cause this to happen."
People who have had an allergic reaction to polyethylene glycol or polysorbate are advised to not get the Pfizer or Moderna vaccines, according to the state health department.
See also: Gloucester resident dies within hours of receiving Pfizer vaccine and Doctors said Drene Keyes, whose death is under investigation, died of flash pulmonary edema likely caused by anaphylaxis, a life-threatening allergic reaction, which some people have experienced after receiving the COVID vaccine..
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Health Canada says 9 adverse reactions after COVID-19 vaccinations
Government launches site tracking vaccine safety
"According to the website, nine people reported experiencing a total of 65 symptoms — eight of which were considered severe — as of Jan. 1. All nine people received the Pfizer-BioNTech vaccine."
Of those who reported serious symptoms, three suffered severe allergic reactions. One patient reported a headache, one reported facial paralysis, one suffered chills, another fainted and one reported pain in extremities.
The most frequent non-serious adverse events reported so far have been swelling at the site of injection, nausea and a sensation of pins and needles, according to the data.
The website notes that not all adverse events experienced by people after receiving a vaccine are necessarily caused by the vaccine.
"The benefits of vaccines authorized in Canada continue to outweigh the risks," the site reads.
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Hospital worker with no prior allergies in intensive care with severe reaction after Pfizer Covid vaccine
A hospital worker with no history of allergies was admitted to intensive care over a severe reaction she suffered 10 minutes after having Pfizer’s coronavirus vaccine. The unidentified female worker suffered an anaphylactic reaction shortly after receiving the injection at a hospital in Juneau, Alaska, on Tuesday.
She had no prior history of allergies, and was not allergic to other vaccines.
The woman began to feel flush 10 minutes after receiving the vaccine, and took an antihistamine. She was taken to the emergency room at Bartlett Regional Hospital in Juneau after struggling to breathe.
Emergency room director Dr Lindy Jones said the woman had an elevated heart rate and a red rash on her face and torso.
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Pfizer covid vaccine kills woman in New Zealand
The health ministry on Monday announced a woman had died due to myocarditis, which is known to be a rare side effect of the Pfizer-BioNTech COVID-19 vaccine. Myocarditis is an inflammation of the heart muscle that can limit the organ’s ability to pump blood and can cause changes in heartbeat rhythms.
The health ministry did not provide the woman’s age. Pfizer in New Zealand did not immediately reply to an emailed request for comment.
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Santosh Baral, a nurse working at a long-term care facility in Ottawa, tested positive for COVID-19 weeks after getting his second dose of the Pfizer-BioNTech vaccine.
Just because someone might be immune to the disease, it doesn't mean they can't carry or spread it, Clinical immunologist and allergist Dr. Zainab Abdurrahman said.
But Jüni Dr. Peter Jüni, scientific director of Ontario's COVID-19 Science Advisory Table and professor of epidemiology at the University of Toronto, said immunized people testing positive "is nothing out of the ordinary," as more people get vaccinated across the country.
"Even if you're vaccinated, you need to continue with physical distancing. You need to continue with wearing masks, especially because you want to protect others," he said.
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Anaphylaxis in UK Following COVID-19 Vaccination
CDC Assessment and Further Actions
Post-authorization pharmacovigilance systems have detected and
confirmed 6 anaphylaxis cases following vaccination
– Notifications received have been timely
– Notifications ruled out suggests systems are sensitive
Reinforce measures to recognize, respond, and report anaphylaxis
Persons with anaphylaxis following COVID-19 vaccination should not
receive additional doses of COVID-19 vaccine
Consultation with allergy/immunology experts to provide guidance on
evaluation of persons following anaphylaxis to COVID-19 vaccine
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Pfizer's CEO cashed out 60% of his stock on the same day the company unveiled the results of its COVID-19 vaccine trial
Pfizer CEO Albert Bourla sold 62% of his stock on the same day the company announced its experimental COVID-19 vaccine succeeded in clinical trials.
The vaccine announcement sent Pfizer's shares soaring almost 15% on the day.
Bourla sold 132,508 shares in the company at an average price of $41.94 a share, or $5.6 million total, according to filings registered with the Securities and Exchange Commission. The 52-week high for Pfizer's stock is $41.99, meaning Bourla sold his stock at almost its highest value in the past year.
