Israel will start offering booster doses of the Pfizer-BioNTech coronavirus vaccine to its older citizens on Sunday, as health officials described new data showing a decline in the vaccine’s protection against severe disease over time.
A key unknown with the COVID-19 vaccine is how long protection will last. The emergence and spread of the Delta variant has intensified that uncertainty, with the variant showing the ability to partially evade the vaccine’s protection.
In response to the latest data, Israel is offering a third dose of the vaccine to its citizens who are 60 and older and at least five months removed from their second shot. Other countries are also considering if and when to roll out booster shots. Israel had already begun offering booster shots to some people with compromised immune systems, such as cancer patients.
There has been a trickle of studies in recent weeks suggesting protection from Pfizer’s vaccine starts to wane after several months. Israel’s decision was motivated by signals of decreased efficacy, The Wall Street Journal reported.
In particular, one Israeli scientist said the country had data showing the vaccine’s protection against severe illness among this 60-plus age group dropped from 97% in April to 81% in July. Those results have yet to be published in a peer-reviewed medical journal or posted on a preprint server.
Eric Topol, the director and founder of the Scripps Research Translational Institute, said on Twitter that if these results held up, they would be “the first sign of a significant dropdown of protection against hospitalizations and death for these vaccines.”
“I hope all of the data will be shared ASAP as the implications are big,” he tweeted.
Pfizer presented more results on Wednesday supporting the company’s stance that boosters would be needed six to 12 months after initial vaccination. Laboratory testing by Pfizer showed neutralizing antibodies, a key part of the immune response, significantly declined eight months after the second dose of its vaccine among all age groups.
The New York drugmaking giant also posted new, detailed results from its clinical trial that enrolled more than 40,000 volunteers. Longer-term follow-up showed the vaccine’s ability to prevent symptomatic COVID-19 cases, regardless of severity, dipped to 84% starting four months after the second dose, compared with 96% efficacy in the first two months.
The vaccine’s overall efficacy against severe disease in that study was 97%, with 30 cases occurring among people who received placebo shots and one case in a person who got the vaccine.
Pfizer’s findings have also yet to be published in a peer-reviewed medical journal, and the company said it would submit an application to US regulators in August to begin offering booster shots.
Janet Woodcock, acting commissioner of the FDA, published a letter Friday asking the federal government’s top inspector to investigate if FDA staff worked inappropriately with biotech company Biogen to approve the new drug.
“To the extent these concerns could undermine the public’s confidence in FDA’s decision, I believe that it is critical that the events at issue be reviewed by an independent body such as the Office of the Inspector General, in order to determine whether any interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures,” she wrote in the open letter.
The drug in question, Aduhelm, was approved by the agency last month and has caused an uproar in the scientific community. Three of the agency’s scientific advisors resigned following the decision.
The interactions pre-dated Woodcock, who became interim commissioner in January when the Biden Administration took office. She has been with the FDA for more than two decades and is one of the top contenders to permanently take the role, according to biotech analysts.
After the FDA approved Aduhelm, Biogen set its price at about $56,000 a year. Analysts estimate the US Medicare program could pay anywhere from $6 billion to $29 billion per year for Aduhelm, according to a recent New York Times analysis.
Biogen’s stock, which surged when the FDA approved Aduhelm, declined 3.2% to $357.09 a share on Friday afternoon.
Health insurer upstarts have made care delivery a core part of their business strategies.
Alignment, Bright, Clover, and Devoted all employ doctors and care for their directly.
They’re betting that doing so will help them lower costs and compete against industry giants.
This article is part of a series called “Future of Healthcare,” which explores how technology is driving innovation in the development of healthcare.
A new breed of health insurers is betting that providing care directly to patients will help them compete against industry giants and grow their footprints across the country.
These young insurers, like Alignment Healthcare, Bright Health, Clover Health, and Devoted Health have made employing doctors and delivering healthcare a core part of their strategies.
In some ways, they’re following a playbook etched out years before them by incumbents like UnitedHealth Group, which has worked for more than a decade to assemble a fleet of 56,000 doctors and counting by acquiring medical groups.
But while the big players have waded into providing care over time, the new-age insurers, which bank on using sophisticated technology to improve care and lower costs, have it in their DNA. Unlike the dominant insurers, they’ve largely steered clear of physical clinics, focusing instead on providing care virtually or in people’s homes.
It’s an approach that requires less capital, but still arms the upstarts with the tools needed give their members more ways to get care, and better control how much they spend on care.
“It gives us the reliability of making sure we can bend that cost curve everywhere we go without having to go into each market with a bunch of bricks and mortar,” Alignment CEO John Kao said. Alignment employs about 150 clinicians that care for the sickest plan members virtually and at their homes.
Alignment and Devoted are seeing patients online and at home
Alignment, the California-based Medicare Advantage insurer with 83,000 members, uses its technology to find the sickest, most expensive plan members who have chronic illnesses and frequent the hospital.
Alignment’s group of employed doctors, nurses, case managers, social workers, and behavioral health coaches care for 4,000 of these members, in partnership with their regular primary-care doctors. Being able to provide care itself is just more efficient, Kao said, and it helps save Alignment some money, which it can put back into better health benefits and attract more customers.
Waltham, Massachusetts-based Devoted, which had a little more than 20,000 Medicare Advantage members at the end of 2020, has its own medical group of employed doctors and other clinicians who provide virtual care to plan members at home.
Its services “wrap around and complement” the health care providers that Devoted partners with, so members get the best care at the right place and time, a spokesman for the company said in an email.
