Novovax Covid vaccine likely to get nod in India ahead of USA

Rediff ^ | 08/18/2021 | Sohini Das

[SeekAndFind]

Covid vaccine from US biotech company, Novavax may get a nod from the Indian drug regulator even before the vaccine is approved in the US.

The company and its partner Serum Institute of India (SII) had, on August 5, applied for an emergency use authorisation with the Drugs Controller General of India (DCGI) and regulatory bodies in Indonesia and the Philippines.

India has said any vaccine, which has approval from stringent regulatory bodies like the US Food and Drug Administration (USFDA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, among others, would be approved for use in India.

Novavax’s protein nano-particle two-dose Covid vaccine is not yet approved in the US or the UK. This raised concerns around its approval timelines in India.

However, a senior government official clarified: “Indian regulator can review the global data from phase 3 trials, as well as the bridging trial data from the 1,600 volunteers in India to consider granting an approval. Whe­ther or not it is appr­oved in the US does not matter. The Indian regulator can conduct an independent review.”

SII and Novavax have now completed submission of all modules required by regulatory agencies in India, Indonesia and the Philippines for the initiation of review of the vaccine, including preclinical, clinical, and chemistry, manufacturing and controls data, Novavax said.

A ‘good manufacturing practice’ joint site inspection of SII was successfully completed by DCGI in May 2021, it added.

SII chief executive officer (CEO) Adar Poonawalla said a few days ago that he is hopeful that Covovax, the Novavax vaccine made by SII , will be launched around October this year for adults and for children by the first quarter of next year, depending on DCGI approvals.

A Novavax spokesperson told Business Standard that the company also intends to apply for emergency use authorisation with the World Health Organisation (WHO), UK-MHRA, European Medicines Agency (EMA), and other stringent regulatory authorities.

“We continue to work with these authorities to ensure we are aligned. Regulators in different countries have different requirements. We are leveraging the expertise and knowledge of our many partners to progress as rapidly as possible, while ensuring that we meet all stringent requirements that guarantee safety and quality,” the spokesperson said.

She added that in the US, the company continues to work with the FDA for emergency use authorisation.

“SII is manufacturing, and developing it, and is responsible for commercialising the vaccine in India. Novavax and SII have cumulative commitments to provide more than 1.1 billion doses to the COVAX facility,” Novavax said.

However, before supplies to the COVAX can begin, a World Health Organisation (WHO) pre-qualification wou­ld be necessary. A submission to the WHO for emergency use listing, based on the DCGI submission, is expected to be filed in August, Novavax said.

The Maryland-based company expects to achieve a global production target of 100 million doses per month by the end of the third quarter of 2021 and 150 million doses a month by the end of the fourth quarter.

Covovax has been evaluated in two pivotal phase 3 trials -- the UK trial has shown an efficacy of 96.4 per cent against the original virus strain, and 86.3 per cent against the Alpha variant. The US trials showed 90.4 per cent efficacy.

[peggybac]

I’ve been reading up on this, as well as reading posts from FReepers about it. Interesting.

[WoofDog123]

given how crony capitalism works, the issue with the FDA could be as simple as the right people not being involved in the company or specific patents.

[Jonty30]

I’m being denied the vaccine of my choice!!!!

My vaccine of choice is no vaccine.

[SoConPubbie]

Too bad India didn’t just stick with common sense and Ivermectin.

They have already proven that it is much more effective than BIG-PHARMA’s deadly vaccines.

[ransomnote]

Novavax is an injection of pure spike proteins. In case it's of interest, I'll repost my reply to another FReeper who also said Novavax is supposed to be more traditional. I don't have time to edit it down right now. I hope there's something of use in it for you. That FReeper had read it contained harmless 'protein subunits'.

 ~~~~

 They are lying. If spike proteins didn't have the horrible evidence surfacing everywhere right now, the content you quoted wouldn't refer to the spike proteins as 'protein subunits!'.

The spike they are trying to hide are not 'harmless'. Can they get any more evil?

I found this Novavax article from someone whitewashing it, and it still sounded bad. Only the first part of the notes i wrote relates to the vax.

My notes on Dr. John Campbell's video "TUESDAY UPDATE" in which he reviews Novavax and a small Ivermectin study in Israel.

6/16/2021, 2:03:15 AM · by ransomnote · 8 replies

youtube.com ^ | Jun 15, 2021 | Dr. John Campbell and vanity

"How Novavax works:

DNA designed to make the spike proteins is put into another virus and that virus is put into moth cells. The DNA instructs the moth cells to mass produce the spike proteins, then the spike proteins are harvested (purified) from the moth cells. 

The spike cells stick together and have the antigenic properties of the Sars 2 Covid virus, without the actual presence of the Covid virus."

ransomnote: Then there's proof the company was failing, just like Moderna. Why did the NIH choose failed companies, offer them massive amounts of money etc. Weren't there successful ones to choose from, or ones that didn't have substantial lawsuits against them like Johnson & Johnson, PFizer have?

The long shot [Novavax Covid Vaccine]

6/15/2021, 11:38:33 PM · by ransomnote · 16 replies

sciencemag.org ^ | 06 Nov 2020: | Meredith Wadman

 

Novavax's vaccine is made of tiny particles studded with the coronavirus spike protein plus honeycomblike molecules, derived from plants, that stimulate the immune system.

 

Image of Novavax's tiny particles studded with coronavirus spike proteins

 

Eighteen months ago, a small vaccinemaker here called Novavax faced an existential threat: delisting by the NASDAQ stock index. On the heels of a second failed vaccine trial in less than 3 years, the firm's shares had plunged to less than $1 for 30 straight days, triggering a warning by NASDAQ. Frantic to conserve cash, the company sold its two Maryland manufacturing facilities, slicing its payroll by more...

~~~~~~~~~~~

 

Basically, the CDC, NIH, FDA have collaborated to cause harm and anything that is good, they suppress and anything that is bad they promote.

So, we should be okay if we do the opposite of anything they say. 
Have you seen this? More proof that the CDC is toxic and all their 'advice' must be rejected.

 

Our First Hand ICU Story - What is ACTUALLY Killing People In The Hospital [Includes my notes on video,post #1 lists treatments that helped her husband recover]

8/11/2021, 6:42:39 PM · by ransomnote · 44 replies

 

[Tired of Taxes]

bookmark

[Governor Dinwiddie]

Novavax doesn't contain any mRNA. Supposedly it is more similar to a conventional vaccine than the others.

[Dick Bachert]

AMEN!!
PERHAPS THE MOST CHILLING 4 MINUTE VIDEO YOU’LL SEE!
No way to know if this is true or not. That said, given the PAST behavior of these &%$#@ elites, I put NOTHING PAST THEM.
NOTHING CAN STOP WHAT’S COMING, DR. SEAN BROOKS
https://www.bitchute.com/video/Ecux1OTy56oK/

[SeekAndFind]

RE: Novavax doesn’t contain any mRNA

No it does not, but there are some causes for concern as posted in Post #6 above.

[ducttape45]

ping for later