Gottlieb: Nursing homes need Covid boosters sooner

 Dr. Scott Gottlieb on Friday urged fellow vaccinated Americans to be on guard about the Covid delta variant, telling CNBC its highly transmissible nature cannot be ignored even by people who have immunity protection.

“The original premise around the vaccines — that they reduce the risk of serious disease and hospitalization — is still intact,” the former Food and Drug Administration commissioner said on “Squawk Box.” “We still see in the data that the vast majority of people who are getting in trouble with Covid are people who are unvaccinated.”

However, Gottlieb, who serves on the board of Covid vaccine maker Pfizer, said the risk to vaccinated people is not zero.

“People who are vaccinated in a setting of this epidemic surge, especially if they’re in places where there’s a high prevalence of infection, need to take appropriate precautions,” he said. “You can’t just throw caution to the wind. You can still become a vehicle for spread in your community.”

The seven-day average of daily new coronavirus cases in the U.S. is 141,060, according to a CNBC analysis of Johns Hopkins University data. That’s up 14% from a week ago. Cases are increasing by more than 5% in 42 states plus Washington, D.C.

Gottlieb’s comments Friday came in response to a question about three vaccinated U.S. senators — Roger Wicker, Angus King, and John Hickenlooper — who announced a day earlier they had tested positive for Covid.

“I think there’s now a recognition that this delta is sufficiently contagious that it can pierce the protections offered by the vaccine, particularly if you were vaccinated a while ago and have declining immunity, as these senators probably did because they were vaccinated a long time ago,” said Gottlieb, who led the FDA from 2017 to 2019.

While some scientists disagree with U.S. health officials’ recent decision to authorize Covid booster shots beginning next month, Gottlieb said he believes the delta variant’s transmissibility supports the idea of delivering third doses to Americans. Noting his role on Pfizer’s board, Gottlieb said he’s studied the data that shows declining immunity protection over time.

“It happens to be the case that we vaccinated some of our most vulnerable older individuals in our society last December and January, particularly nursing homes,” Gottlieb said. “I think the prudent thing to do would be to get additional immunity in that population, especially considering the fact we’re dealing with a much more contagious variant.”

https://www.cnbc.com/2021/08/20/covid-delta-scott-gottlieb-says-vaccinated-people-cant-throw-caution-to-the-wind.html

Most private insurers no longer waive cost-sharing for COVID-19 treatment

 Federal law requires all private insurance plans to cover the entire cost associated with approved COVID-19 testing so long as the test is deemed medically appropriate. Additionally, the U.S. government pre-paid for COVID-19 vaccines and required COVID-19 vaccines be made available at no out-of-pocket costs regardless of whether the vaccine recipient is insured. However, while a handful of states required or created agreements with insurers to waive COVID-19 out-of-pocket treatment costs for their fully-insured plan enrollees, there is no federal mandate requiring insurers to do so.

Earlier in the pandemic, we found that the vast majority (88%) of people enrolled in fully-insured private health plans nonetheless would have had their out-of-pocket costs waived if they were hospitalized with COVID-19. At the time, health insurers were highly profitable due to lower-than-expected health care use, while hospitals and health care workers were overwhelmed with COVID-19 patients. Insurers may have also wanted to be sympathetic toward COVID-19 patients, and some may have also feared the possibility of a federal mandate to provide care free-of-charge to COVID-19 patients, so they voluntarily waived these costs for at least some period of time during the pandemic. Our subsequent analysis found that several of these insurers were starting to phase out COVID-19 cost-sharing waivers by November 2020.

In the last few months, the environment has shifted with safe and highly effective vaccines now widely available. In this brief, we once again review how many private insurers are continuing to waive patient cost sharing for COVID-19 treatment. We find that 72% of the two largest insurers in each state and DC (102 health plans) are no longer waiving these costs, and another 10% of plans are phasing out waivers by the end of October.

Nearly three-quarters of the largest health plans are no longer waiving cost-sharing for COVID-19 treatment

Across the two largest health plans in each state and D.C. (102 plans), 73 plans (72% of 102 plans) are no longer waiving out-of-pocket costs for COVID-19 treatment. Almost half these plans (50 plans) ended cost-sharing waivers by April 2021, which is around the time most states were opening vaccinations to all adults. Of the 29 plans still waiving cost-sharing for COVID-19 treatment, 10 waivers are set to expire by the end of October. This includes waivers that tie to the end of the federal Public Health Emergency, which is currently set to expire on October 17, 2021, though may be extended. Another 12 plans state that their cost-sharing waivers will expire by the end of 2021. Two plans specified end dates for COVID-19 treatment waivers in 2022 and 5 plans did not specify an expiration date.

