A highly anticipated clinical trial in eight sub-Saharan countries is the first to specifically evaluate the efficacy of a COVID-19 vaccine in people living with HIV, including those with poorly controlled infections. It also is the first study to evaluate the efficacy of vaccines in this case, Moderna mRNA-1273 against the omicron variant of SARS-CoV-2, the virus that causes COVID-19.
In addition to examining the efficacy of COVID-19 mRNA vaccines in people living with HIV, the study investigators seek to identify the optimal regimen for this population and how it might vary based on whether an individual has previously had COVID-19 or not.
The trial will be conducted in East and Southern Africa regions of the world that have been highly impacted by HIV. It is expected to enroll about 14,000 volunteers at 54 clinical research sites in South Africa, Botswana, Zimbabwe, Eswatini, Malawi, Zambia, Uganda and Kenya, where adult HIV prevalence ranges from 4.5% to 27%.
The study name, Ubuntu, borrows the Nguni word meaning 'I am because you are,' and embraces the concept of African coexistence and community. It refers to the interconnectedness of African nations and their collaborative efforts to combat HIV and COVID-19 in this region of the continent.
Sub-Saharan Africa has been hit hard by the COVID-19 pandemic, but access to effective vaccines, especially mRNA technology, has been very limited. The Ubuntu trial will provide safety data to regulators and assess correlates of protection from COVID-19, and it will answer important questions on mRNA vaccine dosage regimens among people living with HIV."
Dr. Nigel Garrett, co-chair of the study and head of Vaccine and HIV Pathogenesis Research at the Center for the AIDS Program of Research in South Africa (CAPRISA)
To find these and other answers, the study is expected to enroll about 12,600 people living with HIV and about 1,400 who are HIV-negative. About 5,000 of the volunteers will have previously had COVID-19, confirmed by an antibody blood test done at initial enrollment. All participants will receive the Moderna vaccine, but dosages and schedules will vary depending on previous SARS-CoV-2 infection. Organizers said study participants living with HIV will receive access to optimal HIV treatment throughout the course of the trial.
"This region faces a huge HIV burden," said Dr. Glenda Gray, Ubuntu study protocol lead adviser and president of the South African Medical Research Council (SAMRC). "Although safe and effective vaccines have been developed for COVID-19, HIV and COVID-19 are on a collision course," she added. "The impact of COVID-19 on people living with HIV is a concern for the continent, particularly in light of the recently-sequenced omicron variant set to drive South Africa's fourth wave and further infections globally."
Dr. Philip Kotz, one of the lead study investigators, said the Ubuntu study would not be possible without the crucial participation of rural communities across Southern and East Africa. "These communities have been disproportionately impacted by the twin pandemics of HIV and COVID-19, and they now have an unprecedented opportunity to help advance science and improve our understanding of the immune response to SARS-CoV-2 in the context of HIV."
Dr. Larry Corey, principal investigator of both the HIV Vaccine Trials Network (HVTN) and the COVID-19 Prevention Network (CoVPN), and co-leader of the network's vaccine testing pipeline, said there currently are no U.S. government-sponsored studies of COVID-19 vaccines that quantitate vaccine efficacy among a diverse population of people infected with HIV. This study seeks to address this knowledge gap and establish whether mRNA vaccines are as effective in people living with HIV, particularly those with advanced disease, as they are in those who are HIV-negative.
The trial is sponsored by the SAMRC and funded by the U.S. government and supported by the National Institute of Allergy and Infectious Diseases (NIAID) within the National Institutes of Health. Funding originates from the Department of Health and Human Services (HHS) through the Countermeasures Acceleration Group (CAG).
"Vaccination and treatment are critical for those who face the dual threat of HIV and COVID-19, as they remain at high risk of acquisition and transmission and potentially can be the origin of future variants," Corey said. "It is imperative that we as scientists and as society double-down on global efforts to find and make available effective vaccines and treatments. This study represents an important step forward in our efforts to reduce the burden of COVID-19 among HIV-infected persons and understand whether current dosage regimens are adequate."
The Ubuntu study is led by the NIH's CoVPN and modeled on extensive community engagement protocols pioneered and successfully implemented by the CoVPN and its research partner, the HVTN. Both networks are headquartered at the Fred Hutchinson Cancer Research Center in Seattle, Washington.
