Where allowed, Costco will waive masks for vaccinated customers, employees

 May 14, 2021

Dear Costco Member,

The U.S. Centers for Disease Control recently announced new guidance regarding COVID-19 and vaccines. Among other things, the CDC now says that fully vaccinated people no longer need to wear a mask in most settings, except where required by state and local laws. People are considered fully vaccinated 2 weeks after their second dose in a 2-dose series, or 2 weeks after a single-dose vaccine.

Based on this new guidance regarding vaccine effectiveness, beginning May 14, 2021, we are modifying our policy regarding face coverings in some U.S. Costco locations.

U.S. locations with no state or local mask requirements - revised policy
In Costco locations where the state or local jurisdiction does not have a mask mandate, we will allow members and guests who are fully vaccinated to enter Costco without a face mask or face shield. We will not require proof of vaccination, but we ask for members’ responsible and respectful cooperation with this revised policy. Face coverings will still be required in healthcare settings, including Pharmacy, Optical, Hearing Aid. Costco continues to recommend that all members and guests, especially those who are at higher risk, wear a mask or shield.

U.S. locations with state or local mask requirements - no policy change
In those Costco locations where the state or local jurisdiction does have a mask mandate, we will follow the state or local regulations and continue to require members and guests to wear a face mask or face shield. Children under the age of 2 are exempt. If a member or guest has a medical condition that prevents them from wearing a mask, they must wear a face shield.

As before, our goal is to continue to provide a safe shopping environment for our members and guests and to provide a safe work environment for our employees, while following public health advice and applicable laws.

Thank you for your continued cooperation and support.

Craig Jelinek
President and CEO
Costco Wholesale

https://www.costco.com/coronavirus.html

Humanigen eyes COVID-19 drug emergency filing by June

 Humanigen is prepping its COVID-19 drug lenzilumab for an emergency use authorization with the FDA before the month’s end.

This is according to its financials out Thursday after-hours in which the biotech said it had “recently held a meeting with FDA” to discuss the filing of an EUA for lenzilumab, specifically for hospitalized, hypoxic COVID-19 patients, “at the end of May.” It is also seeking a biologics license application for its drug in the same setting, though it may need more trials for a full approval.

The EUA application comes after top-line data from its recent phase 3 that showed lenzilumab in hospitalized COVID-19 patients met its primary endpoint.

Lenzilumab targets GM-CSF, a cytokine associated with negative outcomes in COVID-19 patients. By neutralizing the cytokine, drug developers including Humanigen and GlaxoSmithKline have predicted that they may be able to counter life-threatening complications that arise when the immune system reacts particularly strongly to the virus.

To test the hypothesis, investigators randomized 520 hospitalized COVID-19 patients to receive an infusion of lenzilumab or placebo on top of standard-of-care treatments such as dexamethasone or Gilead Sciences' Veklury.

After 28 days, the rate of ventilator-free survival was higher in the lenzilumab arm, causing the trial to hit its primary endpoint with a p-value of 0.0365. Humanigen changed the primary endpoint twice in the months after initiating the phase 3 trial in April 2020. 

In the treatment group, the Kaplan-Meier estimate for invasive mechanical ventilation and/or death was 15.6% compared to 22.1% in the placebo group. Humanigen also reported a “favorable trend” in the mortality rate, which was 9.6% in the lenzilumab arm and 13.9% in the placebo group.

Humanigen said it has also been talking with U.K. drug regulator the Medicines and Healthcare products Regulatory Agency and is plotting a rolling submission “before the end of the second quarter of 2021,” with similar plans for Europe.

“We are encouraged by the achievements Humanigen has made since the beginning of 2021 and by our progress on the emergency use authorization application,” said Cameron Durrant, M.D., CEO at Humanigen.

The biotech’s shares jumped 13% premarket Friday.

https://www.fiercebiotech.com/biotech/a-new-cmo-and-phase-3-data-to-hand-humanigen-eyes-covid-drug-emergency-filing-by-june

Otonomy eyes trial of hearing loss gene therapy with promising animal data

 Otonomy may have hit a snag with development of its lead ear disorder candidate Otividex, but the biotech is trumpeting an early win for a gene therapy designed to treat congenital hearing loss.

