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(Precision Vaccinations News)
Novavax, Inc. today announced that it has filed for a type II variation of existing Marketing Authorization with the European Medicines Agency (EMA) for its JN.1 COVID-19 vaccine (NVX-CoV2705) for individuals aged 12 and older.
The submission follows guidance from EMA and theWorld Health Organizationto target the JN.1 lineage for the Fall 2024 season.
Novavax's non-mRNA JN.1 COVID-19 vaccine targets the "parent strain" of KP.2 and KP.3.2
NVX-CoV2705 is an updated version of Novavax's authorizedCOVID-19 vaccine (NVX-CoV2373).
"Novavax is working closely with European markets seeking to offer a protein-based alternative to mRNA this fall for COVID-19 vaccination," saidJohn C. Jacobs, President and Chief Executive Officer, Novavax, in a press release on June 24, 2024.
"Our updated COVID-19 vaccine is active against current circulating (SARS-CoV-2) strains, including KP.2 and KP.3."
Nonclinical data have demonstrated that Novavax's JN.1 COVID-19 vaccine induces broad neutralization responses to JN.1 lineage viruses, including those containing the F456L and R346T mutations, and to "FLiRT" and "FLuQE" variants.
Novavax's vaccine also produces conserved polyfunctional, Th1-biased CD4+ T cell responses to a range of JN.1 lineage variants.
Novavax confirmed it intends to have its JN.1 COVID-19 vaccine in unit-dose vials available for immediate release in the European Union after approval.
Novavax has alsofiledwith the U.S. FDAand is working with other regulatory authorities globally to authorize or approve its JN.1 COVID-19 vaccine.
TAMPA, Fla. The FDA has issued an updated recommendation for the fall COVID-19 vaccine formula.
"Coverage in the fall is going to be interesting because we dont know what will happen in the fall, right? said Dr. Jill Roberts, associate professor for the USF College of Public Health.
Thats why vaccine advisors are tasked with making the best decision based on which COVID-19 strains are circulating.
These two strains, the KP.2 and KP.3, are now counting for half of all of cases in the U.S., said Roberts.
Theyre part of the FLiRT variants, which, in total, make up 62.9% of new COVID-19 cases in the United States right now, according to the latest CDC data. This is something the FDA has been closely monitoring.
Whats likely going to happen is that the two strains are going to continue to take off. Theyll probably cover most of the percentage of all the strains that we see in the U.S., said Roberts.
A few days ago, the FDA told drugmakers to update the fall COVID-19 vaccine formula to target the KP.2 strain if possible to create a more effective vaccine for the fall.
This change in the recommendation comes just after the group voted earlier this month for the fall boosters to target the JN.1 variant.
They changed their recommendation to say, 'Okay, lets actually put these KP guys in the vaccine,' said Roberts.
After further monitoring of the circulating strains, the FDA made the change since the spread of the JN.1 mutation has drastically declined in recent weeks.
The changes should not delay the vaccine rollout.
However, not all drug manufacturers can pivot that quickly since production of the new shots is already underway.
And so your two mRNAs Pfizer and Moderna, can change really fast. Novavax cannot because of the way that vaccine is actually made. Its harder to change it, so it probably wont. In fact, the company has already said, were not going to change it, weve already started production for fall shots, said Roberts.
The FDA did not make a recommendation on who should get the new booster in the fall. That will be left up to the CDC.
That advisory meeting is scheduled for June 26-28.
The CDC is reporting low COVID-19 activity nationally, but that it is likely growing in Texas and 29 other states. That includes some recent upticks in Dallas County.
County Health Director Dr. Phillip Huangsays data from wastewater testing points to increased activity. But the same upticks have occurred the past several summers.
"A lot of the vaccinations occurred prior to winter, some of that protection starts to wane during that period,' Dr. Huang said. "Then with more travel, and a lot of exposure and people getting together during the summer months."
However, Dallas County is urging people 65 and older to get up to date on booster vaccinations.
We still see hospitalizations. And almost all of the hospitalizations have been in that 65 and older group, Dr. Huang said. And so, that's where the CDC updated recommendations, for that age group to get the booster or another shot for that additional protection.
Dr. Huang said the rest of the population should maintain precautions, including wearing masks in crowded situations or if youre in a higher-risk population.
