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Recent mRNA vaccine approvals for Covid-19 are anticipated to give rise to a novel competitive landscape in the oncology market – Clinical Trials Arena



The ongoing Covid-19 pandemic has yielded an unexpected advancement in the pharmaceutical industry with the approval of the first mRNA vaccines, which GlobalData expects will soon impact other indications.

This historical landmark could have significant implications, primarily in the oncology market since mRNA vaccines were being exclusively investigated in infectious and oncology diseases prior to the pandemic. Historically, mRNA vaccines were of interest in the oncology setting because multiple biomarkers could be targeted by this novel mechanism.

Given the current role of immunotherapies in oncology, mRNA vaccines pose a novel approach to trigger immune reactions against cancer cells. However, the novelty of mRNA vaccines has raised regulatory and manufacturing questions in addition to clinical limitations.



Covid-19 approvals showcase potential of mRNA vaccines

The recent approvals of Pfizer / BioNTech’s and Moderna’s mRNA vaccines in healthy patients, complemented by the historically unmatched magnitude to reach healthy patients worldwide, has helped surpass many barriers for mRNA vaccines while highlighting this novel mechanism of action. GlobalData expects this will propagate a new epicenter of interest in pursuing this drug class in oncology.

Currently, there are 44 ongoing clinical trials exploring mRNA vaccines, of which 23 are investigating infectious diseases. This includes Covid-19, which accounts for 60% of those clinical trials. Interestingly, only four out of the 44 clinical trials have made it to Phase III as a result of the sudden and immense demand to prevent the spread of Covid-19.

From an oncology viewpoint, the current pandemic will still serve to provide essential real-world data about the tolerability and effects of mRNA vaccines, since despite their approval and initial vaccination rollout, the long-term efficacy and side effects are still to be understood. As more data are gathered on these vaccines, GlobalData expects an increasing interest in bringing them into the oncology sector.

Key opinion leaders (KOLs) interviewed by GlobalData have repeatedly shown interest in novel mechanisms of action, particularly in immunotherapy. Prior to the pandemic, mRNA vaccines were one of many promising drug classes that were being explored equally with each other, with no expectation about which would be the next to impact the market. However, the sudden rise of mRNA vaccines makes it a prime candidate since there is a current spotlight on this drug class.

A supporting argument for the interest in mRNA vaccines is that out of the 21 ongoing non-infectious disease clinical trials that are exploring mRNA vaccines, all are being developed for oncology indications. Of these 21 trials, only seven are in Phase II, which demonstrates the relatively early stage of mRNA vaccines in oncology. Interestingly, the most represented company in these clinical trials is BioNTech, with seven of the 21 trials, followed by Roche/Genentech with three clinical trials and Moderna Inc with two clinical trials.

Big Pharma: the mRNA race in oncology

GlobalData expects that large pharmaceutical companies will look to enter the race for the first mRNA vaccine approval in oncology. Given the current role of both BioNTech and Moderna in the Covid-19 mRNA vaccines market, GlobalData assumes these companies will be heavily sought out for marketing deals in the oncology market as well. BioNTech is already involved in licensing deals for its mRNA vaccine BNT-122 with Genentech and Roche, the latter being of great significance since it explores a combination with Roche’s Tecentriq (atezolizumab).

Similarly, Moderna has a deal with Merck & Co., which has led to the co-development of two mRNA vaccines: mRNA-4157, a personalized cancer vaccine, and mRNA-5671, a KRAS vaccine. Pfizer’s involvement with BioNTech during the pandemic may provide it with an advantage over other companies that may be interested in entering this novel market.

Therefore, GlobalData expects that a novel competitive landscape will emerge in the oncology immunotherapy market, which will help identify which indications better benefit from this approach and eventually give rise to the first therapeutic mRNA vaccine in oncology.

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B.C. call centres to book vaccines will 'do better' after hectic first day: minister – North Shore News



VANCOUVER — British Columbia’s health minister promised to “do better” on Monday after call centres to schedule vaccine appointments were overwhelmed on the first day of booking.

Adrian Dix said there were 1.7 million calls in less than three hours after the phone lines opened for people over 90 and Indigenous elders over 65 to book their appointments.

Dix said he believed that people who were not yet eligible for the COVID-19 vaccine were flooding the lines, but he also acknowledged that more staffing was needed.

“It’s really important in order to allow those over 90 to get their appointments that we only call when our age group becomes open for calling,” he told the province’s COVID-19 briefing.

“It’s also important that we do better. I know that people have called in and have waited a long time today.” 

Dix said that more resources would be added in the coming weeks, as more age groups become eligible to call to book their vaccines.

