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Vaccine Compensation ProgramOn March 17, 2021, Health and Human Services (HHS) published a notice on the Federal Register alerting the public that the proposed rule change previously published on January 21, 2021 changing how cases involving shoulder injuries and vasovagal syncope are handled in the Vaccine Injury Compensation Program (VICP), is likely to be withdrawn following a thirty day comment period for public response ending on April 16, 2021.

The January 2021 rule by HHS would have removed shoulder and vasovagal injuries from the Vaccine Injury Table, requiring injured parties to pursue these injuries through “causation-in-fact” claims which often require the retention of medical experts and very often, an in-person hearing years down the line before a Special Master (Judge) in Washington, D.C. That rule change was initially due to go into effect on February 22, 2021, however, the effective date was pushed back two months until April 23, 2021 following a request by the Biden administration for time to review all administrative actions that occurred during the sunset of the previous administration.

Now, it appears that HHS is moving to withdraw that rule entirely. If that comes to pass, shoulder injuries and vasovagal syncope would continue to be included in the Vaccine Injury Table, allowing the claims to continue to be resolved more efficiently than if they were causation-in-fact cases.

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Vaccine Injury LawyerOn February 4, 2021, USA Today published an article about the upcoming removal of Shoulder Injury Related to Vaccine Administration (“SIRVA”) from the vaccine injury table. We discussed this rule change, which goes into effect on February 22, 2021, in a previous blog post. You can find our blog discussing that issue here.

The USA Today article discusses not only the rule change impacting SIRVA, but also touches on additional rule changes put in place by Health & Human Services (HHS) at the same time, all pushed through at the very end of the Trump administration with at best, minimal support, (chiefly from HHS). There was substantial pushback from players in the vaccine injury program, including the Advisory Commission on Childhood Vaccines (ACCV), the Vaccine Injured Petitioners Bar Association, members of the general public, physicians, pharmaceutical chains, etc., and individuals that have taken their SIRVA cases through the vaccine injury program.

You can find the USA Today article here.

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Chicago vaccine attorneyAs the clamor grows for an effective Covid-19 vaccine, questions regarding vaccine safety have been foremost in the minds of the public. A recently published article in the pre-eminent journal, Science, by lead author, David M. Knipe, provides an overview into the vaccine safety regulatory framework in place in the United States and discusses how that framework came-to-be over the last several decades.

Among the common vaccine safety measures discussed by the authors are quality control checks to ensure that each batch of vaccine meets strict formulation standards and monitoring adverse events both before and after licensing to determine whether additional study, or alternate action, is needed. The article also discusses the Food and Drug Administration’s (“FDA”) specific guidance to pharmaceutical companies developing potential Covid-19 vaccines, including recommendations for post-licensure reporting and post-licensure studies in light of the likelihood for emergency-use approval of Covid-19 vaccines.

Given the news over the last few weeks of three different Covid-19 vaccines with encouraging Phase-3 clinical trial results, this informative article is extremely well-timed.

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Chicago SIRVA vaccine shoulder injury attorneyLast week, makers of the influenza vaccine began shipping their first doses of flu vaccine for the 2017 – 2018 flu season to healthcare providers, pharmacies, and immunizers. People will be able to begin getting immunized for the upcoming flu season beginning in late September. 

There are a small number of people who should take precautions when getting the flu vaccine, and a small number of people who should not get it at all. Suitability for the vaccine is determined by health status, age, and allergies to components of the flu vaccine. You should talk to your health care provider before getting immunized if you are concerned about your suitability for the influenza vaccine.

For the approximately 160 million people who will get the 2017-2018 flu vaccine, it a good time to learn or to review some tips how to protect yourself from Shoulder Injury Related to Vaccine Administration (SIRVA) injury

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Pandemrix, the H1N1 vaccine produced by GlaxoSmithKline, has been linked to an increased incidence of narcolepsy in children that received the vaccine.  Narcolepsy is a chronic sleep disorder with symptoms including, daytime sleepiness, hallucinations, and cataplexy (sudden loss of muscle tone and inability to move triggered by strong emotion).

The vaccine, administered in 2009-2010, has been linked to more than eight hundred cases of narcolepsy in children.  Studies in Finland and Britain found that children are 13-14 times more likely to suffer from narcolepsy after receiving the vaccine.

While studies regarding the cause of this increase are ongoing, it is likely that the vaccine’s adjuvant, AS03, a squalene-based adjuvant, plays a role.  Some researchers believe that the increased effectiveness of AS03 in boosting an immune response could have increased an adverse immune response as well.

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