Category: Covid-19 Vaccine

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EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU | European Medicines Agency – European Medicines Agency |

June 24, 2022

EMA has recommended granting a marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted) Valneva for use in the primary vaccination of people from 18 to 50 years of age.

COVID-19 Vaccine (inactivated, adjuvanted) Valneva contains inactivated (killed) whole particles of the original strain of SARS-CoV-2 that cannot cause disease. It is the sixth vaccine recommended in the EU for protecting against COVID-19 and, together with the vaccines already authorised, will support vaccination campaigns in EU Member States during the pandemic.

After a thorough evaluation, EMAs human medicines committee (CHMP) concluded by consensus that the data on the vaccine were robust and met the EU criteria for efficacy, safety and quality.

The main study conducted with Valnevas vaccine is an immunobridging trial. Immunobridging trials compare the immune response induced by a new vaccine with that induced by an authorised comparator vaccine proven to be effective against the disease.

Results from the study, which involvednearly 3,000 people aged 30 years and older, showed that the vaccine triggers the production of higher levels of antibodies against the original strain of SARS-CoV-2 than the comparator, Vaxzevria. In addition, the proportion of people who produced a high level of antibodies was similar for both vaccines.

Additional data from this study also showed that the vaccine is as effective at triggering the production of antibodies in people aged between 18 and 29 as it is in people aged 30 years and older.

The CHMP therefore concluded that COVID-19 Vaccine (inactivated, adjuvanted) Valneva is expected to be at least as effective as Vaxzevria at protecting against the disease. Based on the data provided, it was not possible to draw any conclusion on the immunogenicity of Valnevas vaccine (its ability to trigger the production of antibodies) in people above 50 years of age; therefore, the vaccine is currently recommended only for use in people between 18 and 50 years of age.

There are limited data on the immunogenicity of COVID-19 Vaccine (inactivated, adjuvanted) Valneva against variants of concern, including Omicron subvariants which are currently the dominant strains in many EU countries.

The side effects observed with COVID-19 Vaccine (inactivated, adjuvanted) Valneva in studies were usually mild and cleared within a couple of days after vaccination. The most common ones were tenderness or pain at the injection site, tiredness, headache, muscle pain and nausea (feeling sick) or vomiting.

The safety and effectiveness of the vaccine will continue to be monitored as the vaccine is used across the EU, through the EU pharmacovigilance system and additional studies by the company and European authorities.

Based on the available evidence, the CHMP concluded that the benefits of COVID-19 Vaccine (inactivated, adjuvanted) Valneva outweigh its risks and recommended granting a standard marketing authorisation in the EU.

The dossier for the vaccine includes the results from an immunobridging trial. Although efficacy placebo-controlled trials have been the gold standard for authorising COVID-19 vaccines so far, EMA considers that a well-justified and appropriately designed immunobridging study is adequate for authorising future COVID-19 vaccines at this point in the pandemic. This is because there are now a number of COVID-19 vaccines authorised in the EU that are proven to be safe and effective and that can be used as comparators in studies. Additionally, at present, it would be difficult to recruit enough individuals who have not been vaccinated nor previously exposed to the virus to conduct large efficacy clinical trials.

The European Commission will now fast-track the decision-making process to grant a decision on the standard marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted) Valneva, allowing this vaccine to be included in vaccination programmes rolled out across the EU. A standard marketing authorisation is considered appropriate for this vaccine since the immunobridging study met its objectives and data provided are considered sufficient.

The product information for COVID-19 Vaccine (inactivated, adjuvanted) Valneva contains information for healthcare professionals, a package leaflet for members of the public and details of the vaccines authorisation.

An assessment report with details of EMAs evaluation of COVID-19 Vaccine (inactivated, adjuvanted) Valneva and the full risk management plan will be published shortly. Clinical trial data submitted by the company in the application for marketing authorisation will be published on the Agencys clinical data website in due course.

More information is available in an overview of the vaccine in lay language, including a description of the vaccines benefits and risks and why EMA recommended its authorisation in the EU.

COVID-19 Vaccine (inactivated, adjuvanted) Valneva works by preparing the body to defend itself against COVID-19. The vaccine contains whole particles of the original strain of SARS-CoV-2 that has been inactivated (killed) and cannot cause the disease. It also contains two adjuvants, substances that help strengthen the immune responses to the vaccine.

When a person is given the vaccine, their immune system identifies the inactivated virus as foreign and makes antibodies against it. If, later on, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognise the virus and be ready to defend the body against it.

COVID-19 Vaccine (inactivated, adjuvanted) Valneva is given as two injections, usually into the muscle of the upper arm, 28 days apart.

In line with the EUs safety monitoring plan for COVID-19 vaccines, COVID-19 Vaccine (inactivated, adjuvanted) Valneva will be closely monitored and subject to several activities that apply specifically to COVID-19 vaccines. Although large numbers of people have received COVID-19 vaccines in clinical trials, certain side effects may only emerge when millions of people are vaccinated.

The company is required to provide monthly safety reports in addition to the regular updates required by legislation. In addition, independent studiesof COVID-19 vaccines coordinated by EU authorities will give more information on the vaccines long-term safety and benefits in the general population.

These measures will allow regulators to swiftly assess data emerging from a range of different sources and take any necessary regulatory action to protect public health.

During the assessment of COVID-19 Vaccine (inactivated, adjuvanted) Valneva, the CHMPhad the support of EMAs safety committee, the PRAC, who assessed therisk management plan of the vaccine, and the COVID-19 EMA pandemic task force (COVID-ETF), a group that brings together experts from across the European medicines regulatory network to facilitate rapid and coordinated regulatory action on medicines and vaccines for COVID-19.

