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CDC To Hold “Emergency Meeting” After 100s Suffer Heart Inflammation Following COVID Vaccines

CDC To Hold "Emergency Meeting" After 100s Suffer Heart Inflammation Following COVID Vaccines

Update (2000ET): The Centers for Disease Control and Prevention announced Thursday that it will convene an "emergency meeting" of its advisers…

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CDC To Hold "Emergency Meeting" After 100s Suffer Heart Inflammation Following COVID Vaccines

Update (2000ET): The Centers for Disease Control and Prevention announced Thursday that it will convene an "emergency meeting" of its advisers on June 18th to discuss rare but higher-than-expected reports of heart inflammation following doses of the mRNA-based Pfizer and Moderna COVID-19 vaccines.

The new details about myocarditis and pericarditis emerged first in presentations to a panel of independent advisers for the Food and Drug Administration, who are meeting Thursday to discuss how the regulator should approach emergency use authorization for using COVID-19 vaccines in younger children.

As CBS reports, the CDC previously disclosed that reports of heart inflammation were detected mostly in younger men and teenage boys following their second dose, and that there was a "higher number of observed than expected" cases in 16- to 24-year-olds. Last month, the CDC urged providers to "ask about prior COVID-19 vaccination" in patients with symptoms of heart inflammation.

We'll leave the judgment up to someone far more qualified...

Does anyone else not find it odd that after discovering 800 cases in the VAERS database the "emergency" meeting is in 7 days? ... and in the meantime, every public health authority figure is encouraging parents to get their young children vaccinated?

*  *  *

As The Epoch Times' Zachary Stieber detailed earlier, Federal authorities have received over 800 reports of heart inflammation in people who received a COVID-19 vaccine, a health official said Thursday.

The reports of myocarditis or pericarditis were submitted to the Vaccine Adverse Event Reporting System, a passive reporting system run jointly by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration, through May 31.

The bulk of the reports described heart inflammation appearing after the second of two doses of either the Pfizer of Moderna vaccines, both of which utilize messenger RNA technology.

Authorities stress that anybody can submit reports through the reporting system but authorities have already verified that 226 of the reports meet the CDC’s working case definition, Dr. Tom Shimabukuro, a deputy director at the agency, said during a presentation of the data. Followup and review are in progress for the rest.

Of the 285 case reports for which the disposition was known at the time of the review, 270 patients had been discharged and 15 were still hospitalized, officials said. Myocarditis typically requires hospital care. No deaths were reported.

A slide on myocarditis reports post-COVID-19 vaccination is shown during the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee meeting on June 10, 2021. (FDA/Screenshot via The Epoch Times)

The CDC announced last month that it was investigating reports of heart inflammation in teenagers and young adults who received a COVID-19 vaccine, though it took no definitive action besides saying it would continue reviewing case data.

An advisory committee to the agency, the Advisory Committee on Immunization Practices, said in a little-noticed update published dated May 24 and published on June 1 that data from VAERS showed that in the 30 days following the second dose of mRNA vaccinations, “there was a higher number of observed than expected myocarditis/pericarditis cases in 16–24-year-olds.”

Data from the Vaccine Safety Datalink, an active reporting system that relies on nine healthcare organizations in seven states, did not show higher than expected cases, it added.

“However, analyses suggest that these data need to be carefully followed as more persons in younger age groups are vaccinated,” the advisory committee’s vaccine safety workgroup said in its report.

Israel’s Health Ministry said that same day that it found 275 cases of heart inflammation among the more than 5 million people in the country who received a vaccine between December 2020 and May. An Israeli study found “a probable link” between receiving the second dose of the Pfizer jab “and the appearance of myocarditis among men aged 16 to 30,” the ministry said.

Shimabukuro said the U.S. passive surveillance data “are consistent with the surveillance data that emerged from Israel.”

The figures are also consistent with other case reports and data from the Department of Defense.

The vast majority of the U.S. reports deal with male patients. Approximately 300 preliminary reports indicated the patients suffered chest pain, with nearly as many having elevated cardiac enzymes.

