Our Take: Leading drugmakers persist in the battle against COVID-19
The last week brought a spate of news about vaccines and treatments for COVID-19, offering more hope as the not-so-novel-anymore coronavirus continues to wreak havoc around the world.
- On Friday, topline results from an international Phase III trial of Johnson & Johnson (J&J) subsidiary Janssen’s vaccine showed that it was 66% effective overall in preventing moderate to severe COVID-19. The vaccine was 72% effective in the U.S. but just 66% effective in Latin America and 57% effective in South Africa, where newer, more contagious and potentially more lethal variants of the coronavirus have emerged. Of note, J&J said the vaccine was 85% effective in preventing severe disease regardless of the virus variant. Although the efficacy appears to be lower than that demonstrated by Pfizer and BioNTech’s vaccine and Moderna’s, Janssen’s vaccine only requires one dose rather than two, and it does not require the ultra-cold storage that the others do — important considerations as health officials aim to head off the newer variants by getting as much of the U.S. population vaccinated as quickly as possible. The FDA has said that 50% efficacy is sufficient for a vaccine to be authorized for emergency use. If J&J files for EUA this week, the vaccine could be available to the public by late February or early March.
- Also on Friday, AstraZeneca announced that the European Medicines Agency granted a conditional marketing authorization for the company’s vaccine, which was co-invented by the University of Oxford and a spin-out company called Vaccitech. The Washington Post reported that Germany is recommending use of the vaccine only in adults younger than 65 because of a lack of efficacy data for older adults. U.S. health officials are waiting for additional trial data. This vaccine requires two doses administered four to 12 weeks apart but can be stored at normal refrigeration temperatures for at least six months.
- Moderna will evaluate a booster shot that might enhance the efficacy of its vaccine against the newer South African variant of the coronavirus, as will Pfizer and BioNTech. The companies said their current vaccines should be effective in preventing COVID-19 even with exposure to emerging variants, but Moderna said a booster engineered specifically against the South African variant might offer greater protection against that particular strain. Albert Bourla, Pfizer’s CEO, said the company should be able to test the efficacy of its vaccine each time a new variant of the coronavirus arises, and if the efficacy is lower, “we will very, very quickly be able to produce a booster dose that will be a small variation to the current vaccine,” Bloomberg reported. Bourla said eventually a one-shot annual COVID vaccine could be developed to protect against whatever strain is expected to circulate, much like the flu.
- Sanofi, who in December announced a delay in its shared vaccine program with GSK because of the low immune response observed in older adults in early-stage clinical testing, said Wednesday that it would give BioNTech access to its production infrastructure to increase vaccine accessibility. Specifically, Sanofi said it would “perform late-stage manufacturing to supply over 125 million doses of COVID-19 vaccine for the European Union.” Sanofi and GSK plan to start a new Phase II study this month to evaluate their recombinant protein-based vaccine candidate with an improved antigen formulation. Sanofi is also developing a messenger RNA vaccine, similar to those developed by Moderna and Pfizer/BioNTech, in partnership with Translate Bio.
- Meanwhile, Merck announced last Monday that it was discontinuing development of its two COVID-19 vaccine candidates but would proceed with the development of two investigational treatments for the disease. The decision to halt development of the vaccines was based on results from Phase I clinical studies that showed the immune responses produced by the vaccines were inferior to immune responses reported for other vaccines or those generated by natural infection. The two investigational treatments that Merck will continue to develop are MK-7110, a potential first-in-class recombinant fusion protein, and molnupiravir, an oral antiviral the company is co-developing with Ridgeback Biotherapeutics.
While we await the availability of more vaccines and vaccine doses, monoclonal antibody treatments might prove helpful in preventing COVID-19 hospitalizations and deaths.
- In a news release, Eli Lilly said its bamlanivimab significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff members in long-term care facilities in the Phase III BLAZE-2 clinical trial. Specifically, nursing home residents who were randomized to receive bamlanivimab had up to an 80% lower risk of contracting the disease as compared with those who received placebo. In the Phase III BLAZE-1 trial, bamlanivimab was evaluated in combination with etesevimab, another monoclonal antibody developed by Lilly, in 1,035 high-risk patients who had recently contracted COVID-19. The results showed a 70% decrease in the risk of hospitalization or death for those who received the combined regimen compared with those who received placebo, and there were no deaths among the group that received the combination therapy (vs. 10 in the placebo group).
- Lilly just announced a collaboration with GSK and Vir Biotechnology to test bamlanivimab and VIR-7831, an investigational dual-action monoclonal antibody, administered at the same time but as two separate infusions in low-risk patients with mild to moderate COVID-19 in the expanded BLAZE-4 trial.
