About 100 suspected cases of GBS — among 12.8 million people who have gotten the J&J shot — have been identified in the federal government’s database.

FDA is preparing to add a warning to Johnson & Johnson’s Covid-19 vaccine after receiving preliminary reports of patients developing the rare neurological condition Guillain-Barré syndrome after receiving the shot, a senior CDC official confirmed to NANN.

About 100 suspected cases of GBS — among the 12.8 million people who have gotten the J&J shot — have been identified in the federal government’s database for adverse side effects after vaccination, the official said.

Number of Deaths Reported After COVID Vaccines Jumps by More Than 2,000 in 1 Week, According to VAERS

VAERS data released today by the CDC showed a total of 438,441 reports of adverse events from all age groups following COVID vaccines, including 9,048 deaths and 41,015 serious injuries between Dec. 14, 2020 and July 2, 2021.

Of the 9,048 deaths reported as of July 2, 22% occurred within 48 hours of vaccination, 15% occurred within 24 hours and 37% occurred in people who became ill within 48 hours of being vaccinated.

This week’s data for 12- to 17-year-olds show:

• 13,385 total adverse events, including 801 rated as serious and 14 reported deaths among 12- to 17-year-olds. Two of the nine deaths were suicides.
• The most recent reported death includes a 13-year-old boy (VAERS I.D. 1431289) with a previous history of COVID who suffered cardiac arrest and died 17 days after vaccination with Pfizer.Other reports include a 13-year-old boy (VAERS I.D. 1406840) who died two days after receiving a Pfizer vaccine, three 15-year-olds (VAERS I.D. 1187918, 1382906 and 1242573), four 16-year-olds (VAERS I.D. 1420630, 1426828, 1225942 and 1386841) and three 17-year-olds (VAERS I.D. 1199455, 1388042 and 1420762).
• 1,934 reports of anaphylaxis among 12- to 17-year-olds with 99% of cases
  attributed to Pfizer’s vaccine, 1.1% to Moderna and 0.2% (or four cases) to J&J.
• 347 reports of myocarditis and pericarditis (heart inflammation) with 343 attributed to Pfizer’s vaccine.
• 57 reports of blood clotting disorders, 56 attributed to Pfizer and 1 attributed to Moderna.

This week’s total VAERS data, from Dec. 14, 2020 to July 2, 2021, for all age groups show:

• 22% of deaths were related to cardiac disorders.
• 50% of those who died were male, 45% were female and the remaining death reports did not include gender of the deceased.
• The average age of death was 74.7.
• As of July 2, 2,678 pregnant women reported adverse events related to COVID vaccines, including 994 reports of miscarriage or premature birth.
• Of the 4,456 cases of Bell’s Palsy reported, 59% were attributed to Pfizer vaccinations, 39% to Moderna vaccine and 7% to J&J.
• 398 reports of Guillain-Barré Syndrome, with 47% of cases attributed to Pfizer, 40% to Moderna and 19% to J&J.
• 121,092 reports of anaphylaxis with 46% of cases attributed to Pfizer’s vaccine, 46% to Moderna and 7% to J&J.
• 8,256 reports of blood clotting disorders. Of those, 3,959 reports were attributed to Pfizer, 2,699 reports to Moderna and 1,552 reports to J&J.
• 1,796 cases of myocarditis and pericarditis with 1,177 cases attributed to Pfizer, 563 cases to Moderna and 52 cases to J&J’s COVID vaccine.

Pfizer says boosters needed, U.S. federal health agencies, scientists disagree

As The Defender reported today, U.S. federal health agencies and the maker of one of the most popular COVID vaccines are publicly at odds over if or when fully vaccinated people will need a third “booster” dose.

Pfizer announced Thursday it will seek Emergency Use Authorization from the FDA in August for a third dose of its COVID vaccine. The drugmaker predicted those who have been fully vaccinated will need a booster shot within six to 12 months of receiving their second dose of the Pfizer vaccine.

But the U.S.Department of Health and Human Services (HHS) hours later issued a joint statement by the FDA and Centers for Disease and Control and Prevention (CDC) saying, “Americans who have been fully vaccinated do not need a booster shot at this time.”Tell Schools/Universities No Vaccine Mandates for Children/Young Adults!

The HHS statement did not explicitly mention Pfizer, but said “a science-based, rigorous process” headed by the CDC, FDA and the National Institutes of Health would determine when or whether boosters were necessary.

Pfizer’s assertions about the need for boosters contradict other research, and several experts pushed back against the claim.

“There’s really no indication for a third booster or a third dose of an mRNA vaccine, given the variants that we have circulating at this time,” Dr. Céline Gounder, an infectious disease specialist at Bellevue Hospital Center in New York, told the New York Times. “In fact, many of us question whether you will ever need boosters.”

John P. Moore, professor of microbiology and immunology at Weill Cornell Medicine, told the Washington Post:

“No one is saying we’ll never need a booster, but to say we need it now and give the public the impression the vaccines are failing and something needs to be done as a matter of urgency. … The time isn’t now. The decisions that are going to be made will be made by federal agencies.”

Pfizer and BioNTech are developing a version of their COVID vaccine that targets the Delta variant, The New York Times reported this week. The companies expect to begin clinical trials of the vaccine in August.

Pfizer and BioNTech reported — based on their own studies that have not been published, nor peer-reviewed, according to the Times — that a booster given six months after the second dose of vaccine increased the potency of antibodies against the original virus and the Beta variant by five- to tenfold.

Vaccine efficacy may decline six months after immunization, the companies said in a news release, and booster doses may be needed to fend off virus variants. The vaccine makers said they will submit their findings to the FDA in the coming weeks, a step toward gaining authorization for booster shots.

17-year-old student required to get vaccinated suffers heart condition

Concerns around COVID vaccines and heart inflammation, especially in young males, continue to circulate. But according to an update posted today on the CDC website, the agency’s researchers have concluded the benefits of the vaccine outweigh the risks of myocarditis after vaccination.

European drug regulators today announced they also have found a “possible link” between a “very rare heart inflammation” and the Pfizer and Moderna vaccines, but sided with U.S. regulators, saying they also believe the benefits of the shots outweighed any risks.

Meanwhile, The Defender continues to report on teens who have experienced heart issues after taking the vaccines — including a 17-year-old student who developed symptoms of a heart condition about one week after his first dose of Pfizer’s COVID and subsequently was diagnosed with a heart condition.

The teen’s father, Fabio Berlingieri, told “Fox & Friends” his son had COVID and recovered, but was required to get the vaccine in order to play soccer.