Singapore may get non-mRNA Novavax Covid-19 vaccine

[Jamesc]

2 hours ago, Kb27 said:

During the 2003 SARS outbreak, these researchers created a similar type of vaccine by inserting the genetic information for a portion of the SARS virus spike protein into yeast to produce large amounts of the protein. After isolating the virus spike protein from the yeast and adding an adjuvant, which helps trigger an immune response, the vaccine was ready for use.

Yeast is used to beer and bread so that's the safe one to use!

[Jamesc]

The only thing is why they call it CORBEVAX

Sounds like KobeVax

It was made by Texas Hospital

so they should just call it TexVax.

2 hours ago, Kb27 said:

Corbevax just as powerful as Novavax, should be pursued by HSA

 

CORBEVAX, a new patent-free COVID-19 vaccine, could be a pandemic game changer globally

The world now has a new COVID-19 vaccine in its arsenal, and at a fraction of the cost per dose.

Two years into the COVID-19 pandemic, the world has seen over 314 million infections and over 5.5 million deaths worldwide. Approximately 60% of the world population has received at least one dose of a COVID-19 vaccine. But there is still a glaring and alarming gap in global access to these vaccines. As a virologist who has followed this pandemic closely, I contend that this vaccine inequity should be of grave concern to everyone.

If the world has learned anything from this pandemic, it’s that viruses do not need a passport. And yet approximately 77% of people in high- and upper-middle-income countries have received at least one dose of the vaccine – and only 10% in low-income countries. Wealthy countries are giving boosters, and even fourth doses, while first and second doses are not available to many worldwide.

But there is hope that a new vaccine called CORBEVAX will help close this vaccination gap.

How does the CORBEVAX vaccine work?

All COVID-19 vaccines teach the immune system how to recognize the virus and prepare the body to mount an attack. The CORBEVAX vaccine is a protein subunit vaccine. It uses a harmless piece of the spike protein from the coronavirus that causes COVID-19 to stimulate and prepare the immune system for future encounters with the virus.

Unlike the three vaccines approved in the U.S. – Pfizer and Moderna’s mRNA vaccines and Johnson & Johnson’s viral vector vaccine, which provide the body instructions on how to produce the spike protein – CORBEVAX delivers the spike protein to the body directly. Like those other approved COVID-19 mRNA vaccines, CORBEVAX also requires two doses.

How was CORBEVAX developed?

CORBEVAX was developed by the co-directors of the Texas Children’s Hospital Center for Vaccine Development at Baylor College of Medicine, Drs. Maria Elena Bottazzi and Peter Hotez.

During the 2003 SARS outbreak, these researchers created a similar type of vaccine by inserting the genetic information for a portion of the SARS virus spike protein into yeast to produce large amounts of the protein. After isolating the virus spike protein from the yeast and adding an adjuvant, which helps trigger an immune response, the vaccine was ready for use.

The first SARS epidemic was short-lived, and there was little need for Bottazzi and Hotez’s vaccine – until the virus that causes COVID-19, SARS-CoV-2, emerged in 2019. So they dusted off their vaccine and updated the spike protein to match that of SARS-CoV-2, creating the CORBEVAX vaccine.

Two large clinical trials of over 3,000 people in India found the vaccine to be safe, well-tolerated and over 90% effective at preventing symptomatic infections from the original strain of COVID-19, and over 80% effective against the delta variant. The vaccine received emergency use authorization in India, and other developing countries are expected to follow.

Interestingly, the group at Baylor was not able to drum up interest or funding in the U.S. for their vaccine. Instead, newer technologies such as mRNA vaccines raced ahead, even though Bottazzi and Hotez’s vaccine design was more advanced, thanks to their previous work during the 2003 SARS and 2012 MERS outbreaks.

A vaccine built for the world

Protein subunit vaccines have an advantage over mRNA vaccines in that they can be readily produced using well-established recombinant DNA technology that is relatively inexpensive and fairly easy to scale up. A similar protein recombinant technology that’s been around for 40 years has been used for the Novavax COVID-19 vaccine, which is available for use in 170 countries, and the recombinant hepatitis B vaccine.

