Moderna Inc.’s COVID-19 vaccine produced antibodies to the coronavirus in all patients tested in an initial safety trial, federal researchers said.
The neutralizing antibody levels produced were equivalent to the upper half of what’s seen in patients who get infected with the virus and recover, according to the results published Tuesday in the New England Journal of Medicine. The Moderna vaccine is one of the farthest along for COVID-19.
While stimulating production of neutralizing antibodies doesn’t prove a vaccine will be effective, it’s considered an important early step in testing. Meanwhile, the side effects reported weren’t severe enough in the majority of patients to preclude further testing, according to the report by researchers from the National Institute of Allergy and Infectious Diseases.
More than half of those who got the middle of three doses suffered mild to moderate fatigue, chills, headache and muscle pain. Also, 40 per cent of people in the middle-dose group experienced a fever after the second vaccination. Three of 14 patients given the highest dose of the vaccine experienced severe side effects, but that dose is not being used in larger trials.
“Man, that is a lot of adverse events,” said Tony Moody, a doctor and researcher at the Duke Human Vaccine Institute. He said it would be “unusual” for a vaccine to have this rate of side effects. On the plus side, he said that the antibody levels produced were “really encouraging.”
If researchers are measuring the right thing, the vaccine should work, he said, noting that this can only be proved in large trials.
The initial results are from the first group of 45 patients who received the vaccine, and evaluated three doses of the vaccine that were given in a two-shot regimen. The middle dose from this initial trial will be used in a large final-stage trial off the Moderna vaccine, called mRNA-1273, that is slated to begin on July 27th.
The final stage trial will compare the vaccine to placebo shots in 30,000 healthy people at high risk of coming down with the coronavirus.
One significant limitation of the data is it only includes data from the first 45 patients in the study, all of whom were from age 18 to 55. Results from a second portion of the phase 1 trial that included people older than this — a key demographic for any COVID-19 vaccine, given the high death rate in older patients — are not available yet.
William Haseltine, a former Harvard Medical School researcher who chairs Access Health International, said the levels of neutralizing antibodies produced were “respectable” and possibly protective. But he said “the jury is out” on safety of the vaccine.
Unlike traditional vaccines, which inject a weakened or inactivated virus or a piece of a virus to trigger an immune response, the Moderna product uses genetic material called messenger RNA to cause cells to produce the coronavirus spike protein. The goal is to produce antibodies to the virus that protect against the disease when someone is later exposed to the coronavirus.
The vaccine “clearly worked in that antibodies against the spikeprotein were generated, including antibodies that had virus neutralizing capability,” said Paula Cannon, professor of microbiology at Keck School of Medicine of USC. A key question will be how long will the antibodies last before they start to wane, she said.
The initial findings from the Phase 1 trial are largely in line with top-line results Moderna published in a press release in May, but provide more details on the antibody levels produced and side-effects that were seen.
At the time, Moderna was criticized by some scientists for putting out a release describing positive results that temporarily drove up the company’s stock price, but included few numbers that would allow scientists to interpret the data.
The government-sponsored trial was led by Lisa A. Jackson of Kaiser Permanente Washington Health Research Institute in Seattle, the NIAID said in its statement. Emory University in Atlanta also enrolled participants in the trial.
PM: Feds, provinces agree vaccine prioritization should be consistent Canada-wide – CTV News
As the precise order of who will follow seniors, health care workers and high-risk populations in line to get COVID-19 vaccines is still being sorted out, Prime Minister Justin Trudeau says the federal and provincial governments agree that there should be a cross-Canada “consensus” on the matter.
With Health Canada now beginning its assessment of a fourth potential vaccine candidate — Johnson & Johnson’s — the prime minister said talks are ongoing with the provinces and territories about the “challenging ethical and societal” aspect of the country’s vaccine rollout.
Logistics aside, governments and health care experts are having to weigh and decide who will be prioritized and what the eventual order of precedence will be for Canadians to line up and be vaccinated.
