International [U.S COVID Vaccine News] CDC to Lift COVID-19 Testing Requirement for international Travelers

[Arkain2K]

Novavax Files Final Data on Covid Vaccine to U.S. Regulators
By Angelica Peebles | December 31, 2021

Novavax Inc. submitted the final data package for its Covid-19 vaccine candidate to U.S. regulators, bringing it one step closer to clearance.

The submission to the Food and Drug Administration included details on chemistry, manufacturing and controls for the shot known as NVX-CoV2373, Novavax said in a statement. The company expects to file a request for emergency use authorization in one month, in line with the FDA’s guidance around such filings.

If authorized, the shot would become the fourth Covid vaccine cleared in the U.S. and the first of its kind. European regulators and the World Health Organization cleared the product this month after months of delays. Novavax has grappled with manufacturing problems despite securing some of the largest funding from the Trump administration in the early stages of the pandemic.

The Novavax product is a protein-based shot, unlike messenger RNA and viral vector vaccines that were cleared earlier.

“Novavax is committed to delivering our protein-based vaccine in the United States, where the Covid-19 pandemic continues to evolve with the emergence of new variants, ongoing need to ensure primary vaccination for the eligible population, and need for boosting,” Chief Executive Officer Stanley Erck said in a statement.

The company’s filing includes only one manufacturing site, the Serum Institute of India. Novavax said it expects to file data from other sites at a later date.

The shot could prove useful in supplying countries that have struggled to get enough doses to vaccinate their populations. However, Politico reported on Friday that Biden administration officials are concerned about the company’s ability to produce enough doses in the year ahead.

https://www.bloomberg.com/news/arti...al-data-on-covid-19-vaccine-to-u-s-regulators

 

[Whippy McGee]

Welp.... CNN is caught lying straight up. Omicron has killed no one, but they report "1st Death".

 

[Arkain2K]

COVID vaccine from Novavax 1 month from FDA application
By Jeff Clabaugh | January 3, 2022

​

Gaithersburg, Maryland-based Novavax could file for Food and Drug Administration approval for its COVID-19 vaccine within weeks, after completing one of the final steps in the process.

Novavax said Friday it had completed submission of the final data package, including chemistry, manufacturing and the controls module to the FDA, the final prerequisite in the emergency use authorization application process.

Novavax now expects to submit a request for emergency use with the FDA in one month, in accordance with submission guidance for emergency use authorization vaccines.

“Novavax is committed to delivering our protein-based vaccine in the United States, where the COVID-19 pandemic continues to evolve with the emergence of new variants, ongoing need to ensure primary vaccination for the eligible population, and need for boosting,” said Novavax CEO Stanley Erck.

In late-December, Novavax received authorization for its vaccine in India, as well as the European Union.

Its two-dose vaccine is already being distributed in Indonesia and the Philippines. It has authorizations pending in several other countries, including South Korea and Japan.

The Novavax vaccine differs from existing messenger RNA vaccines currently in use, and can be shipped and stored at much higher refrigeration temperatures, which could increase access in hard-to-reach areas.

Novavax received $1.6 billion from the federal government in 2020 to develop and manufacture its COVID vaccine, as part of Operation Warp Speed, the program intended to accelerate vaccine development.

https://wtop.com/business-finance/2022/01/novavax-vaccine-one-month-from-fda-application/

 

[Arkain2K]

Korea set to approve Novavax COVID-19 vaccine by this month
By Lee Hyo-jin, The Korea Time | 2022-01-08​

​

The Korean drug regulator is set to approve the use of a COVID-19 vaccine developed by U.S. drugmaker Novavax this month, making it the fifth vaccine to be used in the country.

The Korea Disease Control and Prevention Agency (KDCA) said Friday that the Ministry of Food and Drug Safety, which is currently reviewing Novavax's Nuvaxovid, is expected to give the green light by the end of January.

"The drug ministry is close to approving the vaccine. Once approved, the priority recipients of the vaccine will be those who are yet to be vaccinated," Hong Jeong-ik, a senior official at the KDCA, said during a media briefing.

Local drugmaker SK Bioscience, with which Novavax has signed a manufacturing contract, applied on Nov. 15 for product approval.

The Novavax vaccine will become the fifth COVID-19 vaccine product approved by the Korean authorities, after AstraZeneca, Pfizer, Moderna and Johnson & Johnson. The government has so far secured 40 million doses of Novavax, enough to inoculate 20 million people.

