The study results, published Monday in a letter to the Journal of the American Medical Association, proposed that the differences in immune response might be explained by two things:
There is a longer amount of time between the doses of the Moderna vaccine than the Pfizer vaccine. Moderna’s two shots are spread out by four weeks while Pfizer’s shots are spread out by three weeks.
Article From & Read More ( Moderna vaccine could create twice as many COVID antibodies as Pfizer vaccine, study says - NJ.com )
https://ift.tt/3t480mO
Health
When her husband had gotten so sick from the coronavirus that he was forced into a medically induced coma this month, Julie Smith turned to ivermectin — a deworming drug that some people are using to treat or prevent covid-19.
“My husband is on death’s doorstep,” she wrote, according to an affidavit, “he has no other options.”
Yet when Julie Smith got a prescription from an Ohio doctor, a hospital in West Chester Township, Ohio, allegedly refused to administer the drug to Jeffrey Smith while he was seriously ill and on a ventilator, according to a lawsuit she filed on behalf of her husband this month.
Now, the hospital is being forced to administer the unproven treatment to Jeffrey Smith, 51, after a judge ruled in Julie Smith’s favor.
On Aug. 23, Butler County Judge J. Gregory Howard ordered West Chester Hospital to treat Smith with ivermectin for three weeks, as requested by his wife. The judge’s decision last week came despite the Food and Drug Administration not approving ivermectin to treat or prevent covid-19, the disease caused by the coronavirus, and urging against that use in a recent public advisory amid news of spiking calls to poison centers driven by people taking potent versions of the drug meant for livestock.
The Aug. 23 order, which does not explain the judge’s reasons, says Smith shall be administered 30 milligrams of ivermectin daily for 21 days. Smith’s vaccination status is not mentioned in the lawsuit, and Jonathan Davidson, an attorney for Julie Smith, declined to comment to The Washington Post on whether the Ohio man had been vaccinated.
Davidson said Tuesday that Jeffrey Smith is alive but declined to share details of his client’s medical condition, citing the family’s privacy.
“We’re just waiting right now,” Davidson told The Post.
A spokeswoman for UC Health, which includes West Chester Hospital, said she cannot comment on litigation or the specifics of patient care because of privacy laws.
The judge’s decision came as state and federal health agencies have expressed alarm at overdoses involving the deworming drug in recent weeks. The FDA, the Centers for Disease Control and Prevention and the National Institutes of Health have warned for months against using the drug to treat the coronavirus, saying its use can “cause serious harm.” The Mississippi State Department of Health recently issued an alert advising people not to take the drug, saying that “at least 70 percent of the recent calls” at the state’s poison-control center have been from people ingesting ivermectin to treat or prevent covid-19.
A version of ivermectin approved for humans has long been used to fight parasitic infections, and some doctors have become vocal advocates of using the drug for covid, prescribing it routinely. A group of researchers who reviewed data from 14 ivermectin studies found that the results “cannot confirm the widely advertised benefits,” though other trials are ongoing.
The drug has found particular traction in conservative circles, promoted by talk-show hosts and Republican lawmakers.
Ohio reported nearly 6,000 new coronavirus infections on Tuesday, bringing the state’s seven-day average for new cases to 4,717, according to data compiled by The Post. More than 2,700 people are hospitalized for covid in Ohio at this time.
More than 48 percent of the state is fully vaccinated. Data from the Ohio Department of Health shows that only about 500 of the roughly 21,000 state residents who’ve been hospitalized with covid since Jan. 1 were vaccinated.
Jeffrey Smith, of Fairfield Township, Ohio, tested positive for the coronavirus on July 9 and was admitted to an intensive care unit six days later, according to the lawsuit filed in Butler County Common Pleas Court. The hospital, less than 30 miles outside Cincinnati, treated the father of three with its usual coronavirus protocol of remdesivir, plasma and steroids. Smith was experiencing “a period of relative stability” before his condition worsened July 27, according to the lawsuit, and was sedated and placed on a ventilator days later.
After her husband was placed in a medically induced coma on Aug. 20, Julie Smith sought and was given a prescription of the drug by Fred Wagshul, an Ohio doctor who told the Capital Journal that the government’s stance toward ivermectin amounts to “genocide.”
Wagshul backed off the word choice in an interview with The Post but falsely claimed that ivermectin has proved more effective at warding off the coronavirus than the vaccines, though he said he also recommended immunization.
But when Smith asked doctors to administer the drug, the hospital refused to do so, telling her that ivermectin could interfere with other treatments and that there was nothing left for them to do, according to the lawsuit. Davidson acknowledged to The Post that the drug is “controversial” and said the hospital was “adamant.”