COVID-19 Vaccine (inactivated, adjuvanted) Valneva was evaluated as part of OPEN, an initiative started in December 2020 with the aim of increasing international collaboration in the EU review of COVID-19 vaccines and therapeutics. More information can be found on the EMAs governance during COVID-19 pandemic webpage.

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EMA recommends Valneva's COVID-19 vaccine for authorisation in the EU | European Medicines Agency - European Medicines Agency |

Former employees suing Mayo Clinic over COVID-19 vaccine mandate terminations – Star Tribune

June 24, 2022

More than two dozen former employees have brought lawsuits against Mayo Clinic and related entities alleging they were wrongly terminated after the clinic did not grant them religious exemptions to a policy mandating COVID-19 vaccination.

Nine lawsuits against Mayo, listing a total of 27 plaintiffs, have been filed in the U.S. District Court of Minnesota during May and June.

Former workers say the clinic failed to undertake an individual and interactive process for evaluating their requests for religious exemptions.

The clinic "put itself in the position of deciding the sincerity of the religious belief of the plaintiffs and whether a belief was 'religious' or not," says the first of the lawsuits, which was filed by Sherry Ihde, a supervisor in the bacteriology lab who worked at Mayo for 23 years.

"Defendant Mayo did not provide information about its process for determining whether the employees' sincerely held religious beliefs would be accommodated," her lawsuit states.

Mayo says it disputes many of the allegations in the lawsuits and will defend its vaccine program implementation.

"Mayo Clinic recognizes that some employees have deeply held religious beliefs that led them to seek exemption from COVID-19 vaccination," the clinic says. "In compliance with established laws, Mayo offered its employees the option to request a religious accommodation. The majority of religious exemption requests were granted."

In January, the clinic said that about 700 workers were losing their jobs for failing to comply with its policy, which called on employees to either receive their first shots or obtain an exemption for medical or religious reasons.

The clinic introduced its policy in 2021, saying it was necessary to provide the safest possible environment at Mayo, which treats patients who come from around the world for complex care.

Some plaintiffs, however, argued that they either worked remotely, didn't work directly with patients or had shown they could provide care safely without being vaccinated.

A few months after the workers were terminated, plaintiffs say Mayo reversed a testing requirement within its vaccine mandate policy a move the former employees argue shows their terminations were either unnecessary or a pretext. Some plaintiffs say the clinic granted religious exemptions to younger and lesser-paid employees.

In a statement, Mayo said its vaccination program remains in effect.

The lawsuits bring claims under religious discrimination statutes, the Americans with Disabilities Act and the Minnesota Human Rights Act. Plaintiffs say they've suffered economic and other damages, including financial losses that exceed $75,000 each.

"There are 90 more [plaintiffs] that are going to be filed for a total of approximately 120 wrongful terminations," Gregory Erickson, the lead attorney on the lawsuits, said in an email. Some cases are being brought against Olmsted Medical Center in Rochester, said Erickson, a lawyer with the Minneapolis-based firm Mohrman, Kaardal & Erickson.

In the lawsuits against Mayo, most plaintiffs are Minnesota residents, although a few live in Arizona and Wisconsin two other states where the Rochester-based clinic operates. Terminations primarily involved employees who didn't get vaccinated, although Erickson estimated that about 15% received religious exemptions to the vaccine but not from a requirement that they undergo routine testing.

One such former employee CT technologist Kristin Rubin, who worked at the clinic for more than 25 years questioned the fairness of testing only unvaccinated workers.

"Mayo's vaccinated employees were contracting and transmitting the omicron and delta variants at substantially similar rates to their unvaccinated employees and were not required to submit to weekly testing," she said in her lawsuit.

Mayo said it would not comment further on pending litigation. In general, the clinic said it implemented a required COVID-19 vaccination program in order to prioritize patient care needs.

"Based on science and data, COVID-19 vaccinations prevent hospitalizations and save lives among those who become infected with COVID-19," the clinic said in a statement. "That's true for everyone in our communities and it's especially true for the many patients with serious or complex diseases who seek care at Mayo Clinic each day."

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Former employees suing Mayo Clinic over COVID-19 vaccine mandate terminations - Star Tribune

Video misrepresents study on COVID-19 vaccines and male fertility – The Associated Press – en Espaol

June 24, 2022

CLAIM: A new study shows that a second dose of a COVID-19 vaccine decreases sperm count and after a third shot its almost unrecoverable.

APS ASSESSMENT: Partly false. A new Israeli study did report a reduction in sperm count about three months after a second dose of Pfizers vaccine but the effect was temporary and disappeared in subsequent samples. Experts say this is likely due to a fever, which can follow vaccination or infection and temporarily affect sperm production. The Israeli study did not examine the effects of a third dose.

THE FACTS: In a widely viewed video shared on Instagram this week, one man claims that sperm count in men is declining at a rapid rate and its all because of the vaccine.

New studies have shown that after the second shot theres a 22% decrease in sperm count and after the third shot, after the third booster, its almost unrecoverable, he continues. Almost half a billion men have been vaccinated. Now what is going to happen with society?

A recent Israeli study in the journal Andrology did find that there was a temporary reduction in sperm count of about 22% among samples from donors three months after the second dose of Pfizers vaccine.

But an author of the study told The Associated Press the findings were not cause for alarm, and are typical of whats seen with a fever.

