Novavax seeks US FDA authorization of its coronavirus vaccine - CTV News | Canada News Media
Connect with us

Business

Novavax seeks US FDA authorization of its coronavirus vaccine – CTV News

Published

 on


Novavax announced Monday that it has formally submitted a request for the U.S. Food and Drug Administration to authorize its coronavirus vaccine for emergency use in the United States.

The request is based on data that includes the results of two large clinical trials that demonstrated an overall efficacy of approximately 90 per cent and a “reassuring safety profile,” according to the company.

“We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,” Stanley Erck, Novavax’s president and chief executive officer, said in the announcement Monday.

Novavax announced in June that its vaccine candidate was found to have an overall efficacy of 90.4 per cent in a Phase 3 trial conducted across the United States and Mexico; the trial took place before the Omicron variant dominated in the United States.

Then in December, the company said that it had finished its final submission package to the FDA for emergency use authorization (EUA) of the vaccine, called NVX-CoV2373.

The vaccine can be stored at normal refrigeration temperatures, between 2 and 8 C, and has a shelf life of about nine months, according to the company. Erck told CNN in November that if the FDA gives the green light for the EUA, the first 100 million doses of the protein-based vaccine will be ready to ship following authorization.

Novavax’s vaccine — administered as two doses, three weeks apart — is made using small, laboratory-built pieces of the coronavirus to stimulate immunity, which is a more traditional approach for vaccine development that some people may be more familiar or comfortable with compared with the mRNA vaccines made by Moderna or Pfizer.

“In the U.S., the primary market I think in 2022 is going to be to supply a vaccine, our normal two-dose regimen, to a lot of people who have been hesitant to get other vaccines,” Erck said in November. “And to provide a booster.”

The FDA has previously authorized vaccines made by Pfizer, Moderna and Johnson & Johnson for emergency use in the United States. The Pfizer vaccine is now approved for use in people age 16 and older and the Moderna vaccines is approved for adults.

In November, Indonesia became the first country to grant emergency use authorization of Novavax’s vaccine. Since then, South Korea’s Ministry of Food and Drug Safety has approved the vaccine, Australia’s Therapeutic Goods Administration has granted approval for provisional registration of the vaccine and the Drugs Controller General of India has granted emergency use authorization of the vaccine.

Novavax so far has applied for authorization in several other countries, including the United Kingdom, Canada, New Zealand, the European Union and the Philippines.

Adblock test (Why?)



Source link

Continue Reading

Business

Netflix’s subscriber growth slows as gains from password-sharing crackdown subside

Published

 on

 

Netflix on Thursday reported that its subscriber growth slowed dramatically during the summer, a sign the huge gains from the video-streaming service’s crackdown on freeloading viewers is tapering off.

The 5.1 million subscribers that Netflix added during the July-September period represented a 42% decline from the total gained during the same time last year. Even so, the company’s revenue and profit rose at a faster pace than analysts had projected, according to FactSet Research.

Netflix ended September with 282.7 million worldwide subscribers — far more than any other streaming service.

The Los Gatos, California, company earned $2.36 billion, or $5.40 per share, a 41% increase from the same time last year. Revenue climbed 15% from a year ago to $9.82 billion. Netflix management predicted the company’s revenue will rise at the same 15% year-over-year pace during the October-December period, slightly than better than analysts have been expecting.

The strong financial performance in the past quarter coupled with the upbeat forecast eclipsed any worries about slowing subscriber growth. Netflix’s stock price surged nearly 4% in extended trading after the numbers came out, building upon a more than 40% increase in the company’s shares so far this year.

The past quarter’s subscriber gains were the lowest posted in any three-month period since the beginning of last year. That drop-off indicates Netflix is shifting to a new phase after reaping the benefits from a ban on the once-rampant practice of sharing account passwords that enabled an estimated 100 million people watch its popular service without paying for it.

The crackdown, triggered by a rare loss of subscribers coming out of the pandemic in 2022, helped Netflix add 57 million subscribers from June 2022 through this June — an average of more than 7 million per quarter, while many of its industry rivals have been struggling as households curbed their discretionary spending.

Netflix’s gains also were propelled by a low-priced version of its service that included commercials for the first time in its history. The company still is only getting a small fraction of its revenue from the 2-year-old advertising push, but Netflix is intensifying its focus on that segment of its business to help boost its profits.

In a letter to shareholder, Netflix reiterated previous cautionary notes about its expansion into advertising, though the low-priced option including commercials has become its fastest growing segment.

“We have much more work to do improving our offering for advertisers, which will be a priority over the next few years,” Netflix management wrote in the letter.

As part of its evolution, Netflix has been increasingly supplementing its lineup of scripted TV series and movies with live programming, such as a Labor Day spectacle featuring renowned glutton Joey Chestnut setting a world record for gorging on hot dogs in a showdown with his longtime nemesis Takeru Kobayashi.

Netflix will be trying to attract more viewer during the current quarter with a Nov. 15 fight pitting former heavyweight champion Mike Tyson against Jake Paul, a YouTube sensation turned boxer, and two National Football League games on Christmas Day.

The Canadian Press. All rights reserved.

Source link

Continue Reading

Business

All Magic Spells (TM) : Top Converting Magic Spell eCommerce Store

Published

 on

Product Name: All Magic Spells (TM) : Top Converting Magic Spell eCommerce Store

Click here to get All Magic Spells (TM) : Top Converting Magic Spell eCommerce Store at discounted price while it’s still available…

All orders are protected by SSL encryption – the highest industry standard for online security from trusted vendors.

All Magic Spells (TM) : Top Converting Magic Spell eCommerce Store is backed with a 60 Day No Questions Asked Money Back Guarantee. If within the first 60 days of receipt you are not satisfied with Wake Up Lean™, you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked.

(more…)

Continue Reading

Business

Turn Your Wife Into Your Personal Sex Kitten

Published

 on

Product Name: Turn Your Wife Into Your Personal Sex Kitten

Click here to get Turn Your Wife Into Your Personal Sex Kitten at discounted price while it’s still available…

All orders are protected by SSL encryption – the highest industry standard for online security from trusted vendors.

Turn Your Wife Into Your Personal Sex Kitten is backed with a 60 Day No Questions Asked Money Back Guarantee. If within the first 60 days of receipt you are not satisfied with Wake Up Lean™, you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked.

(more…)

Continue Reading

Trending

Exit mobile version