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.
COVID-19 vaccine boosters not widely needed, top FDA and WHO scientists say
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.
From zippers to glass, shortages of basic goods hobble U.S. economy
Shortages of metals, plastics, wood and even liquor bottles are now the norm. The upshot is a world where buyers must wait for delivery of items that were once plentiful, if they can get them at all. Along with the shortages come hefty price increases, which has fueled fears of a wave of sustained inflation. There’s growing tension among Federal Reserve policymakers over how to gauge the long-term impact on prices. Some Fed policymakers are more convinced than others that price pressures will recede after some of the supply chain disruptions are resolved. How this debate evolves could influence how quickly the Fed moves to reduce the pace of asset purchases launched at the start of the pandemic, and how soon it lifts the policy interest rate from its current level near zero.
Rash and other local producers were part of a wide ranging forum recently with Richmond Fed president Tom Barkin that focused on the challenges to the U.S. recovery posed by supply chain issues that are not getting resolved as fast as policymakers had hoped. Shortages are hitting everything from bulldozers to bourbon. Heavy-equipment maker Caterpillar Inc (CAT.N) warned in July that its profits would suffer in the current quarter in part because of rising prices on hard-to-get components. The company said, among other things, it is looking for ways to get supplies from non-traditional sources to deal with shortages of plastic resin and semiconductors. Lawson Whiting, chief executive of spirits producer Brown-Forman Corp (BFb.N) , told investors earlier this month that shortages of “key packaging materials, most notably glass” continue to create problems for the maker of brands such as Jack Daniel’s and Woodford Reserve. New challenges continue to arise, including hurricane disruptions to U.S. oil refineries which is again threatening supplies of plastics and other basic materials. Some industries are rushing to build new factories, including semiconductor producers under pressure to feed a growing appetite for chips needed in cars and electronics. But not all producers are eager to build new plants. The bike industry, for instance, is heavily concentrated in Asia and producers there worry that the current surge in demand is only temporary. “The Asian factories have seen this time and time again,” said Brent Graves, CEO of Cane Creek Cycling Components, another small manufacturer in Fletcher, N.C., which relies heavily on Asian suppliers for bike parts. “They say, ‘Well, we will run some extra overtime.’ But in terms of raw investment in facilities, on the whole they are reluctant to do it.” Compounding the current problem are clogged supply lines. With so many manufacturers rushing to build supplies at the same time, the containers, ships, and trucks needed to move the goods often aren’t available, and have soared in cost when they are. That has disrupted some of the mechanisms that normally help keep supplies, and prices, in check. David Reilly, president of United Solutions, a plastics maker in Leominster, Mass., said soaring resin prices – he estimates they’re up 100% for some types in the past year – is his biggest challenge. Normally he would have his buyers scouring overseas markets, including China, for cheaper resins. “But we can’t do that,” he said, because shipping prices have risen so much that they wipe out any price advantage. “Right now, producers in North America don’t have the stiff competition that they would if container prices came back down.
Markets Sniffing Out The End Of The Delta-Driven Economic Slowdown
While Covid infections continue to rise and weigh on economic data, the markets seem to be seeing a receding in the impact on the horizon. Some might point to the weakness in U.S. stocks last week to refute the point, but that selling was likely exacerbated by investors realizing capital gains in advance of the likely increase in the capital gains tax rate. Since late July, the U.S. economic surprise index has been below zero, with readings below zero indicating that economic releases have been weaker than expected. In contrast, positive readings indicate better than expected economic releases. Despite the continued weakness in the U.S. economic surprise readings, the 10-year Treasury yield has begun to move higher. This weakness in the economic surprise data combined with rising yields is not just a domestic phenomenon. While the Citi global economic surprise readings have been trending lower since mid-June and are currently negative, the percentage of debt currently with a negative yield has also been trending lower since late August. A rise in the amount of negatively yielding debt has typically been associated with weaker expected economic growth. The move higher in global bond yields corresponds with the U.S. 10-year Treasury yields rising While Covid infections are continuing to rise in the U.S. and many other countries, perhaps the decline in the rate of change is some indication that things are already beginning to improve. The momentum of U.K. infections seems to have peaked for now, and the U.S. appears to be following suit. The speed of increase in U.S. Covid cases finally declined after 11 straight increases in week-over-week cases. Interestingly, Japan adds another data point to this narrative since Japan has had significant Covid issues, and the Japanese economy is very dependent on the global economy. The economic surprise data in Japan has been weakening since late May, while the pace of infections began to rise sharply in July. While the weekly growth of infections remains high, the peak momentum was in late August. Japanese stocks hit their recent bottom at roughly the same time as the pace of infections peaked and have outperformed the S&P 500 by almost eleven percentage points since that time. The TOPIX just made a 30-year high by exceeding the level set back in March 1991 The Senate returns from recess on September 13, so the whirlwind of legislative activity from Congress is beginning. While much of the tax and spending bills will likely take until the fourth quarter to be completed, the contemplated actions are likely to add noise and volatility to markets. In addition, the effective date of any proposed increase in the capital gains tax might be on September 15, when the Senate has set the deadline for committees to submit their reconciliation bills. Tuesday’s August consumer inflation readings should still reflect pricing pressures, with the year-over-year rate expected to be at 5.3%. Supply chain issues remain to haunt the data along with demand, but the year-over-year rate should have peaked in July. The August retail sales report should continue the streak of weaker U.S. economic readings. Spending on services had been keeping the retail sales levels near peak levels with goods spending softening. The increase in Delta variant infections likely negatively impacted services spending on the margin. In addition, supply chain issues will put a lid on auto-related sales. Keep an eye on the continued reaction to the weaker economic activity to see if markets look past the current challenges and continue to think the global economy will “break on through to the other side.”