Unlike mRNA vaccines such as Pfizer and Moderna which contain a genetic code that the body creates an immune response to, Nuvaxovid uses a more traditional vaccine approach, containing purified pieces of the target virus.

The vaccine spurs an immune response in the recipient by injecting a spike protein from the coronavirus. The purified protein antigens in the vaccine cannot replicate or cause the COVID-19 infection. The two-dose vaccine should be administered with a three-week interval.

If approved, the KDCA plans to use the initial batches of Novavax on people aged over 18 who have yet to receive a vaccine, rather than using them as booster shots.

Regarding questions as to whether this means giving unvaccinated groups a choice between an mRNA vaccine and Novavax's, Hong said, "It may seem like giving them a choice."

Since the COVID-19 vaccination program began here in February 2021, the government has maintained its stance that individuals will not be able to choose the type of vaccine they receive.

Hong added, "But the current situation is different from the beginning stages of the vaccine program. At that time, the government had to decide which vaccine an individual would receive depending on the supply situation."

https://m.koreatimes.co.kr/pages/article.amp.asp?newsIdx=321886

 

[ElKarlo]

Korea set to approve Novavax COVID-19 vaccine by this month
By Lee Hyo-jin, The Korea Time | 2022-01-08​

​

The Korean drug regulator is set to approve the use of a COVID-19 vaccine developed by U.S. drugmaker Novavax this month, making it the fifth vaccine to be used in the country.

The Korea Disease Control and Prevention Agency (KDCA) said Friday that the Ministry of Food and Drug Safety, which is currently reviewing Novavax's Nuvaxovid, is expected to give the green light by the end of January.

"The drug ministry is close to approving the vaccine. Once approved, the priority recipients of the vaccine will be those who are yet to be vaccinated," Hong Jeong-ik, a senior official at the KDCA, said during a media briefing.

Local drugmaker SK Bioscience, with which Novavax has signed a manufacturing contract, applied on Nov. 15 for product approval.

The Novavax vaccine will become the fifth COVID-19 vaccine product approved by the Korean authorities, after AstraZeneca, Pfizer, Moderna and Johnson & Johnson. The government has so far secured 40 million doses of Novavax, enough to inoculate 20 million people.

Unlike mRNA vaccines such as Pfizer and Moderna which contain a genetic code that the body creates an immune response to, Nuvaxovid uses a more traditional vaccine approach, containing purified pieces of the target virus.

The vaccine spurs an immune response in the recipient by injecting a spike protein from the coronavirus. The purified protein antigens in the vaccine cannot replicate or cause the COVID-19 infection. The two-dose vaccine should be administered with a three-week interval.

If approved, the KDCA plans to use the initial batches of Novavax on people aged over 18 who have yet to receive a vaccine, rather than using them as booster shots.

Regarding questions as to whether this means giving unvaccinated groups a choice between an mRNA vaccine and Novavax's, Hong said, "It may seem like giving them a choice."

Since the COVID-19 vaccination program began here in February 2021, the government has maintained its stance that individuals will not be able to choose the type of vaccine they receive.

Hong added, "But the current situation is different from the beginning stages of the vaccine program. At that time, the government had to decide which vaccine an individual would receive depending on the supply situation."

https://m.koreatimes.co.kr/pages/article.amp.asp?newsIdx=321886

Think Novavax outside of their actual science has showed they don’t understand the political world and we’re slower to push their vaccine through the FDA and such. It was more them not knowing how to go through the regulations and regulators imho

 

[badascan]

Two questions, would this novovak treatment qualify as a "vaccine" according to the old definition not the new one? And after receiving it would I be more or less susceptible to the current and future variants of the flu?

 

[Arkain2K]

Think Novavax outside of their actual science has showed they don’t understand the political world and we’re slower to push their vaccine through the FDA and such. It was more them not knowing how to go through the regulations and regulators imho

I think it's a sound business strategy for a small company with limited resources that came late to the game, especially now that their Federal funding had been cut off after their repeated delays.

They got the approval by the WHO and the European Union first, while partnering with a major pharmaceutical producer in each developed countries that still needs to innoculate their population (who already placed large purchase orders with them) and jointly filed for approval there (SK Bioscience in Korea, Takeda in Japan, et al).

They also already went ahead and got the approval by India, which is crucial because their Indian manufacturing partner SII is producing their supply for the middle and lower-income countries that also approved their protein-based shot (Indonesia, Philippines, et al)

The U.S market is very much saturated by now, and we've been sitting nicely on a giant stockpile of Pfizer and Moderna's mRNA vaccine supply hoarded from the start, plenty enough to provide a booster to any American who wants it, so it doesn't change Novavax's economic prospect at all to focus their efforts and attention States-side rather than their targeted markets.

