By Brenda Goodman, CNN
A panel of independent experts advising the U. S. Food and Drug AdministrationThe U. S. Food and Drug Administration voted unanimously Thursday to update all COVID-19 vaccines to include the same ingredients as the two-strain injections now used as booster doses.
The vote means that young people and others who have not been vaccinated could soon be eligible to receive vaccines from two strains that are better suited to circulating viruses as series one.
The FDA will have to approve the committee’s recommendation, which it likely will, before it takes effect.
Currently, the United States offers two types of vaccines against covid-19. The first vaccines other people get, also known as the number one series, include a unique set of commands that teach the immune formula to combat the original edition of the virus. that gave the impression in 2019.
This index strain no longer circulates. It invaded months ago through an ever-changing parade of new variants.
Last year, in consultation with its advisers, the FDA came on time to update the vaccines. These bivalent or bivalent aircraft involve two sets of instructions; one set recalls the immune formula of the original coronavirus edition, and the moments set teaches the immune formula to recognize and combat Omicron’s BA. 4 and BA. 5 subvariants, which emerged in the US. Last year, the U. S. government last year.
People who have had their number one series — nearly 70 percent of all Americans — were asked to get the new two-strain booster expired last year in an effort for coverage against previous variants.
The advisory committee heard testimony and knowledge suggesting that the complexity of having two types of COVID-19 vaccines and schedules for teams of other ages is possibly one of the reasons for the low vaccination rate in the United States.
Currently, only about two-thirds of Americans have had the full string of number one hits. Only 15% of the population earned an updated bivalent retirement.
Data presented to the committee shows that COVID-19 hospitalizations are highest for children under 2 over the past year, as Omicron and its many subvariants have been circulating. Only 5% of this age group, eligible for vaccination against covid-19 in 6 months, has been fully vaccinated. Ninety percent of children under the age of four are still vaccinated.
“The maximum point of knowledge I saw all day is this incredibly low vaccination policy between 6 months and 2 years and also between 2 and 4 years,” said Dr. Brown. Amanda Cohn, director of the Division for Disease Control and Prevention at the U. S. Centers for DiseaseUU. de Congenital Malformations and Childhood Disorders. ” We want to do much, much better. “
Cohn says having a single covid-19 vaccine in the U. S. A U. S. study for number one and booster doses would go a long way toward making the procedure less confusing and getting more children vaccinated.
Others, convenience is important, but also noted that knowledge has supported change.
“It’s not just a matter of convenience, expanding the number of other people vaccinated, which, I agree with my colleagues, is incredibly vital to all the evidence that’s linked, but I also think it’s very important to move toward the strains that are circulating. I would also say that science supports this decision,” said Dr. Brown. Hayley Gans, pediatric infectious disease specialist at Stanford University.
Many other committee members were also pleased after seeing new knowledge about the vaccine’s efficacy of bivalent boosters, who threaten to get sick, be hospitalized or die from COVID-19 infection.
“I am totally convinced that the bivalent vaccine is favorable as a number one series and as a booster series. In addition, the up-to-date knowledge on vaccine protection is encouraging so far,” said Dr. David Kim, director of the U. S. Department. UU. de Health and the National Human Services Immunization Program, in a public debate after the vote.
Thursday’s vote is part of a broader FDA plan to simplify how covid-19 vaccines are administered in the United States.
The firm has proposed a plan to convene its vaccine advisers, called the Advisory Committee on Vaccines and Related Biologics, or VRBPAC, in May or June to assess whether covid-19 vaccine commands want to be replaced more closely. correspond to circulating strains of the virus.
The timeframe selected to give brands around 3 months to redesign their injections and supply new doses to pharmacies in time for the fall.
“The point, of course, first of all, is not to chase variants. None of us think that’s realistic,” said Jerry Weir, director of the Division of Viral Products in the FDA’s Office of Vaccine Research and Review.
“But I think our delight so far, with the bivalent vaccines that we have, indicates that we can continue to make innovations to the vaccine, and that would be the end of those meetings,” Weir said.
During discussions following the vote, committee members supported this plan, but pointed out many things we have yet to perceive about Covid-19 and vaccination that are likely to complicate the task of updating vaccines.
For example, we now appear to have outbreaks of covid-19 in both summer and winter, said Dr. Michael Nelson, an allergist and immunologist at the University of Virginia. Are sudden increases in strength related? And if so, is autumn the time to do a vaccination campaign?
The CDC’s Dr. Jefferson Jones said that with only three years of experience with the virus, it’s too early to realize its seasonality.
Other questions similar to the durability of mRNA vaccines and whether other platforms can offer longer protection.
