A safety panel of the European drug regulator on Friday recommended adding a rare spinal inflammation called transverse myelitis as a side effect of AstraZeneca’s COVID-19 vaccine.
The European Medicines Agency’s (EMA) safety committee also recommended a similar warning be included for Johnson & Johnson’s one-shot vaccine in October, and reiterated the decision on Friday.
Transverse myelitis is an inflammation of one or both sides of the spinal cord and can cause weakness in the arms or legs, sensory symptoms or problems with bladder or bowel function.
“There is currently no confirmed mechanism that has been verified by which a COVID-19 vaccine could cause the very rare event transverse myelitis,” an AstraZeneca spokesperson said.
The EMA’s committee, after reviewing data, concluded there was a reasonable possibility of a causal relationship between the two vaccines and transverse myelitis.
However, it added the benefit-risk profile of both vaccines remains unchanged.
The regulatory agency did not provide any information on how many such cases were reported after the vaccination was given but said transverse myelitis has been added as an adverse reaction of unknown frequency to the product information.
AstraZeneca’s vaccine has faced several setbacks, including production delays and probes by regulators following rare cases of severe side effects such as blood clots with low platelets, which led to several countries restricting or stopping its use.
Transverse myelitis was also at the heart of trial halts in the early stages of development for both AstraZeneca and J&J’s shots, which are based on similar technology.
EMA also recommended updating the product information for AstraZeneca’s vaccine regarding rare blood clotting with a low platelet count following the first shot, to say fewer such side effects were observed after the second dose.
Among 1,809 cases of the condition called thrombosis with thrombocytopenia syndrome reported worldwide, it said 1,643 were reported after the first dose and 166 after the second.
(Reporting by Mrinalika Roy and Manojna Maddipatla in Bengaluru; Editing by Shinjini Ganguli and Krishna Chandra Eluri)
Omicron-specific vaccine likely to come too late to help in this wave: Sharma – Victoria News
Health Canada’s chief medical adviser says variant-specific vaccines can be approved faster than the general ones first issued to combat COVID-19, but one targeting the Omicron strain still likely won’t be ready in time to help with the latest wave.
Dr. Supriya Sharma said what is really needed are vaccines that can possibly stop more than one variant at a time, including those yet to come.
Omicron became the dominant variant in Canada in just over two weeks, and the Public Health Agency of Canada said Friday it’s now believed to be responsible for more than 90 per cent of all COVID-19 cases.
Studies suggest two doses of the existing mRNA vaccines from Pfizer-BioNTech and Moderna are not good at preventing infection from Omicron.
Multiple studies, however, suggest the vaccines are excellent at keeping symptoms mild, preventing hospitalizations, and shortening the stay and lowering the level of care for those who do get admitted to hospital. Fewer vaccinated Omicron patients, for example, need mechanical ventilation.
Both Pfizer and Moderna are working on new versions of their vaccines that specifically target the Omicron variant.
Moderna is hoping to get its product into trials early this year. Pfizer said it could have 100 million doses of theirs ready as early as March, and Canada has contracts for boosters from both companies that would include vaccines for variants too.
But Sharma said even with the expedited review process for vaccine variants, that’s “probably not” fast enough.
“By that time, based on what we’ve known about the Omicron wave, it might well and truly be through,” she said. “And then the question is always, ‘is there another variant that’s coming up?’”
The solution, she said, likely lies with vaccines that can target more than one variant at a time.
The COVID-19 vaccine technical committee of the World Health Organization said the same thing on Jan. 11, noting Omicron is the fifth variant of concern in two years and “is unlikely to be the last.”
Booster shots that heighten antibody development became the immediate response to Omicron for many governments, including Canada.
Dr. Srinivas Murthy, a British Columbia pediatrician and co-chair of the WHO’s clinical research committee on COVID-19, told The Canadian Press that boosters aren’t a long-term viable option.
“Boosting your way out of a pandemic is going to inevitably shoot you in the foot in the sense that you’re going to have a future variant that’s going to emerge that’s going to cause problems,” he said. “It’s going to evade your vaccines, and then you’re going to have to scramble.”
Omicron doesn’t evade the existing vaccines entirely but a future variant could, he said. The issue largely stems from the fact that the original vaccines train the body’s immune system to recognize what is called the spike protein found on the surface of a virus, and that spike protein is mutating significantly.
Think of the mutated spike protein as a bit of a disguise that makes it harder for the immune system to recognize the virus and mount a defence to kill it off.
Omicron has more than 50 mutations, and at least 36 are on the spike protein.
Multivalent vaccines that use the spike protein from more than one variant, or that target the genetic components of a virus rather than the spike protein, are possibly the ones that could offer protection for both this pandemic and the next novel coronavirus that emerges.
“It’s pan-coronavirus, where it’s looking at big broad neutralizing responses and you don’t have to update it every season and so on,” said Murthy. “That’s been the Holy Grail of flu vaccinology for the past number of decades. We haven’t achieved that yet, because flu is a bit tricky, but we think that it’s achievable for coronavirus, specifically.”
The United States Army has a version heading into Phase 2 trials that can attach multiple spike proteins. A vaccine with the specific spike proteins from all five COVID-19 variants of concern would likely be more successful, even against future variants, because they all share some of the same mutations and what one might miss another may catch.