Among those who filed the lawsuit was Ralph Lorigo, the Erie County Conservative Party chairman, who has sued successfully in Illinois and New York for similar orders to use ivermectin. Davidson said he believes Julie Smith read about Lorigo’s successful court actions, which resulted in her finding a physician in Wagshul who was willing to prescribe the drug. Attempts to reach Lorigo were unsuccessful.
The Front Line Covid-19 Critical Care Alliance, a nonprofit touting ivermectin as a preventive treatment for covid that lists Wagshul as a founding physician, is referenced in the Ohio lawsuit. The organization includes prices and locations of pharmacies that will supply the deworming drug, according to the Capital Journal.
As part of the complaint filed to the judge, Julie Smith signed a full release that relieved West Chester Hospital of any liability related to the ivermectin treatment. Davidson told The Post on Tuesday that Jeffrey Smith “hasn’t gotten any worse” eight days into his treatment.
Steve Feagins, chief clinical officer with Mercy Health in Cincinnati, told WCPO that while he understands people’s desperation in looking for something that’s not a vaccine to help prevent or treat the virus, he called the decision to prescribe ivermectin to covid patients “a tough risk-to-benefit ratio.”
“Anything we give in a hospital, you have to know that has been pharmacy-vetted, approved, is the benefit exceeds the harm,” Feagins said. “But I could tell you, if something works and is approved and authorized, we will do it.”
Article From & Read More ( Ohio judge orders hospital to give ivermectin to covid patient Jeffrey Smith after wife's lawsuit - The Washington Post )
https://ift.tt/3mM449b
Health
Pfizer BioNTech's COVID-19 vaccine is called Comirnaty. Pete Bannan/MediaNews Group/Daily Local News via Getty Images
On Monday, independent experts to the CDC voted unanimously to recommend Pfizer's vaccine to everyone over 16.
Their decision was data-driven, and factored in both the risks and benefits of vaccination.
They reviewed graphs and tables showing that, while vaccinated people can get mild infections, Pfizer's vaccine does a great job keeping people alive and out of the hospital.
Pfizer's COVID-19 vaccine is now not only approved for everyone over 16 years old, it's recommended.
On Monday, an independent advisory committee to the Centers for Disease Control and Prevention voted unanimously to support recommending the vaccine.
The decision of those 14 experts was based on overwhelming evidence that Pfizer's 2-shot immunization, named Comirnaty, which was fully approved by the Food and Drug Administration last week, is not only safe but also works very well at preventing disease.
The independent experts on the CDC panel cheered on the creation of the COVID-19 vaccines in the midst of a pandemic, calling it a "miraculous accomplishment" and "a moment of incredible scientific innovation."
Here are eight charts and graphs that lay out why Pfizer's vaccine was given a big thumbs up:
COVID-19 vaccines are doing a great job keeping people healthy, alive, and out of the hospital.
Centers for Disease Control and Prevention ACIP meeting Aug. 30, 2021 https://ift.tt/3gODatg
The CDC committee looked at data from across the US showing unvaccinated adults are being hospitalized for COVID-19 at rates roughly 16 times higher than the vaccinated.
As of August 23, 0.006% of vaccinated Americans (fewer than 9,000 people) have had a severe enough case of COVID-19 to be hospitalized, according to CDC data.
The number of vaccinated people who've died from COVID-19 is even smaller. Of the 636,015 American COVID-19 deaths, just 2,063, or 0.3% have been in vaccinated people, a tiny fraction when you consider that more than 174 million people are fully vaccinated in the US.
Unvaccinated people under age 50 are getting hospitalized at especially high rates this year.
The CDC tracks these rates of COVID-19 hospitalizations through COVID-NET, a system which collects data from 250 hospitals across 14 states (located in different areas of the country) every week.
It's true that more vaccinated people are now catching COVID-19, due to the Delta variant. But their cases are generally mild and the vaccines are still preventing severe disease well.
This graph was compiled by the CDC for the advisory committee, and it is based on 14 separate studies from independent experts around the world, who all aimed to evaluate how well COVID-19 vaccines work in the face of the Delta variant.
The blue colored circles represent Pfizer-only studies, while the red circles are for studies that evaluated both Pfizer and Moderna. The Y-axis on the left represents vaccine effectiveness, as determined in each study.
As you can see, the effectiveness of Pfizer, Moderna, and Johnson & Johnson's vaccines against any infection ranges widely in these new studies, from around 40% to 80%.
That's in line with what we know about Delta — it is more contagious. Delta spreads more easily from person to person than other variants, and thus vaccinated people are now more vulnerable to COVID-19 infections when they are exposed to other people who are contagious.
However, the COVID-19 vaccine remains over 80% effective against severe disease in all of these new studies, suggesting that the vaccines are still doing their primary job of fighting off severe infections in vaccinated people very well, even with Delta here.
