Category: Covid-19 Vaccine

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Significance of Vaccination in Mitigating COVID-19 Severity in Young People – Medriva

January 9, 2024

Significance of Vaccination in Mitigating COVID-19 Severity in Young People

A recent study has underscored the importance of COVID-19 vaccination in reducing the severity of the disease in children and teens. The research found that those who received the vaccine demonstrated high protection against moderate and severe COVID-19 cases throughout the duration of the pandemic. This proves the efficacy of the vaccines in curbing not only the spread but also the severity of the disease among the younger population.

Notably, the research also revealed a reduced risk of cardiac complications in the vaccinated group, particularly in the context of the Omicron variant. This is a crucial finding that further underscores the benefits of vaccination, as it suggests that vaccines can help to prevent potential heart issues that could arise as a result of a COVID-19 infection.

Many parents and guardians have questions and concerns about the impacts of the COVID-19 vaccine on their children. However, health experts emphasize the necessity of vaccination in young children to prevent severe disease. The COVID-19 vaccines currently available in the U.S. have undergone rigorous testing and have been found to be safe and effective for use in children.

While vaccination significantly reduces the risk of severe disease, some children may be more prone to severe COVID-19 infection due to certain risk factors. A study in Germany identified obesity, Trisomy 21, being between five and 11 years of age, neurological neuromuscular diseases, and coinfections as factors that increased the risk of severe infection in children and adolescents. The study noted a decrease in hospitalization and ICU admission rates during the Omicron variant circulation, which was attributed to reduced virulence and higher vaccination coverage.

Despite the increased transmissibility of newer variants such as the JN1, infections have generally been causing less severe disease than earlier in the pandemic. However, the threat of long COVID remains significant, with some recovering patients experiencing persistent symptoms months after their initial infection. This further emphasizes the importance of vaccination to guard against severe disease and potential long-term health complications.

In the United States, the National Vaccine Injury Compensation Program (VICP) provides liability protections to vaccine manufacturers and administrators under the National Childhood Vaccine Injury Act of 1986. However, COVID-19 vaccines are covered under the Countermeasures Injury Compensation Program (CICP), not the VICP. The CICP provides benefits to individuals who sustain a covered serious physical injury as a direct result of the administration or use of covered countermeasures.

In conclusion, with the available data, it is clear that vaccination plays a pivotal role in mitigating the impact of COVID-19, especially in children and teenagers. It not only aids in reducing the severity of the disease but also lowers the risk of cardiac complications. Hence, vaccination should be considered a crucial part of the global strategy against COVID-19.

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Significance of Vaccination in Mitigating COVID-19 Severity in Young People - Medriva

Effectiveness of COVID-19 Vaccines for Young People: Study Details & Significance – Medriva

January 9, 2024

Unveiling the Effectiveness of COVID-19 Vaccines for Young People

As the world continues to grapple with the ongoing pandemic, the role of COVID-19 vaccines in safeguarding our children and adolescents has been a topic of much discussion and study. A real-world study spearheaded by researchers from the Perelman School of Medicine at the University of Pennsylvania and Childrens Hospital of Philadelphia has shed significant light on this crucial issue. The study, which examined the effects of the COVID-19 vaccines on children and adolescents, found that these vaccines provide significant protection against the illness and do not increase the risk of cardiac complications in these young recipients.

The study spanned the periods when the delta and omicron variants were dominant and encompassed a sample of 250,000 patients, about half of whom had received at least one dose of the BNT162b2 vaccine. The results were rather encouraging. Vaccinated young people were found to be 98% less likely to contract the delta variant and 86% less likely to be infected with the omicron variant. Furthermore, there was no indication of increased cardiac risks during either variant phase, countering some of the concerns raised about potential cardiac complications from the vaccines.

While the vaccines effectiveness did decline slightly against the omicron variant, it still offered substantial protection. Even amidst the rise of the omicron variant, vaccinated individuals maintained a lower risk of cardiac complications. This highlights the vaccines continued relevance and necessity, despite the emergence of new variants.

