Former FDA Commissioner Dr. Scott Gottlieb said Sunday that a COVID-19 vaccine for children age 4 and under could be approved by early March.
Gottlieb said the authorization would depend on whether federal officials move forward with Pfizer’s two-dose candidate, as opposed to the three-dose one added last month to the company’s clinical trials.
The two-dose shot could presumably be approved the fastest of the two, since trials on it are further ahead, so it’s just a question of whether its potency is considered enough protection for the age group at this point, Gottlieb said.
“Getting two doses into a child can provide baseline immunity that protects them from severe disease [and] from hospitalization,” the-ex-Food and Drug Administration chief told anchor Margaret Brennan on CBS’s “Face the Nation.”
“And I think that may be why federal health officials are rethinking this if, in fact, they decide to authorize this on the basis of two doses. It could be out much sooner, perhaps as early as early March.”
Pfizer had announced that it was amending its clinical trials and reviewing the effects of a third dose after finding two shots didn’t elicit the same kind of robust immune response in 2- to 5-year-olds as with adults.
But Gottlieb said it may be enough that the two-dose regimen prevents severe disease, as opposed to stopping infection entirely.
“I think the decision matrix has changed around the vaccine for [ages] 6 months to 4 years old and so far as we know that the vaccine isn’t as protective at preventing infection,” he said.
“Previously, we had data showing that the childhood vaccine for 6 months to 4 years wasn’t as protective against infection as the adult vaccine,” he said.
“That’s the reason why they pushed it out and asked for that third dose. But now, if the goal of the vaccine is to get baseline immunity in the kids to prevent really bad outcomes, and you’re really not using the vaccine as a tool to prevent infection in the first place, two doses could do that,” he continued.
Last week, Dr. Anthony Fauci offered a different prediction.
“It looks like it will be a three-dose regimen,” he said at a White House COVID-19 briefing on Wednesday, though he added that he can’t speak for the FDA, which must give the first round of potential approval before use, followed by the CDC for the final OK.
The two-dose Pfizer vaccine has been authorized for kids 5 and older since late October, while anyone 12 and up are eligible for an additional booster.
Westmount Mall to open COVID-19 vaccination clinic for month of July – CTV News London
A new COVID-19 vaccination clinic may soon open in a mall near you.
According to a press release issued by the Middlesex-London Health Unit (MLHU) on Tuesday, the latest mall-based COVID-19 vaccination clinic is set to open in southwest London in early July.
Westmount Shopping Centre will be the home of the newest vaccination clinic and is slated to open on July 7.
In the press release, the MLHU said due to the previous success of the clinics at CF Masonville Place and White Oaks Mall, “The opening of this latest COVID-19 vaccination clinic continues the Health Unit’s strategy of creating easy and convenient ways for area residents to have optimal protection against the virus.”
The clinic will operate out of a space beside the Bulk Barrel located near the mall’s entrance one location, off Viscount Road.
It will be open Thursdays, Fridays and Saturdays from 11:30 a.m. to 5:30 p.m. throughout the month of July. It will operate on a walk-in basis, and individuals can receive any dose they are currently eligible for.
Dr. Alex Summers, MLHU medical officer of health said that due to the summer weather and more people spending time outdoors, Londoners might not be thinking about COVID-19. But, he hopes the new clinic will change that for the better.
“Our clinic at Westmount Shopping Centre will allow people who have not received all the doses they are eligible for to get vaccinated. This will provide additional protection against the COVID-19 virus that continues to circulate in our community.”
Likewise, Amanda Smith, property administrator at Westmount Shopping Centre is optimistic at the upcoming partnership with the MLHU.
“Westmount Shopping Centre Management is pleased to be collaborating with the Middlesex-London Health Unit, as they offer these vaccination services to our Centre and our community,” she said.
A list of the MLHU’s COVID-19 vaccination clinics can be found on the health unit’s website.
Vitamin D supplement 'overdosing' is possible and harmful, warn doctors – Medical Xpress
‘Overdosing’ on vitamin D supplements is both possible and harmful, warn doctors in the journal BMJ Case Reports after they treated a man who needed hospital admission for his excessive vitamin D intake.
‘Hypervitaminosis D’, as the condition is formerly known, is on the rise and linked to a wide range of potentially serious health issues, they highlight.
The case concerns a middle-aged man who was referred to hospital by his family doctor after complaining of recurrent vomiting, nausea, abdominal pain, leg cramps, tinnitus (ringing in the ear), dry mouth, increased thirst, diarrhea, and weight loss (28 lbs or 12.7 kg).
These symptoms had been going on for nearly 3 months, and had started around 1 month after he began an intensive vitamin supplement regimen on the advice of a nutritional therapist.
The man had had various health issues, including tuberculosis, an inner ear tumor (left vestibular schwannoma), which had resulted in deafness in that ear, a build-up of fluid in the brain (hydrocephalus), bacterial meningitis, and chronic sinusitis.
He had been taking high doses of more than 20 over the counter supplements every day containing: vitamin D 50000 mg—the daily requirement is 600 mg or 400 IU; vitamin K2 100 mg (daily requirement 100–300 μg); vitamin C, vitamin B9 (folate) 1000 mg (daily requirement 400 μg); vitamin B2 (riboflavin), vitamin B6, omega-3 2000 mg twice daily (daily requirement 200–500 mg), plus several other vitamin, mineral, nutrient, and probiotic supplements.
Once symptoms developed, he stopped taking his daily supplement cocktail, but his symptoms didn’t go away.
The results of blood tests ordered by his family doctor revealed that he had very high levels of calcium and slightly raised levels of magnesium. And his vitamin D level was 7 times over the level required for sufficiency.
