(480) 923-0802

Our Take: Pfizer’s COVID-19 vaccine demonstrates more than 90% efficacy, early data show; Lilly’s antibody drug is first to receive EUA

Nov 16, 2020

Last Monday, Pfizer and BioNTech released results from the first interim efficacy analysis of a Phase III study of their mRNA-based vaccine candidate, BNT162b2. The data indicated that the investigational vaccine was more than 90% effective in preventing COVID-19 in people with no evidence of previous SARS-CoV-2 infection.

The reported efficacy rate was observed at seven days after the second dose had been administered, indicating “that protection is achieved 28 days after the initiation of the vaccination,” the companies said.

A total of 43,538 participants had been enrolled in the study at the time these results were reported; of those, 38,955 had received a second dose of the vaccine or placebo. The interim analysis evaluated 94 confirmed cases of COVID-19.

The companies intend to continue enrollment in the trial “through the final analysis, when a total of 164 confirmed COVID-19 cases have accrued.” Collecting additional data will allow them to evaluate the vaccine’s performance against other endpoints.

Pfizer and BioNTech said they plan to request emergency use authorization after the trial’s safety milestone is achieved, which they anticipate will occur this week or shortly thereafter. So far, the trial’s independent Data Monitoring Committee has not reported any serious safety concerns.

Reuters reported that Alex Azar, secretary of the Department of Health and Human Services (HHS), stated on Monday that it would take the FDA several weeks to review the study data, before potentially approving the vaccine.

Meanwhile, the FDA granted Novavax’s vaccine candidate fast track designation, the Gaithersburg, Md.-based company said last Monday in a press release. Novavax anticipates starting a pivotal Phase III trial of the investigational vaccine in the U.S. and Mexico before the end of this month. A late-stage trial is already underway in the U.K.; Novavax said it expects that trial to be fully enrolled by month-end.

Also last Monday, the FDA issued an emergency use authorization (EUA) for Eli Lilly’s bamlanivimab for the treatment of mild to moderate COVID-19 in patients aged 12 years or older who are at high risk for progressing to severe COVID-19 or hospitalization. The EUA does not extend to patients who are hospitalized with COVID-19 or those who require oxygen therapy because of COVID-19.

The drug, which Lilly is co-developing with AbCellera, a biotechnology firm based in Vancouver, British Columbia, is administered via a single infusion over the course of an hour, followed by an hour of observation. Lilly advises that bamlanivimab be administered “as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.”

HHS said it would begin distributing the initial doses of bamlanivimab the federal government purchased to hospitals last week, noting that allocation would be based on both the number of new COVID-19 cases and the rates of hospitalization reported in the previous seven days. HHS said these doses would be available at no cost to patients, although facilities could charge for administering them.

CMS said there would be no cost sharing for Medicare beneficiaries who receive bamlanivimab and other monoclonal antibodies for COVID-19 during the public health emergency. According to Becker’s Hospital Review, CMS said hospitals can apply for reimbursement of infusion services for uninsured patients through the CARES Act Provider Relief Fund.

Outpatient facilities will receive bamlanivimab in the second phase of the government’s distribution. To avoid exposing patients who typically use outpatient infusion centers to receive treatments for cancer and immune disorders, separate sites will need to be established for patients with COVID-19 to receive bamlanivimab.

Our Take: Roughly nine months into the pandemic, with COVID-19 cases and hospitalizations surging at an alarming rate as we head into winter, people are weary and becoming desperate for any indication that an end could be in sight.

Knowing that there’s an FDA-authorized (though not yet approved) treatment for some who become sick seems like good news. So does the report of Pfizer’s vaccine efficacy.

These are glimmers of hope.

Nonetheless, there’s still so much we don’t yet know — about Lilly’s investigational monoclonal antibody and others like it, about Pfizer’s vaccine candidate, and even about the coronavirus itself.

In the Phase III Blaze-2 trial, Lilly is evaluating bamlanivimab to see if it can be used to prevent COVID-19. Promising results from that study, if they materialize, might help to dispel some concerns surrounding the vaccines that are being developed.

We understand that the results Pfizer reported are preliminary. Until we have access to a peer-reviewed, published article, we won’t know important details about the study that could shed light on whether it’s truly time to breathe a sigh of relief. And even then, we won’t know what kind of long-term effects the vaccine might have, say, on people with underlying conditions, or whether the vaccine could trigger an undesired autoimmune response in some people that can’t be reversed. To date, no mRNA drug or vaccine has been approved, but eventually there will be a first. Is this the one?