His stock sale was carried out through a routine Rule 10b5-1, a predetermined trading plan that allows company staff members to sell their stock in line with insider-trading laws. Bourla's sale was part of a plan adopted August 19, the filing showed. He continues to own 81,812 Pfizer shares.
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Ahead of the FDA’s Thursday meeting on the nRNA Pfizer vaccine, the administration announced Tuesday that two trial participants had died after receiving it; the FDA said that currently there is not enough research to guarantee the vaccine’s safety for immunocompromized groups, pregnant women and children.
One of the deceased individuals was immunocompromised, meaning the person’s immune defenses were low.
The information was obtained from documents released by the FDA on Tuesday.
The documents were released ahead of a meeting on Thursday of external experts who will debate whether emergency authorization for the vaccine should be granted.
At the same time, the FDA said that currently there is not enough research to guarantee the vaccine’s safety for immunocompromized groups, pregnant women and children.
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Covid-19 vaccination associated with adverse drug reactions in elderly people who are frail
23 deaths associated with covid-19 vaccination of which 13 have been assessed. Common adverse reactions may have contributed to a severe course in elderly people who are frail.
The reports suggest that common adverse reactions to mRNA vaccines, such as fever and nausea, may have contributed to a fatal outcome in some frail patients, says Sigurd Hortemo, chief physician at the Norwegian Medicines Agency.
The large studies on Comirnaty (BioNTec/Pfizer) did not include patients with unstable or acute illness - and included few participants over 85 years of age. In Norway we are now vaccinating the elderly and people in nursing homes with serious underlying diseases, therefore it is expected that deaths close to the time vaccination may occur. In Norway, an average of 400 people die each week in nursing homes and long-term care facilities.
All deaths that occur within the first few days of vaccination are carefully assessed. We cannot rule out that adverse reactions to the vaccine occurring within the first days following vaccination (such as fever and nausea) may contribute to more serious course and fatal outcome in patients with severe underlying disease.
The Norwegian Medicines Agency and the National Institute of Public Health jointly assess all reports of suspected adverse reactions. As a result, the Norwegian Institute of Public Health has updated the covid-19 vaccination guide with more detailed advice on vaccinating the elderly who are frail.
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Pfizer and Moderna vaccines linked with heart problems
Dr June Raine, MHRA Chief Executive, said: “We have carefully reviewed reports of suspected adverse reactions involving types of heart inflammation known as myocarditis and pericarditis.
"We have concluded that the Covid-19 vaccines made by Pfizer/BioNTech and Moderna may be linked with a small increase in the risk of these very rare conditions.
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Pfizer chairman: We're not sure if someone can transmit virus after vaccination
Dec. 3, 2020 - Pfizer chairman Albert Bourla told Dateline host Lester Holt that the pharmaceutical company was “not certain” if the vaccine prevented the coronavirus from being transmitted, saying, “This is something that needs to be examined.”
In a prime-time special titled “Race for a Vaccine” set to air Thursday, Holt questioned Bourla and other individuals involved in the development and distribution of the medicine.
In November, Pfizer announced that its vaccine candidate had been shown to be more than 90 percent effective at preventing COVID-19 and has applied for emergency use authorization from the Food and Drug Administration (FDA).
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'Stay very vigilant': Doctor warns COVID vaccine is not a cure after contracting virus 10 days after second dose of the vaccine.
PHILADELPHIA (WPVI) -- As many wait their turn in line to get the vaccine, one local doctor is offering a reminder that it may not be a free pass to resume life as it was.
As a frontline worker, Dr. Sam Toroghi was one of the first to receive the Pfizer vaccine, but then got something else - a positive COVID test.
"About nine to 10 days after getting the first dose of vaccine, I started to feel sick again; fever, chills, headaches, sore throat, cough, some shortness of breath," said Toroghi.
He says despite getting the first of a two-dose vaccine, he was now a COVID-19 patient.
One of the most important things for Pennsylvanians to remember regarding the COVID-19 vaccine is that it is not a "cure" for the virus. It is simply another tool in our toolbelt, and we must continue mitigating efforts like hand washing, social distancing and wearing a mask."
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The number of those who got Covid-19 despite being vaccinated was at around 240 people
With the vaccine not providing immediate immunity to the coronavirus, over two hundred Israeli citizens have been diagnosed with the disease days after getting the Pfizer/BioNTech jabs, local media reported.
