Category: Covid-19 Vaccine

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

June 15, 2022 - (Tarrant County) Tarrant County Public Health hosts numerous pop-up COVID-19 clinics across Tarrant County each week in partnership with public and private organizations listed below. Each site has the Moderna and Pfizer vaccines and at times the Johnson & Johnson. Children five and older are eligible for the vaccination. Parents need to bring proof of the childs age and their own ID for the vaccination. Booster vaccinations are available at all of the vaccination locations.

TCPH would like to bring a COVID-19 vaccination clinic to businesses, churches and organizations in the community who are interested in hosting a pop-up clinic. Its easy and free to host a clinic.In addition to the vaccination opportunities below, the cities of Arlington, Fort Worth, Mansfield, North Richland Hills, Hurst, and Tarrant County College have also added opportunities for vaccinations. To find a local vaccine site, the County created a vaccine finder page:VaxUpTC website.

Pop-Up COVID-19 locations:

Our Lady of GuadalupeWednesday, June 22: 10 a.m. to 2 p.m.4100 Blue Mound Rd.Fort Worth, TX 76106

Vaxmobile Haltom City Public Library Thursday, June 23: 9 a.m. to 4 p.m.4809 Haltom Rd. Haltom City, TX 76117

Cornerstone Assistance Network Thursday, June 23: 10 a.m. to 4 p.m.3500 Noble Ave.Fort Worth, TX 76111

Bedford Public Library Friday, June 24: 10 a.m. to 2 p.m.2424 Forest Ridge Dr.Bedford, TX 76021

Tarrant County Public Health CIinics:

Northwest Public Health CenterMonday to Friday:8 a.m. to 12 p.m.and1 to 5 p.m.3800 Adam Grubb RoadLake Worth, TX 76135

Bagsby-Williams Health CenterMonday to Friday:8 a.m. to 12 p.m.and1 to 5 p.m.3212 Miller Ave.Fort Worth, TX 76119

Southeast Public Health CenterMonday to Friday:9 a.m. to 12 p.m.and1 to6p.m.536 W Randol MillArlington TX, 76011

Main Public Health CenterMonday to Friday:8 a.m. to 12 p.m.and1 to 6 p.m.1101 S. Main StreetFort Worth, TX 76104

Southwest Public Health CenterMonday to Friday:8 a.m. to 12 p.m.and1 to 5 p.m.6551 Granbury RoadFort Worth, TX 76133

Watauga Public Health CenterMonday to Friday:8 a.m. to 12 p.m.and1 to 5 p.m.6601 Watauga RoadWatauga, TX 76148

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COVID-19 Vaccine Clinics for the Week of June 18 - Tarrantcounty.com

The FDA is expected to quickly authorize for emergency use the Pfizer-BioNTech vaccine for kids under 5 and the Moderna vaccines for kids under 6. Both options could be used in children as young as 6 months old.

The CDCs panel of expert advisers will consider whether to recommend the shots administration during meetings on Friday and Saturday. Once CDC Director Rochelle Walensky signs off on a recommendation, children are expected to begin receiving shots by Tuesday. Children under 6 who receive the Moderna vaccine will get two 25-microgram doses, four weeks apart. The Pfizer vaccine is two 3-microgram doses three weeks apart, followed by a third dose at least eight weeks later.

Some panel members signaled concern that parents may get confused by the products different dose regimens particularly since the Pfizer-BioNTech vaccine doesnt offer much protection after two doses, while Modernas primary series is complete with two doses.

I have a lot of concern that many of these kids will not get the third dose, Jeannette Yen Lee, a biostatistics professor at the University of Arkansas for Medical Sciences, said of the Pfizer vaccine. Its a struggle to get people in for two, she added, noting that booster uptake for older populations is also low.

Michael Nelson, chief of UVA Healths asthma, allergy and immunology division, urged the manufacturers to quickly gather data on the prospect of vaccinating these children against Covid at the same time they receive other routine immunizations.

If we dont get a quick answer to the coadministration question, it will serve as a barrier to completion of the three-dose series for [the Pfizer] vaccine and likely for the Moderna vaccine, he said. Having to get it in isolation is going to be a great challenge to families and children here in the U.S.