“We can’t keep doing what we’re doing,” said Dr. Bruce Gellin, leader of the Rockefeller Foundation’s global public fitness strategy. “This has been articulated in those meetings despite the quality of those vaccines. We want more vaccines. “
The committee also encouraged government and industry scientists to provide a more complete picture of how vaccination and immunity to infections.
One of the main tactics researchers measure vaccine effectiveness is through how well they build first-line defenders called neutralizing antibodies.
Neutralizing antibodies are like firefighters rushing to the site of an infection to engage and extinguish it. They are wonderful in a crisis, but their numbers tend to decrease over time if they are not needed. Other parts of the immune formula such as B cells and T cells attach to a virus’ memory and are able to react if the frame finds it again.
Scientists don’t know much about how much Covid-19 vaccination stimulates those responses and how long this coverage lasts.
Another puzzle will be how the strains contained in vaccines.
The strain variety process for influenza vaccines is a global effort that relies on surveillance data from other countries. It works because flu strains tend to become dominant and sweep the world. But the Covid-19 strains didn’t work the same way. that have caused large waves in other countries have slightly become the combination of American variants.
“For the future, it’s difficult. The variants don’t sweep the world as evenly as they seem to do with the flu,” the FDA’s Weir said. “But our primary duty is what’s most productive for the U. S. market, and that’s where we’re going to focus. “
Eventually, the FDA hopes Americans will be able to get an updated covid-19 vaccine once a year, the same way they do for the flu. – such as the elderly or those with weakened immune systems – may need more doses, as may other people receiving COVID-19 vaccines for the first time.
At Thursday’s meeting, the advisory committee also heard about a protective sign marked through a surveillance formula called the Vaccine Safety Data Link.
The CDC and FDA reported Jan. 13 that the system, which is based on fitness records from a network of giant hospital systems in the United States, had detected a potential protective factor with Pfizer’s bivalent boosters.
In this database, other people over age 65 who gained a bivalent booster from Pfizer were more likely to have a stroke caused by a blood clot within 3 weeks of vaccination than other people who gained a bivalent booster and were still between 22 and 42 days old. after injection.
After a thorough review of other vaccine protection knowledge in the U. S. In the U. S. and other countries using Pfizer’s bivalent boosters, the agencies concluded that the threat of stroke is likely a statistical match and said no adjustments to vaccination schedules were recommended.
At Thursday’s meeting, Dr. Nicola Klein, principal investigator at Kaiser Permanente Northern California, explained how they emit the signal.
The researchers compared other people who had received a vaccine in the past three weeks with others who were 22 to 42 days away from receiving their vaccines, as this helps skew the data.
When they looked at how many other people had had a stroke at the time of vaccination, they discovered an imbalance in the data.
Of another 550,000 people over the age of 65 who had gained a bivalent booster from Pfizer, 130 suffered a stroke caused by a blood clot within three weeks of vaccination, and another 92 people in the organization were farther away from their shots.
Researchers detected the signal the week of Nov. 27 and it continued for about seven weeks. The signal has declined over time, from a threat that nearly doubled in November to a 47 percent threat in early January, Klein said. days, it has been posted at all.
Klein said they didn’t see the sign on any of the other age teams or with the organization that won Moderna reinforcements. They also didn’t see a difference when they compared Pfizer-powered seniors to those who were still eligible for bivalent retirement. He didn’t get one.
Other studies have suggested that the symptom may occur not because other people who are within 3 weeks of a Pfizer booster have more strokes, but because other people who are within 22 to 42 days of their Pfizer boosters have fewer strokes.
Overall, Klein said, they were seeing fewer strokes than expected in this population in that period, suggesting a statistical stroke of luck.
However, another interesting thing that emerged from that data was an imaginable combination between stroke and high-dose flu vaccination. rate like those who were 22 to 42 days before their injections.
In addition, Klein said, the researchers did not find the same arrangement between stroke and time since vaccination in other people who did not receive the flu vaccine on the same day.
However, the total number of strokes in the population of others who received the flu vaccine and covid-19 boosters on the same day is small, making the situation fragile.
“I don’t think the evidence is enough to conclude that there is a fix,” said Dr. Tom Shimabukuro, director of the CDC’s Office of Vaccine Safety.
Still, Richard Forshee, deputy director of the FDA’s Office of Biostatistics and Pharmacovigilance, said the FDA plans to read more about protective problem data collected through Medicare.
The FDA showed the company is taking a closer look.
“The goal of the study is 1) to compare the initial symptom of ischemic stroke reported by CDC with an independent dataset and more physically potent epidemiological methods; and 2) assess whether there is an increased risk of ischemic stroke with the bivalent COVID-19 vaccine if administered on the same day as a full-dose or adjuvanted seasonal flu vaccine,” a spokesperson said in a statement.
The FDA has not given a timeline for when those studies have results.
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