Unprecedented Budget Surplus Is Focus of May Revision

Despite surplus, analyst warns of California 'fiscal cliff'

Source: CalChamber, by Loren Kaye

To nobody’s surprise, Governor Gavin Newsom on Friday announced another upward revision in the state’s general revenues—a $55 billion bump since January. To the surprise of many, this means that discretionary surpluses for three consecutive fiscal years will top $100 billion. Nobody had this number on their bingo card as the state tumbled into the pandemic recession just two years ago.

This unprecedented and unexpected streak of budget surpluses has been amassed in large part from the strong economic performance by key California economic sectors and entrepreneurs. This creativity and adaptability by employers, along with the commitment of millions of California workers, has seen the state through the tragedy of COVID-19, with extra revenues to bolster the social safety net.

Experience with the California budget teaches that what goes up must come back down, so the Governor prudently sets aside $37 billion into various reserve funds, and calculates that 94% of all spending from surplus funds is dedicated to one-time purposes.

Since the state budget is pushing against the so-called Gann Limit, which caps annual expenditures from the state budget, the Governor targeted several of his initiatives toward spending exempt from the limit, in particular, infrastructure and tax relief.

Noting the toll that inflation has recently taken on individual family budgets (not to mention the already high cost of living endemic to California), the May Revision calls for more than $18 billion in various tax relief or rebate programs, including:

  • * A $400 rebate to households based on registered motor vehicles.
  • * A temporary reduction to the diesel sales tax.
  • * Funding for rental assistance and payments for outstanding utility arrearages built up during the pandemic.
  • * Covering all family fees for subsidized child care programs as well as continued health care subsidies for the middle class if federal subsidies expire.
  • * Retention bonus payments to approximately 600,000 workers in hospitals and nursing homes.

The Governor is also proposing some targeted tax benefits for businesses, including:

  • * Extending the CalCompetes tax credit program for five years at $180 million per year, and extending the CalCompetes grant program for another year at $120 million.
  • * Fully conforming California law to the extended federal Paycheck Protection Program (PPP), which prevents these federal grants from being subject to state taxation.
  • * Another $500 million for a grant program administered by the Small Business Advocate to provide additional relief to small businesses most affected by the pandemic, focusing on the top ten industries hardest hit by the pandemic.

California will receive $13.9 billion in new federal funds from the Infrastructure Investment and Jobs Act that will support transportation, broadband and other projects over the next five years. On top of that, the May Revision will target another $17 billion (on top of $20 billion from the January budget proposal) for electric vehicle infrastructure and clean energy innovation, transportation projects, broadband build-out, and reducing wildfire risk and supporting drought resiliency.

Schools automatically receive a portion of every new general tax dollar, courtesy of a 1988 ballot measure, Proposition 98. The May Revision includes total funding of $128.3 billion for all K-12 education programs—more than $20,000 per student. This is $20 billion more than the Governor proposed in January, and a stunning $35 billion higher than the current year budget. Some $8 billion of this amount is a one-time allocation that schools can use to address the continuing effects of the pandemic by supporting students’ mental health and learning challenges and to take actions to preserve staffing levels.

The Governor made good on his pledge to give annual budget increases of 5% to the University of California and California State University systems over the next five years. In exchange, the systems will be expected to make progress and report annually on goals including improved graduation rates, growing enrollment, making college more affordable and preparing more students for high-demand careers.

Governor Newsom increased his spending commitment for programs related to climate change and drought mitigation, adding $9.5 billion to a $23.5 billion multi-year commitment made in January. The spending will cover drought relief and water projects, investments in clean energy, and subsidies for electric vehicle purchases and charging infrastructure.

The Governor made no changes to his January proposal to transfer $3 billion to the Unemployment Insurance Fund to offset future employer tax liabilities.

Leapfrog Group: Patients report worse hospital experiences during COVID-19 pandemic, raising safety concerns

Leapfrog sees 'significant' infection increases across its largest-to-date  release of hospital safety grades | Fierce HealthcareSource: Fierce Healthcare, by Dave Muoio

The latest batch of hospital patient safety ratings from the Leapfrog Group shows a general decline among “several” hospital safety measures concurrent with the onset of the COVID-19 pandemic, according to the healthcare safety watchdog.


