Category: Covid-19 Vaccine

DAKAR, Dec 13 (Reuters) - At least 200,000 COVID-19 vaccines have expired in Senegal without being used in the past two months and another 200,000 are set to expire at the end of December because demand is too slow, the head of its immunisation programme said on Monday.

African governments have been calling for more COVID-19 vaccines to help catch up with richer regions, where vaccine rollouts have been humming along for more than a year.

Yet, as the pace of supply has picked up in recent weeks some countries have struggled to keep pace. Logistical problems, the short shelf life of vaccines that arrive from donors, and vaccine hesitancy have all kept doses from reaching arms.

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Up to 1 million COVID-19 vaccines expired in Nigeria last month, Reuters revealed.

"The main problem is vaccine hesitation," said Ousseynou Badiane, who is in charge of Senegal's vaccine rollout. "The number of cases is decreasing. They ask: 'why is it important to get vaccinated if the illness is not there now'?"

The majority of the expired doses were made by AstraZeneca (AZN.L) and supplied via COVAX, the dose-sharing facility led by the GAVI vaccine alliance and the WHO, he said.

Low vaccination rates in Africa will help prolong the pandemic and raise the risk of new variants emerging, such as the Omicron variant that was first identified in southern Africa and Hong Kong and is now spreading in many countries.

'NOT OPTIMISTIC'

Senegal has recorded more than 74,000 COVID-19 infections and 1,886 deaths, far below the numbers seen in many nations hit harder by the virus. The pace of infection has dropped off since a third wave in July spurred a spike in vaccine demand. The country occasionally records no new daily cases.

But apathy hurts the vaccination drive. Senegal has administered nearly 2 million doses of vaccines so far, Reuters data shows, enough to fully vaccinate only about 5.9% of the population.

It is currently vaccinating between 1,000 and 2,000 people per day, Badiane told Reuters, down from 15,000 during the summer. At this pace, it cannot use all the vaccines it has.

"We are not optimistic" about using the other 200,000 doses before they expire at the end of the month, he said. "We don't expect any demand increase before then."

Part of the problem is the short shelf life of vaccines that arrive from donors that include the United States and China. Senegal refuses to take vaccines with a shelf life shorter than three months, but even that creates difficulties.

Badiane hopes the government can introduce some kind of restrictions on the unvaccinated to drive up inoculation rates, including the use of a health pass as many other countries have done.

"Without the restriction, the population will not get vaccinated," he said.

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Reporting By Edward McAllister; Editing by Alex Richardson

Our Standards: The Thomson Reuters Trust Principles.

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Exclusive: Senegal expects 400000 COVID-19 vaccines to expire by year-end - Reuters

In the northern hemisphere, the arrival of winter has brought concerns about COVID-19 back to the forefront, with multiple countries reporting high case rates and warning of increasing pressure on hospital services.

The situation prompted Austria, a small EU member state where the daily infection rate neared 15,000 in mid-November, to go for the nuclear option it not only reimposed a three-week lockdown, but also made vaccines mandatory for adults from February 2022 in an attempt to increase its national vaccination rate, which currently stands at 66 percent.

The emergence of the latest COVID-19 variant of concern, Omicron, further ramped up the pressures on governments to make decisive interventions before their health systems are overwhelmed. With its unusually high levels of mutations, the Omicron variant might mean faster transmission and higher resistance to our current crop of vaccines. Thankfully, initial research from South Africa suggests that existing vaccines and boosters should still provide some measure of protection from hospitalisation or worse. Moreover, modern development and production methods should allow for the creation of an adjusted vaccine in a matter of months rather than years.

But many developed countries where vaccines are readily available have seen a relatively modest uptake. EU members Romania and Bulgaria, for example, have under 40 percent of their populations fully vaccinated. Dr Anthony Fauci, chief medical adviser to the President of the United States, reckons lasting community protection can be reached only after nearly 90 percent of the population is jabbed.

Thus, as they try to mitigate the threat posed by high case rates and the spread of Omicron, governments are introducing new policies to increase vaccination uptake in their countries.

The relatively politically palatable option of requiring vaccine passports for entering certain venues and shops, and thereby making the lives of unvaccinated people more restricted, has already been used extensively across Europe, despite it triggering significant protests in many countries, including Italy, Croatia and the Netherlands.

Policymakers in many countries may, therefore, be tempted to follow Austrias lead and introduce vaccine mandates in the near future to reduce hospitalisation rates and avoid more economically damaging restrictions. EU Commission President Ursula von der Leyen has already called for a debate on mandatory vaccines and Germanys new chancellor, Olaf Schulz, also voiced support for vaccine mandates.

