NIH director expects booster shots to be expanded, despite FDA advice

 Francis Collins, director of the National Institutes of Health (NIH), said on Sunday that it would "surprise" him if COVID-19 booster shot aren't expanded, despite a recommendation from a Food and Drug Administration (FDA) panel advising against widespread use.

"I think the big news is that they actually did approve the initiation of boosters and remember they're taking a snapshot of right now. We're going to see what happens in the coming weeks," Collins said while appearing on "Fox News Sunday." "It would surprise me if it does not become clear over the next few weeks, that administration of boosters may need to be enlarged."

"Based upon the data that we've already seen both in the U.S. and in Israel, it's clear that waning of the effectiveness of those vaccines is a reality, and we need to respond to it," he added.

On Friday, an advisory panel voted to recommend that the FDA authorize a third booster shot of Pfizer's COVID-19 vaccine for people over the age of 65 and others who are at a high risk for COVID-19. However, the panel voted against recommending a booster shot for everyone over the age of 16.

When asked by host Chris Wallace on Sunday if he felt that a booster shot would still be needed by everyone, Collins he wasn't sure if it will be necessary for "absolutely everyone," but reiterated that he would be "surprised" if boosters are not recommended for people under 65 in the coming weeks.

"What you're seeing here is science playing out in a very transparent way. This is the way it ought to be," Collins added.

"I'm a little troubled that people are complaining that the process isn't working for them. The process is to look at the data have the experts consider it, and then make their best judgment at that point, recognizing that the judgments may change."

https://thehill.com/homenews/sunday-talk-shows/572911-nih-director-expects-booster-shot-administration-to-be-expanded

Topol : More will eventually need Covid booster shot as immunity wanes

 More Americans will need a third Covid vaccine booster shot as immunity wanes, according to Dr. Eric Topol, founder and director of the Scripps Research Translational Institute.

“Eventually, a lot more people are going to need these third shots. That was always part of the plan from the beginning,” Topol said on Friday’s episode of “Mad Money.”

A Food and Drug Administration advisory committee on Friday rejected a proposal to distribute booster shots of Pfizer and BioNTech’s Covid-19 vaccine to the general public. The panel did, however, recommend the third shot to people 65 years of age and older and other vulnerable Americans.

More research should provide better insights into the efficacy of booster vaccine shots, according to Topol.

“We’re going to get more data out of Israel, out of the UK and other places,” Topol said.

The Biden administration has said it wants to begin offering the third Covid vaccine shot to the general public as early as next week, as long as U.S. health regulators authorize the booster. The FDA in August authorized Covid vaccine booster shots for people with weakened immune systems.

“We got to have the hard truth. What it shows is we have more symptomatic infections starting around four to five months [after vaccination]. It’s going to affect all the vaccines eventually because this was never really conceived as a two shot story. It was going to be three shots,” Topol said.

https://www.cnbc.com/2021/09/17/dr-eric-topol-says-more-americans-will-need-a-covid-vaccine-booster.html

With huge tumor progression edge, AstraZeneca-Daiichi Enhertu shows up Roche Kadcyla in breast cancer

 Pharma watchers have always suspected that AstraZeneca and Daiichi Sankyo’s Enhertu is a better HER2 therapy than Roche’s Kadcyla. But guessing is all they could do without a head-to-head trial to show just how different the two antibody-drug conjugates are.

Enhertu slashed the risk of disease progression or death by a massive 71.6% over Kadcyla in second-line HER2-positive metastatic breast cancer patients previously treated with Roche’s Herceptin and chemo, AstraZeneca and Daiichi reported at the European Society for Medical Oncology 2021 virtual meeting.

The showing is so impressive that the study authors concluded that the study, dubbed Destiny-Breast03, will lead to a paradigm shift in the treatment of HER2-positive breast cancer. Jefferies analysts recently pegged Enhertu’s peak sales in the second-line setting at $500 million.

Enhertu showed superior benefits on several fronts in the trial. The median time to disease progression or death was not reached for Enhertu and 6.8 months for Kadcyla, according to a blinded independent review, which led to the above 71.6% progression-free survival edge. By investigator’s analysis, the median time to progression or death was 25.1 months for Enhertu versus 7.2 months for Kadcyla, and there was a risk reduction of 73.5%.