Released Tuesday, the scores are accompanied by a report from Leapfrog that highlights a “significant” decline in the experiences of adult inpatients at acute care hospitals during the pandemic, with many areas “already in dire need” prior to the pandemic deteriorating even further.

“The healthcare workforce has faced unprecedented levels of pressure during the pandemic, and as a result, patients’ experience with their care appears to have suffered,” Leah Binder, president and CEO of the Leapfrog Group, said in a statement.


Leapfrog’s twice-annual reports assess more than 30 patient safety measures and component measures compiled from the Centers for Medicare & Medicaid Services (CMS) and Leapfrog’s hospital surveys between July 2018 and March 2021. The most recent release assigns letter grades to nearly 3,000 U.S. general hospitals and is the second collection of scores to incorporate safety and experience data from the COVID-19 pandemic.

This time around, Leapfrog assigned 33% of hospitals an “A,” 24% a “B,” 36% a “C,” 7% a “D” and less than 1% an “F”—a roughly equivalent distribution to those given in the fall.

Eight states had 50% or more of its hospitals receive an “A” grade, with North Carolina (59.8%) and Virginia (59.2%) leading the way.


On the other end of the spectrum, Wyoming, West Virginia, North Dakota and the District of Columbia had zero hospitals that received an “A” from the watchdog.

As before, Binder said that the “significant variation in safety performance” across different facilities underscores the need for public access to hospital assessment tools “so patients can make the best decision for themselves and their loved ones.”

Alongside the scores, Leapfrog placed a spotlight on patient experiences in a report comparing Hospital Consumer Assessment of Healthcare Providers and Systems Survey (HCAHPS) scores across more than 3,500 U.S. hospitals before (2019) and during (mid-2020 to mid-2021) the COVID-19 pandemic.

The group found statistically significant declines between the survey periods in the average percentage of hospital patients who gave the most favorable responses for nine of the 10 HCAHPS measures.


The greatest decline was seen among patients’ experiences with hospital staff responsiveness (a 3.7 percentage point decrease), followed by communication about medicines (a 2.9 point decrease), and cleanliness of the hospital (a 2.9 point decrease).

Leapfrog noted that these patient experience areas and others—like understanding care transitions (which already claimed the least favorable responses)—are directly tied to patient safety events and likely took a hit due to pandemic strains on the healthcare workforce.

“We commend the workforce for their heroic efforts these past few years and now strongly urge hospital leadership to recommit to improved care—from communication to responsiveness—and get back on track with patient safety outcomes,” Binder said.

The inpatient experience report is the second in a series of three such analyses from Leapfrog focused on patient experience during the pandemic. The first report, released in early April, focused on a decline in favorable patient ratings for communications about procedures across ambulatory surgery centers and hospital outpatient departments alike.

Leapfrog’s broader Hospital Safety Grade rankings are available online as a free resource for patients and their families. The organization said its analyses are independently assessed and peer-reviewed, with the methodology of the scoring available online for review.

The prior round of ratings highlighted “significant” declines in hospitals’ performance on preventable hospital-acquired infections. Those findings echoed similar concerns from patient experience intelligence firm Press Ganey and the Centers for Disease Control and Prevention.

White House Warns Of COVID Surges In The Winter

White House warns of Covid surges in the winter - POLITICO

Source: Politico, by Hannah Farrow

Covid cases surged during the last two winters and are likely to again this year — unless the country can prepare and act, White House Covid-19 response coordinator Ashish Jha said Sunday morning.

“If we don’t get ahead of this thing, we’ll have a lot of waning immunity, this virus continues to evolve and we may see a pretty sizable wave of infections, hospitalizations and deaths this fall and winter,” Jha said on ABC’s “This Week.”