Peter Marks, FDAs top vaccine regulator, started the daylong meeting pointing to the burden of Covid hospitalizations for young children during the recent Omicron wave at rates that have equaled or exceeded those for other common childhood vaccine-preventable diseases like the flu. More than half of children under 5 who have been hospitalized for Covid did not have underlying health conditions, and 202 in the 6-month to 4-year-old age group have died of the disease as of May 11.

The intervention were talking about here is one that is something that we have accepted in the past to try to prevent deaths from influenza, he said. Here we have a different pathogen, but one that has created a lot of havoc just the same.

The Biden administration is girding for a slog in convincing parents to quickly vaccinate their young children. Summer vacations and young children receiving various levels of schooling before age 5 along with misinformation about vaccines could depress early turnout. Many young children also contracted Covid during the Omicron surge, which could convince parents to hold off on immunizing them until theyre further removed from their natural infections.

Recent polling by the Kaiser Family Foundation suggests about 20 percent of parents are eager to vaccinate their children under 5 as soon as theyre allowed, while nearly 40 percent plan to wait and see how the vaccine works and another 40 percent are reluctant to immunize at all.

Just 29 percent of U.S. children ages 5 to 11 are fully vaccinated against Covid, compared to nearly 56 percent of 12- to 15-year-olds and 67 percent of 16- and 17-year-olds, according to CDC data ending April 30.

The FDA analyzed the vaccines ability to induce neutralizing antibody responses in kids that were comparable to young adults, a concept known as immunobridging. Both met the agencys success criteria.

Real-world efficacy against the Omicron variant in the 6-month-to-5-year-old age group for Modernas vaccine ranged from 36 percent to 51 percent, and efficacy estimates were generally consistent with rates seen in observational studies of adults during the same variant waves, the FDA said.

Preliminary analyses of the Pfizer vaccine showed efficacy of 80 percent in kids under 5 against disease, though only 10 Covid cases were reported among study participants before the data cutoff date in April, limiting confidence in that figure.

Panel member Amanda Cohn of the CDC expressed concern that parents will compare efficacy percentages put forward by the companies and base which product they pick solely on those numbers.

My level of confidence in that number ... I do not have any idea what that number will end up being, she said of the 80 percent figure for Pfizers vaccine, adding that she does think it is effective.

In both companies data, there were several unknowns that reflect the current state of adult vaccination in the U.S., including duration of effectiveness and how well vaccination protects against outcomes like long Covid, the FDA said. Children will likely need booster doses in the future, given adults experience with waning antibody protection, reviewers said.

Adverse reactions like headaches and fatigue were more common in teens than in younger kids, likely because they received larger vaccine doses, the FDA said. Fever was reported more frequently among the youngest vaccine recipients.

The manufacturers did not report any events in their trials that met the CDC definition for probable or confirmed myocarditis or pericarditis two types of heart inflammation that have been detected as potential side effects of the messenger RNA vaccines, particularly for males ages 12 to 39.

The FDAs reviews of Pfizers and Modernas data come after months of angst from parents who felt strung along by statements that Covid-19 vaccines would be available for the countrys youngest children by early 2022, only to see dates shift. The FDA scheduled an advisory committee meeting in February to consider a two-dose primary series of Pfizers vaccine, only to pull back once the data suggested a third dose could bolster its effectiveness.

Parents and advocates for children under 5 to get access to vaccines erupted over a POLITICO report in April that the Biden administration was leaning toward authorizing both Pfizer-BioNTechs and Modernas products at the same time to make it easier to promote the shots, a move some believed resulted in regulators sitting on Modernas application while Pfizer continued to collect data and complete its submission. FDA Commissioner Robert Califf later insisted there would be no holdup on Modernas application, but the advisory committee meeting schedule ultimately ensured both vaccines would be considered head-to-head.

Parents who spoke during the public comment period Tuesday and Wednesday indicated they were still angry at the perceived delay, noting that most children who end up receiving Pfizers three-dose series wont be fully vaccinated by the time the school year starts.

We have waited too long, and too many families have suffered already, said Fatima Khan, cofounder of Protect Their Future, a grassroots group that has advocated for vaccine access for the youngest kids.

Arnold Monto, the committees acting chair and a University of Michigan infectious disease expert, said the 18-month gap in making Covid vaccines available to the youngest children in the U.S. was a function of needing to take extra care with trialing the immunizations, along with determining how best to vaccinate older Americans as the pandemic evolved.

