Finally a vaccine to banish Covid for good? Nasal spray reduces risk of infection 86% — nearly DOUBLE protection given by shot in arm

A nasal vaccine that could finally curb Covid infections is one step closer to a reality after promising early trial results.

The inhaled vaccine, made by researchers in Georgia, successfully reduced the risk of symptomatic Covid infections by 86 percent for three months in people who received it as a booster - almost double the protection the mRNA boosters provide.

While still in early stages, it is an exciting development that could prove more effective than the booster doses administered as injections.

The nasal, or ‘mucosal’ vaccines are appealing for their ability to prime immune cells in the mucous membranes that line the nostril cavities and the mouth where the coronavirus first enters the body, and stop the virus in its tracks.

Nasal vaccines such as the one currently in development at Georgia-based startup Blue Lake Biotechnology Inc. concentrate the immune protection in the upper airways, positioning powerful antibodies right on the frontlines.

In their phase 1 trial starting in August 2021, researchers at Blue Lake Biotechnology included 72 participants ages 18 to 55 who had already received two doses of an mRNA vaccine as well as unvaccinated healthy people. They plan to expand the sample size and will continue recruiting subjects through December.

The vaccine technology relies on a type of parainfluenza virus that has been encoded with Covid’s trademark spike protein to train the immune system to recognize and fight it off.

Once the vaccine contents are inhaled, little bits of the parainfluenza virus replicate inside the nasal cavity to such an extent that it triggers an immune response without actually getting the person sick.

Dr Biao He, founder and CEO of Blue Lake Biotechnology said: ‘We were pleasantly surprised to see indications of a protective effect in this Phase 1 trial.’

‘We are excited and encouraged with this result, and through our affiliate, CyanVac LLC, we have submitted a protocol to FDA for a randomized controlled phase 2 trial in which we look forward to more fully evaluating the immunogenicity of the vaccine and to better understanding its protective efficacy.’

The immune response launched by the nasal spray vaccine could potentially be significantly more robust than a vaccine administered via syringe.

In addition to prompting a strong immune response, nasal vaccine technology could ease pressure on health professionals giving vaccine injections, cut medical waste and provide better vaccine access to developing countries.

Booster shots currently in use across the US have been shown to reduce symptomatic infections by 43 percent in people 65 and younger over roughly the same amount of time that the spray is able to confer 86 percent protection.

People in the trials who received the nasal spray experienced fewer adverse reactions than those who received the injectable vaccine.

Nasal spray vaccines will appear to many a less invasive means of gaining protection against severe illness, potentially attracting the needle-phobic vaccine holdouts.

The finished product is still a ways off and this is the type of next generation Covid vaccines that public health officials have said are urgently needed in the event that a new variant that is able to circumvent vaccine protection arises.

Dr Peter Marks, director of the Center for Biologics Evaluation and Research within the Food and Drug Administration and fellow experts at Brown University said late last year: ‘Introduction of these bivalent boosters likely only represents a temporizing measure until variants emerge that necessitate additional booster vaccination or modification of the current generation of vaccines.

‘Serious consideration therefore needs to be given to the development of a distinctly improved generation of SARS-CoV-2 vaccines offering longer protection with greater scope.’

https://www.dailymail.co.uk/health/article-11790943/A-vaccine-end-Covid-good-Early-results-nasal-spray-reduced-risk-severe-covid-86.html

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Protection From New COVID-19 Vaccines Drops Sharply Within Months: CDC

The new COVID-19 vaccines provide a boost to protection against hospitalization but that shielding wanes within months, according to unpublished data presented on Feb. 24.

A bivalent Pfizer or Moderna booster increased protection against hospitalization initially by 52 percent, but that protection dropped to 36 percent beyond 59 days, U.S. Centers for Disease Control and Prevention (CDC) researchers said.

The researchers separately looked at the protection people who had received two or more monovalent doses, or doses of the original vaccines, and no bivalent booster. They found that people aged 18 to 64 had just 19 percent protection against COVID-19 associated hospitalization and those aged 65 and older had just 28 percent protection.

That means the protection after two months was around 60 percent in total for the elderly and goes below 50 percent for all other adults.

The data came from the CDC’s VISION network. Data from a different CDC-run network, called IVY, showed “minimal to no residual protection” against hospitalization from the original vaccine, Dr. Amadea Britton, a CDC official, said. Two or more monovalent doses provided just 17 percent protection, with uncertain confidence intervals.

A bivalent vaccine on top of a monovalent primary series brought the protection to just 55 percent at seven or more days after the booster.

Waning wasn’t measured in the IVY network.

The bivalent vaccines were authorized and recommended in the fall of 2022 despite no clinical trial data being available. Clinical efficacy data remains unavailable at present.

The COVID-19 vaccines are authorized in the United States to prevent COVID-19 disease but officials have increasingly described the goal of vaccination as preventing severe disease, because the vaccines have performed worse and worse against symptomatic infection as newer variants have emerged.

