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Coronavirus

FDA Adds Warning about Rare Reaction to J&J COVID-19 Vaccine

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On Monday, the Food and Drug Administration warned that the Johnson & Johnson (Janssen) COVID-19 vaccine could cause a rare and dangerous neurological disorder.

What We Know:

  • Guillain-Barre Syndrome (GBS) is “a neurological disorder in which the body’s immune system damages nerve cells, causing muscle weakness and sometimes paralysis.” Tingling or weakness of extremities is one of the first signs of the disorder. The cause of GBS is unknown, but symptoms began to show days after having been sick “with a lung or sinus illness.” Between 3,000 and 6,000 people in the US develop GBS, with those over the age of 50 at greater risk of developing the neurological disorder.
  • According to the Centers for Disease Control and Prevention, there have been rare cases in which people developed GBS after receiving a vaccine. There is no cure for the rare disorder, but treatments help subside symptoms and illness. The mortality rate is between 4% and 7%, with most people who experienced paralysis eventually regaining their ability to walk.
  • The FDA released an updated label regarding the vaccine possibly causing an increased risk of developing GBS. They stated that those who did develop the disorder did so during the first 42 days of getting the vaccination shot. The FDA has not determined if the J&J vaccine is the true cause of GBS developing in some vaccinated people but has determined that no signs point to the other approved vaccines causing a similar outcome.
  • Out of the 12.8 million J&J vaccines that were given out, the Vaccine Adverse Event Reporting System has only received 100 “preliminary” reports of people developing GBS. Of those 100 reported cases, 95 had to be hospitalized, and one died. Most of the cases reported have been men over the age of 50 who experienced symptoms two weeks after getting the vaccine.
  • J&J has communicated with the CDC and FDA regarding the possible correlation between GBS and their vaccine. Both agencies will monitor the vaccine and use the federal vaccines safety database to read over side effect reports sent in by drugmakers, physicians, and those who receive the vaccine. They will also be placing the GBS warning inside pamphlets that are given to those who receive the J&J vaccine.
  • The medical company has had its share of setbacks since having its one-shot vaccine approved for emergency release by the CDC. Earlier this year, there were reports that the vaccine caused a rare type of blood clot, which prompted a temporary halt on distribution until April. Dr. Anthony Fauci Told CNN that risks are to be expected with vaccines. However, the benefits of getting vaccinated outweigh those risks.

“When you vaccinate tens of millions of people, you will always find a rare event. You’ve got to make a decision — does the benefit outweigh the unusual risk of an adverse event? Thus far with the vaccines, it’s always been decided that the benefit of the vaccine outweighs the risk of an adverse event,” said Fauci

Those who receive the J&J vaccine should be mindful of the symptoms associated with GBS, such as double vision, trouble walking, swallowing, or tingling sensations, and should seek medical attention immediately if they experience any of them.

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Coronavirus

Biden Calls Out DeSantis’ Refusal on Mask Mandates

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President Joe Biden told reporters that Governors Ron DeSantis’s decisions against mask mandates would eventually have results that will affect constituents.

What We Know:

  • Biden’s message comes after DeSantis declared he would not impose mask mandates in Florida. DeSantis also said he would withhold funds from any schools that attempt to place guidelines on wearing masks. Currently, Florida faces a severe spike in cases due to the Delta variant and lower vaccination rates.
  • Because of this, Biden gave his stern commandment. The President stated the country needs leadership from everyone, and if some governors do not want “to do the right thing” to beat the pandemic, they should allow businesses and universities to do so. Pres. Biden further reminded the governors that they hold the power to save lives.

 “But if you are not going to help, at least get out of the way of the people who are trying to do the right thing,” said Biden.

  • DeSantis believes the spike in cases is just a pattern, similar to those seen last year despite the President’s pleas. In addition, the Florida governor downplayed the state’s surge in hospitalizations; according to DeSantis, COVID patients only “represent a fraction of the overall hospital beds.”
  • Furthermore, DeSantis responded to Biden’s comments at an August 4th press conference. He claimed the President was singling out Florida over the coronavirus pandemic. Additionally, DeSantis stated Biden did not live up to his promise to end the virus’ spread, as he allows the United States to have a “wide open southern border.” DeSantis stated that until Pres. Biden secures the border, he wishes not to hear anything about COVID from him.

