Many parents and pediatricians are clamoring for protection for children younger than 12, today’s age cutoff for the vaccine made by Pfizer and its German partner BioNTech. Not only can youngsters sometimes get seriously ill, but keeping them in school can be a challenge with the coronavirus still raging in poorly vaccinated communities.
Pfizer announced in a tweet that it had formally filed its application with the Food and Drug Administration.
Now the FDA will have to decide if there’s enough evidence that the shots are safe and will work for younger children like they do for teens and adults. An independent expert panel will publicly debate the evidence on Oct. 26.
One big change: Pfizer says its research shows the younger kids should get a third of the dose now given to everyone else. After their second dose, the 5- to 11-year-olds developed virus-fighting antibody levels just as strong as teens and young adults get from regular-strength shots.
While kids are at lower risk of severe illness or death than older people, COVID-19 does sometimes kill children and cases in youngsters have skyrocketed as the extra-contagious delta variant has swept through the country
“It makes me very happy that I am helping other kids get the vaccine,” said Sebastian Prybol, 8, of Raleigh, North Carolina. He is enrolled in Pfizer’s study at Duke University and doesn’t yet know if he received the vaccine or dummy shots.
“We do want to make sure that it is absolutely safe for them,” said Sebastian’s mother, Britni Prybol. But she said she will be “overjoyed” if the FDA clears the vaccine.
Pfizer studied the lower dose in 2,268 volunteers ages 5 to 11, and has said there were no serious side effects. The study isn’t large enough to detect any extremely rare side effects, such as the heart inflammation that sometimes occurs after the second dose of the regular-strength vaccine, mostly in young men.
If the FDA authorizes emergency use of the kid-sized doses, there’s another hurdle before vaccinations in this age group can begin. Advisers to the Centers for Disease Control and Prevention will decide whether to recommend the shots for youngsters, and the CDC will make a final decision.
To avoid dosing mix-ups, Pfizer is planning to ship vials specially marked for pediatric use containing the lower dose.
World AIDS Day: Makinde’s Wife Declares Support For Victims
Wife of Oyo State Governor, Engr. (Mrs). Tamunominini Makinde has reaffirmed her commitment to the well-being of people living with HIV/AIDS, calling on World leaders to join hands with the State Government to promote policies geared towards the victims’ total healthiness.
Engr. Makinde, who Chairs Oyo State Agency for the Control of AIDS (OYSACA) made the call today, while delivering an address during a rally to mark the 2021 World AIDS Day held at Agodi, Ibadan.
Mrs. Makinde who was represented by the Executive Secretary OYSACA, Dr. Lanre Abass while speaking at this year’s celebration tagged “End Inequalities, End AIDS, Through Sustainable Finance”, noted that it is high time political and world leaders keep to their promises.
“Tackling inequalities will advance the human rights of key populations and people living with HIV, make societies better prepared to beat Covid-19 and other pandemics and support economic recovery and stability. Fulfilling the promise to tackle inequalities will save millions of lives and will benefit society as a whole, but it requires trans-formative change. Political economic and social policies need to protect the rights of everyone and pay attention to the needs of disadvantaged and marginalized communities”, she said.
She opined that global inequalities affect everyone irrespective of ethnic group and geographical location, adding that without bold actions, the world risks missing the target to end AIDS by 2030 as highlighted by the United Nations on AIDS (UNAIDS).
She noted that the prolonged COVID-19 pandemics which have spiralled into social and economic crises across the globe are factors that should be looked into in tackling AIDS.
“Leaders must now move commitment to action and be bold to implement policies on inequalities. They must promote inclusive social and economic growth, discriminatory laws, policies and. practices must be eliminated in order to ensure equal opportunity and reduce inequalities. It is time for our leaders to keep their promises to act now.”
“So let us remind our leaders that global inequalities affect us all, no matter who we are or where we came from, let us come together to end inequalities, end AIDS and all other pandemics that thrive on inequalities.”
“And if the transformative measures needed on AIDS are not taken, the world will also stay trapped in Covid-19 crisis and be dangerously unprepared for the pandemics to come.”
“We can still end AIDS by 2030, but only if we act courageously as the transformation approach that we need to end AIDS will also protect the world against future pandemics”, she said.
She then appealed to citizens of the State to avail themselves the opportunity of getting tested which is free throughout the world, in order for them to know their status.
“The reason being that if one is positive, it is not a death sentence. Treatment is free, drugs are free and are accessible in numbers of our Primary and Secondary Healthcare Centers; about Twenty-two across the State.”
She however said, “And if you are negative, then you continue to do those things that you have been doing that have kept you negative”.
UBA Foundation Sensitises Staff, Customers on Mental Health Awareness, offers Therapies, Creative Opportunities, Giveaways
In line with its commitment towards giving back and impacting lives, UBA Foundation – the corporate social responsibility arm of United Bank for Africa (UBA) Plc – has kicked-off a week-long series of activities aimed at promoting mental health awareness for staff and customers starting with a panel session on Wellness at the Workplace.
Whilst studies revealed that over 19% of adults struggle with their mental health every year, a majority of those affected are reluctant to speak-out and seek help for fear of stigmatisation, UBA Foundation, through the panel discussion, sought to address the challenges that individuals are facing and how it has now become important to create consciousness and prioritise the general well-being of employees and clients.
