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NIH director says new Israel information is constructing case within the U.S.

New data from Israel on the effectiveness of Covid-19 vaccines over time is causing U.S. health leaders to rethink their position on vaccine booster shots in the U.S., National Institutes of Health Director Dr. Francis Collins said Tuesday.

“The people who got immunized in January are the ones that are now having more breakthrough cases,” Collins said during an interview on “The Hugh Hewitt Show,” referring to Covid infections in fully vaccinated individuals. Israel released new data Monday showing a reduction in the effectiveness of Pfizer’s Covid vaccine against severe illness among people 65 and older who were fully vaccinated in January or February.

NIH Director Fr. Francis Collins holds up a model of the coronavirus as he testifies before a hearing looking into the budget estimates for National Institute of Health (NIH) and the state of medical research on Capitol Hill in Washington, DC on May 26, 2021.

Sarah Silbiger | AFP | Getty Images

Collins said the rise in so-called breakthrough cases in Israel is likely due to a combination of the highly contagious delta variant and Covid vaccine protection waning over time.

“Mostly, of course, these are symptomatic, but not serious,” he said. “But you’re starting to see a little bit of a trend toward some of those requiring hospitalization.”

Collins’ comments come as federal health officials are expected to recommend that most people in the U.S. who are eligible for Covid vaccinations should get booster shots eight months after their second doses.

The federal guidance, which would apply only to the two-shot Pfizer and Moderna vaccines, could go into effect as early as mid-September, pending FDA authorization, a person familiar with the discussions told CNBC.

The New York Times reported Monday that federal health officials are particularly concerned about data from Israel, where Covid vaccinations began ahead of many other countries. The data reportedly showed that for people vaccinated in January who are age 65 and older, the Pfizer vaccine was less than 55% effective against severe disease and hospitalization.

Collins said Tuesday that federal officials are starting to see the same thing in U.S. data.

“Although right now, it still as if our vaccine protection is working really well,” he said. “But we don’t want to wait until it’s like oh, too late. So that’s why we’re looking at the data.”

Up until now, federal officials haven’t recommended booster doses for the general public. On Friday, they approved administering Covid booster shots of Pfizer’s and Moderna’s vaccines to Americans with weakened immune systems, which includes cancer and HIV patients and people who have had organ transplants.

Covid vaccine makers, including Pfizer and Moderna, have repeatedly contended that everyone will eventually need a booster shot and potentially extra doses every year, just like for the seasonal flu.

The NIH, Food and Drug Administration and the Centers for Disease Control and Prevention released a joint statement Tuesday saying they have a “rigorous process” to determine when boosters would be necessary.

“This process takes into account laboratory data, clinical trial data, and cohort data – which can include data from specific pharmaceutical companies, but does not rely on those data exclusively,” the agencies said. “We continue to review any new data as it becomes available and will keep the public informed.”

On Monday, Pfizer and BioNTech said they have submitted early stage clinical trial data to the FDA as part of their U.S. application seeking authorization of a Covid vaccine booster for everyone 16 and older. The companies said they would seek approval for a booster dose via a supplement to their application once the agency grants the vaccine full approval.

If the booster shots are approved, the U.S. would likely vaccinate nursing homes, health-care providers and the elderly first, Collins said Tuesday. He said “ideally” people should stick with the same manufacturer they got their first two doses from.

“But if for some reason you don’t have access to it, well, then get the other one,” he said. “Again, I’d feel more comfortable as a scientist fixing our plans on real data, and that means sticking to the same kind of vaccine that you got to begin with.”

–CNBC’s Tom Franck contributed to this report.

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NIH scientists say they could have discovered a promising new oral antiviral drug

Alex Raths | Getty Images

Scientists may have found promising new treatment for Covid-19 after an experimental oral antiviral drug demonstrated the ability to prevent the coronavirus from replicating, the National Institutes of Health said Thursday, citing a new study.

The drug called TEMPOL can reduce Covid-19 infections by interfering with an enzyme that the virus needs to make copies of itself once it’s in human cells, which could potentially limit the severity of the disease, des researchers said NIH. The drug was tested in a live virus cell culture experiment.