Kadcyla appeared to show an inferior efficacy profile compared with its historical clinical results. In its own phase 3 Emilia trial among second-line patients, Kadcyla recorded a progression-free survival of 9.6 months.

Kadcyla did seem to have underperformed in some patients, Dave Fredrickson, AstraZeneca’s head of oncology business unit, acknowledged in an interview, but he pointed out that the Emilia trial was run at a time when Roche’s Perjeta wasn’t approved for the postsurgery treatment of patients with early breast cancer. So those patients didn’t have the big upfront impact from early treatment with Perjeta. In the post-Perjeta as adjuvant era, Kadcyla’s performance is largely in line with real-world experience, he said.

In Destiny-Breast03, Enhertu also more than doubled the number of patients who responded to treatment, as the AZ-Daiichi med shrunk tumors in about 8 of 10 its patients, while the rate for Kadcyla was just a little over one third.

“The investigators that we talked to start talking about maybe we’re opening up the possibility for some women that a cure could be possible in advance disease,” Fredrickson said.

The life extension data remain immature; Enhertu cut the risk of death by 44.5% at the interim analysis, though it hasn’t met the statistical significance bar. The estimated 12-month survival rate was 94.1% for Enhertu versus 85.9% for Kadcyla. 

Decreasing interstitial lung disease rate 'very encouraging'

Beyond the unquestionable efficacy win, industry watchers have been keeping a close eye on the potentially dangerous side effect of interstitial lung disease (ILD), which has appeared at higher rates in drugs developed with Daiichi’s antibody-drug conjugate technology. Doctors often cite the safety signal as a key reason why they aren’t already prescribing Enhertu in the FDA-approved third-line breast cancer setting.

Here, Fredrickson described Enhertu’s safety profile as “very encouraging.” ILD turned up in 10.5% of Enhertu patients, none in the severe grade 4 or 5 groups. For Kadcyla, the problem occurred in 1.9% of patients, all belonging to grade 1 or 2. Previously, the Destiny-Breast01 trial in late-line disease linked Enhertu to a 13.6% ILD rate, including 2.2% of deaths.

Lower overall ILD rate and no patient deaths are improvements for Enhertu, but two breast cancer experts had previously told SVB Leerink that Enhertu’s ILD rate needs to come in along the lines of 5% to significantly penetrate the front- or second-line breast cancer settings.

Fredrickson argued that physicians are mainly focused on grade 4 or 5 ILD event, because “there is an acceptance that grade 1/ 2 ILD is something that is manageable.” AZ has invested in awareness, monitoring and management of ILD, he added, and the rates in the real-world appear to be “much lower” as a result of those efforts.

AZ and Daiichi have recently moved Enhertu into a front-line HER2-positive breast cancer trial and are exploring the ADC in a range of disease areas. These include the Destiny-Breast 04 trial in second-line HER2-low breast cancer, which expects to read out in the first half of 2022.

Adding new stomach cancer, lung cancer data

Also at ESMO 2021, the pair unveiled data from the single-arm Destiny-Gastric02 trial of Enhertu in Western patients with HER2-positive metastatic gastric cancer or gastroesophageal junction adenocarcinoma. Among patients who received one or two prior lines of therapy, Enhertu triggered a response in 38% of patients, lasting a median 8.1 months.

The numbers were slightly weaker than in the pivotal Destiny-Gastric01 trial in Japan and South Korea that earned Enhertu its FDA go-ahead in previously treated stomach cancer in January. There, the drug spurred a response in 43% of patients, with a median duration of 11.3 months among a group of patients who had received a median two previous therapies for advanced disease.

The prevalence of stomach cancer and how it’s treated are different between Asian populations and in the West, Fredrickson explained. AstraZeneca said the two trials complement each other and “will support ongoing discussions with global health authorities.”

In addition, Enhertu also reported at ESMO 2021 more data from the phase 2 Destiny-Lung01 trial. After a median follow-up of 13.1 months, Enhertu shrunk tumors in 54.9% of patients with HER2-mutant non-small cell lung cancer who had received a median two prior cancer therapies.

Probably because these patients already suffered from lung disease, the rate of ILD was high at 26.4% in the trial, including 6.6% at grade 3 or above.

