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

[lifelessheap]

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

Is it actually a vaccine?


Unlike the others?

 

[Arkain2K]

Canada approves Novavax's COVID-19 vaccine for adults
Reuters | February 17, 2022

Canada on Thursday approved Novavax Inc's (NVAX.O) COVID-19 vaccine for people aged 18 years and older, making it the fifth such shot to be cleared for use in the country.

Novavax's recombinant protein vaccine, Nuvaxovid, uses a more established technology than mRNA, the novel method behind the two most commonly used COVID-19 vaccines - from Pfizer-BioNTech (PFE.N) and Moderna (MRNA.O).

Some experts have voiced hopes that Novavax's product could convince as-yet unvaccinated people who are sceptical about the novel mRNA technology to get a shot. read more

"Having more authorised COVID-19 vaccines provides provinces and territories with an additional option ... it can help remove barriers to vaccination by providing an additional option to adults who have not yet received a COVID-19 vaccine," Canada's chief public health officer Theresa Tam told reporters at a briefing.

About 80% of Canadians have received two doses of a COVID vaccine, and over 40% have also received a third or a booster shot.

On Wednesday, Novavax Chief Commercial Officer John Trizzino said there is still significant demand for vaccination across the globe, especially in light of Omicron, the threat of more variants and a high percentage of unvaccinated people who need primary vaccination.

"We also know that many of the booster programs that are in process right now will drive demand for our product."

While Nuvaxovid is not currently authorised for use as a booster dose in Canada, it may be offered as a booster to people who are unable or unwilling to receive an mRNA vaccine, Tam said.

The Canadian government has committed to purchase 52 million doses of the vaccine, with an option to buy up to 24 million more doses. The first shipment of the vaccine is expected to arrive in the country in March, health officials said.

Novavax has been plagued by supply and manufacturing issues as well as regulatory delays, and has delivered just a small fraction of the 2 billion COVID-19 shots it plans to supply worldwide in 2022.

The company expects to supply 27 million doses of its vaccine to Europe in the first quarter, but did not provide guidance on how many overall doses it plans to ship during the period.

Novavax's protein-based vaccine is being reviewed by the U.S. Food and Drug Administration and has received approvals from the European Union and the World Health Organization. read more

https://www.reuters.com/business/he...pproves-novavaxs-covid-19-vaccine-2022-02-17/

 

[Rational Poster]

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

Don't worry they'll still scramble for an excuse to remain selfish.

 

[deadon]

Don't worry they'll still scramble for an excuse to remain selfish.

No excuse needed. Not taking any of this garbage that has had no long term studies.
Plus covid is going away. Dems are now saying no need for mandates or masks. Biden will say he beat covid. The CDC is going to give new guidance.

They're late to the party.

 

[Rational Poster]

No excuse needed. Not taking any of this garbage that has had no long term studies.
Plus covid is going away. Dems are now saying no need for mandates or masks. Biden will say he beat covid. The CDC is going to give new guidance.

They're late to the party.

This is the grown up thread.

 

[Arkain2K]

Novavax starts shipping COVID vaccine to the European Union
February 23, 2022

Feb 23 (Reuters) - Novavax Inc (NVAX.O) said on Wednesday it had started shipping doses of its COVID-19 vaccine to European Union member states, with France, Austria and Germany expected to be the first to receive the shots in the coming days.

Shipments of Nuvaxovid to additional EU member states from the company's Netherlands distribution center are expected to quickly follow, adding to the stockpile of the region as it struggles with a surge in infections due to the Omicron variant.

Novavax's recombinant protein vaccine uses a more established technology than mRNA, the novel method behind the two most commonly used COVID-19 vaccines made by Pfizer (PFE.N)/BioNTech and Moderna (MRNA.O).

The initial doses of Nuvaxovid were manufactured by Novavax' partner the Serum Institute of India, company said.

Public health leaders have voiced hopes that Novavax's product could convince as-yet unvaccinated people who are sceptical about the novel mRNA technology to get a shot.

"Today's announcement paves the way for vaccination with Nuvaxovid to begin in Europe within the coming days. The Novavax COVID-19 vaccine provides a differentiated option to bolster vaccination rates across Europe," Chief Executive Officer Stanley Erck said.