KERAs Sam Baker talked with Dr. Jeff SoRelle, an assistant professor of pathology at UT Southwestern Medical Center in Dallas about the latest variants contributing to COVID spread in North Texas.
The main variants that we're seeing right now are called CP.2 and CP.3. They're really kind of in the same family as the JN.1. That was the previous dominant variant over the springtime.
Are these part of the group of variants known as FLiRT?
Yes. These are called FLiRT variants, mostly because of the kind of mutations that they have. It had an F change to an L amino acid, and they had an R change to a T amino acid. So that's where you get the f-l-r-t. And that sounds like a flirt when you add it together.
How do they compare to what we have seen before? Are they more infectious, for instance?
They are appearing to be more infectious insofar as they are resistant to the immune response. The key, though, is that they are the same positions that are important for the virus to enter into cells and infect them.
So, while they also are in immune systems, they're also not quite as effective at infecting. This just goes to show how important it is to evade immunity.
Explain that a bit.
Sure. So, there's a dynamic arms race between the virus and host. The virus continues to evolve, but so does our immune system. The immune system is very effective at preventing the virus from becoming very severe. And in these cases, the viruses gain a little bit more ahead. But the immune system will likely continue to catch up. It's getting help as well from vaccines that are continuing to be evolved.
Are the variants then more dangerous in any way?
As far as severity, there's no change there. There's no real change in the symptoms. Most people will get a cold or flu-like symptoms, last for a few days less than a week usually, and then begin to resolve.
Do the current vaccinations offer protection from the new variants?
The most recent vaccines that we have do still provide protection, and at the same time, we are getting an updated formulation for the next rollout that will come next fall, late summer.
So the best thing we can hope for now is for the public to maintain or take the right precautions here, maybe to keep infections at a minimum?
That's a great question. I think it's important to know that the people that are most vulnerable are those who are more elderly or have immune-compromised conditions, such they don't respond to vaccines very well or don't have an immune system that is able to mount that effective response to evolve its variants.
And so I think we can do to protect ourselves as there are still medications such as Paxlovid that is still recommended for high-risk individuals and still shown to be effective against these JN.1 and KP.2 and KP.3 variants.
It's also important that you notice we do have some symptoms that seem like Covid, and you may have exposure to some of these vulnerable populations. It's a good idea to keep a few COVID tests at home and test yourself quickly. Sometimes it is good to do two different kinds of testing just to make sure that you don't miss it.
In the meantime, are we in the midst or is there the potential for a summer Covid wave?
You know, over the last several years, there seem to be these timed waves of increases in COVID-19 cases, and we tend to have them in the middle of the winter and at the end of the summer.
And what we've seen in the last several years, though, is that the waves become much gentler and lower, and fewer people get into the hospital becoming, well, not quite as sick. And the case rates are much lower overall nationally. And I think that we hope to see that trend continue this year.
RESOURCES:
Are We Headed for Another Summer COVID-19 Wave?
New virus variants threaten a summer Covid-19 wave, but experts say the risk remains uncertain
COVID Data Tracker
Dallas County HHS Dashboard
WASHINGTON The Supreme Court on Monday turned away two Covid-related appeals brought by Children's Health Defense, the anti-vaccine group founded by independent presidential candidate Robert F. Kennedy Jr.
The decision by the justices not to hear the cases leaves in place lower court rulings against the group.
One case challenged the Food and Drug Administration's emergency authorization of Covid-19 vaccines in December 2020, while the other was brought against Rutgers University in New Jersey over its Covid-19 vaccine mandate.
In the FDA case, the group claimed in court papers that Covid vaccines were "ineffective and lacked proper vetting." The New Orleans-based 5th U.S. Circuit Court of Appeals found that Kennedy's group did not have legal standing to sue.
In the Rutgers dispute, the Philadelphia-based 3rd U.S. Circuit Court of Appeals concluded that the plaintiffs "have not stated any plausible claim for relief."
Kennedy himself took leave from the group in April 2023 to run for president. He failed to make inroads in the Democratic primaries and is now running as an independent.
On the campaign trail he has mostly downplayed his anti-vaccine activity, but in November he spoke at a Children's Health Defense conference.