The observation we saw, which is characterized by window of impairment 3 months after vaccination, is very similar to previously reported sperm decline after common febrile diseases (such as flu), Dr. Itai Gat, of the Shamir Medical Center in Israel, said in an email.

The researchers found at six months that the reduction disappeared, Gat said. We came to the conclusion that impairment is temporary and long term outcome remains good.

In a 2021 statement on the COVID-19 vaccines, two organizations focused on male reproduction also noted that fevers in general including from COVID-19 infection or vaccination can temporarily affect sperm production.

Fevers can cause temporary declines in sperm production, reads the statement from the Society for Male Reproduction and Urology and the Society for the Study of Male Reproduction. Thus, if a man experiences fever as the result of the COVID-19 vaccine, he may experience a temporary decline in sperm production, but that would be similar to or less than if the individual experienced fever from developing COVID-19 or for other reasons.

Dr. Ranjith Ramasamy, director of male reproductive medicine and surgery at the University of Miamis health system, who has separately researched the issue, told the AP the Israeli study was small but added interesting information to the field.

It would be among the first to demonstrate that COVID-19 vaccines (specifically Pfizer) could lead to a decrease in sperm parameters in the short-term, Ramasamy said in an email.

Importantly, the authors note that unlike the actual SARS-CoV-2 virus that can cross the blood-testis barrier and impact the local testicular environment these temporary decreases described in this study are most likely attributed to the fever some people experience with vaccination, Ramasamy said.

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This is part of APs effort to address widely shared misinformation, including work with outside companies and organizations to add factual context to misleading content that is circulating online. Learn more about fact-checking at AP.

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Video misrepresents study on COVID-19 vaccines and male fertility - The Associated Press - en Espaol

Independent Inquiry Hears From Doctors, Professors on COVID-19 Vaccine Injuries – The Epoch Times

June 24, 2022

TORONTOSeveral experts spoke about COVID-19 vaccine injuries at a citizens-based independent inquiry looking into Canadas pandemic response and giving a platform to those adversely harmed by COVID-19 mandates to share their stories.

The Citizens Hearingentered its second day on June 23, featuring doctors, professors, and other experts who presented data and evidence showing the deficiencies of the governments COVID-19 vaccine mandates. The three-day inquiry, which winds up on June 24, is being co-hosted by the Canadian COVID Care Alliance.

One speaker was Dr. Patrick Phillips, a family doctor who primarily practised in Englehart, Ontario. He told the panelists that he noticed some pretty major issues with Canadas COVID-19 vaccination system when he saw some patients reporting to the emergency department with new or worsening symptoms after getting their shots.

But after reporting the initial five cases to the provinces public health officials, Phillips said he was told in a letter from the officials that none of the cases could be categorized as being adversely affected by the vaccines.

I was quite surprised at this. Id understand if one or two were rejected, but all of them essentiallywere rejected, he said.

Phillips said a document from the public health agency says an adverse event is only counted as a vaccine injury when it occurs within 30 minutes after the injection. He noted that there were even stricter criteria for adverse events to be reported to Health Canada.

Phillips later publicized the letter, believing that people should know such adverse events are not being reported. But this and a series of events that followed eventually led to his licence being suspended in May by Ontarios regulatory college for medical doctors. He was also prohibited fromprescribing ivermectinan anti-parasitic agent thatHealth Canada saysshould not be used to treat COVID-19though some experts have recommended using it for the early treatment of the disease.

Canadas Chief Public Health Office Dr. Theresa Tam said last week that because vaccine efficiency wanes significantly over time, she recommends health officials urge Canadians to keep their vaccinations up to date rather than focusing on the specific number of doses.

However, Dr. Eric Payne, a pediatric neurologist from Alberta, told the panelists that the provinces public health data shows that people who received two doses of the vaccine were more likely to be infected with the Omicron variant compared to those who just got one shot; starting in late March, people who got three shots became the most likely group to be infected. Similarly, those fully vaccinated in Ontario were the majority group to contract the virus from mid-December 2021 to January 2022.

What you hear all the time now is: Thank goodness I got vaccinated. I got COVID, my whole family got COVID, but I didnt end up in the hospital,' Payne said. The reality is, if you are 60 and healthy, youre notobese, and you dont have type 2 diabetes, your risk of getting COVID and being hospitalized for it is less than 1 percent.

Everybody is saying Thank goodness I got vaccinated and not in the hospitalit is faulty logic. You had a 99 percent chance of not ending up in the hospital before the vaccine.

However, Payne said there were no platforms for people like him, who object the official discourse, to share data and evidence.

There is no public debate thats allowed to take place, he said, adding that the problemright now is that the mainstream media are perpetuating a false narrative.

Preston Manning, a former Conservative MP and panelist at the hearing, told The Epoch Times that after listening to the testimonies, he found it most disturbing that the government refuses to listen to experts who hold contrary views of its pandemic response policies.

The most disturbing thing is when you ask them: Have you presented this [information] to the government? Have you presented this to the health officials? And if so, what response have you got? Almost everyone says, Yes, we have made these arguments to the government, and get no reply,' Manning said.

[This] is an indication of the weakness of our democracy, not just the weakness of the health system.

He urged Canadian youths to be concerned about how the government handles the COVID-19 pandemic, as the younger generation will be most affected by the public health measures.

The most serious negative impacts of these measures are the impacts on children and the younger generation because theyve got the implications for years and for years, and if we cant satisfactorily address those kinds of impact, then were jeopardizing the future,Manning said.

