COVID-19 vaccination eligibility and information is changing all the time. Check out these local health department websites for the latest.
Click here for more COVID-19 information at Cornerstone.
May 13, 2021 – According an article by Yasmeen Abutaleb and Laurie McGinley in the Washington Post, CDC Director Dr. Rochelle Walensky announced that fully vaccinated Americans can go without masks or physical distancing in most cases, even indoors or in large groups.
As the article says, “The change represents a huge shift symbolically and practically for pandemic-weary Americans, millions of whom have lived with the restrictions for more than a year. A growing number have complained they cannot do more even after being fully vaccinated and criticized the Centers for Disease Control and Prevention of being overly cautious. More than 117 million Americans are now fully vaccinated, about 35 percent of the population.
“We have all longed for this moment when we can get back to some sense of normalcy,” CDC Director Rochelle Walensky said at a briefing. “Based on the continuing downward trajectory of cases, the scientific data on the performance of our vaccines and our understanding of how the virus spreads, that moment has come for those who are fully vaccinated.”
Walensky cited a growing body of real-world evidence demonstrating the efficacy of the coronavirus vaccines and noted the shots offer protection even against more contagious variants circulating in the United States. She also noted the rarity of breakthrough infections in people who are fully vaccinated.”
She also stated that guidelines could shift again, and that the change does not apply to airplanes, buses, trains and other public transportation, or healthcare settings. Get more details here.
CDC Director Dr. Rochelle P. Walensky issued a statement about providing COVID-19 vaccine to children aged 12 to 15. On Wednesday, May 12, 2021, she wrote:
“Today, I adopted CDC’s Advisory Committee on Immunization Practices’ (ACIP) recommendation that endorsed the safety and effectiveness of the Pfizer-BioNTech COVID-19 vaccine and its use in 12- through 15-year-old adolescents. CDC now recommends that this vaccine be used among this population, and providers may begin vaccinating them right away.
Though most children with COVID-19 have mild or no symptoms, some children can get severely ill and require hospitalization. There have also been rare, tragic cases of children dying from COVID-19 and its effects, including multisystem inflammatory syndrome in children, or MIS-C.
This official CDC recommendation follows Monday’s FDA decision to authorize emergency use of this vaccine in 12- through 15-year-old adolescents, and is another important step to getting out of the COVID-19 pandemic, and closer to normalcy.
For vaccination to do its job, we must do our critical part. That means vaccinating as many people as possible who are eligible. This official CDC action opens vaccination to approximately 17 million adolescents in the United States and strengthens our nation’s efforts to protect even more people from the effects of COVID-19. Getting adolescents vaccinated means their faster return to social activities and can provide parents and caregivers peace of mind knowing their family is protected.
Some parents have already made plans for their adolescents to receive a COVID-19 vaccine. Understandably, some parents want more information before their children receive a vaccine. I encourage parents with questions to talk to your child’s healthcare provider or your family doctor to learn more about the vaccine. And if your adolescent is behind on routinely recommended vaccines due to the pandemic or for other reasons, now would be a good time to work with your child’s nurse or doctor to make sure they get caught up.
Getting a COVID-19 vaccine is faster and more convenient than ever. About nine out of 10 Americans live within 5 miles of a COVID-19 vaccination site.”
Check back with us soon for more information on Cornerstone Family Healthcare’s plans for vaccinating teens. For patients aged 16 and up, visit our vaccination sign-up form.
As of April 27, 2021, CDC updated its recommendations for people who are fully vaccinated (two weeks after receiving two doses of Moderna or Pfizer, or one dose of Johnson & Johnson vaccine). The guidance includes an update on mask wearing in outdoor settings.
Fully vaccinated people can:
For now, fully vaccinated people should continue to:
As of April 25, 2021, CDC and the U.S. Food and Drug Administration (FDA) ended its temporary pause of Johnson & Johnson’s Janssen (J&J/Janssen) COVID-19 Vaccine in the United States. Reports of adverse events following the use of J&J/Janssen vaccine suggest an increased risk of a rare adverse event called thrombosis with thrombocytopenia syndrome (TTS). Nearly all reports of this serious condition, which involves blood clots with low platelets, have been in adult women younger than 50 years old.
A review of all available data at this time shows that the J&J/Janssen COVID-19 Vaccine’s known and potential benefits outweigh its known and potential risks. However, women younger than 50 years old should be aware of the rare but increased risk of this adverse event and that there are other COVID-19 vaccine options available for which this risk has not been seen.
CDC and FDA will continue to monitor the safety of all COVID-19 vaccines.