Congress needs to provide resources, Jha said, specifically $22.5 billion, a number that will help with a vaccine supply that’s dwindling. In March, White House Coronavirus Response Coordinator Jeff Zients said: “If the science shows that fourth doses are needed for the general population later this year, we will not have the supply necessary to ensure shots are available.”

The money, once allocated, would go toward Covid vaccine supply and coronavirus testing.

“If Congress doesn’t step up and fund these, I think, urgent and emergent priorities … they can’t wait until the fall, it will be too late,” Jha said.

And the proof is in the jab. With cases increasing in the Northeast, deaths remain low because of high vaccination rates.

“That’s not true for the whole country,” Jha said.

With enough resources to get more people vaccinated and more therapeutics in place, he said, “I do think we can get through this winter without a lot of suffering and death.”

WTW: A Look At Employers’ Strategies For Addressing Affordability

WTW surveys employers on healthcare costs

Source: Fierce Healthcare, by Paige Minemyer

Most employers are putting a focus on managing healthcare costs coming out of the pandemic, a new survey shows.


Analysts at WTW polled 636 employers representing 10 million workers and found that 94% are naming healthcare costs a top priority over the next two years. A close second was enhancing mental health benefits, with 87% calling it a key priority.

Nearly two-thirds of the surveyed employers (64%) said they will be taking steps to address affordability over the next two years. These efforts include enhanced low- or no-cost benefits, named by 41% of the employers, as well as addressing outcomes and care quality, named by 55%.

“Employers are really having to manage a lot of things at the same time,” Courtney Stubblefield, insights and solutions leader for health and benefits at WTW, told Fierce Healthcare. “It’s a lot of really substantial things that are durable. We’re in a challenging time for employers as they try to put together the best benefit package they can.”

Close to one-third of employers (32%) said they expect to make changes to employees’ out-of-pocket costs over the next two years, and 21% said they plan to make changes to the health plan payroll contributions.

Behavioral health is not a new source of focus for employers but has become an even more significant challenge coming out of COVID-19. By the end of 2023, most employers (95%) said they will offer virtual care for physical and behavioral health, and 61% said they expect to lower the out-of-pocket costs for virtual care.


More than half (55%) said they expect virtual care will drive down care costs in the long run.

Stubblefield said key challenges in addressing behavioral health include providing care to unique populations such as children and adolescents. They’re also looking at ways to integrate behavioral health coverage into other apps and member-facing tools to ensure workers are aware of the benefits they have access to, she said.

“All eyes are focused on this,” she said. “It’s a very concerted effort.”

Small Businesses Owe Billions In Unforgiven PPP Loans

Small Businesses Owe Billions in Unforgiven PPP Loans | Word & Brown

Source: Word & Brown, by Alex Strautman

The Paycheck Protection Program (PPP), launched as part of the federal government’s Coronavirus Aid, Relief, and Economic Security (CARES) Act to aid to small businesses coping with the impact of COVID-19, ended on May 31, 2021. However, nearly 350,000 small businesses that received a PPP loan have not had their loans forgiven. Another 380,000 loans have been only partially forgiven.

A recent analysis by Bloomberg News says total PPP debt amounts to $28 billion, with most loans for less than $25,000. During 2021, the Small Business Administration (SBA) reported distributing more than $400 billion to more than six million businesses through the PPP, Restaurant Revitalization Fund, Shuttered Venue Operators Grant, COVID Economic Injury Disaster Loan (EIDL), and targeted and supplemental advance programs.

Employers receiving a PPP loan during the first funding round had until August 30, 2021, to apply for loan forgiveness. However, advocacy groups, community leaders, and business owners say the process for seeking forgiveness is burdensome for businesses. Indeed, the loan forgiveness application, SBA Form 3508S (07/21), is seven pages and requires considerable documentation regarding how PPP funds were used.

