Novavax’s Covid-19 vaccine one step closer to FDA clearance decision


Novavax Inc.

The long-awaited Covid-19 vaccine is heading for US licensing after the company said it resolved manufacturing issues that had delayed its application.

Approval in the United States is not imminent because the Food and Drug Administration must sort through a large amount of study data from several countries, said a person familiar with the matter. A decision is approaching, however, since Novavax formally filed a request for authorization at the end of January.

If the vaccine is rolled out in the United States, it could boost vaccine efforts that have been lacking among the hesitant, Novavax and doctors say.

Unlike Pfizer’s cutting-edge messenger RNA vaccines Inc.

and Modern Inc.,

Novavax’s jab uses familiar technology, which has been used for decades to vaccinate babies against hepatitis B, which some hesitant people might find more appealing. Some people have also expressed concern about how quickly mRNA injections have been developed and their lack of long-term data.

“It’s important to provide choice,” said Carina Rodriguez, chief of infectious diseases at the University of South Florida. “Perhaps this will not completely eliminate the problem of vaccine hesitancy, but will help people who are not comfortable with an mRNA vaccine.”

Novavax, of Gaithersburg, Md., emerged in early 2020 as a dark horse candidate in the race to make a Covid-19 vaccine. In July 2020, the United States awarded the company a $1.6 billion contract to develop and deliver 100 million doses of its vaccine candidate.

Still, Novavax has struggled to keep pace with larger and more experienced Pfizer and wealthier biotech Moderna, said Jefferies biotech analyst Roger Song. “All the major players were much better funded,” Dr. Song said. “Novavax was an underdog and didn’t have the capital to do it.”

Novavax had to quickly increase its workforce and find partners to strengthen its manufacturing capacity. By the end of 2020, it had quadrupled its workforce to around 690, then doubled it last year to more than 1,500 employees.

Novavax’s biggest challenges were showing the FDA that it could reliably and consistently manufacture its vaccine at scale, said Filip Dubovsky, chief medical officer of Novavax.

The Novavax vaccine, known as a recombinant protein vaccine, directly delivers a version of the spike protein the coronavirus uses to infect human cells, training the immune system to fight off the virus. (In contrast, mRNA vaccines deliver the genetic material the body uses to make the spike protein to trigger the same immune response.)

Novavax had to demonstrate that it can reliably and consistently manufacture its vaccine at scale.

The vaccine includes a so-called adjuvant, an ingredient that is sometimes used in vaccines to stimulate an immune response. Novavax is a substance called Matrix-M, derived from the bark of a tree native to Chile.

To obtain FDA clearance, Novavax had to show that its spike protein and adjuvant were the same in each manufacturing batch. The process took longer than expected, but Novavax was able to work it out, Dr. Dubovsky said.

“That’s why we’ve been delayed compared to some of the other platforms,” Dr. Dubovsky said. “Because it was harder to convince regulators than we understood.”

Novavax’s extensive manufacturing network further complicated the process, Silvia Taylor, Novavax’s senior vice president for global corporate affairs, said in an interview. The company is initially relying on the Serum Institute of India to manufacture the spike protein part of the vaccine and to complete the bottling of the vaccine.

The FDA intended to make sure Novavax was manufactured to U.S. standards, a person familiar with the matter has said, after millions of doses of Johnson & Johnson vaccines were ruined in 2021 due to manufacturing issues. quality control at its contract manufacturer Emergent BioSolutions. Inc.

in Baltimore.

Still, pandemic safety protocols have made it harder for FDA inspectors to access Novavax manufacturing sites overseas, the person said.

Novavax’s vaccine provided 90% protection against symptomatic infections and 100% against serious illness in a large Phase 3 trial conducted in the United States and Mexico. According to doctors, it also appears to have lower rates of side effects, including headaches and fatigue, than mRNA vaccines.

Novavax said its vaccine lost some potency against the Omicron variant after two doses, but a third booster should provide strong protection. The company is also working on an Omicron-specific vaccine, but the company said it does not yet know if it will be needed.

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Health officials in Europe, Australia and elsewhere have cleared the vaccine for use in recent months. Some, including in Canada and South Korea, have actively promoted it as an alternative to mRNA injections for people who have not been vaccinated or boosted.

Australia recently said it would allow people for whom mRNA vaccines are unsuitable to use the Novavax vaccine as a booster, but currently recommends Pfizer or Moderna vaccines for everyone else over 18. Doctors interpreted the recommendation as a way to make the Novavax vaccine. available for people who do not want to be boosted by an mRNA vaccine.

The FDA will review Novavax’s application “as quickly as possible,” an FDA spokeswoman said. The agency plans to hold an advisory committee hearing before making a decision on whether to license Novavax’s vaccine, she said. No date has been scheduled.

Novavax's Covid-19 vaccine one step closer to FDA clearance decision

An analysis of the highly purified Covid-19 Omicron spike protein performed at Novavax’s facilities in Gaithersburg, Maryland.

According to the Centers for Disease Control and Prevention, some 75% of American adults were fully immunized by early March, up from about 61% in August.

The percentage of adults saying they would “definitely” not get vaccinated or “only if necessary” rose from 16% in September to 19% in February, according to an opinion poll by the Kaiser Family Foundation. The percentage saying they would “wait and see” was 4%, down from 7% in September.

“It surprises me every day how many people contact us and say, ‘I’m waiting for your vaccine,'” said Ms Taylor of Novavax.

Write to Joseph Walker at joseph.walker@wsj.com

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