Combined with the latest data with the positive readout reported earlier from the HER2-overexpressing cohort of the study, AZ and Daiichi are talking to regulators about a path forward for Enhertu in NSCLC, Fredrickson said.

https://www.fiercepharma.com/pharma/massive-tumor-progression-edge-astrazeneca-and-daiichi-s-enhertu-shows-roche-s-kadcyla-who-s

Why does Biden's vaccine mandate not apply to welfare recipients and others?

 On Sept. 9, President Biden declared that all companies with more than 100 employees must “ensure their workforces are fully vaccinated or show a negative test at least once a week.”

According to Biden’s federal vaccine mandate, any company that does not comply will face a fine of $14,000 per case.

During his speech, Biden also declared that “all nursing home workers who treat patients on Medicare and Medicaid” and that “those who work in hospitals, home healthcare facilities, or other medical facilities” as well as “all executive branch federal employees” and “federal contractors” must get vaccinated.

If these Americans choose not to get vaccinated, they will lose their livelihoods. As Biden said, “This is not about freedom or personal choice.”

But Biden’s federal vaccine mandate does not apply to Americans on welfare, illegal immigrants, members of Congress, U.S. Postal Service employees and several other groups.

This is not only unfair, but it flies in the face of Biden’s goal “to require more Americans to be vaccinated, to combat those blocking public health.”

So, per Biden’s edict, Americans who work at a company that employs more than 100 people have no choice but to get vaccinated. The same standard applies to the health care workers who have heroically put their lives on the line treating COVID-19 patients.

But for reasons unexplained, Biden refuses to mandate vaccines for the 59 million Americans who receive welfare benefits.

Put another way, Biden is mandating that the Americans who supply most of the tax revenue to pay for America’s welfare system be vaccinated or lose employment. But the beneficiaries of the welfare state are exempt.

This is even more flummoxing given that data shows Medicaid recipients are among the least vaccinated.

In Georgia, for example, only 10 percent of Medicaid recipients were fully vaccinated, compared with 33 percent of the Peach State’s general population, as of May 31. Similarly, in Idaho, only 20 percent of Medicaid recipients were fully vaccinated, while 44 percent of the state’s general population had been fully vaccinated, as of June 1.Similar trends apply throughout the states.

Illegal immigrants are also exempt from Biden’s vaccine mandate.

According to a spokesman for Immigration and Customs Enforcement, “The Department of Homeland Security continues its vaccination efforts to include voluntary vaccinations for individuals in the care and custody of U.S. Immigration and Customs Enforcement.”

Once again, for working American citizens, Biden says it is not about freedom or personal choice, but for illegal immigrants, vaccinations are voluntary.

When pressed about this blatant double standard, Biden’s White House press secretary, Jen Psaki, simply replied, “That’s correct.”

Apparently, voluntary vaccination also applies to Postal Service workers. According to Dave Partenheimer, a Postal Service spokesman, “The COVID-19 vaccination requirements included in the White House executive order issued on September 9, 2021 for federal employees do not apply to the Postal Service.”

Finally, Biden’s vaccine mandate does not apply to Congress, even though there are 535 members, which puts Congress well over the 100-employee threshold.

Biden’s vaccine mandate is narrowly targeted toward the 80 to 100 million American citizens who get up and go to work but ignores the 60 million Americans on welfare, the thousands who illegally cross our southern border every day, the 640,000 Postal Service workers and Congress, among others.

Biden’s vaccine mandate is not about getting the vulnerable vaccinated. It is about the Biden administration unfairly and unnecessarily forcing hard-working Americans to choose between their bodily autonomy and their livelihood.

Chris Talgo (ctalgo@heartland.org) is senior editor at The Heartland Institute.

https://thehill.com/opinion/healthcare/572858-why-does-bidens-vaccine-mandate-not-apply-to-welfare-recipients-and-others

Gottlieb: Government's early COVID-19 response was a 'failure of vision'

Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb said the government’s early response to the coronavirus pandemic was a “failure of vision.”

During an interview with CBS’s “Face the Nation,” Gottlieb explained that the perception that the Centers for Disease Control and Prevention (CDC) could quickly respond to the pandemic was wrong.