Hospitalizations of vaccinated patients remain rare, even with Delta.
These two graphs, also created by the CDC, pull together findings from six different studies across the US, UK and Israel, which each aim to compare COVID-19 vaccine effectiveness before and after Delta showed up.
The blue dots represent pre-Delta effectiveness percentages, while the orange dots represent vaccine effectiveness with Delta.
As you can see in the graph on the left, vaccine effectiveness is reduced for any symptomatic disease with Delta, but the graph on the right adds more nuance to the story, telling us that hospitalizations and severe COVID-19 cases are still rare in vaccinated people.
So instead of getting really sick and landing in the hospital, fully vaccinated people who catch COVID-19 may have more mundane symptoms, like headache, sniffles, or a fever.
In the young and generally healthy 16-29 year old age group, the amount of suffering that could be avoided through more vaccinations is staggering.
This graph takes into account a lower vaccine effectiveness with Delta and still shows (in light blue bars) a huge number of hospitalizations that could now be avoided by using Pfizer's vaccine in young adults from ages 16 to 29.
For every million doses administered of Pfizer's vaccine, 9,980 people under 29 could avoid hospitalization from COVID-19.
The dark blue bars represent even more severe intensive care unit COVID-19 cases. For every one million doses of Pfizer's vaccine administered, 1,300 people from ages 16 to 29 will not end up in the ICU, the CDC estimates.
The red bars on the right directly compare how those tangible benefits outweigh the potential risk of myocarditis for every age group.
Myocarditis is a temporary, treatable condition.
For every million doses of Pfizer vaccine given, roughly 136 teens and young adults, most of them teenage boys, have a risk of myocarditis after vaccination, the CDC says.
The panel said the benefits of Pfizer's shot outweigh the very small risk of myocarditis, an inflammation of the heart, in teens and young adults.
This chart shows the number of myocarditis cases to be expected after vaccination with Pfizer's shot, broken down by age and sex, per million doses.
It's estimated here that fewer than 150 myocarditis cases in teens and young adults ages 16-29 would materialize, for every 1 million doses of COVID-19 vaccine given to such young people.
Meanwhile, hundreds of thousands of COVID-19 cases, some of them life-threatening, could be avoided by vaccination in that same age group.
Allergic reactions after Pfizer's vaccine are also exceedingly rare, and treatable.
In the table above, the line circled in red shows the number of expected anaphylaxis cases per million doses of vaccine administered, for Pfizer, Moderna, and Johnson & Johnson's shots.
Anaphylaxis is generally treatable with epinephrine, which all COVID-19 vaccination sites nationwide are required to have on hand.
"I'm delighted to say that we now have a fully FDA approved, CDC recommended vaccine available," CDC Director Rochelle Walensky said during a White House briefing on Tuesday afternoon, in a nod to all this new data.
"For anyone who's been waiting to get vaccinated until we had more evidence on safety and effectiveness, I hope yesterday's announcement will have you join the more than 170 million people who have decided to protect themselves against COVID 19 by getting vaccinated."
Article From & Read More ( CDC shares 8 new charts that show how powerful Pfizer's vaccine is against COVID-19 and the Delta variant - Yahoo! Voices )
https://ift.tt/3jv97sA
Health
An HIV vaccine candidate manufactured by Johnson & Johnson failed to provide sufficient protection against infection, the company announced Tuesday, the latest blow to the HIV vaccination effort.
The company said its Imbokodo study posed no safety concerns, but will not continue. The study enrolled approximately 2,600 young women across five countries in sub-Saharan Africa, a region where women and girls accounted for 63 percent of all new HIV infections in 2020.
Participants were randomly selected to receive either the vaccine or a placebo, and researchers found the vaccine's efficacy was only about 25 percent, which was not statistically significant.
The investigational HIV vaccine was manufactured using a strain of common-cold virus engineered to not cause illness, the same basic technology as Johnson & Johnson's coronavirus vaccine. It was administered to participants through four vaccination visits over a year.
"While we are disappointed that the vaccine candidate did not provide a sufficient level of protection against HIV infection in the Imbokodo trial, the study will give us important scientific findings in the ongoing pursuit for a vaccine to prevent HIV," Paul Stoffels, chief scientific officer at Johnson & Johnson, said in a statement.
"We continue to stand in solidarity with people living with and vulnerable to HIV, and remain committed to furthering our research against this devastating virus,” he said.
About 38 million people worldwide are infected with HIV. It is currently a treatable disease, but there's still no vaccine prevention and it can be deadly, especially in poor countries.
The study was first launched in 2017 and was funded by the Bill & Melinda Gates Foundation and the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
In the study, 63 of 1,109 volunteers in the placebo group developed HIV, while 51 of the 1,079 volunteers who received the vaccine developed HIV.
