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FDA authorizes 4th COVID vaccine for adults

FDA authorizes 4th COVID vaccine for adults

Pending final CDC approval, Americans will soon have the option of getting Novavax's two-dose, non-mRNA vaccine

  • A phase III trial volunteer receives the Novavax COVID-19 vaccine.
    NovavaxA phase III trial volunteer receives the Novavax COVID-19 vaccine.

The U.S. Food and Drug Administration authorized a new non-mRNA COVID-19 vaccine for emergency use Wednesday, greenlighting a shot made by Novavax that the government secured 3.2 million doses of earlier this week.

“Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalization and death,” FDA Commissioner Robert Califf said in a statement Wednesday, announcing the Novavax vaccine met the agency’s standards for safety, effectiveness and manufacturing quality. 

Pending the FDA’s expected approval, the U.S. Department of Health and Human Services and the Department of Defense announced the federal government’s purchase of millions of doses of the vaccine Monday. 

Jason Roos, chief operating office of the HHS Coordination Operations and Response Element, said in a statement that while more than two-thirds of the American public are already fully vaccinated, the government urges all eligible individuals get vaccinated heading into the fall.

Califf echoed this sentiment Wednesday. 

“COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so,” he said.

Novavax’s two-dose, protein-based shot utilizes the same technology as the hepatitis B and HPV vaccines, and may appeal to those who are allergic to components of mRNA COVID-19 vaccines like the ones made by Pfizer and Moderna or those hesitant about getting a shot that employs mRNA technology. The Novavax jab will be the second approved non-mRNA vaccination in the U.S., behind the one-shot Johnson & Johnson vaccine, which became available for adults in February 2021 and uses a disabled adenovirus to trigger an immune response.

Before Novavax’s shot can be distributed to the public, the Centers for Disease Control and Prevention will also need to sign off on the vaccine.

The FDA’s Vaccines and Related Biological Products Advisory Committee reviewed the vaccine’s clinical trial results in early June, voting unanimously after a full day of review to recommend the two-dose jab, which would become the fourth authorized vaccine option in the U.S. for those 18 and up. 

According to clinical data, the Novavax shots have a 90% efficacy rate against mild to severe COVID-19 and has few side effects, with most symptoms resolving after one or two days.

None of those who received the vaccine in the clinical trials experienced moderate or severe infection. Notable, the trial took place before the Delta and Omicron variants evolved. 

There is currently no shortage of Pfizer, Moderna and Johnson & Johnson shots, which have been authorized in the U.S. for over a year. Still, Novavax could occupy a unique niche in the market among the roughly 27 million American adults who have yet to be vaccinated.

While one concern about heart inflammation associated with the Novavax vaccine was brought to light in briefing documents released in June by the FDA, Novavax brushed off the concern in a statement. 

Although the documents said that six cases of myocarditis and pericarditis occurred in 40,000 trial volunteers, flagging a potential “causal association,” the company maintained that there was “insufficient evidence to establish a causal relationship” and said it would continue monitoring for adverse events.

While no cases of myocarditis or pericarditis were found in Pfizer or Moderna’s clinical trials, both were found after authorization to slightly increase the risk of myocarditis for boys and young men.

Delayed by development and manufacturing issues, Novavax filed for U.S. authorization in late January, a year after it had first intended to. A Maryland-based startup, Novavax received funding early on from the government program Operation Warp Speed. 

The vaccine’s approval by the FDA comes as the country rides the latest wave of cases, attributed to the highly transmissible Omicron subvariant BA.5 spreading across the country.

On Tuesday, the U.S. saw 129,858 new COVID-19 cases, according to data from The New York Times — a 19% increase from two weeks ago. COVID-19 hospitalizations have also climbed steadily in the last few weeks, with a current average of more than 33,000 per day, a level last seen in early March.

Around 78% of American adults have already received two doses of COVID-19 vaccines, according to the CDC.

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