'Second wave' of COVID-19 shots could come with advantages

 Typically in drug and vaccine development, first-to-market products command a big advantage that can deter follow-up products. Not so with COVID-19 vaccines, experts said Tuesday. There’s still plenty of need for new entrants.

Even as the first COVID-19 vaccines from Pfizer-BioNTech, Moderna and AstraZeneca are deploying in the U.S. and other countries, more programs will need to succeed to vaccinate the entire world, Swati Gupta, Ph.D., vice president and head of emerging infectious diseases and scientific strategy at IAVI, said on a Fierce JPM Week panel. IAVI, a nonprofit research group, is partnered with Merck & Co. on an early-stage candidate based on the same technology used in Merck's Ebola vaccine.

The ongoing COVID-19 vaccine launches will hopefully “help us to end the acute phase of the pandemic,” Gupta said, but, because COVID-19 is likely to become endemic, “we also need to plan for longer-term management of the disease.”

How many vaccines will be needed? Given the more than 8 billion people on the planet, Gupta sees the need for 16 billion vaccine doses under a two-dose regimen. The world will “definitely need” more vaccines to defeat the pandemic, she said. Plus, it isn't known how long protection will last from various vaccines.

Aside from the sheer demand, follow-up vaccines could offer advantages over the first programs. Follow-up vaccines could come in a single dose. They might be easier to scale up for mass manufacturing. They could be more stable at refrigerated temperatures, she said.

The first mRNA vaccines from Pfizer-BioNTech and Moderna posted efficacy figures above 90%, but Thomas Lingelbach, CEO of vaccine maker Valneva, said the industry and regulators should “agree that everything above 70% or 80% is a good efficacy for a vaccine.”

Head-to-head comparisons between vaccines are “not really relevant,” Lingelbach said. As programs from Valneva and numerous other biotechs move ahead, Lingelbach said he’s “absolutely sure” there will be demand for follow-up vaccines. Valneva's inactivated coronavirus vaccine candidate, VLA2001, is in a phase 1/2 trial.

Overall, the high level of efficacy seen for Pfizer and Moderna’s vaccines “doesn’t change much” for the companies pursuing their own programs, Nathalie Landry, executive vice president of scientific and medical affairs at Medicago, said during the discussion. Medicago and its partner GlaxoSmithKline recently entered a phase 2/3 trial for a plant-derived candidate.

"The rule is still to demonstrate significant efficacy, good immune response and monitor that efficacy for a long period of time,” she said.

Still, the process of testing a vaccine candidate poses challenges when there's already an authorized program. There will be a “moment in time” when a placebo-controlled trial isn’t feasible, Lingelbach said, either for “ethical reasons” or “practical reasons.” Right now, it’s “very difficult” to say when that moment will be.

When vaccines become widely available, many people would argue it’s not ethical to test against placebo because there’s “already something out there that works," Gupta said.

Researchers could run a noninferiority trial, Lingelbach and Gupta said, which would test whether the candidate works as well as existing vaccines. At the end of the day, regulators and researchers are going to need to work together to find the best approach given the circumstances, Gupta said.

Aside from the Pfizer, Moderna and AstraZeneca programs, which have scored authorizations in various countries, Novavax and Johnson & Johnson are in phase 3 testing for their shots. Dozens of other programs are in various stages of testing.

https://www.fiercepharma.com/pharma/as-first-covid-19-vaccines-roll-out-a-second-wave-candidates-waiting-wings

Merck nears Pfizer in next-gen pneumococcal vax race as FDA fast-tracks 15-strain vax

 Pfizer’s $5.8 billion-a-year Prevnar 13 is one of the company’s top blockbusters and the undisputed leader in the market for pneumococcal vaccines. But when it comes to the next generation of pneumonia protection, Pfizer is facing a tough rival in Merck.

Merck is neck-and-neck with Pfizer in the race to get a next-gen pneumococcal vaccine on the market thanks to the FDA, which accepted the company’s application for its experimental shot, V114—and granted it priority review. The agency is set to rule on Merck's product by July 18.

The FDA granted V114 its speedy review just one month after doing the same for Pfizer’s next-gen vaccine candidate, 20vPnC. The agency expects to make a decision on that vaccine in June. Pfizer’s vaccine covers 20 strains of the pneumococcal bacterium, while Merck’s guards against 15.

The FDA prioritized review of Merck’s vaccine based on phase 2 and 3 studies in which adults received the shot in a variety of settings, including co-administration with the flu vaccine, the company said in a statement.

But Merck has also put V114 in head-to-head matchups against Prevnar 13 and turned out some impressive results. In one study of healthy adults age 50 and older, Merck’s experimental vaccine was equally effective as Prevnar 13 in shielding against the 13 serotypes that Pfizer’s shot covers.

Merck’s next-gen shot outperformed Prevnar in protecting against two additional serotypes that the company estimates cause 13% of invasive pneumonia cases in Americans over age 65.