The drug, dubbed OTO-825, reduced hearing loss and repaired structural damage in the inner ear in two mouse models of genetically driven hearing deficiency, the company and its partner Applied Genetic Technologies Corporation reported at the American Society of Gene & Cell Therapy (ASGCT) annual meeting.

Based on the encouraging results, plus previous findings in monkeys, the companies are preparing an FDA application to start a first-in-human clinical trial, Alan Foster, Ph.D., Otonomy’s chief scientific officer, said in a statement.

OTO-825 uses an adeno-associated virus vector to carry an optimized genetic sequence for the GJB2 gene and a “promoter” to help control its expression in the target ear tissue. The gene encodes the CX26 protein in non-sensory cells of the inner ear to form a structure called gap junction. That helps maintain the function of sound-sensing hair cells in the cochlea and allows small molecules and ions to pass between cells. Therefore, these structures are critical for hearing.

Mutations in GJB2 account for about 30% of congenital hearing loss cases, or about 2,000 newborns in the U.S. per year, according to Otonomy.

Otonomy tested OTO-825 in two different mouse models with partially crippled GJB2 to mimic severe and intermediate hearing loss in humans. One injection administered into the inner ears of the mice improved the animals’ hearing function and the organ’s structure, according to the presentation.

In a normal mouse, there are three rows of outer hair cells and a single row of inner hair cells in the cochlea. These are damaged or missing in the genetically modified mice with dysfunctional GJB2. But OTO-825 restored those structures, a showing that was consistent with the hearing function improvement, the company said.

The researchers measured hearing function using an auditory brainstem response test. The minimum strength of the sound needed to trigger a response from the mice moved 25% to 75% closer to normal levels across hearing frequencies in treated animals, according to the company.

“This provides clear evidence that OTO-825 can restore meaningful hearing function in these two independent models of GJB2 deficiency,” the company said in an email to Fierce Biotech Research.

Other drugmakers are working on gene therapies for deafness. In November, Boston-based Decibel Therapeutics raised $82 million in series D financing to support its hearing disorder pipeline, including a Regeneron-partnered preclinical gene therapy dubbed DB-OTO for congenital hearing loss due to a problem in the otoferlin gene.

Also at the ASGCT event, another Boston biotech, Akouos, presented encouraging preclinical data for its lead candidate, a gene therapy dubbed AK-OTOF that also targets the otoferlin gene.

The OTO-825 news came on the heels of the phase 3 failure of Otonomy’s former lead candidate Otividex, a sustained-exposure formulation of the steroid dexamethasone to treat the inner ear condition Ménière's disease. Now the company is focusing on other drugs, including OTO-825. The company plans to share more about its IND-enabling activities later this year.

https://www.fiercebiotech.com/research/otonomy-eyes-clinical-trial-hearing-loss-gene-therapy-promising-mice-data

Feds stop sending Lilly COVID-19 cocktail to Illinois on concerns of P.1 variant

 Eli Lilly's COVID-19 antibody bamlanivimab already lost its solo FDA authorization as viral variants cropped up. Now, the company's two-antibody combo is running into trouble.

Federal officials are pausing shipments of the bamlanivimab-etesevimab cocktail to Illinois because of worries about one specific variant called P.1.

In a notice last week, authorities raised concerns about the combo's effectiveness against that variant, first identified in Brazil. The Office of the Assistant Secretary for Preparedness and Response said it is pausing distribution of the antibody cocktail, plus etesevimab alone, in the state

The Centers for Disease Control and Prevention saw that the P.1 variant is "circulating with increasing frequency" in Illinois, ASPR and the FDA said in a joint notice. In vitro studies have indicated that Lilly's combo medicine is "not active against the P.1 variant," they added.

On the flip side, Regeneron's Regen-Cov carries the same emergency use authorization and is "likely to retain activity against the P.1 variant," ASPR said, based on similar studies.

"The FDA recommends that healthcare providers in the State of Illinois use this alternative authorized monoclonal antibody therapy until further notice," the notice said.

Both antibody combos are authorized for newly diagnosed patients at a high risk of developing severe disease. The move doesn't affect other states, including those near Illinois, authorities said.

An Eli Lilly representative said the company recognizes the government's decision, and that recent data show its combo can neutralize the majority of variants in the U.S. 

"Therefore, we believe that sites outside Illinois with access to bamlanivimab administered with etesevimab together can continue to use the available therapy," she said.