All of the 102 plans we reviewed (two largest plans in each state) had waived cost-sharing for COVID-19 treatment at some point since 2020. (These health plans represent 62% of enrollment across the fully insured individual and group markets).

In early 2021, about one-third of employers said their largest plan waived COVID-19 treatment costs

Many employers offering self-funded and fully insured health plans to their employees also reported waiving COVID-19 treatment cost sharing based on preliminary results from the 2021 KFF Employer Health Benefits Survey (EHBS), which was fielded between January and July 2021 with over 70% of the interviews completed before April 19th when vaccines became available for most adults. Since this survey was conducted earlier in the year, many of the waivers may have already expired by the time of this report.

Based on preliminary results from the 2021 EHBS, 36% of firms (with 50 or more employees) reported that their largest plan waived cost sharing for COVID-19 treatment at the time of the survey. Larger firms with 1,000 or more workers were more likely to waive COVID-19 treatment cost-sharing for enrollees than smaller employers.

This survey includes both self-funded employers and those buying fully insured coverage. Before this survey, there was no way to know whether self-funded employers were also waiving these costs as the decision was not up to the insurer administering the plan. In the survey, we see that self-funded employers were similarly likely as employers purchasing fully-insured plans to offer waivers for COVID-19 cost sharing.

https://www.healthsystemtracker.org/brief/most-private-insurers-are-no-longer-waiving-cost-sharing-for-covid-19-treatment/

In nod to Delta variant, Fed moves Jackson Hole meet online

 The Federal Reserve Bank of Kansas City said on Friday its annual economic symposium in Jackson Hole, Wyoming, will take place on Aug. 27 virtually and not in person as planned, the clearest sign yet of the impact of the COVID-19 Delta variant on the Fed’s plans.

“While we are disappointed that health conditions will prevent us from being able to gather in person at the Jackson Lake Lodge this year as we had planned, the safety of our guests and the Teton County community is our priority,” said Kansas City Fed President Esther George in a statement, citing the recently elevated COVID-19 health risk level in Teton County.

Under the county’s guidelines, people should not gather with non-family members or host in-person social activities.

The reversal raises questions about the Fed’s broader assessment of the Delta variant’s economic impact, which Chair Jerome Powell and other policymakers have mostly played down, saying that businesses and households have learned to live with the virus.

“It certainly is going to be a communications challenge” for Powell to stick to the view of only minor impact from the recent surge when he’ll be giving his highly anticipated speech on the economic outlook to an online-only audience,” said Yale School of Management’s Steven Kelly.

Or, as Grant Thornton Chief Economist Diane Swonk quipped on Twitter, “I think the tenor of @federalreserve Powell’s comments just shifted a bit on the economic outlook.”

At their meeting last week, Fed policymakers began coalescing around a plan to begin to reduce their support for the economy before the end of the year, as long as the labor market continued to improve as expected.

The Delta variant, however, is raising questions around that. Earlier on Friday, Dallas Fed President Robert Kaplan, who backs a plan to start trimming the Fed’s economy-bolstering bond purchases by October, said he was already seeing some signs of the rising caseloads’ impact on hiring and would be watching it carefully in the run-up to the Fed’s next meeting, in September.

MUTED AFFAIR

The gathering was already going to be a muted affair. The guest list had been scaled back, with foreign central bankers not attending, many of the lodge facilities closed or limited, and masks mandatory outside of meals.

Vaccines were required for all attendees and their families.

Even as late as Friday afternoon Fed policymakers had still been planning to attend, with their staffs pinning down details for meetings outside of the scheduled events.

The Fed said this week, however, that Powell would give his marquee speech remotely. And now everyone else will attend online as well.

Sparsely populated Wyoming on a per capita basis has averaged 54 cases per 100,000 people in the last week versus 43 per 100,000 for the country as a whole. Teton County’s rate is 62 per 100,000.

While Fed officials remain convinced this wave will not derail the recovery, the pace of the virus’ current surge is starting to be felt.

Economists this week began trimming forecasts of economic growth, and while the cuts weren’t dramatic in what is still a strong recovery, they marked a turn from the exuberance of the first half of the year.