The SBA boasted in 2021 that it had streamlined its forgiveness application processes. In a press release, the SBA said, “a borrower of a participating lender can now complete most or all of a forgiveness application using a computer or, for the first time, their smartphone. On average, users are able to complete and submit directly to the SBA their applications in just six minutes, and most receive their forgiveness decisions within a week from the date of submission.“

More than six months after the forgiveness application deadline, 50+ business and advocacy groups are still pushing the SBA, Treasury Department, and Congress to forgive automatically PPP loans of $25,000 and less. They argue that many sole proprietors face challenges with income, payroll, and expense documentation. They are also seeking rescission of a rule that denied forgiveness to businesses making a good-faith effort to comply with forgives rules.

In other PPP-related news, the Justice Department continues to go after individuals and businesses that have misused funds related to CARES assistance. In March, charges were filed in Louisiana against an Amtrak employee who sought approximately $89,000 in PPP funds, even while working full-time.

Sentencing also took place last month for two Michigan residents who obtained nearly $1.5 million in PPP funds. Authorities have recovered more than $1.123 million traced to the fraudulently obtained funds through a parallel civil asset forfeiture action. California convictions include seven individuals in Los Angeles sentenced in November for PPP and EIDL fraud in excess of $20 million, as well as a separate action last year against a Temecula business owner who sought and obtained $7.25 million in federal assistance.

Trump Era Rule That Expanded Duration Of Short-Term Health Plans In Democrats’ Crosshairs

Trump era rule that expanded duration of short-term health plans in  Democrats' crosshairs | Fierce Healthcare

Source: Fierce Healthcare, by Robert King

Democratic lawmakers and advocacy groups are making a push to convince the Biden administration to nix a controversial Trump-era rule that expanded the duration of short-term health plans.


A collection of more than 40 House Democrats wrote to Department Health and Human Services (HHS) Secretary Xavier Becerra earlier this week calling for the agency to pull the rule. The action comes after more than 20 advocacy groups wrote to Becerra back in January asking for the rule to be nixed or modified.

“Junk plans pose clear risks to consumers, undermine the strength of the Affordable Care Act and are incompatible with the goal of making affordable, high-quality health insurance accessible to all Americans,” the letter, led by Rep. Cindy Axne, D-Iowa, told Becerra.

Advocates say urgency has been rising to get the administration to reverse the rule, which was finalized in 2018 and lengthened the duration of short-term plans from three months to a year.

A major concern is the potential end of the COVID-19 public health emergency (PHE), which was extended until July. Once the PHE goes away, states will be able to disenroll ineligible Medicaid beneficiaries and extra COBRA subsidies will go away.

“The second that the PHE is allowed to end all of those people are suddenly uninsured and the worry is that if we don’t do something now a lot of those people continue to stay uninsured or will buy a short-term plan that doesn’t meet their needs,” said Caitlin Donovan, senior director of the National Patient Advocate Foundation, one of the groups pressing the administration to act.


Donovan said she was confident the rule will eventually be rescinded, as it has not been popular.

The Trump administration finalized the regulation in 2018 for short-term limited duration plans that can bypass requirements under the Affordable Care Act (ACA) to cover preexisting conditions and essential health benefits. The rule said that the 12-month plans can be renewed for up to 36 months.

HHS at the time said the plans were necessary to give consumers options as premiums on the ACA’s exchanges were too high. However, the insurance industry and consumer advocates charged the plans offer skimpy coverage and can deceive consumers that they are getting more robust benefits.

“Individuals that unwittingly purchase a short-term plan that are later diagnosed with a chronic or acute condition may find themselves seriously uninsured as short-term plans typically exclude coverage of key services such as prescription drugs and mental health services, among others,” the letter, led by the National Patient Advocate Foundation and more than 20 other groups, said.


The letter has proposed several changes to the initial 2018 rule, chief among them to restore the original three-month limit for the plans.

Other recommended changes include:

  • * Halting sales of short-term plans during the ACA open enrollment. Advocates pointed to studies that indicate the plans can be “aggressively and deceptively marketed to consumers.”
  • * Limit sales of plans via internet and phones to help clamp down on deceptive marketing tactics.
  • * Improve disclosure of the types of risks associated with short-term health plans, including by telling the consumer the plan is not comprehensive.

The Biden administration has been in favor of getting rid of the rule or making changes, referencing it in the latest Unified Agenda that outlines regulatory priorities for the coming year.

