August 14, 2022

Novavax: FDA grants emergency use authorization for Covid-19 vaccine

Novavax: FDA grants emergency use authorization for Covid-19 vaccine

Novavax will be available as an initial series of two doses for people 18 years of age or older.

The Food and Drug Administration’s Independent Advisory Committee on Vaccines and Biological Products voted in favor of licensing the vaccine on June 7, saying the vaccine’s benefits outweigh its risks for adults. It is also used in 170 other countries.

Vaccines cannot be given until the CDC’s independent vaccine advisors decide whether to recommend a vaccine and the CDC director agrees to the recommendation. The Centers for Disease Control and Prevention’s Immunization Practices Advisory Committee is scheduled to meet on July 19.

Like more familiar vaccines like hepatitis B and whooping cough, the Covid-19 vaccine is protein-based, using harmless protein fragments from the virus to teach the immune system how to detect and fight the virus. The vaccine was created from the genetic sequence of the first strain of Corona Virus.

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

About 1 in 3 Americans were not Vaccine against Covid-19, more than 100 million people. Many officials and health care workers hope that a vaccine like Novavax, which uses more common technology, will be enough to convince people who are reluctant to get vaccinated.

“We think a part of those 100 million people are waiting for our vaccine. And if you look at my cart, every day when I come into the office, you’ll see that there are quite a few of those people who say ‘let’s get approved for this vaccine.’ I want it.” So I don’t know what percentage of that 100 million is, but I think it’s no small feat,” Stanley Erk, president and CEO of Novavax told CNN.

In addition to the initial vaccine series, he says, the company hopes to soon obtain permission to use its shots as boosters for other vaccines.

“We’ve talked with the Food and Drug Administration a lot about this,” Erk said. “I think the FDA will process that approval within weeks.”

Late-stage trials have found the vaccine’s effectiveness against mild, moderate and severe disease to be 90.4%, according to the company. There is insufficient evidence to assess the effect of the vaccine on transmission of the virus.

Novavax also announced in early July that its vaccine shows a “broad” immune response to currently circulating variants, including Omicron BA.4/5 sub variants.

The Novavax vaccine was developed with funding from the federal government’s Operation Warp Speed.

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

The company said Wednesday that it expects a vaccine to be available quickly, pending approval from the CDC.

“We have a vaccine that we made for the United States,” Erk said. “It is shipped and it is waiting in the warehouse.” “The government has been very keen to get these doses into its own distribution system.

“I expect it to be widely distributed quickly.”

Erk also said the company was planning to offer vaccines to teens and children as young as two years old. Data on the efficacy of the children’s shots will be available “in the coming months,” and Novavax hopes to offer the shots to children later this year.