Kennedy is listed as a lawyer on the Rutgers filing at the Supreme Court despite his leave of absence from the group.
In a separate vaccine-related case, the court also turned away a challenge to Connecticut's decision to repeal a religious exemption for school vaccinations.
Lawrence Hurley covers the Supreme Court for NBC News.
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WASHINGTON Scientists debated the origins of COVID-19 on Tuesday, trading barbs over whether the bulk of evidence available points to a natural spillover event from a wild animal or a virus designed in a lab and then let loose through an inadvertent leak.
The hearing in front of the U.S. Senate Homeland Security and Governmental Affairs Committee was part of ongoing efforts in Congress to apply the lessons learned during the pandemic to prevent or blunt the next outbreak.
Gregory Koblentz, associate professor and director of the Biodefense Graduate Program at George Mason University in Virginia, said during the two-hour hearing that debate continues in the scientific community about the origins.
The possibility that SARS-CoV-2 was deliberately developed as a biological weapon has been unanimously rejected by all U.S. intelligence agencies, Koblentz testified. While the intelligence community is divided on the origin of the pandemic, most of the agencies have determined that the virus was not genetically engineered.
Residents in Wuhan, China, were first diagnosed with an atypical pneumonia-like illness in December 2019, according to a COVID-19 timeline from the Centers for Disease Control and Prevention.
Initial cases all appeared linked to the Huanan Seafood Wholesale Market at the time, though there has since been much speculation about the types of research taking place at the Wuhan Institute of Virology.
Koblentz said he believes the available evidence points to a spillover event from an animal, though he added a research-related accident cant be ruled out at this time.
The lack of transparency and data from the Chinese government has significantly hindered scientists efforts to unify around the origin of COVID-19, he said.
Richard Ebright, board of governors professor of chemistry and chemical biology and laboratory director at the Waksman Institute of Microbiology at Rutgers University in New Jersey, testified he believes a large preponderance of evidence indicates SARS-CoV-2, the virus that causes COVID-19, entered humans through a research incident.
Ebright also leveled criticism at fellow panelist Robert Garry, who, along with a handful of co-authors, published an opinion article in the journal nature medicine in March 2020, titled The proximal origin of SARS-CoV-2.
In the commentary, Garry and the other scientists wrote, we do not believe that any type of laboratory-based scenario is plausible.
Ebright said during Tuesdays hearing that the opinion article represented scientific misconduct up to and including fraud, a characterization that Garry rejected during the hearing.
The authors were stating their opinion, but that opinion was not well-founded, Ebright said. In March of 2020, there was no basis to state that as a conclusion, as opposed to simply being a hypothesis.
Garry, professor and associate dean of the School of Medicine at Tulane University in Louisiana, argued on behalf of the spillover event during the hearing, testifying that the virus likely didnt move directly from a bat to humans, but went to an unidentified intermediary animal.
The bat coronaviruses are viruses that are spread by the gastrointestinal route, Garry said. For a virus like this to become a respiratory virus its just going to require too many mutations, too many changes for a bat virus to spill directly over to a human being. That could only really happen in nature with replication through an intermediate animal.
Garry also defended gain-of-function research during the hearing, arguing that it has had some beneficial impact, though he noted that it does need appropriate safeguards and restrictions.
Lawmakers and pundits have used several, often evolving, definitions for gain-of-function research in the wake of the COVID-19 pandemic. The American Society for Microbiology defines it as techniques used in research to alter the function of an organism in such a way that it is able to do more than it used to do.
When research is responsibly performed on highly transmissible and pathogenic viruses, it can lead to advances in public health and national security, Garry testified.
Without gain-of-function research, wed have no Tamiflu. Without gain-of-function research, we wouldnt have a vaccine to prevent cancer caused by infection by the human papilloma virus, Garry said. And without gain-of-function research, we wont be able to identify how novel viruses infect us. And if we dont know how they infect us, we cannot develop appropriate treatments and cures for the next potential pandemic creating virus.
New Hampshire Democratic Sen. Maggie Hassan raised several questions about whether theres enough oversight of how the United States spends research dollars as well as what mechanisms are in place to monitor how private entities conduct certain types of research.
While their research has the potential to cure diseases and boost our economy, unless they accept federal funding, there is very little federal oversight to ensure that private labs are engaged in safe and ethical research, she said.