No vaccine passports: UK PM to set out winter COVID-19 plan
LONDON, Sept 12 (Reuters) – British Prime Minister Boris Johnson will this week set out his plans to manage the COVID-19 pandemic in the winter months, announcing a decision to scrap the introduction of vaccine passports and steps to end some emergency powers.
Johnson, under fire from some in his governing Conservative Party for raising taxes to fix a health and social care crisis, looks set to try to soothe those critics by ditching plans to introduce passports despite an increasing number of coronavirus cases.
Speaking to broadcasters, Health Minister Sajid Javid said he did not anticipate more lockdowns and that the vaccine passports would not be introduced in England, as the government depends instead on vaccines and testing to defend the public. “Now that we’re entering autumn and winter … the prime minister this week will be setting out our plans to manage COVID over the coming few months and in that we will be making it clear that our vaccine program is working,” Sajid Javid told Sky News.
He told the BBC he was not “anticipating any more lockdowns” but would not take the measure off the table, that the government would not go ahead with vaccine passports to allow people to attend mass events and he wanted to “get rid of” PCR tests for travelers as soon as possible.
Javid added the government would remain “cautious,” but “the vaccine program, our testing program, our surveillance program, the new treatments… this is all our wall of defense and whilst there’s a lot of virus around, it is working.”
Exclusive-U.S. could authorize Pfizer COVID-19 shot for kids age 5-11 in October – sources
A nurse fills a syringe with Pfizer vaccine as mobile vaccination teams begin visiting every Los Angeles Unified middle and high school campus to deliver first and second doses of the coronavirus disease (COVID-19) vaccines in Los Angeles, California, U.S., August 30, 2021. REUTERS/Mike Blake Top U.S. health officials believe that Pfizer Inc’s (PFE.N) COVID-19 vaccine could be authorized for children aged 5-11 years old by the end of October, two sources familiar with the situation said on Friday.The timeline is based on the expectation that Pfizer, which developed the shot with Germany’s BioNTech (22UAy.DE), will have enough data from clinical trials to seek emergency use authorization (EUA) for that age group from the U.S. Food and Drug Administration (FDA) towards the end of this month, the sources said. They anticipate the FDA could make a decision on whether the shot is safe and effective in younger children within three weeks of the EUA submission.
Vaccine mandate comes due to high opposition – Psaki
A number of conservative governors across the U.S. are vowing to fight President Joe Biden’s newly announced vaccine mandate plan, which will require businesses with more than 100 employees to require inoculation or weekly COVID-19 testing. The move, predictably, was both applauded and condemned by Americans, political leaders and union heads. It will be enacted through a forthcoming rule from the Occupational Safety and Health Administration that carries penalties up to $14,000 per violation, an administration official said.