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Texas youngest students could once again be in the middle of a federal and state tug-of-war over vaccine and masking requirements.
Head Start, a federal program that works to get children ready for school by age 5, rolled out new rules in late November that require anyone older than 2 to wear a mask and all employees to be fully vaccinated by the end of January.
While the early childhood program is funded with federal money, many Texas-based programs are run by local school districts or community groups. Those running Head Start programs in the state are weighing the new federal rules against Gov. Greg Abbotts executive orders that prohibit mask mandates and vaccine requirements.
The new rule will have a broad impact on the nearly 280,000 staff and contractors who work for Head Start across the nation, including thousands in Texas. Nearly 21,000 workers are part of Head Start across Texas with almost 80,000 seats for eligible children.
Abbotts spokeswoman Renae Eze pointed to recent court injunctions against federal COVID-19 regulations as evidence that courts agree the Biden administration is overstepping their constitutional authority and attempting to trample Americans right to choose for themselves whether to get vaccinated.
Having spent his entire time in office fighting for the rights and freedoms of all Texans, the governor will not abandon Texans worried about putting food on the table, and our office is working with the Office of the Attorney General to continue that fight, Eze said. She did not clarify whether Abbott and Attorney General Ken Paxton plan to sue the federal government over the new Head Start rules.
Paxton did not respond to a request for comment.
The conflicting guidance and state orders could put Texas Head Start providers in a tricky position. Some are still deciding how to move forward.
In Plano, administrators are working with their legal counsel to determine how to implement the new federal requirements, said spokeswoman Rosemary Gladden. The district is in the process of working with employees to meet the Jan. 31 vaccination deadline.
Dallas ISD has continued to require universal masking on all its campuses, in defiance of Abbotts order. So the new Head Start rules wont make a difference in DISD-run centers when it comes to face coverings.
Elena Hill, who oversees early learning, said officials are taking time to work through the requirements.
The vaccination requirement is definitely whats going to be most in play, she said. We do encourage vaccinations here in the district, and we have provided incentives for staff to receive them -- but its not been mandated. Thats definitely the point that well have to just really discuss to see what type of impact that will have.
Duncanville ISD also continues to require masks when inside district facilities. Its Head Start management is working with teams to comply with the mandate, officials said.
Head Start aims to help children most in need of additional support to be prepared for school, such as those who are living in poverty. The public comment period on the federal rules for the program is open through December.
ChildCareGroup, a 120-year-old organization that operates Head Start programs across North Texas, sought legal advice on how the mandate applied to the organization, president and CEO Tori Mannes said.
Lawyers advised that the mandate did apply to ChildCareGroup, so to ensure the continuation of federal funding -- and to protect their students and staffs health -- the organization will be in full compliance with the new rules, she said.
We are educating and caring for children who are birth to 5, and they are too young to receive the vaccine, Mannes said. We think its important that our teachers and everyone who is around those children do everything that we can do to help ensure the safety of the young children we serve.
Exemptions to the federal rules are allowed for medical conditions or religious beliefs, but those with approved exceptions will have to comply with a weekly testing requirement.
The goal of these new regulations is to surround children with vaccinated adults to reduce the transmission of COVID-19 from staff to children and their families, Head Start officials said during a recent webinar.
We feel strongly and know that this will result in fewer closures at Head Start programs, reduced transmission would support fewer closers, which really create instability and stress for children and families, Kate Troy, an official with Head Start, said on the webinar.
The Head Start office plans to monitor the new vaccine and mask requirements in the same way it monitors other health and safety requirements included in its regulations, officials said. Individual programs must document vaccination status, including exemptions granted.
The Office of Head Start does not issue financial penalties for non-compliance but offers support and training to help programs meet guidelines, spokeswoman Lorri Crowley said.
In response to questions about state laws or orders that prohibit vaccine requirements, Head Start federal officials said the supremacy clause of the U.S. Constitution preempts any state law to the contrary.
Executive orders from Gov. Abbott and several lawsuits filed by Attorney General Paxton have challenged masking and vaccine protocols both from the federal government and local education systems.