- Last Tuesday, Regeneron reported interim data from an ongoing Phase III trial of its REGEN-COV antibody cocktail, which consists of casirivimab and imdevimab. The trial is assessing the cocktail as a “passive vaccine” for the prevention of COVID-19 in people who are at high risk of infection because they live with someone who has contracted COVID-19. The interim results demonstrated 100% prevention of symptomatic infection with REGEN-COV and approximately 50% lower overall rates of infection (i.e., symptomatic and asymptomatic combined). Dr. George Yancopoulos, Regeneron’s president and chief scientific officer, said the data suggest that REGEN-COV administered as a passive vaccine “may both reduce transmission of the virus as well as reduce viral and disease burden in those who still get infected.”
Last, but far from least, Fierce Biotech reported on a cancer treatment called plitidepsin, derived from sea squirts and developed by Spanish drugmaker PharmaMar, that could be nearly 30 times more potent than Gilead Sciences’ Veklury (remdesivir) against the SARS-CoV-2 virus. Results of a preclinical study of plitidepsin conducted by researchers at the Icahn School of Medicine at Mount Sinai and the University of California, San Francisco were published online Jan. 25 in the journal Science. Additional findings indicate that plitidepsin had similar antiviral activity against both the early SARS-CoV-2 coronavirus strain and the newer U.K. variant.
President Joe Biden is taking steps to shore up the Affordable Care Act (ACA), starting with reopening the Health Insurance Marketplace for a special enrollment period from Feb. 15 to May 15 so that people who have lost their employer-provided health insurance because of the pandemic can enroll for coverage. He has also directed federal agencies to review rules and policies that restrict access to care, including limitations on Medicaid coverage, and to consider additional actions to strengthen and protect access to care. A newly released Kaiser Family Foundation analysis found that during fiscal years 2018-2020, the Department of Health and Human Services accumulated more than $1 billion in unused federal user fee revenue (money that insurers pay to use HealthCare.gov). The new administration will invest part of those funds in outreach efforts and other measures to help people sign up.
OptumCare expects to increase its employed and affiliated physicians by at least 10,000 in 2021, UnitedHealth Group’s CEO said during an earnings call. OptumCare is the business unit of UnitedHealth Group that provides patient care. It started the year with more than 50,000 physicians and 1,400 clinics.
The number of ACOs participating in the Medicare Shared Savings Program (MSSP) this year dropped from a high of 561 in 2018 to 477, serving 10.7 million beneficiaries. Nearly 3 in 5 of this year’s participating ACOs are in the one-sided risk track, and the remainder are in two-sided risk. The National Association of ACOs (NAACOS) attributed the drop — the third in as many years — to several policies that CMS has implemented, including the “Pathways to Success” program in 2018, which reduced both the time ACOs have before taking on financial risk and the share of savings most of them are eligible to keep, the association said in a news release. Additionally, NAACOS pointed out that last year CMS eliminated the option for new ACOs to apply to join the MSSP in 2021, citing the pandemic. Although there have been fewer ACOs in recent years, the program has continued to produce greater savings every year through 2019 (the latest year for which data is available).
HCA Healthcare formed a consortium with the Agency for Health Research and Quality (AHRQ) and several research institutions, including Johns Hopkins University, Duke University, Columbia University, and Harvard Pilgrim Health Care Institute, among others. Organizations in the consortium will use data from HCA Healthcare’s COVID-19 patient registry to “improve the safety and quality of care for people with COVID-19 and serve as a model for the development of a national learning health system,” Dr. David Meyers, acting director of AHRQ, said in a press statement about the consortium.
In separate news, HCA Healthcare entered into a joint venture business with A Plus International to increase access to personal protective equipment. The partnership will focus on producing Level 1 and Level 3 surgical and procedure masks at a manufacturing center in Asheville, N.C., HCA Healthcare said.
Henry Ford Health System and Michigan State University officially expanded their partnership last week by signing a 30-year agreement to “achieve critical health care and educational goals, while addressing social issues that impact health outcomes,” the organizations said in a press release. The partnership will emphasize diversity, equity, and inclusion. One of its goals is to attain a National Cancer Institute designation within five to seven years. Additionally, the university will develop a regional campus “within the existing Henry Ford Detroit Campus footprint,” and the two institutions will create a new Health Sciences Center. They are also planning a new urban-based public health program that will focus on education and research.
Walgreens Boots Alliance will have a new CEO on March 15, the company announced last week. Rosalind Brewer will succeed Stefano Pessina, who will become executive chairman of the board. Brewer most recently was chief operating officer, group president, and a board member at Starbucks and previously served as president and CEO of Sam’s Club.
Brigham and Women’s Hospital will have a new interim president, effective March 1, Mass General Brigham said in a press statement. Dr. Sunil “Sunny” Eappen, who is currently senior vice president of medical affairs and chief medical officer at the hospital, will take over for Dr. Betsy Nabel, who said earlier this month that she is leaving to work in the biotech field.