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.
5 reasons men need to eat pineapple before sexual intercourse
Sex ought to be an enjoyable activity, but many factors can get in the way of such enjoyment. Factors like low libido, lack of stamina, and erections can prevent such enjoyment. That’s why pineapples are so important. Many people believe it only benefits women, but it has many sexual benefits for men.
Pineapples are rich in manganese, an antioxidant that fights free radicals and prevents cellular damage. A manganese deficiency can lead to diseases like heart disease and diabetes, which are linked to erectile dysfunction. However, adequate manganese intake can increase blood flow and prevent infertility.
Pineapples are rich in bromelain, which increases testosterone production and provides many sexual benefits in bed. This hormone regulates libido and encourages nitric oxide oxidation which makes men more sexually active.
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Pineapples are also rich in vitamin C and thiamine which can increase low libido in men. Thiamine stimulates the development of sex hormones, and this is especially important when men can’t have an erection during sex.
Pineapple can help increase sexual stamina, especially for those who find themselves exhausted from sex. Sex requires endurance and stamina, with studies showing men can burn up to 101 calories in 30 minutes of sex. To enjoy bedroom fun without exercising, consider indulging in pineapples, which are rich in vitamins B1 and C, which can help increase sexual stamina.
Pineapple consumption before sex can enhance the taste of ejaculate by making it sweeter. This is due to the high levels of acid and sugar in pineapple, which make semen less bitter and more sweet. The primary benefit for partners is the added sweetness, in case they want to taste it.
Raw pineapple, rich in vitamin C, is an antioxidant that strengthens the immune system and prevents inflammation. Studies on rats have linked reduced inflammation to improved blood flow, which is important for sexual health.
This is because healthy blood flow is essential for achieving sexual arousal and erectile function for penetrative sex. This increased blood flow and higher blood pressure within the penis make the penis firm and erect.
Finally, a cup of pineapple or one pineapple finely chopped is enough; do not eat more than that, as it will have the opposite effect.
NAFDAC alerts to counterfeit Tandak injection in Nigeria
The National Drug Law Enforcement Agency (NAFDAC) has alerted Nigerians about the sale of counterfeit TANDAK injection 1.5g powder and water for injection, manufactured by Intracin Pharmaceuticals PVT. LTD C-1, B-53, G.I.D.C Estate, Nadiad- 387001, Gujarat, India.
A statement released by the agency on Wednesday, April 10, says the counterfeit product was discovered in Gombe State, Nigeria, and reported to the Agency by Marcson Healthcare Ltd. – the Marketing Authorisation Holder (MAH).
‘’Tandak® injection of 1.5g powder is a co-formulation of Ceftriaxone 1000mg and Sulbactam 500mg. It is prescribed for use in the treatment of various types of bacterial infections. It fights against micro organisms by preventing their growth, and further spread of the infection. Ceftriaxone+Sulbactam 1000mg/500mg Injection should only be administered under the supervision of a healthcare professional. the statement read
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The illegal marketing of counterfeit medicines poses a risk to the health of people, since by not complying with the regulatory provisions, the safety, quality, and efficacy of the products are not guaranteed.
NAFDAC has directed all its Zonal Directors and State Coordinators to carry out surveillance and mop up the counterfeit products within the Zones and States.
Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, call 0800-162-3322 or send an email to sf.alert@nafdac.gov.ng.
NAFDAC recalls Benylin cough syrup
The National Agency for Food and Drugs Administration and Control has recalled Benylin Paediatrics Syrup manufactured by Johnson & Johnson, following recent toxicity findings in the laboratory on the product.
NAFDAC said laboratory analysis conducted on the product showed that it contains an unacceptable high level of Diethylene glycol and was found to cause acute oral toxicity in laboratory animals.
The agency disclosed this on its website on Wednesday.
A product recall is an important method of managing risks in response to product safety events and emergencies.
According to an online health portal, Science Direct, a product recall is a request to return to the maker, a batch, or an entire production run of a product, usually over safety concerns, design defects, or labelling errors.
“Benylin Paediatric syrup is indicated for the relief of cough and its congestive symptoms and for the treatment of hay fever and other allergic conditions in children aged two to 12 years.
“Diethylene glycol is toxic to humans when consumed and can prove fatal. Toxic effects can include abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death,” it noted.
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The details of the product showed that the product is manufactured by Johnson & Johnson in Cape Town, South Africa.
With batch number 329304, the product was manufactured in May 2021, and it is to expire this month, April 2024.
NAFDAC, however, implored importers, distributors, retailers, and consumers to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of substandard (contaminated) regulated products.
It said all medical products must be obtained from authorised/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
“Anyone in possession of the above-mentioned product is advised to immediately discontinue the sale or use and submit stock to the nearest NAFDAC office. If you witness any adverse reaction/event after the use of this product in any children, you are advised to direct such patients to immediate medical attention from a qualified healthcare professional.
“Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
“Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of the medicinal product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med-safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng,” it added.
Meanwhile, the agency said it has directed the marketing authorisation holder (Johnson and Johnson company, West Africa) to initiate the recall of the batch and the notice will also be uploaded to the WHO Global Surveillance and Monitoring System.
NAFDAC regulates and controls the manufacture, importation, exportation, distribution, advertisement, sale, and use of food, drugs, cosmetics, medical devices, packaged water, chemicals, and detergents.
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