Now that they got the WHO and EMA's endorsement, I fully expects subsequent approvals and rollouts in their intended middle-income markets next month, including your Japanese home.

Meanwhile, Novavax isn't even actively seeking a manufacturing partner in the U.S, and the FDA's approval (and any added business here in the future, if at all) is merely icing on the cake for them at this point in time, I think.

 

[ElKarlo]

I think it's a sound business strategy for a small company with limited resources that came late to the game, especially now that their Federal funding had been cut off after their repeated delays.

They got the approval by the WHO and the European Union first, while partnering with a major pharmaceutical producer in each developed countries that still needs to innoculate their population (who already placed large purchase orders with them) and jointly filed for approval there (SK Bioscience in Korea, Takeda in Japan, et al).

They also already went ahead and got the approval by India, which is crucial because their Indian manufacturing partner SII is producing their supply for the middle and lower-income countries that also approved their protein-based shot (Indonesia, Philippines, et al)

The U.S market is very much saturated by now, and we've been sitting nicely on a giant stockpile of Pfizer and Moderna's mRNA vaccine supply hoarded from the start, plenty enough to provide a booster to any American who wants it, so it doesn't change Novavax's economic prospect at all to focus their efforts and attention States-side rather than their targeted markets.

Now that they got the WHO and EMA's endorsement, I fully expects subsequent approvals and rollouts in their intended middle-income markets next month, including your Japanese home.

Meanwhile, Novavax isn't even actively seeking a manufacturing partner in the U.S, and the FDA's approval (and any added business here in the future, if at all) is merely icing on the cake for them at this point in time, I think.

I agree that they played their cards as best they could. I just think they didn’t play politics as well as the other start up moderna did. I think it shows with almost all their approvals coming much later. Especially now with omnicron being out there, it might be too late as I’m not sure if the next variant will be affected by a vaccine.
Anyhow I got out of NVAX breaking even after being in it for 5 years. Was a top I got as it was created by former meddimmune management and the such so they had a track record, they just haven’t gotten much done in this iteration is what I’ve seen so far

 

[Crom Cruach]

One thing for sure Vaccine technology itself has had a great leap forward.

When this pandemic is out of the way I wonder what they could apply it to next.

We could be seeing then end of a few chronic diseases in the next 20 years.

 

[Arkain2K]

Novavax Says Covid Vaccine Shipments to Europe Have Started
By Robert Langreth | January 10, 2022

​

Novavax Inc. has shipped the first doses of its Covid-19 vaccine to Europe, marking the drug company’s entry into a potentially large new market.

Chief Executive Officer Stanley Erck announced the shipments during a presentation on Monday at the JPMorgan Healthcare Conference. The company also said in a statement that it and its partner Serum Institute of India Pvt. Ltd. had filed for an emergency-use authorization for the shot in South Africa.

The shipments to Europe are “a big milestone for the company,” Erck said in an interview on Monday with Bloomberg Television. “There is a lot of pent-up demand for our vaccine.”

The company’s vaccine was authorized in Europe last month. The shot is also in use in several countries in Asia, including Indonesia, and it has also been granted emergency-use status by the World Health Organization. Novavax is now seeking clearance in the U.S., and Erck said the company expects feedback from regulators sometime in February.

In the TV interview, Erck said the company was working on a vaccine that would combine its Covid shot with a flu vaccine in one inoculation. Novavax expects to get initial human data from a combination in a couple months, Erck said.

“It is becoming more and more clear that you are going to need to boost Covid,” Erck said, noting the optimal interval between Covid boosters isn’t clear yet. If the combination approach works, “that would be a great breakthrough so that everybody could get just one shot with the combination vaccine a year,” he said.

Manufacturing problems had earlier slowed Novavax’s entry into the global vaccine market. The company’s shares rose 5.1% at 2:28 p.m. in New York.

https://www.bloomberg.com/news/arti...ovid-vaccine-shipments-to-europe-have-started

 

[Yehudim]

Two questions, would this novovak treatment qualify as a "vaccine" according to the old definition not the new one? And after receiving it would I be more or less susceptible to the current and future variants of the flu?

