Novavax vaccine 96% effective against original coronavirus, 86% vs British variant in UK trial
By Dania Nadeem and Carl O'Donnell

FILE PHOTO: Vials labelled "COVID-19 Coronavirus Vaccine" and sryinge are seen in front of displayed Novavax logo in this illustration taken, February 9, 2021. REUTERS/Dado Ruvic/Illustration/File Photo

(Reuters) - Novavax Inc's COVID-19 vaccine was 96% effective in preventing cases caused by the original version of the coronavirus in a late-stage trial conducted in the United Kingdom, the company said on Thursday, moving it a step closer to regulatory approval.

There were no cases of severe illness or deaths among those who got the vaccine, the company said, in a sign that it could stop the worse effects of new variants that have cropped up.

The vaccine was 86% effective in protecting against the more contagious virus variant first discovered and now prevalent in the United Kingdom, for a combined 90% effectiveness rate overall based on data from infections of both versions of the coronavirus.

Novavax shares jumped 22% in after-hours trading to $229. They were trading below $10 on Jan. 21, 2020, when the company announced it was developing a coronavirus vaccine.

In a smaller trial conducted in South Africa - where volunteers were primarily exposed to another newer, more contagious variant widely circulating there and spreading around the world - the Novavax vaccine was 55% effective, based on people without HIV, but still fully prevented severe illness.

Novavax Chief Medical Officer Filip Dubovsky said the performance in South Africa suggests there may still be a case for using it in areas where the South African variant is dominant.

Novavax is also developing new formulations of its vaccine to protect against emerging variants and plans to initiate clinical testing of these shots in the second quarter of this year.

Results from the final analysis of the UK trial were largely in line with interim data released in January.

The company expects to use the data to submit for regulatory authorization in various countries. It is not clear when it will seek U.S. authorization or if regulators will require it to complete an ongoing trial in the United States.

Novavax expects data from a 30,000-person trial in the United States and Mexico by early April.

Dubovsky said that Novavax is still planning to file for authorization from UK regulators early in the second quarter of 2021.

The UK trial, which enrolled more than 15,000 people aged 18 to 84, assessed efficacy of the vaccine during a period with high transmission of the UK virus variant now circulating widely.

The shot's effectiveness in the South Africa trial declined to around 49% when the analysis included data from HIV-positive participants.

The vaccine could be cleared for use in the United States as soon as May if U.S. regulators decide the UK data is enough to make a decision. It could take a couple months longer if they insist on first seeing data from the U.S. trial, its chief executive told Reuters earlier this month.

"Ultimately, they have to decide whether the data we can bring to the table is adequate or whether they would prefer to wait on data from our U.S. study," Dubovsky said on Thursday.

Novavax’s vaccine production plants should all be fully functional by April, executives said on a March investor call. The drugmaker expects to have tens of millions of doses stockpiled and ready to ship in the United States when it receives authorization, CEO Stanley Erck told Reuters.

Novavax plans to produce its two-shot vaccine at eight manufacturing locations, including the Serum Institute of India.

If authorized, it would follow three COVID-19 vaccines previously approved for use in Britain from Pfizer and partner BioNTech, Moderna Inc and the AstraZeneca shot developed with Oxford University.

The Maryland-based company has received $1.6 billion from the U.S. government in funding for the vaccine trial and to secure 100 million doses.

(Reporting by Dania Nadeem in Bengaluru and Carl O'Donnell in New York; Editing by Bill Berkrot and Lisa Shumaker)

-- © Copyright Reuters 2021-03-12

 

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Sounds like more tools in our collective arsenal against this scourge excellent news!

Good to see that quality vaccines are now becoming available. Another of four to choose from: Moderna, J&J, Pfizer, and Novavax.

1 hour ago, John Drake said:

Good to see that quality vaccines are now becoming available. Another of four to choose from: Moderna, J&J, Pfizer, and Novavax.

Actually all the vaccines are quality vaccines where it counts the most: preventing hospitalizations and death. The various efficacy percentages for different vaccines signifies how effective they are preventing any Covid 19 symptoms from manifesting  in a vaccinated cohort versus an unvaccinated one. So whlle you're more likely to get symptoms from a vaccine that has an efficacy rating of 50%, you're still very very unlikely to get symptoms severe enough to get you hospitalized or even die.