The study underlines the critical role that vaccinating children and adolescents plays in controlling the viruss spread and safeguarding public health. Besides providing direct protection to the vaccinated individuals, it also contributes to building the community-wide immunity necessary to curb the pandemic.

The researchers are not stopping here. They are carrying out additional work to assess the direct and indirect impacts of vaccination on outcomes tied to long COVID, a condition where COVID-19 symptoms persist for weeks or even months after the acute illness has resolved. Also, they believe that further research is necessary to understand how well the vaccines continue to protect their recipients, especially considering the newer variants. As our knowledge about the virus and its variants continues to evolve, so will our strategies to combat it. Vaccination remains a potent tool in our arsenal, and studies like this underscore its effectiveness and importance in our fight against this global health crisis.

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Effectiveness of COVID-19 Vaccines for Young People: Study Details & Significance - Medriva

Why fears over a tripledemic are surging – The Hill

January 9, 2024

Cases of three major respiratory viruses — the flu, COVID-19 and RSV — are surging in the U.S., pushing the country toward a feared “tripledemic” during its first post-pandemic respiratory viral season. 

Optimism was high this autumn as the U.S. headed into the viral season. The national arsenal against these viruses had vaccines against RSV for the first time, newly updated COVID-19 vaccines, and the flu “immunity debt” that plagued children in 2022 was history.

But now, confidence is waning. Accessing the vaccine for RSV, or respiratory syncytial virus, has been a struggle for many, and enthusiasm for the new COVID-19 vaccines turned out to be abysmal. COVID-19 hospital admissions have been rising since November and wastewater detection indicates most sites — 69 percent — are seeing large increases in virus levels. 

Flu activity across the country is currently “elevated and continues to increase in most parts of the country,” according to the latest update from the Centers for Disease Control and Prevention (CDC). And vaccine uptake for the flu seems to be lagging, with the CDC saying nearly 8 million fewer people got the shot by mid-December compared to the same period in 2022. 

During the first couple of years of the pandemic, flu activity remained low, attributed to the precautionary measures that communities took to mitigate the viral spread of COVID. The 2022-23 flu season appeared to mark a return to normal flu levels.

Only about a fifth of U.S. adults say they’ve received the newest COVID-19 shot, according to polling from KFF. Uptake for the previous bivalent shots was similarly low and many Americans likely haven’t been immunized since receiving their first doses in 2020 or 2021. 

“We’re definitely seeing an increase in the number of flu cases, COVID-19. They’re both surging right now,” said Luis Ostrosky, chief of infectious diseases and epidemiology with UTHealth Houston and Memorial Hermann. 

Speaking on the RSV cases he’s seen in the Houston area, Ostrosky said infections appeared to surge earlier in December, though he is still seeing a “steady” number. 

“This is so alarming that it prompted CDC to send out a health alert towards the end of December reminding all clinicians to really work on getting patients vaccinated and, when they have symptoms, tested so that they can access therapy if they need it,” Ostrosky noted. 

Available RSV data from the CDC does seem to suggest test positivity peaked toward the end of November, with the positivity rates for antigen and PCR tests just beginning to drop in recent weeks. 

Hopes were high that the approval of two RSV vaccines for seniors and a preventive monoclonal antibody for infants would help keep cases low this season. 

But Sanofi, the maker of the monoclonal antibody Beyfortus, said in October that “unprecedented demand” had led to short supply, leading the CDC to advise doctors to reserve doses for their highest-risk patients. 

And RSV vaccine uptake among seniors appears rather lackluster, with CDC data suggesting only about 10 percent of nursing home residents had gotten immunized against the virus by mid-December. 

“The numbers are not looking good,” said Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials, of the three circulating viruses. 

“I think when we get some new numbers for the last week, it’s going to be sort of continued trends in the same direction and increased activity across all of those conditions,” added Plescia. 

A holiday “bump” in cases is to be expected following weeks of year-end travel. AAA estimated in December that more than 115 million people in the U.S. would be traveling 50 miles or more from home during the festivities. 

Amid all the travel, Plescia lamented that social norms which he hoped became commonplace following the pandemic appeared to have been largely abandoned. 