Im optimistic that that can be done, but efforts have to be made to make it happen. Its not going to happen naturally.

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Andrew Chen is an Epoch Times reporter based in Toronto.

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Independent Inquiry Hears From Doctors, Professors on COVID-19 Vaccine Injuries - The Epoch Times

Biolexis and Akston Biosciences Announce Encouraging Top-Line Results from Phase II/III Trial of their Thermostable 2nd Gen COVID-19 Vaccine -…

June 24, 2022

BEVERLY, Mass. & BANGALORE, India--(BUSINESS WIRE)--Akston Biosciences Corporation and Biolexis, a Strides Group Company, today announced results from a Phase II/III clinical trial in India of the SARS-CoV-2 vaccine, AKS-452, in which 1,600 healthy volunteers participated 100 in an open-label bridging study and 1,500 in Phase II/III, double-blind, placebo-controlled trial.

An interim analysis of this data shows no significant safety issues and a 91% seroconversion rate at Day 56. Volunteers in the bridging study had antibody titers that persisted at statistically-significant high levels through six months, with serum taken from them showing protection against variants of concern. The results will be submitted as a prime vaccine in India for Emergency Use Authorization (EUA). Later clinical studies are planned to support approval for use as a booster shot to itself and other approved vaccines. Earlier studies in the Netherlands have demonstrated robust antibody neutralization of variants, including Delta and Omicron.

Akston and Strides group have already signed a licensing, manufacturing, and commercialization agreement to launch this vaccine worldwide as AmbiVax-CTM. Under the agreement, Biolexis, the vaccine and biosimilar arm of the Strides Group, has the rights to manufacture and commercialize AmbiVax-CTM in India and over 130 countries in Asia, Latin America, and Africa, mainly covering the low-and-middle-income countries (LMICs) where a significant population lacks dependable access to vaccines as a result of insufficient infrastructure to support the cold chain requirements of other COVID-19 vaccines. The vaccine is a reliable, accessible alternative in these regions, allowing immunization and longevity of immunity with the boosters against the Covid variants of concern. The partnership will leverage the capabilities of Strides Group, which has an in Africa for Africa strategy and will offer the vaccine to countries with a deep market presence and established relationships.

Arun Kumar, Founder of Strides Group, added, We are pleased to know the encouraging results from the India studies of AmbiVax-CTM, particularly the high seroconversion rate that the vaccine demonstrated. This vaccine differentiates itself by allowing room-temperature stability, higher efficacy, and safety and can offer accessibility and affordability through the economical supply chain and infrastructure requirements. As we progress to receiving the approval, we will continue exploring opportunities to fast-track its launch for the global markets.

Todd Zion, Ph.D., President & CEO of Akston Biosciences, said, The latest clinical data demonstrate the potential of this low-cost protein vaccine intended specifically for those most in need. We are very pleased to be working closely with Biolexis and Strides Group, which can supply the vaccine at scale to countries that need a practical and affordable way to protect their populations during this worldwide pandemic.

The Phase II/III trial, managed by Ahmedabad-based Veeda Clinical Research Limited, evaluated the safety, tolerability, and humoral immunogenicity profile, i.e., SP/RBD-specific IgG titers. Of the 1,500 healthy volunteers, 1,125 received the two 90 g doses 28 days apart, with the first dose including AKS-452 and an adjuvant, while the second dose consisted of only AKS-452. The remaining 375 also received two doses, with the first dose including placebo and the adjuvant, while the second dose consisted only of placebo.

AKS-452 does not include mRNA technology, viral vectors, or a weakened SARS-CoV-2 virus. It has been engineered to use established, low-cost antibody manufacturing techniques, such that a single production line could be capable of producing over one billion doses per year. Stability studies have demonstrated thermostability at room temperature for over six months at 25 Celsius (77 Fahrenheit) and maintenance of potency for one month at 37 Celsius (99 Fahrenheit).

About Akston Biosciences

Akston Biosciences Corporation leverages its novel fusion protein platform to develop and manufacture new classes of biologics, including vaccines, ultra-long-acting insulins, and autoimmune disease therapies. It was founded by the team that developed the worlds first clinical glucose-responsive insulin at SmartCells, Inc. (sold to Merck & Co.). Besides out-licensing AmbiVax-CTM to Biolexis, Akston has partnered with Dechra Pharmaceuticals PLC (DPH) to commercialize once-a-week canine and feline insulin therapies. It operates a GMP biologics manufacturing cleanroom facility and research laboratory at its Beverly, Mass. location. Additional information is available at http://www.akstonbio.com.

About Strides

Strides, a global pharmaceutical company headquartered in Bengaluru, India, is listed on the BSE (532531) and National Stock Exchange of India Limited (STAR). The Company mainly operates in the regulated markets, has an in Africa for Africa strategy, and an institutional business to service donor-funded needs. The Companys global manufacturing sites are located in India (Chennai, Puducherry, and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi), and the United States (New York). The Company focuses on difficult to manufacture products sold in over 100 countries. Additional information is available at http://www.strides.com.

About Stelis

Stelis Biopharma Limited (Stelis) is an emerging global biopharmaceutical CDMO with a complete and integrated end-to-end offering. It is equipped with world-class Process Development (PD) and manufacturing infrastructure for both drug substances (mammalian and microbial-based therapeutic proteins and other emerging modalities) and drug products (lyophilized vials, liquid vials, pre-filled syringes, cartridges, and devices). Stelis offers the complete spectrum of services, from cell line tech transfer to clinical and commercial manufacturing, with in-house capability to convert drug substances to stable formulations and fill and finish in all formats. Stelis has three state-of-the-art facilities, with ~85,000 square meters of PD and manufacturing space and over 800 highly talented professionals. Its facilities are highly automated to increase accuracy, efficiency, and speed at every process stage. Additional details are available at http://www.stelis.com.