Yet, government-imposed vaccine mandates can have serious long-term consequences they can brew social unrest, increase mistrust in government, and scar societies as severely as the pandemic itself.

In Austria, draft legislation has suggested that those unvaccinated would be summoned to some administrative authority and could eventually incur fines of up to 3,600 euros (about $4,060). With millions still unvaccinated, it may not take long for hundreds of thousands of Austrians to be reprimanded. Tens of thousands of Austrians have already been protesting, sensing a government overreach.

Most people who are hesitant to take the COVID-19 vaccine are not loud, somewhat unhinged anti-vaxxers who worry about being implanted with tracking chips through the jab. Many of them are sincerely concerned about introducing something new into their bodies, or simply want to understand the risks and benefits of the jab better. But vaccine mandates can change that. If governments impose vaccines on vaccine-hesitant people in a heavy-handed way, they may become more vulnerable to fake news or conspiracy theories, and end up joining more extreme anti-vax movements.

Rather than forcing the vaccine on people, policymakers should try to understand why people might be hesitant to take it, and focus their efforts on changing minds. This could help drive longer-term vaccination uptake, which will be crucial especially if annual COVID-19 vaccine boosters are needed.

The moment a government recommendation becomes a forced requirement, it changes the power dynamic between the state and the individual. Government-imposed mandates feel inherently sinister, even when the intentions behind them are wholly well-meaning. This is why even the World Health Organization (WTO) has cautioned against implementing COVID vaccine mandates, unless every other feasible option has been tried to convince people to get jabbed.

Vaccine mandates may make some people trust institutions less, which can in turn further reduce vaccine uptake. A study on attitudes to vaccination in Europe, published in Social Science & Medicine Journal in 2014, has shown that those who trust institutions involved in the vaccination process are more likely to be jabbed, and those who do not suffer an information deficit and become more vaccine-hesitant.

The continuing debate on vaccine mandates in wealthy nations also feels jarring in the face of poorer countries continuing lack of access to vaccines. Indeed, the share of people who received one dose of COVID-19 vaccine is already more than 76 percent in high-income countries, but stands at just 6 percent in low-income ones.

COVAX an initiative led by WHO to reduce vaccine disparity between high- and low-income countries initially aimed to distribute 2.2 billion COVID-19 vaccine doses to countries unable to independently procure them by the beginning of 2022. But this lofty ambition has since been revised to 1.4 billion doses, partly due to supply issues. WHO is now concerned that the emergence of Omicron will lead to richer countries hoarding more jabs, which will exacerbate the inequality of vaccine distribution.

On the bright side, the toolkit for tackling COVID-19 is constantly growing, which can help countries with low vaccination rates. Antibody treatments, including the UKs recently approved Xevudy drug from GSK, has been found to reduce hospital admission and death by nearly 80 percent in high-risk adults. The easily consumed oral anti-viral drug molnupiravir has also been found to reduce the risk of serious illness by at least a third.

In an ideal world, everyone who has access to a safe vaccine that can protect them against COVID-19 and help mitigate the spread of the virus would take it. But in the real world, where many people have existing fears about vaccines and are routinely exposed to misinformation, getting everyone to accept the jab is not an easy task.

Forcing people to get vaccinated by imposing harsh penalties and restrictions, however, may do more harm than good. It can confirm peoples fears that the government elite is against them, or that they are losing their rights and liberties. All this could result in those who are vaccine-hesitant today becoming even more reluctant to follow the advice of authorities during future health crises.

Public health programmes require public consent to succeed. Governments that are currently considering imposing COVID-19 vaccine mandates should therefore be aware that, while tempting in the short term, such policies can have grave consequences for us all in the long term.

The views expressed in this article are the authors own and do not necessarily reflect Al Jazeeras editorial stance.

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Mandatory COVID-19 vaccines are not the solution - Al Jazeera English

Acceptability of the COVID-19 vaccine among patients with chronic rheumatic diseases and health-care professionals: a cross-sectional study in 19 Arab countries  The Lancet

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Acceptability of the COVID-19 vaccine among patients with chronic rheumatic diseases and health-care professionals: a cross-sectional study in 19 Arab...

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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Trial in sub-Saharan Africa evaluates the efficacy of COVID-19 vaccine in people living with HIV - News-Medical.Net

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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Will new Head Start rules on masks and COVID-19 vaccines trigger another Texas lawsuit? - The Dallas Morning News

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.

mwagner@dispatch.com

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'You should just get the shot. It's going to be OK,' Ohio kids are getting the COVID-19 vaccine - The Columbus Dispatch

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

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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mRNA COVID-19 Vaccination Sparks Strong Antibody Response in Patients With AML and MDS - Curetoday.com