Public health leaders have voiced hopes that Novavax's product could convince as-yet unvaccinated people who are sceptical about the novel mRNA technology to get a shot.

"Today's announcement paves the way for vaccination with Nuvaxovid to begin in Europe within the coming days. The Novavax COVID-19 vaccine provides a differentiated option to bolster vaccination rates across Europe," Chief Executive Officer Stanley Erck said.

The European Union authorized the use of Novavax's vaccine in people 18 years and older in December and has ordered 27 million doses for the first quarter of this year, as part of a contract for 100 million vaccines and another 100 million optional.

https://www.reuters.com/business/he...-shipping-covid-vaccine-eu-states-2022-02-23/

 

[Arkain2K]

Pfizer vaccine's protection against COVID wanes quickly in kids ages 5-11, study says
By Vanessa Romo and Rob Stein | February 28, 2022

The low-dose version of the Pfizer-BioNTech COVID-19 vaccine appears to be much less effective at protecting young children against infection than the higher-dose version of the vaccine given to older children and adults, a new study shows.

In all cases, the vaccine proved to provide strong protection against becoming seriously ill. The preprint study looked at data collected from more than 1.2 million fully vaccinated children and adolescents between the ages of 5 and 17 from Dec. 13 to Jan. 30.

Researchers from the New York State Department of Health found the ability of the vaccine to protect children who got the lowest dose — kids ages 5 to 11 — from catching the virus dropped the most, falling from 68 percent to just 12 percent. Those children received an injection containing just 10 milligrams, one-third of the dose given to older children, adolescents and adults.

Meanwhile, the effectiveness in children ages 12 to 17, who got the same 30-milligram dose as adults, showed a smaller decline, dropping from 66 percent to 51 percent.

"These results highlight the potential need to study alternative vaccine dosing for children and the continued importance [of] layered protections, including mask wearing, to prevent infection and transmission," the study stated.

The results of the study come just days after the Centers for Disease Control and Prevention eased masking guidelines in many parts of the U.S. and the same day several school districts, including New York City's — the largest in the nation — announced that student mask mandates would soon be lifted.

It also follows an unexpected delay in the process for an emergency use authorization for the Pfizer COVID-19 vaccine in children 6 months through 4 years of age. The company said new data emerged, and the Food and Drug Administration said it needed more time to evaluate the data.

https://www.mprnews.org/amp/story/2022/02/28/npr-pfizer-vaccine-protection-kids

 

[Arkain2K]

We're starting to see major diminishing returns in still using the same old two-dose formula meant for the original strain from China three years ago, and at a much lower dose for very young children.

It's long overdue for the pharma suits to update to a newer formula that effectively targets all newer variants for their boosters, rather than milking the same old cashcow to maximize revenues.
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Pfizer's lower-dosage Covid vaccine was just 12% effective against Omicron in kids 5 to 11, study finds
Kids in this age group are given 10-microgram shots, while children aged 12 to 17 receive 30-microgram shots.
PUBLISHED MON, FEB 28 2022

​

Pfizer and BioNTech's two-dose Covid vaccine provided very little protection for children aged 5 to 11 during the wave of omicron infection in New York, according to a study published Monday.

The New York State Department of Health found that the effectiveness of Pfizer's vaccine against Covid infection plummeted from 68% to 12% for kids in that age group during the omicron surge from Dec. 13 through Jan 24. Protection against hospitalization dropped from 100% to 48% during the same period.

The study has not yet undergone peer review, the academic gold standard. Due to the public health urgency of the pandemic, scientists have been publishing the results of their studies before such review.

The team of public health officials who conducted the study said the dramatic drop in vaccine effectiveness among children 5 to 11 years old was likely due to the lower dosage they received. Kids in this age group are given two 10-microgram shots, while children aged 12 to 17 receive 30-microgram shots.

The researchers also compared 11 and 12 year olds during the weekend ended Jan. 30. They found the vaccine effectiveness plunged to 11% for the low-dosage group but offered 67% protection to the group that received the higher dose.

"Given rapid loss of protection against infections, these results highlight the continued importance of layered protections, including mask wearing, for children to prevent infection and transmission," the public health officials wrote in the study.