After a federal judge issued an injunction on Abbotts ban on school mask mandates, judges with the U.S. 5th Circuit Court of Appeals halted the lower court ruling, putting Abbotts mandate back in effect at least temporarily.
Another one of Abbotts executive orders prohibits any entity in Texas from requiring COVID-19 vaccines.
In November, Paxton and several other states attorneys general sued the Biden administration to block a federal Occupational Safety and Health Administration rule that would have required companies with more than 100 employees from requiring workers to get coronavirus vaccines or get tested for COVID-19 each week. Judges with the 5th Circuit temporarily blocked the rule.
Since then, almost every single Republican state representative has backed legal arguments that urge a federal appeals court to strike down the workplace vaccine requirement.
But Head Start officials have said the injunction doesnt impact their own regulations, which are independent of the OSHA regulation.
The DMN Education Lab deepens the coverage and conversation about urgent education issues critical to the future of North Texas.
The DMN Education Lab is a community-funded journalism initiative, with support from The Beck Group, Bobby and Lottye Lyle, Communities Foundation of Texas, The Dallas Foundation, Dallas Regional Chamber, Deedie Rose, The Meadows Foundation, Solutions Journalism Network, Southern Methodist University and Todd A. Williams Family Foundation. The Dallas Morning News retains full editorial control of the Education Labs journalism.
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Dec 14, 2021, 3:16amUpdated 7h ago
By: News 12 Staff
The COVID-19 vaccination requirement for indoor public spaces in New York City will extend to kids ages 5 to 11 starting Tuesday.
Parents will have to show proof that their child has received at least one dose of the vaccine before entering certain indoor places. If they dont have proof, this means dining inside restaurants is off limits.
This is the next step in Mayor Bill de Blasio's Key to NYC initiative, which did not impact younger kids until this week.
The rule will be enforced whenever children enter any indoor gyms, entertainment venues and restaurants.
While this could pose a challenge for some families against vaccinating their kids, some residents told News 12 they understand the need.
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Proof of COVID-19 vaccination for kids ages 5-11 begins Tuesday in NYC - News 12 Bronx
The AP Interview: CDC Director on booster expansion
The U.S. is expanding COVID-19 boosters, opening a third dose of Pfizer's vaccine to people as young as age 16. (Dec. 9)
AP
Nine-year-old Elian Jarvis rolled up his sleeve, took one deep breathand closed his eyes just before the needle entered his little arm.
He didnt flinch or grimace, and the whole thing took a little over a second for him to be vaccinated from COVID-19.
But his little brother Benson wasnt so confident. The 6-year-old climbed up on his dads lap and was in near tears awaiting his COVID vaccine shot.
It wasnt until he looked over at his big brother that calm set in.
The shot took far less time than it did to pick out what flavor sucker Benson wanted.
Dont let these shots bother you, said Elian, who wanted to reassure children around his age. Just let it (the fear) go. It doesnt hurt at all. It will be fine.
The Jarvis boys were just two of about 1,500 children between the ages of 5 and 11 who received their second COVID vaccination shots on Saturday at a clinic in Westerville sponsored by Central Ohio Primary Care (COPC).
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It was the final event as part of a COPC clinic series that started about a year ago. Altogether, the program held 137 clinic days that distributed about 60,000 free vaccine shots for between 30,000 and 40,000 people.It's a process that COPC officials say can help protect the vaccinated or save someone else.
The clinicswere open to the public and people had to register in advance, which eliminated the lines seen at some other vaccination events around the nation.
But Saturdays clinic was all about the young children, who started walking in with their parents at 8 a.m. Once inside, families were escorted to one of the dozen or so vaccination stations, where the entire process took just a few minutes.
Our kids werent excited to get a shot but they understood what it meant, said Melissa Madden, program director for nursing services at COPC. I think the kids understand its not just about them. Its about making sacrifices for each other.
To date, around 15.95% of Ohio kids ages 5 to 11 have started the vaccine, meaning159,110 have received at least one dose, according to the Ohio Department of Health.
So far, 246,841 Ohio kids from infants to age 17 have contracted COVID, 2,386 have been hospitalized and 20 have died, the state health department reports.