To say there have been delays, unnecessary delays, is not representing the true situation, which involved not working with adults but with a vulnerable, younger population for whom special care is necessary, he said.

Read more:

FDA advisers endorse administration of Moderna, Pfizer Covid-19 vaccines in babies, toddlers - POLITICO

CNN

Rohit Kumar Rai and his wife have both lost family members in India to Covid-19, so they know how serious the disease can be. Thats why they have been living so carefully in Texas until their 4-year-old son can be vaccinated as well.

That means reining in playdates and school attendance when cases are higher, an inconsistency that can frustrate their son, he said.

Sometimes you are saying its OK to go, and sometimes you are saying not, Rai said his son complains to him.

Vaccines against Covid-19 have meant many steps closer to normalcy for much for the United States, but not everyone has access yet.

This week, the US Food and Drug Administration is expected to review data on the Moderna and Pfizer/BioNTech vaccines for younger children. If the FDA gives authorization and the US Centers for Disease Control recommends them later in the week, Covid-19 vaccination shots may be administered to the youngest Americans as soon as June 21.

Parenting young children can be isolating as it is, said Vaile Wright, senior director of health care innovation at the American Psychological Association. Add precautions to protect unvaccinated children, and it can be even harder to get support from the community. The research shows that parents of children under 18 have been reporting extremely high levels of stress over the pandemic, she said.

While some families hesitate or refuse to vaccinate their young children, for many, the news brings a huge sigh of relief.

Its not like I am expecting some miracle vaccine; like as soon as he gets it it is going to end, Rai said. He might get Covid, he might be affected, but the worst-case scenario wouldnt happen. Thats my ultimate goal for my kid.

Some families who felt left behind and are eagerly anticipating their childrens vaccinations shared what it was like to raise youngsters in the Covid-19 pandemic and what they are most hopeful for in the future.

For Jennifer Reimers Gaydo, who lives in upstate New York, forgotten is the word that comes to mind when raising a young child during the Covid-19 era.

Everybody else has moved on, and we have not, she said. In peoples desire to move on, its almost like they blocked (the fear of being unvaccinated) out.

Reimers Gaydos husband is a doctor, so their family reduces risk to their 3-year-old son, Jim, wherever possible.

My husband is a front-line worker so with Jim not vaccinated its like, Is this coming for me in my own home? she added.

Precautions mean no more music and movement classes, limited playtime with kids his age, and his relationship with his grandparents reduced to a computer screen.

There was excitement and fanfare when adults got access to the vaccine, then when it was extended to teens, but the youngest members of our population have been spending all this time lonely and ignored, she said.

Along with fears about physical safety and concerns around social needs, parenting young children during the pandemic without an available vaccine means constant conversations between families about whether they are doing the right things for their kids, Jason Jackson in Michigan said.

One of Jacksons three children is not yet eligible to be vaccinated, but until his youngest can be protected, his 7-year-old son and 5-year-old daughter also have to take precautions to protect their little brother, he said. None of them go to school in person, and none take indoor swimming lessons.

My daughter, she is really extroverted. And so, I pulled up to the playground, and she said, Yes, theres a car here that means I can meet a new friend. This is the best day of my life! Jackson recalled. That was freaking depressing.

We were just like, Oh my god, what are we keeping our kids from?

Getting a vaccine for their 3-year-old son would be a huge relief from the battle between physical and social health for their kids, he said.

I honestly think everyone wants the same things. Everyone wants to get things back to normal. Its just that we have a very, very different pathway of what we think is best to get us there, Jackson said. Our best pathway of getting back to normal is this vaccine.

Sometimes, even when she is playing outdoors, Sarah Enders 4-year-old daughter chooses to wear a mask.

She was diagnosed with leukemia about a year ago, and she knows that getting Covid-19 could make her really sick, Enders in Oregon said.

She understands that there are things she doesnt get to do because of the fact that she doesnt have the shot, she added.

Her diagnosis came as the rest of the US started to open back up from Covid-19, but Enders family had to clamp down even harder for her daughters safety.

You go through the diagnosis of your child having cancer, and thats when you really need to rely on the world around you and your community, she said, whether its emotional support or physical support, and we really couldnt do that because we had to keep her protected.

Her family is looking forward to everyone in the home having the vaccine in hopes they can send their children back to school.