For children aged 12 to 17 years old, vaccine effectiveness against infection dropped from 66% to 51% from December through the end of January. Protection against hospitalization dropped from 85% to 73% for teenagers during the same period.

The data comes as New York City plans to end its school mask mandate by March 7, with California doing the same four days later. State governments are easing mandates and restrictions as Covid infections decline dramatically after the omicron variant swept the nation in December and January.

Covid infections are down 91% from a pandemic high in January. The U.S. reported a daily average of nearly 66,000 new infections on Sunday, compared to the more than 802,000 on Jan. 15, according to a CNBC analysis of data from Johns Hopkins University.

The U.S. suffered a spike in hospitalizations of children with Covid during the omicron wave. The Food and Drug Administration sought to fast track Pfizer's vaccine for kids aged six months through 4 years old this month in response to the number of children hospitalized with Covid.

However, the FDA and Pfizer decided to put those plans on hold after data on the first two doses did not meet expectations. The FDA is now waiting to see clinical trial data on a third dose for the youngest kids, which is expected in April.

https://www.cnbc.com/amp/2022/02/28...inst-omicron-in-kids-5-to-11-study-finds.html

 

[SheetsMMAfan]

I believe the Pfizer documents warrant a bump in this thread. All info to anything discussed in this video he did link below it if you would like to see this stuff for yourselves.

 

[Ezekiel 25:17]

Didnt Trudeau just announce 400k new immigrants per year for next three years? 1.3 million in a pandemic. LOL!

Those job gaps....

Him and his entire administration are clueless morons who are being ridiculed by anyone with a clue.

 

[cottagecheesefan]

Lol, cdc already said masks worthless especially the ones most use in school. Also the vaxx is hardly effective to begin with and actually might make kids more likely to be infected after 35 days. If anything the FL surgeon general has been vindicated on everything and this hack and his buddies as discredited

 

[Arkain2K]

Moderna says 'bivalent' Covid booster provides stronger protection against Omicron
The company has called the updated vaccine, which targets two strains of the coronavirus, its “lead candidate” for the fall.
By Berkeley Lovelace Jr. | June 8, 2022

​

A redesigned version of Moderna's Covid-19 booster shot appears to provide stronger protection against the omicron variant than its current vaccine, the company said in a news release Wednesday.

Early trial results found the bivalent vaccine — which is designed to target both the omicron variant and the original coronavirus strain in a single shot — led to an eightfold increase in neutralizing antibody levels, according to the company.

The updated vaccine also increased antibody levels against all other known variants of concern, it said.

Moderna has called the omicron bivalent vaccine its “lead candidate” for the fall.

The new shot, called mRNA-1273.214, was tested in a Phase 2/3 clinical trial of 437 people at 50 micrograms — the same dosage given in the current booster shot.

The new shot was generally well-tolerated, the company said, with side effects similar to those with a booster dose of its existing vaccine.

Moderna has only announced the trial results in a news release; the data have not yet been made available to outside scientists for review.

“We anticipate more durable protection against variants of concern with mRNA-1273.214, making it our lead candidate for a Fall 2022 booster," CEO Stéphane Bancel said in a statement.

Two omicron subvariants, called BA.4 and BA.5, continue to gain ground in the U.S.

Omicron and its growing family of subvariants have dealt a significant blow to the protection provided by the existing booster shots from Moderna and Pfizer-BioNTech.

Moderna has been testing updated versions of its booster shots that could be distributed across the country this fall, when immunity from previous shots will likely begin to wane and Covid cases are expected to rise again.

In April, Moderna announced that another bivalent vaccine candidate — which combines a beta variant-specific vaccine with the company’s original formula — generated a strong immune response against multiple variants of concern, including omicron. The beta variant, which was first detected in 2020, was particularly good at evading immunity, but it has almost entirely fallen out of circulation.

Dr. Anna Durbin, a vaccine researcher at Johns Hopkins University in Baltimore, said the bivalent omicron vaccine "makes sense," as a more specific target is needed to generate more antibodies that can attack the omicron variant specifically.

