Canadians Awaiting Rescue

"It's going to be extremely profound to see those groups immunized, plus those people who have taken care of them."

"That's a big amount that's actually taken off the table. That essentially makes this much more of a manageable disease."

"There is an end to these restrictions. There's an end to this lifestyle, so holding on for longer just gives us time to get that vaccination out there."

"There's going to be a point where you cross where that risk starts settling down to something that's very tolerable."

Dr.Zain Chagla, infectious disease physician, professor, McMaster University, Hamilton 

"By protecting those in long-term care, and reducing the rate of infection in long-term care, you also have significant positive ripple effects in the general community."

"If you just have fewer people in long-term care sick with this infection, that will result in fewer people being transferred to hospitals."

"It's not going to be like a light switch. I don't think it's going to be one day they're going to say, 'OK, it's back to normal'."

"It's not going to be like summer of 2019. But it'll certainly be closer to summer of 2019 than summer of 2020."

Dr.Isaac Bogoch, infectious disease physician, member Ontario Task Force for the Rollout

 

The global community is in a hiatus period, waiting for rescue from the confines of a huge concentration camp that places firm strictures on the way we live, making near-recluses of us, hampering our freedoms so long taken for granted, giving us breathing room but just barely where some peoples' lives have been so afflicted with the worst excesses that the SARS-CoV-2 virus is capable of producing that their mental balance hovers on the edge of managing to cope, but barely.

But the first approved vaccines against COVID-19 are now in circulation, and governments are arranging for the most vulnerable among their populations to receive the initial doses, relieving them of the dangers that have ended the lives of so many others in those vulnerable groups. A just-in-time solution to a raging pandemic whose predations are nowhere near finished even as the frantic race to immunize as many people as possible trudges on. Rescue is there, somewhere on the tip of the horizon.

Research through the American Centers for Disease Control and Prevention certified that people over age 85 risk death from COVID-19 -- 630 times greater than anyone aged between 18 and 29. Roughly 70 percent of the virus death toll in Canada struck those over 80. The Canadian government has expectations of receiving four million doses of the Pfizer vaccine, available for injection into the arms of Canadians by the end of March. An additional two million doses of Moderna's vaccine is anticipated within the same time frame.

 

The provinces are behind targets of getting COVID-19 vaccine into Canadians' arms, and experts say logistical challenges are largely to blame but are hopeful the arrival of the Moderna vaccine will help speed things up.

 

But Canada's population is around 38 million people, and would need at the very least 74 million doses to ensure that the entire population could be vaccinated. Even if only 60 percent vaccination occurs, it should guarantee herd immunity, protecting that portion of the population for whom vaccinations are not recommended, or who refuse to be vaccinated, unwilling to place their trust in a new vaccine using a new bio-engineering technology that was produced in record-short time.

Both the Pfizer and Moderna vaccinations use similar cutting-edge biomedical techniques. And both require two doses be applied for full efficacy in which case with the incoming vaccines no more than three million people in Canada could be fully immunized by the end of March. April is forecasted as the soonest the vaccine will be available on a more widespread basis. As for the entire population to be immunized, the time frame stretches to the fall of 2021.

In the United States estimates projected by both the outgoing and the incoming administrations see the potential for a full third of the entire American population to be vaccinated by spring. Placing the U.S. well ahead of Canada. Most of the at-risk population is set to be vaccinated by March or April, in the United Kingdom. The estimate for Canada is for eight percent to be vaccinated in the first quarter of the year. Experts appear to agree, however, that the target population being vaccinated has a huge potential to alter the impact of the virus.

Generally speaking, immunizations are recommended for long-term care residents and workers, front-line hospital staff and Canadians over 80 to receive the first vaccine arrivals. To the present in Canada, about 100 deaths occur daily, a number anticipated to fall once the initial vaccinations have been completed. About 1.7 million Canadians are aged over 80, according to Statistics Canada. The 2015 census found 224,000 people live in long-term care or nursing homes, with an additional 127,000 housed in retirement residences of some kind.

It is estimated that the first three million doses should represent enough vaccine to inoculate most of the people in those three categories. Over a third of the COVID cases requiring hospitalization have been among people over age 80, and over half are over the age of 70, groups represented in the targeted rollout. Confirmed orders to date are expected to vaccinate 30 million Canadians with the Pfizer and Moderna vaccines.

AstraZeneca's vaccine was approved this week by Britain, along with Oxford University's homegrown U.K. vaccine requiring a booster after 12 weeks. A single-dose vaccine is expected from Johnson and Johnson, 38 million doses of which has also been ordered by Canada, with early trials showing an immune response in 98 percent of vaccine recipients. 

