Sept 20 (Reuters) – Pfizer Inc (PFE.N) and BioNTech SE said on Monday their COVID-19 vaccine induced a robust immune response in 5 to 11 year olds, and they plan to ask for authorization to use the vaccine in children in that age range in the United States, Europe and elsewhere as soon as possible.
The companies said the vaccine generated an immune response in the 5-to-11 year olds in their Phase II/III clinical trial that matched what they had previously observed in 16-to-25 year olds. The safety profile was also generally comparable to the older age group, they said.
“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination,” Pfizer Chief Executive Albert Bourla said in a news release.
“These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”
Top U.S. health officials believe regulators could make a decision on whether the shot is safe and effective in younger children within three weeks of the companies submitting a request for authorization, two sources told Reuters earlier this month.
COVID-19 hospitalizations and deaths have surged in the United States in recent months due to the highly contagious Delta variant. Pediatric cases are also up, particularly as children under 12 are all unvaccinated, but there is no indication that, beyond being more transmissive, the Delta virus is more dangerous in kids.
A rapid authorization could help mitigate a potential surge of cases in the fall, especially with schools already open nationwide.
The companies’ vaccine, called Comirnaty, is already authorized for use in children as young as 12 in many countries, including the United States. The vaccine was originally authorized for emerenecy use in people 16 or older in the United States in December 2020 and received full U.S. approval in that age group last month.
The 5-to-11 year olds were given two shots of a 10-microgram dose of the vaccine, one-third the dose size that has been given to people 12 and older. The companies expect data on how well the vaccine works in children 2-to-5 years of age and children 6 months-to-2 years of age as soon as the fourth quarter of this year.
Unlike the larger clinical trial the drugmakers previously conducted in adults, the 2,268 participant pediatric trial was not primarily designed to measure the vaccine’s efficacy by comparing the number of COVID-19 cases in vaccine recipients to those who received a placebo.
Instead, the trial compares the amount of neutralizing antibodies induced by the vaccine in the children to the response of older recipients in the adult trial.
A Pfizer spokesperson said the companies may later disclose vaccine efficacy from the trial but there had not been enough cases of COVID-19 yet among the participants to make that determination.
The vaccine was around 95 percent effective in the adult clinical trial, but Pfizer has said that immunity wanes some months after the second dose. U.S. regulators are expected to authorize a third, booster dose of the vaccine for older and high-risk Americans early this week. read more
The companies said the vaccine was well-tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.
Both the Pfizer and Moderna vaccines have been linked by regulators to rare cases of heart inflammation in adolescents and young adults, particularly young men. Pfizer said they did not see any instances of heart inflammation in the trial participants.
Just in: Abia doctors begin strike over kidnap of colleague
Doctors in Abia State have begun an indefinite strike in protest against the kidnap and continued detention of their colleague, Prof. Uwadinachi Iweha.
Iweha was Kidnapped on Sunday June 6, 2022, around 4pm, in front of his house at Umuokpara in Umuahia South Local Government Area.
The doctors had during their earlier protest last Friday, threatened to down tools if after 47 hours their Kidnapped colleague were not released.
Declaring the decision of the doctors Tuesday after a rally and prayer session at the car park of the Federal Medical Centre Umuahia, the Chairman of the Nigeria Medical Association, NMA, Abia State, Dr Chimezie Okwuonu, said the action was to alert the world that the safety of doctors in the state was no longer guaranteed.
NMA argued that there was no way doctors would continue to provide maximum services amid uncertainties over the safety of their members who are always on duty to serve humanity.
Reading from a prepared speech he co-signed with the Secretary of the body, Dr Robinson Ugwuanyi, the NMA Chairman said:” As an Association deeply involved in the welfare of Medical Doctors in Abia State, we are worried that 9 days down the line, Prof Uwadinachi Iweha is still within the kidnappers Den. This is traumatic, depressing, dehumanising and has instilled a lot of fear within the medical community whose primary objective is to save the life of Abians from the medical point of view.
“The Nigerian Medical Association Abia State hereby condemns the kidnap of its member and calls on the Abia State Government and security apparatus to do all that is necessary to secure his release.
“Our ernest prayer is that his health condition does not deteriorate further and he comes back alive to us and his family.
“The recent spate of kidnap with its attendant consequences on the morale of its citizens has the capability of eroding the achievement we have made, as a state, in the area of security.
“Medical Doctors work all round the clock. This includes normal duties, surgeries, clinical calls, emergencies and administrative duties. The nature and scope of our work involves been on the road any time you are called, as more than 95% of Doctors reside outside their place of work.
“With the current state of fear caused by the kidnap and detention of our colleague, safety cannot be guaranteed and it will be difficult to attend to duties as normal as no one knows who will be the next victim.
