Early data from Moderna Inc.’s COVID-19 vaccine, the first to be tested in the United States, showed that it produced protective antibodies in a small group of healthy volunteers, the company said Monday.
The data comes from eight people who took part in a 45-subject safety trial that kicked off in March. The Moderna vaccine is one of more than 100 under development intended to protect against the coronavirus that has infected more than 4.7 million people globally and killed over 315,000.
Moderna’s mRNA vaccine uses genetic material from the virus in the form of nucleic acid. That tells the human body how to make proteins that mimic viral proteins, and this should provoke an immune response. Overall, the study showed the vaccine was safe, and all study participants produced antibodies against the virus.
An analysis of the response in the eight individuals showed that those who received a 100-microgram dose and a 25-microgram dose had levels of protective antibodies to fend off the virus that exceeded those found in the blood of people who recovered from COVID-19, the illness caused by the coronavirus.
The news, issued in a release by the U.S. biotechnology company, lifted shares of Cambridge, Mass.-based Moderna by 20 per cent. The stock later fell 1.6 per cent in extended trading after the company said it plans to sell $1.25 billion US in common stock to raise money for vaccine development and manufacturing.
Important not to ‘overstate’ results
“These are significant findings, but it is a Phase 1 clinical trial that only included eight people,” said Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security, who was not involved in the study. “It was designed for safety, not for efficacy.”
The very early data offers a glimmer of hope for a vaccine among the most advanced in development.
Adalja said many glitches can occur between now and the time this vaccine is tested for efficacy in thousands of people. “What we do see is encouraging,” he said.
Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said in a Science Media Centre commentary on Monday that this was a Phase 1 study whose goal is to show the vaccine “is able to induce an antibody response and that the dose range is appropriate.” He was not involved with the study.
“The trial is not intended to show efficacy in reducing or preventing COVID19 disease, and it cannot be assumed on the basis of these results that it will do so. The Phase 3 trials will assess this, so it is important not to overstate these results.”
Scientists are trying to understand what level of antibodies will ultimately prove protective against the coronavirus and how long that protection will last.
Moderna said the vaccine appeared to show a dose response, meaning that people with the 100-microgram dose produced more antibodies than people who got the lower dose.
The vaccine has gotten the green light to start the second stage of human testing. Last week, U.S. regulators gave the vaccine “fast-track” status to speed up the regulatory review.
In the Phase 2, or midstage, trial designed to further test effectiveness and find the optimal dose, Moderna said it will drop plans to test a 250-microgram dose and test a 50-microgram dose instead.
Reducing the dose required to produce immunity could help spare the amount of vaccine required in each shot, meaning the company could ultimately produce more of the vaccine.
Maximizing number of doses
“In the context of a pandemic, we expect demand to far outstrip supply, and the lower the dose, the more people we expect to be able to protect,” said Moderna’s chief medical officer Tal Zaks.
The U.S. government in April placed a big bet on Moderna, backing its vaccine with $483 million from the Biomedical Advanced Research and Development Authority, a part of the U.S. Department of Health and Human Services.
The company said that grant will enable it to supply millions of doses per month in 2020 and, with further investments, tens of million a month in 2021 if the vaccine proves successful.
In May, Moderna struck a 10-year strategic collaboration with Lonza Group that over time will allow the manufacture of up to one billion doses a year.
“We are investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from SARS-CoV-2,” Moderna CEO Stéphane Bancel said, using the official name for the new virus.
Moderna said it expects to start a larger late-stage, or Phase 3, trial in July.
There are currently no approved treatments or vaccines for COVID-19, and experts predict a safe and effective vaccine could take 12 to 18 months to develop.
The most notable side-effects reported from the early testing of Moderna’s vaccine were three participants with flu-like symptoms following a second shot of the highest dose. The company said it believed the symptoms were an indirect measure of a strong immune response.
Edited By Harry Miller
30-day limit on prescriptions in Ontario expected to end by July 1; Ontario completes more than 20000 coronavirus tests in a day for the first time – Toronto Star
The latest novel coronavirus news from Canada and around the world Sunday (this file will be updated throughout the day). Web links to longer stories if available.
9 a.m.: Pope Francis cheerfully greeted people in St. Peter’s Square on Sunday, as he resumed his practice of speaking to the faithful there for the first time since a coronavirus lockdown began in Italy and at the Vatican in early March.
Instead of the tens of thousands of people who might have turned out on a similarly sunny day like in pre-pandemic times, perhaps a few hundred came to the square on Sunday, standing well apart from others or in small family groups.
Until June 3, people aren’t allowed to travel between regions in Italy or arrive from abroad for tourism, so the people in the square came from Rome or places in the region.