A second study, called Mosaico, which is testing a somewhat different vaccine in men who have sex with men and transgender people in the Americas and Europe, will continue, the company said.
This picture shows the tablets of Ivermectin drugs in Tehatta, West Benga, India on 19 May on 2021.
Soumyabrata Roy | NurPhoto | Getty Images
Amazon is directing users to an anti-parasitic drug falsely claimed to be a treatment for Covid-19.
The drug, called ivermectin, is typically used to treat or prevent parasites in animals. In recent weeks, it has become the latest false cure for Covid-19, prompting warnings from the Food and Drug Administration and the Centers for Disease Control and Prevention.
When CNBC searched for the term "iv" on Amazon, the website's auto-complete function suggested a range of ivermectin products, including "ivermectin pills," "ivermectin paste" and "ivermectin injectable." The auto-complete search results are a sign that enough people have been searching for "ivermectin" that Amazon's search algorithm was automatically trained to put it at the top of suggested results.
When CNBC searched for the term "iv" on Amazon, the website's auto-complete function suggested a range of ivermectin products, including "ivermectin pills," "ivermectin paste" and "ivermectin injectable."
User reviews on some of the products appeared to make reference to false claims that ivermectin is a treatment for Covid-19. One review read, "Yes I used it for that. Two doses, completely gone. This stuff absolutely works. The rumors are true."
On a separate ivermectin listing, one reviewer provided dosing directions and included a link to a website promoting Covid misinformation, including that ivermectin is "safe and effective" for treating Covid-19.
Representatives from Amazon didn't respond to requests for comment.
Ivermectin can be used by humans in small doses to treat parasites such as head lice, but it is most commonly used by veterinarians to deworm large animals. While it has been referred to as a "wonder drug" for treating some parasitic illnesses, it has not been shown to be effective against Covid-19 or other viruses.
Nevertheless, it has gotten a lot of attention, including in some Facebook groups and Reddit communities, NBC News reported.
Prescriptions written for ivermectin are up 24-fold compared with before the pandemic, according to the CDC. Normally, about 3,600 prescriptions are written for ivermectin per week. "Since early July 2021, outpatient ivermectin dispensing has again begun to rapidly increase, reaching more than 88,000 prescriptions in the week ending August 13, 2021," the CDC said.
Earlier this month, the FDA put out an advisory that warned Americans not to ingest ivermectin.
Amazon has previously faced scrutiny over the sale of products with misleading coronavirus claims on its marketplace. Last February, amid a rise in products with suspect coronavirus claims, the company added a notice to searches for "coronavirus," "Covid-19," "n95 mask" and other terms that directed users to the CDC for more information about prevention and treatment of the disease.
Amazon has struggled to remove books and other products containing coronavirus misinformation. A recent study by University of Washington researchers found that more than 10% of Amazon search results show products that promote health misinformation. Researchers examined books, e-books, audiobooks, apparel and dietary supplements.
Sen. Rand Paul (R-Ky.) says hatred of former President Trump is hindering research into whether a drug used to treat parasitic infections in animals and humans can treat COVID-19, according tothe Cincinnati Enquirer.
The Food and Drug Administration (FDA)recently said ithas received several reports of people requiring hospitalization after “self-medicating with Ivermectin intended for horses” to treat COVID-19, and warned people against doing so.
“You are not a horse. You are not a cow. Seriously, ya’ll. Stop it,” the health agency tweeted last week.
Health officials say Ivermectin intended for human use and medication used on livestock is significantly different, with the latter containing high levels of the drug that can be toxic to people.
And while Ivermectin made for human consumption has been used for decades to treat parasitic worms and other conditions, the drug has not been approved to treat COVID-19, although several ongoing clinical trials involving Ivermectin as a possible treatment are underway.
Despite this, demand for the drug has surged across the country among people infected with the coronavirus in recent weeks, with some pharmacists reporting a shortage of the drug, according toThe New York Times.
Our country is in a historic fight against the coronavirus. Add Changing America to your Facebook or Twitter feed to stay on top of the news.
The phenomenon is similar to last year’s polarizing debate on the anti-malaria drug hydroxychloroquine, which was touted by Trump during his presidency as a treatment for the coronavirus. The Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) concluded the drug had little effect or no effect on preventing illness, hospitalization or death from COVID-19.
During a meeting with dozens of his constituents Friday in Cold Spring, Ky., Paul claimed researchers are unwilling to take the drug seriously as a COVID-19 treatment because of their dislike for the former president, according to the Cincinnati Enquirer.
“The hatred for Trump deranged these people so much, that they’re unwilling to objectively study it,” Paul reportedly told his constituents.
