Updated COVID-19 vaccine recommended for everyone; old, young, immunocompromised will benefit most

Everyone should be able to get an updated COVID-19 vaccine, an expert panel decided Tuesday, with vaccines likely to become widely available within days.

The recommendation comes just a day after the Food and Drug administration signed off on the updated vaccines from Pfizer-BioNTech and Moderna. The director of the Centers for Disease Control and Prevention also signed off on the shots.

Vaccine makers already have begun shipping supplies of the new vaccines after receiving FDA approval.

The vaccines have been updated to target more recent variants of the virus that causes COVID-19, which has been evolving since it first appeared in late 2019. Although the variant targeted by the new shots is no longer the most commonly circulating one, studies have suggested that the new vaccines will be effective against current variants.

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Right now, a variant called EG.5 is the most common in the United States, according to CDC data, but it accounts for only about 22% of cases, with another half-dozen variants each accounting for 5% or more. All are part of the omicron family of variants, which began spreading globally around Thanksgiving of 2021.

That's likely why vaccines still provide protection, even against the newest variant. BA.2.86, which has not spread much in the U.S. yet, but which had raised early concerns because it has a large number of mutations distinguishing it from other variants.

Research presented at Tuesday's advisory committee meeting show that vaccines continue to provide people with safe, effective protection against COVID-19.

The people who get the most benefit from the shots are those at highest risk for severe disease from infection, including people with weakened immune systems from older age, health conditions or medications.

The federal advisory panel, which consists of 14 experts in infectious diseases, immunology, family medicine or medical research, recommends everyone get vaccinated, but particularly emphasized the need for vaccines for people who are:

  • 65 or older;

  • Infants under 6 months;

  • Pregnant people; and

  • Those younger than 65 who have conditions that affect their immune system, or are taking immune-suppressing medications to treat cancer, because of conditions like rheumatoid arthritis, or following an organ transplant.

COVID-19 infections have been rising since early July, data from the Centers for Disease Control and Prevention shows. Hospitalizations are up nearly 16% and deaths about 11% in the week that ended Thursday, compared with the week before, though totals remain well below previous peaks.

The bivalent vaccine, which has been available since last year, is no longer recommended.

What the data shows about COVID vaccines

As of this week, 700 million doses of COVID-19 vaccines have been administered in the United States.

They have proven safe overall, CDC data shows, despite short-term side effects and some cases of myocarditis, a swelling of the heart, largely among older adolescent males and young men. Myocarditis occurred most often after the second vaccine dose and was not seen after the most recent booster, though not very many in the most vulnerable age groups received that shot.

The only other safety signal picked up by national data was an increased risk for stroke among people over 65 who received both the flu and COVID-19 vaccines last winter. That risk was short-lived, however, and it's not clear exactly what was driving it, whether it was a coincidence or caused by the combined vaccines or an increase in COVID-19 infections, CDC officials told the committee.

About 5 people per every 1 million vaccinated suffered a severe allergic reaction to the shot.

Among children hospitalized with COVID-19 this year, 75% of babies had no underlying health conditions, 59% of those ages 6 months to 2 years had no previous health problems and 42% of toddlers were otherwise healthy, CDC data shows. Among older children and adolescents hospitalized for COVID-19, asthma was the most common health condition followed by neurological disorders and obesity.

Of babies hospitalized for COVID-19, 86% were unvaccinated. More than 60% of children ages 5-11 hospitalized with COVID-19 were unvaccinated and another 28% had not gotten a COVID-19 booster. Among adolescents hospitalized for COVID-19, only 6% were fully vaccinated and boosted, the data shows.

For adults hospitalized with COVID-19, most of all ages had three or more health problems, such as cardiovascular disease, diabetes or neurological disorders. Many more adults of all age groups were hospitalized from COVID-19 than from flu between October of last year and July of this year.

What the committee members considered

The lone member of the committee to vote against the recommendation said he supports the vaccine but felt it should be limited to people at highest risk for severe disease.

“We really need to level with our patients and say what is known and is unknown rather than make a complete recommendation,” said Dr. Pablo Sanchez, a professor of pediatrics at The Ohio State University – Nationwide Children’s Hospital. He advocated a “shared decision-making” process for people outside the highest risk groups, in which patients and their doctors decide together whether a shot is beneficial.

Other committee members opposed shared decision-making, saying it excluded people who did not have easy access to a doctor.

Plus, CDC data found that a number of people, including half of the young children hospitalized from COVID-19, had no previous health conditions putting them at high risk for severe disease. Limiting vaccine access to people at high risk would prevent those who might not fit into a preordained category from getting vaccinated.

“Those deaths are vaccine preventable,” said member Dr. Matthew Daley, a senior investigator with the Institute for Health Research at Kaiser Permanente Colorado in Aurora. “The disease burden does vary greatly by age, but there is serious illness, death across all age groups, including those without underlying medical conditions."

The other 12 members agreed and voted to recommend vaccination for everyone

“I have been astonished at the number of people who have not been vaccinated,” said member Dr. Camille Kotton an infectious disease specialist at Massachusetts General Hospital in Boston. She said a clear, simple recommendation that allowed anyone to choose to get a vaccine would be the best, most equitable approach. “Let’s keep America strong. Healthy. Let’s do away with COVID-19 as best we can.”

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Which COVID vaccines will be available soon?

The FDA's actions Monday related just to the vaccines manufactured by Moderna and Pfizer-BioNTech.

Both of their vaccines will be updated to target the omicron variant XBB.1.5, which was the dominant variant this spring and early summer.

It has since been replaced by other variants, but early research suggests the new vaccines will be protective against those, too.

Unlike previous years of the pandemic, the government will no longer cover the cost of all COVID-19 vaccinations. People with health insurance should have coverage for the shot, but people without insurance may have to pay out of pocket for the $110 to $130 cost per shot.

A third vaccine, made by Novavax, is also ready for delivery, though it was not covered by the FDA's action Monday. Novavax presented updated data on its vaccine at Tuesday's committee meeting. The FDA is considering emergency authorization for the vaccine in people ages 12 and up.

According to the company, doses of the vaccine, which is protein-based and does not use the mRNA technology of the other two, arrived in the U.S. on Monday.

Contact Karen Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.

This article originally appeared on USA TODAY: New COVID vaccine booster recommended for everyone by expert panel