Family members watch as a 12-year-old is inoculated with Pfizer’s vaccine against COVID-19 at Dekalb Pediatric Center in Decatur, Ga., on May 11, 2021. (Chris Aluka Berry/Reuters)

A case report examining myocarditis in seven adolescents following vaccination with Pfizer’s jab, published in Pediatrics, the journal of the American Academy of Pediatrics, this month, said all seven developed the inflammation within 4 days of receiving the second dose, did not have evidence of COVID-19 infection, and did not meet the criteria for MIS-C, a rare disease.

The seven males, between the ages of 14 and 19, all required hospital care but each was eventually discharged.

Authors, who did not respond to requests for comment, said no link has been established between the vaccines and myocarditis and that the benefits of the vaccines outweigh the risks. But they also urged healthcare workers “to consider myocarditis in the evaluation of adolescents and young adults who develop chest pain after COVID-19 vaccination.”

commentary on the study published in the same journal, said “there are some concerns regarding this case series that might suggest a causal relationship and therefore warrant further analysis through established surveillance systems.”

“First, the consistent timing of symptoms in these seven cases after the second vaccination suggests a uniform biological process. Second, the similarities in clinical findings and laboratory characteristics in this series suggest a common etiology. Finally, these cases occurred in the context of a dearth of circulation of common respiratory viruses known to be associated with myocarditis, and thorough diagnostic evaluations did not identify infectious etiologies,” they added.

The expected number of myocarditis/pericarditis cases in those aged 16 or 17, based on background incidence rates and the number of doses administered to that population through May 31, is between two and 19. But based on the VAERS reports, the number is 79.

Likewise, the expected number for cases among young adults between the ages of 18 and 24 is eight to 83. The number based on the reports is 196.

“In the 16- to 17 year-olds and the 18- to 24-year-olds, the observed reports are exceeding the expected based on the known background rates that are published in literature,” Shimabukuro told members of a Food and Drug Administration vaccine advisory committee in the meeting on Thursday, though he cautioned that not all the reports will “turn out to be true myocarditis/pericarditis reports.”

Of note, of these 528 reports after second dose with symptom onset within 30 days, over half of them were in these younger age groups, 12–24 years old, whereas roughly 9 percent of total doses administered were in those age groups, so we “clearly have an imbalance there,” he added later.

A slide on myocarditis reports post-COVID-19 vaccination is shown during the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee meeting on June 10, 2021. (FDA/Screenshot via The Epoch Times)

Data from the Vaccine Safety Datalink, which comes from nine healthcare groups that have collectively administered over 8.8 million doses—only some 284,000 of those have been given to 12- to 17-year-olds—did not indicate safety concerns, with just 60 myocarditis or pericarditis events reported through May 29, the doctor continued.

A Food and Drug Administration surveillance system, the Biologics Effectiveness and Safety Initiative, which utilizes claims data from CVS and two other partners, has detected 99 cases of myocarditis/pericarditis in the 42 days following vaccination among some 3.1 million shots given to people between the ages of 12 and 64, the panel was told earlier by an official from the drug regulating agency.

Another 1,260 were reported in people 65 or older through claims data from Medicare claims data.

Neither number raised safety signals, Steve Anderson, director of the FDA’s Office of Biostatistics and Epidemiology said.

Dr. Cody Meissner, chief of the Division of Pediatric Infectious Disease at the Tufts Children’s Hospital, and a member of the panel that heard from Shimabukuro and others, said after the presentations that he was “struck by the fact” that myocarditis “occurs more commonly after the second dose.”

“It’s a pretty specific interval of time, it’s primarily after the mRNA vaccines as far as we know, we know that the consistent age, there’s a lack of alternative explanations even though these patients have been pretty well worked up, and it’s a widespread occurrence because, as you said, Israel has found a pretty similar situation,” he said during the meeting.

He asked Shimabukuro about the rates of blood clots seen in women between the ages of 30 and 49 after vaccination—most of the clots appeared in that population after getting a Johnson & Johnson shot, though officials ultimately lifted a pause, saying the benefits outweighed the risks—and to restate the rate of incidence of myocarditis in adolescents after a jab.

