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FDA to Warn J&J Vaccine Can Increase Guillain-Barré Risk: Media

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People receiving the Johnson and Johnson COVID-19 vaccine could be at increased risk for developing Guillain-Barré syndrome, the US Food and Drug Administration (FDA) is expected to announce as early as tomorrow, according to multiple media reports.

While the FDA is projected to add the new warning to the labeling for the vaccine, the agency still calculates the benefit of vaccination with the J&J product continues to outweigh the risk. Benefits include protection against the Delta variant and serious COVID-19 outcomes.

More than 100 cases of Guillain-Barré reported to the Vaccine Adverse Event Reporting System, a federal program for reporting vaccine issues, spurred the FDA to act.

Men and people older than 50 appear to be at highest risk, according to reports of a July 12 Centers for Disease Control and Prevention (CDC) statement. The CDC also revealed that most cases occur about 2 weeks following immunization.

Guillain-Barré syndrome often causes muscle weakness and sometimes temporary paralysis. Most people who develop the rare syndrome recover.

Such was not the case for a 57-year-old man, The New York Times reported Monday. He had a history of both a heart attack and stroke in the previous 4 years and died in April after vaccination with the J&J vaccine and developing Guillain-Barré.

The new warning comes in the wake of a number of setbacks for the company’s COVID-19 vaccine. On April 13, the FDA and CDC both recommended a 10-day pause on administration of the J&J vaccine after reports of rare blood clot events emerged. In mid-June the FDA requested that Johnson and Johnson discard millions of vaccine doses produced at a manufacturing facility in Baltimore.

The mRNA vaccines from Pfizer/BioNTech and Moderna are not affected by the new FDA warning.

The Biden administration is expected to make a formal announcement of the new warning for the Johnson and Johnson vaccine as early as Tuesday, the Times reports.

Damian McNamara is a staff journalist based in Miami. He covers a wide range of medical specialties, including infectious diseases, gastroenterology, and critical care. Follow Damian on Twitter:  @MedReporter.

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Case Reports Identify Guillain-Barré Variants After COVID Vaccine

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.

Guillain-Barré syndrome, a rare peripheral nerve disorder that can occur after certain types of viral and bacterial infections, has not to date been definitively linked to infection by SARS-CoV-2 or with vaccination against the virus, despite surveillance searching for such associations.

Spikes in Guillain-Barré syndrome incidence have previously, but rarely, been associated with outbreaks of other viral diseases, including Zika, but not with vaccination, except for a 1976-1977 swine influenza vaccine campaign in the United States that was seen associated with a slight elevation in risk, and was halted when that risk became known. Since then, all sorts of vaccines in the European Union and United States have come with warnings about Guillain-Barré syndrome in their package inserts — a fact that some Guillain-Barré syndrome experts lament as perpetuating the notion that vaccines cause Guillain-Barré syndrome.

Epidemiologic studies in the United Kingdom and Singapore did not detect increases in Guillain-Barré syndrome incidence during the COVID-19 pandemic. And as mass vaccination against COVID-19 got underway early this year, experts cautioned against the temptation to attribute incident Guillain-Barré syndrome cases following vaccination to SARS-CoV-2 without careful statistical and epidemiological analysis.

Until now reports of Guillain-Barré syndrome have been scant: clinical trials of a viral vector vaccine developed by Johnson & Johnson saw one in the placebo arm and another in the intervention arm, while another case was reported following administration of a Pfizer mRNA SARS-Cov-2 vaccine.

Recent Case Reports

Two reports published this month in the Annals of Neurology — one from India and one from the United Kingdom — describe multiple cases of Guillain-Barré syndrome following a first dose of the ChAdOx1-S/nCoV-19, (Covishield, AstraZeneca) vector vaccine. None of the patients had evidence of current SARS-CoV-2 infection.

From India, Boby V. Maramattom, MD, of Aster Medcity in Kochi, India, and colleagues reported on seven severe cases of Guillain-Barré syndrome occurring between 10 and 14 days after a first dose of the AstraZeneca vaccine. All but one of the patients were women, all had bilateral facial paresis, all progressed to areflexic quadriplegia, and six required respiratory support. Patients’ ages ranged from 43 to 70. Four developed other cranial neuropathies, including abducens palsy and trigeminal sensory nerve involvement, which are rare in reports of Guillain-Barré syndrome from India, Maramattom and colleagues noted.

The authors argued that their findings “should prompt all physicians to be vigilant in recognizing Guillain-Barré syndrome in patients who have received the AstraZeneca vaccine. While the risk per patient (5.8 per million) may be relatively low, our observations suggest that this clinically distinct [Guillain-Barré syndrome] variant is more severe than usual and may require mechanical ventilation.”

