CDC advisers to weigh recommendations for updated Covid-19 vaccines

CNN
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A panel of experts that advises the US Centers for Disease Control and Prevention on its vaccine recommendations is meeting Tuesday to consider how safe and effective three updated Covid-19 vaccines — including the two recently authorized by the US Food and Drug Administration — may be for Americans over the fall and winter.

The meeting follows Monday’s move by the US Food and Drug Administration to green-light Moderna and Pfizer/BioNTech’s updated vaccinations. Novavax’s vaccine is under review by the FDA for authorization in people 12 and older.

The members of the CDC panel, called the Advisory Committee on Immunization Practices, or ACIP, will vote on recommendations for who should get the vaccines, and then CDC Director Dr. Mandy Cohen may sign off.

If she does, the vaccines will be available at pharmacies and public health departments and clinics nationwide within days.

The three vaccines have been tweaked to help the body’s immune system make antibodies against the XBB.1.5 coronavirus variant, which was the main cause of Covid-19 in the US this spring and continues to circulate.

Several virus families that are closely related to XBB.1.5 are now dominating transmission in the United States. The hope is that these new vaccines will some protection against these newer offshoots, too.

“COVID-19 remains a leading cause of death in the U.S. and poses a significant threat to vulnerable populations, particularly as we enter peak respiratory virus season,” Stéphane Bancel, CEO of Moderna, said in a news release Monday.

“As the primary circulating strain continues to evolve, updated vaccines will be critical to protecting the population this season,” Bancel said.

There aren’t expected to be any big surprises at the ACIP meeting, but the committee could influence how the vaccines are given, said Dr. Bill Schaffner, an infectious disease expert at Vanderbilt University who represents the National Foundation of Infectious Diseases during the ACIP discussions.

He expects that the committee will weigh whether to make a blanket recommendation, as it does for the annual influenza vaccine that’s recommended for everyone over 6 months old, or to make a risk-based one.

A risk-based recommendation would mean the vaccines might be recommended only for people deemed to be at higher risk for severe outcomes from Covid-19, such as health care workers, those who are age 60 and older, who are pregnant, or who have compromised immune function. Everyone else might be eligible after something called shared clinical decision-making, meaning you can get the vaccine after consultation with a doctor or nurse practitioner.

The World Health Organization revised its vaccine recommendations in March, saying countries should consider disease burden and cost-effectiveness when deciding whether to vaccinate healthy kids and teens against Covid-19

Schaffner says he expects that the ACIP members will also want to learn more about the government’s plan to continue to provide Covid-19 vaccines for free to people who are uninsured or underinsured under the Bridge Access Plan. This is the first time the vaccines will be available on the commercial market, which means the cost of paying for them has shifted to individuals and their insurance providers.

“They want this vaccine available to everyone for whom they recommended, even if they don’t have insurance, now that we have transitioned from the government buying all the vaccine to our usual chaotic non-system of funding vaccines,” he said. “The committee is very interested in equity.”

Schaffner said the committee will probably also be interested in hearing from the drugmakers about how they plan to package the vaccines. Doses that come as single-dose prefilled syringes, rather than multidose vials, will be more attractive to doctor’s offices.

“They have not liked very much having to deal with 10-dose vials, giving out two doses and then having the rest of the vaccine expire. So if there are single-dose presentations, that will make it much easier for your doctor, your family doctor, your internist, whomever, to actually participate in this program and make the vaccine accessible to as many people as possible,” he said.

Covid-19 hospitalizations and deaths are on the rise, though they are nowhere near the heights of past surges. Covid community levels are generally considered low across the country, but a growing number of counties, including many in Florida, have levels at which the CDC recommends masking for people at higher risk of severe illness.

The Pfizer/BioNTech and Moderna vaccines teach the body to recognize the virus that causes Covid-19 with mRNA technology. Novavax’s uses the spike proteins from the virus to stimulate the immune system to make antibodies.

The companies are expected to present clinical data at the ACIP meeting on how well these updated shots seem to be working.

ACIP’s recommendations are not binding, but how they vote determines insurance coverage for immunizations. Many physicians also follow their guidance when prescribing vaccinations.

CNN’s Carma Hassan, Deidre McPhillips and Jacqueline Howard contributed to this report..