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She had already vaccinated her 14 year-old son “as soon as it was available”, saying vaccines are “mostly safe”, but that “Jacob is dead now”.
Health officials in the US are now investigating a possible link between Covid-19 vaccines and heart inflammation in younger males, after seven vaccinated boys between the age of 14 and 19 suffered from a “very rare type of heart inflammation” according to CNN.
“Before we start vaccinating millions of adolescents and children, it’s so important to find out what the consequences are,” Dr. Cody Meissner of the Food and Drug Administration said.
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Pfizer’s UK boss refuses to explain why the business needs protection from legal action
Pfizer given protection from legal action over coronavirus vaccine by UK government
independe
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Mexican doctor hospitalized after receiving COVID-19 vaccine
MEXICO CITY (Reuters) - Mexican authorities said they are studying the case of a 32-year-old female doctor who was hospitalized after receiving the Pfizer-BioNTech COVID-19 vaccine.
The doctor, whose name has not been released, was admitted to the intensive care unit of a public hospital in the northern state of Nuevo Leon after she experienced seizures, difficulty breathing and a skin rash.
“The initial diagnosis is encephalomyelitis,” the Health Ministry said in a statement released on Friday night. Encephalomyelitis is an inflammation of the brain and spinal cord.
The ministry added that the doctor has a history of allergic reactions and said that there is no evidence from clinical trials that anyone has developed an inflammation of the brain after the vaccine’s application.
That last line is not actually true:
Suspended: Vaccine developed by AstraZeneca and the University of Oxford has been put on hold over a “potentially unexplained illness” in the United Kingdom
https://globalnews.ca/news/7322708/oxford-covid-vaccine-hold/
Trial: AstraZeneca/Oxford COVID-19 vaccine trial on pause due to possible serious side effect - neurological symptoms associated with a spinal inflammatory disorder called transverse myelitis
https://www.cbc.ca/news/health/oxford-vaccine-covid-19-pause-1.5717719
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"Pfizer and BioNTech are aware of the death of a healthcare professional sixteen days after receiving a first dose of BNT162b2.
Gregory Michael, 56, was a Miami Beach doctor who was described by his wife as "very healthy".
The 56-year-old worked as a Obstetrician, specializing in women's pregnancy, childbirth and in the diagnosis and treatment of diseases of the female reproductive organs.
Michael died on January 3, 2021, two weeks after he received Pfizer's Covid-19 vaccine.
"He was vaccinated with the Pfizer vaccine at MSMC on December 18, 3 days later he saw a strong set of petechiae on his feet and hands which made him seek attention at the emergency room at MSMC.
"The CBC that was done at his arrival showed his platelet count to be 0 (A normal platelet count ranges from 150,000 to 450,000 platelets per microliter of blood.)," wrote Michael's wife.
"He was admitted in the ICU with a diagnosis of acute ITP caused by a reaction to the COVID vaccine. A team of expert doctors tried for 2 weeks to raise his platelet count to no avail.
"Experts from all over the country were involved in his care. No matter what they did, the platelets count refused to go up.
"He was conscious and energetic through the whole process but 2 days before a last resort surgery, he got a hemorrhagic stroke caused by the lack of platelets that took his life in a matter of minutes," Neckelmann explained.
Michael's wife went on to explain how her husband was a "pro vaccine advocate," however she believes that the jab is not good for everyone and urged people to understand the side effects that could arise from the shots.
The Miami-Dade County Medical Examiner's Office is still investigating Michael's death.
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Israel sees probable link between Pfizer-BioNTech vaccine and myocarditis cases
Israel's Health Ministry said on Tuesday it found the small number of heart inflammation cases observed mainly in young men who received Pfizer-BioNTech's COVID-19 vaccine in Israel were likely linked to their vaccination.
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Norway probes deaths of two nursing home residents who got Pfizer’s COVID vaccine
Norway has launched an investigation into the deaths of two nursing home residents after they received Pfizer’s COVID-19 vaccine.
The Norwegian Medicines Agency said Tuesday that the deaths occurred “a few days” after they were administered the shot.
“Now the weakest and most vulnerable, who have serious diseases, are vaccinated,” Steinar Madsen, the agency’s medical director, said in a statement.
“There will probably be deaths close to the time of vaccination. We must then assess whether it is the vaccine that is the cause of the death, or whether it is a coincidence that it happens so soon after vaccination.”