According to the preliminary guidance issued by the National Advisory Committee on Immunization, prioritization will be based on three factors: the state of the pandemic when the vaccine is available; the supply available and number of doses required; and the risk-benefit analysis of key populations such as those who are at higher risk for adverse outcomes if they contract the novel coronavirus.
Based on that advisory group’s preliminary guidance, the recommendation is that essential workers and others who face increased risks related to COVID-19 should be vaccinated against the disease before everyone else. Examples of those at higher risk include providers of essential services, or those whose living or working conditions put them at higher risk.
The subsequent order of who gets vaccinated next remains a largely open question, however, in the race to see 70 per cent of Canadians vaccinated by September.
“We talked about it with the provinces last week on our 22nd first minister’s call, and there was a number of perspectives, but there seemed to be a consensus that we should all agree across the country on what that list looks like and make sure that it is applied fairly right across the country,” Trudeau told reporters on Tuesday.
“There are more conversations to come and we will keep Canadians informed as we determine what that right order of priority is. Other elements of it is, certain vaccines might be more effective with certain populations versus others, and that’s why the experts are going to be so important in making determinations around, what is the best path to move forward for our country,” said the prime minister.
Though, Health Minister Patty Hajdu said later that provinces will be able to refine the prioritizations based on their own regional demographics.
“At the end of the day it is the provinces who deliver health care and it is the provinces who will decide on the priority populations and of course we’re working closely to make sure that we have coordination across the country, and that we agree on the principles, which in fact we have, we have a shared set of principles,” Hajdu said.
“There are also some federal populations that we will obviously have to take care of ourselves as the federal government,” Hajdu said. Examples of these groups would presumably be Indigenous communities and federal inmates.
Manitoba Premier Brian Pallister said on Tuesday that he and other premiers still have outstanding questions that need to be answered.
“Clearly we need our most vulnerable folks, our seniors… our front-line care workers to get the vaccine earlier, we can all agree on that. But the devil’s in the details, when you get beyond that. Should it be done on the basis of age? Or how do you determine vulnerability? Should it be done on the basis of ethnicity? Should it be done on the basis of race in some way? These questions have to be addressed,” Pallister said.
“We’re not saying the federal government has to do it all but we’re saying that we need to have the criteria established and the priority should be common, not different in one side of Saskatchewan’s border with Alberta than it is on the other, or not different than it is in Ottawa from Gatineau, but rather that we have a co-ordinated strategy.”
In an interview on CTV’s Power Play, New Brunswick Premier Blaine Higgs said in his province he doesn’t anticipate there will be a huge line up of people who want to get vaccinated early on, but communicating as clearly as possible in advance of who will be eligible first will help avoid a “panic situation.”
So far, just over $284 million has been spent on distributing vaccines to Canadians, with overall more than $1 billion allocated to Canada’s vaccine procurement effort, as part of a more than $14-billion commitment over the next several years on research into and development of vaccines and therapeutics.
AGE MAY BE KEY FACTOR: TAM
Chief Public Health Officer Dr. Theresa Tam said Tuesday that work is underway right now on getting more “granular” in planning who among the highest risk groups will be first.
“That detail work is, you know, being taken very seriously by the provinces and territories as they begin to plan their immunization clinics.”
Then, once the priority groups are immunized, it’s possible the next easiest way to break down the order would be by age, said Tam.
“The age group, based on our analysis is actually the easiest and the most scientifically-sound way, I think, of increasing the population coverage,” she said.
“We know that underlying medical conditions put people at high risk but when we actually analyze all the different underlying medical conditions, and their age, it still comes out that the age is in fact the most important where you look at severe illness and mortality.”
There will also be groups who won’t be able to get a vaccine early on, due to the lack of research into the potential impacts on them, such as children and people who are pregnant.
“Kids haven’t really been engaged in a lot of the clinical trials, so that would be another age group for which data is needed, and we’ll be looking towards more data on pregnant women as well,” Dr. Tam said.
Asked whether he anticipates being among the earliest groups to get vaccinated, Trudeau said that he’s “going to trust the experts to make the right determination of what the priority populations are.”
