Details

Written by: Prakash Nagarkatti, University of South Carolina and Mitzi Nagarkatti, University of South Carolina

Published: 05 September 2022

 

On Sept. 1, 2022, the Centers for Disease Control and Prevention endorsed the use of updated COVID-19 booster shots that are specifically tailored to combat the two most prevalent omicron subvariants, BA.4 and BA.5. The decision comes just a day after the Food and Drug Administration’s emergency use authorization of the shots. The CDC’s backing will enable a full roll-out of the reformulated vaccines to begin within days.

The new booster shots – one by Moderna and another from Pfizer-BioNTech – come as more than 450 people are still dying of COVID-19 every day in the U.S.

As of Aug. 31, 2022, only 48.5% of booster-eligible people in the U.S. have received their first booster shot, and just under 34% of those eligible have received their second. These low numbers may in part be influenced by people waiting for the newer versions of the vaccines to provide better protection. But booster shots have proven to be an essential layer of protection against COVID-19.

Prakash Nagarkatti and Mitzi Nagarkatti are immunologists who study infectious disorders and how vaccines trigger different aspects of the immune system to fight infection. They weigh in on how the updated booster shots train the immune system and how protective they might be against COVID-19.

1. What is different about the updated booster shots?

The newly authorized shots are the first updates to the original COVID-19 vaccines that were introduced in late 2020. They use the same mRNA technology as the original vaccines. The key difference between the original COVID-19 shots and the new “bivalent” version is that the latter consists of a mixture of mRNA that encodes the spike proteins of both the original SARS-CoV-2 virus and the more recent omicron subvariants, BA.4 and BA.5.

As of late August 2022, the BA.4 and BA.5 omicron subvariants are dominant worldwide. In the U.S., currently 89% of COVID-19 infections are caused by BA.5 and 11% are caused by BA.4.

The inability of the original vaccine strains to prevent reinfection and to trigger long-term protective immunity prompted the need for the reformulated vaccines.

2. How does a bivalent vaccine trigger an immune response?

In an actual COVID-19 infection, the SARS-CoV-2 virus uses its protruding spike protein to latch onto human cells and gain entry into cells. The spike protein triggers the production of so-called neutralizing antibodies, which bind to the spike protein and prevent the virus from invading other cells.

But when the virus mutates, as we know that it does, the antibodies that were previously produced in response to the virus can no longer effectively bind to the newly mutated spike protein. In this respect, the SARS-CoV-2 virus acts like a chameleon – a master of disguise – by changing its body configuration and escaping recognition by the immune system.

The ongoing viral mutations are why antibodies produced in response to the original vaccine strains have over time become less effective at fending off infections by new variants.

The concept of bivalent vaccines aimed at protecting against two different strains of a virus is not new. For instance, Cervarix is an FDA-approved bivalent vaccine that provides protection against two different types of human papillomaviruses that cause cancer.

3. How protective will the new shots be against infection?

There are as of yet no human studies on the efficacy of the new bivalent vaccine at preventing reinfections and providing long-term immune protection.

However, in human clinical trials and laboratory studies, both Pfizer-BioNTech and Moderna found that their initial version of the bivalent vaccine, which was directed against the original SARS-CoV-2 virus and an earlier omicron strain, BA.1, induced a strong immune response and longer protection against both the original strain and the BA.1 variant. In addition, the companies reported that the same early combination generated a significant antibody response against the newest omicron subvariants, BA.4 and BA.5, though this antibody response was lower than that seen against subvariant BA.1.

Based on those results, in spring 2022 the FDA rejected the BA.1 bivalent boosters because the agency felt the boosters may fall short of providing sufficient protection against the newest strains, BA.4 and BA.5, which were by then spreading quickly throughout the U.S. and the world. So the FDA asked Pfizer-BioNTech and Moderna to develop bivalent vaccines specifically targeting BA.4 and BA.5, instead of BA.1.

Because clinical trials are time-consuming, the FDA was willing to consider animal studies and other laboratory findings, such as the ability of antibodies to neutralize the virus, to decide whether to authorize the bivalent boosters.

This decision has stirred up controversy over whether it is appropriate for the FDA to approve a booster without direct human data to support it. However, the FDA has stated that millions of people have safely received the mRNA vaccines – which were originally tested in humans – and that the changes in the mRNA sequences in the vaccines do not affect vaccine safety. Thus, it concluded that the bivalent vaccines are safe and that there is no need to wait for human clinical trials.