During a presentation at the annual J.P. Morgan healthcare conference Monday, Merck CEO Ken Frazier called V114 a key driver in the company’s late-stage portfolio and part of a “suite of vaccines” to protect against pneumonia that are approaching the market. Merck expects to advance clinical trials for two additional pneumococcal vaccines, V116 and V117, this year, he said.

Merck’s V117 is in development for children and could become a key player in the company’s effort to compete with Pfizer in the pediatric market for pneumococcal vaccines. Merck’s Pneumovax is only approved for adults, while Pfizer’s Prevnar 13 is cleared for both adults and children.

Merck built V114 with a similar conjugate technology to that used for Prevnar 13, and the company is testing it in children. It expects to finish the pediatric trials in November, which could actually put it ahead of Pfizer’s next-gen vaccine in that market. Pfizer has said it will apply for pediatric approval for its 20-valent vaccine in late 2022.

https://www.fiercepharma.com/pharma/merck-pulls-close-to-pfizer-next-gen-pneumococcal-vaccine-race-as-fda-fast-tracks-15-strain

Americans increasingly paying medical bills through crowdfunding

 Twenty-seven percent of the over 1 million fundraisers on GoFundMe from May 2010 to December 2018 were held to help patients cover medical costs, according to research published Jan. 11 in the Journal of the American Medical Association.

The 281 ,881 medical bill-focused fundraising campaigns posted on the website from May 2010 to December 2018 sought about $10 .3 billion. As of April 2019, the campaigns had raised about $3.7 billion.

Forty-two medical bill-focused fundraisers were housed on the website in 2010, with that number increasing to 119,373 in 2018. The most common type of medical bill-focused campaigns were for patients with cancer (35 percent), trauma and injuries (19 percent) and neurological conditions (17 percent).

https://www.beckershospitalreview.com/finance/americans-increasingly-paying-medical-bills-through-crowdfunding-study-shows.html

Pfizer has enough COVID-19 vaccine for Trump's expanded plan: CEO

 Pfizer CEO Albert Bourla, PhD, told CNBC Jan. 12 that the drugmaker has enough doses of COVID-19 vaccines to support the Trump administration's decision to expand vaccine eligibility to everyone age 65 and older. 

A concern about increasing eligibility had been inadequate vaccine supply, but Dr. Bourla said inadequate supply isn't what is holding back vaccine administration in the U.S., CNBC reported. 

"We have much more than they can use right now, so I think the main bottleneck right now is to make sure we ramp up our prioritization so we can administer more vaccines," he said. 

He told CNBC that Pfizer's partner, BioNTech, has hiked its vaccine manufacturing target for 2021 up to 2 billion doses, from its previous estimate of 1.3 billion. 

https://www.beckershospitalreview.com/pharmacy/pfizer-has-enough-covid-19-vaccine-for-trump-s-expanded-plan-ceo-says.html

CMS issues final rule for Medicare coverage of breakthrough technologies

 CMS issued a final rule Jan. 12 that will speed up the FDA approval process for Medicare coverage of new and innovative medical devices and technologies.

Five things to know:

1. The Medicare Coverage of Innovative Technology final rule will reduce the lag time between the FDA's approval of innovative medical tech products and Medicare establishing coverage for the devices.

2. When the proposed rule was published in August 2020, CMS Administrator Seema Verma referred to the approval process as a "chicken and egg issue," adding that "Innovators had to prove their technologies were appropriate for seniors, but that was almost impossible since the technology was not yet covered by Medicare and thus not widely used enough to demonstrate their suitability for Medicare beneficiaries."

3. The final rule will create a new, accelerated Medicare coverage process for innovative products that the FDA calls "breakthrough," which the FDA approves on an expedited basis and may include devices using new technologies such as implants.

4. The final rule will also let Medicare provide national coverage simultaneously with FDA approval up to a four-year period. Once the four years is up, CMS will reevaluate the device based on clinical and real-world evidence of health outcome improvements among Medicare beneficiaries.

5. After the final rule goes into effect, manufacturers can request that Medicare cover eligible breakthrough devices FDA has approved, including those that received FDA marketing authorization approval within two years before the final rules' effective date.

https://www.beckershospitalreview.com/digital-transformation/cms-issues-final-rule-for-medicare-coverage-of-breakthrough-technologies-5-things-to-know.html

AHA Rural Health Care Leadership Virtual Conference and Engagement Experience Feb 17-18

 The AHA Rural Health Care Leadership Virtual Conference and Engagement Experience - one of AHA's flagship events - will be held Feb. 17-18. In this blog, AHA Executive Vice President Michelle Hood previews the conference, designed to help rural health care leaders and trustees propel the transformation to a more integrated and sustainable rural health system. Read more.

