As COVID Booster Shots Become Available, Here’s What You Should Know

 

Biden administration officials announced plans for COVID-19 booster shots to be made widely available starting September 20. But local health departments and experts are scrambling to keep up with the latest guidance and research.

Starting in September, booster shots of the COVID-19 vaccine will be available for all teens and adults in the U.S., federal officials announced on Wednesday. The news arrived just a few days after booster shots were authorized for people who have compromised immune systems.

The shots are meant to provide additional protection as the delta variant drives a new case surge. However, some experts say data supporting the use of the booster is still limited, and health departments are scrambling to keep up with the changing recommendations.

Here’s what people need to know about booster shots.

Who will be able to get the shots?

Biden administration officials on Wednesday outlined plans for COVID-19 booster shots to be made widely available starting on September 20. The guidance applies to the mRNA vaccines made by Pfizer and Moderna.

People would be eligible for booster shots starting eight months after they received their last shot, explained Surgeon General Dr. Vivek Murthy, although the rollout would need to be authorized by federal regulators. Health care workers, nursing home residents and older people would get first access, and other groups would follow.

On August 12, the Food and Drug Administration authorized booster shots for people who have compromised immune systems, and shots for these people are currently available. This group includes people receiving cancer treatment, organ or stem cell transplant recipients, people who have immunodeficiency, those with HIV, and people taking medications that suppress immune response.

Why are the boosters needed?

The immunity offered by existing COVID-19 vaccines appear to decline over time, according to data presented by the Centers For Disease Control and Prevention on Wednesday. The studies indicate that, while the mRNA vaccines are still effective against hospitalizations, people who have received them seem to currently be more susceptible to infection than earlier research indicated.

That waning immunity may be due to the more-contagious delta variant, reduced efficacy of the vaccines, and/or people taking fewer precautions than earlier in the pandemic.

Real-world studies that show declines in immunity among vaccinated people make clear the need for addition protection, according to Dr. Mary Anne Jackson, infectious disease specialist and dean of the University of Missouri – Kansas City School of Medicine.

“It wanes by about 6% each month after being fully vaccinated. So we see that, even within the general population, there is utility to a third dose,” Jackson said.

Does these mean the vaccines aren’t working?

Though the vaccines may not appear to be performing as well as initial research showed, they are still powerful tools for fighting the coronavirus, says Dr. Dana Hawkinson, infectious disease specialist at the University of Kansas Health System.

“Although they may not protect enough maybe against mild disease, what we’re really looking for is to decrease the burden of people missing work due to significant illness or the capacity issues with the hospitals,” Hawkinson said Wednesday on KCUR’s Up To Date.

Where are the booster shots being offered?

Many of the clinics and health departments that were already giving out first and second vaccine doses are now administering third doses for immunocompromised people.

Locations that have already announced they're offering booster shots include pharmacy chains, such as CVS and Walgreens, and public health departments.

State officials say they are now getting guidance from the federal government as they open access to booster shots and plan outreach.

“We’re listening now on what some of those plans regarding supply and pharmacy programs will look like,” Missouri Department of Health and Senior Services spokeswoman Lisa Cox told KCUR in an email.

What about people who got the Johnson & Johnson vaccine?

The Biden administration's new recommendations are for people who received the mRNA vaccines, which include the Pfizer and Moderna vaccines. The Johnson & Johnson vaccine is not an mRNA vaccines, and Hawkinson acknowledged on Wednesday that data regarding the J&J vaccine remains limited.

He said that while there’s no official guidance on J&J recipients getting an mRNA booster, this appears to be safe.

“The official guidance is not to do anything,” Hawkinson said. “Unofficially, yes. It is probably very safe, will not add any harm. But what is the benefit? We just don’t have that answer.”

Does getting a booster shot create additional health risks?

No, booster shots don't carry extra risks, according to Gene Olinger, science advisor with MRI Global.