So far, HHS has not released any regulations on the issue, and the Centers for Medicare & Medicaid Services did not return a request for comment as of press time.

FDA Grants Emergency Authorization For First COVID-19 Breathalyzer Test

FDA grants emergency authorization for first COVID breath test | KHQA

Source: USA Today, by Jeanine Santucci

Americans will be able to find out if they have COVID-19 with a breathalyzer test, the Food and Drug Administration announced Thursday.

The FDA granted an emergency use authorization to a test produced by InspectIR Systems that collects a breath sample and analyzes for chemical compounds associated with the coronavirus, the first of its kind to be authorized for use.

In a study of 2,409 people, the test correctly identified a positive COVID infection in 91.2% of cases and correctly identified negative samples 99.3% of the time, the FDA said in a release. A similar result was seen in a follow-up study focused on the contagious omicron variant of the coronavirus.

According to InspectIR, the test is performed by exhaling into a tube in a similar manner to blowing up a balloon and produces results within three minutes.

The FDA said the testing instrument is about the size of a piece of carry-on luggage, and that breath tests can be performed in doctor’s offices, hospitals, and other testing sites.

“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the U.S. for the next public health emergency.”

The FDA said a positive result yielded through the InspectIR COVID-19 breathalyzer should be confirmed with a molecular test.

Small Businesses Face $2 Billion Cut From Covid-19 Relief Fund

Small businesses face $2 billion cut from Covid-19 relief fund - KTVZSource: CNN Politics, by Katie Lobosco

Congress is considering taking back some of the money it authorized last year for a small business aid program in order to pay for new Covid-19 vaccines, testing and therapeutics.

The Biden administration asked Congress to provide more money weeks ago, warning that funds are needed to continue fighting Covid-19. But lawmakers have disagreed on how to pay for the request. Senate Republicans have insisted any new funding be fully offset by repurposing money from Covid-19 relief legislation that Congress previously passed.

A bipartisan deal reached in the Senate earlier this month would fully offset the $10 billion legislation by reallocating a variety of Covid-19 relief funds that were previously authorized by Congress but have not yet been spent.

A majority of those unspent funds were left over from programs that have already expired. But the deal also proposes taking about $2 billion from a $10 billion small business program that hasn’t disbursed any funds yet.

“There’s a big difference between funds that have not been used and funds that have yet to be deployed,” said Katie Kramer, vice president of the Council of Development Finance Agencies, a national association dedicated to supporting economic development.

The program in question, known as the State Small Business Credit Initiative, provides money to states to help create small business financing programs. It’s a long-term aid program that is meant to help small businesses have access to capital as the economy rebounds, instead of providing emergency grants and loans like other Covid-19 aid programs.

Funding cut threat puts state plans on hold

After months of planning how best to use the money, the threat of the cut is putting states’ plans on ice.

Like many states, Oregon was ready to launch several small business financing programs as soon as it receives the money from the Treasury Department. If the funds are cut, it could mean big delays.

“The frustrating thing for us is that we’ve been engaging with communities for months, letting them know these resources are coming,” said John Saris, finance manager at Business Oregon, the state’s economic development agency.

He was expecting Oregon to receive more than $83 million, enough to potentially reach 1,000 businesses. But if Congress rescinds some of the money, the state could see a reduction by as much as $20 million, leaving it with resources to help just 700 small businesses.

“With these cuts, we will have to totally revamp our plans. Some programs might go away completely – that’s how dire this is,” Saris said.

The State Small Business Credit Initiative allows states to create a variety of financing programs for small businesses and startups emerging from the pandemic, including venture capital programs and loan guarantees to lenders, for example.

Governments are required to match some of the federal funds with private capital, and Treasury expects that the programs should generate small business lending and investment of at least 10 times the federal contribution amount.

That means that a $2 billion cut in federal funding from the State Small Business Credit Initiative could result in more than a $20 billion reduction in private investment for small businesses, according to the Council of Development Finance Agencies.