If enough children get vaccinated, it could result in an8% decline in cases by March 2022 across the U.S.,according to estimates from the Centers for Disease Control and Prevention.
And as the number of COVID cases have continued to rise in recent weeks in Ohio and in many other places nationwide, so has the demand for the childrens vaccine both locally and nationally, according to Dr. Don Deep, COPCs Senior Medical Director .
We are trending in the right direction with getting children vaccinated, Deep said. Its the best way to keep our community safe and healthy.
Many parents say thebest way to approach children about getting vaccinated is to be honest. They said most children are already used to receiving shots for other vaccinations, and the COVID vaccine shouldnt be portrayed as something that can heighten their anxiety.
I think its the best way to come out of this pandemic as quickly as we can, and our girls understand that, said Karen Tackett, of Galena, whose daughters Leila, 10, and Eva, 6, just received their second shots. And this is the best way to protect one another.
Meanwhile, the Jarvis boys were enjoying their post-shot suckers in the waiting area with their dad, Jason Jarvis.
He said his sons sadly understood the importance of the vaccine because they lost a great-grandparent to COVID last year.
Im proud of them for handling this so well, said Jason, an elementary school teacher, who has been vaccinated and has had the booster.
Little Elian again offered what medical say is the best advice.
You should just get the shot, he said. Its going to be OK.
@MikeWagner48
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A Navy commander on a ship's leadership team was fired on Friday after he refused to get the COVID-19 vaccine and refused testing for the virus, the first member of the sea service to be punished for refusing to comply with COVID-19 rules.
Commander Lucian Kins was relieved of his duties as second in command of the destroyer USS Winston Churchill because the head of Naval Surface Squadron 14, Capt. Ken Anderson, lost confidence in Kins' ability to perform his duties, according to Navy spokesman Lt. Cmdr. Jason Fischer. Fischer declined to give the precise reason why Kins was fired, citing privacy concerns.
Other officials said Kins refused to get the COVID-19 vaccine, refused testing for the virus and had applied for a religious exemption to the Pentagon's vaccine mandate. That request was denied, although Kins is reportedly appealing the decision, according to a report from Stars and Stripes.
Navy personnel had until late November to comply with the Department of Defense COVID-19 vaccine requirement or request exemptions. No religious exemptions have been given by any branch of the military services despite thousands of applications from service members.
Fisher said Kins has been reassigned to the staff of Naval Surface Squadron 14.
Attempts to reach Kins were unsuccessful on Monday.
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For the 1st time, the Navy fired an officer who refused to get COVID-19 vaccine - Business Insider
The Houston Rockets were among the first NBA teams to be fully vaccinated against COVID-19 entering the 2021-22 season, and they are one of the first known teams to have 100% coverage among players for the recommended coronavirus vaccine booster shots.
Beginning Dec. 17, players around the league who have not received a booster dose will be subject to COVID-19 testing on game days, even if they were previously considered fully vaccinated. This would add burdensome logistical requirements and could potentially lead to a player being more likely to miss games, depending on the result.
However, the Rockets will not be subject to these new protocols. The news of the teams players all receiving the booster was first reported by Jonathan Feigen of the Houston Chronicle and confirmed by head coach Stephen Silas at Mondays game day shootaround in Atlanta.
Everybodys done, Silas said on Monday, Dec. 13, as relayed by Feigen. Its good. Theres all these cases (and) were definitely conscious of whats going on around the league, for sure.
The Chicago Bulls have had their next two games postponed due to a COVID-19 outbreak among Tier 1 players and staffers.
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Rockets have all received COVID-19 vaccine boosters: Stephen Silas - Rockets Wire
GAITHERSBURG, Md., Dec. 13, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it has submitted a regulatory filing to the Ministry of Health and Prevention (MoHaP) for emergency use of its COVID-19 vaccine in the United Arab Emirates (UAE).
"The rapid emergence and continuedspread of variants is a stark reminder that no one is safe until everyone is safe in the fight against COVID-19," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We remain committed to delivering our vaccine, which is based on a proven, well understood platform, to countries around the world as we anticipate that ongoing vaccination will be necessary over the long term to end the pandemic."