Koblentz from George Mason University said there is much less oversight of biosafety and biosecurity for private research facilities that dont receive federal funding.
In order to expand the scope of oversight to all privately funded research, (it) would require legislative action, Koblentz said.
Congress, he said, should establish a national bio-risk management agency that would have authority over biosafety and biosecurity regardless of the source of funding.
At the end of the day, it shouldnt matter where the funding comes from in terms of making sure this research is being done safely, securely and responsibly, Koblentz said.
Kentucky Republican Sen. Rand Paul, ranking member on the committee, said the panel will hold an upcoming hearing specifically on gain-of-function research, including what steps Congress should take to ensure it doesnt put the public at risk.
Committee Chairman Gary Peters, a Michigan Democrat, said during the hearing that lawmakers must learn from the challenges faced during this pandemic to ensure we can better protect Americans from future potential biological incidents.
Our government needs the flexibility to determine the origins of naturally occurring outbreaks, as well as potential outbreaks that could arise from mistakes or malicious intent, Peters said.
Utah Republican Sen. Mitt Romney, after listening to some of the debate, expressed exasperation that so much attention is going toward what caused the last pandemic and not on how to prepare for the next one.
Given the fact that it could have been either, we know what action we ought to take to protect from either, Romney said. And so why theres so much passion around that makes me think its more political than scientific, but maybe Im wrong.
The United States, he said, shouldnt be funding gain-of-function research and should insist that anyone who receives federal funding follow the standards of the International Organization for Standardization.
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Hyderabad (Precision Vaccinations News)
Bharat Biotech International Limited (BBIL) recently statedX thatthe company unintentionallyomitted the Indian Council of Medical Research (ICMR) as a co-owner of the inactivated COVAXINvaccine patent.
On June 22, 2024, the Hyderabad-based vaccine producer Tweeted that it was taking legal action to correct this issue.
According to media reporting, ICMR was to receive a 5%royalty on net sales and product branding rights, which include 'co-inventor' status.
COVAXINwas developed from a SARS-CoV-2 coronavirus strain isolated at the National Institute of Virology, under the ICMR. The government health research agency also supported the vaccine's clinical development through assistance in conducting clinical trials.
This non-mRNAvaccine wasdeveloped usingWhole-Virion Inactivated Vero Cell-derived platform technology.
During the initial stages of the recent pandemic, the World Health Organization Listed the COVAXIN vaccine as effective in November 2021.
BBIL says inactivated vaccines do not replicate and are unlikely to revert and cause pathological effects. They contain dead viruses, incapable of infecting people but still able to instruct the immune system to mount a defensive reaction against an infection.
However,a report published inSpringer Nature in August 2023found certain people wereat a higher risk of adverse events after receiving COVAXIN.
As of June 2024, COVAXIN is available in about 14 countries, but not the United States.
Embargoed until: Publicly released: 2024-06-25 01:00
The updated Pfizer COVID-19 vaccines targeting the XBB variant are 62% effective at preventing COVID-19-related hospitalisation, compared to being unvaccinated or only receiving the original vaccines, according to international researchers who say continued booster shots are likely important for people across a broad age range. The researchers looked at US data on COVID-19 hospitalisations in late 2023 and vaccination histories, and say there was no clear difference in risk for unvaccinated people and those who'd only received the original vaccines. In an accompanying editorial, independent researchers say it is difficult now to untangle whether the protection is coming from getting the newer vaccine, or simply getting boosted more recently and it is likely both vaccinated and unvaccinated people have some baseline immunity now the virus has been circulating so long.
Journal/conference: JAMA Internal Medicine
Link to research (DOI): 10.1001/jamainternmed.2024.1640
Organisation/s: Kaiser Permanente Southern California, USA
Funder: This study was sponsored by Pfizer.
About The Study:The findings of this case-control study reaffirm current recommendations for broad age-based use of annually updated COVID-19 vaccines given that (1) the BNT162b2 XBB vaccine (Pfizer-BioNTech; 2023-2024 formulation) provided statistically significant additional protection againsta range of COVID-19 outcomes and (2) older versions of COVID-19 vaccines offered little, if any, long-term protection, including against hospital admission, regardless of the number or type of prior doses received.
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