I'm sure this has been beaten to death, but my understanding is that the COVID vaccine was very much a vaccine in the traditional sense but the variant it covered was from 2019 (Chinese researchers leaked the genome in Jan. 2020) and of course were in 2022 where it has mutated quite a bit.

 

[Arkain2K]

One thing for sure Vaccine technology itself has had a great leap forward.

When this pandemic is out of the way I wonder what they could apply it to next.

We could be seeing then end of a few chronic diseases in the next 20 years.

Definitely. There are many diseases that are known to be caused by the body simply not making enough of certain important proteins, with the current solution being the extremely-expensive protein-based meds.

mRNA can easily instructs the body to simply produce more of that protein, so I expect that to be the next breakthrough (along with an improved influenza shot that covers multiple strains rather than the current piss-poor vector roulette that only targets one predicted strain and rarely reaches 50% effectiveness in any given year).

 

[Crom Cruach]

Definitely. There are many diseases that are known to be caused by the body simply not making enough of certain important proteins, with the current solution being the extremely-expensive protein-based meds.

mRNA can easily instructs the body to simply produce more of that protein, so I expect that to be the next breakthrough (along with an improved influenza shot that covers multiple strains rather than the current piss-poor vector roulette that only targets one predicted strain and rarely reaches 50% effectiveness in any given year).

I'm not a scientist but I work in a science-adjacent role with some of the Research Institutes.

The amount of money that Horizon2020 put into Covid vaccine research would boggle your mind and as for staff re-assugnment. It was like Gary Oldfield in Leon.

To see the quantity and quality of the hours put into vaccine research in the last 24 months makes me really hopeful for the human race.

It really makes a mockery of the typical whitterings you get here.

 

[chardog]

Two questions, would this novovak treatment qualify as a "vaccine" according to the old definition not the new one? And after receiving it would I be more or less susceptible to the current and future variants of the flu?

there's never been a flu vaccine that worked well in the past, there wont be one now

covid is the flu

 

[Arkain2K]

Novavax says its Covid vaccine could be cleared in multiple countries over next 90 days
By Jessica Bursztynsky | JAN 10 2022​

The Novavax coronavirus vaccine could be cleared by regulators for use in multiple countries, including the U.S., in the coming months, the vaccine maker's CEO said Monday.

The company has filed for emergency approval with 10 different regulatory agencies, Stanley Erck told CNBC's "Squawk on the Street." It's currently available for use in 170 countries, he said.

"I expect in the next 90 days we could have all 10 of them," Erck said.

The company submitted its final data to the U.S. Food and Drug Administration on New Year's Eve. It has yet to file the full application for emergency-use authorization, but will do so shortly and expects a decision from American regulators in February, he said.

Erck didn't name the other regulatory agencies, but according to the company site, it has recently applied for approval in Japan, the United Arab Emirates, Singapore, New Zealand, Canada, Australia, South Africa and the United Kingdom.

Several other health agencies across the globe have already given their nod of approval to the vaccine.

Novavax recently shipped its first doses of the vaccine to Europe, Erck said, after receiving authorization from European Union regulators last month.

"Everything is coming together," Erck told CNBC.

The vaccine could be in high demand. Novavax's vaccine is protein based, using an alternative technology to the more widespread mRNA vaccines. Skeptics leery of the mRNA technology may be inclined to get the Novavax version, Erck said, which also has been seen to present fewer adverse side effects than other vaccines.

https://www.cnbc.com/amp/2022/01/10...ld-be-cleared-in-multiple-countries-soon.html

 

[Arkain2K]

Florida's top health official is put on administrative leave after he urges unvaxxed government staff to get vaccinated.

 

[12ga.]

I read an article in the Atlantic that said Novavax was a real vaccine and probably best for those hesitant. YMMV

https://www.theatlantic.com/health/archive/2021/06/novavax-now-best-covid-19-vaccine/619276/

I'm personally done with covid. Had the bug which is better than vax and vax.

 

[Arkain2K]

Novavax COVID vaccine gets final ATAGI approval, rollout in Australia to start in February​

​

The Novavax COVID-19 vaccine has been given the final green light needed for it to be added to Australia's vaccine rollout.

The Australian Technical Advisory Group on Immunisation (ATAGI) has approved the vaccine for people aged 18 and over.

ATAGI's approval is the final regulatory hurdle the vaccine had to pass after the Therapeutic Goods Administration (TGA) approved it last week.

The vaccine course will be two doses, administered three weeks apart.

Health Minister Greg Hunt said if all goes to plan, Novavax should be available next month.