Moderna is working on trials for multivalent vaccines using combinations of the spike proteins from the original virus and one of the variants, or two of the variants together. It’s not clear when they would be ready for use.
Sharma said even if the vaccines aren’t working as well against variants as they were against the original virus, to her “they’re still miraculous.”
“To have a vaccine that was developed that quickly, that still has, through multiple variants … with boosters, up to 70, 80 per cent effectiveness against serious disease, ailments, hospitalization and death,” she said. “That is miraculous for a new vaccine for a new virus.”
Mia Rabson, The Canadian Press
Canada approves Pfizer’s oral COVID-19 antiviral treatment, seeks supplies
Canada on Monday approved Pfizer Inc’s oral antiviral treatment for mild to moderate cases of COVID-19 in people aged 18 and older but said supply shortages would keep doses from being made available immediately.
Infections and hospitalizations due the Omicron variant have been rising in Canada, forcing provinces to put in restrictions and the federal government to support impacted businesses.
“(This) is particularly important, as access to easy to use treatments could help to reduce the severity of COVID-19 in adults who become newly infected at high risk of progressing to serious illness,” said chief public health officer Theresa Tam.
Pfizer’s two-drug antiviral regimen, Paxlovid, was nearly 90% effective in preventing hospitalizations and deaths in patients at high risk of severe illness, according to data from the company’s clinical trial.
It is meant to be taken at home for five days beginning shortly after onset of symptoms.
Ottawa said last month it had signed a deal with Pfizer for a million treatment courses, pending approval. But getting those supplies could face hurdles.
“While there is currently limited global supply of Paxlovid, we are working to firm up a delivery schedule with the intent of bringing treatment courses to Canada as quickly as possible,” Tam told a briefing.
Ontario, the most populous of the 10 provinces, is seeing signs that Omicron cases may have peaked, said chief medical officer Kieran Moore.
“I’m starting to have much more hope … the number of cases is decelerating instead of accelerating in terms of hospitalizations and (people admitted to) intensive care units,” he told an Ottawa radio station.
Official data show that as of Jan 8, 87.8% of Canadians aged 12 and above had received two doses of a COVID-19 vaccine.
The U.S. authorized the Pfizer treatment for people ages 12 and older last month.
Canada is still looking at whether to approve Merck & Co’s oral antiviral pill, molnupiravir, which had less impressive results than Paxlovid in its pivotal clinical trial.
(Reporting by David Ljunggren in Ottawa and Ismail Shakil in Bengaluru; Editing by Franklin Paul and Bill Berkrot)
January 16, 2022 coronavirus update for Oakville – Oakville News
This is Oakville’s coronavirus update for Sunday, Jan. 16, 2022. As children head back to school tomorrow, the main takeaway from today’s COVID-19 update is the increase in the number of outbreaks in long-term care, retirement, and hospital facilities. OTMH is now dealing with two outbreaks as a new one was declared at 5 South, and the province has 231 hospitals recording ongoing outbreaks, an increase nice.
A new outbreak at OTMH was declared but not shown on the region’s update of Friday, Jan. 14, 2022. Halton does not provide new information on weekends or holidays.
- Oakville – 70 patients – plus 6
- Halton – 126 patients – plus 10
- Ontario – 3,595 patients – minus 362 (ICU 563 plus 19, Ventilators 327 plus 19)
There are currently nine active outbreaks with 58 cases (LTC-41, retirement homes-13, hospitals-2) in Oakville.
Long-term care facilities status
- 424 ongoing outbreaks -plus 9
- 27,391 cases – plus 320
- 39,06 resident deaths – plus 9
- 319 ongoing outbreaks – plus 16
- 231 ongoing outbreaks – plus 16
- 1st Dose (5+) – 90%
- 2nd Dose (5+) – 83%
- Boosters (18+) – 48%
Ontario administered 117,300 vaccinations
- 1st Dose (5+) – 82%
- 2nd Dose (5+) – 3%
The number of confirmed new cases in Oakville, Halton and Ontario is under-reported since the province restricted access to testing, limiting it to high-risk individuals, healthcare providers, and patients.
- 36,184 cases – plus 552 or 5,962.2 cases per million
- 634.6 new weekly cases per 100,000, down 15.9 per cent from 2 weeks ago
- 948,086 total cases – plus 10,450 or 6,434.7 cases per million
- 503.1 new weekly cases per 100,000, down 22.4 per cent from 2 weeks ago
- 843,073 recoveries – plus 15,317
- 10,605 deaths – plus 40
- 94,408 active cases – minus 4,907
**Vaccine booking: Halton continues to book first and second-dose vaccinations for all residents age five and older, plus third-dose boosters for all adults age 18 and up.
Parents must make booster doses and appointments for children in advance, but first and second doses for those 12 and up are available on a walk-in basis.
All vaccines approved for use in Canada effectively protect you against COVID-19 and all known variants of concern.
The evidence is clear: vaccination is the best way to be protected. Local, provincial, national and international health units all affirm the same data that Canada’s approved vaccines effectively protect you from COVID-19 and significantly reduce your risks of getting sick, going to the hospital, and dying from the disease.
Pictured right is a graph from the Halton region showing how dramatically your risk of getting sick or being admitted to hospital is when vaccinated.
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