Novavax hopes FDA go-ahead will boost lagging US vaccinations

 Federal regulators appear poised to finally authorize a COVID-19 vaccine from Novavax in the coming weeks, a move that the company hopes can help improve the lagging U.S. vaccination effort.  

But winning over even a small number of eligible people who haven’t yet been vaccinated could be a difficult task. It’s not clear how much success the company will find.  

Even as COVID-19 infections rise, much of the U.S. has moved on from thinking about the pandemic, and demand for vaccines has waned considerably.  

“There’s a lot of potential benefits to having this additional vaccine in the arsenal, but the circumstances of the pandemic have changed significantly,” said Josh Michaud, associate director for global health policy at the Kaiser Family Foundation.  

Across the U.S., restaurants are packed with people, and many Americans have given up on  wearing masks, even on public transit or on airplanes. 

The vaccination rate has also not changed significantly in recent weeks.  

While about 77 percent of adults have received two doses of an mRNA shot, only about 50 percent have received a single booster, and only about 20 percent of those eligible have received a second booster.

John Trizzino, Novavax’s chief commercial officer, said he doesn’t see an issue with waning demand.  

He wants to give people a different option, especially since the government is limiting the use of Johnson & Johnson’s vaccine.  

“There are a substantial number of people that are not yet vaccinated. And I think it’s important to make sure that this is an option made available to them. I think we’ll see uptake in those people that have either been vaccine hesitant or have a preference for something other than mRNA vaccine,” Trizzino told reporters during a media briefing. 

Novavax relies on more traditional vaccine technology, similar to those used to protect against flu, and for routine childhood immunizations against whooping cough and meningitis. The two-dose vaccine can be stored at normal refrigerator temperatures, making it easier to ship and use. 

Kaiser’s Michaud said he considers it a victory even if the Novavax shot convinces just a small minority of the vaccine-hesitant.  

“Every vaccination is a good thing and protects people, especially as we’re looking down to potentially difficult fall and winter seasons. So is it going to completely transform vaccinations in the U.S. and convince a whole wave of people to get vaccinated? Unlikely. But … it’s worth having this other option out there,” he said.  

In a separate interview, Trizzino said he is taking a longer view. Novavax might have missed out on the initial vaccinations at the peak of the pandemic, but there will likely be a need for annual revaccination. 

“I think the opportunity as we see is what lies in front of us. I can’t make up for what didn’t happen, but we know that we’ve got a safe and effective vaccine, we know that there’s going to be an ongoing need for vaccination … once the pandemic ends,” Trizzino said. 

It’s still not clear how immunity from Novavax’s shot compares to the mRNA vaccines, but clinical trials showed the vaccine was 90 percent effective against all the variants of concern that were circulating at the time of the trials.  

The trials took place before the omicron variant became dominant, though the company said it is confident protection is maintained. 

The effectiveness of Pfizer and Moderna’s shots against infection appears to wane after several months, but they still protect against severe disease and hospitalization.   

Prior to the COVID-19 pandemic, Novavax had never brought a drug to market. The Maryland-based company secured a $1.8 billion contract from the Trump administration’s Operation Warp Speed early in the pandemic to scale up research and purchase up to 100 million doses.  

Novavax originally wanted to ask the FDA for authorization by May 2021, but was beset by manufacturing problems and struggled to scale up production. It wasn’t able to file until the end of January 2022. 

Trizzino said negotiations are ongoing about how many doses the government will purchase from the initial agreement. 

“The government is going to be buying some amount of doses … not certain how much under that agreement, and there will be doses available within a short few weeks after the emergency use authorization is granted under that contract,” he said. 

Novavax is banking on being able to use its shot as a booster. Trizzino said the company has data showing it can boost the immune response in people that received an mRNA shot initially, but the FDA is only considering it as a primary dose.  

Assuming the FDA grants emergency authorization for the vaccine in adults, Trizzino said he expects to formally submit data on booster effectiveness as well as use in adolescents “in a very short period of time, weeks, if not days” after that. 

https://thehill.com/policy/3504620-novavax-hopes-fda-go-ahead-will-boost-lagging-us-vaccinations/