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Tag: booster dose

  • F.D.A approves COVID 19 booster dose for children 5 through 11

    F.D.A approves COVID 19 booster dose for children 5 through 11

    A Press Release of the FDA:

    On Tuesday, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine. 

    “While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” said FDA Commissioner Robert M. Califf, M.D. “The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age to provide continued protection against COVID-19. Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe. If your child is eligible for the Pfizer-BioNTech COVID-19 Vaccine and has not yet received their primary series, getting them vaccinated can help protect them from the potentially severe consequences that can occur, such as hospitalization and death.”   

    On Jan. 3, the FDA authorized the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for administration to individuals 12 through 15 years of age after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine. Today’s action expands the use of a single booster dose of the vaccine for administration to individuals 5 through 11 years age at least five months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine. The FDA has authorized the Pfizer-BioNTech COVID-19 Vaccine for use in individuals 5 years of age and older and has approved Comirnaty (COVID-19 Vaccine, mRNA) for use in individuals 16 years of age and older.

    “The Pfizer-BioNTech COVID-19 Vaccine is effective in helping to prevent the most severe consequences of COVID-19 in individuals 5 years of age and older,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Since authorizing the vaccine for children down to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations. The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age at least five months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups.”

    Data Supporting Effectiveness

    The EUA for a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age is based on FDA’s analysis of immune response data in a subset of children from the ongoing randomized placebo-controlled trial that supported the October 2021 authorization of the Pfizer-BioNTech COVID-19 Vaccine primary series in this age group. Antibody responses were evaluated in 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine. The antibody level against the SARS-CoV-2 virus one month after the booster dose was increased compared to before the booster dose.

    FDA Evaluation of Safety

    The safety of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine in this age group was assessed in approximately 400 children who received a booster dose at least five months (range 5 to 9 months) after completing a two-dose primary series. The most commonly reported side effects were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain and chills and fever.

    The FDA did not hold a meeting of its Vaccines and Related Biological Products Advisory Committee on today’s action, as the agency previously convened the committee for extensive discussions regarding the use of booster doses of COVID-19 vaccines and, after review of Pfizer’s EUA request, the FDA concluded that the request did not raise questions that would benefit from additional discussion by committee members. The FDA will make available on its website relevant documents regarding today’s authorization. 

    The amendment to the EUA was granted to Pfizer Inc.
     

    Related Information

  • Expert: Hard to know if COVID variant will surge in U.S. or how badly

    Expert: Hard to know if COVID variant will surge in U.S. or how badly

    BY: MARTY SCHLADEN – Ohio Capital Journal

    The last thing people want to hear right now is that the coronavirus might have mutated yet again into yet another deadly variant, extending the pain, death, and inconvenience of a pandemic that we long hoped would be over.

    However, whether the subvariant of omicron known as BA.2 will hit the United States as hard as it’s hitting other parts of the world is hard to say at this point, an expert at modeling the disease said Wednesday.

    The pandemic has been full of unpleasant surprises and BA.2 is no exception. Scientists estimate that it’s one-and-a-half times as transmissible as the original omicron strain, BA.1, and is overtaking it.

    Europe, and particularly the United Kingdom, have seen an increase in the new variant in recent months, but that hasn’t been the case everywhere, said Stephen Kissler, a research fellow in the Department of Immunology and Infectious Diseases of Harvard University’s T.H. Chan School of Public Health.

    “The question of if and when a surge is coming and how large is very open,” Kissler said in a Zoom conference with reporters. “I know that we’ve seen surges that are dominated by BA.2 across much of Europe. But in contrast, for example, in South Africa we saw a major BA.1 wave — that’s where we saw the omicron wave first — and now there’s a lot of circulation of BA.2, but it hasn’t really caused an increase in cases so much that it’s lengthened the decline and given the epidemic a very long tail.”

    Kissler explained that vaccination rates in the U.S. are lower than those in Europe, but higher than those in South Africa. That could mean that more Americans have developed antibodies against the omicron variants than have Europeans.

    “To the extent that that gives us protection against BA.2 we might see dynamics that are more similar to what happened in South Africa,” he said.

    Seasonality and other factors likely will play a role, Kissler said, with spring in the United States being a season of relatively low spread and fall a season of relatively high spread.