Novavax made the submission for the regulatory evaluation by MoHaP of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant. The filing includes clinical data from two pivotal Phase 3 clinical trials: PREVENT-19, which included 30,000 participants in the U.S. and Mexico and demonstrated 100% protection against moderate and severe disease, 93.2% efficacy against the predominantly circulatingvariants of concern and variants of interest, and 90.4% efficacy overall; and a trial of 15,000 participants in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall. In both trials, NVX-CoV2373 demonstrated a reassuring safety and tolerability profile.
Novavax and Serum Institute of India Pvt. Ltd. (SII) recently received Emergency Use Authorization (EUA) for the vaccine inIndonesiaand thePhilippines, and the companies have filed for EUA inIndiaand for Emergency Use Listing (EUL) with theWorld Health Organization(WHO). Novavax also announced regulatory filings for its vaccine in theUnited Kingdom,Australia,New Zealand,Canada, theEuropean Union, Singapore and with theWHO.Additionally, Novavax and SK bioscience announced a Biologics License Application (BLA)submission to MFDSinSouth Korea. Novavax expects to submit the complete package to the U.S. FDA by the end of the year.
The chemistry, manufacturing and controls (CMC) data package submitted to MoHaP and other global regulatory agencies leverages Novavax' manufacturing partnership with SII, the world's largest vaccine manufacturer by volume. It will later be supplemented with data from additional manufacturing sites in Novavax' global supply chain.
About the NVX-CoV2373 Phase 3 trials
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall; and the PREVENT-19 trial in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease, 93.2% efficacy against the predominantly circulatingvariants of concern and variants of interest, and 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response.
About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2- 8 Celsius, enabling the use of existing vaccine supply and cold chain channels.
About Matrix-M Adjuvant
Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
About Novavax
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. NVX-CoV2373, the company's COVID-19 vaccine, received Emergency Use Authorization in Indonesia and the Philippines and has been submitted for regulatory authorization in multiple markets globally. NanoFlu, the company's quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Novavax is currently evaluating a COVID-NanoFlu combination vaccine in a Phase 1/2 clinical trial, which combines the company's NVX-CoV2373 and NanoFlu vaccine candidates. These vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
For more information, visitwww.novavax.comand connect with us on Twitter,LinkedIn, Instagram and Facebook.
Forward-Looking StatementsStatements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the ongoing development of NVX-CoV2373, the scope, timing and outcome of future regulatory filings and actions, Novavax' plans to submit a complete package to the U.S. FDA by the end of the year, and Novavax' plan to supplement the CMC data submitted to the MoHaP with data from the additional manufacturing sites in Novavax' global supply chain are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax' Annual Report on Form 10-K for the year ended December 31, 2020 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at http://www.sec.gov and http://www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
Contacts:
InvestorsNovavax, Inc.Erika Schultz| 240-268-2022[emailprotected]
Solebury TroutAlexandra Roy| 617-221-9197[emailprotected]
MediaAlison Chartan| 240-720-7804Laura KeenanLindsey | 202-709-7521[emailprotected]
SOURCE Novavax, Inc.
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Novavax Files for Emergency Use of COVID-19 Vaccine in the United Arab Emirates - PRNewswire
The mRNA COVID-19 vaccine induced a strong antibody response in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), according to observational study results presented during the 2021 ASH Annual Meeting.
Among 46 patients with AML or MDS vaccinated against COVID-19 at Moffitt Cancer Center, 69.6% were seropositive after the first vaccine dose, meaning that COVID-19 markers were found in their blood. This improved to 95.7% after the second vaccine dose, reported Dr. Jeffrey Lancet, at a press briefing delivered during the meeting. Seropositivity indicates that the vaccinated individual is forming antibodies to fight the virus that causes COVID-19.
Antibody levels increased dramatically following the second vaccine dose, which indicated the potential utility of serial vaccination with good efficacy in poorly responsive patients after the first vaccine dose, said Lancet, chair of the Department of Hematologic Malignancies at Moffitt Cancer Center.
Antibody titer levels were at a mean of 3,806 after the second vaccine dose, compared with 315 after the first dose, and these levels did not differ between patients with AML or MDS.This difference was observed across different clinical and laboratory variables, including neutropenia, lymphopenia and subsets.
