Health
Pfizer/BioNTech data shows COVID-19 vaccine safe and protective in kids
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.
Health
Poisonous fluorides in toothpaste: Pharmacists counter televangelist’s claims
Poisonous fluorides in toothpaste: Pharmacists counter televangelist’s claims
Pharmacists have refuted recent claims made by a popular pastor that fluorides in food, toothpaste, and pharmaceutical products are poisonous and carcinogenic.
While acknowledging the pastor’s spiritual influence, the pharmacists provided crucial scientific clarity, asserting that fluoride, when used in approved quantities by regulatory bodies, is safe and beneficial for public health.
The pharmacists, on the platform of the Association of Community Pharmacists of Nigeria, ACPN, made the clarifications, weekend.
Their intervention comes in response to trending videos where the religious leader vehemently condemned the pharmaceutical industry over the inclusion of fluorides in various consumer products.
Scientific facts
In a statement by the National Chairman, Ambrose Ezeh, and Secretary, Omokhafe Ashore, the pharmacists said: “We at ACPN will not attempt to tackle the pastor’s anointing in God’s word.
“But (we) will clarify with some scientific insight and background that the pastor’s exposition on fluorides was not totally in alignment with scientific facts.
“The ‘Use of Fluorides in Pharmaceutical Preparations and Foods’ declared: ‘Fluorides used in approved quantities by the relevant and appropriate food and drug regulatory agencies are safe’.
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“In strictly public health interest, the ACPN wishes to posit as follows: Fluoride used in approved quantities by the relevant and appropriate Food and Drug regulatory agencies are safe.
“While some researchers have indeed linked Fluoride with some cancers, oftentimes such incidences have been proven to be in instances where excessive amounts beyond the approved limits were used.”
Health
Drug prices may drop as FG implements zero VAT, duties
Drug prices may drop as FG implements zero VAT, duties
Experts say prices of drugs are likely to drop following the implementation of the federal government’s executive order on zero VAT and excise duties on pharmaceutical products and medical devices.
The Nigeria Customs Service yesterday said it had commenced the implementation of Value Added Tax (VAT) and import duty exemption on raw materials essential for the production of pharmaceutical products.
The National Public Relations Officer of the Nigerian Customs Service (NCS), Assistant Comptroller of Customs, Abdullahi Maiwada, in a statement on Wednesday, said the decision was in line with the presidential order to boost local production of healthcare products
President Bola Tinubu had, in June last year, signed the Executive Order to increase local production of pharmaceutical, diagnostics and medical devices.
The NCS’ spokesman said: “Critical raw materials essential for the production of pharmaceutical products will be exempted from import duty and Value Added Tax (VAT) for a period of two years.”
The statement added that the exemption covers Active Pharmaceutical Ingredients (APIs), excipients and other vital raw materials required for manufacturing essential medicines, Long-Lasting Insecticidal Nets (LLINs), Rapid Diagnostic Kits, reagents and packaging materials.
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Maiwada said to ensure that these fiscal incentives are fully utilised, eligibility is limited to manufacturers of pharmaceutical products recognised by the Federal Ministry of Health and Social Welfare, provided they possess a valid Tax Identification Number (TIN).
Experts speak
Experts said the implementation of the Executive Order would address the skyrocketing cost of medicines.
A former National Secretary of the Pharmaceutical Society of Nigeria (PSN), Pharm. Iyiola Gbolagade, in a chat with our correspondent, described the implementation of the Executive Order as commendable, saying it would lead to reduction of prices some locally manufactured medicines like antibiotics and antimalarial drugs.
A former chairman of the Association of Community Pharmacists of Nigeria (ACPN) FCT chapter, Pharmacist Eneojo Made, said the implementation of Zero VAT and exercise duties on Active Pharmaceutical Ingredients (APIs), which are used to produce medicines, would boost the production of essential medicines for various categories of diseases thereby enhancing availability and access to them in the country.