States are still waiting for the money

The State Small Business Credit Initiative was originally created in 2010 to help small businesses recover from the Great Recession. The American Rescue Plan Act, which was signed into law by President Joe Biden in March 2021, reauthorized the program and provided $10 billion in new funding.

States were required to submit applications to Treasury in February and tribal governments have until May 11. But no applications have been approved yet and none of the money has been disbursed by Treasury.

A Treasury official told CNN that the agency’s rollout of the State Small Business Credit Initiative “has been consistent with the statute and included outreach, input, and engagement with states, tribes, lenders, small businesses and experts, as well as technical assistance to ensure programs are set up to deploy these funds effectively.”

The official noted that Congress created some new elements for the program that weren’t included in 2010, including the addition of allocations for tribal governments and socially and economically disadvantaged business owners, along with a new technical assistance program.

Bill remains in limbo

After weeks of negotiation on the Covid-19 relief bill, lawmakers left for a two-week recess without voting on the bill. The latest hurdle came as Republicans demanded a vote on an immigration amendment to restore Title 42, a pandemic-era rule that allowed immigrants to be returned immediately to their home countries citing a public health emergency.

The bill calls for repurposing several buckets of previously approved Covid-19 relief funds to pay for the new health spending, in addition to the money it would take back from the State Small Business Credit Initiative.

The bill would use nearly $2 billion left over from the Shuttered Venues Operators Grant program, which gave money to live music venues, theaters and museums that were forced to shut their doors for some period of time due to the pandemic. The program stopped taking applications in August. It awarded more than $14 billion in grants.

The bill would also repurpose about $900 million that is remaining for the Covid-19 Economic Injury Disaster Loan advance program, which allowed some small businesses to receive up to $15,000 that did not need to be paid back. The program would be left with enough money to accommodate pending loan modifications and the recently announced six-month deferment on loan payments, according to a summary of the bill provided by Senate Democrats.

More than $2.3 billion would come from the Aviation Manufacturing Jobs Protection Program, which provided funding to businesses to cover up to half of their payroll costs for certain categories of employees for up to six months. In return, those businesses were required to make several commitments, including to not involuntarily furlough or lay off employees within that group during the same six-month period.

The bill would also use remaining unspent money in the Higher Education Emergency Relief Fund, totaling $500 million. That program provided funds to colleges so that they could give emergency financial aid grants to students whose lives were disrupted by the pandemic. Another $1.6 billion of unspent funds that were previously given to the US Department of Agriculture would also be repurposed.

Congress could take up the new Covid-19 relief legislation next week after lawmakers return from recess. Spokespeople for Senate Majority Leader Chuck Schumer and Republican Sen. Mitt Romney of Utah, who was negotiating the funding deal for Republicans, did not return emails from CNN requesting comment for this story.

Your Next COVID-19 Vaccine Will Be Different

Source: The Mercury News, by Lisa M. Krieger

After deploying four COVID-19 shots in a little more than two years, the nation is absorbing a troubling realization: That’s a pace that’s impossible to sustain.

This past week, experts began charting a path to a future that is less perfect – but more practical.

It means building a vaccine that targets more than one strain of the virus. It would reduce severe disease and death, but not prevent every infection. If the design is changed, all vaccines will be updated. Manufacturers will likely offer the same vaccine formulation to everyone, rather than a mélange of different products for different people on different schedules.

And the goal is to have it ready by next fall when the risk of illness is likely to soar. That’s a very tight deadline.

Faced with the triple threats of fading immunity, an evolving virus and holiday gatherings, “we have to be prepared, from a standpoint of national security, making sure that we can protect our population with a vaccine in hand,” Dr. Peter Marks told an expert advisory FDA committee on Wednesday.

What will that look like?

“If we settle down to one shot per year that combines COVID and flu, I think that will be sustainable,” said UC San Francisco infectious disease expert Dr. Peter Chin-Hong.

“Nobody will want to get a vaccine every six months,” he said. “So we have to change the strategy.”

