FDA experts are still confused about who should get which Covid shot and when

At a meeting aimed at simplifying the nation’s covid vaccination policy, the FDA’s panel of experts could only agree on one thing: An unfortunate lack of information about how often different groups of Americans need to be vaccinated. vaccination. That data gap has contributed to widespread skepticism, under-vaccination, and ultimately, unnecessary deaths from covid-19.

The committee voted unanimously on Thursday to support the FDA’s proposal for all vaccine manufacturers to use the same strain of the virus when making changes to their vaccines, and proposed they may meet in May or June to select a vaccine strain that will hit the market. out this fall.

However, panel members disagreed with the FDA’s recommendation that everyone should get the shot at least once a year, saying more information is needed to make such a claim. Some panelists noted that in recent research, only about a third of people hospitalized with positive covid test was actually there for covid disease. That’s because everyone entering the hospital is tested for covid, so the deaths of patients with random infections are counted as covid deaths even if it wasn’t the cause.

Experts question the rationale for getting an annual vaccination for everyone, as current vaccines do not seem to protect against infection for more than a few months. However, even a single boost seems to prevent death and hospitalization in most people, with the exception of the very old and those with certain medical conditions.

“We need CDC to tell us exactly who is being hospitalized and dying from this virus – their age, vulnerability, type of immunosuppression, and whether they are being treated with antibiotics. virus or not. And we need immunological data to figure out who is at risk,” said Dr. Paul Offit, director of the Center for Vaccine Education and pediatrician at Children’s Hospital of Philadelphia. “Only then can we decide who gets what and when.”

Offit and others have expressed frustration at the government’s lack of clear messaging about what the public can expect from a covid vaccine. While regular booster doses can be important to keep the elderly and otherwise healthy from being hospitalized, the annual boosters recommended by the FDA and drug companies, he said. may not be necessary for everyone.

“The goal is to keep people out of the hospital,” he said. “For vulnerable people, it is important for vaccines to keep up with circulating strains. But for the general population, we have a vaccine that prevents hospitalization.”

Other panelists said the government needs to step up research further to get a better vaccine. Pamela McGinnis, a retired official with the National Institutes of Health, said she had trouble explaining to her two teenage sons why they quickly fell ill after venting out of a bar on a night just a few weeks after a booster dose of chemotherapy.

“‘Think how sick you would be if you weren’t fully vaccinated’ is not a good message,” she said. “I’m not sure ‘You’ll be hospitalized’ resonates with people with the disease.”

Members of the FDA’s advisory committee have expressed outrage in recent months, saying the agency did not provide them with all data on the bivalent vaccine before it was released in September. . And some reviewers have said The FDA should have instructed drug companies to only put newer strains of the virus in the shot.

When asked about that Thursday, Jerry Weir, a senior FDA vaccine official, said his “hunch” was that a vaccine tailored to a single omicron strain would work better than a single omicron strain. with the bivalent vaccine, which also contains the original covid strain. “But the real question is where are we headed,” he said, “and I don’t know the answer.”

Probably most Thursday important presentation by Heather Scobie, a covid monitor at the Centers for Disease Control and Prevention. She reports that less than half of Americans age 65 and older get their latest booster shot, and only two-thirds of that age group get even one booster.

However, evidence continues to suggest that most elderly people are at risk for severe covid disease. The death rate from the disease has decreased in every age group, except those over 75 since April, despite an increase in new strains. With the exception of the very old, the death rate has hovered around 1 in 100,000 since April. In early 2022, infants aged 6 months and younger were hospitalized and died at a relatively high rate. Vaccination levels in the group of 4 years and under fluctuated at about 10%.

While acknowledging the FDA’s desire to legitimize its covid vaccine policy, panel members said it was too early to know for sure if covid would only emerge in the winter, like the flu. , respiratory syncytial virus and other respiratory infections.

“Over the next few years, we may not know how often we need to change vaccine strains,” said Dr. Steven Pergam, medical director for infection prevention at the Seattle Cancer Care Alliance. Or even those who are not in poor health, the elderly also need to supplement with strengthening medicine.

A vaccine manufacturer represented at the meeting, Novavax, said it would need to know by the end of March which strains should be included in the vaccine for the fall. Companies with mRNA vaccines like Pfizer and Moderna can change their formulations faster, but their products are clearly no better than Novavax’s.

All three vaccine manufacturers revealed at the meeting that they were developing single-dose vials or pre-filled syringes. So far, they have offered vaccines in multi-dose vials, but because the government has run out of money to buy vaccines, pediatricians may order them in the future. Because the vaccine must be used quickly after opening the vial, doctors are very worried about wasting the vaccine and losing money.


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