It is also noteworthy that influenza vaccines are introduced each year based on prediction of the strain that is likely to be dominant, and such formulations do not undergo new clinical trials.

Based on available evidence from the previous COVID-19 vaccines, we believe it is very likely that the new boosters will continue to offer strong protection from severe COVID-19 leading to hospitalization and death. But whether they will protect against reinfection and breakthrough infections remains to be seen.

4. Will it only be a booster shot?

The bivalent vaccines can only be used as a booster shot at least two months after the completion of the primary series – or initial required shots – or following a previous booster shot. The Moderna bivalent vaccine is authorized for use in people 18 years of age, while the Pfizer bivalent vaccine is authorized for those 12 years of age and older.

Because of the superiority of the bivalent vaccines, the FDA has also removed the use authorization for the original monovalent Moderna and Pfizer COVID-19 vaccines for booster purposes in individuals 18 years of age and older and 12 years of age and older, respectively.

The new bivalent vaccines contain a lower dose of mRNA, and as such are meant to be used only as boosters and not in people who have never received a COVID-19 vaccination.

5. Will the new shots protect against future variants?

How well the bivalent vaccines will perform in the face of new variants that might arise will depend on the nature of future spike protein mutations.

If it is a minor mutation or set of mutations when compared to the original strain or to omicron variants BA.4 and BA.5, the new shots will provide good protection. However, if a hypothetical new strain were to possess highly unique mutations in its spike protein, then it’s likely that it could once again dodge immune protection.

On the flip side, the successful development of the updated vaccines demonstrates that the mRNA vaccine technology is nimble and innovative enough that – within a couple of months of the emergence of a new variant – it is now likely possible to develop and distribute new vaccines that are tailor-made to fight an emerging variant.

This article has been updated to reflect the CDC’s endorsement of the reformulated shots.

Prakash Nagarkatti, Professor of Pathology, Microbiology and Immunology, University of South Carolina and Mitzi Nagarkatti, Professor of Pathology, Microbiology and Immunology, University of South Carolina

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Details

Written by: US CENSUS BUREAU

Published: 05 September 2022

September is National Wilderness Month, a time to put special focus on the United States’ amazing natural resources.

From Wilderness Connect, Learn About Wilderness, Fast Facts:

The Beginnings of the National Wilderness Preservation System

“When the Wilderness Act was passed in 1964, 54 areas (9.1 million acres) in 13 states were designated as wilderness. This law established these areas as part of the National Wilderness Preservation System. Since 1964, the NWPS has grown almost every year and now includes 803 areas (111,706,287) in 44 states and Puerto Rico. In 1980, the passage of the Alaska National Interest Lands Conservation Act (ANILCA) added over 56 million acres of wilderness to the system, the largest addition in a single year. 1984 marks the year when the most new wilderness areas were added.

“Overall, however, only about 5% of the entire United States—an area slightly larger than the state of California—is protected as wilderness. Because Alaska contains just over half of America's wilderness, only about 2.7% of the contiguous United States—an area about the size of Minnesota—is protected as wilderness.”

From The American Presidency Project, Proclamation 10248—National Wilderness Month, 2021:

“During National Wilderness Month, we affirm that our Nation's public lands and waters must be accessible to all Americans, we recognize that our lands and waters can revitalize the soul and solidify our respect for the natural wonders that surround us and the earth we share, and we recommit to their preservation and protection, today and for future generations.

“The Wilderness Act, signed into law by President Lyndon B. Johnson in 1964, opened a new chapter in American conservation by creating the National Wilderness Preservation System. The primary goal of the act is to preserve the places "where the earth and its community of life are untrammeled." Today, the National Wilderness Preservation System includes more than 800 wilderness areas spanning more than 111 million acres. These wilderness areas are located within national forests, parks, wildlife refuges, and conservation lands and waters. During the COVID-19 pandemic, many Americans turned to these areas for physical recreation, mental well-being, and inspiration, and our public lands and waters became places of healing and sanctuary.

“But our natural wonders are at risk. Now more than ever, we must come together to combat the climate crisis and unprecedented acceleration of species extinction, to protect and conserve our great outdoors before it is too late.”

Details

Written by: Elizabeth Larson

Published: 04 September 2022

LAKE COUNTY, Calif. — A group of Kelseyville residents determined to find ways to protect their communities against wildland fire have formed a new organization that has received an important donation from the district supervisor.

