Is FDA Authorization for Novavax's Covid Vaccine Imminent?

Motley Fool via NASDAQ ^ | 03/09/2022 | David Jagielski

[SeekAndFind]

Since the start of 2020, shares of Novavax (NASDAQ: NVAX) have soared by more than 1,600%, making the S&P 500's 30% returns during that period look minuscule. And the main reason for all that bullishness has been the COVID-19 vaccine the company has been developing, which could lead to billions in revenue for the business.

The company only recently filed for an Emergency Use Authorization (EUA) of its vaccine, and if it obtains it, shares of the stock could once again go soaring. Is approval imminent for Novavax, and is now a good time to buy shares of the healthcare stock?

Novavax filed for an EUA in January

On Jan. 31, Novavax formally submitted its request to the Food and Drug Administration (FDA) to have its COVID-19 vaccine approved for EUA. Up until now, the FDA has only given the OK to three vaccines: from Pfizer, Moderna, and Johnson & Johnson.

Based on the previous submissions, it took the FDA roughly three weeks to issue an EUA. As of March 8, it has been 36 days since the Novavax submission.

Should investors be worried?

It may be unsettling for investors that Novavax's COVID-19 vaccine hasn't secured EUA yet, but no response doesn't necessarily mean that the FDA won't give it the green light. There are a few reasons investors shouldn't worry just yet.

If the FDA has concerns about the vaccine, investors will likely learn about them. When biotech company Ocugen announced in May of last year that it was planning to file for an EUA for its COVID-19 vaccine, the company told investors on June 10, 2021, that the FDA had already encouraged it to seek a more comprehensive Biologics License Application instead, which takes longer (the vaccine still hasn't gained approval in the U.S.).

[SeekAndFind]

OTHER THAN THE USA: There are 36 countries that have approved Novavax’s vaccine for use, including Canada, which granted authorization last month.

[Robert DeLong]

I Don't Care Anymore

[canuck_conservative]

Original Problem - the FDA is nothing but Democrat propagandists pretending to be objective scientists

so right on cue, the FDA says Ivermectin (a cheap, effective alternative to vaccines) is ineffective horse-paste ... because if any cheap alternatives are available, the FDA cannot issue emergency approval for any vaccine

result 1 - Big Pharma can now qualify for their EUA’s, now that Ivermectin is discredited

result 2 - no doctor in the US can prescribe Ivermectin without threat of losing their license, because of the FDA’s ruling

result 2 - every other country’s “health experts” takes their cue from the FDA, so no country will approve Ivermectin

the shut-down is complete ... Big Pharma controls the narrative

[systemjim]

A bit late to the party, isn’t it?

[Bigbrown]

Just another one that I won’t put in my body…

[cgbg]

We need another vaccine to throw in the trash—hazardous medical waste is good for the planet!

[olivia3boys]

I’m traveling to Hawaii, Canada, Spain, and England in 2022 and 2023. I’m waiting to find out which places will require a booster and I’m hoping if any of them do by the time I travel that I can pick the Norovax one. So far my only vax is a single J&J a year ago.

[O6ret]

Same here but understand Canada will approve US citizens to receive the Novavax vaccine if they travel to Canada to get it.