Mandatory Quarantine Remains in Effect for International Travelers
All Travelers Covered Must Continue to Fill Out Traveler Health Form Upon Arrival Into New York State
Governor Andrew M. Cuomo on March 11, 2021 announced that domestic travelers will no longer be required to quarantine after entering New York from another U.S. State or U.S. Territory starting April 1st. While no longer required, the NYS Department of Health still recommends quarantine after domestic travel as an added precaution. Mandatory quarantine remains in effect for international travelers. All travelers must continue to fill out the Traveler Health Form. Individuals should continue strict adherence to all safety guidelines to stop the spread – wearing masks, socially distancing and avoiding gatherings.
“New Yorkers have shown strength and perseverance throughout this entire pandemic, and it shows through the numbers that continue to decrease every day,” Governor Cuomo said. “As we work to build our vaccination infrastructure even further and get more shots in arms, we’re making significant progress in winning the footrace between the infection rate and the vaccination rate, allowing us to open new sectors of our economy and start our transition to a new normal in a post-pandemic world. As part of that transition, quarantine for domestic travelers is no longer required, but it is still being advised as an added precaution. This is great news, but it is not an all-clear for New Yorkers to let their guard down. To beat this virus once and for all we all must continue doing what we know works to stop the spread, including wearing masks, washing our hands and practicing social distancing.”
Regardless of quarantine status, all individuals exposed to COVID-19 or returning from travel must:
•Continue daily symptom monitoring through Day 14;
•Continue strict adherence to all recommended non-pharmaceutical interventions, including hand hygiene and the use of face coverings, through Day 14 (even if fully vaccinated);
•Must immediately self-isolate if any symptoms develop and contact the local public health authority or their healthcare provider to report this change in clinical status and determine if they should seek testing.
From the New York State Governor’s Office.
By LAURAN NEERGAARD AP Medical Writer
March 5, 2021 1:15 PM
Getting a mammogram or other cancer check soon after a COVID-19 vaccination? Be sure to tell the doctor about the shot to avoid false alarm over a temporary side effect.
That’s the advice from cancer experts and radiologists. Sometimes lymph nodes, especially in the armpit, swell after the vaccinations. It’s a normal reaction by the immune system but one that might be mistaken for cancer if it shows up on a mammogram or other scan.
“We need to get the word out,” said Dr. Melissa Chen, a radiologist at the MD Anderson Cancer Center in Houston who recently had to reassure a frightened patient who sought cancer testing because of an enlarged lymph node.
An expert panel from three cancer centers — MD Anderson, New York’s Memorial Sloan Kettering and Boston’s Dana-Farber — published recommendations in the journal Radiology last week on how to handle scans complicated by the side effect.
The main message: “This should not prevent patients from getting the vaccine,” stressed Chen, one of the coauthors.
Lymph nodes are part of the immune system where infection-fighting white blood cells gather, spots usually too small to feel. But they can swell during illness and after other types of vaccines. And with the anticipated jump in COVID-19 vaccinations, doctors should “prepare to see large volumes” of imaging exams — including chest CTs, PET scans and mammograms — that show swollen lymph nodes, according to similar recommendations in the Journal of the American College of Radiology this week.
The nodes most commonly affected are in the armpit and near the collarbone, on the same side as the vaccination, Chen said.
The Food and Drug Administration lists the swelling along with other injection-related reactions commonly reported in studies of the Pfizer and Moderna vaccines, although not for the Johnson & Johnson vaccine.
It’s not clear how often it happens. The FDA found 16% of participants in the Moderna study reported some underarm swelling after their second dose. But if the lymph nodes are only slightly enlarged, they may show up on a medical scan without people noticing any bumps.
The consumer advice still is evolving. Where experts agree: If you’ve recently been vaccinated, tell the radiologist before any scan. That will help them evaluate if an enlarged lymph node is probably vaccine-related and can simply be monitored, or if it’s worrisome enough for a biopsy or other test.
And try to schedule an upcoming screening or other cancer-related scan ahead of vaccination if it’s possible without losing your place in the vaccine line, the Radiology panel said.
People with active cancer that’s on one side of the body can choose vaccination on the opposite side to minimize confusion.
Don’t delay any urgent exams, radiologists stress. But there’s some disagreement about non-urgent scans. The Radiology panel said to consider scheduling purely routine screenings six weeks after vaccination. In contrast, recommendations from Massachusetts General Hospital urge handling the side effect with good communication rather than delayed screening.
Newly-announced data from Eli Lilly’s Phase III BLAZE-1 clinical trial show a combination of two of the company’s monoclonal antibodies, bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016), significantly reduced the risk of hospitalization and death in high-risk patients with newly diagnosed coronavirus disease 2019 (COVID-19).