“We urgently need additional effective, accessible treatments for COVID-19,” wrote Dr. Diana W. Bianchi, director of the National Institute of Child Health and Human Development at the NIH, in a statement. “An oral drug that prevents SARS-CoV-2 from replicating would be an important tool in reducing the severity of the disease.”

The results were published in the journal Science.

While vaccines have been incredibly useful in containing Covid-19 cases in the United States and other parts of the world, scientists say treatments are still badly needed for those who contract the virus.

According to the Johns Hopkins University, the US reported an average of around 16,300 infections per day on Wednesday. Gilead Sciences’ remdesivir is the only drug that has received full US approval from the Food and Drug Administration for the treatment of Covid and that must be administered intravenously in a hospital.

Pfizer, who worked with German drug maker BioNTech to develop the first approved Covid-19 vaccine in the United States, is also developing an oral drug against Covid that can be taken at home at the first signs of illness. The researchers hope the drug will prevent the disease from getting worse and prevent hospital stays. It started with an early trial in March.

The NIH researchers said they intend to conduct additional preliminary studies and look for ways to evaluate the drug in a clinical study on Covid.

The results of the study are “hopeful,” said Dr. Tracey Rouault, another NIH officer who led the study.

“However, clinical trials are needed to determine whether the drug will be effective in patients, especially early on in the disease process when the virus begins to replicate.”

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Fauci testifies earlier than U.S. Home on NIH finances

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Officials from the National Institutes of Health testified before Congress Tuesday the agency’s annual budget as the nation battles the Covid-19 pandemic.

Witnesses include the White House Chief Medical Officer, Dr. Anthony Fauci, who also directs the National Institute for Allergies and Infectious Diseases within the NIH, and directors of the country’s top medical institutions.

NIH Director Dr. Francis S. Collins also testifies before the House Committee on Appropriations and the Subcommittee on Labor, Health and Human Services, along with Dr. Diana W. Bianchi, the director of the National Institute for Child Health and Human Development by Eunice Kennedy Shriver.

Other witnesses are Dr. Gary H. Gibbons, the director of the National Heart, Lung, and Blood Institute; Dr. Norman E. Sharples, the director of the National Cancer Institute, and Dr. Nora D. Volkow, the director of the National Institute on Drug Abuse.

Read CNBC’s live updates for the latest news on the Covid-19 outbreak.

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‘It’s a giant deal’ for America’s push to reopen, says NIH Director on Pfizer vaccine approval for adolescents

The director of the National Institutes of Health, Dr. Francis Collins, called the Food and Drug Administration approval for emergency use of Pfizer and BioNTech’s Covid vaccine for children ages 12-15 as “a big deal” in America’s drive to reopen.

“This is exciting news,” said Collins. “We know that since this pandemic started, one and a half million teenagers have been infected with Covid-19, and not all have been as good as most. And some of them have ended up where they have been with this long Covid We are not doing any better , even weeks or months after the illness, so we really want to protect young people. “

The Centers for Disease Control and Prevention’s Vaccine Advisory Board has scheduled a meeting on Wednesday to review recordings for children. If approved by the CDC as expected, it could be distributed to teens as early as this week.

More than 44% of all adults in the US are fully vaccinated, and according to the CDC, around 58% have now received at least one dose of the Covid vaccine. The White House aims to increase that number to 70% by July 4th.

Collins told CNBC’s “The News with Shepard Smith” that the US is “on a pretty good path” and that the nation should be able to see CDC regulations to relax indoor masks.

“It’s just about finding the right way to balance the desire not to create another wave. This is the last thing we need right now with the fact that people are really fed up with masks to wear, “said Collins.

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The C.D.C. and N.I.H. launch a fast, at-home testing initiative in Tennessee and North Carolina.

The Centers for Disease Control and Prevention and the National Institutes of Health announced a new initiative on Wednesday to see if the frequent and widespread use of rapid coronavirus tests is slowing the spread of the virus.

The program will provide free antigen testing at home to everyone in two communities, Pitt County, NC, and Hamilton County, Tennessee, for free, bringing a total of 160,000 people to test for the coronavirus three times a week for a while a month.