I struggle with people who are unwilling to get vaccinated, unwilling to wear masks and things like that because they feel its their right not to, Enders said. But our children who dont have that option and that flexibility are the ones suffering from that.

Gabriele Goulet and her family started both parenthood and the pandemic in a terrifying way.

On March 12, 2020, her first child was born early and couldnt breathe on his own, so he needed to stay in the neonatal intensive care unit. Shortly afterward, their state, Utah, shut down because of Covid-19.

Goulet and her husband drove down empty freeways every day to see their son at the hospital, entering the building where the National Guard was deployed to help with the demand from the virus, she said.

Becoming a parent in that time has really shaped the type of parent that I am, and Im probably overprotective, Goulet said.

They locked down when their first son was born, and they stayed as isolated as possible as the years passed and they had their second child, she said.

But now that her second maternity leave is over, she and her husband need to go back to their offices, and their kids will need to go to day care after years of not even going inside grocery stores, she said.

Goulet and her husband worry about the transition out of isolation with two unvaccinated kids, she said. Now, she said she just hopes they can stave off infection until the kids are eligible for the vaccine.

I do totally understand and respect other peoples perspectives like it does seem like these vaccines are coming out pretty quickly, Goulet said, but she trusts her pediatricians advice to get the shots.

I think were probably going to cry when were in the pediatricians office because its been over two years that weve been looking forward to this.

Top image: Gabriele Goulets son spends time with his dad social distancing from his grandparents. (Courtesy Gabriele Goulet)

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They felt like the world left them behind: Raising young children in a pandemic - CNN

Now that the region has enough vaccines to protect everyone, including the most vulnerable, it is time to turn vaccines into immunity, PAHO Director says.

Washington D.C. 15 June 2022 (PAHO) As COVID-19 cases continue to rise in the Americas for the eighth week running, PAHO Director, Carissa F. Etienne, has called on countries to increase efforts towards achieving the World Health Organization (WHO) target of 70% vaccination coverage by mid-2022.

Last week, countries of the region reported more than 1.2 million new cases of COVID-19, an 11% hike from the previous week.

Thanks to the commitment of donors and national governments, we now have the supplies and financial and technical support to help countries reach the 70% target, the Director said during a media briefing today.

Our priority now should be turning vaccines into immunity, ensuring that the doses we have are making it into peoples arms and saving lives.

But while 16 countries and territories of the region have already vaccinated 70% of eligible populations, and Colombia, Bermuda and El Salvador are close behind at 65%, 11 others have yet to reach even 40% coverage.

Since the start of COVAX in 2021, PAHOs Revolving Fund has delivered over 142 million vaccines to countries in the Americas, and thanks to the commitment of donors and governments, the region now has the necessary financial and technical support to help all countries reach the 70% target, Dr. Etienne said.

It is therefore crucial that countries redouble their efforts to protect those most at risk, she added, including the elderly and immunocompromised, health professionals and pregnant women.

To achieve this, they must tailor efforts to address the concerns that still surround vaccines and collaborate with communities to develop outreach strategies in areas where coverage is poor.

As some countries begin to scale back local vaccination centers such as those in grocery stores, schools and local marketplaces, Dr. Etienne urged governments to continue to use resources wisely and try to reach people where they are.

The COVID-19 pandemic is not a short-term problem, the PAHO Director said. And with PAHOs latest Essential Health Services survey revealing that routine immunizations were heavily disrupted by the pandemic, it is vital that countries integrate COVID vaccination into their national immunization programs so that we have robust services in place to deliver routine vaccines, expand COVID coverage and better prepare for future emergencies.

Dr. Etienne also highlighted that the recent cases of monkeypox and acute hepatitis further underscore the need to build more resilient health systems that can respond quickly to new and emerging risks. To ensure this, PAHO is working to support and train healthcare providers to help reduce the shortfall of 600,000 public health workers in the region.

Now is the time for countries to take everything we have learned from the response to the pandemic, and commit to investing in stronger, more resilient health systems, she said.

Turning to the COVID-19 situation in the region, in North America over the past week, cases increased by 71% in Mexico, and the United States reported a 2% increase in hospitalizations and 4.2% rise in ICU admissions.

South America reported a 20% hike in cases, while in the Caribbean, the number of new infections increased by 3.7%.

Central America was the only sub-region to report a downward trend, with a 32% reduction in COVID-19 cases and a 36% fall in deaths.