“It’s the same risk you have with the original indications within the vaccine platform itself that you’ve received,” Olinger told Up To Date. “Generally speaking, people can have various responses that are very similar to the original, or can actually be a lot less.”

Will we still need boosters specifically for the delta variant later on?

Though the delta variant is currently the most urgent cause for concern, Jackson says that new COVID-19 variants will continue to emerge.

She says that the booster shots will likely provide sufficient protection from the delta variant, but it’s possible future versions of the vaccine may be developed to contend with the changing virus.

“I’m concerned about the next variant that’s out there,” Jackson said. “That’s where I think we might see — although I don’t think it’s highly likely — a year from now, you’ll see a different vaccine.”

https://www.kcur.org/health/2021-08-18/as-covid-booster-shots-become-available-heres-what-kansas-and-missouri-residents-should-know

Polio Vaccination Induces Humoral Immune Response That Cross Reacts With SARS-CoV-2

 Brittany A. Comunale1*, Lilly Engineer1,2, Yong Jiang3, John C. Andrews4, Qianna Liu3, Lyuqing Ji3, James T. Yurkovich5, Roderick A. Comunale4 and Qiyi Xie4

DOI:  https://doi.org/10.3389/fmed.2021.710010

PDF: https://www.frontiersin.org/articles/10.3389/fmed.2021.710010/pdf

Background: Millions have been exposed to SARS-CoV-2, but the severity of resultant infections has varied among adults and children, with adults presenting more serious symptomatic cases. Children may possess an immunity that adults lack, possibly from childhood vaccinations. This retrospective study suggests immunization against the poliovirus may provide an immunity to SARS-CoV-2.

Methods: Publicly available data were analyzed for possible correlations between national median ages and epidemiological outbreak patterns across 100 countries. Sera from 204 adults and children, who were immunized with the poliovirus vaccine, were analyzed using an enzyme-linked immunosorbent assay. The effects of polio-immune serum on SARS-CoV-2-induced cytopathology in cell culture were then evaluated.

Results: Analyses of median population age demonstrated a positive correlation between median age and SARS-CoV-2 prevalence and death rates. Countries with effective poliovirus immunization protocols and younger populations have fewer and less pathogenic cases of COVID-19. Antibodies to poliovirus and SARS-CoV-2 were found in pediatric sera and in sera from adults recently immunized with polio. Sera from polio-immunized individuals inhibited SARS-CoV-2 infection of Vero cell cultures. These results suggest the anti-D3-pol-antibody, induced by poliovirus vaccination, may provide a similar degree of protection from SARS-CoV-2 to adults as to children.

Conclusions: Poliovirus vaccination induces an adaptive humoral immune response. Antibodies created by poliovirus vaccination bind the RNA-dependent RNA polymerase (RdRp) protein of both poliovirus and SARS-CoV-2, thereby preventing SARS-CoV-2 infection. These findings suggest proteins other than “spike” proteins may be suitable targets for immunity and vaccine development.

https://www.frontiersin.org/articles/10.3389/fmed.2021.710010/full

Prophylactic Protection from Respiratory Viruses Conferred by Prototype Live Attenuated Flu Vaccine

 

Raveen Rathnasinghe, Mirella Salvatore, Hongyong Zheng, Sonia Jangra, Thomas Kehrer, Ignacio Mena, Michael Schotsaert, Thomas Muster, Peter Palese, Adolfo Garcia-Sastre

DOI: 10.21203/rs.3.rs-668116/v1

PDF: https://www.researchsquare.com/article/rs-668116/v1.pdf?c=1628880085000

This preprint is under consideration at Scientific Reports. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.

