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




Novavax’s vaccine will be available as a two-dose primary series for people 18 years and older.

The FDA’s independent advisory committee on vaccines and related biological products voted in favor of the vaccine on June 7, saying the benefits of the vaccine outweigh the risks to adults. It is also used in 170 other countries.

The syringes cannot be administered until the independent vaccine advisers of the US Centers for Disease Control and Prevention consider whether to recommend the vaccine, and the CDC director has signed the recommendation. The CDC’s Advisory Committee on Immunization Practice is scheduled to meet on 19 July.

Like more well-known vaccines such as hepatitis B and pertussis, the Covid-19 vaccine is protein-based, and uses harmless protein fragments of the virus to teach the immune system how to detect the virus and fight it. The vaccine was made from a genetic sequence of the first strain of the coronavirus.

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

About 1 in 3 Americans have still not been vaccinated against Covid-19, more than 100 million people. Many officials and health workers hope that a vaccine like Novavax’s, which uses more well-known technology, may be enough to persuade people who have been hesitant to be inoculated.

“We believe that part of the 100 million people are waiting for our vaccine. And if you look at my basket, every day when I come to the office, you will see that quite a few of the people are saying ‘let’s get this vaccine approved. I want it. “So I do not know what the proportion of these 100 million people is, but I do not think it is insignificant,” Novavax President and CEO Stanley Erck told CNN.

In addition to the primary series of shots, he says, the company hopes to get permission soon to use the shots as boosters for other vaccines.

“We’ve talked a lot with the FDA about this,” Erck said. “I think the FDA will process this approval in a matter of weeks.”

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Late stage studies found that the effect of the vaccine against mild, moderate and severe disease is 90.4%, according to the company. There is insufficient evidence to assess the effect of the vaccine on the transmission of the virus.

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

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

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

The company said on Wednesday that it expects the vaccine to be available soon, pending signing by the CDC.

“We have a vaccine that we have produced for the United States. It has been shipped and is waiting in stock,” Erck said. “The government has been very concerned about getting these doses into the distribution system.

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

Erck also said that the company planned to offer vaccines to adolescents and children as young as 2 years. Data on the effect of children’s shots will be available “in the coming months”, and Novavax hopes to offer shots to children later this year.



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