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Novavax faces high-stakes FDA review this week that will decide the fate of its Covid vaccine in the U.S.


The Novavax and Food and Drug Administration logos can be seen in this photograph illustration behind an syringe and vials.

Pavlo Gonchar | LightRocket | Getty Images

Novavax’s Covid-19The Food and Drug Administration will be reviewing vaccine this week. This is a critical step in the process toward U.S. regulatory approval. It comes two years after the Maryland-based biotech company was awarded taxpayer money to develop the shot.

At Tuesday’s all-day public meeting, the committee of vaccine specialists will evaluate Novavax shots for safety and their effectiveness to prevent Covid. The FDA is almost certain to approve the shipment of Novavax vaccines from India’s Serum Institute of India. The shots of the company have been approved in 41 countries other than the United States, which includes Australia, Canada and the European Union.

Silvia Taylor, spokeswoman for Novavax said that she is confident about the submitted data. Taylor explained that if previous success can be used as a guide for future success, Taylor felt really good.

Novavax participated in Operation Warp Speed, which saw $1.8 billion in funding for a vaccine to combat Covid. But, Novavax was unable to increase its manufacturing capability and improve its clinical trial data. wasModerna and Pfizer developed their vaccines at breakneck speeds, but they were not the first to do so.

John Trizzino was the chief commercial officer of Novavax. The company had only 100 employees when the pandemic hit in 2020. Trizzino stated that the company can now produce two billion doses annually.

Novavax shots use the same protein technology that has been used in HPV and hepatitis B vaccines for many decades. PfizerThe s are ModernaHowever,’s vaccines were among the first to be approved by the FDA using messengerRNA technology. Novavax is confident that it will reach those who are not yet vaccinated. Taylor stated that they prefer to use technology with a long track record.

Protein vs mRNA

Moderna’s and Pfizer’s shots depend on messengerRNA to convert human cells to factories that make copies of Covid’s spike protein. This induces an immune reaction that combats the virus. The spike of the virus is what latches on to human cells and invades them.

Novavax produces the virus spike in the absence of human intervention. A baculovirus is used to infect moth cells. They then make copies of the virus spike, which are later purified and extracted. To instill an immune response, the spike copy is injectable into individuals.

Filip Dubovsky is the Chief Medical Officer. He said the manufacturing of spike proteins outside the human body allows them to guarantee that vaccines are designed in the most efficient way possible.

Dubovsky explained that he knows exactly what he’s made, and that he tests it before releasing vaccines to ensure it conforms.

To induce an increased immune response, the vaccine uses an adjuvant. This is an extract from South American trees’ bark. It has also been approved for use in vaccines against shingles and malaria. These shots contain 50 micrograms each of the adjuvant as well as 5 micrograms each of the spike code.

Novavax vaccine efficacy

Novavax’s two dose vaccine for adults aged 18 or older proved to be 90% effective in preventing Covid-related illness and 100% effective in preventing severe diseases, according the company’s clinical trials results in Mexico and the U.S. These results were comparable to Moderna and Pfizer’s 2020 initial trials results.

Novavax will face immediate difficulties if it is allowed to use its vaccine by the FDA. Around 70% of Americans eligible for vaccines in the U.S. received their two first doses. Most people were given Moderna or Pfizer shots. The world now has to fight the omicron strain, which is quite different from the original virus, that was discovered in Wuhan in China late 2019.

Novavax’s adult study was completed between December 2020 to September 2021. This occurred before the dominance of the omicron strain. According to FDA briefing materials published before Tuesday’s meeting, there is not enough data to evaluate Novavax against the omicron variant, which has continued to evolve into more transmissible forms of the virus. FDA officials stated that the vaccine’s two doses would not provide significant protection from severe diseases.

Novavax released a December lab study that found that people who had received two doses of omicron showed an increase in their immune responses. However, the number of antibodies that can block the infection fell about fourfold compared with the original Wuhan strain. According to study data, the booster increased protective antibodies by about 20 times against omicron compared to peak responses from the two first doses of the Wuhan strain. However, the increased antibody levels do not necessarily indicate that a third dose of high-level protection.

Novavax officials believe that even though the majority of Americans are already immunized, Novavax can still play an important role in boosters for adults as well as primary vaccines for teens 12-17. Only Pfizer’s vaccine for teenagers is currently available. However, the FDA will be reviewing Moderna shots for this age group in June 14. According to the Centers for Disease Control and Prevention, about 50% of adults still haven’t had a third shot and 40% are still not fully vaccinated.

The FDA committee will only be reviewing Novavax’s primary two-dose series for adults Tuesday. Taylor explained that Novavax intends to apply to the FDA to allow a third dose. This is in addition to the primary series for teens 12-17. Novavax also plans to study a third dose for teens.

Heart inflammation worries

According to FDA briefing documents, injection site pain, fatigue and headache were the top side effects of Novavax shots. The FDA reports that four of the participants experienced heart inflammation. This could be either myocarditis (or pericarditis), or abnormal chest pain. Although they were eventually discharged, all of the participants had to be admitted for several days.

FDA officials indicated that these events raised concerns about the possibility of a causal link with the vaccine. This is similar to what was documented for the mRNA COVID19 vaccinations. Young men, especially teenage boys, are at increased risk for heart disease after receiving Moderna and Pfizer’s second-dose vaccines.

Novavax released a statement saying that it doesn’t have sufficient evidence to show a causal connection between heart inflammation and the vaccine. Novavax stated that it would continue monitoring for myocarditis or pericarditis throughout its clinical trials.

Fall booster campaign

If the FDA approves Novavax this week, it is not clear how many Novavax doses will be made available in America. Novavax had initially committed to supplying 100 million doses of Novavax to the U.S. as part of its $1.8-bill Operation Warp Speed agreement. But some funding went to Novavax to help with research on vaccines for children and third doses.

Trizzino indicated that an initial shipment of shot will take place within the next few weeks following FDA approval without specifying a quantity. Novavax, the U.S. Government have yet to reach an agreement on future orders.

Trizzino stated that Novavax was looking into the demand for a fall vaccine campaign in the U.S. as public health officials anticipate another round of Covid infections due to people spending more time indoors during weather change. To increase effectiveness against mild illnesses, the FDA may change all Covid vaccines and target the omicron variant before the fall.

Novavax started a clinical study in May that examined a shot which only targets the omicron and one that includes both Wuhan and Omicron strains. Unfortunately, there is not enough time to bring up the updated vaccines in the fall. Independent experts from FDA will be meeting again on June 28th to decide if it is necessary to switch strains. That would mean Novavax, and all other vaccine producers, have just months to make updated shots.

Trizzino stated that the pathway to deliver vaccines for fall based only on the Wuhan or omicron strain is fairly straightforward. However, it is difficult to produce shots that contain both of these strains under the compressed schedule. While it’s unclear what the FDA will decide for the fall, Covid vaccines – whether they’re based on Wuhan or omicron or both – will be needed well beyond this year, Trizzino said.

Trizzino stated that “this virus won’t go away anytime soon.” He stated that there is a high probability of it being an annual revaccination in the near future.

CNBC Health & Science

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