About Biolexis

Biolexis Private Limited (Biolexis) is an emerging biotech and vaccine company capable of developing and commercializing products for the Global markets. The Company is a wholly-owned subsidiary of Stelis and is focused on building and in-licensing a portfolio of advanced biosimilars, peptides, and vaccines. The Company endeavors to attain leadership in commercializing its portfolio of products with a high focus on quality, affordability, and accessibility. Besides in-licensing AmbiVax-CTM from Akston, Biolexis has a proprietary platform technology to develop and commercialize recombinant insulin and insulin analogs with high purity and consistent quality. The current programs of the Company include Rh-Teriparatide (biosimilar to Forteo and Forsteo), Insulin glargine (biosimilar to Sanofis Lantus), Insulin Lispro (biosimilar to Eli-Lillys Humalog), Insulin Aspart (biosimilar to Novo Nordisks Novolog), a recently filed peptide for diabetes and a novel anti-hemorrhoid.

About Veeda Clinical Research Limited

Veeda Clinical Research Limited (Veeda) is one of the largest independent, full-service clinical research organizations headquartered in Ahmedabad, India. Veeda offers a range of bioequivalence studies and early and late phase clinical trials. Veeda has completed several regulatory inspections and is approved by USFDA, UK MHRA, ANVISA (Brazil), and WHO. Veeda has experience in conducting complex clinical studies. Visit https://www.veedacr.com.

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Biolexis and Akston Biosciences Announce Encouraging Top-Line Results from Phase II/III Trial of their Thermostable 2nd Gen COVID-19 Vaccine -...

CDC recommends COVID-19 vaccines for the youngest children – Vermont Biz

June 20, 2022

Vaccines will be mainly available through pediatricians offices

Vermont Business Magazine On Saturday, the Centers for Disease Control and Prevention recommended COVID-19 vaccines for children age 6 months through 5 years of age, paving the way for vaccinating the youngest Vermonters later this month.

This is very welcome news for the parents and caregivers who have been waiting for more than a year now for their young children to benefit from a COVID-19 vaccine, said Health Commissioner Mark Levine, MD. Vaccines are the safer way to build protection against the virus and help prevent serious outcomes.

Both the Pfizer BioNTech and Moderna vaccines have been authorized for use. Providers will begin receiving the vaccines this week, but will have their own plans for administering them, so parents and caregivers should expect to hear from their childs pediatrician when they are ready to begin vaccinations.

Pediatricians are a trusted resource for parents, and they can answer questions and provide a familiar, comfortable setting for children to be vaccinated, Dr. Levine said.

There are about 26,000 children age 6 months through 4 years old in Vermont who will now be eligible for vaccination.

This is an important and welcomed step forward, said Governor Scott. Vermont has led the nation in vaccination uptake, especially among our youth. Im confident Vermont parents and caregivers will continue to step up in this new phase of our vaccination efforts.

The Health Department will also offer the vaccines at a limited number of walk-in clinics, including at equity-focused clinics. Information about clinics with vaccines for this age group will be updated athealthvermont.gov/KidsVaccineas soon as its available. There is no registration for these clinics. Families enrolled in WIC may also be able to get vaccinated through their local WIC office. Some pharmacies will also carry the vaccine, but can only vaccinate children age 3 and older.

The Pfizer COVID-19 vaccine is authorized to be given to children age 6 months through 4 years in two doses that are three weeks apart, followed by a third dose at least two months later. The Moderna COVID-19 vaccine is authorized to be given to children 6 months through 5 years in two doses four weeks apart.

Pfizer doses are one-tenth the dosage given to adults, while the Moderna doses are one-fourth the dosage.

The vaccines were found to be safe, with side effects typically mild and temporary.

For more information visithealthvermont.gov/KidsVaccine.

Department of Health

We have been the state's public health agency for more than 130 years, working every day to protect and promote the health of Vermonters.

BURLINGTON, VT healthvermont.gov

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CDC recommends COVID-19 vaccines for the youngest children - Vermont Biz

These children lost young parents to Covid-19. Here’s what they want other kids — and adults — to know – CNN

June 20, 2022

Here's what some children and families who have lost young parents to the pandemic want everyone else to know.

Laila Dominguez never thought she'd have to grow up this fast.

When Covid-19 struck both her parents last winter, the 13-year-old helped watch her two younger siblings and take care of her mother, who was severely sick and had violent chills.

"The cold chills were bad. She was shivering like she was in Antarctica or something," said the girl from East Troy, Wisconsin.

Her mom, Amanda Nelson, felt like she got hit by a train. "It was hard to even get up and move," the 42-year-old said.

But "I couldn't go to the hospital because I was the only parent at home."

The children's father, Benny Dominguez, was already hospitalized with Covid-19 -- and in much worse condition.

The 43-year-old, who loved bike riding with his kids and playing with them at the park, was intubated and could no longer breathe on his own.

On January 10, when Dominguez's condition turned grave, Nelson faced an agonizing decision: try to see her longtime partner one last time, or stay with their children -- ages 13, 9 and 4 -- who couldn't go to the hospital.