The creation and distribution of COVID-19 vaccines will go down in history as one of medicine’s greatest achievements. Only one year after cases were first documented, a shot was available. Fifteen months later, an impressive total of four doses were available for many people: a two-dose primary series and two boosters.

But, with each announced dose, interest fades. While 77% of the eligible U.S. population has gotten one shot, that rate dips to 65% who have gotten two shots and only 50% who have gotten three shots. The fourth dose is just beginning to be rolled out.

Vaccine protection is fading, too. After every shot, our immunity follows the same disappointing downward trajectory. Vaccines that are 91% effective in preventing hospitalization during the first two months fall to 78% after four months – and, over time, keep declining.

This means that people who got their one shot back in early 2021 are increasingly vulnerable.

Funding also will fade. Today’s federal funding free-for-all strategy won’t continue indefinitely, predict experts. Costs will be shifted to private insurers. That puts pressure on efficiency and effectiveness.

Yet the virus is here to stay. And it will keep changing. The virus has mutated two to 10 times faster than the flu, depending on the strain, reported virologist Trevor Bedford of the Fred Hutchinson Cancer Research Center in Seattle. He said it will continue mutating a little or a lot – either is possible.

Initially, experts hoped that a three-dose regimen would offer long-term protection. That strategy works for measles, mumps, rubella, hepatitis B, HPV and other viruses.

But COVID is different because it changes more, said Chin-Hong. That creates special challenges for vaccination planning.

This means things must move fast. The FDA hopes to decide on the composition of a future vaccine in May or June. While some clinical trials of potential products are already underway, vaccine manufacturers need several months to produce enough doses of a reconfigured vaccine, according to Robert Johnson, director of an infectious disease division within the Department of Health and Human Services.

The panel agreed on these points:

• The promise of a new “bivalent” or “multivalent” vaccine.

There’s a diminishing return by repeatedly giving the same “monovalent” vaccine, which targets the original strain, especially as new variants emerge. It also seems unlikely that an omicron-specific booster is the best idea. The virus changes so frequently that it could quickly be out of date.

A better approach may be to design something that targets two or more strains of the virus, called a “bivalent” or “multivalent” vaccine. Such vaccines are already in the works at Moderna and Novovax.

“A multivalent vaccine is going to be important in hopefully prolonging the duration of protection,” said Dr. Mark Sawyer, professor of clinical pediatrics at UC San Diego.

• Therapeutics must play a growing role.

Rather than constantly adding vaccines, we should seek the help of antiviral drugs, monoclonal antibodies and other future therapies to treat infections to keep people out of hospitals.

With 80% protection against hospitalization in older and sicker adults, “I think we may have to accept that level of protection and then use other alternative ways to protect individuals with therapeutics and other measures,” said Amanda Cohn of the U.S. Centers for Disease Control and Prevention.

• Take a more unified approach to manufacturing.

Vaccine makers should target the same strains, using similar doses, panelists said. It will prove impossible to keep track of multiple vaccines with different compositions.

The CDC must take the lead in deciding when the vaccines are no longer effective against severe illness, said Dr. Paul Offit, professor of pediatrics at The Children’s Hospital of Philadelphia. “At some level, the companies kind of dictate the conversation here,” he said.

If a new vaccine is needed to respond to a scary variant, it won’t just be a booster. The whole two-dose “primary series” would be replaced.

Better data and new designs are needed.

Because we’re in a rush, we’re relying on what the data tells us about the immune response in blood. But we also need to get better at interpreting what these lab studies mean for protection out in the real world, said Dr. Hayley Ganz, professor of pediatrics at Stanford University Medical Center. Antibody counts are important, she said. But so are other parts of the immune system, as well as clinical outcomes.

Finally, we need to know what future products await us in the research pipeline, even if they are not yet FDA authorized.

“The current mRNA vaccines are great. They can be turned around quickly,” said infectious disease expert Dr. Ofer Levy of Boston Children’s Hospital. “But it may be that other platforms emerge that give broader protection. So as we move forward, we don’t want to bake in a system that excludes other types of vaccines.”

Last Updated 05/25/2022

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