“I think we’re kind of going back to, you know, the old approach of people don’t stay home when they’re sick,” said Plescia. “And they think it’s sort of a minor thing and the thought that they might infect somebody else just doesn’t really occur to them.” 

Masking has also become rare once again, though Plescia noted many hospital systems are bringing back mask requirements amid the rise in respiratory viruses. These hospital-enacted requirements may be more easily accepted by communities than those issued by the government, and Plescia expects to see more like them in the future. 

While cases are rising, Plescia said his organization hasn’t yet heard of any health systems around the country being unduly stressed by the respiratory viral situation. 

“That is sort of the first concern with some kind of ‘tripledemic’ is that we would have so many people getting sick that hospitals would become overwhelmed either because they didn’t have enough beds or they didn’t have enough staff to care for that number of people. We’re not hearing that we’re approaching that, but that is the thing that we’re most concerned about,” he said.

Ostrosky is optimistic case rates will begin to go down soon after a potential holiday bump, with past winter peaks indicating a drop sometime in early January. He emphasized it is still worthwhile to get tested if you experience symptoms because there is now a plethora of therapeutics available for treating these infections. 

Going forward, Plescia also recommended that more focus be placed on vaccinations among health care workers. 

“That’s important not just because we don’t want health care workers to get sick and give it to their patients but also, you know, when you have a lot of health care workers getting sick, this whole capacity thing becomes problematic,” Plescia said.

“Because what we’re hearing now is that hospitals are less concerned about not having enough beds. They’re more concerned about having enough health care workers to staff those beds.” 

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Why fears over a tripledemic are surging - The Hill

Updated COVID vaccine 71% effective against hospitalization for older adults – University of Minnesota Twin Cities

January 7, 2024

The Cystic Fibrosis (CF) Foundation announced today that it's investing up to $5 million in Ohio-based Clarametyx Biosciences to develop a drug that could help CF patients clear difficult-to-treat bacterial infections.

The money will support development of CMTX-101, a monoclonal antibody that has shown the ability to disrupt biofilm formation across several species of bacteria, including the species that tend to cause chronic infection in CF patients, such as Pseudomonas aeruginosa, Burkholderia cepacia, and nontuberculosis mycobacteria.

CF patients with chronic P aeruginosa infections are currently being enrolled in a phase 1b/2a clinical trial that will investigate the safety and tolerability of CTXM-101 in combination with inhaled tobramycin.

Because of the mucus that builds up in their lungs, CF patients are prone to bacterial infections that can exacerbate their condition. Most of those infections involve bacteria that form biofilmscommunities of microbes that can grow on human tissue, medical devices, and prosthetic joints and form a protective layer around the bacteria, shielding them from the immune system and antibiotics.

CTXM-101 is designed to collapse biofilms by targeting a region of proteins that help stabilize and maintain biofilm integrity. Without the protection of the biofilm, the bacteria causing the infection become more susceptible to antibiotics. CF Foundation officials say the approach may also reduce the inflammation that results from chronic infections in CF patients.

"We hope that this potential therapy will ultimately help people with CF clear many different types of difficult-to-treat infections," JP Clancy, MD, senior vice president of clinical research at the Cystic Fibrosis Foundation, said in a press release. "This could provide a crucial new tool that could be used alongside traditional antibiotics in the fight against antimicrobial resistance."

CTXM-101 is among the antibacterial candidates that have received pre-clinical funding from CARB-X (the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator).

This could provide a crucial new tool that could be used alongside traditional antibiotics in the fight against antimicrobial resistance.

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Updated COVID vaccine 71% effective against hospitalization for older adults - University of Minnesota Twin Cities

COVID-19 vaccine hesitancy: assessing the prevalence, predictors, and effectiveness of a community pharmacy based … – BMC Public Health

January 7, 2024

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COVID-19 vaccine hesitancy: assessing the prevalence, predictors, and effectiveness of a community pharmacy based ... - BMC Public Health

Man Finds Out Not to Compare COVID Shots to Holocaust – Newser

January 7, 2024

A German man has been hit with a $3,300 fine after expressing some unconventional views on COVID-19 vaccines. Deutsche Welle reports that the unnamed vocational-college teacher, a 62-year-old from Berlin, heard his financial fate on Thursday from the Tiergarten Local Court, where a presiding judge slammed him for comparing coronavirus vaccinations to the Holocaust. The man had posted footage online that showed the Nazi slogan "Arbeit macht frei" ("work sets you free"), often found posted at World War II concentration campsexcept he'd altered it to sarcastically read "Vaccination sets you free."