The move comes after the feds halted distribution of Eli Lilly's solo antibody, bamlanivimab, first in three states and then nationwide, over variant concerns.

Responding to that news, a Lilly representative previously said it's “always been our view that additional antibodies from Lilly and others will need to be developed to address the evolution of the virus, including emerging variants that can differ by country or even by state." That belief drove the company’s push for a combo antibody and “continues to underpin our strategy moving forward.” 

With Lilly's antibody combo showing susceptibility to one troublesome variant, it remains to be seen how the company will proceed. 

Meanwhile, COVID-19 vaccines are rolling out at an impressive clip in the United States. More than 264 million doses have been administered, and nearly 60% of adults have had at least one dose. Pfizer's vaccine just scored an FDA emergency authorization in children, helping to widen the eligible population for shots, as well.

Even as vaccines reach more and more Americans, Regeneron's CEO recently said he expects an extended need for monoclonal antibodies, both for people who don't get vaccines, and for people who need more protection. 

Eli Lilly reported $810 million in global COVID-19 antibody sales during the first quarter, while Regeneron reported $439 million.

https://www.fiercepharma.com/pharma/feds-stop-sending-lilly-s-covid-19-cocktail-to-illinois-concerns-p-1-variant

Merck, Glaxo, Pfizer vaccines get lift as CDC lifts 2-week restriction on pandemic shots

 As revenues for several Big Pharma players slumped to start the year, execs blamed part of the problem on the accelerating COVID-19 vaccine rollout. The CDC had recommended people don't get another shot within two weeks of their COVID-19 vaccine, hitting sales for key products.

Now, the CDC is doing away with that suggestion entirely in an effort to boost routine immunizations among teens. The move could spell financial rewards for leading vaccine companies such as Merck, GlaxoSmithKline and Pfizer.

During the CDC’s Advisory Committee on Immunization Practices (ACIP) meeting on Wednesday, experts endorsed the COVID-19 shot from Pfizer and BioNTech in adolescents aged 12 to 15 and additionally tossed out the agency's two-week restriction on administering other vaccines.

Under the previous guidance, coadministration was only allowed in emergency situations, such as a tetanus vaccine for after wound management, or to vaccinate residents of long-term care facilities to avoid COVID-19 vaccination delays. Now, COVID-19 vaccines may be administered with other shots during the same visit to a doctor.

Given the “substantial” safety information surrounding all pandemic shots under emergency authorization so far, as well as previous experience that shows immunogenicity and adverse event profiles are similar when shots are administered together, the CDC decided coadministration “may facilitate catch up vaccination.”

While intended to recover lagging immunization schedules, the move will likely create a windfall for pharma companies that blamed the COVID-19 vaccine rollout for disappointing sales for their other vaccines during the first part of the year. Many expected sales to rebound at some point in the second half of 2021 once people finish their pandemic shot cycle.

During the first quarter, sales of GlaxoSmithKline’s blockbuster shingles vaccine Shingrix slid nearly 50% compared with the same quarter last year, according to the company’s earnings presented in April. The decision to prioritize pandemic vaccination “led to significant disruption in Shingrix prescriptions,” Luke Miels, GSK’s president of pharmaceutical, told analysts on a conference call. 

Meanwhile, sales of Merck’s HPV vaccine Gardasil fell 16% to $917 million during the first quarter, while revenues for its polysaccharide pneumococcal vaccine Pneumovax 23 dropped 33% to $171 million. Merck execs also cited the two-week buffer for the declines. 

Even Pfizer has had to face headwinds against the vaccine it created. While its COVID-19 shot skyrockets, revenues for the drugmaker's pneumococcal vaccine Prevnar 13, which has long been the world's bestselling vaccine, fell 11% to $1.28 billion during the first three months of the year. 

Since the most widely deployed COVID-19 vaccines in the U.S. from Pfizer and Moderna require two doses spread weeks apart, drugmakers had warned that immunizations for other diseases could be delayed by several months under the CDC's prior recommendation.

https://www.fiercepharma.com/pharma/cdc-throws-out-covid-19-vaccine-coadministation-rule-to-boost-routine-immunizations-but

Roche CEO Schwan joins chorus of pharma execs blasting COVID patent waiver

 Another COVID-19 heavyweight is shunning a controversial measure that would waive intellectual property rights for pandemic drugs and vaccines. But while some executives have simply shrugged off the idea, Roche CEO Severin Schwan says it could lead to a “catastrophe.” 

