White House To Launch Effort To Develop Next Generation Of COVID Vaccines

White House discusses next generation of COVID-19 vaccines

Source: STAT News, by Matthew Herper and Lev Facher

The Biden administration is preparing a sweeping initiative to develop a next generation of Covid-19 immunizations that would thwart future coronavirus variants and dramatically reduce rates of coronavirus infection or transmission, building on current shots whose impact has been mainly to prevent serious illness and death, the White House told STAT.

To kick off the effort, the White House is gathering key federal officials, top scientists, and pharmaceutical executives including representatives of Pfizer and Moderna for a Tuesday “summit” to discuss the new technologies and lay out a road map for developing them.

“These are vaccines that are going to be far more durable, that are going to provide far longer-lasting protection, no matter what the virus does or how it evolves,” Ashish Jha, the White House Covid-19 response coordinator, said in an interview. “If we can drive down infections by 90% … Covid really begins to fade into the background, and becomes just one more respiratory illness that we have to deal with.”

Jha acknowledged that such a campaign would likely require more money from Congress, though he declined to provide a specific estimate.

The summit is the strongest sign of support to date for developing a new generation of Covid-19 vaccines — an effort that several prominent researchers have long advocated, but that has languished due to lack of investment. Several of those scientists praised the new White House initiative, expressing hope that it is a harbinger of bigger steps that will yield a next generation of Covid vaccines.

“I’m very thrilled they’re having this summit,” said Akiko Iwasaki, a researcher at Yale who conducted a promising study of a nasal vaccine booster and who co-founded a company that would seek to commercialize the technology. She will be attending the summit.

“It’s really important that the entire country be thinking about next-generation vaccines that may potentially prevent infection and transmission,” she said. “And that’s probably the only way to contain the spread of the virus.”

For all the initiative’s ambition, it is not without risk, both scientific and political. The Biden administration has struggled in recent months to execute a two-pronged messaging strategy: convincing Americans that the federal Covid response has been a success, while also stressing that the pandemic remains a clear and present danger. The vaccine initiative is likely to draw limited interest from the large segment of the public that would sooner act as if the virus threat is over. And it also risks wasting political capital on an initiative that would cost untold billions of dollars — and that lawmakers may be unwilling to fund.

Nonetheless, the administration is setting lofty goals.

One of the biggest hopes is for a new vaccine that would prevent infection no matter how the SARS-CoV-2 virus mutates. While current vaccines, like Pfizer’s and Moderna’s mRNA shots, are highly effective at preventing serious illness and death, they are less capable of preventing Covid from spreading. The recent emergence of new strains, like Omicron and its sublineages BA.4 and BA.5, have led the companies to develop new jabs specifically targeted at those variants, which should be available in the fall.

Experts, however, say that strategy is unsustainable.

“Variant chasing will never get us to where we need to be,” said Eric Topol, director and founder of the Scripps Research Translational Institute. “Variant chasing is a losing strategy. It’s temporally flawed and unacceptable.”

Jha said that there are two major strategies for creating a new vaccine, both of which likely require support from the federal government to develop, test, and manufacture.

One strategy would focus on the development of nasal vaccines that could create antibodies at the mucosal surfaces in the nose and elsewhere where viruses enter the body, thereby preventing infection and transmission. A second strategy would aim to create vaccine antigens that would work against a broader array of coronavirus strains, thereby providing more durable immunity. It may or may not be possible to combine the two strategies.

The scientific challenges ahead for either approach are massive, and will be even bigger if researchers hope to create a vaccine that both prevents infection and is resistant to variants.

A few studies have shown promise for the nasal approach, but among other issues, it’s not clear how long immunity from a nasal vaccine would last. More broadly, while researchers have found antibodies that appear to be effective against a wider variety of coronaviruses, there will be no guarantee that a new vaccine is “variant-proof” until it has been in use for several years.

Jha said that the administration’s current thinking was that the new technologies might be three to five years from broad use, but that the right investment could dramatically speed that timeline.

Scientific challenges aside, there’s also that matter of money — specifically, getting it from Congress, which has been increasingly resistant to allocating new funds for Covid efforts.