No further details were provided about the cases.
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Health care worker dies after second dose of COVID vaccine; when someone gets symptoms 2 1/2 hours after a vaccine, that’s a reaction.
“The message is, be safe, take the vaccine — but the officials need to do more research.
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23 die in Norway after receiving Pfizer COVID-19 vaccine: officials
Twenty-three people died in Norway within days of receiving their first dose of the Pfizer COVID-19 vaccine, with 13 of those deaths — all nursing home patients — apparently related to the side effects of the shots, health officials said.
Common reactions to the vaccine, including fever and nausea, “may have contributed to a fatal outcome in some frail patients,” Sigurd Hortemo, chief physician at the Norwegian Medicines Agency, said in a Friday statement.
All 13 were nursing home patients and at least 80 years old. While officials aren’t expressing serious concern, they are adjusting their guidance on who should receive the vaccine.
ThePeople who have had an allergic reaction to polyethylene glycol or polysorbate are advised to not get the Pfizer or Moderna vaccines, according to the state health department. news comes just over a week after officials reported the deaths of just two nursing home residents after they received the Pfizer jab.
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X-ray tech who died after second COVID-19 vaccine killed by heart disease, coroner says
Tim Zook fell ill shortly after getting his second Pfizer COVID-19 vaccine. Widow remains convinced that played a role.
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4 volunteers develop FACIAL PARALYSIS after taking Pfizer Covid-19 jab, prompting FDA to recommend ‘surveillance for cases’
Four trial participants who received the Pfizer Covid-19 vaccine experienced facial paralysis, according to the Food and Drug Administration. The FDA said the issue should be monitored as the jab becomes more widely available.
The potentially concerning cases were revealed after the US drug regulator published an analysis of the Pfizer-BioNTech vaccine ahead of a meeting to consider emergency use authorization for the jab in the United States.
According to the documents, Bell’s palsy, a form of temporary facial paralysis, was reported by four participants during phase 3 trials. The individuals had been administered the jab, and no members of the placebo group experienced similar adverse effects.
The condition resembles a stroke, with most sufferers watching helplessly as one side of their face droops and their muscles go limp. In some rare situations, both sides of the face may become paralyzed. It is unclear what causes Bell’s palsy, although the temporary paralysis usually goes away on its own.
Mass vaccination delayed in US and UK, as drug firms struggle to meet demand Mass vaccination delayed in US and UK, as drug firms struggle to meet demand.
However, the FDA claimed that the frequency of the health issue is “consistent with the expected background rate in the general population,” and added that there was no clear evidence linking the coronavirus vaccine to the unpleasant medical condition. Still, the federal regulator recommended “surveillance for cases of Bell’s palsy with deployment of the vaccine into larger populations.”
The FDA noted the “numerical imbalance” of Bell’s palsy cases among the vaccine and placebo groups, but said there were no other “non-serious adverse events” that showed a similar pattern.
Editors note: it only happened with the vaccinate patients. Saying "it only happens as oftern is it does out there in the world" is of little consequence if vaccines are causing all cases of it.
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Suspicions grow that nanoparticles in Pfizer’s COVID-19 vaccine trigger rare allergic reactions
Dec. 21, 2020
Severe allergy-like reactions in at least eight people who received the COVID-19 vaccine produced by Pfizer and BioNTech over the past 2 weeks may be due to a compound in the packaging of the messenger RNA (mRNA) that forms the vaccine’s main ingredient, scientists say. A similar mRNA vaccine developed by Moderna, which was authorized for emergency use in the United States on Friday, also contains the compound, polyethylene glycol (PEG).
PEG has never been used before in an approved vaccine, but it is found in many drugs that have occasionally triggered anaphylaxis—a potentially life-threatening reaction that can cause rashes, a plummeting blood pressure, shortness of breath, and a fast heartbeat. Some allergists and immunologists believe a small number of people previously exposed to PEG may have high levels of antibodies against PEG, putting them at risk of an anaphylactic reaction to the vaccine.
Anaphylactic reactions can occur with any vaccine, but are usually extremely rare—about one per 1 million doses. As of 19 December, the United States had seen six cases of anaphylaxis among 272,001 people who received the COVID-19 vaccine, according to a recent presentation by Thomas Clark of the U.S. Centers for Disease Control and Prevention (CDC); the United Kingdom has recorded two. Because the Pfizer and Moderna mRNA vaccines use a new platform, the reactions call for careful scrutiny, says Elizabeth Phillips, a drug hypersensitivity researcher at Vanderbilt University Medical Center who attended an NIAID meeting on 16 December. “This is new.”
