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FDA vaccine advisors vote to harmonize Covid-19 vaccines in US






CNN

A panel of independent experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously on Thursday to update all Covid-1[ads1]9 vaccines to contain the same ingredients as the two-strain shots now used as booster doses.

The vote means young children and others who have not been vaccinated may soon be eligible to receive two-strain vaccines that more closely match the circulating viruses as their primary series.

The FDA must sign off on the committee’s recommendation, which it likely will, before it takes effect.

Currently, the US offers two types of Covid-19 vaccines. The first shots people receive – also called the primary series – contain a simple set of instructions that teach the immune system to fight the original version of the virus, which appeared in 2019.

This index stem is no longer circulating. It was overtaken months ago by an ever-evolving parade of new variants.

Last year, the FDA, in consultation with its advisors, decided it was time to update the vaccines. These two-stem, or bivalent, shoots contain two sets of instructions; one set reminds the immune system of the original version of the coronavirus, and the other set teaches the immune system to recognize and fight Omicron’s BA.4 and BA.5 subvariants, which appeared in the US last year.

People who have had their primary strain — nearly 70% of all Americans — were advised to get the new two-strain booster late last year in an effort to upgrade their protection against the latest strains.

The advisory committee heard testimony and data suggesting that the complexity of having two types of Covid-19 vaccines and schedules for different age groups may be one of the reasons for low vaccine uptake in the United States.

Currently, only about two-thirds of Americans have had the full primary series of shots. Only 15% of the population has received an updated bivalent booster.

Data presented to the committee show that Covid-19 hospitalizations have increased for children under the age of 2 over the past year, as Omicron and its many subvariants have circulated. Only 5% of this age group, who are eligible for Covid-19 vaccination at 6 months of age, are fully vaccinated. Ninety percent of children under the age of 4 are still unvaccinated.

“The most concerning data point I saw all day was the extremely low vaccination coverage for ages 6 months to 2 years and also 2 years to 4 years,” said Dr. Amanda Cohn, director of the US Centers for Disease Control and Prevention’s Division of Birth Defects and Infant Disorders . – We have to do much, much better.

Cohn says that having a single vaccine against Covid-19 in the US for both primary and booster doses will go a long way in making the process less complicated and will help get more children vaccinated.

Others feel that convenience is important, but also emphasized that data supported the switch.

“This is not just a matter of convenience, increasing the number of people who are vaccinated, which I agree with my colleagues is extremely important for all the evidence that was related, but I also think moving against the strains that are circulating is very important, so I would also say that the science supports this move, says Dr. Hayley Gans, a pediatric infectious disease specialist at Stanford University.

Many others on the committee were similarly pleased after seeing new data on the vaccine effectiveness of the bivalent boosters, which reduce the risk of getting sick, being hospitalized or dying from a Covid-19 infection.

“I am completely convinced that the bivalent vaccine is beneficial as a primary series and as a booster series. Also, the updated vaccine safety data is really encouraging so far,” said Dr. David Kim, director of the US Department of Health’s National Immunization Program, in public discussion after the vote.

Thursday’s vote is part of a larger plan by the FDA to simplify and improve the way Covid-19 vaccines are given in the United States.

The agency has proposed a plan to convene its vaccine advisers — called the Vaccines and Related Biological Products Advisory Committee, or VRBPAC — each year in May or June to consider whether the instructions in the Covid-19 vaccines should be changed to better match circulation. strains of the virus.

The time frame was chosen to give manufacturers about three months to redesign their shots and get new doses to pharmacies in time for the fall.

“The intention – before anyone says anything – is of course 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 experience so far, with the bivalent vaccines that we have, indicates that we can continue to make improvements to the vaccine, and that would be the goal of these meetings,” Weir said.

In discussions after the vote, committee members supported this plan, but pointed out many of the things we still don’t understand about Covid-19 and vaccination that are likely to complicate the task of updating the vaccines.

For example, we now seem to have Covid-19 spikes in summer as well as winter, noted Dr. Michael Nelson, an allergist and immunologist at the University of Virginia. Is the surge related? And if so, is autumn the best time to be a vaccination campaign?

The CDC’s Dr. Jefferson Jones said that with only three years of experience with the virus, it’s really too early to understand seasonality.

Other important questions relate to the durability of the mRNA vaccines and whether other platforms can provide longer protection.

“We can’t keep doing what we’re doing,” said Dr. Bruce Gellin, chief of global public health strategy at the Rockefeller Foundation. “It’s been articulated in all these meetings despite how good these vaccines are. We need better vaccines.”

The committee also called on researchers from both government and industry to provide a more complete picture of how vaccination and infection affect immunity.