"It was really hard to explain it to the kids because they weren't allowed to go up there because of their ages. So nobody got to say goodbye," Nelson said.

"I didn't go because I had to be here for the kids. I couldn't leave them because I knew what was occurring. ... They knew they were going to lose their dad."

For Laila, the nightmare didn't seem real.

"I was in a state of shock and disbelief and sadness. Sometimes, I still am in shock," Laila said. At times, "it will get really, really dark. And sometimes it's way too much for me."

Her family's home, which used to be filled with her dad's boisterous laugh, is now eerily quiet. And the grief is now exacerbated by anxiety about the future.

Dominguez was a stay-at-home dad who took care of Laila, 9-year-old Aurora and 4-year-old Benny, who has special needs. Nelson juggled bartending and waitressing to support the family.

But Nelson hasn't been able to work since her partner's death. She's been overwhelmed by her own grief while taking care of three despondent children by herself.

"I'm barely getting by and living off of whatever I had in savings," she said.

Nelson has only a few more months' worth of savings, she said. Soon, she will have to find a job.

And 13-year-old Laila will likely shoulder more responsibilities, including babysitting her brother and sister. Her last experience taking care of her traumatized siblings led to a panic attack.

"It's definitely been stressful for me. I can't explain it," Laila said.

But since her dad's death, Laila has gained a powerful new skill: the ability to stand up to bullies who make fun of her for wearing a mask.

Before, Laila would try to ignore such taunts. Now, she replies with a painfully blunt answer: "My dad died."

Some bullies were stunned and actually learned from her unexpected answer, Laila said. She hopes more kids learn from her story and take Covid-19 seriously.

"What I wish they knew about Covid is how dangerous it is ... and be more aware of what they say."

A 5-year-old boy witnessed his young mother collapse

As a four-time cancer survivor, Katie Klosterman always thought she would be the one who would have to worry about Covid-19 -- not her healthy, vivacious 24-year-old daughter, Tina Owens.

But during the height of the Delta variant surge, when more young people were getting hospitalized, Owens collapsed on the living room floor of her Texas apartment.

The only other person at home was Owens' 5-year-old son, Tye. He had just finished his first day of kindergarten.

"Knowing that his last vision of his mother is stuff coming out of her nose and her mouth ... it breaks my heart," Klosterman said.

Owens told her son to go get their neighbor -- a certified nursing assistant. The neighbor rushed in, called 911 and started performing chest compressions -- but to no avail.

Owens died at 6:44 p.m. That evening, Tye was taken into custody by Child Protective Services.

When Klosterman learned of her daughter's death a few hours later, she jumped on the next flight to San Antonio to bring her grandson to Florida.

"When I got there the next day and went and picked him up from CPS' care, I sat him down and I explained to him that Mommy's in heaven," Klosterman said.

"You can't see her or touch her like you can me. But she's here. She's always around you," the grandmother told the little boy. "It's OK to be sad. It's OK to cry."

Covid-19 stole not just Tye's mother, but also her plans for a new life for them.

Despite the challenges of becoming a teen mom, Owens excelled in school and was on her way to launching her dream career.

"She was actually a full-time student (studying) physical therapy -- a 4.0 student," Klosterman said. "She was absolutely loving it. She was getting her life going."

Klosterman said her daughter was also committed to getting vaccinated against Covid-19. But she fell ill before she became fully vaccinated.

"You don't expect a 24-year-old to pass away," Klosterman said.

Owens was an avid TikTok user and recorded many videos. Klosterman now shares her daughter's TikTok videos with her grandson.

"I'm trying to make sure he remembers her voice," she said. "I'll play them for him so it can feel more like she's alive to him."

But raising an orphan of Covid can be immensely challenging. Tye, now 6, sometimes talks about traumatic details such as "stuff was coming out mommy's nose and mouth."

Klosterman keeps her own grief bottled up and won't let herself cry until after Tye goes to sleep, she said.

And she's had to switch from a grandmother who spoils her grandchild to a parental figure who can command authority -- which can be difficult for a child to accept.

For others who are suddenly raising orphans of Covid, Klosterman advises getting therapy for every family member -- and parenting classes for grandparents like herself.

"A lot of parenting roles have changed from when we raised our children," Klosterman said. "And as a grandparent, now you're doing it all over again."

An EMT who was on the front lines of the pandemic won't see his son follow in his footsteps

While many teens try to detach from their parents, Connor Luensman couldn't get enough of his father, James.

Just like his dad, Connor became a star high school wrestler -- even making the varsity team his freshman year in Cedar Rapids, Iowa.

They also shared a passion for helping others. James proudly served his community as an EMT. Connor has enrolled in an EMT program for next year.

"I always wanted to be in the medical field, for sure," said Connor, now 17. "I was surrounded by it my whole life. My dad did it since I was born. So that just felt natural."

But James will never see his son fulfill that dream. In October 2020, just weeks before health care workers became eligible to get vaccinated, James Luensman fell sick with Covid-19.

Even while seriously ill, Luensman was hoping to recover, get vaccinated and get back to helping patients as soon as possible.

"He didn't want others to feel the same way he did," Connor said.

But Luensman's condition deteriorated. Connor remembers his final conversation with his lifelong idol. He told him, "Don't give up, and that I loved him."

James Luensman died October 30, 2020. He was 43 years old.

A few months later, on the first day Connor became eligible to get vaccinated, he went and got a shot along with his mother Sallie Luensman.

"I wanted to do it for my dad because he never got the opportunity to," Connor said. "It almost felt like he was there."