    So if there is a surge here of the new variant, how will it affect Americans of varying ages?

    “In many ways it will likely resemble our experience with COVID-19 up to this point,” Kissler said.

    And past experience has shown one factor to be hugely important: vaccination. 

    Kissler said that being vaccinated, along with a booster dose, “really goes a long way toward helping to protect you from symptomatic disease and especially severe disease. The biggest delineation I imagine seeing is that people who are boosted will probably fare better than people who are unboosted.”

    Another important factor is age, with the elderly having less natural resistance to all variants of the coronavirus than the young. Vaccines and boosters, though, can be a great equalizer.

    “A vaccinated and boosted person over the age of 75, their risk is probably on the order of — if not lower than — an unvaccinated 20-year-old,” Kissler said.

    COVID eventually will go from being a pandemic disease that spikes rapidly and overwhelms resources to an endemic one where a background level is present, sickening and even killing people, but in semi-predictable ways. Sadly, however, hopes that it will disappear altogether are small.

    Looking forward, one simple public-health measure might be most effective, Kissler said.

    “In many ways, one of the best things we can do to manage outbreaks is to just to continue to keep informing people how much COVID is circulating in their communities and make it just as accessible as a weather report,” he said. “A lot of data suggest that people tend to adjust their behavior accordingly.”

    He said that probably won’t be enough to quell future waves of COVID, or be adequate in the face of major new variants.

    “But as we continue to deal with COVID and we think about this permanent circulation of COVID-19 in the population — recognizing that there’s going to be different dynamics in different places, different patterns across the year — making it clear what’s happening in any given community at any given time through passive surveillance is probably the best thing we can do right now,” he said.

  • Governor provides update on COVID-19 hospitalizations and Ohio National Guard deployment

    Governor provides update on COVID-19 hospitalizations and Ohio National Guard deployment

    Ohio Governor Mike DeWine announced today that he has ordered the mobilization of an additional 1,250 members of the Ohio National Guard to support hospitals with the most critical needs across the state. The mobilization comes on the same day the state set an all-time high for the total number of COVID-19 hospitalizations during the pandemic.

    The Ohio Hospital Association reported today that 5,356 people are currently hospitalized with COVID-19. One in four patients are COVID-19 positive. This surpasses the previous hospitalizations record of 5,308 on Dec. 15, 2020. Of today’s hospitalizations, 1,228 patients are in the ICU, which is approaching the record high of 1,318 ICU patients reported on Dec. 15, 2020.

    While Southwest Ohio is not seeing the same volume of patients as northern parts of the state, Richard P. Lofgren, MD, President and Chief Executive Officer, UC Health, expressed concerns about the surge in cases making its way across the entire state during the coming weeks.

    Ohio National Guard Deployment
    As hospitals struggle with staffing to support the surge in COVID-19 patients, Governor DeWine announced during a press conference today, that he has asked Major General John C. Harris, Jr., Adjutant General, Ohio National Guard, to mobilize an additional 1,250 members of the Ohio National Guard, bringing the total deployment of National Guard members working with Ohio’s healthcare systems to 2,300 members.

    “This is not something we take lightly… We are asking them to leave their families, their jobs and homes. This is a huge sacrifice,” Governor DeWine said.

    Governor DeWine previously authorized the deployment of 1,050 Ohio National Guard members on Friday, Dec. 17. Major General Harris said the Ohio National Guard’s goal is to augment hospitals’ medical staff and wraparound services. Teams including nurses and medics will provide clinical care and non-medical teams will offer support services such as food service, patient transportation within facilities, and administrative support.

    Approximately 460 Guard members are deployed in the Cleveland area; more than 160 in the Toledo area; about 100 in Columbus area. Smaller numbers of the Guard will be deployed in the coming days in Mansfield, Dayton, and Lima to support hospitals. Guard personnel are also supporting testing sites in Cleveland and Akron.

    “The National Guard has been indispensable,” said Robert Wyllie, MD, Chief Medical Operations Officer, Cleveland Clinic.

    The Ohio Department of Health and the Ohio Hospital Association are working daily with Ohio hospitals to assess staffing needs to determine the most appropriate support from the Ohio National Guard.