“So someone like me that’s in the middle on it, I can’t tell you because they will not study ivermectin. They will not study hydroxychloroquine without the taint of their hatred for Donald Trump,” Paul said.
The senator said he was unsure if Ivermectin works because there has yet to be enough research, but told the Cincinnati Enquirer he keeps an open mind.
He also reportedly railed against mask and vaccine mandates but encouraged people to get vaccinated.
“I think I’m in the middle ground of the vaccines,” he told the local news outlet. “CNN invites me on all the time. They have announcers calling me an ‘ass’ on TV. Then they have doctors saying I’m thorougly anti-vaccine. You heard me, I’m not against the vaccine. I’ve already recommended if you’are at risk to take it...It’s still your choice if it’s a free country,” he reportedly said.
Article From & Read More ( Rand Paul says 'hatred for Trump' is stopping study of horse and human drug to treat COVID-19 | TheHill - The Hill )
https://ift.tt/2Y3WQmw
Health
An investigational HIV vaccine tested in the “Imbokodo” clinical trial conducted in sub-Saharan Africa posed no safety concerns but did not provide sufficient protection against HIV infection, according to a primary analysis of the study data. The Phase 2b proof-of-concept study, which began in November 2017, enrolled 2,637 women ages 18 to 35 years from five countries.
The Imbokodo primary analysis was conducted 24 months after participants received their first vaccinations. The study’s primary endpoint was based on the difference in the number of new HIV infections between the placebo and vaccine groups from month seven (one month after the third vaccination timepoint) through month 24. When comparing the number of new HIV infections between study participants who were randomly assigned to receive either placebo or the investigational vaccine, statisticians found that 63 participants who received the placebo and 51 participants who received the experimental vaccine acquired HIV infection. Therefore, the investigational vaccine’s efficacy was 25.2% (95% confidence interval of vaccine efficacy -10.5% to 49.3%). The study vaccine was found to be safe with no serious adverse events associated with it. Study participants are being informed of the findings and will have follow-up visits with the study investigators. Further analysis of the Imbokodo study will continue, and the study is thought to have provided sufficient data for further immunological correlates research.
The Imbokodo study, also known as HVTN 705/HPX2008, is sponsored by Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson. It is funded by two primary partners, the Bill & Melinda Gates Foundation (BMGF) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
“The development of a safe and effective vaccine to prevent HIV infection has proven to be a formidable scientific challenge,” said NIAID Director Anthony S. Fauci, M.D. “Although this is certainly not the study outcome for which we had hoped, we must apply the knowledge learned from the Imbokodo trial and continue our efforts to find a vaccine that will be protective against HIV.”
The investigational vaccine tested in the Imbokodo study is based on “mosaic” immunogens—vaccine components designed to induce immune responses against a wide variety of global HIV strains. The vaccine candidate used a strain of common-cold virus (adenovirus serotype 26, or Ad26), engineered to not cause illness, to deliver four (quadrivalent) mosaic antigens to spur an immune response. Earlier research indicated the vaccine was both well-tolerated and could induce an anti-HIV immune response. Imbokodo participants received four vaccinations during a one-year period. This included four doses of the investigational quadrivalent vaccine. The final two doses were administered together with doses of an HIV protein, clade C gp140, and an adjuvant to boost immune responses. Participants were followed for at least two years. The primary analysis occurred one year after the last study participant’s final vaccination.
Study participants were offered pre-exposure prophylaxis medication to prevent HIV infection during the clinical trial. The women who acquired HIV infection were directed to medical care and offered antiretroviral treatment.
NIAID provided funding for preclinical and early phase clinical development of the investigational mosaic HIV vaccine, which was initially developed by the laboratory of Dan H. Barouch, M.D., Ph.D., at Beth Israel Deaconness Medical Center, together with Janssen and other partners. The mosaic immunogens used in the experimental vaccine were designed by the Los Alamos National Laboratory. The Imbokodo study was conducted by the NIAID-funded HIV Vaccine Trials Network (HVTN), based at the Fred Hutchinson Cancer Research Center in Seattle. Additional support for the trial was provided by the U.S. Army Medical Research and Development Command; and the Ragon Institute of MGH, MIT and Harvard. The South African Medical Research Council helped to implement the study in South Africa.
In addition to its primary review of the Imbokodo study, the partners in consultation with an independent data and safety monitoring board (DSMB) determined that a complementary Phase 3 HIV vaccine study called Mosaico (HVTN 706/HPX3002) should continue. That clinical trial is testing the safety and efficacy of a different investigational HIV vaccine among a different patient population (men who have sex with men and transgender populations) and in different geographical locations (the Americas and Europe) than the Imbokodo trial. The Mosaico study is estimated to be completed in March 2024.
NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
Article From & Read More ( HIV Vaccine Candidate Does Not Sufficiently Protect Women Against HIV Infection - National Institutes of Health )
https://ift.tt/3t2Nl2u
Health
Nurse Mary Ezzat administers a Pfizer COVID-19 booster shot to Jessica M. at UCI Medical Center in Orange, CA, on Thursday, August 19, 2021.
Jeff Gritchen | MediaNews Group | Orange County Register via Getty Images
Nearly 1 million Covid-19 booster shots have already been administered in the U.S. since health officials authorized administering extra shots of Pfizer or Moderna's vaccines to people with weakened immune systems on Aug. 12, according to data compiled by the Centers for Disease Control and Prevention.
So far, about 955,000 fully vaccinated people have received an additional dose of a Covid vaccine, according to data collected by the CDC. That number includes those who had previously received two doses of Pfizer or Moderna's vaccines or one dose of Johnson and Johnson's, the agency said.
It's unclear if all of those people were considered immunocompromised.
In approving the booster shots in people with weak immune systems, which includes cancer, HIV patients and organ transplant patients, CDC officials cited several small studies that showed they didn't produce an adequate immune response after receiving two doses of Pfizer or Moderna's vaccines. FDA and CDC officials didn't approve booster doses of J&J's vaccine earlier this month, saying they were waiting on more data.
CNBC Health & Science
Read CNBC's latest global coverage of the Covid pandemic:
Some Americans were already finding ways to get additional doses of the Covid vaccines on their own prior to the formal approval with some even going as far as receiving the extra shots from different companies – a practice known as "mixing and matching."
The CDC and Food and Drug Administration are currently reviewing whether to administer booster shots to the general population.
President Joe Biden said the U.S. plans to widely distribute Covid booster shots beginning the week of Sept. 20, pending clearance from FDA and CDC scientists.
Dr. Helen Keipp Talbot, a voting member of the CDC advisory group, told the committee Monday that many hospitals in the south are already administering third doses in health-care workers and patients.
New Jersey officials said Monday more than 36,000 extra doses have been administered to the immunocompromised, frontline health-care workers and seniors so far.
State health commissioner Judy Persichilli said the state is looking to identify more people who qualify for a third dose.
"Nationally we think about 3% of the population is immunocompromised, so we're really asking particularly medical directors in long-term care to do a deep analysis of those medical records and identify individuals who should be queued up to get that third dose right now," she said.
–CNBC's Bob Towey and Nate Rattner contributed to this report.
Article From & Read More ( Nearly 1 million Covid booster shots have already been administered in the U.S., CDC data shows - CNBC )
https://ift.tt/3BykqGJ
Health
Researchers ended a large trial in South Africa after finding that an experimental vaccine offered little protection.
An advanced H.I.V. vaccine trial in Africa has been shut down after data showed the shots offered only limited protection against the virus, researchers announced on Tuesday.
The vaccine, made by Johnson & Johnson, is one in a long line found to offer little defense against H.I.V., one of medicine’s most intractable adversaries. One candidate vaccine even increased the risk of infection.
Another trial was halted last year in South Africa after a different experimental vaccine failed to offer sufficient protection. Some 1.5 million people were infected with H.I.V. worldwide in 2020, and 38 million are living with the infection.
Scientists were dismayed by the most recent failure.
“I should be used to it by now, but you’re never used to it — you still put your heart and soul into it,” said Glenda Gray, the principal investigator of the trial and chair of the South African Medical Research Council. Dr. Gray has been working to develop an H.I.V. vaccine for more than 15 years.
Entirely new approaches may be needed. This month, Moderna announced that it would test a vaccine based on the mRNA platform used to devise the company’s coronavirus vaccine.
The trial, called Imbokodo, tested an experimental vaccine in 2,600 young women deemed at high risk of H.I.V. infection in five sub-Saharan African countries. Women and girls accounted for almost two-thirds of new H.I.V. infections in the region last year.
The trial was funded by Johnson & Johnson, the Bill and Melinda Gates Foundation, and the National Institutes of Health.
The vaccine relied on an adenovirus called Ad26, modified to carry fragments of four H.I.V. subtypes into the body in hopes of provoking an immune response that might defend against infection.
Mitchell Warren, executive director of AVAC, an advocacy group that lobbies for AIDS prevention and treatment, said the cancellation of the trial was a “reality check” amid excitement about new vaccine technologies.
“It’s a grand reminder that H.I.V. is a pathogen unlike any other in its complexity,” he said. “We know the platform worked, but what do we put in it? Because this virus is infecting the exact same immune system that we’re trying to boost with a vaccine.”
Participants in the Imbokodo trial, which began in 2017, were given two initial shots and two boosters over the course of a year. Researchers tracked the numbers of new infections in the placebo and vaccine groups from the seventh month (one month after the third vaccination) through the 24th month.