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Countries of the Americas must redouble efforts to meet 70% vaccination target for COVID-19 - Pan American Health Organization

Reuben Arasaratnam, M.D.

DALLAS June 15, 2022 Individuals should weigh their own personal health and risk levels in deciding when to receive a second booster of the COVID-19 vaccine, UTSouthwestern infectious diseases experts advise.

Patients who are immunocompromised due to a chronic condition or medications that curb the immune system should get a second booster shot when they are eligible. But if youre healthy, have received your first booster, your risk of catching the virus is low, and if youre planning to travel during the summer, its reasonable to wait until closer to your travel time to get the second booster, said Reuben Arasaratnam, M.D., Assistant Professor of Internal Medicine.

What the booster does is re-awaken the immune system so that it is specifically poised to fight COVID-19, he said.

In late May, the Centers for Disease Control and Prevention strengthened its recommendations to saypeople 50 or older should get a second booster shot if at least four months have passed since their first booster.Evidence has shown that antibodies generated from the first booster begin to wane after about four months. Others included in the guidance are people 12 and older who are moderately or severely immunocompromised.

Pearlie Chong, M.D.

Pearlie Chong, M.D., Assistant Professor of Internal Medicine, said the side effects of a second booster would be similar to what an individual experienced with their first booster shot. You might get chills or fatigue, but it would be transient, and the benefits outweigh the risks.

Dr. Chong said that individuals considering a second booster shouldnt feel discouraged upon hearing that antibodies will wane after several months.

The protective value of the booster continues beyond that time because our immune system has multiple types of protection. And some parts of our immune system, such as B-cells and T-cells, are not easily measurable, but they are continuing to protect, Dr. Chong said. A single booster shot continues to provide high levels of protection against severe disease.

Drs. Arasaratnam and Chong shared their perspectives on a recent episode of What to Know, a video series produced by UTSouthwestern to provide information on medical topics for the community.

Dr. Chong is a Dedman Family Scholar in Clinical Care.

About UTSouthwestern Medical Center

UTSouthwestern, one of the nations premier academic medical centers, integrates pioneering biomedical research with exceptional clinical care and education. The institutions faculty has received six Nobel Prizes, and includes 26 members of the National Academy of Sciences, 17 members of the National Academy of Medicine, and 14 Howard Hughes Medical Institute Investigators. The full-time faculty of more than 2,900 is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. UTSouthwestern physicians provide care in more than 80 specialties to more than 100,000 hospitalized patients, more than 360,000 emergency room cases, and oversee nearly 4 million outpatient visits a year.

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UTSW infectious diseases experts offer advice on second COVID-19 booster - UT Southwestern

On 10 June 2022, the World Health Organization (WHO) in Zambia with the kind support of the Gavi Alliance donated 700 data collection electronic devices and related accessories worth One Hundred and Twenty Two Thousand, Two Hundred and Ninety US Dollars (US$122,290) to the Monitoring and Evaluation (M&E) Department of the Ministry of Health (MoH) to support the efficient and effective real-time data collection, monitoring and evaluation of the COVID-19 vaccination process and related information.

Dr Nathan Bakyaita, WHO Country Representative, said, We acknowledge the many challenges that the Ministry is facing, especially in the real-time data collection and tracking of COVID-19 related information, and specifically during the COVID-19 vaccination exercise. Our appreciation also goes to Gavi who has been a valuable partner to WHO and the Government of Zambia supporting the National Immunisation program and keeping Zambians safe from vaccine preventable diseases such as diarrhoea, measles, polio, cholera, and COVID-19. WHO in Zambia will continue to work with partners, like the Gavi Alliance to bridge gaps and provide better interventions, including the provision of necessary tools, so that all critical information is captured for a continued better response and management of the COVID-19 pandemic.

Hon Sylvia Masebo, Minister of Health, said, The donation is timely and will used for the intended purpose. We are grateful to the WHO Zambia, as through your office, we continue to get support for various interventions. As a ministry we know that the figures we report are not complete due to the many challenges that our workers face in data collection. These tablets will help us manage the COVID-19 data, bridge the gap in data backlog and allow for our foot soldiers to efficiently enter and manage COVID-19 and related information.For Zambia to attain the target of 70 percent of the population fully vaccinated against COVID-19, there is need for accurate and up-to-date data collection, capture and management.