John Moore, a professor of microbiology and immunology at Weill Cornell Medical College, said Moderna's release on Wednesday shows that the omicron bivalent vaccine "may be marginally better" than the original vaccine, though he added he needs to see the full data to confirm.

It's also unclear, Moore added, if the protection from the bivalent vaccine will in fact be more durable, as the company only measured antibody responses after a month.

Based on the release, it's also uncertain if the vaccine will provide significant protection against BA.4 and BA.5, two subvariants that are spreading in the U.S., said Dr. Isaac Bogoch, an infectious disease physician at the University of Toronto.

The bivalent vaccine targets the original omicron variant. BA.4 and BA.5 share many similarities to the original variant, but also appear to have mutations that make them more transmissible.

The release is "helpful" but "we need more clinical data," Bogoch said.

A vaccine that targets more than one strain in a single shot is not a new concept. This year’s flu shot, for example, targets four influenza strains.

Moderna said it plans to submit the data to the Food and Drug Administration “in the coming weeks,” with the hope that the new shot could be available late this summer.

On June 28, the FDA's advisory committee is scheduled to meet to discuss what strain or strains should be included in Covid booster shots for the fall.

During a call with investors Wednesday, Moderna said that the FDA has asked the company to join the June 28 meeting to provide a "brief update" on its vaccine.

https://www.nbcnews.com/health/heal...rovides-stronger-protection-omicron-rcna32460

 

[The_Renaissance]

No thanks. Declined the first booster, won't be taking this one either. My life's been completely normal now for around 5-6 months, I'm no longer partaking in any of this.

By all means, offer it to the immunocompromised and the elderly and fat, unhealthy cunts.

 

[SBJJ]

These Covdmania threads should be a blueprint on who NOT to listen to if we ever have something like this happen again.

They were wrong on damn near everything. And the world and especially the world's children are now suffering from their hysteria.

It's beyond shameful and if they had an ounce of integrity they'd just all crawl in a hole.

 

[Arkain2K]

FDA advisers greenlight Novavax COVID-19 vaccine
BYMEREDITH WADMAN | June 7, 2022
​

A key committee of advisers to the U.S. Food and Drug Administration (FDA) today recommended nearly unanimously that the agency grant an emergency authorization to a COVID-19 vaccine from Novavax, opening the way for the first protein-based COVID-19 vaccine to become available to people in the United States.

The 21-0 vote, with one abstention, marks a hard-won and long-sought milestone for the small Gaithersburg, Maryland–based biotechnology company that was moribund as the pandemic began. It found a new life as it collected $2 billion to develop a vaccine, first from an international organization that supports vaccinemaking and then from the U.S. government.

“This is a case study of perseverance,” Bruce Gellin, chief of global public health strategy at the Rockefeller Foundation, said after the vote. Yet Gellin was the lone abstaining vote, saying the committee wasn’t given data on how the vaccine performs against the Omicron variants now circulating, or for how many months its protection lasts.

Still, Gellin said, “This vaccine has incredible potential.” It is easy to store and transport, lasting at refrigerator temperatures for months, unlike the dominant messenger RNA (mRNA) vaccines.

The thumbs up from the FDA advisers likely means the agency will allow the company to enter the U.S. market, as FDA usually follows its advisers’ lead. Novavax hopes holdouts skeptical of mRNA vaccines and, ultimately, others seeking booster shots will opt for its tried-and-true technology.

If it wins final authorization, the vaccine will be the fourth COVID-19 jab marketed in the United States. Unlike the other three, which deliver genetic material that directs host cells to make the coronavirus’ spike protein, Novavax’s product delivers spike protein directly to recipients. Approved vaccines for shingles, hepatitis B, and influenza use similar protein-based technology.

Just days before today’s meeting, the company’s stock price tumbled when FDA published data indicating the vaccine may rarely cause myocarditis and pericarditis, a problem that has also dogged mRNA vaccines from Moderna and the Pfizer-BioNTech collaboration. Perhaps in response to the volatility, NASDAQ froze trading of the stock today before the meeting opened.

But 21 of the 22 advisers concluded any risk posed by heart inflammation was outweighed by the benefits of a vaccine that showed 90.4% efficacy against early strains of SARS-CoV-2 in a trial involving 30,000 people in the United States and Mexico. The Novavax shot also has low “reactogenicity”—meaning immediate side effects, from painful arms to malaise. The committee recommended authorization for the two-shot series in adults 18 years and older.

