Category: Breaking News

WASHINGTON — White House coronavirus response coordinator Jeff Zients said Wednesday the United States is a developing a “new system for international travel” that will include new strong mitigation procedures like contact tracing. the administration does not plan to immediately relax any travel restrictions because of COVID-19 Delta variant cases. “We are exploring considering vaccination requirements for foreign nationals traveling to the United States,” Zients said. Coronavirus response coordinator Jeff Zients said Wednesday the United States is a developing a “new system for international travel” that will include new strong mitigation procedures like contact tracing. Zients told the U.S. Travel and Tourism Advisory Board Wednesday the administration does not plan to immediately relax any travel restrictions because of COVID-19 Delta variant cases. “We are exploring considering vaccination requirements for foreign nationals traveling to the United States,” Zients said. he idea was shelved, but top White House officials say that proposal and similar ones are still under consideration – including, potentially, a broader vaccine mandate that would include domestic air travel. “We’re discussing it,” Anthony Fauci, President Joe Biden’s chief medical adviser, said about the idea of a broader requirement in an interview. “It’s on the table for discussion.”

A third dose of the Pfizer-BioNTech COVID-19 vaccine could offer strong protection against the Indian ‘Delta’ variant, data reveals, as a separate study finds protection provided by the vaccine could wane after six months. New data released by the company on Wednesday showed antibody levels increased five-fold among people ages 18 to 55 who were given the booster shot. The third dose was especially effecting for the elderly, with antibody levels spiking 11-fold among people aged 65 to 85 who had already received the standard two doses. In the slides published online, the researchers wrote there there is ‘estimated potential for up to 100-fold increase in Delta neutralization post-dose three compared to pre-dose three.’

 

Data from Pfizer shows that the third dose of the company’s COVID vaccine can increase antibodies to fight the Delta variant 11-fold in people 65 to 85 The Delta variant continues to spread across the country, making up at least 83 percent of all new infections. Pfizer produces the most commonly used vaccine in the U.S., having been administered over 190 million times, according to data from the Centers for Disease Control and Prevention (CDC). Early adopters of the vaccine may soon has their immunity to the virus slightly diminished. Research, which has not been peer-reviewed, led by Pfizer and Syracuse University in New York finds that the vaccine was 91 percent effective in preventing the virus for six months. It continues to drop at that rate, researchers say, the vaccine could drop below 50 percent efficacy 18 months after administration. Those who received the vaccine first may have already had its efficacy drop, meaning a third dose could be required soon.

Proof NIH funded Wuhan Covid19 Experiments

The Whole World Is Giving The Third Booster Shot

Surprise, surprise, surprise… The U.S. is not. I wonder why? We explore this mystery in the current edition of Radio Free Wall Street.