Arising from its meeting on Friday 10th June 2022, the NMA Abia State Branch took a peaceful protest to the Government house where it registered its displeasure at the kidnap of its senior medical colleague.
“We were received by the Chief of Staff Chief Okey Ahaiwe, who assured us, on behalf of the Governor, that government will do all the needful to ensure release of its colleague. We are still looking up to this promise.
“Today, Tuesday 14th, the NMA Abia State has commenced a withdrawal of services in both public and private sectors, to register its deep displeasure at this unfortunate incident and give its members time to join the family in searching for its members.
”However, emergency services are still going on to enable our members attend to critical patients.
“We shall also take out time to pray for Prof Iweha and carry out a very peaceful rally to show that we stand by our own in this time of trial. These, in addition to this press conference, are the main three activities for today.
“Our Physicians pledge, as amended by the 68th World Medical Association General Assembly Chicago in 2017 states in line 11 ‘ I will take care of my health and well being, and abilities in order to provide care of the highest standards’.
“With the kidnap and continued detention of our colleague, we are not assured of our health and well-being as Doctors in this environment; hence may not provide care of highest standard.
“It is our utmost desire that the Government enables a secured release of our colleague and restores the peace and security we enjoy.
The Nigerian Medical Association Abia State wishes to ask its members to pray for Prof Uwadinachi Iweha, and ask any member of the public with useful information about his whereabouts to report to the nearest police station.”
Prof Iweha served as the Chief Medical Director of Abia State University Teaching Hospital Aba; and Abia Specialist Hospital and Diagnostic Centre.
He is currently the Provost of Gregory University College Of Medicine, Umuahia Campus.
420,000 die annually of contaminated food, 600 million fall ill – Minister
Health Minister, Dr Osagie Ehanire, has said that every year, nearly one in every ten people in the world, an estimated 600 million people fall ill and 420,000 others die after eating food contaminated by bacteria, viruses, parasites or chemical substances such as heavy metals.
Ehanire disclosed this during an event to mark 2022 World Food Safety Day, adding, over 200 diseases are caused by eating contaminated food.
According to him, food, if not safe, is not food. Food is a health product and the first component of basic health care delivery. The slogan for World Food Safety Day is “Food Safety is Every One’s Business and is a reminder that we all play a role in keeping food safe. This calls for prioritization of food safety throughout the d supply chain, from farm to table.”
He also said, “Children under the age of five are at higher risk of malnutrition and mortality due to unsafe food and they carry 40% of food borne disease burden. Unsafe food causes one in six deaths from diarrhea, a major killer in this age group. World Food Safety Day is a unique opportunity to raise awareness about the dangers of unsafe food with governments, producers, handlers and consumers having a role to play in making food safe.”
The Minister noted that unsafe food hinted that World Food Safety Day is a unique opportunity to raise awareness about the dangers of unsafe food with governments, producers, handlers and consumers having a role to play in making food safe.
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“Unsafe food hinders development especially on low- and middle-income economies, which lose around US$ 95 billion in productivity associated with illness, disability, and premature death suffered by workers (farmers, processors, handlers and marketers and consumers).
“This is standing in accord with World Health Organization (WHO), Food and Agriculture Organisation of the United Nations (FAO), the National Food Safety Management Committee (NFSMC) and the global Food Safety Community with the aim to draw attention and inspire action that prevents, detect and manage food borne risks that guarantee safer food for better health.
“In line with this year’s theme “Safer food, better health” emphasizes that all are consumers and food safety counts first for better health. Safe food is essential to human health and well-being. Only when food is safe can we fully benefit from its nutritional value and from the mental and social benefits of sharing a safe meal.
“Safe food is one of the most critical guarantors for good health. Unsafe foods are the cause of many diseases and contribute to other poor health conditions, such as impaired growth and development.
“The good news is that most food borne diseases are preventable. Our behaviour, the way we build food systems and how we organize food supply chains can prevent infectious and toxic hazards, microbial pathogens (bacteria, viruses and parasites), chemical residues, biotoxins and other noxious or dangerous substances from getting into our plates. We need to transform food systems to deliver better health, and we need to do so in a sustainable manner.
“Food systems policy-makers, practitioners and investors should reorient their activities to increase the sustainable production and consumption of safe foods in order to improve health outcomes, to make safe and healthy diets”, he stated.
Measles kills 14 children in Anambra
The Anambra State government has confirmed the death of 14 children from measles outbreak in nine local government areas of the state.
Commissioner for Health Dr Afam Obidike announced the figure at a news conference in Awka yesterday.
He said that 414 cases of measles were recorded in nine local government areas in the state.
Obidike listed the affected local government areas as Anambra East, Anambra West, Ayamelum, Ihiala, Idemili North, Nnewi North, Onitsha North, Njikoka, and Oyi.
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