Gottlieb recalled the CDC developing a coronavirus test kit that would be mass-manufactured and deployed to public health labs, but the kits were later found to be faulty due to likely contamination.  Even if the agency was successful, Gottlieb said, the CDC didn’t have the capacity to perform the necessary number of tests.

“I think it's very difficult for an agency to have this self awareness that they don't have the capacity to respond the way they're being asked,” Gottlieb explained. “And I think it's very difficult for an agency to self organize differently in the setting of a crisis.”

Gottlieb also said that the CDC needed to work with other agencies and that the federal government needed to turn to the private sector to ramp up its response. Government agencies eventually came together for the Trump administration's Operation Warp Speed to accelerate the development of coronavirus vaccines.

The project involved the FDA, the National Institutes of Health and the Department of Defense scaling up manufacturing.

“We needed to do that at day one, we need to get FEMA [the Federal Emergency Management Agency] and the DOJ [Department of Justice] engaged with the CDC in trying to organize a national-level response,” Gottlieb said.

CBS reporter Margaret Brennan interjected during the former official's explanation, asking why the CDC did not partner with its other agencies. 

"Why didn't they?" she asked. "Is that a failure of Robert Redfield, the head of the CDC at the time?"

“That was a failure of political leadership, and it was a failure vision. But you know there were a lot of people who were good political leaders who all wrongly assumed that CDC had this mission,” Gottlieb said.

The former FDA commissioner has been open about his thoughts on the CDC’s response to the pandemic.

n his book “Uncontrolled Spread,” set for release Sept. 21, Gottlieb says the agency hindered the pandemic response because it was too slow to implement policies and changes.

https://thehill.com/policy/healthcare/572857-gottlieb-says-early-government-covid-19-response-was-a-failure-of-vision

Did Biden make vaccine mandate for only half of US teachers?

 President Biden recently announced forthcoming federal safety regulations mandating vaccines against COVID-19, or weekly testing, for an estimated 100 million Americans. The Occupational Safety and Health Administration (OSHA) will draft the regulations over the coming weeks, which apply to employers with more than 100 employees. For one key group, the nation’s 3.5 million public school teachers, Biden’s vaccine mandate will cover only half.

Why half? Because Biden’s only politically feasible path forward for this mandate was through OSHA, even if bizarre technicalities of the agency’s authority across states drastically limits coverage for schools.

Counterintuitively, the way OSHA laws define “employer” means the new regulations will only apply to school districts with more than 100 employees in states that are not subject to direct oversight by OSHA. Within the 24 states under OSHA’s direct jurisdiction, the term “employer” explicitly excludes state and local government employees, including public school teachers and staff. State and local government employees in those states — including 47 percent of the nation’s public school staff — would be subject to state-issued mandates only.

tate and local government employees in the remaining 26 states are outside of OSHA’s direct enforcement authority because they have OSHA-approved state occupational safety and health plans. However, those states’ plans must be “at least as effective” as OSHA standards, and they must include all state and local government employees. Ironically, it will be these states that, on paper, have direct control over their own health and safety regulations that will be subject to the forthcoming federal mandate.

How far reaching will this mandate be for public schools? Very far reaching, or not at all, depending on the state. Individual schools often have fewer than 100 employees, but teachers and staff are employees of school districts. In the 26 states covered by “state plans,” over 95 percent of public school employees work for districts with more than 100 employees. Half of the nation’s teachers work in those states, and will be required to get vaccinated or submit to weekly testing. The mandate would cover no public school teachers in the remaining 24 states.

Biden’s OSHA mandate will almost certainly be challenged in the courts, but chances are good that it will stand. The Federal legislation that created OSHA gives the Department of Labor authority to issue an “emergency temporary standard” (ETS), and the Biden administration issued one this June aimed at protecting healthcare workers from COVID. So far, that rule has withstood opposition.

Challenges will likely hinge on whether COVID is considered a “grave danger” under the law and whether the emergency measure is “necessary.” Courts have historically given administrative agencies wide latitude in making policy decisions, including when the last pre-COVID ETS was challenged. Further, the choice implicit in the proposed rule, to become vaccinated or submit to weekly testing, reduces the burden of the mandate on employees, giving OSHA more wiggle room in arguing that the ETS is “necessary.” Of course, the final decision depends on the courts, and likely a conservative-dominated Supreme Court.