“Certainly the benefits outweigh the risks,” said adviser Michael Nelson, an allergist and immunologist at the University of Virginia School of Medicine. But in response to a query from Doran Fink, acting deputy director of FDA’s vaccine approval branch, Nelson said the agency should include a warning about heart risks in the package insert. “It would be a travesty if we didn’t mention this in the … documentation for the public to show the concern that we have.”

Novavax’s vaccine, which is produced in insect cells and combined with an immune-boosting substance called an adjuvant, has already been authorized in more than 40 countries including the United Kingdom, Canada, Germany, and Australia; it has also won emergency authorizations from the European Union and the World Health Organization.

But manufacturing issues have hampered Novavax’s effort and sidelined its would-be U.S. vaccinemaking facilities. In addition, the company struggled mightily to show it could make the vaccine consistently. If authorized in the United States, the product will initially be manufactured, as all Novavax vaccine currently is, by the Serum Institute of India, one of the world’s largest vaccine manufacturers.

Myocarditis concerns may also dog the vaccine. The data revealed on 3 June by FDA described five cases of myocarditis that occurred in people in the vaccine arms of the Novavax clinical trials in the United States and the United Kingdom. Four occurred within 20 days of vaccination, a time frame during which there were no cases in the placebo arm. Three cases were in men ages 16 to 20. Young men have had the highest rates of myocarditis or pericarditis after receiving mRNA vaccines. “These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID-19 vaccines,” FDA wrote.

Novavax countered that collectively across all of its clinical trials, the risk of myocarditis and pericarditis was not significantly different in the vaccine group (0.007%) and in the placebo groups (0.005%). “We believe that the totality of the clinical evidence here is not enough to establish an overall causal relationship with the vaccine,” Denny Kim, Novavax’s chief safety officer, told the FDA advisers.

But Paul Offit, a committee member and infectious disease physician at the Children’s Hospital of Philadelphia, told today’s meeting that the “handful of cases of myocarditis [that] occurred within 3 or 4 days of receiving the second dose of vaccine in young men is consistent with what was seen with the mRNA-induced myocarditis. So I think that is likely a cause and not a coincidental association.”

The law governing emergency use authorizations (EUAs) by FDA requires that there is no “adequate, approved and available alternative” to a product. One advisory committee member asked Peter Marks, FDA’s top vaccine official, why the Novavax vaccine meets that requirement given that three other vaccines are already available to people in the United States.

“Having a protein-based alternative may be more comfortable for some in terms of their acceptance of vaccines,” Marks replied, noting that the law “allows us some leeway” to address unmet needs. “Anything we can do to get people … to be able to accept these potentially lifesaving medical products is something that we feel we are compelled to do.”

Some committee members raised eyebrows at the suggestion that the Novavax vaccine would win over a substantial number of the 27 million unvaccinated Americans with its familiar technology.

“I’m very skeptical that vaccine-hesitant people will elect to get this vaccine,” said committee member Jay Portnoy, an allergist and immunologist at Children’s Mercy Hospital. “Their hesitancy is more ideological than technological.”

But a parade of public speakers at the meeting mostly urged the committee to authorize the vaccine. “We need to … provide options to reduce excuses,” Martha Dawson, president of the National Black Nurses Association, told the advisers. “It could be the next thing that saves your life or your loved one’s life.”

When FDA’s advisers gave a green light to the Moderna and Pfizer vaccines in late 2020, the agency acted quickly to issue EUAs for those vaccines. But the Novavax process may not move so speedily: FDA says it needs additional manufacturing and product information before an EUA can be issued. The U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices would also need to make a recommendation for who should receive the vaccine, and that committee has not yet scheduled a meeting.

https://www.science.org/content/article/fda-advisers-greenlight-novavax-covid-19-vaccine

 

[Arkain2K]

The Biden administration is dropping the requirement for international travelers to test negative for COVID-19 before entering the U.S.

Clint Henderson, managing editor at The Points Guy, broke down how this will affect summer travel and the airline industry.