Novavax, at long last, clinches FDA emergency nod for protein-based COVID shot

It’s official: A new COVID-19 vaccine will soon be on tap in the U.S.

Late Wednesday, the U.S. FDA gave the all-clear to Novavax’s adjuvanted, protein-based shot, teeing up the nation’s fourth pandemic prophylactic behind those from Pfizer-BioNTech, Moderna and Johnson & Johnson.

The FDA’s emergency use authorization covers the prevention of COVID-19 caused by SARS-CoV-2 among adults ages 18 and up. The company aims to file a full biologics license application by year-end and figures it will be the last COVID vaccine player blessed with an emergency nod, Novavax’s John Trizzino, executive vice president, chief commercial officer and chief business officer, told Fierce Biotech at this year’s BIO International Convention.

Two and a half years into the COVID-19 pandemic, Novavax has had to get creative with its marketing pitch, angling its more traditional shot as an added option for kids, vaccine skeptics and others who may have avoided the mRNA offerings that reign supreme in the U.S.

“Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” FDA Commissioner Robert Califf, M.D., said in a statement.

Novavax’s shot “provides another alternative for adults and adds another vaccine to the COVID-19 vaccine supply for the United States,” added Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

The FDA based its approval on data from Novavax’s ongoing, late-stage study in the U.S. and Mexico, which have shown the company’s protein-based shot is 90.4% effective at thwarting mild, moderate or severe COVID-19.

In the Novavax trial, 17,200 subjects received the company’s shot, while another 8,300 were given placebo. All told, 17 cases of COVID-19 have cropped up in the vaccine group, versus 79 cases in the control arm.

Further, no cases of moderate or severe COVID-19 were reported in participants who got the vaccine, versus nine cases of moderate COVID-19 and four cases of severe COVID-19 in placebo recipients.

In a subset of patients ages 65 and older, Novavax’s shot has demonstrated efficacy around 78.6%. The FDA cautioned that Novavax’s trial was conducted prior to the onslaught of delta and omicron variants in North America.

One issue that threatened to scuttle Novavax’s authorization on the eve of its green light was manufacturing data. Early last month, the FDA said it still needed to sign off on changes Novavax had recently made to the vaccine's production process. The company had informed the regulator of the changes the preceding Friday, the FDA told CNBC at the time, just four days before the agency’s expert review panel was to weigh the company’s application.

But all is well, according to the FDA, which specified in its approval announcement that the public and medical community should be assured “that a thorough analysis and evaluation of the available safety and effectiveness data and manufacturing information have been conducted.”

The commercial fate of Novavax’s vaccine is uncertain, though the company is confident its shot has a spot in the prophylactic mix, and especially so if COVID-19 vaccinations become an annual ordeal.

Earlier this year, Jefferies analysts predicted Novavax’s shot could reap $4 billion to $5 billion internationally by the end of this year. The analysts credited that potential haul to “meaningful product sales mostly from high income countries” in the first quarter and ensuing months of the year.

Outside the U.S., Novavax’s shot, branded Nuvaxovid, has racked up green lights in places like the EU, the U.K., Australia and South Korea.

Meanwhile, the rest of Novavax’s vaccine story is “still to be told,” Trizzino said earlier this year.

“What does a COVID circulating virus look like for the next 10 years?” he asked at this year’s BIO conference in San Diego. “What does the COVID vaccine landscape look like for the next 10 years? And I think while we may have been late to that party, we're right on time for what is needed from a global health standpoint as far as an annual revaccination."

With that angle in mind, Trizzino figures Novavax is “perfectly suited” for “annual re-vaccination and to continue to boost the immune system to be protected against whatever the latest COVID strain is."

Across the pond, meanwhile, European regulators on Thursday added two new side effects to Nuvaxovid’s label. The vaccine’s product information will be updated to flag the potential risk of severe allergic reactions, as well as paresthesia, or a “pins and needles” sensation, and hypoesthesia, where feeling in the skin is decreased.

Since its December launch, just 250,000 doses of Novavax’s shot have been administered in Europe so far, Reuters reports, citing the European Centre for Disease Prevention and Control.