One of the main ways researchers measure the effectiveness of vaccines is by looking at how much they raise front-line defenders called neutralizing antibodies.

Neutralizing antibodies are like firefighters who rush to the scene of an infection to contain and extinguish it. They are good in a crisis, but they tend to dwindle in number over time if they are not needed. Other components of the immune system such as B cells and T cells hang on to the memory of a virus and are ready to react if the body encounters it again.

Scientists do not understand much about how well Covid-19 vaccination boosts these responses and how long the protection lasts.

Another puzzle will be how to pick the strains that are in the vaccines.

The process of selecting strains for influenza vaccines is a global effort that relies on surveillance data from other countries. This works because flu strains tend to become dominant and sweep around the world. But Covid-19 strains have not worked in quite the same way. Some who have made big waves in other countries have barely made it into the American variety mix.

– Going forward, it is still challenging. Variants do not sweep across the world as uniformly as they appear to do with the flu, FDA’s Weir said. “But our primary responsibility is what’s best for the U.S. market, and that’s where our focus will be.”

Eventually, the FDA hopes Americans will be able to get an updated Covid-19 shot once a year, the same way they do for the flu. People who are unlikely to have an adequate response to a single dose of the vaccine – such as the elderly or those with weakened immune systems – may need multiple doses, as may people receiving Covid-19 vaccines for the first time.

At Thursday’s meeting, the advisory committee also heard more about a safety signal flagged by a state monitoring system called the Vaccine Safety Datalink.

The CDC and FDA reported on January 13 that this system, which relies on health records from a network of major US hospital systems, had discovered a potential safety issue with Pfizer’s bivalent boosters.

In this database, people 65 and older who received a Pfizer bivalent booster were slightly more likely to have a stroke caused by a blood clot within three weeks of vaccination than people who had received a bivalent booster but were 22 to 42 days after the shot. .

After a thorough review of other vaccine safety data in the United States and in other countries that use Pfizer bivalent boosters, the agencies concluded that the stroke risk was likely a statistical feature and said no changes to vaccination schedules were recommended.

At Thursday’s meeting, Dr. Nicola Klein, a senior researcher at Kaiser Permanente in Northern California, explained how they found the signal.

The researchers compared people who had received a vaccine within the past three weeks with people who were 22 to 42 days away from their shots, because this helps eliminate bias in the data.

When they looked to see how many people had strokes around the time of vaccination, they found an imbalance in the data.

Of 550,000 people over 65 who had received a Pfizer bivalent booster, 130 had a stroke caused by a blood clot within three weeks of vaccination, compared with 92 people in the group further away from the shots.

The researchers detected the signal the week of November 27, and it continued for about seven weeks. The signal has declined over time, falling from a nearly two-fold risk in November to a 47 percent risk in early January, Klein said. For the last few days it has not appeared at all.

Klein said they did not see the signal in any of the other age groups or in the group that received Moderna boosters. They also saw no difference when comparing Pfizer-boosted seniors with those who were eligible for a bivalent booster but had not received one.

Further analysis has suggested that the signal may be occurring not because people who are within three weeks of a Pfizer booster have more strokes, but because people who are within 22 to 42 days of the Pfizer booster actually have fewer strokes.

Overall, Klein said, they saw fewer strokes than expected in this population over that time period, suggesting a statistical fluke.

Another interesting thing that came out of this data, however, was a possible link between stroke and high-dose flu vaccination. Seniors who received both shots on the same day and were within three weeks of those shots had twice as many strokes compared to those who were 22 to 42 days away from the shots.

Also, Klein said, the researchers did not see the same association between stroke and time since vaccination in people who did not receive the flu vaccine on the same day.

However, the total number of strokes in the population of people who received flu shots and Covid-19 boosters on the same day is small, which makes the association appalling.

“I don’t think the evidence is sufficient to conclude that there is an association there,” said Dr. Tom Shimabukuro, director of the CDC’s Office of Immunization Safety.

Still, Richard Forshee, assistant director of the FDA’s Office of Biostatistics and Pharmacovigilance, said the FDA plans to look at these safety issues further using data collected by Medicare.

The FDA confirmed that the agency is looking into it.

“The purpose of the study is 1) to evaluate the preliminary ischemic stroke signal reported by the CDC using an independent data set and more robust epidemiologic methods; and 2) to assess whether there is an elevated risk of ischemic stroke with the covid-19 bivalent vaccine if the given on the same day as a high-dose or adjuvanted seasonal flu vaccine, a spokesperson said in a statement.

The FDA did not provide a time frame for when these studies might have results.



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