Bamlanivimab, a recombinant, neutralizing human IgG1 monoclonal antibody, directs itself against the spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The antibody blocks viral attachment and entry of the novel coronavirus into human cells.
Bamlanivimab is a product born from a collaboration between Lilly and AbCellera, with Lilly reportedly developing the therapy in under three months following discovery by AbCellera. The antibody received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for COVID-19 in February.
Etesevimab represents another recombinant fully human monoclonal neutralizing antibody, this one licensed by Lilly from Junshi Biosciences. The antibody specifically binds to the surface spike protein receptor domain on SARS-CoV-2 and can block binding of the novel coronavirus to the ACE2 host cell surface receptor.
The study enrolled 769 high-risk patients 12 years of age and older who presented with symptomatic mild-to-moderate COVID-19. A total of 511 patients were randomly assigned to a combination of bamlanivimab 700 mg and etesevimab 1400 mg, while 258 patients were randomized to placebo. Treatments were administered in the outpatient setting and early in the course of the disease.
The primary outcome was the proportion of patients who experienced hospitalization or death from any cause by day 29.
Researchers observed four events in the bamlanivimab with etesevimab arm versus 15 events in patients taking placebo. This meant that treatment with the combination regimen led to an 87% reduction in the risk of hospitalization or death (p<0.0001). Key secondary endpoints – viral load, time to sustained symptom resolution, COVID-19-related hospitalization, and emergency room (ER) visit or death from any cause – were also improved with the monoclonal antibody combo.
The company said the findings were consistent with data from other analyses of the BLAZE-1 trial, including a previous Phase III cohort showing that treatment with bamlanivimab 2800 mg with etesevimab 2800 mg significantly reduced the risk of hospitalizations and deaths by 70%. A previous Phase II cohort also found that bamlanivimab monotherapy significantly reduced the risk of hospitalizations and ER visits by 70%.
There were four total deaths in the new Phase III cohort; these deaths were all attributable to COVID-19 and occurred in only patients who took placebo. To date, there have been no recorded deaths in patients who received bamlanivimab and etesevimab together in two Phase III cohorts of the BLAZE-1 trial.
In contrast, there have been 14 deaths in patients who have received placebo, with 13 of these events deemed related to COVID-19.
According to the company, the new findings from the BLAZE-1 trial offer additional safety and efficacy data to support the use of the studied dose recently granted EUA by the FDA. Additionally, the studied dose was also given a positive scientific opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
“These compelling data – in addition to the recent EUA from FDA, the CHMP decision from EMA and the recommendation for the therapy in the National Institutes of Health’s COVID-19 Treatment Guidelines – give healthcare providers additional information regarding the use of bamlanivimab and etesevimab together as a potentially life-saving treatment to help those most at risk for severe complications of COVID-19,” said Lilly’s chief scientific officer Daniel Skovronsky, M.D., Ph.D., who also serves as president of Lilly Research Laboratories “The consistent results observed in multiple cohorts of this trial over several months, even as new strains of COVID-19 have emerged, indicate bamlanivimab with etesevimab maintains its effects against a range of variants, particularly those circulating in the U.S.”
Dr. Avi Silber, Chief Medical Officer, also notes:
“St. Luke’s has a program that gives a 1 hour intravenous infusion of antibodies against COVID. The medicine is called Bamlanvimab, but we call it “Bam Bam” for simplicity. This medicine, and ones like it are given to patients who are newly diagnosed with COVID and are at high risk for severe disease as an option for treatment. It is still new , and under Emergency Use authorization by the FDA. but it has been shown to reduce risk of hospitalization or ER Visits by 70%. At St. Luke’s they have used this treatment with a lot of success. Out of 140 high risk patients treated only one ultimately ended up needing admission.
• “BAM BAM” treatment is meant only for people who are at high risk for getting sick from COVID . This includes people over 65 years old, diabetics, people with high blood pressure, COPD, Obesity and others.
• The earlier the treatment the better. This is meant for preventing high risk people from getting sick, so the idea is to give it before patients get worse, although it can be given as late at 10 days into the disease
• If someone you know is high risk and contract COVID encourage them to discuss this option with their provider right away.
• Vaccination and preventative measures are still the best way to avoid getting sick from COVID.”
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To be contacted when a COVID-19 vaccine appointment is available at Cornerstone, fill out the form below.
Para contactarlo cuando haya un cita disponible para la vacuna del COVID-19 en Cornerstone, por favor llene el formulario abajo.