UBA’s Group Managing Director, Kennedy Uzoka, delivered a good will message at the event emphasising the importance of wellness and mental health. He stressed the need for more organisations to ensure that the mental health of their staff and families are taken more seriously.
He said, “UBA has always engaged in a lot of ground-breaking initiatives and the issue of mental health is important to us. We have found that people do not want to talk about mental health because they think it is bad, but the truth is that you can only get good productive people when challenges like these are addressed and I am so happy that this has commenced here. “
The panel was moderated by the Managing Director/Chief Executive Officer, UBA Foundation, Bola Atta, who spoke about UBA’s goal to remain the best place to work. She noted that the bank is addressing these issues and championing the narrative that says that mental health issues shouldn’t be swept under the carpet.
“We want to create a workplace environment where people feel comfortable and encouraged to seek help when necessary, so that they can give the best of themselves in their respective roles. We hope to stomp out the stigma that keeps people suffering in silence and bridge the gap between mental health inclusivity, support and recovery in Africa,” Atta who is also UBA’s Group Head Corporate Communications, explained.
The panellists, UBA’s Group Head, Human Resources, Patricia Aderibigbe, Consultant Clinical Psychologist, BTH Therapy, Chris Abojei, Co-founder Africa’s Health Matters Foundation, Vanessa Adebayo and Angel Yinkore all agreed that wellness, especially at the workplace, has become a front burning issue and should be well addressed.
Atta announced the partnership with UBA Foundation and Inside Out as part of the weeklong activities to shine some light on mental health. Inside Out aims at teaching youths to channel their feelings through art expression and photography. She added that staff members would be able to benefit from free therapy sessions from BHT Therapy and many wellness giveaways such as spa and fitness vouchers.
Another major highlight of the week will be an intimate discussion with the Founder, Genevieve Magazine, Betty Irabor, on Thursday, November 11th, where she will share insights around her personal journey and the realities of balancing life, family, and mental health.
Merck Asks US FDA To Authorize Promising Anti-COVID Pill
If cleared by the Food and Drug Administration — a decision that could come in a matter of weeks — it would be the first pill shown to treat COVID-19. All other FDA-backed treatments against the disease require an IV or injection.
An antiviral pill that people could take at home to reduce their symptoms and speed recovery could prove groundbreaking, easing the crushing caseload on U.S. hospitals and helping to curb outbreaks in poorer countries with weak health care systems. It would also bolster the two-pronged approach to the pandemic: treatment, by way of medication, and prevention, primarily through vaccinations.
The FDA will scrutinize company data on the safety and effectiveness of the drug, molnupiravir, before rendering a decision.
Merck and its partner Ridgeback Biotherapeutic said they specifically asked the agency to grant emergency use for adults with mild-to-moderate COVID-19 who are at risk for severe disease or hospitalization. That is roughly the way COVID-19 infusion drugs are used.
“The value here is that it’s a pill so you don’t have to deal with the infusion centers and all the factors around that,” said Dr. Nicholas Kartsonis, a senior vice president with Merck’s infectious disease unit. “I think it’s a very powerful tool to add to the toolbox.”
The company reported earlier this month that the pill cut hospitalizations and deaths by half among patients with early symptoms of COVID-19. The results were so strong that independent medical experts monitoring the trial recommended stopping it early.
Side effects were similar between patients who got the drug and those in a testing group who received a dummy pill. But Merck has not publicly detailed the types of problems reported, which will be a key part of the FDA’s review.
Top U.S. health officials continue to push vaccinations as the best way to protect against COVID-19.
“It’s much, much better to prevent yourself from getting infected than to have to treat an infection,” Dr. Anthony Fauci said while discussing Merck’s drug last week.
Still, some 68 million eligible Americans remain unvaccinated, underscoring the need for effective drugs to control future waves of infection.
Since the beginning of the pandemic, health experts have stressed the need for a convenient pill. The goal is for something similar to Tamiflu, the 20-year-old flu medication that shortens the illness by a day or two and blunts the severity of symptoms like fever, cough and stuffy nose.
Three FDA-authorized antibody drugs have proved highly effective at reducing COVID-19 deaths, but they are expensive, hard to produce and require specialty equipment and health professionals to deliver.
Assuming FDA authorization, the U.S. government has agreed to buy enough of the pills to treat 1.7 million people, at a price of roughly $700 for each course of treatment. That’s less than half the price of the antibody drugs purchased by the U.S. government — over $2,000 per infusion — but still more expensive than many antiviral pills for other conditions.
Merck’s Kartsonis said in an interview that the $700 figure does not represent the final price for the medication.
“We set that price before we had any data, so that’s just one contract,” Kartsonis said. “Obviously we’re going to be responsible about this and make this drug as accessible to as many people around the world as we can.”
Kenilworth, New Jersey-based Merck has said it is in purchase talks with governments around the world and will use a sliding price scale based on each country’s economic means. Also, the company has signed licensing deals with several Indian generic drugmakers to produce low-cost versions of the drug for lower-income countries.
Several other companies, including Pfizer and Roche, are studying similar drugs and are expected to report results in the coming weeks and months. AstraZeneca is also seeking FDA authorization for a long-acting antibody drug intended to provide months of protection for patients who have immune-system disorders and do not adequately respond to vaccination.
Eventually some experts predict various COVID-19 therapies will be prescribed in combination to better protect against the worst effects of the virus.
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