We won’t know until a vaccine is administered in real-world settings — where people could have different degrees of exposure than trial participants did, and might not engage in the same levels of mask wearing and social distancing as trial participants did — whether the vaccine will be as effective as it was in the study population. We won’t know what happens when asymptomatic people who have unknowingly been exposed to the coronavirus get vaccinated. We won’t know how the vaccine will affect various subpopulations, or how long it will protect.

Even though it feels like we’ve been dealing with COVID-19 for a really long time, the fact is we’re still in relatively early days. Kudos to all of the drug companies and scientists and government agencies around the globe that are working relentlessly to give us effective weapons again the virus. While we wait, we’ll take those glimmers of hope as they appear.

We can also take some comfort in knowing that even as work proceeds on the first round of potential treatments and vaccines, companies like Pfizer are already working on follow-on versions. The vaccine that Pfizer and BioNTech just reported on has to be stored at -94 degrees Fahrenheit — far colder than currently approved vaccines require. Those ultra-cold storage needs are creating a supply chain nightmare, but Business Insider reported that Pfizer is working on a second-generation powder formulation of the vaccine that might only require refrigeration.

Patience can be hard to come by, especially when the stakes are so high. But impatience can be as costly as inaction. Only with time will we have enough verifiable information to take the right steps.

What else you need to know
The Center for Medicare and Medicaid Innovation (CMMI) announced that 51 provider and accountable care organizations (ACOs) are participating in the implementation period of the new Direct Contracting model, which evolved from the Next Generation ACO model. The implementation period started on Oct. 1 and will run through March 31, 2021; the first performance year of the new alternative payment model starts on April 1, 2021. When CMMI announced the list of the 51 participating direct contracting entities, the center said these organizations serve beneficiaries in 39 states, Puerto Rico, and the District of Columbia. The application period for the second cohort of the Direct Contracting model will begin in the first quarter of 2021, and the performance year for that cohort will start in 2022. The Next Generation ACO model was set to end next month, after five years, but CMS extended it for another year because of the pandemic.

RWJBarnabas Health has formed a strategic council to assist with the restructuring process as the West Orange, N.J.-based health system works toward streamlining and optimizing its operations. CEO Barry Ostrowsky said the realignment would allow RWJBarnabas Health to “better serve New Jersey through a more concerted approach to population health management and a nimble platform that can quickly adapt to the pandemics and emergencies of the future.” In conjunction with the realignment, which also includes a renewed commitment to ending systemic racism, the health system announced the promotions of nine leaders last week.

In separate news, Elizabeth, N.J.-based Trinitas Regional Medical Center entered into a definitive agreement on Wednesday to become part of RWJBarnabas Health. The two organizations signed a letter of intent to explore their options in October of last year. State and federal regulatory authorities, as well as the Catholic Church, will need to approve the transaction before it can be finalized. RWJBarnabas said the process could take up to a year.

Vizient agreed to acquire Intalere, Intermountain Healthcare’s supply chain management business, for an undisclosed amount, the Irving, Texas-based health care services company announced earlier this month. If it receives regulatory approval, the transaction is expected to close in the first quarter of next year. Intermountain Healthcare already had a relationship with Vizient with regard to clinical and cost analytics and will now partner with Vizient for the health system’s supply chain services and solutions.

Providence Southern California joined Anthem Blue Cross’ Vivity Health Plan as a joint-venture partner, effective Nov. 1, the insurer said in a press release last Monday, marking Vivity’s first expansion since the integrated health network was launched in 2015. The agreement gives plan members access to Providence’s network of 746 primary care physicians, 2,800 specialists, and nine hospitals in Los Angeles and Orange counties, in addition to providers at Vivity’s seven founding health systems. Providence Southern California is part of the Renton, Wash.-based Providence health system.

CVS Health has chosen Daniel Finke to succeed Karen Lynch as president of the company’s Aetna health care benefits segment. When he assumes that role on Feb. 1, 2021, he will also become the executive vice president of CVS Health, the company announced last week. Lynch will take on the roles of president and CEO of CVS Health when Larry Merlo steps down, also on Feb. 1.  Finke has been with Aetna since 2014.


Contact Darwin Research Group and we will get right back to you.