Zambia now stands at over three million persons fully vaccinated giving an average of about 37 per cent of the population fully vaccinated against COVID-19. The tablets will make it easier for health personnel to capture and share data related to COVID-19 vaccination in Zambia.

The Gavi Alliance has been WHOs number six top contributor globally with a contribution of more than USD 432m in 2020/21 and is moreover, along with Germany the number one top contributor to WHO Zambia. Gavi is also one of the co-leads of COVAX, an alliance that aims to accelerate the development and manufacture of COVID-19 vaccines, and to guarantee fair and equitable access for every country in the world.

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WHO with funding from the Gavi Alliance donates 700 Tablets for COVID-19 Vaccination Data Collection, Monitoring and Evaluation to the Ministry of...

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Pfizer already agreed to delay supply of COVID-19 shots to EU, now the bloc wants more - FiercePharma

NEW YORK and MAINZ, GERMANY, APRIL 26, 2022 Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a 10-g booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as children ages 5 through <12).

The submission included data from the Phase 2/3 clinical trial in children ages 5 through 11 years who received a booster dose approximately 6 months after the second dose of the Pfizer-BioNTech COVID-19 Vaccine 10-g two-dose primary series, which was authorized under EUA for this age group in October 2021. Data from this study demonstrated a strong immune response in this age group following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine with no new safety signals.

The companies also plan to submit these data to the European Medicines Agency (EMA) and other regulatory agencies around the world for authorization in the coming weeks.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTechs proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

About the Phase 1/2/3 Trial in ChildrenThe Phase 1/2/3 trial initially enrolled up to 4,500 children ages 6 months to under 12 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. Additional children have been enrolled in all age groups following study amendments and the trial currently includes more than 10,000 children. The trial was originally designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 Vaccine on a two-dose schedule (approximately 21 days apart) in three age groups: ages 5 to under 12 years; ages 2 to under 5 years; and ages 6 months to under 2 years. Based on the Phase 1 dose-escalation portion of the trial, children ages 5 to under 12 years received a two-dose schedule of 10-g each while children under age 5 received a lower 3-g dose for each injection in the Phase 2/3 study. The trial enrolled children with or without prior evidence of SARS-CoV-2 infection. In December 2021, Pfizer and BioNTech announced the companies would test a third 3-g dose given at least two months after the second dose in children under age 5 and a third dose of the 10-g formulation in children 5 to under 12 years of age. The companies expect to share data from the ongoing study in children 6 months to under 5 years of age later this quarter.

U.S. Indication & Authorized Use

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 5 years of age and older. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide:

Primary Series

Booster Series

COMIRNATY INDICATIONCOMIRNATY (COVID-19 Vaccine, mRNA) is a vaccine approved for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

COMIRNATY AUTHORIZED USESCOMIRNATY (COVID-19 Vaccine, mRNA) is FDA authorized under Emergency Use Authorization (EUA) to provide:

Primary Series

Booster Dose

Emergency Use AuthorizationEmergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in either individuals 12 years of age and older, or in individuals 5 through 11 years of age, as appropriate. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

INTERCHANGEABILITYFDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA-authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use.

The formulation of the Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 5 through 11 years of age differs from the formulations authorized for individuals 12 years of age and older and should therefore not be used interchangeably. The Pfizer-BioNTech COVID-19 Vaccine authorized for use in children 5 through 11 years of age should not be used interchangeably with COMIRNATY (COVID-19 Vaccine, mRNA).

IMPORTANT SAFETY INFORMATION

Tell your vaccination provider about all of your medical conditions, including if you:

Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA) may not protect all vaccine recipients

You should not receive Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA) if you have had a severe allergic reaction to any of its ingredients or had a severe allergic reaction to a previous dose of Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY

There is a remote chance that Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA) could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. If you experience a severe allergic reaction, call 9-1-1 or go to the nearest hospital

Seek medical attention right away if you have any of the following symptoms:

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine, more commonly in males under 40 years of age than among females and older males. In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low

Seek medical attention right away if you have any of the following symptoms after receiving the vaccine:

Fainting can happen after getting injectable vaccines, including Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA). Sometimes people who faint can fall and hurt themselves. For this reason, your vaccination provider may ask you to sit or lie down for 15 minutes after receiving the vaccine

Some people with weakened immune systems may have reduced immune responses to Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY (COVID-19 Vaccine, mRNA)

Additional side effects include injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); decreased appetite; diarrhea; vomiting; arm pain; and fainting in association with injection of the vaccine

These may not be all the possible side effects of the vaccine. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.