People born in 1936 or earlier can start calling for appointments on March 15 and those born in 1941 or earlier can start to schedule their immunizations March 22.

Fraser Health was the only authority to launch an online booking platform on Monday, but Dix said a web-based system would become widely available on April 12.

Some residents with elderly parents said they spent hours redialing their health authority’s number and only got a busy signal or a recorded message telling them to call back later.

Julie Tapley, whose 90-year-old father lives in the Vancouver Coastal Health region, said she was frustrated that the authority had not yet established an online booking system.

“I just want to get in the queue and start the process so that (my parents) can return to their normal lives.”

B.C.’s provincial health officer, Dr. Bonnie Henry, said creating an online booking system is “quite a large project” and Fraser Health was the only authority with an existing platform.

Of about 80,000 people eligible to book appointments this week, roughly 26,000 have already received a shot, so a relatively small number of people should be calling, Dix said.

He said about 10,000 appointments were booked as of Monday afternoon and a “significant number” of those were scheduled through the Fraser Health online site.

Dix urged eligible residents and their families to keep calling in the coming days. There are plenty of appointments available and it is not a “first-come, first-serve” system, he said.

Although B.C.’s case numbers have been on the rise, Henry said some restrictions would be eased in the coming weeks as the weather warms and immunizations ramp up.

Outdoor gatherings, larger meeting places and layers of protection such as masks will still be recommended, she said.

“I like to think of it as slowly turning up the dial again rather than flicking a switch,” she said. 

She also said she hopes to see the return of sports and in-person religious ceremonies within weeks.

Officials have been developing a plan with faith leaders to enable the gradual return of in-person services, as there are important dates in many religions coming up, Henry said.

A B.C. Supreme Court judge reserved his decision on Friday on a petition filed by three Fraser Valley churches who argued that a ban on in-person services violates charter rights.

Henry reported on Monday 1,462 new COVID-19 cases and 11 deaths over three days, pushing the death toll to 1,391 in the province.

She said there was one new outbreak in a long-term care home, the Cottonwoods Care Centre in Kelowna, where a high number of residents and staff had already been vaccinated.

The flare-up serves as a reminder that while vaccines are effective and prevent severe illness and death, they don’t necessarily mean that all transmission will be stopped, she said.

There have been 144 new cases that are variants of concern, bringing the total to 394 confirmed cases. Officials still do not know how about a quarter of the cases were acquired.

Henry became emotional when quoting Chief Robert Joseph, a knowledge-keeper with the Assembly of First Nations.

“We will celebrate our lives again, dream our dreams again and watch our children regain their hope,” Henry quoted him as saying, with tears in her eyes.

“That’s what we can look forward to in the coming months.”

This report by The Canadian Press was first published March 8, 2021. 

Laura Dhillon Kane, The Canadian Press

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U.S. issues advice to those fully vaccinated, but no shift in Canada yet – BayToday



New U.S. guidelines say people fully inoculated against COVID-19 can drop some precautions when gathering with others, but at least two provincial health ministers say existing public health advice holds for now.

The Centres for Disease Control and Prevention said Monday that Americans who have waited two weeks since their second required shot can spend time with other immunized people indoors without masks or social distancing.

The same applies to gatherings by those at low-risk of severe disease, such as fully vaccinated grandparents visiting healthy grandchildren.

The U.S. guidelines recommend that fully vaccinated people continue to wear masks, avoid large gatherings and physically distance when in public.

British Columbia Health Minister Adrian Dix said Monday that physical distancing and other public health guidelines will be around for some time.

He said about 15 per cent of B.C.’s eligible residents are expected to be immunized by the end of the month, which is “nothing like herd immunity.”

“The future is bright, but we can’t live the future right now. We’ve got to live the now right now.”

Dix does expect visiting restrictions to be loosened in B.C.’s long-term care homes this month as about 90 per cent of residents and staff have been vaccinated.

University of Alberta infectious diseases specialist Dr. Lynora Saxinger said evidence on which the U.S. health agency based its advice is “very much in evolution” and such recommendations might not work everywhere.

Virus variants with the potential to break through vaccine protection are also a “wild card,” she said.

But Saxinger said the principles underlying the U.S. guidance make sense, especially since the initial vaccine rollout has targeted older individuals, many of whom have been kept away from their grandchildren for almost a year.

“They’re basically taking a balance-of-probabilities approach to say that if you’ve received vaccine, you should be highly protected against severe disease. Therefore this should be hopefully OK.”

Ontario Health Minister Christine Elliott said her province is still recommending people take precautions with gatherings and will take its cues from the National Advisory Committee on Immunization.