A government-backed initiative to develop a new generation of coronavirus vaccines would likely cost billions. The Trump administration spent $12.4 billion on Operation Warp Speed, its initial push to develop Covid-19 immunizations, in 2020 alone. The federal government continues to spend massive sums on vaccines: Last month, the Biden administration announced a new $3.2 billion contract with Pfizer to supply another 105 million doses.

In recent months, the administration has struggled to convince lawmakers that more funding is necessary for the ongoing Covid-19 response. Just last month, the White House repurposed $10 billion in existing funding to pay for vaccines and therapeutics, after a failed effort to convince Congress that it couldn’t make the purchases without new money.

Sen. Mitt Romney (R-Utah), in response, called the White House’s messaging “patently false.” Lawmakers still haven’t struck a deal to provide more cash for the Biden administration’s pandemic response.

Biden has also struggled to convince Americans that they should receive third or fourth vaccine doses, despite evidence that shows protection from shots wanes after several months. According to data from Centers for Disease Control and Prevention, as of late June, 71% of Americans over 5 have received the original two-dose vaccine series. But only 49% of those eligible received their first booster dose, and only 26% of those eligible for a second booster dose have received it.

Survey data from the Kaiser Family Foundation indicates that half of unvaccinated Americans say that nothing could convince them to receive a Covid vaccine. Only 3% of unvaccinated people surveyed told the KFF they would get vaccinated if a new vaccine prevented infection.

Still, Jha cast the next generation of vaccines as potentially transformative — not just in terms of their effectiveness, but in terms of the public’s interest.

“When we have a whole new platform of vaccines, I expect a vast majority of Americans to take it,” Jha said.

The regulatory requirements to determine the safety and efficacy of such next-generation vaccines are still unclear. Those decisions will eventually be made by the Food and Drug Administration. One challenge is that they will have to be better options than current vaccines, whose safety has been determined not only by huge clinical trials, but also by administration to billions of people.

“We have fantastic vaccines that are actually doing a lot of good right now and are quite safe,” Jha said. “And so the bar for approving new vaccines is going to be that it has to be better than that. And that’s going to be a high bar.”

While hospitalization rates remain low compared to the devastating Covid waves of January 2021, September 2021, and January 2022, they have steadily climbed since April, as contagious viral variants including BA.4 and BA.5 have rapidly spread. There is really no predicting, experts say, what the virus will throw at society next.

“There’s a sense that we’re playing catch-up with the virus,” Jha said. “The virus is constantly evolving. We’re having to evolve with it, that’s fine. But over the long run, we really need a serious breakthrough.”

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.”

The Next Exchange Open Enrollment Will Be Huge

The number of Americans who buy ObamaCare health insurance in the next open enrollment period will far surpass the 8 million who enrolled in plans earlier this year, according to an analysis by HealthCare.com. Twelve million to 16 million people are expected to purchase plans during the next open enrollment period, which starts on November 15, 2014 and ends on February 15, 2015.

Some of those who enrolled have already discontinued their plans, which is typical in the individual health market. About 20% don’t pay their initial premium. Historically 3% to 4% drop coverage each month as they migrate to new jobs, have a change in income or family status, or determine they no longer need it, etc. “Despite individual market reforms, this normal churn is continuing,” said CEO of HealthCare.com Jeff Smedsrud.

HealthCare.com predicts that enrollment lapses will be offset by a surge of people who did not buy plans last year. The penalties for not being insured for the 2014 tax year were relatively small. In 2015, penalties climb to $325 per adult and $162.50 per child or 2% of adjusted household income, whichever is higher. “It is clear that once the full force of the tax penalties is felt, choosing to remain uninsured will not be an attractive option,” Smedsrud said.

Also, many small businesses will stop providing coverage for employees, which may cause as many as 20 million people to migrate to individual plans. Finally, 8 million to 10 million people are covered by pre-ObamaCare plans that have been grandfathered — most of which will end by December 31, 2014. People covered by these plans will be forced to shop for new insurance in the next open enrollment period. “There could be twice as many people shopping for health plans, but with only half the time to enroll. There is huge pent up demand,” Smedsrud said.

Last Updated 08/10/2022

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