This vaccine can be produced at a much larger scale because appropriate manufacturing facilities are already available. Also key to global access is that CORBEVAX can be stored in a regular refrigerator. Therefore, it is possible to produce millions of doses rapidly and distribute them relatively easily. In comparison, producing mRNA vaccines is more expensive and complicated because they are based on newer technologies, rely on highly skilled workers and often require ultralow temperatures for storage and transport.

Another major difference is that the CORBEVAX vaccine was developed with global vaccine access in mind. The goal was to make a low-cost, easy-to-produce and -transport vaccine using a well-tested and safe method. Key to this, the researchers were not concerned with intellectual property or financial benefit. The vaccine was produced without significant public funding; the US million needed for development was provided by philanthropists.

COBREVAX is currently licensed patent-free to Biological E. Limited (BioE), India’s largest vaccine maker, which plans to manufacture at least 100 million doses per month starting in February 2022. This patent-free arrangement means that other low- and middle-income countries can produce and distribute this cheap, stable and relatively easy-to-scale vaccine locally.

Combined, this means that CORBEVAX is one of the cheapest vaccines currently available. How well it works against the omicron variant is under investigation. However, the CORBEVAX story can be used as a model to address vaccine inequity when it is necessary to vaccinate the world population – against COVID-19 and other diseases on the horizon.

 

[Kb27]

Novavax says protein vaccine works for kids as young as 12 (80% effective)

By The Associated Press

Novavax announced Thursday that its COVID-19 vaccine proved safe and effective in a study of 12- to 17-year-olds.

Novavax makes a protein-based vaccine -- a different type than the most widely used shots -- that’s a late arrival to the COVID-19 arsenal.

Its shots have been cleared for use in adults by regulators in Britain, Europe and elsewhere and by the World Health Organization, and are under review by the U.S. Food and Drug Administration.

Armed with the new data, Novavax plans to soon seek expanded use of its shots down to age 12. Later this year, it plans to begin testing in younger children.

The latest study enrolled 2,247 U.S. kids ages 12 to 17 last summer and found the two-dose vaccine was 80% effective at preventing symptomatic COVID-19 infection.

That was when the extra-contagious delta variant was circulating. The company said six vaccine recipients developed mild COVID-19 compared to 14 kids who received dummy shots. There were no serious infections.

In June, Maryland-based Novavax announced its vaccine was about 90% effective against symptomatic COVID-19 in a study of nearly 30,000 people in the U.S. and Mexico. More recently, it has cited laboratory data suggesting the vaccine offers some protection against the more contagious omicron variant although a booster worked better.

The Novavax vaccine is made with lab-grown copies of the spike protein that coats the coronavirus, mixed with an immune-boosting chemical. That’s similar to shots used for years against other diseases such as hepatitis B. It’s a different technology than the Pfizer and Moderna options that deliver genetic instructions for the body to make its own spike protein.

[13177]

3 hours ago, Kb27 said:

Novavax says protein vaccine works for kids as young as 12 (80% effective)

By The Associated Press

Novavax announced Thursday that its COVID-19 vaccine proved safe and effective in a study of 12- to 17-year-olds.

Novavax makes a protein-based vaccine -- a different type than the most widely used shots -- that’s a late arrival to the COVID-19 arsenal.

Its shots have been cleared for use in adults by regulators in Britain, Europe and elsewhere and by the World Health Organization, and are under review by the U.S. Food and Drug Administration.

Armed with the new data, Novavax plans to soon seek expanded use of its shots down to age 12. Later this year, it plans to begin testing in younger children.

The latest study enrolled 2,247 U.S. kids ages 12 to 17 last summer and found the two-dose vaccine was 80% effective at preventing symptomatic COVID-19 infection.

That was when the extra-contagious delta variant was circulating. The company said six vaccine recipients developed mild COVID-19 compared to 14 kids who received dummy shots. There were no serious infections.

In June, Maryland-based Novavax announced its vaccine was about 90% effective against symptomatic COVID-19 in a study of nearly 30,000 people in the U.S. and Mexico. More recently, it has cited laboratory data suggesting the vaccine offers some protection against the more contagious omicron variant although a booster worked better.