“The impact of the Delta variant on growth and inflation is proving to be somewhat larger than we expected,” Goldman Sachs economists wrote on Thursday, lowering projected 2021 growth to 6% from 6.4%.

High frequency data showed the start of a possible slow down in air travel and dining in restaurants.

Bank of America economists noted a recent decline in credit card spending on leisure – one of the business sectors hardest hit by the pandemic and struggling to re-employ its workforce.

https://www.reuters.com/article/usa-fed-jacksonhole/update-3-in-nod-to-delta-variant-fed-moves-jackson-hole-meet-online-idUSL1N2PR28M

AbbVie eyes $1.2B sales for yet-to-be-approved migraine preventive

 One of the gems AbbVie inherited from the $63 billion Allergan transaction is ready to take a slice of the highly competitive migraine market—and no, it’s not Botox.

The New England Journal of Medicine published results from a phase 3 clinical trial of atogepant for preventing migraines Thursday. Oral atogepant was found to reduce the number of migraine and headache days per month over a treatment period of 12 weeks. AbbVie has already send off the therapy for FDA review, with a decision expected in the coming months.

Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist. CGRP is a neuropeptide, or a small protein produced by the neurons, that is suspected to play an integral role in migraine. As the understanding of the CGRP relationship to migraine became better understood in neuroscience, so too did the ability to find drugs that could target it and potentially relieve the painful and debilitating condition.

Allergan is positioning atogepant to be among the first oral medicines to prevent migraine in a crowd of injectable drugs. SVB Leerink sees AbbVie cracking off about $1.2 billion of the market in peak sales. AbbVie itself anticipates sales of $1 billion; either way, that's a blockbuster number.

“Migraine prevention hasn’t been dominated by any of the injectable medicines, and we expect the orals to take share from the injectables, and to expand the market,” SVB Leerink said.

That’s because the top therapies have fairly comparable efficacy and large numbers of patients simply don’t respond, according to SVB Leerink. So patients tend to shuffle between a few before they find something that works for them.

The once-daily, oral delivery mechanism could help atogepant differentiate in a crowded field of competitors that includes Eli Lilly’s Emgality, Amgen’s Aimovig, Biohaven’s Nurtec, Teva’s Ajovy and finally, Lundbeck’s Vyepti. Emgality, Aimovig, Nurtec, Ajovy and Vyepti are approved to prevent migraines. Nurtec is an oral therapy.

While AbbVie's drug is easier to take, patients may have to contend with a high rate of constipation that was found in clinical trials, SVB Leerink said in a note. This could impact the duration of treatment and the order in which doctors offer the therapy to patients. The adverse events, which were mild to moderate during the trial, should be manageable by physicians.

SVB Leerink expects that atogepant will get the OK from the FDA for preventing episodic migraines by the September deadline. AbbVie is also examining the therapy in chronic migraine prevention. A data readout for that study is expected in 2022.

“Given the results in episodic migraine, and the efficacy results of other CGRP’s in chronic migraine, we expect the chronic trial to be successful,” SVB Leerink said.

Atogepant will, of course, join Allergan’s crown jewel, Botox, in AbbVie’s migraine program. The north Chicago, Illinois-based Big Pharma also has another CGRP inhibitor called Ubrelvy approved for acute migraine treatment, which SVB Leerink expects will bring in $542 million in 2021. that number is expected to rise to over a billion by 2024. The oral medicine is currently approved for acute treatment but no preventive indications. 

With a large salesforce and market position already established, AbbVie should have no trouble moving atogepant once approved.

https://www.fiercebiotech.com/biotech/migraine-market-better-make-way-for-abbvie-as-oral-preventative-treatment-atogepant-poised

US extending travel restrictions with Canada, Mexico

 The U.S. is extending the nonessential closure of its borders with Canada and Mexico to at least Sept. 21 due to the delta variant of the coronavirus, the Department of Homeland Security announced Friday.

"In coordination with public health and medical experts, DHS continues working closely with its partners across the United States and internationally to determine how to safely and sustainably resume normal travel," the agency tweeted.

The extraordinary closures have been extended monthly since they were put in place at the onset of the pandemic in March 2020. 

Canada began letting fully vaccinated U.S. citizens and permanent residents into the country on Aug. 9, but Canadians still can't travel into the U.S. unless it is for an essential purpose.