In a second video, he attacked his home country's government for its COVID mitigation measures, also comparing them to the Holocaust. Deutsche Welle notes it's illegal in Germany to deny the Holocaust, in which about 6 million Jewish people died, or to minimize it or spread Nazi propaganda. The man's actions were "a trivialization," the presiding judge said Thursday before handing down the consequences. "Any other interpretation is far-fetched."

The teacher had hauled his case before a labor court after he was let go from his job in August 2021. That court decided the city of Berlin no longer had to employ him, though he was awarded a severance payout of nearly $80,000. (We've had similar instances of comparing vaccines, vaccine mandates, and COVID restrictions to the Holocaust or Nazi Germany here in the States.)

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Man Finds Out Not to Compare COVID Shots to Holocaust - Newser

Flu and COVID Cases Are Surging: How to Protect Yourself – Yale Medicine

January 7, 2024

Flu is a common illness during the winter. But it can be severe, especially in children younger than age 5 and adults ages 65 and older, pregnant women, and those with compromised immune systems and chronic conditions, such as diabetes or asthma. It attacks the respiratory system, causing fever, body aches, cough, headache, and sore throat.

How to prevent the flu: Get the annual flu shot, which is available to everyone ages 6 months and older. Although the CDC recommends getting the shot by the end of October for peak protection, it is given throughout the season, which usually peaks between December and February, and can extend until May.

Most people ages 6 months and older need only one dose of the flu vaccine; however, some children, ages 6 months through 8 years, may require two doses for the best protection.

Some people will still get the flu after getting the vaccine, Dr. Gleeson says. But data suggests that if you do, the vaccine decreases the risk of severe disease and hospitalization. You might feel bad, but not as dramatically ill as you would have been if you didn't get the vaccine.

This year, special measures for flu vaccination are no longer recommended for people with egg allergies, regardless of the severity of a previous reaction to egg. This is based on studies that show those severe allergic reactions are rare, according to the CDC, which also recommends all vaccines be given in settings where allergic reactions can be recognized and treated quickly. People with allergies to other vaccine ingredients should talk to their providers.

If you get the flu: The CDC recommends staying home for at least 24 hours after your fever is gone. The fever should go away on its own without over-the-counter medication, according to the CDC. Also, children and teenagers should not take aspirin or products that contain salicylate to treat flu symptoms, since that ingredient can cause a rare condition called Reyes syndrome in people 18 and younger.

You can talk to your doctor about getting a prescription for an antiviral drug, such as Tamiflu, especially if you are 65 or older, pregnant, or have a medical condition such as asthma or heart disease. Children can take these medications as well. Antiviral drugs, including pills, inhaled powders, and solutions delivered intravenously, fight the flu virus in your body, and they work best when you start taking them early, one or two days after symptoms start. Antivirals can help reduce symptoms, shorten your illness by one or two days, and prevent pneumonia and other serious complications, including death.

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Flu and COVID Cases Are Surging: How to Protect Yourself - Yale Medicine

Readout of HHS Secretary Becerra’s Meeting with Long-Term Care Facility Leaders – HHS.gov

January 7, 2024

Secretary Becerra reminded leaders of their obligations to offer and educate residents and staff on vaccines in order to increase low COVID-19 vaccination rate among nursing home residents and staff

On Wednesday, January 3, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra met virtually with long-term care facility (LTCF) leaders to express concerns about low vaccination rates among nursing home residents and remind industry leaders of their obligations to offer the COVID-19 vaccine to residents and staff.

