The latest COVID-19 shots are likely days away from being available in pharmacies, health centers and doctors’ offices in Maryland and around the country.
The shots from two mRNA vaccine manufacturers were approved by the U.S. Food and Drug Administration on Monday. An advisory panel for the U.S. Centers for Disease Control and Prevention met Tuesday and voted to recommend everyone age 6 months and older get them.
The panel debated a more focused recommendation for the elderly or those with underlying health conditions, but officials decided on the broader guidance since people of all ages and in all conditions could harshly affected by COVID-19.
Many health experts had already weighed in, noting coronavirus cases have been on the rise and other respiratory viruses are expected with cooler temperatures. They urged people of all ages and health conditions to consider another round of shots when they become available.
One of them was Dr. Matthew Laurens, a clinical trials unit director in the University of Maryland School of Medicine’s Center for Vaccine Development and Global Health. The center was among the labs federally designated to test the mRNA vaccines from Pfizer-BioNTech and Moderna, and scientists there continue to have a hand in COVID-19 and flu vaccines.
Laurens spoke with the The Banner about what Marylanders should know about the newly approved vaccines.
Which shots were approved?
FDA officials signed off on the latest versions of the two mRNA vaccines, which they likened to the annual influenza shot, tailored to circulating strains. The vaccines replace a bivalent booster shot that was in use.
In this case, the new shots targets a single variant, XBB.1.5, which was dominant a few months ago. Testing showed it should be a good match for currently circulating variants as well, including EG.5.
The aim is to protect people from severe disease, though not necessarily from being infected with more mild cases.
The shots were approved for older people and given emergency authorization for children. That means one shot for anyone age 5 and older who has not had a shot in at least two months. Children as young as 6 months, and people who are immunocompromised, could receive more doses to provide protection.
How does the FDA know the vaccines work?
The vaccines initially went through the normal approval process, albeit far more quickly. The updated vaccines rely on extensive testing to assure safety and efficacy and establish potential side effects, Laurens said.
“The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “We very much encourage those who are eligible to consider getting vaccinated.”
The new vaccine has the original formulation, with only a change to something called the spike protein, which is a structure attached to the outside of the virus where mutations can occur. It can be swapped out to adapt the vaccine to new variants.
“They can take it into the lab and see how it performs against different strains, not just the XBB.1.5 but others circulating,” Laurens said. “Its neutralizing capacity was similar.”
Who should get this shot?
Certainly high-risk groups should get the shot, which includes seniors and those who are immunocompromised or have underlying health conditions.
But since few people, about 20%, bothered to get the last booster shot, Laurens says, most people likely have waning immunity. They could become infected, unless they had a case recently.
“It’ll protect people from a hospital and ICU stay,” he said. “It’ll reduce symptomatic COVID-19, which can be really unpleasant. For that reason, people from all walks of life will want to avoid COVID-19 illness. People will avoid missing a lot of work, family activities and social events because they are sick.”
And while younger, healthier people tend to not get terribly sick, they can pass infections to their vulnerable relatives or neighbors. Repeated infections also bring a risk of so-called long COVID, where symptoms continue or new symptoms can arise and linger.
When should people get the new shot?
As soon as it’s available, recommends Laurens.
He said cases are on the rise now. Hospitalizations, though far from pandemic highs, have been rising since June in Maryland. Data from the Maryland Department of Health shows there were 291 people in the hospital as of Sept. 11, and several deaths a day continue to be reported.
Respiratory illnesses remain low in the state. But cases of COVID-19, and the respiratory diseases flu and RSV, came early last year; flu cases in Maryland peaked in November and swamped the health care system.
“As people gather indoors with the cooler weather, there is typically an increase in respiratory viruses, and they can come on without warning,” Laruens said. “It also takes about two weeks for the full effect on the immune system from a vaccine.”
Should people get other vaccines at the same time?
COVID-19 and flu shots can safely be taken at the same time, Laurens said. Most people also find it convenient to go to the pharmacy or doctor’s office only once.
Public and private insurance are expected to cover the shots. The new COVID-19 vaccines are the first since a public health emergency ended earlier this year. The federal government has a bridge plan to help those uninsured or underinsured get the COVID-19 vaccine.
This year, in addition to the COVID-19 and flu vaccines, there are RSV shots available to the elderly and young children. The vaccine for seniors is also available to those who are pregnant, with protections extending to newborns.
RSV, or respiratory syncytial virus, is of particular threat to infants because they can struggle to breathe when infected.
A different antibody treatment called nirsevimab is also available as a shot for children up to 8 months that helps boost their immune systems.