AHA Rural Health Care Leadership Conference

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https://www.marketscreener.com/news/latest/Preview-AHA-Rural-Health-Care-Leadership-Virtual-Conference-and-Engagement-Experience-offers-innova--32181935/

End Covid Now

 More than 22 million doses of Covid-19 vaccine have been distributed in the United States so far, yet only 6.7 million Americans have received the first of the required two doses. Many observers, including President-elect Joe Biden, have argued that the shortfall calls for additional spending and rapid government intervention to speed things up. But experience shows that governments do a poor job at disseminating vaccines. The solution is not more government, but less.

The federal government did an admirable job facilitating the development and manufacture of new Covid-19 vaccines in record time. This achievement included commitments to purchase and distribute, free of charge, 200 million doses from Pfizer and Moderna, as well as doses from other companies when their vaccines are authorized by the FDA. Two hundred million doses, enough to vaccinate 100 million people, should be available by March 31.

Unfortunately, state governments have done a poor job of getting the vaccine into peoples’ arms. Governors have complained that they are not receiving as many doses as they were promised, but they have routinely failed to utilize the doses they have received. A combination of restrictive rules over who can be vaccinated and administrative incompetence means that many doses are sitting unused in the freezer.

New York is typical. It has administered less than half the vaccines it has received. While Governor Andrew Cuomo has blamed local leaders, county executives complain that state officials have bypassed long established county-level vaccination plans. The state’s public-health law requires counties to develop vaccination plans each year, including training and practice sessions. But New York authorities ignored county plans, preferring to micromanage vaccinations at the state level.

Cuomo complicated matters by threatening to fine hospitals that don’t use vaccines within a week of receipt; he would also fine them if they vaccinate anyone out of the strict priority group order set down by the state. This stricture puts providers in a double bind. Hospitals may have trouble finding enough people in the eligible group willing to be vaccinated within the arbitrary one-week limit—a task made more difficult by partisan criticisms of the vaccine development effort that undermined public willingness to be vaccinated—but will be punished if they try to avoid wasting the vaccine by administering doses out of order.

President-elect Biden’s plan to set up federally run vaccination sites and mobile vaccination units is unlikely to improve vaccine utilization in the near term. Outside of the Veterans Administration, the Indian Health Service, and military hospitals—none noted for efficiency—the federal government does not normally provide direct health services. Federal vaccination sites and mobile units don’t exist, and setting them up will not occur overnight.

In the initial weeks after approval of the Pfizer and Moderna vaccines, their limited supply had to be rationed. The federal government set up the Pharmacy Partnership for Long-Term Care Program to provide on-site vaccination of residents and staff of long-term care facilities. These residents are especially vulnerable—they constitute less than 1 percent of the population but 40 percent of Covid-19 deaths—and hard to reach through conventional health-delivery systems. Moreover, the program assures cold chain management, especially important for handling Pfizer’s vaccine, which requires ultra-low temperature storage.

Now the time has come to cut out the state middlemen and loosen counterproductive regulations. Our private system of health-care delivery is superior to creating a public alternative. Every year, about half of the U.S. receives flu shots. The most common vaccination setting is physician offices (67.6 percent for children and 34.3 percent for adults). Another 32.2 percent of adults get vaccinated in pharmacies, local supermarkets, and grocery stores, with an additional 13.3 percent in other medical settings, and 14.9 percent in the workplace. There is no reason not to rely on these channels for Covid-19.

Private entities could be instructed that they are free to vaccinate anyone 45 years and older. People younger than 45 constitute 58 percent of the population but account for only 2 percent of Covid-19 deaths. Nearly everyone who died in this younger age group had other medical conditions—co-morbidities—that made them more vulnerable to Covid-19.

Vaccinating people 45 and older, with vaccines also made available to younger people with co-morbidities, would protect the most vulnerable part of the population. People who know or have reason to think that they had Covid-19 before, and whose immunity is confirmed by serologic testing that demonstrates antibodies, could be safely excluded.

As the vaccine supply expands with increased production and approval of additional vaccines from other makers, the age cutoff could be liberalized. But using the 200 million doses available in the first quarter of 2021 to vaccinate 100 million previously unexposed people 45 and older, should, when combined with those people already immune, get us most of the way toward reaching the estimated 70 percent immunity in the population needed to halt the pandemic.

The federal government has already reached agreements with pharmacies, grocery stores, and retail outlets nationwide, including giants like Costco, RiteAid, Walgreens, and Walmart to administer the vaccines. Physicians’ offices and employers should also be given access if they are capable of safely storing and administering the doses.

There is no need to reinvent the wheel. Let existing private mechanisms vaccinate Americans—and let’s end the Covid-19 pandemic.

Joel Zinberg, M.D., J.D., is a Senior Fellow at the Competitive Enterprise Institute and an Associate Clinical Professor of Surgery at the Icahn Mount Sinai School of Medicine. He was General Counsel and a Senior Economist at the White House Council of Economic Advisers from 2017 to 2019.

https://www.city-journal.org/end-covid-use-existing-vaccination-channels