Todays conversation was a follow-up call from a previous HHS virtual meeting on December 21 with LTCF leaders to discuss the Centers for Disease Control and Preventions (CDC) December 2023 report finding that just 33% of long-term care facility residents were up to date with their COVID-19 vaccinations. The Centers for Medicare & Medicaid Services (CMS) requires all nursing homes to offer COVID-19 vaccines to residents and staff and educate them on their benefits.

During the call, Secretary Becerra expressed his appreciation to long-term care providers for understanding the urgency of this issue and requested that member facilities share their best practices with HHS and any information that they could as to why residents or their guardians may be declining COVID-19 vaccinations this season. Secretary Becerra underscored that older Americans who are not vaccinated face greater risk of serious illness. He also stressed that it is imperative that these leaders do their part by offering vaccinations and education on vaccine protections. Secretary Becerra also reiterated that HHS would continue to work with leaders on this issue.

The Biden-Harris Administration has made historic progress in our nations ability to manage COVID-19 so that it no longer meaningfully disrupts the way we live our lives. For the first time, vaccines are available to protect older adults in the United States against all three winter respiratory illnesses: COVID-19, flu, and RSV.

HHS continues to work closely with the CDC and other federal, state, and local partners to ensure that all providers are encouraging uptake amongst their populations particularly amongst older Americans who are not vaccinated and at greater risk of serious illness. HHS has supported vaccination efforts in long-term health care facilities through:

The following representatives participated in the meeting:

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Readout of HHS Secretary Becerra's Meeting with Long-Term Care Facility Leaders - HHS.gov

COVID-19 intensifies across California, with the worst likely still to come – Los Angeles Times

January 7, 2024

The winter COVID-and-flu season is ramping up in California and nationwide, with doctors and other experts saying the worst of the respiratory illness season is still to come.

New data show pronounced recent jumps in the rate at which coronavirus and flu tests are coming back positive, as well as the number of hospital-admitted patients testing positive for the viruses. Workplaces are also seeing higher numbers of employees call in sick due to infections.

National wastewater data suggest this winter could see the highest number of coronavirus infections occurring during any given week since the first Omicron wave began in fall 2021.

And were probably not quite to the zenith of it yet, said Dr. Elizabeth Hudson, regional chief of infectious diseases at Kaiser Permanente Southern California. Looking at some of the data that we can extrapolate out from the wastewater, by the time we get to about Jan. 10 or so, were probably going to be seeing, within the U.S., about 2 million cases a day.

The good news is the number of people becoming seriously ill remains lower than last year, when hospitals were deluged by a tripledemic of COVID, flu and respiratory syncytial virus, or RSV.

The peak of the 202122 Omicron wave crested at about 5 million cases a day, according to Hudson.

This winter, by contrast, there are far fewer critically ill COVID-19 patients requiring intensive hospital care, even though plenty of people are sick.

Flu is also making its presence felt in a major way.

Theres just this dramatic rise in influenza, said Dr. Caroline Goldzweig, chief medical officer of the Cedars-Sinai Medical Network.

In terms of the demand for outpatient care, Were definitely seeing a huge amount, said Dr. Chris Hiromura, associate program director for the family medicine residency at Adventist Health White Memorial hospital in Boyle Heights.

Theres definitely a huge spike in the outpatient COVID numbers, and just general viral illnesses, he said, as well as a more modest uptick in respiratory illnesses severe enough to require hospitalization.

The rates at which tests for the coronavirus and flu are coming back positive have been rising over the last month in Los Angeles County. For the week that ended Dec. 30, 18% of tests at county surveillance labs were coming back positive for flu, up from 10% a month earlier. As for the coronavirus, 13.5% were coming back positive, up from 9.9% a month earlier.

Our emergency department is very busy, as well as our inpatient units, said Dr. Graham Tse, chief medical officer for MemorialCare Miller Childrens & Womens Hospital Long Beach. Its a mixture of the three viruses influenza, COVID and RSV but theres also many other respiratory viruses that were also seeing that are always more prevalent during the winter.

Nationally, there were 34,798 new coronavirus-positive hospital admissions for the week that ended Dec. 30, a 20% jump over the prior week and the highest one-week total in nearly a year. Last winter peaked at 44,542 new hospital admissions for the week ending Dec. 31, 2022.