Just now, placeholder said:

Actually all the vaccines are quality vaccines where it counts the most: preventing hospitalizations and death. The various efficacy percentages for different vaccines signifies how effective they are preventing any Covid 19 symptoms from manifesting  in a vaccinated cohort versus an unvaccinated one. So whlle you're more likely to get symptoms from a vaccine that has an efficacy rating of 50%, you're still very very unlikely to get symptoms severe enough to get you hospitalized or even die.

Unless you take AZ and develop a blood clot and die.

9 minutes ago, John Drake said:

Unless you take AZ and develop a blood clot and die.

Really? What about if you take the Pfizer vaccine and develop a blood clot and die? So far, the epidemiological evidence is against establishing a connection between the AZ vaccine and blood clots. But even if it were the case, the odds are still so small it would be like drawing the short straw in a massive lottery. And since in this case, each straw comes with the overwhelming likelihood of a crucial benefit, not taking one makes little sense.

 

 

1 hour ago, placeholder said:

So far, the epidemiological evidence is against establishing a connection between the AZ vaccine and blood clots.

Which is why countries have suspended using it, eh?

13 minutes ago, John Drake said:

Which is why countries have suspended using it, eh?

Did you actually read the article? They're suspending its use out of an abundance of caution. And if they were "discontinuing" its use instead of "suspending" it, you would have a better point.

20 minutes ago, placeholder said:

Did you actually read the article? They're suspending its use out of an abundance of caution. And if they were "discontinuing" its use instead of "suspending" it, you would have a better point.

Here's the article.... Notice the word "suspend" in the headline.  They are suspending it for a reason. They weighed the risks and decided it was necessary to stop it rather than continue it. The AZ vaccine continues to have problems. Just as it has been proven inferior to the American vaccines for the treatment of the variants. But for some reason, you seem to want to pump this particular vaccine and dismiss the fact, too, that Sinovac can't even get approval in the West. They are not all of "quality."

Quote

Health authorities in Denmark, Norway and Iceland on Thursday suspended the use of AstraZeneca's COVID-19 vaccine following reports of the formation of blood clots in some people who had been vaccinated.   

 

 

15 minutes ago, John Drake said:

Here's the article.... Notice the word "suspend" in the headline.  They are suspending it for a reason. They weighed the risks and decided it was necessary to stop it rather than continue it. The AZ vaccine continues to have problems. Just as it has been proven inferior to the American vaccines for the treatment of the variants. But for some reason, you seem to want to pump this particular vaccine and dismiss the fact, too, that Sinovac can't even get approval in the West. They are not all of "quality."

 

I noticed the use of "suspend". Not only that, I know what it means. It doesn't mean discontinue. And if you read the article that's posted elsewhere in this forum, you'll note that they are just being very cautious. The statistics don't seem to support the precaution. 

And what don't you understand about the fact that all of the vaccines out there pretty much put a halt to hospitalizations and deaths due to covid. If the most serious  consequence of a covid 19 infections was some temporary misery, it wouldn't' be regarded as a serious threat at all. And if everyone took any of those vaccines, that's what the situation would look like. 

I wonder if the UK are counting covid vaccines deaths the same way they counted covid deaths?If people die within 28 days of a covid vaccination it should be counted as a covid vaccine death, just to be consistent and scientific and to create as much fear about the vaccines as they did for the virus. 

A troll post has been removed

This first round of vaccines is going to save a lot of lives, and allow the world to return to some measure of normalcy. With the information gathered with this first round, we can expect newer, better vaccines soon that will really make a big difference.

Nothing that I read suggests to me at least that the AZ vaccine is nothing but safe.

That being said AZ isn't approved here in the US since they haven't applied to be approved, but April I think is the date.

I have no doubt it will be approved for emergency use, along with Pfizer, Moderna & J&J.

More weapons in the arsenal seems nothing but a good thing.

We're almost at the point where we look on this topic from afar. My wife has already had both her Moderna shots, I've had the first Pfizer, second one on the 29th of March.

So after that you're on your own boys, we're all done and dusted lol