Waiving patent rights would be “counterproductive” and wouldn’t translate to fixed supply shortages in the near term, Schwan told The Financial Times.

In fact, the waiver would squash innovation incentives and result in a “catastrophe” similar to East Germany’s nationalization of the drug industry, Schwan told the newspaper. Supporters of the measure may be looking to score “brownie points” with some institutions in the short term, but the waiver would have long-term consequences, Schwan added.

“This will be harmful for my children and grandchildren when I’m not CEO any more,” Schwan told the FT. 

In a surprise move earlier this month, the Biden administration came out in favor of a proposal presented before the World Trade Organization (WTO) that would temporarily suspend patent rights for COVID-19 products. 

The pharma industry, lobbying groups and some nations have fiercely opposed the IP waiver. While intended to boost supplies of drugs and vaccines for developing nations, critics have said ridding patent protections wouldn’t fix access problems. 

The CEOs for leading COVID-19 vaccine players Pfizer, Moderna, BioNTech have also come out in opposition to the proposal.

Pfizer CEO Albert Bourla wrote last week that the scarcity of raw materials is limiting vaccine production and that waiving patent protections would only exacerbate the problem.

“It will unleash a scramble for the critical inputs we require,” Bourla wrote.

For his part, Moderna chief Stephane Bancel said he didn’t lose a minute of sleep when the U.S. endorsed sharing intellectual property. Similarly to Bourla’s point, Moderna has been racing to scale its mRNA manufacturing capacity, which largely didn’t exist prior to the pandemic. 

“You cannot go hire people who know how to make mRNA," Bancel said during a call with analysts last week. "Those people don’t exist."

While Roche hasn’t entered the COVID-19 vaccine space, it has developed a number of COVID-19 diagnostic tests over the course of the pandemic, and it’s tried to repurpose its rheumatoid arthritis medicine Actemra for hospitalized patients. The company is also collaborating with Regeneron to ramp up supply of its combo antibody treatment. Although discussions are underway, the original IP wavier proposal set forth by India and South Africa last year included COVID-19 diagnostics and medicines beyond vaccines. 

The U.S.-backed  IP waiver has gained some support. Groups such as Oxfam and Public Citizen have lauded the Biden administration's move and thanked the administration for challenging the pharma industry's position.

https://www.fiercepharma.com/pharma/roche-ceo-schwan-joins-pharma-executives-blasting-u-s-backed-patent-waiver-for-covid-19

Zero Johnson & Johnson COVID-19 vaccine doses set to ship next week

 Johnson & Johnson’s COVID-19 vaccine ran into a big setback in late March when U.S. officials paused the rollout to investigate rare blood clots. While that issue has been resolved with a new warning about the rare risk, the company’s shot is running into another type of pause—a lack of supply. 

The federal government doesn’t plan to ship any J&J COVID-19 vaccine doses to states next week as production holdups linger at J&J’s manufacturing partner Emergent BioSciences, CDC weekly distribution data show.

Weeks ago, workers at Emergent’s plant in Baltimore ruined up to 15 million doses of the J&J shot, triggering a controversy for the contract manufacturer that ended up with J&J in charge of the key plant.  Meanwhile, the feds and Emergent have halted production there as the contract manufacturer works through a laundry list of issues highlighted by FDA investigators during a recent site visit. 

On top of that, lawmakers are now investigating Emergent's production contracts and errors. The company's top brass are set to testify in front of Congress next week. 

A J&J spokesman said the company continues to "partner closely with the U.S. government, including the Food and Drug Administration (FDA), along with other global health authorities, regarding the Emergent Bayview facility."

Federal officials sent just 603,600 doses of the J&J shot to states and territories this week. Pfizer and Moderna doses are shipping out at about 10 million and 8 million per week, respectively.

Despite the production woes, J&J last month said it was still confident it could deliver 100 million doses of the vaccine to the U.S. by the end of May. So far, CDC data show that about 20 million doses have been delivered to states, and about 9.3 million doses have been administered. 

https://www.fiercepharma.com/pharma/zero-johnson-johnson-covid-19-vaccine-doses-set-to-ship-next-week-as-production-holdup