Over two years, 63 of 1,109 participants who received the placebo were infected with H.I.V., compared with 51 of 1,079 participants who received the vaccine — giving the vaccine an efficacy rate of 25 percent.
Earlier studies, including one carried out in Thailand, had indicated that the kind of antibodies this vaccine provoked might be sufficient to offer good protection from H.I.V. for at least an initial period of time.
“But in South Africa, the higher rates of H.I.V. incidence means you need something much more potent,” Dr. Gray said. “The kind of immune responses that were induced were just not enough to stop the high attack rates we see in Africa.”
When the disappointing data showed a low efficacy rate, guidelines set up before the trial dictated it should be shut down. A vaccine that offered only 25 percent protection risked giving women a “false sense of security,” Dr. Gray said.
But a parallel trial that uses a different iteration of this vaccine will continue, Johnson & Johnson said. It is being tested on men who have sex with men and transgender people, in eight countries including Poland, Brazil and the United States.
That study, called Mosaico, is testing the vaccine against different subtypes of H.I.V. in different populations, and could produce different efficacy results.
Dr. Gray said that the lesson from the failed trial lies in figuring out why it worked for the 25 percent of people who were protected and not for the others, and then trying to translate those clues into a recipe for a future vaccine.
The new study, published in British journal The Lancet, looked at the effects of the delta variant on public health and social measures. The variant has been identified in 154 countries and has been the most prevalent variant in recent months.
The researchers looked at just under 8,700 patients carrying the delta variant and around 34,600 with the alpha variant, which was confirmed by genome sequencing. They found that patients infected with the delta variant are two times more likely to end up in hospital compared with patients with the alpha variant.
"Emergency care attendance combined with hospital admission was also higher for patients with the delta variant, showing increased use of emergency care services as well as inpatient hospitalization," the study claimed.
The U.S. has reached a new peak of hospitalizations, with a daily average of 100,000 for the first time since the winter peak earlier this year as vaccinations first became available, The New York Times reported.
In January 2021, the U.S. rolling seven-day average for hospitalizations hit around 137,500.
Florida is facing the most severe hospitalization crisis in the country, with 79 hospitalizations per 100,000 people over the past 14 days. Other states in the South, including Alabama (61 per 100,000), Mississippi (59 per 100,000) and Georgia (58 per 100,000) face similarly difficult situations – and also some of the lowest vaccination rates: Mississippi and Alabama each have fully vaccinated just under 38% of their populations.
Nationwide deaths have also jumped by 355% since early July, according to CBS News. Louisiana recorded a high of 139 deaths in a single day on Aug. 24.
Article From & Read More ( Delta variant may double risk of hospitalization for the unvaccinated, study finds - Fox News )
https://ift.tt/3mNtRxx
Health
An Ohio judge ordered a hospital to use the deworming drug ivermectin on a COVID-19 patient, several outlets reported.
Butler County Judge Gregory Howard ruled in favor of a woman who asked that her husband, who is on a ventilator in West Chester Hospital with COVID-19, be treated with the unproven drug, the Ohio Capital Journal and The Enquirer reported.
Jeffrey Smith, 51, contracted COVID-19 in early July. His wife, Julie Smith, asked the court on August 20 for an emergency order to have the drug used on her husband.
On August 23, Howard ruled that Dr. Fred Wagshul should be allowed to give Smith 30mg of the drug daily for three weeks, WXIX reported.
"From the countries that we've seen that have emptied their hospitals. This medicine is very very effective," Dr. Wagshul told the outlet.
However, the Centers for Disease Control and Prevention and the Food and Drug Administration have warned that the drug is not proven to treat COVID-19 and can have serious side effects.
In a health advisory last week, the CDC said the FDA-approved drug can be safely used to treat some parasitic infections but can be harmful in other settings.
The CDC is especially concerned as calls to poison control rise due to people taking variations of the drug meant for horses and cows. Poison control calls about the drug rose by five-fold last month compared to the baseline number of calls before the pandemic.
Insider has reached out to Wagshul and FLCCC for comment.
Article From & Read More ( An Ohio judge ordered a hospital to use deworming drug ivermectin to treat a patient with COVID-19 - Yahoo News )
https://ift.tt/3zIWiQQ
Health
COVID-19 vaccines are still highly effective against hospitalization despite the surge in the more transmissible Delta variant, a scientist with the Centers for Disease Control said on Monday.
The vaccine's ability to prevent infection ranged from 39% to 84% since the introduction of the Delta variant.
"Vaccines remain effective in preventing hospitalization and severe disease but might be less effective in preventing infection or milder symptomatic illness," the presentation said.
