Md.-developed Novavax shots get initial CDC OK
As a highly contagious version of the omicron variant fuels a new wave of COVID-19 cases, another vaccine is on the way. This one, from Gaithersburg-based Novavax, might appeal to some who have not yet gotten any shots and fill other vaccine needs.
The vaccine was recommended Tuesday by an advisory panel for the U.S. Centers for Disease Control and Prevention for those ages 18 and older who have not yet been vaccinated; CDC Director Dr. Rochelle P. Walensky swiftly signed off. The
Food and Drug Administration authorized it last week.
“Today, we have expanded the options available to adults in the U.S. by recommending another safe and effective COVID-19 vaccine,” Walensky said in a statement. “If you have been waiting for a COVID-19 vaccine built on a different technology than those previously available, now is the time to join the millions of Americans who have been vaccinated.”
The two-dose Novavax vaccine is a latecomer to the arsenal in the fight against COVID
“This vaccine can reach millions of people globally, filling a huge niche, especially because it doesn’t need to go into deep freeze like other vaccines and can be transported and stored in refrigerator temperatures.” — Dr. Karen Kotloff, a professor of pediatrics at the University of Maryland School of Medicine
19, but experts say it’s a more traditional vaccine, like those long-accepted by the public for the flu or routine childhood inoculations.
It uses actual protein from the virus to spur production of virus-fighting antibodies in people rather than using genetically engineered material that provides instructions to make the protein. That’s how the widely used Pfizer/ BioNTech or Moderna vaccines work.
Experts point to surveys showing some want the more traditional vaccine, even if that’s a small slice of the holdouts.
The Novavax vaccine also could be used as booster doses eventually, once the FDA authorizes that use. Only about a third of Americans have gotten a booster. Those age 50 and older and others who are immune-compromised are eligible for a second booster dose and those age 5 and older eligible for their first booster.
Another related outcome for the Novavax vaccine may be filling global needs once more is produced, said Dr. Karen Kotloff, a professor of pediatrics at the University of Maryland School of Medicine and a co-lead for the Novavax Phase 3 clinical trial. The vaccine already is authorized in several dozen countries, including Canada and the United Kingdom, but production delays have meant doses have been limited.
“It fills a niche here, though it’s a little bit late and many people already are vaccinated, but I believe some people would be more comfortable with a protein-based vaccine, one that doesn’t have the words ‘genetic material’ in it,” said Kotloff, also associate director of clinical studies in Maryland’s Center for Vaccine Development and Global Health.
“That’s probably a small proportion of the population,” she said. “But this vaccine can reach millions of people globally, filling a huge niche, especially because it doesn’t need to go into deep freeze like other vaccines and can be transported and stored in refrigerator temperatures.”
During Tuesday’s hearing by the CDC’s Advisory Committee on Immunization Practices, experts noted there are still 26 million to 37 million U.S. adults who have noted been immunized against COVID-19. Unvaccinated and unboosted adults were 3.5 times more likely to be hospitalized for COVID19, according to federal data collected in May, and the most likely to be unvaccinated were younger, white and living in rural areas.
Cases have been rising to levels last seen in February as the massive winter wave was abating. Federal officials attribute infections, and a lot of reinfections, to a new omicron subvariant called BA.5 that has become dominant across the country and is adept at evading immune defenses.
There were more than 122,600 infections reported nationally Tuesday, including 1,157 in Maryland, though officials believe cases are undercounted significantly now because many people test at home and don’t report results.
The CDC reports high transmission of COVID-19 for nearly all of the country, including Maryland. Another CDC measure of community spread, which heavily weights the burden on the health care system rather than just counting cases, shows only Howard and Garrett counties at high levels. Other counties and Baltimore were either moderate or low based on burden to hospitals.
Novavax officials said trials showed its vaccine was more than 90% effective against infection with low rates of adverse reactions, though federal officials will continue to monitor for heart inflammation.
Officials said they expect recipients to need a booster dose at some point, as is the case with the other vaccines.
The vaccine wasn’t tested against the latest omicron subvariants specifically, but Novavax officials said they also will work toward an omicron-specific vaccine by year’s end.
Most immediately, Filip Dubovsky, a Novavax official, told the CDC panel that he hoped the vaccine would persuade the “vaccine hesitant.”
The regulators also gave guidance for those who want the Novavax vaccine but have recently taken a vaccine for monkeypox — there are now 46 cases in Maryland among almost 2,000 U.S. cases. Those who get the monkeypox vaccine first should consider waiting four weeks before getting a COVID-19 vaccine. Those who just got a COVID-19 vaccine do not have to wait for a monkeypox vaccine.
The Novavax vaccine is being produced at the Serum Institute of India, and federal authorities have bought 3.2 million doses so far and will distribute it for free to states, pharmacies and elsewhere.
Chase Cook, a spokesman for the Maryland Department of Health, said officials plan to offer the Novavax vaccine but are waiting for more information on how soon the state will receive the Novavax vaccine and in what quantities.
“In early June, Governor Hogan announced COVIDReady Maryland, the state’s plan to maximize all of the available tools and treatments for preventing severe illness and keeping people from being hospitalized, and to maintain an ongoing state of readiness over the long term so that we remain prepared to respond to any emerging variants and any potential waves or surges,” Cook said.
“Every COVID-19 vaccine offered in Maryland is a safe and effective tool in mitigating the symptoms and spread of the virus.”
To find a vaccine clinic, go to covidvax.maryland.gov.