"We'll be able to commence that program from the week of February 21," he said.

The government has ordered 51 million doses of the vaccine, with the head of the TGA, John Skerritt, flagging last week that some of those doses may end up being given away as part of Australia's vaccine donation program.

Speaking when the TGA approved Novavax last Thursday, Professor Skerritt also said he was aware of people who had been waiting for the vaccine to be approved and hoped it would lead to an even further increase in the national vaccination rate.

"The technology on which it is made is an older technology, it uses a protein," he said.

"I would have had several hundred emails from individuals and groups who have said for whatever reason we would like to have [this] particular vaccine … this just gives them further choice."

https://amp.abc.net.au/article/100777186

 

[Arkain2K]

Germans pin hopes on Novavax moving the needle among anti-vaxxers
By Riham Alkousaa | February 13, 2022

BERLIN, Feb 13 (Reuters) - Benedikt Richter, a 40-year-old teacher in the southwest German city of Kaiserslautern, long held out against getting vaccinated against COVID-19. He felt uneasy about the novelty of the mRNA technology used in two of the most commonly administered shots.

It did not help that his sister-in-law was hospitalised with heart muscle inflammation a day after receiving her second shot, which doctors officially linked to her vaccine, Richter said. Regulators have acknowledged such conditions as a rare and mostly mild side-effect.

But when the European Union in December approved the use of the Novavax (NVAX.O) vaccine Nuxavoxid, which deploys a long-established protein-based technology, he became interested.

"I have done my research and I have a slightly better feeling about it," said the father of two.

Data unearthed by Reuters suggests the new two-dose vaccine, recommended in Germany for basic immunisation for people over 18, is already going some way to convince more of the as-yet unvaccinated to get a shot. read more

Some federal states have opened waiting lists to receive Novavax shots. In Rhineland-Palatinate where Richter lives, for example, more than 14,300 people have put down their names. A private Berlin vaccination centre told Reuters they had around 3,000 people registered.

"The number is gigantic. We're overwhelmed ourselves by how many people have signed up," said Daniel Termann, a doctor at the Historic Factory vaccination centre in Berlin.

The recombinant protein technology behind the Novavax shot has been in use since the mid-1980s and is now a standard tool to fight hepatitis B, the human papillomavirus behind cervical cancer, and bacteria that cause meningitis.

A recent survey by researchers at the University of Erfurt with 1,000 participants found that even though unvaccinated Germans had more confidence in traditional vaccines than in mRNA vaccines, trust generally was still low.

Almost two thirds of the unvaccinated were completely against vaccination, the survey found, suggesting that only a small proportion would ever consider taking the Novavax shot.

"We are not convinced that it will be a game changer," study co-author Lars Korn told Reuters.

Much is on the line. Germany has a lower inoculation rate than many other countries in western Europe at just 74.4% fully vaccinated.

But if Nuxavoxid were able to move the needle, that could prompt an easing of restrictions on public life that are dragging on the recovery of Europe's largest economy. read more

The problem then would be more of how to ensure supply.

Germany is set to receive up to 34 million Nuvaxovid doses in 2022 and around 4 million doses should be delivered in the first quarter, a spokesperson for the health ministry said.

But there are around 20 million unvaccinated people in Germany. And a Reuters report showed on Tuesday that Novavax had delivered just a small fraction of the 2 billion COVID-19 shots it plans to send around the world in 2022 and had delayed first-quarter shipments in Europe and lower income countries such as the Philippines. read more

Health sector workers will be prioritised to receive the vaccine in the first quarter as a vaccine mandate for them will come into effect in mid-March, according to the federal health ministry.

That could prove frustrating for those who are nervous of mRNA vaccines but also fed up with restrictions on public life.

In many states in Germany, the unvaccinated are banned from non-essential shops and service providers like restaurants and barber shops.

In a group chat about Novavax on the Telegram messenger service, many of the more than 1,500 members toyed with getting the shot due to pandemic curbs.

Richter, who has had to take a daily COVID test to teach and learned how to cut his hair by himself, said his main motivation to get vaccinated was freedom.

He misses sauna visits, which get him through Germany's dark winters, and would love to take his two children swimming again.

"I have two children and they are also restricted because of me," he said. "I am not doing it out of conviction, but rather from external pressure."

https://www.reuters.com/world/europ...-moving-needle-among-anti-vaxxers-2022-02-13/

 

[TankAbbott4Eva]

So this is the one a few of the anti vaxxers are waiting for apparently, well let's see if they change their mind.