Whether Biden’s proposed rule is an executive overreach is in the eye of the beholder. However, the question takes on an interesting valence in the context of schools, where the limits of circuitous executive authority are on full display. The most appropriate route to a universal vaccine mandate for schools would be through Congress. With Congressional politics making that path impossible, especially so far into the pandemic, Biden is flexing his administrative muscle to get — at least when it comes to schools — quite literally half a loaf.

If the ends justify the means of using whatever administrative tools are at hand in this case, where does that justification end? A mask mandate could easily follow from the OSHA vaccine mandate logic. Biden is already using the Department of Education’s Office of Civil Rights (OCR) to counter bans on mask mandates in several states. Masks are arguably crucial to worker safety, especially in schools that everyday host the highest concentrations of unvaccinated people (children under the age of 12). An OSHA-enforced mask mandate would trump state rules on masking in half of the states, including four of the five states currently under investigation by OCR.

If masking is in play, what about social distancing requirements? The limiting factor in this case is the will of the president. Those in favor Biden’s vaccine mandate would do well to consider how they would feel about the previous president (or future Republican presidents) wielding the same power.

Whether you favor or oppose such vaccine mandates for schools, the unevenness of OSHA authority over public school districts demonstrates the peculiarity of policies that stem from executive authority. Of the three limiting factors on Biden’s exercised OSHA authority — presidential will, the courts, and the technical machinery of the administrative state — the last is the reason that only half of the country’s teachers will face federally mandated vaccination or testing this school year.

Nat Malkus is a senior fellow and the deputy director of education policy studies at the American Enterprise Institute.

https://thehill.com/opinion/education/572870-did-president-biden-institute-a-vaccine-mandate-for-only-half-the-nations

Antibody Treatments For COVID Work. Why Aren't They Being Promoted?

 by Mark Glennon via Wirepoints.org,

It’s perhaps the most effective way to save your life if you are infected with COVID-19, but probably the least known. It reduces the risk of even being hospitalized by 70% to 85%, though it must be administered early to be effective – within four days of infection. Lives probably are being lost unnecessarily because people don’t know about it.

It’s monoclonal antibody treatment, abbreviated as mAb. To the extent the public has any familiarity with it they, may know it as Regeneron, though that’s actually the name of the company that makes the leading treatment, REGEN-COV2, and there are several other mAbs from other makers.

Health authorities for months back should have been issuing this message constantly: “Immediately after being exposed or you have COVID symptoms, get tested and ask if an antibody treatment is right for you.”

But they didn’t. They still aren’t. At least not in Illinois and most of the nation.

Why not?

No reasonable explanation is evident and a significant number of lives may have been lost because of the failure to inform the public properly. And now, with antibody treatments getting more attention, the treatments must be rationed, adding to the tragedy. At least in part, the explanation is a sad one – politics, and politicized media.

The effectiveness of REGEN and other antibody treatments has been known since at least November when the Food and Drug Administration granted emergency authorization for REGEN and another mAb. Earlier tests had found REGEN to be over 70% effective in heading off serious illness and multiple subsequent tests have confirmed it.

“Many of us were talking about this as early as March [2020]" wrote Scott Gottlieb, a former FDA commissioner.

“Regeneron did extraordinary work to secure their own manufacturing, but we needed a concerted industrial effort to get the supply we needed.”

Only over the last month have antibody treatments started to gain more attention. That’s probably because Dr. Anthony Fauci finally – belatedly – spoke up, saying that the treatments can reduce the risk of COVID-19 hospitalization or death by 70% to 85%. That seems to have been a signal to the establishment herd that it was permissible to talk about the treatments positively. The Biden Administration thereafter announced it would be stepping up purchases of the treatments.

But the increased attention has now caused a shortage of the treatments. What was in oversupply only a couple months ago is now being rationed. The Biden Administration just announced restrictions on how much of the treatments may be shipped to each state. From the Washington Post: “Soaring demand for the therapy represents a sharp turn from just two months ago, when monoclonal antibodies were widely available and awareness of them was low. With little promotion by the government, consumers, doctors and states were using just a tiny fraction of the available supply.”