The tests also indicated that his kidneys weren’t working properly (acute kidney injury). The results of various X-rays and scans to check for cancer were normal.
The man stayed in hospital for 8 days, during which time he was given intravenous fluids to flush out his system and treated with bisphosphonates—drugs that are normally used to strengthen bones or lower excessive levels of calcium in the blood.
Two months after discharge from hospital, his calcium level had returned to normal, but his vitamin D level was still abnormally high.
“Globally, there is a growing trend of hypervitaminosis D, a clinical condition characterized by elevated serum vitamin D3 levels,” with women, children and surgical patients most likely to be affected, write the authors.
Recommended vitamin D levels can be obtained from the diet (eg wild mushrooms, oily fish), from exposure to sunlight, and supplements.
“Given its slow turnover (half-life of approximately 2 months), during which vitamin D toxicity develops, symptoms can last for several weeks,” warn the authors.
The symptoms of hypervitaminosis D are many and varied, they point out, and are mostly caused by excess calcium in the blood. They include drowsiness, confusion, apathy, psychosis, depression, stupor, coma, anorexia, abdominal pain, vomiting, constipation, peptic ulcers, pancreatitis, high blood pressure, abnormal heart rhythm, and kidney abnormalities, including renal failure.
Other associated features, such as keratopathy (inflammatory eye disease), joint stiffness (arthralgia), and hearing loss or deafness, have also been reported, they add.
This is just one case, and while hypervitaminosis D is on the rise, it is still relatively uncommon, caution the authors.
Nevertheless, complementary therapy, including the use of dietary supplements, is popular, and people may not realize that it’s possible to overdose on vitamin D, or the potential consequences of doing so, they say.
“This case report further highlights the potential toxicity of supplements that are largely considered safe until taken in unsafe amounts or in unsafe combinations,” they conclude.
Vitamin D intoxication and severe hypercalcaemia complicating nutritional supplements misuse, BMJ Case Reports (2022). DOI: 10.1136/bcr-2022-250553
British Medical Journal
Vitamin D supplement ‘overdosing’ is possible and harmful, warn doctors (2022, July 5)
retrieved 6 July 2022
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no
part may be reproduced without the written permission. The content is provided for information purposes only.
Pharmacists in London, Ont., hope medication shortage is resolved before cold and flu season – CBC.ca
An Ontario-wide shortage of cold and flu medication has led to partially empty shelves in pharmacies in London.
The Ontario Pharmacists Association told CBC News in April that drug stores were seeing an increase in people looking to treat symptoms of upper respiratory tract infections, due to COVID-19, influenza or the common cold, after mask mandates were lifted on March 21.
Months later, pharmacists in London say the shortage has been further exacerbated by allergy season and ongoing supply chain issues.
“Demand is the same, but we hear patients are going from one pharmacy to the other looking for the product,” said Gamal Awad, owner of Guardian Wonderland Pharmacy.
For the past month, wholesalers of over-the-counter medications for cold and flu have been unable to make their delivery dates. Pharmacies have lost out on sales, said Awad, while customers are scrambling for back-ordered items like cough syrup, Tylenol or Advil.
“The only thing we can ask our patients is to wait as we look back on our supplier website to see when those medications are going to be back online or when we can order them,” said Fadi Shatara, a pharmacist at Chapman’s Pharmacy.
The shortage includes medication for children, said Shatara. He advises parents to refer to their doctors for alternatives if they’re unable to find what they need.
Risk of transmission is low, for now
London’s medical officer of health, Dr. Alex Summers, said outdoor movement in summer generally brings a lower risk of respiratory illness transmission, even as COVID-19 restrictions have been lifted.
However, the absence of those measures and return to indoor activity mean risk for cold, flu and COVID-19 will rise in the fall and winter months.
“The more people gather indoors, the greater the risk of transmission. The less people are wearing masks, the greater the risk of transmission, the less people are vaccinated, the greater the risk of transmission,” he said.
That leaves pharmacists like Shatara bracing for the changing seasons and hoping the medication shortage is resolved by then.
“If it happens again, that’s going to be devastating, especially with the lack of medications,” he said. “Now, if that lasts until winter or fall, it’s going to have a huge impact on everyone.”
Rare clouds that glow in the dark are seen in upper US, Canada and Europe – Daily Mail
Who has the power? – Investment Executive
Arabs believe economy is weak under democracy – BBC
Silver investment demand jumped 12% in 2019
Europe kicks off vaccination programs | All media content | DW | 27.12.2020 – Deutsche Welle
Global Media Markets, 2015-2020, 2020-2025F, 2030F – TV and Radio Broadcasting, Film and Music, Information Services, Web Content, Search Portals And Social Media, Print Media, & Cable – GlobeNewswire
Health15 hours ago
Pharmacists in London, Ont., hope medication shortage is resolved before cold and flu season – CBC.ca
Sports15 hours ago
Ailing Nick Kyrgios prevails at Wimbledon, advancing to 3rd career Slam quarter-final – CBC Sports
News14 hours ago
From good job to no job, life in Canada taught me to go with the flow – CBC.ca
Science11 hours ago
My Thesis in 400 Words: Anne Boucher | Institute for Research on Exoplanets – News | Institute for Research on Exoplanets
Business14 hours ago
Recession likely due to BoC rapid rate hikes: study – CTV News
Sports16 hours ago
Argos miss tying convert as Bombers escape with win – TSN
Tech20 hours ago
UM Today | Information Services and Technology | Approvals app in Microsoft 365 Teams – UM Today
Art7 hours ago
New interactive art installation in front of Ackland Art Museum engages community – The Daily Tar Heel