News reports about the allergic reactions have already created anxiety. “Patients with severe allergies in the US are getting nervous about the possibility that they may not be able to get vaccinated, at least with those two vaccines,” Togias wrote in an invitation to meeting participants. “Allergies in general are so common in the population that this could create a resistance against the vaccines in the population,” adds Janos Szebeni, an immunologist at Semmelweis University in Budapest, Hungary, who has long studied hypersensitivity reactions to PEG and who also attended the 16 December gathering.
Scientists who believe PEG may be the culprit stress that vaccination should continue. “We need to get vaccinated,” Phillips says. “We need to try and curtail this pandemic.” But more data are urgently needed, she adds: “These next couple of weeks in the U.S. are going to be extremely important for defining what to do next.”
Toothpaste and shampoo
Pfizer’s and Moderna’s clinical trials of the vaccines, which involved tens of thousands of people, did not find serious adverse events caused by the vaccine. But both studies excluded people with a history of allergies to components of the COVID-19 vaccines; Pfizer also excluded those who previously had a severe adverse reaction from any vaccine. People with previous allergic reactions to food or drugs were not excluded, but may have been underrepresented.
The two vaccines both contain mRNA wrapped in lipid nanoparticles (LNPs) that help carry it to human cells but also act as an adjuvant, a vaccine ingredient that bolsters the immune response. The LNPs are “PEGylated”—chemically attached to PEG molecules that cover the outside of the particles and increase their stability and life span.
PEGs are also used in everyday products such as toothpaste and shampoo as thickeners, solvents, softeners, and moisture carriers, and they’ve been used as a laxative for decades. An increasing number of biopharmaceuticals include PEGylated compounds as well.
PEGs were long thought to be biologically inert, but a growing body of evidence suggests they are not. As much as 72% of people have at least some antibodies against PEGs, according to a 2016 study led by Samuel Lai, a pharmaco-engineer at the University of North Carolina, Chapel Hill, presumably as a result of exposure to cosmetics and pharmaceuticals. About 7% have a level that may be high enough to predispose them to anaphylactic reactions, he found. Other studies have also found antibodies against PEG, but at lower levels.
“Some companies have dropped PEGylated products from their pipeline as a result,” Lai says. But he notes that the safety record of many PEGylated drugs has persuaded others that “concerns about anti-PEG antibodies are overstated.”
Szebeni says the mechanism behind PEG-conjugated anaphylaxis is relatively unknown because it does not involve immunoglobulin E (IgE), the antibody type that causes classical allergic reactions. (That’s why he prefers to call them “anaphylactoid” reactions.) Instead, PEG triggers two other classes of antibodies, immunoglobulin M (IgM) and immunoglobulin G (IgG), involved in a branch of the body’s innate immunity called the complement system, which Szebeni has spent decades studying in a pig model he developed.
In 1999, while working at the Walter Reed Army Institute of Research, Szebeni described a new type of drug-induced reaction he dubbed complement activation-related pseudoallergy (CARPA), a nonspecific immune response to nanoparticle-based medicines, often PEGylated, that are mistakenly recognized by the immune system as viruses.
Szebeni believes CARPA explains the severe anaphylactoid reactions some PEGylated drugs are occasionally known to cause, including cancer blockbuster Doxil. A team assembled by Bruce Sullenger, a surgeon at Duke University, experienced similar issues with an experimental anticoagulant containing PEGylated RNA. The team had to halt a phase III trial in 2014 after about 0.6% of 1600 people who received the drug had severe allergic responses and one participant died. “That stopped the trial,” Sullenger says. The team found that every participant with an anaphylaxis had high levels of anti-PEG IgG. But some with no adverse reaction had high levels as well, Sullenger adds. “So, it is not sufficient to just have these antibodies.”
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Up to one in three have systemic side effects
Around a third of vaccinated people who had COVID-19 in the past reported at least one systemic effect within seven days from their vaccination, compared with just under one in five people who had not already had the virus.
Around one in twenty people who had previously had COVID-19 experienced after effects for more than three days during the first week, and around one in fifty were affected for six days or more.
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