The effectiveness against severe disease may be higher than against hospitalization, according to Britton.

A third CDC network, Increasing Community Access to Testing, found that a new booster initially provided 65 percent protection against symptomatic infection for children aged 5 to 11, and 68 percent protection for children aged 12 to 17.

That protection waned to 54 percent by three months in the younger group and 53 percent by five months in the older group.

A bivalent booster worked much worse in adults, according to other unpublished data from the network presented for the first time during the meeting.

A bivalent increased protection against symptomatic infection by just 38 percent in the elderly, with protection dropping to 21 percent by five months. In people aged 50 to 64, protection started at 46 percent and waned to 28 percent; among adults aged 18 to 49, protection started at 51 percent and waned to 41 percent.

The protection estimates were relative, being measured against two to four doses of an original vaccine. Previous research has found that the original vaccine provides little protection against symptomatic Omicron infection, with some estimating the protection turning negative over time.

“The pattern of waning against symptomatic infection is very similar to what was observed after monovalent booster doses, with VE against symptomatic infection decreasing to minimal protection by around five to six months,” Britton said.

Change in Vaccine

The updated Pfizer and Moderna vaccines target the BA.4 and BA.5 subvariants of Omicron, in addition to the Wuhan strain. The original vaccines were aimed at only the latter. The updated vaccines are only available currently as booster shots.

U.S. authorities are preparing to replace all of the original Pfizer and Moderna vaccines with the bivalent. Advisers to the U.S. Food and Drug Administration backed the move in a recent meeting, and advisers to the CDC on Thursday largely agreed the move would be good.

They cited the improvement in protection the bivalents bestow, however minimal, and the hope that simplifying the vaccines would lead to more uptake.

Many Americans have declined to get any boosters, and even fewer have received one of the new bivalents. The overwhelming majority of parents have chosen not to get their children even a primary series, amid the drop in effectiveness and growing concerns about short- and long-term side effects like heart inflammation.

https://www.theepochtimes.com/protection-from-new-covid-19-vaccines-drops-sharply-within-months-cdc_5080704.html

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New Study Finds ‘No Evidence’ That City-Wide Vaccine Mandates Impacted the Spread of COVID-19

During the pandemic, a slew of left-wing cities established vaccine mandates that required employees to get vaccinated against COVID-19. Those who did not comply faced suspension and termination from their jobs. Many cities took this a step further and mandated all businesses to require patrons to present their vaccine papers in order to enter the business.

This week, the Mercatus Center at George Mason University unveiled a new study,“Indoor Vaccine Mandates in US Cities, Vaccination Behavior, and COVID-19 Outcomes.” The study questioned the efficacy of vaccine mandates in cities that implemented such mandates to visit indoor businesses, which included Boston, Chicago, Los Angeles, New Orleans, New York, Philadelphia, San Francisco, Seattle, and Washington, D.C.

“City vaccine mandates were arguably among the most restrictive and polarizing regulations ever enacted in the United States,” the study write-up said. “Millions of people were prevented from entering restaurants, bars, gyms, theaters, sports arenas, and other public indoor areas without proof of COVID-19 vaccination. The mandates negatively affected unvaccinated individuals and businesses that were not allowed to serve unvaccinated customers.”

The write-up noted that supporters of the mandates said that it would uptick vaccination rates that the spread of COVID-19 would decrease. But, the study shows that this did not happen.

“We find no evidence that the announcement or implementation of indoor vaccine mandate in the cities listed had any significant effect on vaccine uptake, COVID-19 cases, or COVID-19 deaths, and this is largely consistent for all US cities that implemented the mandate,” the study stated.

In New York City, specifically, more than 90 percent of restaurants reported having “customer-related” challenges over the vaccine mandate. And, over 1,400 city workers were fired for refusing to get vaccinated.

"COVID cases were not affected by the mandate, COVID deaths were not affected by it, and people were not more likely to get vaccinated at all in the first place," Vitor Melo, a postdoctoral fellow at the Mercatus Center and one of the authors of the study told Fox 5 DC.

"The idea behind the mandate is more people are gonna get vaccinated, therefore we’re gonna reduce the spread of COVID," Melo added. "That first step really didn’t happen."

One of the reasons why, Melo explained, is because people would travel to neighboring areas without vaccine mandates to go out to eat, etc. In the Washington, D.C. area, for example, people would go out to Arlington, Virginia.

The study pointed out that studies detailing country-wide mandates, like in Europe, were effective and resulted in more people getting a dose of the vaccine. City-wide mandates in America did not have this effect.

“The authors find that city-level mandates had smaller effect on vaccine uptake (and consequently on COVID-19 cases and deaths) than nationwide mandates— and thus failed to achieve their intended objectives,” it concluded.

https://www.msn.com/en-us/health/other/george-mason-study-finds-no-evidence-that-vaccine-mandates-in-major-cities-reduced-covid-19-cases/ar-AA17QYFI

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