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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

U.S. May Approve COVID-19 Booster Shots at 6 Months

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The Food and Drug Administration (FDA) is currently reviewing booster data from vaccine manufacturers and other countries given at 6 months.

What We Know:

  • An unnamed source told the Wall Street Journal the boosters would be approved for all three COVID-19 vaccines administered in the US- Pfizer, Moderna, and Johnson & Johnson. In addition, they declared approval would come in mid-September.
  • The information comes after officials reported that booster shots would become available to some adults 8 months after their last dose beginning on September 20. These include healthcare providers, nursing home residents, and other seniors. However, booster rollout depends on FDA approval and recommendation from a key Centers for Disease Control and Prevention (CDC) outside vaccine advisory committee.
  • Officials want people to receive the third dosage because of the current rise in Delta strain cases. Studies show that the coronavirus vaccine loses potency after several months. Additionally, the Delta strain currently holds the highest number of infections among vaccinated and unvaccinated people; despite this, those who obtained the vaccine experience milder breakthrough infections.
  • In addition, the CDC and FDA urge citizens to receive vaccinations as hospitalizations rise once more. Recently, the U.S. saw 100,000 people hospitalized, a number only seen since before vaccines were easily accessible. A third of the country’s hospitalizations come from states with low vaccination rates, large populations, and governors who disagree with vaccine and mask mandates, such as Texas and Florida. As of Aug. 25, Texas saw 23,412 new daily cases, 248 deaths, and 14,000 hospitalizations. On that same date, Florida saw 26,203 positive cases, 9 fatalities, and 17,000 hospitalizations.

Alongside more hospitalizations, daily numbers are also creeping back up. On Aug. 25, the U.S. saw 148,000 new cases, only 3,000 less than Jan. 30’s report. In contrast, deaths from COVID-19 waned since January, dropping from 3,100 a day to 1,100 a day.

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FDA grants full approval to Pfizer’s Covid vaccine

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The Food and Drug Administration granted full approval to Pfizer-BioNTech’s two-dose vaccine Monday for people ages 16 and up, making it the first Covid-19 vaccine to pass this final regulatory hurdle.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the Covid-19 pandemic,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement. “While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

What We Know:

  • The FDA’s decision may also pave the way for more vaccination mandates: Many businesses were waiting for full approval before they required employees to be vaccinated.

“Full approval could not come at a more important time, as the highly contagious delta variant continues to drive up caseloads and deaths across the U.S.,” the president and CEO of the Robert Wood Johnson Foundation, Dr. Richard Besser, former acting director of the Centers for Disease Control and Prevention, said in a statement. “I am hopeful that full approval will address any remaining concerns and will move many people to a ‘yes’ on vaccination.”

  • Besser said the lack of vaccines in middle- and low-income countries “represents a global failure,” adding, “Ensuring an adequate supply of vaccines in every country and community must be a health, economic, and moral imperative for the world.”
  • Federal health officials announced that, starting September 20th, people who received the Pfizer vaccine will be eligible for third doses eight months after their second doses. The FDA has not yet signed off a third dose.  No Covid vaccines have been authorized or approved for use in children under 12, though this is expected to change soon with FDA approval.

Pfizer’s vaccine is one of three in use in the U.S. Moderna has also applied for full approval, also known as a Biologics Licensing Application. Johnson & Johnson has not yet applied for full approval, and remains in use under emergency authorization.

Pfizer’s product was the first Covid vaccine to gain emergency use authorization, in December. As of Monday, more than 203 million doses have been given in the U.S., according to the CDC.

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Reverend Jesse Jackson and His Wife, Jacqueline, Hospitalized with COVID-19

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Reverend Jesse Jackson and his wife Jacqueline are currently being treated at Northwestern Memorial Hospital in Chicago.

What We Know:

  • News about the couple’s diagnosis became public after a statement released by the Reverend’s Rainbow/Push Coalition on Saturday. In the statement, officials declared that doctors were monitoring both Jesse and Jacqueline; it did not provide any further information.
  • However, their son, Jonathan, provided more information on Sunday. Jonathan told the Associated Press that doctors are carefully observing Jesse and Jacqueline because of their ages. Additionally, the two responded “positively” to treatments and were resting. On Monday, Jonathan said his parents’ status did not change and asked for prayers for the two,
  • Despite his hospitalization, Jesse received his first coronavirus vaccine dosage in January 2021 during a publicized event. Alongside obtaining protection against the disease, he urged his followers to receive the vaccine as soon as possible. The Associated Press reported that it is unclear if Jacqueline also got the vaccine.
  • Underlying health concerns might have been the cause for both of them catching COVID-19. Family members said Jacqueline had an unspecified condition which made them concerned recently. In addition, Jesse was diagnosed in 2015 with Parkinson’s disease and underwent gallbladder surgery earlier this year.
  • Rev. Jesse Jackson worked with mentor Dr. Martin Luther King, Jr. in moving the Civil Rights Movement forward. His impact helped guide the movement on numerous issues, such as voting rights. After the movement and even currently, Jesse continued working to make a change in his society. Police recently arrested Jesse for civil disobedience after participating in a sit-in at Sen. Kyrsten Sinema‘s Phoenix office with 39 others.

Black News Alerts prays that Jesse and Jacqueline make a speedy recovery and continue inspiring many.

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