Here in Illinois, health authorities and the media are completely behind the curve. It’s difficult to find even a word that has been said on the subject. The message isn’t being given that you should get tested fast if you think you are infected and see if antibody treatment is available to you.

Intensive care units in some parts of downstate Illinois are now full of COVID patients. How many of those hospitalizations would have been avoided if the victims had been aware of the treatment and acted quickly to get it?

That goes for most of the nation as well. Florida is one of six states among the exceptions. Those six states have been using the treatments aggressively, consuming 70% of the supply in recent weeks. That’s partly due to high, recent infection rates in most of those states, but also because they have seen the value of antibody treatment that other states have ignored, and they’ve told their people about it. That’s especially true of Florida, which I’ll get to.

Why haven’t health authorities and supposed experts been making a life-saving treatment better known?

One benign but irrational answer is that they don’t want to distract from the importance of vaccinations because they view prevention as better than treatment. For example, CNN’s expert, Dr. Leana Wen, said, “It’s totally backwards to say that we should be focused on treatment instead of emphasizing prevention, and the steps that we know work to stop Covid-19 in the first place.” And Dr. Christian Ramers, an infectious-disease specialist, told the Daily Beast. “It’s so much better to prevent a disease than to use an expensive, cumbersome and difficult-to-use therapy,” Ramers submitted. “It does not make any medical sense to lean into monoclonals to the detriment of vaccines. It’s like playing defense with no offense.”

That seems irrational on its face. Preventative vaccines and therapeutics like antibody treatment are not alternatives. Promote vaccines all you want, but when somebody is facing possible death, treat them.

But another explanation at least partially accounts for why mAbs have been shunned: The establishment doesn’t like the politics of who championed antibody therapy, particularly Florida Governor Ron DeSantis, a leading, likely, Republican candidate for president.

Since at least November, DeSantis has been encouraging Floridians to seek the treatment if they get infected.

“And the good thing about this is millions of doses are ready to ship as we speak,” he said then.

“Soon as the FDA approves they will then go out within the next 24 hours and we expect our hospitals hopefully to receive these within the next three to six weeks. He later set up clinics specifically for providing the treatment.

Well, we certainly can’t be agreeing with anything he says, as MSM sees things, so the Associated Press led the charge. They did it by trying to implicate two others the left doesn’t like, Ken Griffin and his hedge fund, Citadel. Griffin is a Chicago billionaire who frequently supports Republicans and conservative causes.

So, in a column reprinted almost universally in the national and Illinois media, the AP linked DeSantis’ support for antibody treatments to a Citadel investment in Regeneron and Griffin’s campaign contributions to DeSantis.

It was a smear job, creating the impression that Regeneron’s product is snake oil peddled by DeSantis as a return favor. DeSantis responded appropriately, saying the column was a blatant political attack.

The AP wasn’t alone. A Bloomberg columnist on Twitter mocked DeSantis and the Regeneron product because of what he claimed it costs – $1,250 per dose – though vaccines are free. That’s false. DeSantis made the treatment free.

As you would expect, the press had another reason for dismissing the value of antibody treatments – Trump. He credited Regeneron’s product for helping with his recovery when he was infected. But that was because Regeneron’s CEO was a member of Trump’s golf club, said the Daily Mail. And Trump owned shares of Regeneron and Gilead, another mAb maker, so that must explain his claim, as USA Today would have you believe. “No, Regeneron did not cure Donald Trump of COVID,” The New Republic flatly told us in a headline, as if they had any idea.

The facts on antibody treatment have now overrun that political hype. Still today, however, the public remains mostly unaware of the efficacy and availability of the treatment, except in a few states like Florida. Although treatments are now being rationed, they are available to people in high risk groups everywhere.

Too bad the federal government didn’t ramp up its purchases of the product earlier.

Too bad every state didn’t promote it as heavily as Florida did.

Too bad states like Illinois still aren’t talking about it.

Too bad governors in states like Illinois aren’t saying what DeSantis is now saying, which is that he will “fight like hell” to get what he can of the available treatments now being rationed.

Too bad because we will never know how many lives might have been saved.

https://www.zerohedge.com/covid-19/antibody-treatments-covid-work-why-arent-they-being-promoted