Noting this was the first time he could greet people in the square for weeks, Francis said that “one doesn’t emerge from a crisis the same. You either come out better or you come out worse.” He said he’d be back to greet them next Sunday in the same place at noon, smiling and pointing down to the vast square far below his studio window.
8 a.m.: India reported more than 8,000 new cases of the coronavirus in a single day, another record high that topped the deadliest week in the country.
Confirmed infections have risen to 182,143, with 5,164 fatalities, including 193 in the last 24 hours, the Health Ministry said Sunday.
Overall, more than 60 per cent of the virus fatalities have been reported from only two states — Maharashtra, the financial hub, and Gujarat, the home state of Prime Minister Narendra Modi. The new cases are largely concentrated in six Indian states, including the capital New Delhi.
There are concerns the virus may be spreading through India’s villages as millions of jobless migrant workers return home from cities during the lockdown. Experts warn that the pandemic is yet to peak in India.
7:45 a.m.: Russia reported 9,268 new cases of the coronavirus on Sunday, the first time in a week that the daily tally exceeded 9,000, but the lowest death toll in several days: 138.
Overall, Russia has recorded 405,843 cases and 4,693 deaths from COVID-19. The relatively low mortality rate compared with other countries has prompted skepticism domestically and abroad.
7 a.m.:Ontarians who rely on prescription medication will hopefully see an onerous COVID-19 precaution lifted by the end of June.
A 30-day limit on prescriptions was brought in by the Ontario government in the early days of the pandemic in an effort to prevent drug shortages. Spokespeople for Ontario’s seniors community and the province’s pharmacy industry say they expect the limitation will be lifted within the month, returning to the usual 90-day maximum by July 1.
“It’s been a difficult policy,” said Justin Bates, the chief executive officer of the Ontario Pharmacists Association. “We stand by the policy, we think it was the right thing to do, but I think everybody’s hopeful that we can get back to 90 days and to a normal cycle of quantity.”
11 p.m: The Toronto Raptors issued a statement late Saturday, as protests escalated across North America in the wake of the death of George Floyd, a Black man killed in Minneapolis after a police officer pressed his knee into his neck for several minutes.
The Raptors put out the statement hours after thousands of people took to the streets on Saturday demanding justice for Regis Korchinski-Paquet, three days after the 29-year-old woman fell to her death from a High Park highrise, in an incident that is now under investigation by Ontario’s civilian police watchdog.
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Saturday, 7 p.m. Ontario’s regional health units are reporting 320 new COVID-19 infections, according to the Star’s latest count.
As of 5 p.m. Saturday, the health units had reported a total of 29,212 confirmed and probable cases, including 2,316 deaths. The daily counts have fallen from a spike that saw totals above 400 cases per day most of last week.
Saturday’s tally included 123 new cases in Toronto and 114 more in Peel Region; together, the two health units accounted for nearly three-quarters of the province’s new infections.
According to a provincial database of COVID-19 cases, nearly 80 per cent of the 3,933 Ontarians with an active case of COVID-19 reside in the GTA, with nearly 85 per cent of those in Toronto or Peel Region.
Canadian airlines could ‘fail’ if forced to refund passengers
Transport Minister Marc Garneau says that Canadian airlines could go bankrupt if the ailing industry is compelled to refund passengers billions of dollars for flights cancelled due to the pandemic.
“I have said many times that I have enormous sympathy for those who would have preferred to have a cash refund in these difficult circumstances. It is far from being an ideal situation,” Garneau told a press conference earlier today.
“At the same time, if airlines had to immediately reimburse all cancelled tickets, it would have a devastating effect on the air sector, which has been reeling since the COVID 19 pandemic started.”
Garneau was doubling down on a message he delivered to the House of Commons’ pandemic committee on Thursday, when he warned MPs that if airlines “had to reimburse at this time, some of them could fail.”
The minister said today it’s his responsibility to help Canada’s airlines survive the pandemic.
“It is so essential for this country,” he said. “This is the second largest country on Earth, with its distances and remote areas, and we expect and need an airline industry in this country.”
<p class=”canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm” type=”text” content=”Watch | Reporters question Marc Garneau about airline ticket refunds” data-reactid=”38″>Watch | Reporters question Marc Garneau about airline ticket refunds
But his response isn’t sitting well with Canadians struggling financially during the pandemic who argue it’s their right as consumers to get their money back for flights they never took.
“It’s very disappointing and frustrating,” said Tammie Fang, a health care essential worker in B.C. “My rights as a consumer have been put aside to help balance the airline industry.”
Fang works at a New Westminster hospital assisting with open-heart surgeries. She said she spends much of her spare time calling and emailing Air Transat seeking a refund of roughly $500 for a flight to Toronto she never took. She describes it as an extra burden during an already stressful and financially challenging time.