The influenza A non-structural protein 1 (NS1) is known for its ability to hinder the synthesis of type I interferon (IFN) during viral infection. Influenza viruses lacking NS1 (ΔNS1) are under clinical development as live attenuated human influenza virus vaccines and induce potent influenza virus-specific humoral and cellular adaptive immune responses. Attenuation of ΔNS1 influenza viruses is due to their high IFN inducing properties, that limit their replication in vivo. This study demonstrates that pre-treatment with a ΔNS1 virus results in an immediate antiviral state which prevents subsequent replication of homologous and heterologous viruses, preventing disease from virus respiratory pathogens, including SARS-CoV-2. Our studies suggest that ΔNS1 influenza viruses could be used for the prophylaxis of influenza, SARS-CoV-2 and other human respiratory viral infections, and that an influenza virus vaccine based on ΔNS1 live attenuated viruses would confer broad protection against influenza virus infection from the moment of administration, first by non-specific innate immune induction, followed by specific adaptive immunity.

https://www.researchsquare.com/article/rs-668116/v1

'Version 2.0' of COVID-19 vaccine quickly kicks immune system into high gear

 Let the record show that the current COVID-19 vaccines work, and they work well. But what is the next step in vaccine development, especially amid increasing rates of breakthrough infections and emergence of variants of concern?

In a new Northwestern Medicine study in mice, researchers took one of the current vaccines, which is based on the novel coronavirus's infamous spike protein, and added a different antigen, the nucleocapsid protein, to form a new, potentially improved version of the COVID vaccine. The nucleocapsid protein, which is an internal RNA-binding protein, may help kick the immune system into high gear much more quickly than the spike protein is capable of since it is among the most rapidly and highly expressed proteins in coronaviruses.

"At this point, we're just trying to figure out 'What should the 2.0 vaccines be?'" said senior and corresponding study author Pablo Penaloza-MacMaster, an assistant professor of microbiology-immunology at Northwestern University Feinberg School of Medicine. "It seems like adding nucleocapsid to the vaccine renders it more protective, relative to having only the spike."

The combination vaccine improved protection against breakthrough infections in mice. It is the first study to compare side by side the efficacy against breakthrough infection of a current, spike-based vaccine with a vaccine that includes an additional antigen, in this case the nucleocapsid protein.

The study was published August 17 in the journal Cell Reports.

Curtailing a recent infection 'from the get-go'

The well-known coronavirus spike protein is located outside the virus, whereas the nucleocapsid protein is present inside the virus. The nucleocapsid protein is one of the most rapidly and abundantly expressed proteins, making it the perfect target for early detection by the T cell response, Penaloza-MacMaster said. He believes this is what made it so effective at preventing breakthrough infections in mice.

"When a cell gets infected by SARS-CoV-2, you want the T cells to recognize this infected cell as soon as possible," Penaloza-MacMaster said. "If your T cells can detect one of the early proteins expressed during the coronavirus life cycle, then you will be better able to extinguish the infection from the get-go, before the virus starts disseminating exponentially."

Another advantage of incorporating nucleocapsid in next-generation COVID vaccines is that this protein is more conserved (or similar) among SARS-CoV-2 variants and even among other coronaviruses.

"We have to start thinking about a future vaccine that not only targets the spike, which is variable, but also the parts of the virus that don't change that much, like the nucleocapsid."

The 'first side-by-side comparison'

The scientists immunized mice with vaccines made from just the SARS-CoV-2 spike protein, just the nucleocapsid protein or both proteins combined. After several weeks, the researchers exposed the mice via their noses with SARS-CoV-2 and measured viral loads in the mice's respiratory systems (the proximal site of virus exposure) or their nervous system (the distant site of challenge) 72 hours after exposure to capture a breakthrough infection.

The studies allowed the scientists to measure how well each vaccine protected against breakthrough infection, and determine how the infection travels from the respiratory system to other sites of the body (nervous system).

The results could be the basis for developing more effective vaccines not only in terms of preventing, but also clearing breakthrough infections.

Protecting against long-term neurological manifestation of COVID

Scientists are still collecting data to determine whether vaccinated individuals who have a breakthrough COVID infection develop long-term neurological symptoms. In this study, the scientists found evidence of viral infection in the brains of mice that were immunized with a current spike-based vaccine.