Shimabukuro said that in contrast with the clotting situation, when data showed “strong evidence of a causal relationship fairly early on,” further study is needed on heart inflammation.

“At this point, I think we’re still learning about the rates of myocarditis and pericarditis. We continue to collect more information both in VAERS and continue to get more information in VSD, and I think as gather more information we’ll begin to get a better idea of the post-vaccination rates and hopefully will be able to get more detailed information by age group,” he said.

“It’s still early,” he added, noting that authorization for a vaccine for 12- to -15-year-olds didn’t come until mid-May while immunization of older adolescents largely came later than shots for adults.

“I believe that we will ultimately have sufficient information to answer those questions,” he said.

A general view of the Centers for Disease Control and Prevention (CDC) headquarters in Atlanta, Ga., on Sept. 30, 2014. (Tami Chappell/Reuters)

Another panel member, Dr. Jay Portnoy, director of the Division of Allergy, Asthma, & Immunology at Children’s Mercy Hospitals & Clinics, asked for a comparison between the adverse events in vaccinated versus unvaccinated persons, saying if the adverse event rate was lower in those who are vaccinated, then it would still be worth getting a jab.

Shimabukuro said a risk-benefit assessment would be provided by the CDC’s advisory panel, known as ACIP, on vaccines during a meeting next week.

A CDC spokeswoman also referenced the upcoming meeting, which will take place on June 18, after saying reports of myocarditis remain rare, given that over 300 million doses have been administered in the United States.

“Given the number of COVID-19 vaccine doses administered, these reports are rare. More than 18 million people between ages 12-24 have received at least one dose of COVID-19 vaccine in the United States,” she told The Epoch Times via email.

“CDC continues to recommend COVID-19 vaccination for everyone 12 years and older. Getting vaccinated is the best way to help protect yourself and your family from COVID-19.”

A Pfizer spokesperson told The Epoch Times in an email that the company is aware of federal data indicating “rare reports of myocarditis and pericarditis, predominantly in male adolescents and young adults, after mRNA COVID-19 vaccination.” It noted that federal officials have not concluded that mRNA COVID-19 vaccines cause either condition, before expressing support for an assessment of suspected adverse events.

“With a vast number of people vaccinated to date, the benefit risk profile of our vaccine remains positive,” the spokesperson added.

Moderna did not return an inquiry.

Dr. Monica Gandhi, professor of medicine and associate chief at the University of California, San Francisco, told The Epoch Times in an email that in light of the increased risk of myocarditis above expected rates among young people, especially after the second dose, parents should keep a close eye out for when guidance is issued by federal authorities.

“Possibilities include only vaccinating children without prior infection as there is an association between prior COVID and this adverse effect; giving 1 dose instead of 2 below the age of 20; addressing the dosage of the vaccine (currently at 30 micrograms down to the age of 12, which is the same dose as in adults); and extending the duration between doses 1 and 2 for younger people,” she said.

“I look forward to ACIP guidance on this over the next few weeks.”

Tyler Durden Thu, 06/10/2021 - 20:30

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AstraZeneca antibody cocktail fails to prevent Covid-19 symptoms in large trial

AstraZeneca said a late-stage trial failed to provide evidence that the company’s Covid-19 antibody therapy protected people who had contact with an infected person from the disease, a small setback in its efforts to find alternatives to vaccines.

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Astra antibody cocktail fails to prevent COVID-19 symptoms in large trial

(Reuters; )

June 15 (Reuters) – AstraZeneca (AZN.L) said on Tuesday a late-stage trial failed to provide evidence that its COVID-19 antibody therapy protected people who had contact with an infected person from the disease, a small setback in its efforts to find alternatives to vaccines.

The study assessed whether the therapy, a cocktail of two types of antibodies, could prevent adults who had been exposed to the virus in the past eight days from developing COVID-19 symptoms.

The therapy, AZD7442, was 33% effective in reducing the risk of people developing symptoms compared with a placebo, but that result was not statistically significant — meaning it might have been due to chance and not the therapy.

The Phase III study, which has not been peer reviewed, included 1,121 participants in the United Kingdom and the United States. The vast majority, though not all, were free of the virus at the start of the trial.