Connor has now received three doses of Covid-19 vaccine, with no big side effects. That's stunning because Connor had always been allergic to vaccines.

"So anytime he gets a vaccine, we always have to do a high dose of antibiotics and a high dose of a steroid on top of it," Sallie Luensman said.

But with the Covid-19 shots, "that was the first vaccine he's never had a reaction to."

The Luenmans take some comfort knowing their tragedy has inspired others to get vaccinated.

"Other family members and other friends of ours got vaccinated specifically for James, in his honor, because we all know and have seen how traumatic it can be to lose somebody that has made a difference," Sallie Luensman said.

Connor wants everyone -- even children -- to understand the importance of getting vaccinated against Covid-19, he said.

"It's not just about you," he said. "It's about protecting everyone else."

A daddy's girl thought her papa bear was getting better. He didn't

For as long as she can remember, 13-year-old Jessica Barrios and her father had been inseparable.

She often dreamed about celebrating major milestones with her dad, Julio "Robert" Barrios. Her Sweet 16 celebration. Her first time behind the wheel of a car. Walking down the aisle at her wedding.

But Robert won't be there for any of those events. He fell ill with Covid-19 in June 2020 and was hospitalized for 81 days. After he was released, he grappled with long Covid for more than a year at his home in Seneca, South Carolina.

The nagging symptoms included shortness of breath from damaged lungs, extreme fatigue, memory problems and lack of stamina -- "not being able to do even simple housework," his wife Summer Barrios said.

"Staying up long enough to manage the dishes or even bend over to get clothes out of the dryer or taking a shower sometimes would be just debilitating to him, feeling like he had a severe case of the flu."

"Before Covid, I never thought I'd be a widow at 41," Summer Barrios said.

Jessica is still grappling with the reality of never seeing her Papa Bear again.

"I never thought we would be in this position so soon ... to think that he's not coming back," she said.

Jessica and her dad had a evening ritual of cuddling up on a big, comfy chair and watching TV until Jessica fell asleep in her dad's arms. Now, Jessica curls up on that chair alone.

Barrios and her daughter are trying to raise awareness about long Covid -- and how it can be excruciating physically, mentally, financially and emotionally.

"This isn't going to go away anytime soon," Summer Barrios said. "Long-haulers are having to decide between working or losing their jobs or choosing treatment -- if they're lucky enough to even get into a long-hauler clinic."

Kids need to take Covid-19 seriously, too, Jessica said.

"It's not just a bad flu. It's affecting not just older people; it's affecting kids, too," she said. "People need to start taking this seriously and do their part to help try and calm down this virus."

Read more from the original source:

These children lost young parents to Covid-19. Here's what they want other kids -- and adults -- to know - CNN

Counties with the highest COVID-19 vaccination rate in Massachusetts – What’sUpNewp

June 20, 2022

The vaccine deployment in December 2020 signaled a turning point in the COVID-19 pandemic. By the end of May 2021, 40% of the U.S. population was fully vaccinated. But as vaccination rates lagged over the summer, new surges of COVID-19 came, including Delta in the summer of 2021, and now the Omicron variant, which comprises the majority of cases in the U.S.

The United States as of Jun. 18 reached 1 million COVID-19-related deaths and nearly 86 million COVID-19 cases, according to Johns Hopkins University. Currently, 66.8% of the population is fully vaccinated, and 47.2% of vaccinated people have received booster doses.

Stacker compiled a list of the counties with highest COVID-19 vaccination rates in Massachusetts using data from the U.S. Department of Health & Human Services and Covid Act Now. Counties are ranked by the highest vaccination rate as of June 15, 2022. Due to inconsistencies in reporting, some counties do not have vaccination data available. Keep reading to see whether your county ranks among the highest COVID-19 vaccination rates in your state.

Population that is fully vaccinated: 59.8% (74,746 fully vaccinated) 25.1% lower vaccination rate than Massachusetts Cumulative deaths per 100k: 313 (391 total deaths) 3.6% more deaths per 100k residents than Massachusetts Cumulative cases per 100k: 22,722 (28,390 total cases) 17.6% less cases per 100k residents than Massachusetts

Population that is fully vaccinated: 66.8% (377,510 fully vaccinated) 16.3% lower vaccination rate than Massachusetts Cumulative deaths per 100k: 388 (2,195 total deaths) 28.5% more deaths per 100k residents than Massachusetts Cumulative cases per 100k: 28,334 (160,151 total cases) 2.8% more cases per 100k residents than Massachusetts

Population that is fully vaccinated: 66.8% (311,408 fully vaccinated) 16.3% lower vaccination rate than Massachusetts Cumulative deaths per 100k: 392 (1,830 total deaths) 29.8% more deaths per 100k residents than Massachusetts Cumulative cases per 100k: 31,156 (145,305 total cases) 13.0% more cases per 100k residents than Massachusetts

Population that is fully vaccinated: 67.9% (109,223 fully vaccinated) 14.9% lower vaccination rate than Massachusetts Cumulative deaths per 100k: 224 (361 total deaths) 25.8% less deaths per 100k residents than Massachusetts Cumulative cases per 100k: 20,473 (32,927 total cases) 25.7% less cases per 100k residents than Massachusetts

Population that is fully vaccinated: 69.4% (48,693 fully vaccinated) 13.0% lower vaccination rate than Massachusetts Cumulative deaths per 100k: 212 (149 total deaths) 29.8% less deaths per 100k residents than Massachusetts Cumulative cases per 100k: 17,193 (12,066 total cases) 37.6% less cases per 100k residents than Massachusetts