California recorded 3,516 new coronavirus-positive hospital admissions for the week that ended Dec. 30, a 7% increase from the previous week, according to the U.S. Centers for Disease Control and Prevention. The states peak last winter was 5,260 new hospital admissions for the final week of 2022.

Since Oct. 1, the CDC has reported an average of about 1,400 COVID-19 deaths a week nationally. Over the same time period last year, there were about 2,400 weekly COVID-19 deaths.

Seven California counties Friday joined the CDCs medium level of coronavirus-positive hospitalizations from the low level: Orange County; Alameda and Contra Costa counties in the Bay Area; and in the Central Valley and Sierra, Stanislaus, Merced, Tuolumne and Mariposa counties. Los Angeles County and the four-county Sacramento area were already in the medium level.

A more contagious subvariant may be aiding the spread of COVID-19. Nationally, the subvariant JN.1 was estimated to account for 62% of coronavirus specimens for the two-week period that ended Saturday; it accounted for 39% of specimens for the prior comparable period.

Last winters viral tripledemic taxed hospitals, with the burden of RSV weighing particularly heavily on pediatric facilities. Though there are a lot of cases of RSV this winter, Hudson said, its not quite as severe as it was last winter.

In general, whats different this year is this really does seem to be something that is impacting adults a lot more particularly those who are over the age of 65, Hudson said.

Even if someones bout with COVID is relatively mild, it poses a risk of exacerbating underlying health problems. For instance, a person with a lung disease like emphysema who comes down with COVID-19 may need hospitalization to get additional oxygen, Hudson said.

Flu is also putting many patients out of commission.

We are definitely seeing a pretty big uptick in flu ... mostly on the outpatient side, Hudson said. But, you know, flu is pretty miserable. If youve never had it, I always describe it as being hit by a Mack truck, because its the only way that you can really understand how crummy you can actually feel with it.

Flu has also forced concert cancellations in recent months, waylaying performances by Christina Aguilera and the rock band KISS.

One complication Hudson has noticed in recent months is that people might have COVID-19, but its taking longer for rapid tests to return a positive result. It used to be that someone might test positive for the coronavirus one or two days after the onset of symptoms using a rapid test, Hudson said. Now, positive results might not show up until perhaps the fourth day after symptoms start.

People who initially test negative for COVID-19 despite having symptoms and dont retest later could be getting a false sense of security that they dont have COVID when they actually do, and are contagious, Hudson said.

The delay in accurate test results is probably a result of people having accumulated immunity from COVID-19 over the years, whether from vaccination or previous infection, that is prolonging the testing window, according to Hudson.

Its important that people take steps to limit their risk of getting or developing severe complications from COVID-19, flu or other viral illnesses, doctors say. Those include getting a fresh COVID-19 and flu vaccine this winter, which many people have not yet done. For babies, pregnant people and older adults, an RSV immunization is also available.

People who are diligent and get the updated vaccinations as they come out, theyre just going to be less likely to have severe disease, Goldzweig said.

Its important to realize that COVID-19, despite being less deadly than the pandemics more harrowing phases, is no mere common cold virus.

We still see people getting long COVID even if theyve had COVID before, even if theyve been vaccinated, Goldzweig said.

Even people who are younger face about a 20% increased risk of heart attacks and stroke within six months of a COVID illness, which for people who are in their 30s and 40s is a pretty big increase, Hudson added. So while for some COVID infections might feel like a regular cold, it can potentially have longer-lasting impacts that were only really starting to understand.

Its not about living in fear. Its just about understanding that there are more risks to this than just a run-of-the-mill sore throat, Hudson said.

The latest wave has also continued to infect the diminishing number of people who had never had COVID-19 previously, including Dr. Eric Topol, director of the Scripps Research Translational Institute in La Jolla.

Topol, who got it last month, has remained careful about trying to avoid the coronavirus, but was infected after a colleague with whom he shares an office came down with COVID-19. That colleague was similarly cautious, so neither wore masks while sharing their office, Topol said. The colleague doesnt know how he was infected.