The Konocti Fire Safe Council on Tuesday received a $10,000 donation from District 5 Supervisor Jessica Pyska. The funds came from supervisors’ discretionary cannabis funds.

“For many years now, homeowners associations in the Kelseyville-area communities known as the Rivieras have been showing strong leadership, and working effectively to reduce the risk of wildfire,” Pyska said in a statement issued by the County Administrative Office. “Establishment of the Konocti Fire Safe Council brings valuable coordination to these efforts, and better positions these communities to access grant funding in the future.”

“Everyone in the county, by and large, agrees the Rivieras would be the worst place for a rural fire to occur. There are many homes, with a lot of local fuels, and limited access and firefighting capabilities,” said Konocti Fire Safe Council President Kathy Andre.

Council Treasurer Bill Groody told Lake County News the group officially formed in June, but that it has actually been meeting a year or longer. It grew out of an effort to get a new firehouse in the Soda Bay corridor as a means of lowering insurance rates and increasing response times.

He said that morphed into Measure A, which the Kelseyville Fire Protection District put before voters late last year. In addition to the firehouse, the measure was meant to increase staffing and equipment.

However, the measure failed. As a result, Groody said the new group grew out of community members in four homeowners associations — Clear Lake Riviera, Buckingham, Riviera West and Riviera Heights — asking how they could improve safety conditions in the Soda Bay corridor without the measure.

Thus the Konocti Fire Safe Council was born. In addition to Groody, the board includes President Kathy Andre, Vice President Phil Hartley, and members Cindy Jassar, John Nowell, Rian Sommerfield and Kathy Sylar.

Its coverage area runs along Clear Lake State Park and follows the lakeshore, extends down to Point Lakeview Road then back along Highway 29, up along Kelsey Creek in Kelseyville and Gaddy Lane to the state park. Groody said they also are including the western side of Mount Konocti, where a fire could potentially start and come over the mountain.

Groody said they are trying to bring together not just the four homeowners associations but also representatives from areas outside the associations’ boundaries.

The council seeks to increase community wildfire preparedness and survivability through education, project and resource development, evacuation readiness and hazardous fuel reduction.

When the group formed, Groody said each homeowners association agreed to contribute $1,000 a year. When Pyska saw those and other fundraising efforts were underway, Groody said she offered the discretionary funds. “We’re very thankful for that.”

Thanks to that funding, “We have our core operating expenses taken care of for the next three years,” Groody said, noting they’re operating on a “modest” budget.

That strong financial start will allow them to focus on fundraising and pursuing grants for bigger efforts, he said.

Groody said the group plans to coordinate and work with other community groups and local government agencies to improve wildfire safety around their communities.

He said they are still in the formative stages, getting the group off the ground and preparing to develop a social media presence and website.

They plan to pursue grants and other funding to carry out a number of projects, including working on evacuation routes, Groody said, and removing brush and dead tree clearing along the Soda Bay corridor, which are critical.

The situation on Soda Bay road is very urgent with regard to clearing, he said.

They’ve looked at options for brush clearing, including goats. “Every goat that’s available is out there eating now,” Groody said.

They also want to identify the 100 most hazardous trees in the area in order to have them removed. Groody pointed out that the board, at the request of Pyska, declared a tree mortality emergency.

He pointed out that in the past two and a half weeks there have been three fires in the council’s coverage area.

“The urgency is there,” he said.

The No. 1 priority, said Groody, is coordinating to use grant funds given to the county by Cal Fire to improve Soda Bay Road as an evacuation route.

“I think we’re going to be heavily involved in working on this evacuation plan,” he said.

With the county being short-staffed, Groody said the homeowners’ associations may end up being fiscal agents to help move that project along.

They’re also looking at ways to free up some of the assessment funding covering Clear Lake Riviera, Buckingham, Riviera West and Riviera Heights, as well as lots adjacent to them within County Service Area No. 23 that went into effect in 2019.

The one-time assessment, the proceeds of which were meant to be used for vegetation management, followed approval by voters in the associations and the Board of Supervisors based on a plan put forward by then-District 5 Supervisor Rob Brown.

To reach the council, email This email address is being protected from spambots. You need JavaScript enabled to view it..

Email Elizabeth Larson at This email address is being protected from spambots. You need JavaScript enabled to view it.. Follow her on Twitter, @ERLarson, or Lake County News, @LakeCoNews.