Results for a subset of participants who were not infected to begin with was more encouraging but the primary analysis rested on results from all participants.

FILE PHOTO: A computer image created by Nexu Science Communication together with Trinity College in Dublin, shows a model structurally representative of a betacoronavirus which is the type of virus linked to COVID-19, better known as the coronavirus linked to the Wuhan outbreak, shared with Reuters on February 18, 2020. NEXU Science Communication/via REUTERS

“While this trial did not meet the primary endpoint against symptomatic illness, we are encouraged by the protection seen in the PCR negative participants following treatment with AZD7442,” AstraZeneca Executive Vice President Mene Pangalos said in a statement.

The company is banking on further studies to revive the product’s fortunes. Five more trials are ongoing, testing the antibody cocktail as treatment or in prevention.

The next one will likely be from a larger trial testing the product in people with a weakened immune system due to cancer or an organ transplant, who may not benefit from a vaccine.

TARGETED ALTERNATIVES

AZD7442 belongs to a class of drugs called monoclonal antibodies which mimic natural antibodies produced by the body to fight off infections.

Similar therapies developed by rivals Regeneron (REGN.O) and Eli Lilly (LLY.N) have been approved by U.S. regulators for treating unhospitalised COVID patients.

European regulators have also authorised Regeneron’s therapy and are reviewing those developed by partners GlaxoSmithKline (GSK.L) and Vir Biotechnology (VIR.O) as well as by Lilly and Celltrion (068270.KS).

Regeneron is also seeking U.S. authorisation for its therapy as a preventative treatment.

But the AstraZeneca results are a small blow for the drug industry as it tries to find more targeted alternatives to COVID-19 inoculations, particularly for people who may not be able to get vaccinated or those who may have an inadequate response to inoculations.

The Anglo-Swedish drugmaker, which has faced a rollercoaster of challenges with the rollout of its COVID-19 vaccine, is also developing new treatments and repurposing existing drugs to fight the virus.

AstraZeneca also said on Tuesday it was in talks with the U.S. government on “next steps” regarding a $205 million deal to supply up to 500,000 doses of AZD7442. Swiss manufacturer Lonza (LONN.S) was contracted to produce AZD7442.

Shares in the company were largely unchanged on the London Stock Exchange.

The full results will be submitted for publication in a peer-reviewed medical journal, the company said.

Reporting by Vishwadha Chander in Bengaluru; Editing by Shounak Dasgupta

Our Standards: The Thomson Reuters Trust Principles.

 

Reuters source:

https://www.reuters.com/business/healthcare-pharmaceuticals/astrazeneca-says-its-antibody-treatment-failed-in-preventing-covid-19-exposed-2021-06-15

 

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Government

Former FDA Head Takes on Exec Role at Flagship’s Preemptive Health Initiative

Stephen Hahn, the Commissioner of the U.S. Food and Drug Administration under former President Donald Trump, took on a new role as chief medical officer of a new health security initiative launched by Flagship Pioneering, a life sciences venture firm…

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Former FDA Head Takes on Exec Role at Flagship’s Preemptive Health Initiative

 

Stephen Hahn, the Commissioner of the U.S. Food and Drug Administration (FDA) under former President Donald Trump, has taken on a new role as chief medical officer of a new health security initiative launched by Flagship Pioneering, a life sciences venture firm that incubates and curates biopharma companies.

First announced Monday, Flagship’s Preemptive Medicine and Health Security initiative aimed at developing products that can help people before they get sick. This division will focus on infectious disease threats and pursue bold treatments for existing diseases, including cancer, obesity, and neurodegeneration. 

In a brief statement, Hahn, who served as commissioner from December 2019 until January 2021, said the importance of investing in innovation and preemptive medications has never been more apparent. 

“In my career I have been a doctor and a researcher foremost and it is an honor to join Flagship Pioneering in its efforts to prioritize innovation, particularly in its Preemptive Medicine and Health Security Initiative. The more we can embrace a “what if …” approach the better we can support and protect the health and well-being of people here in the U.S. and around the world,” Hahn said in a statement. 