On August 5th, Florida saw 20,133 new COVID-19 cases. On July 31, the state recorded 21,683 cases, the highest number since the pandemic’s beginning; August 5th’s results were only 1,550 test results lower.

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Coronavirus

Disneyland and Disney World to Require Masks Indoors Again Regardless of Vaccination Status

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The new policy follows the Centers for Disease Control and Prevention (CDC)‘s recommendation that fully vaccinated people wear masks indoors as COVID-19 cases skyrocket in places such as California and Florida.

What We Know:

  • As of July 30, the Walt Disney Company requires all park visitors, regardless of vaccination status, to wear face-coverings indoors at Walt Disney World Resort in Florida and Disneyland Resort in California. The only guests who are exempt from these rules are children under the age of two.
  • On July 27, Orange County Mayor Jerry L. Demings declared a local state of emergency due to a spike in coronavirus cases; according to Demings’ executive order, the county in which Disney World is located saw the 14-day rolling positivity rate go over 15%. Orange County also saw a new record of 1,371 cases, the highest number since the pandemic’s beginning, a day prior to the mayor’s announcement.
  • The CDC further ruled Orange County an area with high transmission levels; officials added that the virus “continues to pose a public health threat.” In addition, Anaheim, the location for Disneyland, is facing “substantial” levels of community transmission. On the week of July 30, the city saw a seven-day positivity rate of 6.33%.
  • The influx in cases comes as the Delta variant runs rampant across the country. Currently, the more contagious version of the virus accounts for approximately 83% of cases in the U.S. The more frequent occurrences of COVID-19 also stem from the fact that vaccination rates have slowed down significantly. Disney Parks might continue to enact these mandates until cases stabilize once more.

Last March, the Walt Disney Company closed down all of its parks worldwide as the world dealt with the COVID-19 pandemic. Walt Disney World in Florida became the first U.S. park to reopen in July 2020. Disneyland opened its gates nine months after Disney World in April 2021.

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Florida Breaks Record for COVID-19 Hospitalizations

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Florida recently saw 10,207 hospitalizations caused by coronavirus cases, the highest number since July 23, 2020.

What We Know:

  • On July 23, 2020, Florida reached a high of 10,170 hospitalizations, just six months before the COVID-19 vaccine became available. The new record makes Florida the leader in per capita hospitalizations for the virus.
  • Most of the new cases come from the highly contagious Delta variant. On average, Florida sees 1,525 adult and 35 children hospitalizations daily. In addition, Saturday revealed a peak in positive numbers, as the stated reported  21,683 occurrences of COVID-19. The day prior, the Sunshine State saw 17,093 cases.
  • Many hospital employees believed the excess hospitalizations would end soon because of an increase in vaccinations. However, the Delta variant changed all this. The Associated Press wrote that several hospitals, including the Mayo Clinic Florida and the UF Health North emergency room, needed to operate overcapacity and put beds in hallways to treat patients; the Mayo Clinic will continue to do so until the current surge ends. In Tampa, some local ambulances already needed to divert ambulances to other locations because of capacity concerns.
  • The higher numbers also are a direct result of a loosening of restrictions and a governor’s stubbornness. Florida’s Governor Ron DeSantis actively declares he will not enact any more mask mandates and vaccine requirements. Along with the state Legislature, this makes it difficult for local officials to impose restrictions that will ease the positive numbers.
  • Medical officials scorned DeSantis for his adamance on the issue. Dr. Bernard Ashby, a Miami-based vascular cardiologist and Florida State Lead for the Committee to Protect Health Care, commented that the state would not be in its position now if DeSantis focused more on lowering cases than proving Dr. Anthony Fauci wrong. Gainesville infectious disease expert Dr. Frederick Southwick agreed with Ashby’s statement, saying that DeSantis needed to stop acting like “Florida won the pandemic.”

DeSantis recently announced that Florida would resist any federal authorities’ campaigns to enforce mask mandates inside schools despite the criticism.

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