FDA grants emergency use authorization for Novavax’s Covid-19 vaccine

The Novavax vaccine is offered as a double-dose primary series for people over the age of 18.

The FDA’s Independent Vaccine and Related Biological Products Advisory Board voted in favor of vaccine approval on June 7, stating that the benefits of vaccines outweigh the risks of adults. It is also used in 170 other countries.

Shots may not be given until the US Centers for Disease Control and Prevention’s independent vaccine advisor considers whether to recommend the vaccine and the CDC director approves the recommendation. The CDC Immunization Implementation Advisory Board will meet on 19 July.

Like more familiar vaccines such as hepatitis B and whooping cough, the Covid-19 vaccine is protein-based and teaches the immune system how to detect and fight off the virus using harmless protein fragments of the virus. .. The vaccine was created from the gene sequence of the first strain of coronavirus.

Unlike other Covid-19 shots, the Novavax vaccine can be stored in standard refrigeration.

About one in three Americans has not yet been vaccinated against more than 100 million Covid-19. Many officials and healthcare professionals hope that vaccines like Novavax, which use more familiar techniques, may be sufficient to convince those who were hesitant to get vaccinated.

“I believe some of the 100 million people are waiting for our vaccine. And when I look at my basket, every day when I come to the office, quite a few people get our vaccine. You can see that they are waiting. Those who are saying, “Let’s get this vaccine approved. I want it.” So I don’t know what that percentage of 100 million people is, but I don’t think it’s important, “Stanley Elk, President and CEO of Nuvaxovid, told CNN.

In addition to the main series of shots, he says, the company wants to be immediately licensed to use the shots as a booster to other vaccines.

“We had a lot of discussion with the FDA about this,” Elk said. “I believe the FDA will work on its approval within a few weeks.”

Experts explain how to protect yourself from the recent surge in Covid

According to the company, late-stage trials found that the vaccine was 90.4% effective against mild, moderate, and severe illnesses. There is not enough evidence to assess the effect of the vaccine on viral infections.

Novavax also announced in early July that the vaccine would exhibit a “widespread” immune response against currently circulating variants, including the Omicron submutant BA.4 / 5.

The Novavax vaccine was developed with funding from the Federal Government’s Operation Warp Speed.

On Monday, the Biden administration announced that it had secured 3.2 million doses of the Novavax vaccine.

The company said Wednesday that it expects the vaccine to be available soon while waiting for approval from the CDC.

“We have a vaccine manufactured for the United States. It has been shipped and is waiting in the warehouse,” Erck said. “The government has been very eager to introduce these doses into the distribution system.

“My expectation is that it will be widely distributed soon.”

Elk also said the company plans to provide vaccines to adolescents and children up to the age of two. Data on the effectiveness of kids shots will be available “within the next few months,” and Novavax hopes to provide shots to children later this year.

Source: www.cnn.com

Leave a Reply

Your email address will not be published. Required fields are marked *

Bảie leveluplimo