Ontario reported 1,631 new cases in its latest update, but said the higher-than-expected count was due to a system “data catch-up.” The seven-day average for new cases was at 1,155.

There were also 10 more deaths linked to the novel coronavirus.

Ontario lifted stay-at-home orders in Toronto, Peel Region and North Bay on Monday — the last three regions subject to the government’s strictest measures introduced two months ago.

Alberta also loosened some rules for banquet halls, community halls, conference centres, hotels, retail shops, performances and post-secondary sports, as hospitalizations stayed well below the provincial target of 450.

Health Minister Tyler Shandro said he believes it is safe enough to immediately ease more restrictions

The province reported 278 new cases of COVID-19 and six additional deaths. Six cases of the more contagious variant were also detected, bringing that total to 659. There were 254 people in hospital.

And residents in five regions of Quebec, including the capital, were again able to eat in restaurants and work out in gyms.

Restrictions remain in place in the Montreal area due to fear that variant cases will cause a spike in infections and hospitalizations.

Quebec reported 579 new cases in its update. New daily infections had been above 700 for the five previous days. The province also recorded nine more deaths.

All of New Brunswick shifted to a lower pandemic response level Monday. That means a circle of 15 regular contacts can socialize, up from 10. The Atlantic province had five new cases and 36 active ones.

Saxinger said a “judicious and slow” reopening is the safest approach.

She noted that many countries have seen their case counts come down, but the proportion of more contagious variants is higher, planting the seeds for a spike.

“We know that it’s possible that the variants can be responsible for another surge, that a variant surge is harder to contain and you need longer and more stringent restrictions to contain them.”

Also Monday, Prime Minister Justin Trudeau announced that Thursday will be a “national day of observance” to commemorate the 22,000 people in Canada who have died from COVID-19 and to acknowledge all the ways the virus has changed our lives in the last year.

This report by The Canadian Press was first published March 8, 2021

— With files from The Associated Press

Lauren Krugel, The Canadian Press

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B.C. reports 1,462 new COVID-19 cases over three days, 11 deaths –



B.C. reported 1,462 new cases of COVID-19 over three days along with 11 deaths.

There were 545 cases from Friday to Saturday while 532 cases were reported from Saturday to Sunday, and 385 from Sunday to Monday.

Of the new cases, 407 were in the Vancouver Coastal Health region, 802 were in the Fraser Health region, 72 in Island Health, 79 in Interior Health, and 102 in Northern Health.

Millions of calls received as phone lines open for B.C. vaccination registration

Millions of calls received as phone lines open for B.C. vaccination registration

Provincial health officer Dr. Bonnie Henry said 144 of the new cases involved variants of concern, bringing the total number of variant cases to 394. The majority of those cases are linked to the B.1.1.7. variant first identified in the U.K.

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The number of active cases linked to COVID-19 variants jumped to 87. On Friday, the province reported just 12 active cases involving variants.

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The number of people in hospital with COVID-19 dropped by 15 to 240. Sixty-six of those patients are in critical or intensive care, a number that remains unchanged from Friday.

There are 4,854 active COVID-19 cases in the province while 8,723 people are in self-isolation due to possible exposure to the novel coronavirus.

The 11 deaths bring the province’s COVID-19 death toll to 1,391.

The update comes after the opening of British Columbia’s call centre to book COVID-19 vaccination appointments.

Click to play video 'B.C.’s mass COVID-19 immunization plan begins Monday'

B.C.’s mass COVID-19 immunization plan begins Monday

B.C.’s mass COVID-19 immunization plan begins Monday

Dix said the appointment booking line received 1.7 million calls as of 9:40 a.m. Monday despite the fact that only about 82,000 people — those born in 1931 or earlier and Indigenous people born in 1946 and earlier — are eligible to receive an appointment at this time.

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Many of those same people have already received a vaccination in long-term care.

“This is not the time to call in if you are not calling for someone over the age of 90 or an Indigenous person 65-plus,” Dix said.

“This is not the time to call in.”

Click to play video 'Dr. Bonnie Henry says British Columbians could see an easing of some COVID-19 restrictions'

Dr. Bonnie Henry says British Columbians could see an easing of some COVID-19 restrictions

Dr. Bonnie Henry says British Columbians could see an easing of some COVID-19 restrictions

Read more:
Upward trend continues as B.C. reports 634 new COVID-19 cases, four deaths

On Friday, B.C. reported 634 new cases of COVID-19 along with four deaths.

— With files from Simon Little and Richard Zussman

© 2021 Global News, a division of Corus Entertainment Inc.

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