The Novavax vaccine is made with lab-grown copies of the spike protein that coats the coronavirus, mixed with an immune-boosting chemical. That’s similar to shots used for years against other diseases such as hepatitis B. It’s a different technology than the Pfizer and Moderna options that deliver genetic instructions for the body to make its own spike protein.

Hopefully available in sg soon.

[Kb27]

1 hour ago, 13177 said:

Hopefully available in sg soon.

Yeap, Novavax appears to be much safer. It used the same technology as hepatitis B vaccine.

Just about everyone is awaiting its availability.

[Ray7456]

3 hours ago, Kb27 said:

Yeap, Novavax appears to be much safer. It used the same technology as hepatitis B vaccine.

Just about everyone is awaiting its availability.

Hopefully, it will provide an alternative to those 12 to 18 too. But our MMTF says it’s going to be long way before an alternative vaccine is going to be made available for 18 & below. 
 

[Ender]

I think our gahment stock too many mRNA liao.

[13177]

40 minutes ago, Ender said:

I think our gahment stock too many mRNA liao.

Thats why people can have free flow of mrna vaccine!

[Ender]

Approved just a few days ago in Australia, already got people pak liao.. A virologist, she said she prefers the traditional vaccine..

https://www.abc.net.au/news/2022-02-11/virologist-angela-luttick-is-the-first-person-novavax/13751000

Edited February 11, 2022 by Ender

[Kb27]

Germans pin hopes on Novavax moving the needle among anti-vaxxers

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. 

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.

[Kb27]

Better late than never. I guess those holding out on mRNA vaccine/booster can get this one:

 

Novavax’s Nuvaxovid COVID-19 vaccine granted interim authorisation in Singapore

SINGAPORE: The Health Sciences Authority (HSA) has granted interim authorisation for Novavax’s Nuvaxovid COVID-19 vaccine to be used in Singapore, it announced on Monday (Feb 14).

The vaccine will be allowed for use in individuals aged 18 and above on Feb 3. The vaccination regimen comprises two doses of 5 micrograms three weeks apart.

The first batch of the vaccine is “expected to arrive in Singapore in the next few months”, HSA said.

The interim authorisation was granted under the Pandemic Special Access Route (PSAR).

“HSA has reviewed that the vaccine meets the quality, safety and efficacy standards, and that the benefits outweigh the risks for the Singapore population," it added.

“Two groups of experts from HSA’s Medicines Advisory Committee and Panel of Infectious Diseases Experts were also consulted and agreed with HSA’s recommendation for PSAR authorisation.”

HSA’s clinical review was based on two Phase 3 clinical studies conducted in the United States, Mexico and the United Kingdom, comprising more than 40,000 clinical trial participants aged between 18 and 95, it said.

"The results showed that Nuvaxovid demonstrated a vaccine efficacy of approximately 90 per cent against symptomatic COVID-19 and 100 per cent in preventing severe COVID-19," HSA added.

"It showed consistent efficacy against the Alpha variant, but there was no data on the Delta and Omicron variants, as these variants were not prevalent at the time Novavax conducted the clinical trials."

Based on the data from the clinical trials to date, the safety profile of Nuvaxovid was "generally consistent with other registered vaccines in Singapore", said the authority.

Common side effects that recipients may experience include injection site pain and/or tenderness, fatigue, headache and muscle pain.

"These symptoms are reactions generally associated with vaccinations and expected as part of the body’s natural response to build immunity against COVID-19," said HSA. 

"These side effects usually resolve on their own within a few days."

As with all vaccines, there will always be a small proportion of susceptible persons who may experience severe allergic reactions upon vaccination, including those with a history of anaphylaxis, said HSA.

"In such cases, immediate medical attention should be sought. "Persons who develop anaphylaxis to the first dose of Nuvaxovid should not be given the second dose," added the authority.

"Safety and efficacy data in severely immunocompromised persons and those under the age of 18 are not available yet. Hence, no recommendation can be made for the use of the vaccine in these individuals."