These are promising findings, considering that previous study results have shown that patients with other hematologic malignancies, such as multiple myeloma, may not have as strong responses to the COVID-19 vaccine.
Patients with myeloid malignancies, including AML and MDS, based on evolving data, are at high risk of severe COVID-19 infection and death, Lancet said. Patients with AML and MDS frequently have quantitative and/or qualitative deficiencies of the white blood cells, including the neutrophils and sometimes the lymphocytes as well, as a result of either the disease itself or the treatment of the disease. Its unclear whether these deficiencies would result in poor immune response to the COVID-19 vaccine, and to date, there has been very little reported on vaccine efficacy amongst patients with AML and MDS.
The group of patients with AML or MDS in the study were part of a larger study of the immune response to mRNA-1273 vaccination in all patients with cancer. Of the 46 patients with myeloid malignancies included, 32 had AML and 14 had MDS and were, on average, about two years from diagnosis.
The average age at vaccination for the entire group was 68 years. Patients were vaccinated between Jan. 12 to 25, 2021. More than half of the patients were male (58.7%) and 95.7% were White. The median time from diagnosis to the start of vaccination series was 24.3 months, with a range of 4.5 to 105 months.
Fifteen patients were on active treatment for their disease at the time of vaccination. A total of 32 patients (69.6%) had undergone allogeneic stem cell transplantation (SCT) for their disease. Average time since allogeneic SCT for the entire group was 17 months. Forty patients (87%) were in remission at the time of vaccination. Two patients with AML relapsed post-vaccination.
Blood specimens were collected from patients prior to the first and second vaccine doses (days 1 and 29) and approximately 28 days after the second vaccine dose (day 57) for antibody analyses.
The seroconversion rate which measures the time between exposure/vaccination and the presence of antibodies was not affected by age, gender, race, disease status, time to vaccination from disease diagnosis, number of prior lines of therapy, receipt of active therapy at the time of vaccination (including targeted therapies), neutrophil and lymphocyte counts, and transplant history, Lancet said.
In the patients who did not respond to the first vaccine dose, there were suggestions of patients that had either been on steroid therapy or immunosuppression as potential contributing factors to not converting after the first dose, but just about everybody converted after the second dose, he said.
Antibody levels were significantly higher in patients with solid tumors in the study after the first vaccine dose compared with patients with AML/MDS, but this difference in antibody response disappeared after the second dose, said Dr. Akriti Jain, a hematology/oncology fellow at Moffitt Cancer Center, during the oral abstract presentation.
The most common side effects following vaccination were mild injection site pain (57.5%), fatigue (40%), headache (25%) and arm swelling (27.5%).
Even though therapy prior to vaccination did not affect antibody levels, the few patients on active treatment included in the study is a potential limitation, Lancet explained. In addition, patients on active aggressive therapy (such as BCL-2 inhibitors) were not included because they were not being vaccinated at that time.
The findings need to be confirmed in a larger and more diverse group of patients, the authors concluded.
A version of this article as originally published on OncLive as, Strong Antibody Response to mRNA COVID-19 Vaccine Observed in AML, MDS.
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At least 90% of adults in Maryland have received one dose of their COVID-19 vaccine, according to the Office of Gov. Larry Hogan.
At least 90% of adults in Maryland have received at least one dose of their COVID-19 vaccine, according to the Office of Gov. Larry Hogan.
Hogan celebrated the milestone in a Saturday news release, saying that Even as we continue to urge booster shots, we are also very focused on getting the remaining unvaccinated individuals vaccinated.
As part of our commitment to leave no arm behind, we will work to get that last remaining 10% vaccinated. This continues to be the single most important thing you can do to protect yourself, your family, and your fellow Marylanders, Hogan continued.
The state identifies adults as everyone who is 18 or older who received their first shot.
Booster shots are also on the rise in Maryland with 60% of the states eligible seniors having received one. On Thursday, Hogan expanded eligibility for boosters to include anyone 16 and older.
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Looking for more information? D.C., Maryland and Virginia are each releasing more data every day. Visit their official sites here: Virginia | Maryland | D.C.
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