“It’s disheartening,” she said. “It’s unbelievable how much effort we have to put in.”
<p class=”canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm” type=”text” content=”Airlines’ survival versus consumers’ rights” data-reactid=”43″>Airlines’ survival versus consumers’ rights
Canada’s airline industry has been hit particularly hard by the pandemic, and most of the country’s airline fleet is sitting idle at airports across the country. Airlines are losing 90 per cent of their normal revenue streams and some have put their operations completely on pause.
At the same time, pressure is mounting on the federal government to step in and force airlines to pay back passengers who also are struggling financially. Two petitions with more than 30,000 signatures combined have been submitted to Parliament in recent weeks calling on the government to demand that airlines tapping into taxpayer-funded government supports reimburse grounded passengers.
<p class=”canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm” type=”text” content=”Billions tied up in refunds” data-reactid=”66″>Billions tied up in refunds
For the most part, Canadian airlines are offering those passengers travel vouchers redeemable for two years. Air Canada also announced last week that it’s allowing people to transfer their tickets to others, which could permit ticket holders to sell them. The Canadian Transportation Agency has said offering vouchers could be a reasonable measure in the current circumstances.
Garneau’s office said it would cost airlines billions of dollars to refund customers. When CBC asked Transport Canada for specific numbers, it was told the figures the government receives from airlines amount to proprietary information that it isn’t authorized to release.
Air Canada’s books are open, since it’s a publicly traded company. It has about $2.6 billion tied up in ticket sales for future travel over the next year.
On March 16, the airline said its current liquidity level was $6.3 billion — a record level — and its balance sheet was solid. Since then, Air Canada has said it’s burning $22 million a day in operating costs and plans to reduce its workforce by 50 to 60 per cent. The company said a dramatic drop in demand during the pandemic caused the airline to slash its flight capacity by 95 per cent.
<p class=”canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm” type=”text” content=”Government in talks with airlines and consumers” data-reactid=”75″>Government in talks with airlines and consumers
Outside Rideau Cottage today, Prime Minister Justin Trudeau repeated a message he’s delivered in the past — that the government has to strike the right balance between keeping airlines afloat and preserving consumers’ rights.
“I hear clearly the concerns that Canadians have around their air tickets,” said Trudeau. “We will continue to work with the industry and with concerned groups of Canadians to ensure that we find a fair way through this.
“But I know Canadians at the same time want to make sure we continue to have an airline industry after this very difficult pandemic.”
The government is in talks with airlines and is looking to see what other countries have done with travel refunds. It’s expected to deliver an update on the file in the coming weeks.
Source: Yahoo News Canada
Edited By Harry Miller
Saint John's cruise ship season officially cancelled as feds extend ban – CBC.ca
Minister of Transport Marc Garneau has extended the cruise ship ban until at least Oct. 31, meaning no cruise ships will be arriving in Saint John this season.
In a press conference Friday, Garneau said cruise ships with overnight accommodations and capacity of over 100 people, including passengers and crew, will be prohibited from operating in Canadian waters until then. The ban was previously set to expire in July.
Port Saint John CEO Jim Quinn said this ban extension means an end to this year’s season for Saint John.
“[It’s] not totally unexpected,” he said. “We respect … the decisions that the government makes because it’s all about protection of our population.”
Quinn said the port was expecting record-setting cruise revenue in 2020, but COVID-19 restrictions nationally and internationally have already cost the city 80,000 visitors. That’s about half of the expected visitors the cruise ships were set to bring.
There were 51 calls still on the schedule between July 31 and Oct. 27.
“The government has said that cruising will not be taking place in Canada before Oct. 31. So I guess… that means there will be no cruise vessels coming into Saint John this season”
In response to a question about what the federal government is planning to help the tourism sector, Garneau said the minister responsible for tourism, Mélanie Joly would be the best person to answer that question.
“I agree with you there will be a serious impact on the tourism industry, especially for cruise ships,” he said. “This is something that is important for some provinces in our country, unfortunately, because we have decided to minimize risk.”
“There will be economic impacts.”
Quinn said the port is hoping there will be a vaccine by the time next season starts. But it’s still too soon to prepare for a cruise ship season if there is no vaccine by 2021.
“It’s too early for us to contemplate that in terms of doing anything with next season,” he said. “The cruise lines are very focused on doing all of the right things and to ensure that safety procedures and protocols are in place to regain the confidence of of the cruising public and officials and communities that they visit.”
He said next season is a full twelve months away “so a lot of water to go under the bridge between now and then.”
He said there are no scheduled Port Saint John layoffs, but the port won’t be hiring the usual seasonal and temporary workers involved with the cruise ship visits.
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