FDAEAU approval may be delayed

The Novavax vaccine is a two-dose regimen and doses are given at 21-day intervals. This is similar to the major series regimens of mRNA-based Pfizer-BioNTech and Moderna vaccines.

In contrast to mRNA vaccines, which are based on new vaccine technology, Novavax products use more traditional technology.

this Protein subunit vaccine Provides a purified copy of the peaplomer of SARS-CoV-2, a coronavirus that causes COVID-19. It produces a protective immune response without causing illness. The vaccine also contains an adjuvant that helps stimulate the immune response.

Also an effective subunit vaccine Developed For whooping cough (whooping cough), hepatitis B, and other illnesses, this type of vaccine has a strong track record.

At the FDA’s meeting, Novavax released data showing that the vaccine is safe and effective.

moreover, study Earlier this year New England Journal of Medicine The vaccine was found to be 90.4% effective against symptomatic infections identified in the laboratory and 100% effective against moderate and severe illnesses.

However, this study was done when the alpha and delta variants were circulating. Additional data is needed to know how well the vaccine works against Omicron mutants and whether booster immunization is needed, as is the case with mRNA vaccines.

Chief Medical Officer of Novavax, Dr. Philip DubovskyAt an FDA meeting, the company said it had data on the use of the vaccine as a booster immunization and would later apply to the authorities for approval of the vaccine booster.

The data presented at the conference also showed that the vaccine is safe and has the same side effects as the mRNA vaccine.

Patients generally have fewer side effects such as pain, fever, and headache at the injection site after vaccination. [with Novavax] Compared to the mRNA vaccine ” Dr. Matthew Freeman, Associate Professor of Microbiology and Immunology, University of Maryland School of Medicine. “This is great for people who are worried about their response to the mRNA vaccine.”

“This vaccine also does not contain PEG. [polyethylene glycol]This is a chemical [used as a stabilizer] With an mRNA vaccine, and something that people can get allergic to, “he added.

One of the potential safety concerns raised during the FDA’s meeting is myocarditis, or inflammation of the heart muscle.

5 cases of myocarditis It was confirmed in people who received the Novavax vaccine during clinical trials. Four of these are young men, similar to those that occur with mRNA vaccines.

Myocarditis after mRNA vaccination is more common in young men, but the overall risk of this side effect is small. Myocarditis also occurs after coronavirus infection and is more common than after vaccination. According to some data..

At the meeting, the FDA asked the company to add myocarditis as a risk factor for product inserts.

Because the Novavax vaccine appeared in the second half of the pandemic, The majority of vaccinated Americans Inoculation of mRNA vaccine — It is not clear what role this vaccine will play in the country’s COVID-19 response in the future.

Dr. Stuart CohenUC Davis Health’s Head of Infectious Diseases in Sacramento, Calif., Said that despite the long road to approval of the Novavax vaccine, there are still benefits to providing an alternative vaccine that is as effective as the mRNA vaccine. I did.

In addition, the Novavax vaccine stimulates the immune system in a slightly different way, so it could act as a booster for the mRNA vaccine, he said.

But “we need to do some research to really determine if it’s a good idea,” Cohen said.

Some people also because Novavax is based on more traditional vaccine techniques. Hesitating to inoculate mRNA vaccine You may be more likely to roll up their sleeves for this.

“This is [vaccine] Convince people who are hesitant about mRNA vaccination [to get vaccinated]For some reason, they are hesitant, “Freeman said.

Cohen Novavax clinical trial It suggests that some people may actually prefer this vaccine over the mRNA vaccine.

“We were in the field of Phase 3 clinical trials, and what seemed to have driven patients to enroll was the availability of vaccination methods and the comfort of technology,” he said. ..