"I'm a little worried to see that the mice had viral loads in the brains because this suggests that perhaps with the current spike-based vaccines, these breakthrough infections could potentially get through to the brain," Penaloza-MacMaster said. "We don't know if that's just in mice or whether it constitutes a general phenomenon. We're investigating that right now, but a technical challenge is that, due to ethical reasons, we cannot sample brain tissue of vaccinated humans to evaluate breakthrough infection."

He hopes the new combination vaccine may better protect the brain from developing neurological symptoms if a breakthrough infection occurs.

Tanushree Dangi, a microbiology and immunology postdoctoral fellow, and Nicole Palacio, a Ph.D. candidate in the Penaloza-MacMaster's laboratory, are co-authors on the paper. This study was a collaboration with Justin Richner and Jacob Class, investigators at the University of Illinois Chicago.

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Explore further

SARS-CoV-2 infections may trigger antibody responses against multiple virus proteins

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More information: Tanushree Dangi et al, Combining spike- and nucleocapsid-based vaccines improves distal control of SARS-CoV-2, Cell Reports (2021). DOI: 10.1016/j.celrep.2021.109664

https://medicalxpress.com/news/2021-08-version-covid-vaccine-quickly-immune.html

Could Aspirin be Key in Unlocking Triple-Negative Breast Cancer?

 A common over-the-counter drug, aspirin, might be the key to finding a viable treatment method for breast cancer.

Scientists from The Christie NHS Foundation Trust have begun human trials on the use of aspirin alongside current cancer medication avelumab in treating patients diagnosed with triple-negative breast cancer (TNBC). This means that the cancer that began in the breast had already spread to other parts of the body. 

To date, there is no cure for triple-negative breast cancer, despite statistics showing that some 8,000 women are diagnosed with the disease every year in the U.K. alone. 

According to the American Cancer Society, TNBC accounts for 10 to 15 percent of breast cancers worldwide. TNBC differs from the other types of breast cancers in that it spreads and grows faster, has limited treatment options, and comes with a worse prognosis. 

It is identified using biopsy and imaging tests that show cells being unable to make HER2 protein and do not have progesterone or estrogen receptors. TNBC tends to be observed in women under 40 years old who are either African-American or have a BRCA1 mutation. 

The Christie trial is the first ever to explore the possibility of combining aspirin with avelumab. According to Dr. Anne Armstrong, the lead scientist of the study and a consultant medical oncologist at Christie NHS, their group will be evaluating patients who receive a combination of aspirin and avelumab versus those who take avelumab alone. The drugs will be given before the patients receive chemotherapy and surgery. 

"Our earlier research has suggested that aspirin can make certain types of immunotherapy more effective by preventing the cancer from making substances that weaken the immune response. Anti-inflammatory drugs like aspirin could hold the key to increasing the effectiveness of immunotherapy when used at the same time," said Dr. Armstrong. 

The proponents of the study, which the Breast Cancer Now Catalyst Programme funds, said they are excited for the outcomes, mainly because aspirin is widely available and inexpensive. They are also ensuring that the benefits of using aspirin will outweigh the risks, as it can also cause serious side effects, like internal bleeding. Those who have stomach ulcers, asthma, and hemophilia are cautioned against taking this drug.

The Breast Cancer Now Catalyst Programme is an initiative that combines the efforts and expertise of top breast cancer researchers in Europe and global pharmaceutical companies, with the goal to stop women from dying of the disease by the year 2050. It has, so far, partnered with Pfizer, but it is looking to forge more partnerships with other leading pharma companies in the future. 