Click for Fact Sheets and Prescribing Information for individuals 5 years of age and older:

Recipients and Caregivers Fact Sheet (5 through 11 years of age)Recipients and Caregivers Fact Sheet (12 years of age and older)COMIRNATY Full Prescribing Information (16 years of age and older), DILUTE BEFORE USE, Purple CapCOMIRNATY Full Prescribing Information (16 years of age and older), DO NOT DILUTE, Gray CapEUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange CapEUA Fact Sheet for Vaccination Providers (12 years of age and older), DILUTE BEFORE USE, Purple CapEUA Fact Sheet for Vaccination Providers (12 years of age and older), DO NOT DILUTE, Gray Cap

About Pfizer: Breakthroughs That Change Patients LivesAt Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the worlds premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at http://www.Pfizer.com. In addition, to learn more, please visit us on http://www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure NoticeThe information contained in this release is as of April 26, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about Pfizers efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including an application submission to the FDA for EUA of a potential booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age and planned submissions to other regulatory agencies, qualitative assessments of available data, potential benefits, expectations for clinical trials, potential regulatory submissions, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including Phase 1/2/3 or Phase 4 data) for BNT162b2 or any other vaccine candidate in the BNT162 program in any of our studies in pediatrics, adolescents or adults or real world evidence, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies, in real world data studies or in larger, more diverse populations following commercialization; the ability of BNT162b2 or any future vaccine to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when submissions to request emergency use or conditional marketing authorizations for BNT162b2 in additional populations, for a potential booster dose for BNT162b2 or any potential future vaccines (including potential submissions for a potential booster dose for children 5 through 11 years of age and potential future annual boosters or re-vaccinations) and/or other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, including a potential variant based, higher dose, or bivalent vaccine, and if obtained, whether or when such emergency use authorizations or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including the application submission to the FDA for EUA of a potential booster dose for children 5 through 11 years of age or any requested amendments to the emergency use or conditional marketing authorizations) or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccines benefits outweigh its known risks and determination of the vaccines efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccines formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant based vaccines; the risk that we may not be able to maintain or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; uncertainties regarding the impact of COVID-19 on Pfizers business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov and http://www.pfizer.com.

About BioNTechBiopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit http://www.BioNTech.de.

BioNTech Forward-looking StatementsThis press release contains forward-looking statements of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTechs efforts to combat COVID-19; the collaboration between BioNTech and Pfizer including the program to develop a COVID-19 vaccine and COMIRNATY (COVID-19 vaccine, mRNA) (BNT162b2) (including an application submission to the FDA for EUA of a potential booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age, who have previously received a two-dose primary series of the Pfizer-BioNTech COVID-19 vaccine, and planned submissions to other regulatory agencies, qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply); our expectations regarding the potential characteristics of BNT162b2 in our clinical trials, real world data studies, and/or in commercial use based on data observations to date; the ability of BNT162b2 or a future vaccine to prevent COVID-19 caused by emerging virus variants; the expected time point for additional readouts on efficacy data of BNT162b2 in our clinical trials; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for BNT162, or any future vaccine, in additional populations, or receipt of, any marketing approval or emergency use authorization or equivalent, including or amendments or variations to such authorizations; the development of other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant based vaccines; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; the ability of BioNTech to supply the quantities of BNT162 to support clinical development and market demand, including our production estimates for 2022; challenges related to public vaccine confidence or awareness; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist; the availability of raw material to manufacture BNT162 or other vaccine formulation; challenges related to our vaccines formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery; and uncertainties regarding the impact of COVID-19 on BioNTechs trials, business and general operations. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties.

For a discussion of these and other risks and uncertainties, see BioNTechs Annual Report as Form 20-F for the Year Ended December 31, 2021, filed with the SEC on March 30, 2022, which is available on the SECs website at http://www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

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Pfizer and BioNTech Submit Application for US Emergency Use Authorization for a COVID-19 Vaccine Booster Dose in Children 5 Through 11 Years of Age -...