The slides said both waning protection over time and the Delta variant may be contributing to the lower effectiveness of the vaccines.
Oliver said it's not uncommon for some vaccines to require multiple doses, including vaccines for hepatitis and HPV. However, she said more information is needed before the group can assess the need for booster shots.
Experts have warned that the spread of the virus, specifically the Delta variant, could lead to a more dangerous variant.
"This is a very wily virus," Fauci said. "If we keep lingering without getting those people vaccinated that should be vaccinated, this thing could linger on, leading to the development of another variant, which could complicate things."
Those most at risk of severe disease should be prioritized for booster shots, the presentation added.
Oliver also said it's important to ensure there is global vaccine availability. "Uncontrolled spread globally that could result in new variants threaten control of the pandemic everywhere," her presentation said.
Article From & Read More ( Even with the Delta variant, the ability of COVID-19 vaccines to prevent hospitalization hasn't significantly dropped, CDC scientist says - Yahoo News )
https://ift.tt/3kIdL5V
Health
Members of the Centers for Disease Control and Prevention's independent vaccine advisory panel voiced frustration Monday with the Biden administration's plan to begin doling out Covid-19 boosters next month, arguing the announcement got ahead of federal regulators and could exacerbate vaccine hesitancy.
The White House strategy, which it announced earlier this month, is contingent upon FDA deeming boosters safe and effective and CDC recommending their use. Still, some CDC committee members made clear they were irked that the announcement came before federal regulators and scientists formally endorsed booster doses.
"That kind of opened the door to a lot of confusion," said Sandra Adamson Fryhofer of the American Medical Association during the panel's discussion of booster doses.
"Many, many, many" hospitals across the South have already begun administering third doses to their health care workers amid an explosion of Covid cases linked to the Delta variant, said Helen Keipp Talbot, a committee member and associate professor of medicine at Vanderbilt University.
"I think since it was given with a date, many assumed that it was given a blessing by the White House and this was the next step," she said, adding that those providers have "now put themselves at risk" by immunizing individuals outside FDA and CDC recommendations.
Demetre Daskalakis, who's been detailed to CDC's Covid response group, warned committee members that health care providers who don't follow federal guidance on how the vaccines should be administered may expose themselves to liability when seeking reimbursement from the federal government.
CDC data shows that 955,000 Americans have received additional vaccine doses, though it's unclear how many of those were technically authorized.
So far, the federal government has authorized boosters only for a small number of people with compromised immune systems, including recipients of solid-organ transplants. Pfizer and BioNTech, whose vaccine received full FDA approval last week, have applied to FDA for permission to offer boosters. The companies behind the two other vaccines used in the U.S. — Moderna and Johnson & Johnson — have said they intend to seek approval for boosters but have not yet done so.
The Biden administration's decision to announce it would offer boosters to all adults has created an awkward situation for federal regulators, who are now left to chart a path forward despite limited, and sometimes confusing, data on vaccines' effectiveness over time.
A presentation from the CDC committee's Covid vaccine work group didn't mention the Biden administration's September time frame for boosters. It also avoided describing booster shots as a fait accompli, emphasizing it's “critical” to await more safety data and regulatory permission before doling them out.
"As with other recommendation for Covid vaccines, we will review the data in a systematic and transparent fashion policy on booster doses will be coordinated with FDA for regulatory allowance," the CDC's Sara Oliver said.
One of the key issues the CDC's independent advisers must grapple with is what the goal should be for the U.S. Covid vaccination program — preventing severe disease, hospitalization and death, or fighting off all infections, even mild ones. Committee chair Grace Lee suggested the latter is impossible right now, but the White House's booster announcement eschewed consideration of which populations may need boosters once those who were among the first to be vaccinated — and thus were more at risk — receive additional doses.
“We are not at the point in the vaccination program in the U.S. or globally where ... that seems to be achievable," she said. While the U.S. has a steady supply of doses at the ready, and hundreds of millions more on order, many countries around the world are struggling to complete a first round of vaccinations.
The CDC vaccine work group believes the top priority should be ensuring unvaccinated Americans get inoculated, Oliver said. But on boosters, it's emphasizing the prevention of severe disease in at-risk groups.
The risk-based booster approach Oliver floated would give initial priority to long-term care facility residents, health care workers and individuals older than 65 or 75. She noted that preventing even mild Covid cases in health care personnel is critical, since they can't work if they're symptomatic.
Committee members pushed for clear guidelines on how to administer boosters once they are approved by FDA. The CDC panel is expected to reconvene in mid-September to assess the latest data, ahead of any FDA decision on additional doses.
“We need to all go in the same direction to get everyone vaccinated, to get everyone protected and to keep everyone protected, and not to waste this precious resource," Fryhofer said.