A former National Publicity Secretary of the Association of Community Pharmacists of Nigeria (ACPN), Kenneth Edeh Ujah, said, “When the cost of production of medicines at various stages is lower, of course, it is going to have that direct impact on the eventual cost of the medicine when people visit the pharmacy to buy their drugs.”
Also, Prof Cyril Odianose Usifoh, the immediate past president, Pharmaceutical Society of Nigeria (PSN), said the potential for success in the order was boosted because specified items include Active Pharmaceutical Ingredients (APIs), excipients, essential raw materials required for manufacturing of crucial products, including drugs, long lasting insecticidal bed nets, rapid diagnostic kits and others.
The Federal Ministry of Health and Social Welfare had, in a statement, said the Executive Order is a significant milestone, as it opens the door for local pharmaceutical and medical device manufacturers to begin fully benefiting from the relief measures outlined by President Bola Ahmed Tinubu in the Executive Order
Drug prices may drop as FG implements zero VAT, duties
Health
Nigerian doctor pioneers W’Africa first robotic prostate cancer surgery
Nigerian doctor pioneers W’Africa first robotic prostate cancer surgery
A Nigerian Consultant Urological/Robotic Surgeon, Professor Kingsley Ekwueme on Monday in Lagos pioneered the first West African robotic surgery on a prostrate cancer patient.
Ekwueme, a UK-based medical doctor returnee recently established The Prostate Clinic, (TPC) Nigeria Centre for Robotic and Laparoscopic Surgery, the first super-specialised clinic in West Africa dedicated to the diagnosis and treatment of prostate cancer, utilising cutting-edge robotic surgery.
“This is truly historic,” declared Ekwueme, the clinic’s founder.
“We are bringing technology that has never been seen before in this region, giving Nigerians access to world-class treatment right here at home.”
The clinic’s centerpiece is the Da Vinci Robot, an advanced surgical system that provides unparalleled precision and minimally invasive procedures. “
Briefing journalists on the feat, Ekwueme explained that: “The Da Vinci Robot offers three-dimensional imaging and seven degrees of freedom, allowing for surgeries with minimal blood loss and faster recovery times.”
“Patients experience significantly less pain and scarring compared to traditional open surgeries.”
Ekwueme, a renowned urologist, emphasised that the technology extends beyond prostate cancer.
“We are treating a range of urological conditions in both men and women, including kidney cancer, bladder cancer, kidney stones, and benign prostatic hyperplasia. Our goal is to transform surgery in Nigeria.”
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Noting that the key focus of the clinic was accessibility, he said he is determined to make these advanced procedures affordable for all Nigerians.
“My mission is to ensure that no one in this country dies needlessly due to a lack of access to quality care.
“We are working to make these procedures as cost-effective as possible, and we are open to partnerships with the government to expand our reach.”
To address Nigeria’s power challenges, the clinic is equipped with a comprehensive solar power system, ensuring uninterrupted operations. “We understand the importance of reliable power.
“Our 24-hour solar system ensures that we can provide consistent, high-quality care.”
He said he is also committed to training local medical professionals in robotic surgery, ensuring the long-term sustainability of the technology in Nigeria.
“We are investing in the future of Nigerian healthcare. We want to empower our doctors with the skills they need to provide world-class care.”
Debunking common misconceptions about prostate and sexual activities, Ekwueme clarified that there is no proven dietary prevention for prostate cancer. “The primary risk factors are age, race, and family history. Early detection and access to advanced treatment are crucial.”
Looking ahead, Ekwueme revealed plans to introduce groundbreaking technology for benign prostatic hyperplasia (BPH) with zero blood loss.
“I am doing a procedure tomorrow, and soon I will unveil a technology that has never been done in Africa, splitting the prostate from the inside with absolutely no blood loss,” he stated.
He said with its state-of-the-art technology, commitment to affordability, and focus on local training, The Prostate Clinic Nigeria Centre for Robotic and Laparoscopic Surgery is poised to revolutionise cancer care in West Africa, offering hope and advanced treatment options to countless Nigerians.
Nigerian doctor pioneers W’Africa first robotic prostate cancer surgery
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