Population that is fully vaccinated: 71.0% (589,520 fully vaccinated) 11.0% lower vaccination rate than Massachusetts Cumulative deaths per 100k: 319 (2,647 total deaths) 5.6% more deaths per 100k residents than Massachusetts Cumulative cases per 100k: 25,237 (209,621 total cases) 8.5% less cases per 100k residents than Massachusetts

Population that is fully vaccinated: 71.0% (369,977 fully vaccinated) 11.0% lower vaccination rate than Massachusetts Cumulative deaths per 100k: 329 (1,716 total deaths) 8.9% more deaths per 100k residents than Massachusetts Cumulative cases per 100k: 23,941 (124,779 total cases) 13.2% less cases per 100k residents than Massachusetts

Population that is fully vaccinated: 74.1% (595,758 fully vaccinated) 7.1% lower vaccination rate than Massachusetts Cumulative deaths per 100k: 253 (2,031 total deaths) 16.2% less deaths per 100k residents than Massachusetts Cumulative cases per 100k: 29,318 (235,687 total cases) 6.3% more cases per 100k residents than Massachusetts

Population that is fully vaccinated: 75.1% (592,861 fully vaccinated) 5.9% lower vaccination rate than Massachusetts Cumulative deaths per 100k: 355 (2,801 total deaths) 17.5% more deaths per 100k residents than Massachusetts Cumulative cases per 100k: 28,234 (222,778 total cases) 2.4% more cases per 100k residents than Massachusetts

Population that is fully vaccinated: 80.0% (565,466 fully vaccinated) 0.3% higher vaccination rate than Massachusetts Cumulative deaths per 100k: 276 (1,951 total deaths) 8.6% less deaths per 100k residents than Massachusetts Cumulative cases per 100k: 21,107 (149,179 total cases) 23.4% less cases per 100k residents than Massachusetts

Population that is fully vaccinated: 80.5% (1,297,364 fully vaccinated) 0.9% higher vaccination rate than Massachusetts Cumulative deaths per 100k: 254 (4,094 total deaths) 15.9% less deaths per 100k residents than Massachusetts Cumulative cases per 100k: 23,199 (373,894 total cases) 15.9% less cases per 100k residents than Massachusetts

This story was written by Stacker and has been re-published pursuant to aCC BY-NC 4.0 License.

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Counties with the highest COVID-19 vaccination rate in Massachusetts - What'sUpNewp

Health Net, MedArrive Partner to Bring In-Home COVID-19 Vaccine to At-Risk Medicaid Members – – HIT Consultant

June 18, 2022

What You Should Know:

One of Californias longest-serving and most-experienced Medi-Cal partners,Health Net(a Centene plan), and virtual care and in-home health services providerMedArriveis collaborating to bring the most vulnerable, at-risk Medicaid members in-home access to COVID-19 vaccinations.

Eligible Health Net members in the Los Angeles, Sacramento, and Fresno regions who opt into the innovative program can schedule their home visit at their convenience. A licensed, trained EMT, or healthcare professional will administer the vaccine to them and any family member who wants to be vaccinated.

At-risk Medi-Cal Members Get Access to Vaccinations

Health Nets in-home vaccination initiative is part of its larger effort to get Californians vaccinated against COVID-19. The insurer also sets up vaccination clinics throughout key markets it operates, including Los Angeles, Sacramento, St. Stanislaus, and Tulare Counties.The MedArrive platform includes physician-led telehealth and home health services that are provided by its field provider network of thousands of highly trained and skilled paramedics, EMTs, and other healthcare professionals

This approach is critical becauseresearchshows that in-home medical appointments are an effective way to remove barriers to COVID-19 vaccination among Medicaid enrollees. The program has already vaccinated many Californians most at risk at a time when there is, once again, rising threats of new COVID-19 surges.

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Health Net, MedArrive Partner to Bring In-Home COVID-19 Vaccine to At-Risk Medicaid Members - - HIT Consultant

UPDATE: No Cost Vaccinations and Booster Shots Available Throughout the City – Corpus Christi

June 18, 2022

CORPUS CHRISTI, TX Multiple locations are available next week for COVID-19 vaccines and first and second-dose booster shots. City-County Public Health District vaccination clinics will be closed on Monday, June 20, for the Juneteenth holiday but will reopen on Tuesday, June 21. However, the clinics at La Palmera Mall and the former outlets at Corpus Christi Bay in Robstown will remain open as scheduled. Vaccinations for children are available at no cost with parental consent at all City-County Public Health District vaccination clinics.

Vaccines

The CDC recommends Pfizers COVID-19 vaccine be given to children ages five and older administered as a two-dose series, three weeks apart. Individuals aged 5 through 17 must have verbal or written parental consent to receive a Pfizer vaccination.

COVID-19 vaccine third doses are available for the following Pfizer and Moderna vaccine recipients who completed their initial series at least 28 days ago and are:

The CDC recommends immunocompromised people who have received one primary Johnson & Johnson vaccine get an additional Pfizer or Moderna vaccine four weeks after their initial dose.

Things to know:

Booster Shots

The Centers for Disease Control and Prevention (CDC) has updated its clinical recommendations to include the following:

First Dose Booster Shots:

Second Dose Booster Shots

Visitwww.cctexas.com/coronavirusfor more information. You can also find updates on city social media channels Facebook@citygovand Twitter@cityofcc.

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UPDATE: No Cost Vaccinations and Booster Shots Available Throughout the City - Corpus Christi

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