Posted on 11/03/2021 8:33:24 AM PDT by SeekAndFind
Novavax Inc (NVAX.O) expects regulators in India, the Philippines and elsewhere to make a decision on its COVID-19 vaccine within "weeks," its chief executive told Reuters, after the shot on Monday received its first emergency use authorization (EUA) from Indonesia.
Novavax shares were up about 13% after the company also said it had filed an application for emergency use of the vaccine to Canada and the European Medicines Agency.
For Indonesia, the shot will be manufactured by the world's largest vaccine manufacturer, Serum Institute in India (SII), and sold under the Indian company's brand name, Covovax. Novavax said initial shipments into Indonesia are expected to begin imminently.
The World Health Organization (WHO) is also reviewing Novavax's regulatory filing and the U.S. drugmaker expects that review to be resolved in the coming weeks, Chief Executive Stanley Erck told Reuters in a phone interview on Monday.
A green light from the WHO would set the stage for Novavax to begin shipping doses to the COVAX program that supplies shots to low-income countries. Novavax and SII have together committed to provide more than 1.1 billion doses to COVAX, which is co-led by the WHO.
“I think we'll get some doses to COVAX this year," Erck said. "But I think (Novavax is) going to really start being able to ship large quantity to COVAX in the first quarter" of 2022.
Erck said Novavax has resolved all of its manufacturing challenges and does not expect regulators to have any further concerns about its production processes.
He said Novavax is “in dialogue with the U.S. FDA and ... we expect a full submission within the next several weeks.”
Novavax had delayed filing for U.S. approval, and Politico reported last month that the company faced production and quality problems.
(Excerpt) Read more at reuters.com ...
Novavax has so far applied for EUA in various countries, including the UK, Australia, India and the Philippines.
“It will be weeks, not months, for them to review” Novavax’s regulatory submissions and potentially clear the shot for use, Erck said.
The company, along with Japanese partner Takeda Pharmaceutical Co , said on Friday it was preparing to seek regulatory approval for a rollout in Japan early next year.
Read more here:
The Novavax shot was shown to be more than 90% effective, including against a variety of concerning variants of the coronavirus in a large, late-stage U.S.-based trial.
They Invermectined themselves and deleted the problem. What is this nonsense.
I’m sure Indonesians will line up to swing machetes at anyone trying to jab them.
I’ve been to Indonesia several times. Although they are a majority Muslim country, their government is very tolerant of other religions. Just go to the Province of Bali for instance, the island is majority Hindu (over 85%) with temples dotted all over the Island. Hundreds of Christian churches dot the islands as well.
The women don’t have dress codes and you will see many wearing miniskirts on the streets.
There are Muslim extremists in that country ( especially in the western part -in Bandah Aceh ) but the government cracks down on them.
Many of us are waiting for this to be rolled out in the US.
That said, as for a booster? I'll choose to wait for Novavax.
It looks like Novavax uses HEK293 fetal cells for their R&D testing.
https://lozierinstitute.org/what-you-need-to-know-about-the-covid-19-vaccine/
https://s27589.pcdn.co/wp-content/uploads/2020/12/CHART-Analysis-of-COVID-19-Vaccines-02June21.pdf
https://www.science.org/doi/10.1126/science.abe1502
If so, no thanks, for me.
I work at a military installation where vaccines have been mandated, but those of who are filing for exemptions really want to utilize the Novavax vaccine since that is allowed. But with them not being available in the US yet, we’re kind of stuck.
A lot of so called pro-life Freepers are fine with abortion as long they think it benefits them.
Kinda is enough to make you go down the road Alex Jones lives on.
You know, the 5th largest held stock by the House and Senate is P**zer & who knows how many were aboard the 24 bagger that was it's main Mnra competitor was, and how how Nova & all the other cheap over the counter stuff that was poo-pooed and destroyed are having such a hard time getting into the mainstream. hmmm.....
The one that everyone wants, and my guess is the one all those were fired would take in a heartbeat, yet they want to stick us w/ what we don't want with a totalitarian fist, feels like pure evil to me and a desire to have everyone submit.
Waiting for the Oravax vaccine. Uses the older protein based technology, oral pill form, includes three proteins so is more resilient to variants.
Due to heart surgery and on going heart conditions I am not getting the currently available vaccinations as they are too great of a risk. Hopefully the phase 2/3 clinical trials (ongoing) for Oravax will show that they do not cause the clotting and heart swelling associated with the current vaccines.
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