Tag: vaccine injury

Covid-19 vaccine trial participant had serious neurological symptoms, but could be discharged today, AstraZeneca CEO says

The participant who triggered a global shutdown of AstraZeneca’s Phase 3 Covid-19 vaccine trials was a woman in the United Kingdom who experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis, the drug maker’s chief executive, Pascal Soriot, said during a private conference call with investors on Wednesday morning.

The woman’s diagnosis has not been confirmed yet, but she is improving and will likely be discharged from the hospital as early as Wednesday, Soriot said.

The board tasked with overseeing the data and safety components of the AstraZeneca clinical trials confirmed that the participant was injected with the company’s Covid-19 vaccine and not a placebo, Soriot said on the conference call, which was set up by the investment bank J.P. Morgan.

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World’s Largest Vaccine Maker Suing Man for Saying COVID-19 Vaccine Injured Him

It should have already been considered a crime against humanity decades ago that law makers were lobbied (bribed) into passing legislation in which vaccine manufacturers cannot be held legally liable for any damage their products may cause. It was an act which established official protocols, such as the secret vaccine injury court to largely sweep under the rug any instances of such side effects.

But now a new lawsuit filed by the world’s largest vaccine manufacturer Serum Institute of India, in association with multinational pharmaceutical giant AstraZeneca, seeks to take this a step further — by attempting to set the precedent that vaccine manufacturers can actually sue those that may have been harmed by their faulty products.

The litigation filed in an Indian court is a countersuit to a lawsuit that has been filed against SII by one of the volunteers who participated in a trial study for the developmental Covisheild. A vaccination for SARS-CoV-2.

After participating in the trial study, the yet to be named volunteer flagged severe neurological and psychological symptoms 10 days after the first injection. Symptoms which were then diagnosed as acute neurological encephalopathy, resulting in memory loss, lapses in cognitive functions such as reasoning, and changes in personality. A legal notice had been sent to ICMR, DCGI, AstraZeneca and Oxford University to stop testing, manufacturing and distributing the vaccine. The plaintiff filed a suit after the notice failed to receive response.

SII then filed a countersuit, worth $13.5 million, for defamation after alleging that the volunteers illness had nothing to do with the vaccine trial. This is a statement which was also backed up by the Data and Safety Monitoring Board (DSMB) and DCGI (Drugs Controllor General of India). However, these assertions have been challenged by independent researcher Dr. Anant Bhan, the former President of the International Association of Bioethics and current professor at India’s Yenepoya Medical University. Dr. Bhan notes that both of these institutions are government entities directly affiliated with SII, and stresses that transparency should be the top priority given that the parties vested financial interests.

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Vaccine Safety to Remain Unclear Until Millions Get Their Shots

Monitoring Covid-19 vaccines for safety issues will fall to a group of U.S. health agencies that also will have a hand in their rollout, a potential hurdle in persuading skeptics to get the shots, say former government officials who helped control an outbreak a decade ago.

The Centers for Disease Control and Prevention, the Food and Drug Administration, the Department of Veterans Affairs and other health agencies all have separate systems to track side effects and safety in people who get the first shots. But there are concerns the groups advising the agencies on all aspects of a vaccine may face public skepticism over their safety assessments at a time when vaccine hesitancy is a major concern.

“The same advisory committee that told them to get it are telling them it’s OK,” said Daniel Salmon, the director of vaccine safety for the National Vaccine Program Office during the 2009 H1N1 swine flu outbreak. “What are the optics of that?”

There’s also worry that a lack of unified oversight could make it more difficult to document and quickly act on safety issues. Meanwhile, the stalled presidential transition could complicate efforts even further, said Jesse Goodman, who led the FDA office that handled vaccines during the 2009 H1N1 outbreak.

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The coronavirus vaccine comes with more side effects than a flu shot. Experts urge people to get it anyway

The first coronavirus vaccine authorized in the United States may cause more side effects than the flu vaccine, but the most common reactions — soreness at the injection site, fatigue and headache — are mild or moderate in most people and fade after a few days, according to analyses of clinical trial data.

Infectious disease experts say most people can safely get the vaccine, but they should be prepared for some of these potential side effects.

“Any robust vaccine may generate some discomfort but it is worth the mild side effects — these side effects are not extraordinary — to be immune against this circulating new pandemic,” said Dr. Monica Gandhi, an infectious disease physician at UCSF.

The FDA granted emergency use authorization late Friday to the first vaccine in the U.S., developed by Pfizer and German firm BioNTech, which has been shown to be 95% effective at preventing COVID-19 illness.

Health care workers and residents of long-term care centers will be first in line to receive the vaccine in California, followed by essential workers. Mass vaccinations of the general public are expected in spring or summer 2021.

The Pfizer vaccine’s most common side effects were fatigue, headache, muscle pain and chills, according to an FDA analysis of Pfizer’s clinical trial data. Less common were joint pain, fever, diarrhea and vomiting. The vast majority of those symptoms were mild or moderate.

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Allergy risk on Pfizer jab: Day before FDA meet to give green light to vaccine UK regulators warn people with ‘significant’ food and medicine allergies NOT to take it after two health workers suffer ‘anaphylactic reaction’

There are fears over how safe Pfizer’s COVID vaccine is after two British healthcare workers who were among the first in the world to receive it on Tuesday went into anaphylactic shock hours later, prompting British authorities to tell anyone with a ‘severe’ allergy to food or medicine not to get it. 

The FDA is due to meet tomorrow to discuss green-lighting the vaccine in America after being lambasted for taking a week longer than the Brits to get it off the ground. 

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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. 

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CBER Plans for Monitoring COVID-19Vaccine Safety and Effectiveness

FDA Safety Surveillance of COVID-19 Vaccines :
DRAFT Working list of possible adverse event outcomes
Subject to change
 Guillain-Barré syndrome
 Acute disseminated encephalomyelitis
 Transverse myelitis
 Encephalitis/myelitis/encephalomyelitis/
meningoencephalitis/meningitis/
encepholapathy
 Convulsions/seizures
 Stroke
 Narcolepsy and cataplexy
 Anaphylaxis
 Acute myocardial infarction
 Myocarditis/pericarditis
 Autoimmune disease
 Deaths
 Pregnancy and birth outcomes
 Other acute demyelinating diseases
 Non-anaphylactic allergic reactions
 Thrombocytopenia
 Disseminated intravascular coagulation
 Venous thromboembolism
 Arthritis and arthralgia/joint pain
 Kawasaki disease
 Multisystem Inflammatory Syndrome
in Children
 Vaccine enhanced disease

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