Clover is expanding its in-house home healthcare program
Meanwhile, insurer Clover Health also built up a home-healthcare program mostly run by employed healthcare providers.
The insurer, which had 66,300 Medicare Advantage members in March, uses claims data and medical records to look for people with multiple chronic illnesses, who are frail or home-bound, or visit the emergency department often. Its technology will then tell an eligible patient’s primary-care doctor that they might benefit from home visits, which are conducted by Clover’s internal care teams, Dr. Kumar Dharmarajan, head of Clover Home Care, told Insider.
Dharmarajan said the program increases access to care for older adults who don’t leave the house. It also allows Clover to get a picture of non-medical factors that could lead to worse health, like disorganized medications or fall hazards like electrical cords on the floor. An office visit wouldn’t reveal that kind of information.
In New Jersey alone, Clover expects to have between 3,000 and 3,500 Medicare Advantage members in its home care program by the end of this year, compared with just 200 patients in 2017, Dharmarajan said. It’s set to expand further as Clover starts offering home care to traditional Medicare enrollees that it’s managing through a federal program.
Bright is buying up medical practices
Most young insurers aren’t building clinics, but Bright Health is the exception.
Its CEO Mike Mikan, a former UnitedHealth Group executive, is following his former employer’s blueprint and buying up medical practices.
Bright, which provides health coverage to 623,000 individuals, families, and seniors, is tucking these acquisitions into its new care delivery business called NeueHealth. The business owns or manages care for 61 clinics, but it also works closely with outside provider groups and arms them with analytics and other tools to they can provide better care.
In both cases, the goal is for the insurer and provider to get on the same page and partner to improve patients’ health and lower costs under a payment model where each side wins when it works.
That’s different the old insurance strategy of restricting care, Mikan said.
“What we really want to promote is the healthcare system to move to a value-based model where you’re really rewarding performance based on the quality of the care they provide, not just the quantity of care,” he said. “Every consumer is better served when they’re part of an aligned model.”
It’s Patricia Kelly Yeo’s last week with us here on Insider’s healthcare team! In her final few weeks, she went deep on what’s happening in women’s health.
On the heels of Ro’s announced deal to buy Modern Fertility, we started wondering what the future of women’s health looks like: Is it possible to grow a startup focused on something like fertility, or contraception? Or is the fate ultimately to become an acquisition target?
A COVID-19 vaccine candidate developed by the German biotech CureVac failed in a critical late-stage study, the company said Wednesday.
It’s the first failure of a major vaccine candidate in a final-stage trial. CureVac said an interim analysis showed the shot was 47% effective, falling short of the study’s goals and the minimum bar for what US regulators find approvable.
The development is a setback to the world’s immunization efforts, as European officials had previously reached deals to acquire up to 405 million doses of the shot.
Despite the disappointing result, CureVac CEO Franz-Werner Haas said the company plans to go “full speed for the final readout.” The trial is still ongoing and the final vaccine efficacy figure may vary as more COVID-19 cases are tallied.
CureVac, which is backed by The Bill & Melinda Gates Foundation, saw its stock price plummet following Wednesday’s announcement. Shares were down more than 50% in post-market trading. The foundation owns about 3.1 million shares of CureVac, or 1.7% of the company, according to data compiled by Bloomberg.
An independent biostatistics expert said it will be nearly impossible for CureVac’s study to still produce success. The 47% estimate of efficacy is based on 134 COVID-19 cases among study participants. “It’s not going to change dramatically,” Natalie Dean, a University of Florida biostatistician, told The Times.
CureVac blames variants, even as other vaccines hold up against different strains
In a statement, CureVac leaders said that the abundance of virus variants played a role in the result. Only one of the 134 analyzed cases resulted from the original strain of the SARS-CoV-2 virus, the company said.
“While we were hoping for a stronger interim outcome, we recognize that demonstrating high efficacy in this unprecedented broad diversity of variants is challenging,” CureVac CEO Franz-Werner Haas said in a statement.
The disappointing result is surprising given some of the similarities CureVac’s experimental vaccine candidate had with other, highly effective immunizations. CureVac’s shot is a messenger RNA vaccine, a new technology platform that’s also used by Moderna and Pfizer-BioNTech.
Those shots proved to be more than 90% effective in late-stage trials last year. They also appear to protect people against some major virus variants.
Other vaccines have also shown success against variants. Novavax, for instance, announced earlier this week its two-dose shot was 90% effective in a late-stage study. What’s more, Novavax’s vaccine was about 93% effective in preventing illnesses caused by variants of concern or variants of interest, the company said.
A quiet existence, until the pandemic
Since its founding in 2000, CureVac had a largely quiet existence until the pandemic. As one of the first companies trying to develop a COVID-19 vaccine, CureVac’s CEO was invited to the White House in March 2020. Shortly after, reports circulated that the US had offered a “large sum” for access to its vaccine program. CureVac disputed the reports. The company also cycled through three CEOs in the span of a week.
Tesla CEO Elon Musk has also drawn attention to CureVac with his tweets. A Tesla subsidiary is working with CureVac in building a “prototype of an automated manufacturing unit,” Insider reported in July.
In its Wednesday press release, CureVac focused attention on its second-generation coronavirus vaccine. Pharma giant GlaxoSmithKline has partnered with CureVac on that research, paying the company roughly $235 million upfront and investing an additional $180 million in multipledeals over the past year.
CureVac said it hopes this next-generation program could start human testing by the end of September, with the goal of launching in 2022.
Dr. Catherine Schuster-Bruce contributed reporting.