Top Biden Covid-19 officials are increasingly clashing with the Centers for Disease Control and Prevention as the administration pushes to begin distributing booster shots widely by Sept. 20. In meetings and conversations over the past month, senior officials from the White House Covid-19 task force and the Food and Drug Administration have repeatedly accused CDC of withholding critical data needed to develop the booster shot plan — delaying work on the next step of President Joe Biden’s vaccination campaign and making it more difficult to set clear expectations for the public. One particularly frustrating episode occurred last month, two officials said, when the agency appeared to publicly reject the administration’s plan to offer boosters to all adults. CDC Director Rochelle Walensky had joined other top Biden health officials in signing a high-profile statement on Aug. 18 endorsing the approach. But less than two weeks later, when it came time for CDC to make the case for boosters to an influential advisory panel, senior agency officials argued that priority should be given to nursing-home residents and frontline health workers before expanding access to other groups based on their vulnerability. The new approach blindsided senior health officials across the federal government, further straining the tenuous relationship between the White House and the CDC. Seven senior administration officials working on the federal pandemic response, and three other people familiar with the matter, described the growing tension in interviews with POLITICO. All spoke on the condition of anonymity to discuss the sensitive matter more openly. The infighting comes as the administration seeks new approaches to quash the Delta variant and win back Americans’ trust after two months of setbacks and missteps. And it raises questions about the administration’s ability to make clear policy recommendations to safeguard Americans as the pandemic rolls on. Doing so will require close collaboration between health agencies and the White House to distill fast-moving and unpredictable discoveries about the virus’ behavior and vaccines’ performance into practical guidance. “We’ve made so much progress during the past seven months of this pandemic,” Biden said during a speech on Thursday laying out sweeping new policies to fight the virus. “Now we just have to finish the job with truth, with science, with confidence, and together as one nation.” Neither the White House nor the CDC responded to a request for comment. At the agency, which is still recovering from the crushing workloads and political pressure it experienced during the last year of the Trump administration, the booster back-and-forth has further lowered morale. Walensky has fiercely defended the CDC throughout the last several weeks, telling White House officials who have pledged for months to follow the science that the late September booster target was likely too ambitious, and that her agency had not yet completed studies that would help provide the rationale for the shots. The CDC and FDA also were still waiting for booster data from vaccine-makers Moderna and Johnson & Johnson. Other CDC officials working on the pandemic response are equally exasperated by the situation and what they see as unrealistic expectations from the White House as it tries to shore up public opinion. “Science takes time,” a CDC official said. “I don’t know how many times we have to say this.” One senior administration official said the Biden administration’s public pledge to let science lead was faltering behind the scenes. “The CDC is getting out what it can when it can,” the official said. But a second senior administration health official pushed back against the idea that the Sept. 20 booster target was foisted on Walensky. The person said that the federal government’s top health leaders agreed to the language and September date before the White House announced the plan in August. The time frame was established based on the FDA’s projections of when it could review specific company data as well as data from manufacturers, that official said. Some at CDC say the agency needs to change its approach, by working quickly with the White House Covid team to develop policy recommendations during what they describe as one of the most chaotic and critical periods of the pandemic. In addition to the planned booster rollout, the CDC and FDA are poised to consider the use of Covid-19 vaccines for children under 12, a group that has seen more infection and death as the nation has returned to in-person schooling. But it is the nascent booster plan that has generated the most friction of late. Three senior officials said they were surprised by the White House’s September deadline, arguing that it set the CDC and FDA on a tight timeline to crunch data, publish vaccine efficacy studies and approve or authorize the shots. White House officials and Anthony Fauci, the president’s chief medical adviser, were eager to begin doling out boosters later this month, citing data from Israel and other countries that suggested vaccines’ efficacy was waning and that breakthrough infections were on the rise. These officials pushed the CDC to share publicly the data from its ongoing studies of vaccine performance and breakthrough cases. Walensky and other senior CDC officials, who agreed vaccine efficacy was declining and that Americans would eventually need booster shots, noted in their conversations with the broader Biden Covid team that the CDC did not yet have enough data from its studies on the matter. Its analyses, which looked at infection rates among frontline health workers and residents of specific cities such as New York and Los Angeles, would take weeks to complete. The White House, and FDA and CDC leaders, are “trying to align” the two agencies more, one official said, particularly amid the departure of two top FDA vaccine regulators, Marion Gruber and Philip Krause. The pair announced their retirements this month, in a move that one former official attributed to frustrations with CDC’s role in the booster plan. FDA’s frustrations with CDC are longstanding and predate the pandemic. The agencies have clashed on data around perennial problems like foodborne illnesses and issues related to other disease outbreaks and emerging conditions, such as the lung injury called EVALI that has been linked to e-cigarette use. FDA has long argued that CDC moves too slowly, two former officials said. That the Biden White House “is starting to exert a little more pressure [on CDC] is long overdue,” said a former Trump health official. “[President Donald] Trump’s mistake was not understanding that the way to fix it wasn’t to publicly berate them … but to actually lead and reform.” The FDA said in a statement that its “longstanding collaboration with CDC continues to have a positive impact on our nation’s public health.” It added: “Particularly for vaccines, our agencies have always had, and continue to have, shared responsibilities where FDA makes regulatory decisions and CDC’s immunization advisory committee provides clinical recommendations.” No matter the motivation, the CDC advisory committee episode in late August only reinforced perceptions in the White House that the agency represents the weakest link in a Covid-19 response predicated on close collaboration and extreme competence. In the aftermath, some officials outside the CDC working on the Covid-19 response have placed blame for turmoil around boosters squarely on Walensky, who they argue has struggled to instill a sense of urgency in the agency’s top scientists. Others have taken a more sympathetic view, chalking the issues up to institutional problems within the CDC that Walensky is trying to iron out. In a sign that even the CDC director herself recognizes the agency has repeatedly fallen short on messaging, multiple people with knowledge of the matter said Walensky has recently weighed bringing on new communications staff. The agency’s main spokespeople are career employees who predate Walensky’s arrival in January. She has also has tried to streamline CDC’s pandemic response team, tapping respected agency veteran Henry Walke to lead the way. Three former health officials applauded Walensky’s restructuring earlier this year, arguing that it could break down some of these issues even though many felt the move sidelined CDC veteran Nancy Messonnier, who resigned earlier this year after decades at the agency working on respiratory illnesses. The reorganization started in the spring, before the Delta variant became the dominant Covid strain in the United States, causing massive upticks in cases and hospitalizations. With Delta’s rise, officials on the CDC pandemic team told POLITICO, they have grown increasingly overwhelmed. Within the last two weeks, Walensky has moved to yet again build back up that team. Since the Biden administration began in January, the CDC chief has worked to address inefficiencies within the agency, streamlining its Covid-19 response and ensuring her office coordinates more closely with the White House, two senior CDC officials said. One of her main goals, those officials said, has been to put the agency back on the map after the Trump administration sidelined its scientists throughout 2020. Biden, too, promised to let science, and science agencies, lead the policy conversations around Covid. Senior administration officials working on the pandemic response have grown frustrated with the CDC’s messaging on Covid policies, including masks, over the last several months — and what they see as a sluggish response to crises such as the emergence of the Delta variant. Much of the criticism pointed at the CDC focuses on its data collection and analysis, officials said. The agency has for years struggled with obtaining accurate disease data from state health departments, and the pandemic strained the country’s public health infrastructure, causing massive delays in reporting and case investigation. That has made it difficult for CDC to gather information on breakthrough infections to inform the administration’s policies around boosters. The CDC also often publishes its studies in medical journals, but that approach can delay the release of critical information to the public. Walensky has recently taken steps to address the issue, telling CNN this month that the CDC worked with the New England Journal of Medicine to release data about pregnant women and vaccines on its website before it published the findings in the journal.