Republican governors criticized the mandate and many – including the governors of Arizona, Indiana, Georgia, Montana, South Carolina, Tennessee and Texas – vowed to fight it. The Republican National Committee said it would file a lawsuit against the Biden administration when the requirement goes into effect. Biden said Friday he was “disappointed” in the governors who said they plan to challenge his new requirements, adding that they have been “so cavalier” about the health of children and their communities. During a visit with first lady Jill Biden to Brookland Middle School in Washington, the president was asked what his message was to Republicans who decry the vaccine mandates as federal overreach and plan to challenge them in court. “Have at it,” Biden said following remarks in the school’s courtyard. “We’re playing for real here. This isn’t a game.” The plan, which Biden announced Thursday as part of a new six-part strategy, is expected to affect about 100 million workers in the country. “Many of us are frustrated with the nearly 80 million Americans who are still not vaccinated,” Biden said Thursday when announcing the new strategy. “This is not about freedom from personal choice, it’s about protecting yourself and those around you.”
📈Today’s numbers: The U.S. has recorded more than 40.6 million confirmed COVID-19 cases and more than 655,800 deaths, according to Johns Hopkins University data. Global totals: More than 223 million cases and 4.6 million deaths. More than 177.8 million Americans — 53.6% of the population — have been fully vaccinated, according to the CDC.
Dow sinks 270 pts at close as US mandates vaccines
Wall Street closed on Friday with major losses as investors digested the government’s decision to impose the COVID-19 vaccination mandate for all federal workers and employees working in large private companies. Commenting on the move, coronavirus response coordinator Jeff Zients said at today’s press briefing the White House hasn’t excluded the possibility of also requiring vaccinations for all international travelers. In business news, a California court ruled that Apple’s enforcement of anti-steering provisions on its App Store is anticompetitive, with the ruling coming as part of the Apple-Epic Games case.
The Dow Jones plunged 0.78% or 271 points at the closing bell, with Apple tumbling as much as 3.31%. The Nasdaq 100 lost 0.77% or 120 points, as the Kroger Co. sank 7.50%. The S&P 500 fell by 0.77%. Okta was the worst performer by declining 4.68%. The euro traded 0.10% lower against the dollar to sell for 1.18138 at 3:53 pm ET.
Radio Free Wall Street
Biden Did Something Really Crazy
The untold story in America is the Delta variant is ripping through the country. Infections, hospitalizations and deaths are approaching record highs. Super spreader events are the order of the day. And now, they’re opening up schools to millions of innocent, unvaccinated children.
White House COVID-19 test mandate could overwhelm already-strained suppliers
(Reuters) – A White House plan to mandate COVID-19 vaccination or repeated testing for around two-thirds of U.S. workers announced on Thursday could be hampered by supply challenges as COVID-19 test manufacturers strain to keep pace with demand. U.S. President Joe Biden will require all federal employees to get vaccinated against COVID-19 and the U.S. Department of Labor will issue a rule requiring private businesses with more than 100 employees to have their workers vaccinated or tested weekly, officials said on Thursday. Around 25% of the approximately 255 million Americans 18 years of age and older have not yet received a COVID-19 shot, according to federal data. The White House said it will spend nearly $2 billion on 280 million rapid COVID-19 tests to help boost supply, but industry experts are doubtful that manufacturers can produce tests fast enough to keep up with the administration’s mandate.
The U.S. testing industry currently can only produce around 50 million rapid COVID-19 tests each month, said Vijay Kumar, an analyst at Evercore ISI who covers medical technology companies. That’s only enough tests to cover around 12 million people taking weekly tests.
The White House said on Thursday it will employ a wartime law known at the Defense Production Act to help test manufacturers access needed supplies. “It has to be a priority to increase the availability of tests,” said Dr. Amesh Adalja, infectious disease expert at the Johns Hopkins Center for Health Security in Baltimore. “Rapid tests should’ve been available from the very start of this pandemic and the shortages now are unacceptable.”
The largest U.S. manufacturers of rapid COVID-19 tests – Becton Dickinson and Co, Quidel Corp and Abbott Laboratories – did not immediately respond to requests for comment on the White House’s announcement. The Advanced Medical Technology Association, a trade group for testmakers, told Reuters that rapid point-of-care test supplies are still ramping up to meet demand although laboratory-based testing capacity is strong. It added that it sent a letter to the administration in September requesting additional support for test production. U.S. companies have been already been straining to provide COVID-19 tests requested by K-12 schools around the country as they roll out surveillance programs going into the new school year.
“We’re seeing unprecedented demand as case rates rise,” Abbott told Reuters in a statement in August. “There will be some supply constraints over the coming weeks as increased capacity comes online.” Kumar said that testmakers also need more clarity on how the new mandate will be funded, noting that it is unclear whether employers will be expected to pick up a portion of the costs. The supply issue “won’t be resolved until the test providers have some visibility on demand,” Kumar said.