“This is exactly what I and others have been calling for almost a year – widespread, accessible, rapid testing to contain transmission,” said Michael Mina, Harvard University epidemiologist who advocated rapid rapid testing at home programs.

He added, “It’s something anyone can do if they take 30 seconds out of the day three times a week to do the test.”

Antigen tests are cheaper and faster than PCR tests, which are the gold standard for diagnosing Covid-19, the disease caused by the virus. However, they are less sensitive and more prone to false negative results. Mathematical models have shown that if these tests are used frequently, they can still reduce the transmission of the virus.

The tests can help identify people who may not realize they are infectious and cause them to self-isolate before they can transmit the virus to others. Real world data is limited, however, and with virus cases still high across the country, testing is still essential, according to public health experts.

“We have all hypothesized that large-scale home testing could stop the chain of transmission of the virus and allow communities to discover many more cases,” said Bruce Tromberg, who heads the National Institute for Biomedical Imaging and Bioengineering and its rapid acceleration directs the diagnostic program that provides the tests for the initiative. “All mathematical models predict that. But this is an example from the real world, real life. “

Residents who choose to participate in the program can have the tests brought to their home or collect them from local distribution locations. An online tool guides participants through the testing process and helps them interpret their results. Residents can also volunteer to take surveys to see if frequent tests have changed their behavior, knowledge of Covid-19, or their minds about vaccination.

Researchers from the University of North Carolina and Duke University will compare the positivity, case, and hospitalization rates in these two communities with those in other similar communities that are not in the program.

A. David Paltiel, Professor of Health Policy and Management at the Yale School of Public Health, described the start of a real-world study of the effectiveness of rapid home screening as “simply good news.” However, he cautioned that the results need to be interpreted carefully, especially if residents who choose to participate in the initiative are not representative of the entire community.

“We know that self-selection tends to bring out the concerned and a disproportionate number of people who are already Covid-aware or Covid-conscientious,” he said.

“It will be great to see how it works when it’s in the hands of people who really care,” he added. However, he said the results may not be broadly applicable to screening programs that require participation, as may be the case with some workplace and school programs.

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NIH halts trial of Covid plasma remedy after researchers discovered no profit

Convalescent plasma from a patient with recovered coronavirus disease (COVID-19) is seen at the Central Seattle Donor Center of Bloodworks Northwest during the outbreak in Seattle, Washington on April 17, 2020.

Lindsey Wasson | Reuters

The National Institutes of Health announced Tuesday that they had abandoned a study testing convalescent plasma in patients with mild to moderate Covid-19 symptoms after an independent panel of experts concluded it was unlikely to be beneficial.

The independent data and safety watchdog met on February 25 to review the data and found that while plasma treatment did no harm, it was unlikely to be of benefit to this patient population, the NIH said in a press release. After the meeting, the DSMB recommended that the NIH no longer enroll new patients in the study, the agency said.

Scientists and public health officials had previously said they were skeptical that convalescent plasma would be an effective treatment for patients with Covid, even after the Food and Drug Administration issued emergency approval for the treatment in August and former President Donald Trump said it was ” Breakthrough “denounced. “

At the time, Dr. Scott Gottlieb, a former FDA commissioner, said the treatment could help patients but “doesn’t look like a home run”. He agreed that convalescent plasma “certainly” met the standard for an emergency permit “in the context of a public health emergency.”

The plasma, taken from patients who have recovered from Covid-19 and who have developed antibodies to the virus, is infused into sick patients. Scientists had hoped it would help boost immune systems in these patients to fight the virus.

In January, REMAP-CAP, an international clinical trial investigating possible treatments for Covid, discontinued the study testing convalescent blood plasma after the study’s examiners found no benefit. The decision by REMAP-CAP was made after an initial analysis of more than 900 critically ill study participants in the intensive care unit showed that treatment with the product did not noticeably improve the health of the patients.

The NIH study was conducted in 47 US hospitals emergency departments and had 511 of the 900 participant recruitment targets enrolled. After study participants received either the plasma or a placebo, the researchers tracked whether participants needed additional emergency or urgent treatment, had to be hospitalized, or died within 15 days of the start of the study.