Its picking off a lot of new hosts right now, Topol said.

In an op-ed published in The Times, Topol wrote that the coronavirus, with its ongoing ability to accumulate mutations, has proved to be highly resilient and has not been transformed to common cold status.

To truly get back to normal will require new oral, inhaled vaccines that can achieve high levels of mucosal immunity and protection against infections, which would be variant-proof, Topol wrote. Also helpful would be improved, variant-proof shots with better protection and durability. He said these efforts are not getting the urgent priority they need to be completed this year.

Weve got to come up with a way to, as soon as possible, stop infections and transmission, Topol said in an interview. Thats what were missing now. Thats how we get to normal. Thats how we get variant-proof. And then we can rest and feel really good about it.

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COVID-19 intensifies across California, with the worst likely still to come - Los Angeles Times

Florida State Surgeon General Calls for Halt in the Use of COVID-19 mRNA Vaccines – Florida Hospital News and … – South Florida Hospital News

January 7, 2024

Tallahassee, Fla. On December 6, 2023, State Surgeon General Dr. Joseph A. Ladapo sent a letter to the United States Food and Drug Administration (FDA) Commissioner Dr. Robert M. Califf and Center for Disease Control and Prevention (CDC) Director Dr. Mandy Cohen regarding questions pertaining to the safety assessments and the discovery of billions of DNA fragments per dose of the Pfizer and Moderna COVID-19 mRNA vaccines.

The Surgeon General outlined concerns regarding nucleic acid contaminants in the approved Pfizer and Moderna COVID-19 mRNA vaccines, particularly in the presence of lipid nanoparticle complexes, and Simian Virus 40 (SV40) promoter/enhancer DNA. Lipid nanoparticles are an efficient vehicle for delivery of the mRNA in the COVID-19 vaccines into human cells and may therefore be an equally efficient vehicle for delivering contaminant DNA into human cells. The presence of SV40 promoter/enhancer DNA may also pose a unique and heightened risk of DNA integration into human cells.

In 2007, the FDA published guidance on regulatory limits for DNA vaccines in the Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications (Guidance for Industry). In this Guidance for Industry, the FDA outlines important considerations for vaccines that use novel methods of delivery regarding DNA integration, specifically:

On December 14, 2023, the FDA provided a written response providing no evidence that DNA integration assessments have been conducted to address risks outlined by the FDA themselves in 2007. Based on the FDAs recognition of unique risks posed by DNA integration, the efficacy of the COVID-19 mRNA vaccines lipid nanoparticle delivery system, and the presence of DNA fragments in these vaccines, it is essential to human health to assess the risks of contaminant DNA integration into human DNA. The FDA has provided no evidence that these risks have been assessed to ensure safety. As such, Florida State Surgeon General Dr. Joseph A. Ladapo has released the following statement:

The FDAs response does not provide data or evidence that the DNA integration assessments they recommended themselves have been performed. Instead, they pointed to genotoxicity studies which are inadequate assessments for DNA integration risk. In addition, they obfuscated the difference between the SV40 promoter/enhancer and SV40 proteins, two elements that are distinct.

DNA integration poses a unique and elevated risk to human health and to the integrity of the human genome, including the risk that DNA integrated into sperm or egg gametes could be passed onto offspring of mRNA COVID-19 vaccine recipients. If the risks of DNA integration have not been assessed for mRNA COVID-19 vaccines, these vaccines are not appropriate for use in human beings.

Providers concerned about patient health risks associated with COVID-19 should prioritize patient access to non-mRNA COVID-19 vaccines and treatment. It is my hope that, in regard to COVID-19, the FDA will one day seriously consider its regulatory responsibility to protect human health, including the integrity of the human genome.

In the spirit of transparency and scientific integrity, State Surgeon General Dr. Joseph A. Ladapo will continue to assess research surrounding these risks and provide updates to Floridians.

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Florida State Surgeon General Calls for Halt in the Use of COVID-19 mRNA Vaccines - Florida Hospital News and ... - South Florida Hospital News

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