18 leading scientists, including 2 outgoing FDA officials, say COVID-19 booster shots lack evidence and shouldn’t yet be given to the general public

Eighteen top scientists from across the world have warned against giving COVID-19 booster shots to most fully vaccinated people. In an review published in the Lancet on Monday, the experts said that the idea of boosting immunity to reduce COVID-19 cases was “appealing.” But current evidence didn’t support “widespread use of booster vaccination” in the general population, they said, citing 93 references. “Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics,” the review authors said. The group included Philip Krause and Marion Gruber, the two Food and Drug Administration officials who resigned over the Biden administration’s booster shot plan earlier in September. The US is expected to start rolling out booster shots from September 20 to shore up immunity against the Delta variant, which has mutations that can help it avoid the immune response. Immunocompromized Americans can already get an extra shot. Insider’s Hilary Brueck has reported on other experts’ concerns about the lack of booster data. The group, which included scientists from the US, UK, Mexico, Jamaica, France, Portugal, South Africa, and Colombia, said that there could be a significant risk of side effects if boosters were “widely introduced too soon, or too frequently.” This was especially the case for vaccines with “immune-mediated side-effects,” such as a type of heart inflammation, called myocarditis, that has been reported in very rare cases after the second dose of Pfizer or Moderna’s vaccines. The researchers warned that if lots of people got side effects with the extra doses, this could reduce vaccine acceptance. Dr. Ana-Maria Henao-Restrepo, the lead author of the review and a scientist at the World Health Organization, said in a statement that “even if some gain can ultimately be obtained from boosting,” the world should focus on getting shots to unvaccinated people. The WHO has urged countries with good vaccine coverage to hold off boosters until every country has fully vaccinated at least 10% of its population. The group said that current vaccine supplies could “save more lives” if they weren’t used for boosters. “Unvaccinated people are still the major drivers of transmission and are themselves at highest risk of serious disease,” they said. Existing COVID-19 vacccines were holding up against newer variants like Delta, the review authors said. The antibody response for vaccination can decrease over time, but this is just one aspect of the immune response. Other parts of the immune system, such as memory cells and T cells, are often longer-lived, and can also provide protection, they said. The scientists said that an increasing numbers of breakthrough infections were “inevitable” as more people become fully vaccinated and people’s behavior changed. The study authors did not rule out boosters entirely. Boosters tailored to the variants most likely to evolve could “ultimately be needed.” “Now is the opportunity to study, before there is a widespread need,” they said.