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FDA 'slow-walking' Novavax authorization: Expert

·Senior Reporter
·5 min read

What began as branding and fandom at the start of the rollout of COVID-19 vaccines last year continues despite the slowdown in vaccine uptake. Increasing support for still unauthorized COVID-19 vaccines in the U.S. is growing, even as restrictions are waning amid the ongoing pandemic.

That is most evident with Novavax (NVAX). The company's fervent followers (sometimes referred to as "Novastans") are made up of both investors and individuals who want the still-unauthorized vaccine.

Retail investors are agitated by the delays on returns from a pending U.S. approval — even as the company continues to receive authorizations in other countries and from the World Health Organization.

But the individuals waiting to take Novavax's vaccine have different reasons. They either want a more traditional non-mNRA shot or have medical conditions that don't allow them to take the other available options, according to social media comments on Twitter and Reddit, as well as petitions on Change.org.

But none of these public lobbying efforts will make an impact on the FDA's pace of review, according to experts. Some lawmakers are also lobbying President Joe Biden to push for the Novavax shot and another vaccine co-created by a team at Baylor College of Medicine being produced by India's Biological E.

'Slow-walking'

The FDA declined to comment on the pending applications, and Novavax has no updates on a potential time for the FDA's advisory committee meeting.

Lawrence Gostin, director of the O'Neill Institute for National and Global Health Law at Georgetown University, says the FDA is "slow-walking" Novavax's authorization.

"They've got all the data that they need, but I'd say it's also kind of a general irritation with the company," Gostin told Yahoo Finance.

That "irritation" stems from earlier issues with manufacturing and other delays, which are now resolved. But in relying on a plant abroad — the Serum Institute of India, the world's largest vaccine maker — Novavax has opened the door for more scrutiny of manufacturing quality, Gostin said.

"I think another reason they're slow-walking it is there's a widespread perception that we have enough supply here, and that the mRNA vaccines are good, maybe better. But I think that's very short-sighted," he said.

Gostin noted that while mRNA vaccines have proven high efficacy, their durability is a problem. Pfizer has recently acknowledged the need to reformulate the vaccine for that reason.

Not anti-vax

The range of reasons for not taking available vaccines in the U.S. range from all-out anti-vax sentiment to vaccine hesitancy to medical issues.

Officials have maintained that existing vaccines are safe, and they are concerned that some people may simply be avoiding taking whatever is available.

"It just seems rather unusual that people are waiting for something else when you have vaccines that have been given to now 9 billion people," Dr. Anthony Fauci told Yahoo Finance in January.

"I'm not sure what people are waiting for when you say they're waiting for something else," he said.

When asked about the pending vaccines, CDC Director Dr. Rochelle Walensky noted that approval could help address hesitancy.

"So there are options already. The potential for more options, I think, will only be a good thing. But I think we still have a lot of work to do. And that may not be the only ticket out of our vaccine hesitancy," Walensky told Yahoo Finance in February.

Vaccine Fandom

The preference for brands or technologies first started with differences in the two mRNA options in the U.S., as well as comparisons of Pfizer (PFE)/BioNTech (BNTX) and AstraZeneca (AZN) in the U.K.

Johnson & Johnson (JNJ) at first catered to the crowd that didn't want to have to worry about multiple shots, accepting the trade-off of a lower efficacy number. But that perception changed when a second dose was recommended by the FDA and CDC.

Similarly, Novavax fans have their niche. They represent those that want a traditional vaccine option.

Novavax struggled to get to the filing of its EUA in 2021 after running into manufacturing hurdles. The company finally filed for emergency use based on its partnership with the Serum Institute of India this year. It has received approval in several other countries based on the SII data, and is already delivering in Asia and Europe. Some reports show that pickup isn't strong in Europe.

Now, the company's filing is under review at the FDA with many hopeful for a decision soon.

Novavax submitted its emergency use authorization on January 31, and there has been no meeting scheduled of the FDA's advisory committee.

By comparison, Pfizer/BioNTech's meeting was scheduled on December 10, 2020, after filing on November 20. Moderna's (MRNA) meeting was scheduled on December 17, 2020, after filing on November 30. Both vaccines have also now been fully approved for adult use as of January 2022.

J&J also followed a quick timeline, submitting on February 6, 2021 and a meeting scheduled on February 26. It's why Gostin is wary of the FDA's current pace.

"Whatever it is, there's some dynamic other than science going on," he said.

Follow Anjalee on Twitter @AnjKhem

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