The U.K. cases, reported by Christopher Martin Allen, MD, and colleagues at Nottingham (England) University Hospitals NHS Trust, describe bifacial weakness and normal facial sensation in four men between 11 and 22 days after their first doses of the Astra-Zeneca vaccine. This type of facial palsy, the authors wrote, was unusual Guillain-Barré syndrome variant that one rapid review found in 3 of 42 European patients diagnosed with Guillain-Barré syndrome following SARS-CoV-2 infection.

Allen and colleagues acknowledged that causality could not be assumed from the temporal relationship of immunization to onset of bifacial weakness in their report, but argued that their findings argued for “robust postvaccination surveillance” and that “the report of a similar syndrome in the setting of SARS-CoV-2 infection suggests an immunologic response to the spike protein.” If the link is casual, they wrote, “it could be due to a cross-reactive immune response to the SARS-CoV-2 spike protein and components of the peripheral immune system.”

“The Jury Is Still Out”

Asked for comment, neurologist Anthony Amato, MD, of Brigham and Women’s Hospital, Boston, said that he did not see what the two new studies add to what is already known. “Guillain-Barré syndrome has already been reported temporally following COVID-19 along with accompanying editorials that such temporal occurrences do not imply causation and there is a need for surveillance and epidemiological studies.”

Robert Lisak, MD, of Wayne State University, Detroit, and a longtime adviser to the GBS-CIDP Foundation International, commented that “the relationship between vaccines and association with Guillain-Barré syndrome continues to be controversial in part because Guillain-Barré syndrome, a rare disorder, has many reported associated illnesses including infections. Many vaccines have been implicated but with the probable exception of the ‘swine flu‘ vaccine in the 1970s, most have not stood up to scrutiny.”

With SARS-Cov-2 infection and vaccines, “the jury is still out,” Lisak said. “The report from the U.K. is intriguing since they report several cases of an uncommon variant, but the cases from India seem to be more of the usual forms of Guillain-Barré syndrome.”

Lisak noted that, even if an association turns out to be valid, “we are talking about a very low incidence of Guillain-Barré syndrome associated with COVID-19 vaccines,” one that would not justify avoiding them because of a possible association with Guillain-Barré syndrome.

The GBS-CIDP Foundation, which supports research into Guillain-Barré syndrome and related diseases, has likewise stressed the low risk presented by SARS-CoV-2 vaccines, noting on its website that “the risk of death or long-term complications from COVID in adults still far exceeds the risk of any possible risk of Guillain-Barré syndrome by several orders of magnitude.”

None of the study authors reported financial conflicts of interest related to their research. Amato is an adviser to the pharmaceutical firms Alexion and Argenx, while Lisak has received research support or honoraria from Alexion, Novartis, Hoffmann-La Roche, and others.

This article originally appeared on MDedge.com, part of the Medscape Professional Network.

Author: Jennie Smith
This post originally appeared on Medscape Medical News

AstraZeneca vaccine investigation underway over reports of Guillain-Barre syndrome cases

As part of a regular review of safety reports for the vaccine, the European Medicines Agency’s safety committee is analysing data provided on cases of Guillain-Barre syndrome, the regulator said. The EMA has requested more detailed information on the cases from pharmaceutical giant AstraZeneca.
Guillain-Barre syndrome is a rare and serious condition that affects the nerves.

The condition causes symptoms such as numbness, weakness and pain, mainly affecting the feet, hands, arms and legs.

It can be treated and most people will make a full recovery.

However it can be life-threatening and some people are left with long-term problems.

The EMA is also looking into reports of heart inflammation with Pfizer’s jab and Moderna’s vaccine.

The EU’s drugs watchdog and other regulators are already reviewing the possibility of rare blood clotting conditions with vaccines, including the AstraZeneca shot.

Some European countries have restricted use of the AstraZeneca jab to older age groups, citing the risks of rare blood clots in younger people.

Meanwhile, the European Commission has launched legal action against the pharmaceutical giant amid a row over jab supplies.

READ MORE: ‘Stops you from dying’ Andrew Neil speaks out as over 50s to get boost

The JCVI has advised that another jab should be offered to under-40s without underlying health conditions where an alternative is available, and as long as it does not cause any substantial delays to the vaccination programme.

Professor Wei Shen Lim, Covid-19 chairman for JCVI, said: “Safety remains our number one priority.

“We have continued to assess the benefit/risk balance of Covid-19 vaccines in light of UK infection rates and the latest information from the MHRA on the extremely rare event of blood clots and low platelet counts following vaccination.

“As Covid-19 rates continue to come under control, we are advising that adults aged 18 to 39 years with no underlying health conditions are offered an alternative to the Oxford/AstraZeneca vaccine, if available and if it does not cause delays in having the vaccine.

“The advice is specific to circumstances in the UK at this time and maximises use of the wide portfolio of vaccines available.

“The Covid-19 vaccines have already saved thousands of lives and the benefit for the majority of the population is clear – if you are offered the vaccine, you should take it.”

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