During his time at the FDA, Hahn was at the forefront of the government’s effort to battle the COVID-19 pandemic. His office oversaw the regulatory authorization of antivirals, antibody therapeutics and vaccines, as well as diagnostics and other tools to battle the novel coronavirus. 

Kevin Dietsch-Pool/Getty Images

Hahn bore the brunt of verbal barbs aimed at the FDA by the former president for not rushing to authorize a vaccine for COVID-19 ahead of the November 2020 election. The second vaccine authorized by the FDA for COVID-19 was developed by Moderna, a Flagship company. 

Prior to his confirmation as FDA Commissioner, Hahn, a well-respected oncologist, served as chief medical executive of the vaunted The University of Texas MD Anderson Cancer Center. Hahn was named deputy president and chief operating officer in 2017. In that role, he was responsible for the day-to-day operations of the cancer center, which includes managing more than 21,000 employees and a $5.2 billion operating budget. He was promoted to that position two years after joining MD Anderson as division head, department chair and professor of Radiation Oncology. Prior to MD Anderson, Hahn served as head of the radiation oncology department at the University of Pennsylvania’s Perelman School of Medicine.

Flagship Founder and Chief Executive Officer Noubar Afeyan said the COVID-19 pandemic that shut down economies and caused the deaths of more than 3.8 million people across the world was an important reminder that health security is a top global priority. In addition, the ongoing pandemic brings into “stark focus” the importance of preemptive medications. 

Hahn, who helmed the FDA for three years and before that served as chief medical executive at The University of Texas MD Anderson Cancer Center, has extensive experience overseeing clinical and administrative programs. Afeyan said the new division would benefit from Hahn’s experience as FDA Commissioner and help steer the Preemptive Medicine and Health Security initiative as it explores Flagship’s “growing number of explorations and companies in this emerging field.”

It is not unusual for former FDA heads to take prominent roles with companies. For example, former FDA Commissioner Scott Gottlieb, Trump’s first FDA Commissioner, took a position on the Pfizer Board of Directors weeks after departing his government role. He has also taken positions on other boards since then, including Aetion, FasterCures and Illumina.

 

BioSpace source:

https://www.biospace.com/article/former-fda-head-stephen-hahn-takes-cmo-role-at-flagship-pioneering-preemptive-health-initiative-

 

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Five U.S. states had coronavirus infections even before first reported cases – study

At least seven people in five U.S. states were infected with the novel coronavirus weeks before those states reported their first cases, a new government study showed.

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Five U.S. states had coronavirus infections even before first reported cases – study

(Reuters) – At least seven people in five U.S. states were infected with the novel coronavirus weeks before those states reported their first cases, a new government study showed.

Participants who reported antibodies against SARS-CoV-2 were likely exposed to the virus at least several weeks before their sample was taken, as the antibodies do not appear until about two weeks after a person has been infected, the researchers said.

The latest results build on findings from a Centers for Disease Control and Prevention study that suggested the novel coronavirus may have been circulating in the United States last December, well before the first COVID-19 case was diagnosed on Jan. 19, 2020.

A protective face mask lays, as the global outbreak of the coronavirus disease (COVID-19) continues, beside leaves at the lakefront in Chicago, Illinois, U.S., December 6, 2020. REUTERS/Shannon/File Photo

The positive samples came from Illinois, Massachusetts, Mississippi, Pennsylvania and Wisconsin, and were part of a study of more than 24,000 blood samples taken for a National Institutes of Health research program between Jan. 2 and March 18, 2020.

Samples from participants in Illinois were collected on Jan. 7 and Massachusetts on Jan. 8, suggesting that the virus was present in those states as early as late December.

“This study allows us to uncover more information about the beginning of the U.S. epidemic,” said Josh Denny, one of the study authors.

The findings were published in the journal Clinical Infectious Diseases.

Reporting by Mrinalika Roy in Bengaluru; Editing by Anil D’Silva

Our Standards: The Thomson Reuters Trust Principles.

 

Reuters source:

https://www.reuters.com/business/healthcare-pharmaceuticals/five-us-states-had-coronavirus-infections-even-before-first-reported-cases-study-2021-06-15

 

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