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Maryland-based Novavax phase 3 clinical trial expands to include children 12 to 17

A Maryland-based COVID-19 vaccine producer is expanding its late-stage Phase 3 clinical trial study to include children ages 12 to 17.

Novavax, headquartered in Gaithersburg, will assess the safety and effectiveness of its protein-based immunization on up to 3,000 adolescents across the United States, the company said Monday. Participants in the study will be monitored for two years after the last injection.

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Phase 3 clinical trials are the last and longest steps of vaccine research. Novavax sought thousands of participants for its Phase 3 trials in the United States, United Kingdom, South Africa and Mexico.

Novavax’s coronavirus vaccine candidate, like those made by Pfizer/BioNTech and Moderna, calls for a two-dose regimen for best protection. But unlike those two vaccines-makers, Novavax does not require ultra-cold storage, making it easier for providers to handle in rural and more remote regions.

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The vaccine candidate also does not use the messenger RNA technology used by Pfizer and Moderna, making it a more attractive option for people skeptical about receiving a relatively new type of vaccine.

Federal regulators are poised to authorize use of the Pfizer vaccine for kids ages 12 to 15 as early as next week, The New York Times reported late Monday afternoon. Pediatric clinical trials for the Moderna vaccine are currently underway at the University of Maryland School of Medicine.

Matthew Frieman, a researcher and associate professor in the microbiology and immunology department at the University of Maryland School of Medicine, said the Novavax vaccine also reported higher levels of efficacy against some of the new COVID-19 variants than others, firming up its place as an essential component of the national vaccination effort.

“We’re all chasing the new variants as they emerge and looking for new viruses that are emerging but also evading the protection received from preexisting infection,” Frieman said.

Frieman’s lab studied different, early versions of the Novavax vaccine in mice and also analyzed human serum samples in people who received the version that won out.

He said having several COVID-19 vaccines available will be important for life to return to a pre-pandemic rhythm.

“It’s much safer to be vaccinated than it is to be infected with [COVID-19],” he said. “It gives you much better protection than being infected and having antibodies.”

None of the three vaccines currently authorized for use in the U.S. is available for children under 16. But that segment of the population is critical to the vaccination campaign, pushing the country closer toward abating the coronavirus pandemic and reaching herd immunity, or the threshold of protection against COVID-19 in which the virus runs out of hosts, and infections, hospitalizations and deaths plummet.

There’s growing skepticism in the scientific community that herd immunity can be reached, The New York Times reported Monday, as many Americans remain resistant to getting vaccinated. Some experts call for as much as 80% of the population or more to get inoculated against the coronavirus.

A survey published last month from researchers at Harvard University and Medical School and Northeastern, Northwestern and Rutgers universities found some 32% of respondents remain resistant to vaccines after the temporary pause of the Johnson & Johnson immunization as federal regulators studied reports of extremely rare blood clots following injection. The temporary pause of that vaccine did not increase or significantly decrease hesitancy and resistance to vaccination, according to the researchers.

Among the three vaccines, most respondents in the study said they preferred the Pfizer vaccine, followed by Moderna and then Johnson & Johnson.

The Johnson & Johnson vaccine’s role in the pandemic is also critical, as it requires only a single dose and can be stored in standard refrigerators. But Johnson & Johnson’s allotment to states will be limited until the East Baltimore plant tasked with manufacturing them receives emergency use authorization from the U.S. Food and Drug Administration.

With myriad problems found in Emergent BioSolution’s facility during inspections, federal regulators have not said when such authorization could be granted.

Frieman said as many people as possible need to get vaccinated, and Novavax could help fill the gaps.

“The virus is going to continue to spread among unvaccinated people, so the more people we have, the slower that spread,” he said. “The more people it infects, the more mutations that can occur, and when it mutates it can gain an advantage over previous strains.

“By limiting the number of people [left unvaccinated], you limit the advantage.”

Representatives from Novavax did not respond Monday to questions about whether the pediatric Novavax trials were happening in Maryland. The company said in a Monday news release that the trial would run out of 75 sites.

“Through the expansion of our PREVENT-19 clinical trial, we hope to build upon the encouraging safety and efficacy data generated to-date in adults for our vaccine candidate and to play a significant global role in offering vaccination to as many people as possible across age groups to end the suffering caused by the pandemic,” Novavax President Gregory M. Glenn said in a statement.

The company has not yet released trial data from its U.S. study, but did report high levels of efficacy in its United Kingdom trial. But the efficacy results from the South African trail, where a new, more contagious variant is circulating, were less promising. The company is working on a new vaccine that can stave off that variant more effectively.

The company could deliver as many as 100 million doses to the U.S. this year, assuming it wins authorization. Those doses, if unused in the U.S., could play a vital role in the global campaign against the virus.

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