Pfizer has reportedly committed $15 million over three years to fund the program's initiatives. The Catalyst Programme Advisory Group will decide research priorities, and all findings will be peer-reviewed and published.

https://www.biospace.com/article/aspirin-may-hold-the-key-to-breast-cancer-treatment-human-trials-begin-/

Moderna Experimental HIV Vaccine Could Begin Human Trials as Soon as This Week

 Moderna will start trialling its experimental mRNA-based HIV vaccine as early as tomorrow (19 August), according to a new submission to the US National Institutes of Health Clinical Trial registry.

The Phase 1 trial will reportedly involve 56 healthy adults aged 18 to 50 who do not have HIV, and will test the safety of the vaccine as well as look for a basic immune response. The vaccine candidate is functionally similar to the mRNA system that's been so successful in Moderna's COVID-19 vaccine.

For years, researchers have been investigating the potential of mRNA vaccines, but the Pfizer and Moderna COVID-19 vaccines are the first to have been used in humans, and both have been shown to be safe and broadly successful at preventing and reducing severity of SARS-CoV-2 infection.

Moderna will be trialling two versions of its new vaccine candidate, officially called mRNA-1644 (the variant is known as mRNA-1644v2-Core). This is the first mRNA vaccine against HIV to be trialled in humans. 

There will be four groups as part of the trial – two receiving a mix of the vaccine versions, and two receiving one or the other.

At this early stage, the trial isn't 'blind', which means everyone who receives the vaccine will know what they're getting. That's because right now the researchers aren't trying to work out how well the vaccine works. This first phase will last approximately 10 months, and they just want to make sure it's safe and that it mounts a basic immune response.

If the vaccine passes this phase, they will still need to go through phase 2 and phase 3 trials to determine how well they work at preventing HIV infection in the broader population.

So how do mRNA vaccines work? Unlike traditional vaccines, which usually contain some part of a weakened or inactivated virus, mRNA vaccines contain an 'instruction booklet' that's passed into our cells and tells them how to make fragments of specific proteins that sit on the outside of the target virus. 

For a short period of time (usually 24 to 48 hours), our cells start to make these proteins, and our bodies mark them as foreign and mount an immune response. Hopefully that means when you're exposed to the actual virus, your body will recognize the spike proteins and be quick enough to fight it off before infection becomes too severe.

According to the Moderna clinical trial submission about its HIV vaccine candidate: "The hypothesis is that sequential vaccination by a germline-targeting prime followed by directional boost immunogens can induce specific classes of B-cell responses and guide their early maturation toward broadly neutralizing antibody (bnAb) development through an mRNA platform."

That's a bit wordy, but stimulating those broadly neutralizing antibodies (bnAbs) is important when it comes to HIV. 

We're already very good at using antivirals to treat HIV and reduce the risk of someone exposed getting infected. 

But making a vaccine against the virus has proved difficult because of how rapidly it infects our DNA and is able to readily mutate its structure.

The most promising approach we have is stimulating those broadly neutralizing antibodies, which some people naturally develop against HIV – but which we haven't been able to trigger with a vaccine so far.

However, an mRNA approach may be different. Earlier this year, research from the International AIDS Vaccine Initiative and Scripps Research tested a component of the mRNA vaccine candidate – the immunogen – but using a non-mRNA system.

While the vaccine candidate didn't mount the full immune response needed, 97 percent of participants developed the desired immune response – the early stimulation of B cells.

"We and others postulated many years ago that in order to induce bnAbs, you must start the process by triggering the right B cells – cells that have special properties giving them potential to develop into bnAb-secreting cells," said immunologist William Schief who led the Scripps Research team back in February.

"In this trial, the targeted cells were only about one in a million of all naïve B cells. To get the right antibody response, we first need to prime the right B cells. The data from this trial affirms the ability of the vaccine immunogen to do this."

This same immunogen will now be used in this new trial in conjunction with Moderna's mRNA system, which has been so useful against SARS-CoV-2.

The hope is that the combination will result in broadly neutralizing antibodies that are capable of fighting off HIV infection in the first place – and may also be effective against a range of other viruses in the future, such as the 'next pandemic'. The new trial is run in partnership with the Bill and Melinda Gates Foundation.