The current rules have prompted backlash from the travel and tourism industry, as well as from lawmakers in border states who claim the rules are inconsistently applied.

Biden administration officials in June formed working groups with Canada, Mexico, the European Union and the United Kingdom to weigh when to lift international travel restrictions, but so far nothing has come from the effort. The administration has not said when it plans to loosen restrictions on international travel. 

Earlier this month, the White House hinted that the U.S. would require foreign visitors to be fully vaccinated against COVID-19, but a final decision has not been adopted.

Former President Trump moved to lift restrictions on Europe and Brazil in the waning days of his term, but President Biden kept them in place once he took office. Biden also added restrictions on India amid a surge of COVID-19 infections there.

But experts have said picking and choosing countries based off of COVID-19 infections is arbitrary because the disease is already entrenched in the U.S. 

COVID-19 cases have been spiking domestically since the beginning of July due to the rapid spread of the delta variant, but the rising hospitalizations and deaths are almost always among the people who have not been vaccinated. 

Vaccination rates have also been increasing in recent days, after months of plateauing. The Biden administration has started to force the issue, instituting vaccine or stringent testing requirements for federal employees and encouraging private companies to do the same.

About 70 percent of eligible Americans have received at least one dose of coronavirus vaccine.

https://thehill.com/homenews/administration/568728-us-extending-travel-restrictions-with-mexico-canada

Cadila : India gives emergency approval for world's first COVID-19 DNA vaccine

 India's drug regulator has granted emergency use approval for Zydus Cadila's COVID-19 vaccine, the world's first DNA shot against the coronavirus, in adults and children aged 12 years and above.

The approval gives a boost to India's vaccination programme, which aims to inoculate all eligible adults by December, and will provide the first shot for those under 18, as the country still struggles to contain the virus spread in some states.

The vaccine, ZyCoV-D, uses a section of genetic material from the virus that gives instructions as either DNA or RNA to make the specific protein that the immune system recognises and responds to.

Unlike most COVID-19 vaccines, which need two doses or even a single dose, ZyCoV-D is administered in three doses.

The generic drugmaker, listed as Cadila Healthcare Ltd, aims to make 100 million to 120 million doses of ZyCoV-D annually and has already begun stockpiling the vaccine.

Zydus Cadila's vaccine, developed in partnership with the Department of Biotechnology, is the second home-grown shot to get emergency authorization in India after Bharat Biotech's Covaxin.

The drugmaker said in July its COVID-19 vaccine was effective against the new coronavirus mutants, especially the Delta variant, and that the shot is administered using a needle-free applicator as opposed to traditional syringes.

The regulatory nod makes ZyCoV-D the sixth vaccine authorized for use in the country where only about 9.18% of the entire population has been fully vaccinated so far, according to Johns Hopkins data https://coronavirus.jhu.edu/region/india.

Zydus Cadila had also submitted data evaluating a two-dose regimen for the shot in July and plans to seek regulatory approval for the same.

The firm had applied for the authorization of ZyCoV-D on July 1, based on an efficacy rate of 66.6% in a late-stage trial of over 28,000 volunteers nationwide.

https://www.marketscreener.com/quote/stock/CADILA-HEALTHCARE-LIMITED-34067618/news/Cadila-Healthcare-India-gives-emergency-approval-for-world-s-first-COVID-19-DNA-vaccine-36212734/

Full approval for Pfizer Covid vaccine could come from FDA Monday

 The Food and Drug Administration is working to approve the Pfizer and BioNTech Covid-19 vaccine on Monday, The New York Times reported, citing sources.

The review process could move past that date, The Times said, as paperwork and negotiations with the company continue.

The move would make it the first vaccine to go from emergency use authorization to full FDA approval.

The FDA declined to comment on the Times report to CNBC.

Pfizer and BioNTech initially began the process of applying for their biologics license for the two-dose vaccine in May after receiving emergency use authorization from the FDA last December. The FDA sets a six-month target for approving high-priority drugs and a 10-month target for all other standard drugs.

The companies announced Monday that they began the approval process for their third booster dose after submitting clinical trial data to the FDA.

Top health officials from agencies including the CDC and FDA said in a statement Wednesday that the effectiveness of mRNA vaccines declines over time, especially for those with compromised immune systems or for anyone inoculated early in the vaccine rollout.

https://www.cnbc.com/2021/08/20/full-approval-for-pfizer-covid-vaccine-could-come-from-fda-monday-report-says.html