With files from CTV News’ Ryan Flanagan
Canada’s coronavirus cases surge past 380K while daily death toll average stands at 87 – Global News
The data, announced by public health officials across the country, pushed the country’s total COVID-19 cases to 383,132 and its death toll from the virus to 12,211.
To date, a total of 304,888 people — or 79 per cent of all cases — have also recovered from the virus, while over 14,779,000 tests have been administered.
On Tuesday, Canada’s minister of public services and procurement, Anita Anand, said the federal government was in frequent talks with several coronavirus vaccine suppliers to negotiate earlier delivery dates.
Health Canada is currently reviewing the approval of four vaccines, with the government previously estimating an initial rollout of six million doses — enough shots to fully inoculate three million Canadians — to come in the new year.
“The delivery window is within the first quarter of 2021 … I am negotiating with our vaccine suppliers every day for earlier delivery dates. So when the Health Canada approval comes we will kick into the delivery process ASAP,” Anand said.
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Leaked modelling revealed on Tuesday also showed that almost 800 Albertans were projected to be hospitalized with COVID-19 by mid-December, placing an increased strain on hospitals and intensive care units.
Canada currently has over 2,600 hospitalizations from the virus, with the number steadily growing alongside the country’s cases and deaths.
Canada’s chief public health officer, Dr. Theresa Tam, said in a statement Tuesday that the number of people experiencing severe illness continues to increase, with an average of 87 deaths and over 2,250 people being treated in hospital over the past seven days.
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Ontario tallied the highest number of new COVID-19 cases Tuesday, with 1,707 more infections and seven new deaths. The province, which saw its daily coronavirus cases peak at over 1,800 on Friday, sent several of its hotspots into lockdown last week to curb its surge in new cases.
In Quebec, another 1,177 infections and 28 additional deaths were announced by health authorities Tuesday. The province has the highest number of COVID-19-related deaths in the country, which now stands at 7,084 following Tuesday’s increase.
Alberta reported 1,307 more infections as well, pushing it’s total caseload to 59,484. Ten more deaths were also added by health authorities Tuesday, with its provincial death toll now standing at 551. Manitoba reported another 282 cases while Saskatchewan added 181.
B.C. added 653 more cases on Tuesday, of which three were diagnosed as “epi-linked,” meaning cases that displayed symptoms and were close contacts of confirmed infections, but were never tested. A total of 336 patients are considered epi-linked in the province, while the death toll stands at 457 after 16 more fatalities were announced.
Several territories and Atlantic Canadian provinces reported new cases as well, with Nova Scotia adding 10, New Brunswick another seven and both Newfoundland and Labrador and Nunavut reporting just one.
P.E.I., and the Northwest Territories did not add any new infections, while the Yukon has yet to update its Tuesday case figure.
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Cases of the virus continue to rise across the world, with 63,679,000 cases being reported as of today according to a tally kept by Johns Hopkins University.
A total of 1,476,900 people have also died from the virus so far, with the United States, Brazil and India leading in both infections and fatalities.
© 2020 Global News, a division of Corus Entertainment Inc.
Conservatives push for parliamentary committee study into failed vaccine deal – Canada News – Castanet.net
The federal Conservatives are calling for a parliamentary committee to probe the Liberal government’s plan to refit a National Research Council facility in Montreal to start producing a COVID-19 vaccine.
The government announced the $44-million project in May as part of a partnership between the NRC and a Chinese company to develop a made-in-Canada vaccine.
By August, the Liberals confirmed the partnership with CanSino Biologics had fallen apart, after the Chinese government had blocked shipments of vaccine samples meant to be used in clinical trials in Canada.
Conservative Leader Erin O’Toole has criticized the Liberals for putting too much faith in Beijing, and blamed the failed deal for Canada being late to order vaccines from other foreign companies.
The proposed committee probe would look at the investment intended to upgrade the NRC facility and how the deal impacted Canada’s efforts to ensure the country has timely access to vaccines.
Prime Minister Justin Trudeau admitted last week that Canada might have to wait for other countries to get access to vaccines, though the government and vaccine-makers have since downplayed any delay.
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