January 17, 2023 – On Twitter and in real life, many are wondering: When should we predict in regards to the next COVID-19 vaccine? Or should we?
For some individuals who have received a two-dose primary vaccination and all beneficial booster vaccinations, this might mean a sixth shot since vaccines against COVID-19 became available. But is that enough (or an excessive amount of)?
At this point, nobody knows of course, but recent guidelines could also be on the agenda.
At 26 January the FDA Advisory Committee on Vaccines and Related Biological Products The agenda features a discussion of plans for future vaccinations against COVID-19.The committee, made up of external consultants, evaluates data on vaccines and other products for the agency.
According to the FDA statement after the meeting, “The The FDA will consider whether to recommend adjustments to the present approvals and authorizations and can consider probably the most efficient and transparent process for choosing the strains to incorporate in initial and booster doses.”
The CDC will then address the issue and make recommendations.
The issue is important because more than 550 Americans Day still die of COVID-19, as of the week ending January 13, the CDC reported. That's up from 346 per day in the week ending December 28.
However, uptake of the latest vaccine, the bivalent booster, has been slow. As of January 11, only 15.9% of the population aged 5 and over had received it, while among the most vulnerable – those over 65 – the figure is only 39%.
COVID vaccines, 2023 and beyond
Meanwhile, infectious disease experts' opinions vary widely on what the vaccination landscape should look like in 2023 and beyond. There is disagreement, among other things, over how effective the bivalent vaccine is, which people most urgently need another shot and which type of vaccine is most appropriate.
“I feel we're probably going to wish one other booster shot,” says Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of the Center for Vaccine Development at Texas Children's Hospital in Houston. “The query is, what's it going to be? Is it going to be the identical bivalent vaccine we just got, or is it going to be a recent bivalent or perhaps a trivalent vaccine?”
He suggested that the trivalent booster might contain something that better protects against XBB.1.5.
The bivalent booster vaccine provides “prolonged immunity” that is improved compared to the original booster shots, says Dr. Eric Topol, founder and director of the Scripps Research Translational Institute in La Jolla, California, and editor in chief of Medscape, WebMD's sister site for healthcare professionals.
In his publication Fundamental truths, Topol said on January 11 that he had revised his previously skeptical view based on recent data. He had explained that the FDA approved the bivalent vaccine in September with none data on its effects on humans on the time.
Paul Offit, MD, director of the Vaccine Education Center and professor of pediatrics at Children's Hospital of Philadelphia, is a member of the FDA's Vaccine Advisory Committee. He stays more skeptical of dual-dose booster shots, no less than as a blanket suggestion.
While he acknowledges that booster vaccinations can assist some groups – akin to older people, individuals with multiple health problems and people with weakened immune systems – he declines to recommend them for the complete population.
“People who are in those three groups benefit,” he says, “but the recommendation is that everyone over 6 months old gets the bivalent vaccine, and I ask, 'Where are the data that show that a healthy 12-year-old boy needs a booster shot to avoid going to the hospital?'”
Evolving research
“We are trying to understand how we can always be one step ahead instead of lagging several steps behind [the virus],” says Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy on the University of Minnesota.
One of the important thing questions is: How well can a vaccine work against a single subvariant when nobody can predict with certainty which subvariant will probably be dominant next?
Recently, far more research has turn out to be available on the bivalent vaccine and its effectiveness, says Osterholm. “The bivalent vaccine works as well as we expected,” he says, especially in high-risk individuals and people over 65. The challenge for us is to know what meaning for the longer term.”
In his assessment, Topol concludes: “There is now more than sufficient, highly consistent evidence from laboratory studies and clinical results demonstrating the benefit of the bivalent preparation compared to the original booster vaccination.”
Among other things, he examined eight studies, including four in which a live virus was used in the research. Six of the eight studies showed that the bivalent booster vaccine was more effective against the BA.5 variant compared to the original booster vaccines. Two others showed no real difference.
“The 4 live virus studies provide consistent evidence of enhanced immunity from the BA.5 vaccine in comparison with the unique booster shots,” Topol wrote.The evidence also showed that the bivalent antibody response was superior to XBB, he wrote.
Topol also quoted CDC data This underscores the benefits of the bivalent vaccine on hospitalizations in older adults. In November, the number of hospitalizations among adults aged 65 and over was 2.5 times higher among vaccinated people who did not receive a booster than among those who received the updated bivalent booster.
Boosters are important, says Offit. “But not for everyone.” In a perspective published on 11 January in The New England Journal of Medicine – In the same issue that published the two studies that found little difference between initial and bivalent therapy, Offit wrote that booster therapy is best reserved for at-risk groups.
Fighting the variants with a bivalent vaccine, he says, “hasn't worked. There isn’t any evidence that a bivalent vaccine is healthier than what we had. Please show me the info that shows one vaccine is healthier than the opposite.”
Offit believes the goal should not be to prevent all symptomatic infections in healthy, young people by “boosting them with vaccines containing mRNA from strains that will disappear a couple of months later.”
The CDC needs to break down the data into subgroups, says Offit. “The key query is: 'Who is being hospitalized and who’s dying? Who are these people?'”
That data should take into account age, ethnicity, vaccination history and other factors, Offit says, because right now there is no good data to say, “OK, everyone gets a booster.”
Future vaccine costs
Another debate – not just for current but also future booster shots – revolves around cost. Without action from Congress to fund more vaccines, vaccine manufacturers have indicated that their prices could reach $130 per dose, compared to the average cost of $20 per dose that the federal government currently pays, according to a Kaiser Family Foundation report.
The government has spent more than $30 billion on COVID-19 vaccines, including bivalent vaccines, to make them available free of charge.
The proposed price increase has infuriated many. On January 10, Senator Bernie Sanders (I-VT), the incoming chairman of the Senate Committee on Health, Education, Labor and Pensions, sent a letter to Moderna CEO Stéphane Bancel and asked him to reconsider and refrain from increasing his prices.
“The huge price increase you might be proposing may have a major negative impact on the budgets of Medicaid, Medicare and other government programs that may proceed to cover the vaccine without patient cost sharing.”
He also pointed to the $19 billion profit Moderna has made over the past two years.
While most people with health insurance would likely continue to receive the vaccines and boosters for free, according to the Kaiser analysis, will a higher price deter people from getting recommended vaccines, including a possible new booster?
“I think so,” says Hotez, pointing out that vaccine hesitancy is already high, even if the vaccinations are free and easily accessible.
“The government is refusing to pay for the booster vaccinations,” he says. “I feel that may be very insensitive of the pharmaceutical firms. [to increase the price]”Given the help they have received from the American people, I don't think they should be engaging in more profiteering now.”
He identified that the federal government just isn’t only providing firms with money for the vaccines, but can be giving them a “glide path” through the FDA for vaccine approval.
Are recent, variant-specific boosters coming?
Are Moderna, Pfizer-BioNTech and others developing additional variant-specific vaccines, booster shots or other advanced procedures?
Novavax, approved in July 2022 as primary series and in some cases as Booster, “is also developing a bivalent omicron-based vaccine under the direction of health authorities,” says spokeswoman Alison Chartan.
Pfizer responded: “If and when we have something to share, we will let you know.”
Moderna didn’t respond.