June 13, 2022

OSWEGO COUNTY Oswego County continues to see a decrease in the number of COVID-19 positive cases and hospitalizations. Still, residents are reminded to stay vigilant and practice known strategies that work to reduce the spread of the virus. These include staying home when sick, testing when symptomatic, getting vaccinated and boosted when eligible, and choosing to wear a mask as an additional protection measure.

While no vaccine provides 100% immunity, the COVID-19 vaccines are highly effective in protecting you from becoming severely ill, ending up in the hospital, or dying from COVID-19 and getting a booster strengthens that protection even further,said Jodi Martin, director of preventive services for the Oswego County Health Department. Everyone eligible should get vaccinated and boosted as a way to protect the health of all in our community.

Oswego County Associate Public Health Educator Diane Oldenburg added, Getting eligible children and teens vaccinated against COVID-19 can help keep them from getting really sick if they do get the virus. Vaccinations can also keep them in school, summer campsor daycare and safelyparticipating in sports, playdates, and other group activities. Talk with your healthcare provider about getting your children vaccinated and boosted.

The Oswego County Health Department reported an additional 141 residents tested positive for the virus from Monday, June 6 through Sunday, June 12. This includes both lab-confirmed and at-home tests. In addition, three residents were hospitalized due to COVID-19 between Sunday, June 5 and Saturday, June 11.

The following report reflects data collected from Monday, June 6 through Sunday, June 12:

The Oswego County Health Department receives weekly accounts of new hospitalizations due to COVID-19 from local reporting hospitals including Oswego, Crouse, St. Josephs Health and Upstate University. These accounts are not part of a running total of hospitalizations. For details, go to the Oswego County COVID-19 Dashboard at https://oswegogis.maps.arcgis.com/apps/dashboards/3fd162cd12264b418dc03bdebd7f5300.

The Oswego County Health Department holds vaccination clinics every Tuesday afternoon from 12:30 to 3:30 p.m. by appointment only. Clinics are also held the second Wednesday of each month, from 9 to 11 a.m. and 1 to 3 p.m. Walk-ins are accepted on Wednesdays, but residents are strongly encouraged to go to health.oswegocounty.com/vaccines to make an appointment to avoid wait times.

The Oswego County Office for the Aging can help people aged 60 and older who need help navigating the internet to make appointments. Call 315-349-3484.

Vaccines are also available at local pharmacies and health care provider offices. Face masks are required at all clinics and at-home COVID-19 test kits will be distributed to those getting vaccinated at a county clinic while supplies last.

Free transportation is provided to residents to go to COVID-19 testing and vaccination sites through a partnership between Oswego County and Oswego County Opportunities, Inc. Rides are available between 6 a.m. and 7 p.m. Monday through Friday. Call 315-598-1514 to schedule a ride in advance.

Oswego County developed a portal for residents to report positive at-home COVID-19 test results, exposure to the virus and get the necessary isolation/quarantine paperwork for schools and employers. Go to https://health.oswegocounty.com/COVID-19 and click on the appropriate link.

Test results received from doctors offices, pharmacies and other testing sites DO NOT need to be self-reported. However, if isolation orders are needed for school, employers or other reasons, people can request these documents using the portals Report a Positive (Laboratory) Test option.

The health department encourages residents who test positive to immediately notify any close contacts. The close contact should then go to the States website at https://coronavirus.health.ny.gov/new-york-state-contact-tracing to find out if they meet the criteria for quarantine. If they do, they should report the exposure on the County Health Departments online portal.

Residents are urged to continue taking precautions to prevent the spread of COVID-19 including:

For more information, go to the Oswego County Health Departments COVID-19 page at https://health.oswegocounty.com/COVID-19 or call its COVID-19 Hotline at 315-349-3330. Callers may need to leave a message and a staff member will return the call.

Residents should contact their medical providers directly for personal medical advice about COVID-19 and vaccinations or booster shots.

For information about emotional supports, visit the Oswego County Department of Social Services Division of Mental Hygiene at http://www.oswegocounty.com/mentalhygiene.

Under New York State Public Health Law, the Oswego County Health Department is the local public health authority regarding the COVID-19 pandemic response within the County of Oswego. The Oswego County Health Department works closely with New York State Department of Health regarding COVID-19 monitoring, response, and reporting.

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COVID-19 Vaccinations Help Prevent Severe Illness and Keep Kids in Play - Oswego County