In an announcement to shareholders in April, Moderna said it's also developing another HIV vaccine candidate in addition to mRNA-1644, called mRNA-1574. And mRNA vaccines are also being investigated to prevent a variety of other viruses, such as the herpes simplex virus and influenza.

While the COVID-19 pandemic continues to rage around the world, it's promising to see that some of the technology we've developed to fight it could also help us to prevent other devastating viruses in the future.

You can read more about Moderna's Phase 1 trial here.

https://www.sciencealert.com/moderna-s-experimental-hiv-vaccine-could-begin-human-trials-as-soon-as-this-week

Drop in COVID-19 vaccine efficacy against Delta seen in U.S. nursing homes

 The effectiveness of COVID-19 vaccines for people in American nursing homes and long-term care facilities, where residents are often elderly and frail, has dropped since the Delta variant became dominant in the United States, government researchers said on Wednesday.

Despite this decline, the vaccines are still highly effective at preventing illness severe enough to require hospitalization, according to research published in the U.S. Centers for Disease Control and Prevention's (CDC) Morbidity and Mortality Weekly Report.

The spread of the highly infectious Delta variant, which according to CDC data accounted last month for more than 80% of new U.S. infections, has complicated efforts to combat the pandemic in the United States and globally.

CDC researchers compared weekly data from 3,862 nursing homes and long-term care facilities spanning March 1 to May 9, before Delta became widespread, to data from 14,917 such facilities covering June 21 to Aug. 9, when the variant was responsible for the majority of new infections.

They found that efficacy of the two-dose vaccines from Pfizer/BioNTech and Moderna for preventing any coronavirus infection - mild or severe - dropped from 74.7% to 53.1%. Effectiveness estimates were similar for the Pfizer-BioNTech and Moderna vaccines, they said.

President Joe Biden's administration will require nursing home staff to be vaccinated against COVID-19 as a condition of participating in the Medicare and Medicaid government healthcare programs, the White House said on Wednesday.

The new study's findings https://bit.ly/3mebUYT were cited by federal health officials on Wednesday in their announcement that COVID-19 booster shots would be made widely available https://www.reuters.com/world/us/us-start-offering-covid-19-vacc ine-booster-doses-september-2021-08-18 to Americans beginning on Sept. 20, with protection from initial vaccination waning over time.

The first groups to receive those boosters will include nursing home residents and other elderly Americans, as well as people with weak immune systems.

"Because the Delta variant became prominent in the United States within six months after the initial vaccine rollout to nursing home residents, we could not determine if the lower vaccine effectiveness seen in June-July in this study was due to potential waning immunity, reduced protection against the Delta variant, or a combination of both factors," CDC epidemiologist Dr. Srinivas Nanduri said.

In a second study https://bit.ly/3AS7Cub, New York State Department of Health officials found that by late July, 65% of New York adults had been fully vaccinated with two doses of the Pfizer/BioNTech or Moderna shots or one dose of the Johnson & Johnson shot.

Between early May and late July, the vaccines' effectiveness for preventing new infections dropped from 91.7% to 79.8%, the study found. Vaccine efficacy at preventing hospitalization held steady, ranging from 91.9% to 95.3%, it found.

The effectiveness of the two-dose vaccines against hospitalization lasts at least six months, according to a separate study https://bit.ly/2Wa8kEm by researchers in 18 U.S. states who reviewed data from 3,089 hospitalized patients, including 1,194 with COVID-19.

Vaccine efficacy against COVID-19-associated hospitalization was 86% between two and 12 weeks from receipt of the second vaccine dose, they found. It was 84% between 13 and 24 weeks, with no significant change between these periods, they found. Over the full six months, they found, it was 90% among adults without immunocompromising conditions.

https://finance.yahoo.com/news/1-drop-covid-19-vaccine-204417662.html