    “Everybody agreed when the decision was made to send in the National Guard to our hospitals … All the way through this, we are going to be guided by where they are needed most today. It should give people confidence that everybody is on the same page here. Let’s deploy them where they are needed the most,” Governor DeWine said.

    Hospitals
    Hospitals have been taking extraordinary measures to manage this COVID-19 surge, including postponing elective surgeries, while battling staffing shortages as a result of COVID-19 infection or exposure, and burnout.  

    The northern parts of Ohio have been particularly hard hit, especially the greater Cleveland area, where one in three patients are COVID-19 positive, including ICU patients, according to OHA data.

    “The hospital systems are under significant stress in Northern Ohio,” Dr. Wyllie said. “We are running 2,000 tests a day. Let me tell you about those tests: 36% of the people going into the Walker Center for testing are testing positive for COVID.”

    Statewide, the COVID-19 positivity rate is 25%, according to Ohio Department of Health data.

    The state’s strategic hospital zone and region structure has allowed hospitals to work together with neighboring hospitals to balance the load of patients. This structure continues to be vital as cases and hospitalizations dramatically rise statewide and staffing remains a significant concern.

    While Southwest Ohio is not seeing the same volume of patients as northern parts of the state, Richard P. Lofgren, MD, President and Chief Executive Officer, UC Health, expressed concerns about the surge in cases making its way across the entire state during the coming weeks.

    “Unfortunately, the pandemic is not over … we are seeing more cases now than we have ever seen along the way,” he said. “Now, the spread of Omicron is adding fuel to this raging fire. One of the things that I want to make sure that people understand, is that this not only affects the care of people with COVID, but also affects people who don’t have COVID. It squeezes out our ability to take care of patients with other life-serious or life-threatening problems, such as heart attacks and strokes.”

    Governor DeWine also spoke with Jennifer Hollis, a critical care nurse at OhioHealth Riverside Methodist Hospital in Columbus, about her experience in the hospital.

    “I just want everybody to be able to walk a mile in my shoes and kind of understand as a critical care nurse, what I am seeing when I am coming into work. It is beyond difficult,” Hollis said. “Our beds are full. There is nowhere else to go, and we are just as short-staffed as everyone else is seeing as well … We are tired, we are frustrated, and we want the best for all of our patients.”

    Hollis urged Ohioans to get vaccinated to protect themselves, their loved ones, and their communities. “I’ll continue to fight for you, when you won’t fight for yourself. Please get vaccinated. Quarantine if you are symptomatic. Get tested,” she said.

    Vaccination, prevention
    Governor DeWine emphasized that the COVID-19 vaccines remain a powerful tool to keep people out of the hospital. Since June 1, 2021, there have been 35,962 admissions, and 92.5% of those have been among people who are not fully vaccinated.

    Now more than ever, it’s critical to follow prevention strategies including getting vaccinated, getting a booster shot if eligible, wearing face masks, washing your hands frequently, getting tested, and staying home if sick, even if symptoms are mild.

    “We are looking now at an impact of COVID-19 that is unlike anything we’ve seen before in this pandemic,” said Bruce Vanderhoff, MD, MBA, Director, Ohio Department of Health. “We have access to a powerful tool that can really shield us from the worst outcomes of COVID-19, and that is vaccination.”

    As of today, more than 6.9 million Ohioans have received at least their first dose of a COVID-19 vaccine. That’s 63% of those Ohioans eligible (ages 5 and older). More than 2.6 million have received an additional dose, or a booster dose.

    Masking in Schools
    Today, the Ohio Hospital Association also distributed a letter from the Ohio Hospital Association and Ohio Children’s Hospital Association to Ohio school superintendents, administrators and school board members encouraging them to implement a masking requirement when students return from the holiday break. A masking requirement in schools will help limit community spread of COVID-19 and keep students in school, the letter said. 

    Holidays
    Dr. Vanderhoff encouraged Ohioans to celebrate safely this holiday weekend so we can all have a healthy start to 2022. “As we get ready to ring in a new year, please, think about the steps you can take to prevent COVID-19 spread before you gather. Keeping vaccinations up to date, appropriate testing, staying home if you feel the least bit sick, masking especially in crowded indoor environments, proper ventilation, and regular handwashing can all help prevent the spread of COVID-19, flu, and other illnesses this season,” he said.