What about the safety and efficacy of Novavax COVID-19 vaccine?

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What about the safety and efficacy of Novavax COVID-19 vaccine?

Novavax‘s COVID-19 vaccine is about to be approved by the FDA. What about the safety and efficacy of the vaccine?

The latest news shows that after Pfizer/BioNTech, Moderna, Johnson & Johnson’s COVID-19 vaccine, the US FDA may approve a fourth COVID-19 vaccine in the next week or so.

What about the safety and efficacy of Novavax COVID-19 vaccine?

On June 7, the U.S. FDA Vaccines and Related Biologicals Advisory Committee voted with 21 votes in favor, 0 votes against, and 1 abstention, recommending approval of the COVID-19 vaccine developed by Novavax.

Next, the COVID-19 vaccine developed by Novavax will be submitted to the U.S. FDA, which will likely grant it an emergency use authorization (EUA) directly.

In the future, after the vaccine is authorized by the US Centers for Disease Control and Prevention (CDC), the vaccine can be administered to the American public.

However, the safety of Novavax’s COVID-19 vaccine and the real efficacy of Omicron still arouse serious concerns from the outside world, and since most people in the United States have completed the vaccine administration, it is still unknown how much market share the vaccine can grab after it is launched.

01 The true efficacy of Novavax’s COVID-19 vaccine on Omicron is unknown

Novavax’s submission of the COVID-19 vaccine EUA application is mainly based on data from a phase III clinical trial conducted on about 30,000 people between December 2020 and September 2021.

Trial results showed the vaccine had an overall efficacy of 90.4%, but reached 78.6% in people 65 and older.

But it’s worth noting that the study was conducted before the Delta and Omicron variants emerged, so the vaccine’s protection against existing circulating strains is still unknown.

Lucia Lee, MD, an official with the U.S. FDA’s vaccine research division, said that the Novavax COVID-19 vaccine research was conducted a long time ago, and the cases accumulated in the trial were not during the circulation of Omicron.

However, the US FDA pointed out in the briefing document that based on the efficacy of the vaccine in clinical trials, it can be subjectively estimated that the vaccine is likely to have a preventive effect on the Omicron variant virus, especially in preventing severe disease and complications.

Unfortunately, there is currently no scientific and objective evidence directly demonstrating the effectiveness of this vaccine against the Omicron variant.

However, Filip Dubovsky, MD, Novavax’s chief medical officer, argued that the results of the adolescent study showed that two doses of the vaccine induced an immune response against the Omicron virus, but less than that of the Alpha strain until the third dose.

Possibly boosting the immune response to the Omicron virus to levels with the alpha strain.

In fact, Novavax has no efficacy data against the Omicron variant, Dubovsky said, but he believes Novavax has the technology to generate a broad immune response.

Notably, Novavax launched a phase III trial of a vaccine against the Omicron strain on May 31, which involved a bivalent vaccine for NVX-CoV2373 and NVX-CoV2515, of which NVX-CoV2373 is currently available in other countries Vaccines that are marketed and reviewed in the United States.

The Phase 3 trial will last for 10 months, with preliminary results expected in the second half of 2022.

02 Is there a risk of heart disease from the Novavax COVID-19 vaccine?

Ahead of Tuesday’s expert meeting, the FDA released a briefing that specifically highlighted four cases of heart inflammation, or myocarditis, associated with the vaccine observed in pivotal clinical trials.

The FDA warns that the Novavax COVID-19 vaccine has a higher risk of heart disease than other vaccines.

Specifically, Novavax conducted the trial with nearly 30,000 participants between December 27, 2020, and September 27, 2021.

The study found that its COVID-19 vaccine is 90.4% effective in adults. But in the more than 20 days after vaccination, five cases of myocarditis and pericarditis were reported.

The FDA said it had asked Novavax to label myocarditis and pericarditis as “significant identified risks” for its COVID-19 vaccine. But Novavax has yet to agree to such an approach.

Novavax issued a statement saying that in the post-crossover part of the study, the cases of myocarditis found were all within the expected range, and they believed that there was insufficient evidence to establish a causal relationship.

Previously, a large number of safety incidents have occurred in the COVID-19 vaccines manufactured by European and American manufacturers, including the Pfizer-BioNTech and Moderna vaccines, and even the COVID-19 vaccine developed by AstraZeneca-Oxford caused a large number of patients to die after injection.

It has been blocked and banned in countries including the European Union.

03 Novavax: Hope to enhance trust with more traditional vaccine technology

In addition, Novavax has been facing various problems with the manufacturing process, which has directly caused the company to delay production work around the world, but Novavax CEO Stanley Erck said these problems have been resolved.

As of March 2022, Novavax has distributed more than 40 million doses of the vaccine in Asia, Europe and elsewhere.

The Novavax vaccine uses a more traditional form of the vaccine manufacturing process, in which copies of the spike protein are grown in insect cells, purified and then placed into nanoparticles with immunostimulatory adjuvants.

Compared to Moderna and Pfizer-BioNTech’s mRNA vaccines, the Novavax vaccine also has less stringent temperature requirements for shipping and storage.

Both Novavax and the U.S. FDA hope that by using more traditional vaccine technology, it will enable those who do not trust mRNA vaccines to be vaccinated.

The mRNA technology used in the European and American COVID-19 vaccines is relatively short, and long-term side effects and safety hazards are still the focus of public attention.

However, the COVID-19 vaccine developed by Johnson & Johnson does not use mRNA technology, but the US CDC has required strict restrictions on use because the vaccine can induce blood clots (especially after women are administered).

04 Summary

Currently, about 76% of adults 18 and older in the U.S. have received two doses of the COVID-19 vaccine, mostly Pfizer-BioNTech and Moderna, and about 27 million adults have not even received a single dose.

Although Novavax’s COVID-19 vaccine is likely to be approved by the US FDA in the future, it is not clear that Novavax’s COVID-19 vaccine will successfully preempt these unvaccinated populations after approval.

Reference:

Novavax on the Verge as FDA Adcom Recommends COVID-19 Vaccine

What about the safety and efficacy of Novavax COVID-19 vaccine?

(source:internet, reference only)

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