After deploying four COVID-19 shots in a little over two years, the nation is absorbing a troubling realization: it’s a pace that’s impossible to keep up.
This past week, experts began to carve out a path to a future that is less perfect – but more practical.
This means creating a vaccine that targets more than one strain of the virus. This will reduce serious illness and death, but will not prevent every infection. If design changes are made, all vaccines will be updated. Manufacturers will offer the same vaccine formulation for everyone, rather than mixing different products for different people on different schedules.
And the goal is to have it ready by next fall, when the disease risk is likely to rise. This is a very strict time limit.
Dr. Peter Marx said, “Faced with the triple threat of immunity, an evolving virus, and holiday gatherings, we have to be prepared from a national security standpoint, to make sure we can protect our populations. ” An expert advisory FDA committee on Wednesday.
how will it look like?
“If we settle into one shot per year that combines COVID and the flu, I think it will be sustainable,” said UC San Francisco infectious disease specialist Dr. Peter Chin-hong.
“Nobody would want to have a vaccine every six months,” he said. “So we have to change strategy.”
The creation and distribution of COVID-19 vaccines will go down in history as one of the greatest achievements of medicine. Only a year after the cases were first reported, 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 declared dosage, interest wanes. While 77% of the eligible US population has received one shot, that rate has dropped to 65% of those who have received two shots and only 50% of those who have received three shots. The fourth dose is currently being started.
Vaccine protection is also fading away. After each shot, our immunity follows the same frustrating downward trajectory. Vaccines that are 91% effective at preventing hospitalization during the first two months drop to 78% after four months – and, over time, continue to decline.
This means that those who got their one shot back in early 2021 are becoming increasingly vulnerable.
Funding will also run out. Today’s federal free-for-all strategy will not continue indefinitely, experts predict. The cost will be transferred to private insurance companies. This puts a strain on efficiency and effectiveness.
Yet the virus is here to stay. And it will keep changing. Virologist Trevor Bedford of the Fred Hutchinson Cancer Research Center in Seattle explained that the virus mutates two to 10 times faster than the flu, depending on the strain. He said it will continue to change a little or a lot – either is possible.
Initially, experts hoped that the three-dose regimen would provide long-term protection. This strategy works for measles, mumps, rubella, hepatitis B, HPV, and other viruses.
But COVID is different because it changes more, Chin-hong said. This creates special challenges for vaccination planning.
This means that things must move fast. The FDA expects to make a decision on the composition of the future vaccine in May or June. According to Robert Johnson, director of an infectious diseases division within the Department of Health and Human Services, some clinical trials of potential products are already underway, allowing vaccine manufacturers to produce sufficient doses of a reconfigured vaccine. It requires several months.
The panel agreed on these points:
• The promise of a new “bivalent” or “multivalent” vaccine.
There is diminishing return from repeatedly giving the same “monovalent” vaccine that targets the original strain, especially as new variants emerge. It also seems unlikely that an Omicron-specific booster is the best idea. The virus mutates so frequently that it can quickly become obsolete.
A better approach might 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 to hopefully extend the duration of protection,” said Dr. Mark Sawyer, a professor of clinical pediatrics at UC San Diego.
• Therapeutics should play an increasing role.
Instead of constantly adding vaccines, we should turn to antiviral drugs, monoclonal antibodies and other future therapies to treat infections to keep people out of hospitals.
With an 80% protection against hospitalization in older and sick adults, “I think we may have to accept that level of protection and then try other alternative methods to protect individuals with therapeutic and other measures.” May have to use,” said Amanda Cohn of the US Centers for Disease Control. and prevention.
• Adopt a more integrated approach to manufacturing.
Panelists said vaccine manufacturers should target similar strains using similar doses. Keeping track of multiple vaccines with different compositions would prove impossible.
Paul Offit, professor of pediatrics at Children’s Hospital of Philadelphia, said CDC should be leading the way in deciding that vaccines are no longer effective against serious disease. “At some level, companies dictate the conversation here,” he said.
If a new vaccine is needed to respond to a scary version, it won’t be just a booster. The entire two-dose “primary series” will be replaced.
• Better data and new designs are needed.
Because we’re in a hurry, we’re relying on what the data tells us about the immune response in the blood. Professor of Pediatrics at Stanford University Medical Center, Dr. But we also need to be better able to understand what these lab studies mean for safety in the real world, Hayley Ganz said. He said antibody counts are important. But there are clinical consequences for other parts of the immune system as well.
Finally, we need to know what future products await us in the research pipeline, even if they are not yet FDA authorized.
“Current mRNA vaccines are great. They can be rolled out quickly,” said Dr. Ofer Levy, infectious disease specialist at Boston Children’s Hospital. “But it may be that other platforms emerge that offer broader protection. So As we move forward, we don’t want to bake into a system that doesn’t include other types of vaccines.”