[yishunite]

I was waiting for this but...

11 minutes ago, Kb27 said:

The first batch of the vaccine is “expected to arrive in Singapore in the next few months”, HSA said.

Next few months??? MRNA can get within days but this one months... gahmen really dont want to harm their investments in Pfizer/Moderna 🙄

[Vinyl]

17 minutes ago, Kb27 said:

Better late than never. I guess those holding out on mRNA vaccine/booster can get this one:

 

Novavax’s Nuvaxovid COVID-19 vaccine granted interim authorisation in Singapore

SINGAPORE: The Health Sciences Authority (HSA) has granted interim authorisation for Novavax’s Nuvaxovid COVID-19 vaccine to be used in Singapore, it announced on Monday (Feb 14).

The vaccine will be allowed for use in individuals aged 18 and above on Feb 3. The vaccination regimen comprises two doses of 5 micrograms three weeks apart.

The first batch of the vaccine is “expected to arrive in Singapore in the next few months”, HSA said.

The interim authorisation was granted under the Pandemic Special Access Route (PSAR).

“HSA has reviewed that the vaccine meets the quality, safety and efficacy standards, and that the benefits outweigh the risks for the Singapore population," it added.

“Two groups of experts from HSA’s Medicines Advisory Committee and Panel of Infectious Diseases Experts were also consulted and agreed with HSA’s recommendation for PSAR authorisation.”

HSA’s clinical review was based on two Phase 3 clinical studies conducted in the United States, Mexico and the United Kingdom, comprising more than 40,000 clinical trial participants aged between 18 and 95, it said.

"The results showed that Nuvaxovid demonstrated a vaccine efficacy of approximately 90 per cent against symptomatic COVID-19 and 100 per cent in preventing severe COVID-19," HSA added.

"It showed consistent efficacy against the Alpha variant, but there was no data on the Delta and Omicron variants, as these variants were not prevalent at the time Novavax conducted the clinical trials."

Based on the data from the clinical trials to date, the safety profile of Nuvaxovid was "generally consistent with other registered vaccines in Singapore", said the authority.

Common side effects that recipients may experience include injection site pain and/or tenderness, fatigue, headache and muscle pain.

"These symptoms are reactions generally associated with vaccinations and expected as part of the body’s natural response to build immunity against COVID-19," said HSA. 

"These side effects usually resolve on their own within a few days."

As with all vaccines, there will always be a small proportion of susceptible persons who may experience severe allergic reactions upon vaccination, including those with a history of anaphylaxis, said HSA.

"In such cases, immediate medical attention should be sought. "Persons who develop anaphylaxis to the first dose of Nuvaxovid should not be given the second dose," added the authority.

"Safety and efficacy data in severely immunocompromised persons and those under the age of 18 are not available yet. Hence, no recommendation can be made for the use of the vaccine in these individuals."

Approved for two-dose doesn't mean it's approved as a booster. Those waiting for NVAX should take note.

Also note that production for NVAX has been falling behind schedule.

[Ender]

No mention if they can be used for boosting.. And it's a few months wait for the first batch.  

[Ender]

No one excited about this anymore?  For me already pak booster liao.  While I wait for approval for under 16.

 

 

[Fcw75]

4 minutes ago, Ender said:

No one excited about this anymore?  For me already pak booster liao.  While I wait for approval for under 16.

 

 

Covid? What’s that? 😁

Too little too late.

[Sosaria]

9 minutes ago, Ender said:

No one excited about this anymore?  For me already pak booster liao.  While I wait for approval for under 16.

 

 

I believe among kids 5-11 there are still those parents that are holding out against mRNA vaccine until now. Me included

This so-called traditional vaccine will at least gives us a choice to finally go ahead with it, though still have to wait for approval.

Edited May 4, 2022 by Sosaria

[inlinesix]

17 minutes ago, Sosaria said:

I believe among kids 5-11 there are still those parents that are holding out against mRNA vaccine until now. Me included

This so-called traditional vaccine will at least gives us a choice to finally go ahead with it, though still have to wait for approval.

Novavax is approved for 18 and beyond