As FDA delays Novavax’ COVID vaccine approval, patients fight back

By Julie Steenhuysen

CHICAGO (Reuters) -Thousands of Americans campaigning for the Novavax COVID-19 booster got some good news this week: the FDA signaled it might still win approval after Health Secretary Robert F. Kennedy Jr cast doubt on its efficacy.

The Novavax vaccine is the only COVID-19 booster in the United States that does not use messenger RNA technology – which some states have begun to ban – and the only option for many people who cannot or will not take an mRNA vaccine.

While more traditional vaccines, including the Novavax shot, inject a portion of the virus into the body, mRNA vaccines carry instructions for human cells to make the viral protein that triggers an immune response.

Novavax has been available since 2022 through a pandemic-era Emergency Use Authorization. A decision on full approval – which rival mRNA shots from Moderna and Pfizer and its partner BioNTech<BNTX.O> already have – was due from the Food and Drug Administration by April 1, but had been delayed by the FDA without explanation.

On Wednesday, the company got word that the FDA would consider approving the vaccine, provided Novavax agrees to produce additional clinical data on the vaccine’s efficacy following its approval.

Based on its communication, the company said it now believes its application is “approvable.”

Asked the reason for delay and the request for more data, an HHS spokesperson said the agency remains committed to “ensuring products are safe for the American people and grounded in gold-standard science.”

Without FDA approval, patients and vaccine experts say a group of people, including many patients with long COVID, will be left without a means of protecting themselves.

“It’s reassuring to see an update, but we’re not celebrating just yet,” said Paul Hennessy, 35, an entertainment project manager from Los Angeles and volunteer with Organizing for a Better Tomorrow, a long COVID advocacy group.

Hennessy helped organize more than 3,200 people to submit written comments to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices on April 16. The group has also been calling and emailing officials at the FDA.

VACCINE PROMISES

Kennedy, a longtime vaccine critic and environmental lawyer who in 2021 petitioned the FDA to revoke the emergency use authorization for all COVID vaccines, attributed the delay to the shot’s design in an April 10 CBS interview.

He said the Novavax shot targets only one antigen or part of the virus to produce an immune response and “single-antigen vaccines have never worked for respiratory illnesses.” 

The comments baffled vaccine experts, who noted many examples of effective single-antigen vaccines against respiratory illnesses.

All of the first-generation COVID-19 vaccines were single-antigen vaccines, “so they clearly worked,” said one vaccine researcher who requested anonymity for fear of retribution against his university.

Kennedy has repeatedly said he would not take away anyone’s vaccine, including during his Senate confirmation hearing and most recently in his CBS interview. But patients are wary.

“It feels like the complete opposite of that – that he intends to take this option away from many people who need it,” said Kaiti Murphy of Brooklyn, New York.

Murphy, 32, has long COVID and mast cell activation syndrome, a condition in which the immune system becomes hyperactive, which her doctor believes was triggered by her COVID infection in 2020.

“He has advised me not to take any mRNA vaccines,” she said. 

She, like many people with long COVID, relies on COVID boosters to avoid reinfections with the virus, which can cause their symptoms to flare. 

“Pulling it off the market would really be a threat to my health,” said Salvatore Mattera, a finance manager for a technology company who has long COVID, a collection of debilitating symptoms that persist among some people long after a COVID-19 infection.

Mattera, 36, of Foster City, California, has had adverse reactions after taking an mRNA vaccine, including numbness in his face severe enough to send him to the hospital ER.

After he switched to Novavax – which he has had three times – he has had no negative side effects beyond a sore arm.

As with much about long COVID, evidence on the impact of COVID boosters is scant.

In a small, soon-to-be published study by Yale immunobiologist Dr. Akiko Iwasaki and colleagues, the team found that while most people with long COVID fared well with an mRNA booster, 3 out of 16 volunteers had worsening symptoms, including one patient who was hospitalized.

The Novavax vaccine was not available during the study period, but Iwasaki said because it has lower reactogenicity, or short-term side effects such as arm pain or fatigue, “I suspect that patients with long COVID may have an easier time with it.”

In written comments to CDC’s advisory panel last week, many people gave fewer side effects as their reason for urging approval.

Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security, said that while he thinks the Novavax booster may eventually win approval, “it appears that they are trying to increase the regulatory burden,” something he said is to be expected from a department headed by an anti-vaccine advocate such as RFK Jr.

Meanwhile, as the current batch of Novavax boosters expires on April 30, many on the social media platform Reddit are swapping information on where to find the scarce last doses ahead of what has become a routine summer wave of COVID.

“It’s a step in the right direction,” Hennessy said of the FDA action, “but we still need access.”    

(Reporting by Julie Steenhuysen; additional reporting by Michael Erman in New York. Editing by Michael Learmonth)