 

Dr.Bogoch pointed out that the summer of 2020 held a steady increase in infections concentrated among a younger cohort with few hospitalizations. And the summer of 2021 promises to be vastly different than its counterpart of a year earlier.

So yes, Virginia, Santa visited you last month and he probably confided in you that there is indeed 'light at the end of the tunnel'. Did you tell your mother to share the good news?

Countries around the world have started vaccination campaigns

The World on Tenterhooks

"So 94 percent of people we have no disease, no symptoms ... Those who get it will be very, very mild and so you will almost stop, if not entirely stop, hospitalization, and death."

"The U.S. has done extremely well. This has been months and months of preparation and planning."

"I don't think the other countries are as ready [to roll out their vaccines]."

"We don’t have a billion-dose manufacturing capacity sitting idle somewhere. We are increasing our output more and more and all our key engineers are working to make that happen." 

"So if we pull them out and say, ‘Hey, you have to go and get on a plane on the other side of the world to teach somebody else how to do it,’ they won’t be able to scale up manufacturing in the U.S. or in Switzerland."

Stephane Bancel, CEO. Moderna

This Vaccine against Covid-19 from Moderna would be nearly 95% effective, marking a second major step forward in the quest to end the Covid-19 pandemic.   Joel Saget | AFP | Getty Images

 

So, good for Moderna, good for Pfizer and BioNTech and AstraZeneca, and coming up behind, Johnson & Johnson, and all the other front-runners who have yet to complete their Third-Phase Trials, since it seems the rescue the world is looking for is beginning to arrive. New trial data for Moderna indicate vaccine efficacy rate of 94.2 percent, out-distancing all expectations. That no safety concerns arose is another dose of good cheer. Moderna hopes to produce 500 million to 1 billion doses in 2021.

In Moderna's trial of 30,000 participants [using mRNA-1273] no one vaccinated developed severe COVID-19. Among those study participants who were given a placebo, 30 cases of severe disease and one death arose. The trial included a good number of ethnic minorities, the elderly and people with underlying health conditions. Which would account for those receiving the placebo developing severe disease turned out to be three times higher than what occurred in the placebo portion of the Pfizer-BioNTech trial.

Moderna plans to send its trial data to regulators already reviewing the vaccine, the U.K. included, in addition to filing in the U.S. and E.U for approval. The likely date for the U.S. Food and Drug Administration's advisory group to discuss the Modeerna vaccine would be a week after they analyze the vaccine from Pfizer and BioNTech, around December 17.

The country that has the distinction to become the first in the West to roll out a COVID-19 vaccine is the United Kingdom, with the first Pfizer-BioNTech shots to be given as early as December 7 if all goes as planned. It seemed "highly possible" another developed country would approve the Moderna vaccine before the U.S. Mr. Bancel felt, that perhaps the U.K. or Canada could be the first for an emergency approval to be issued.

It is the United States, however, that has the capability to distribute an approved vaccine within a 24-hour period following approval. Moderna vaccines are produced in Switzerland for the European market, the vaccine made market-ready into vials in Spain, so that the U.K. regulator would have to approve the vaccine prior to it leaving the Spanish factory. 

Moderna tracked the average trial participant for at least two months to ensure safety, following FDA guidelines. No serious safety concerns arose. Side effects were inclusive of joint and muscle pain, headaches and fatigue. Last week a large gap between efficacy rates arose with AstraZeneca and the University of Oxford's vaccine data.The efficacy rate turned out to be 62 percent in the largest group of participants with two doses, whereas in the subset of participants under age 55 who were given one-and-a-half doses instead of two, the efficacy rate was 90 percent. 

An advantage of the messenger RNA technique Moderna uses along with Pfizer and BioNTech  is "strong efficacy across the board", in comparison with the adenovirus-based technology AstraZeneca and Oxford use. "You don't have the same patient-to-patient variability", explained Mr. Bancel of Moderna.  Moderna’s vaccine can be kept at –20°C. and once thawed, its vaccine can remain stable for 30 days at 2°C to 8°C, home refrigerator temperatures.

"The data we have are that these vaccines protect you against severe illness, but it doesn’t mean that you can’t get infected and give it to your patient, your neighbor, your customer, or whomever."

Ruth Karron, head, Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health

A Washington, D.C., participant in the Moderna efficacy trial is prepared for her COVID-19 vaccine shot.     ERIN SCHAFF/The New York Times/Redux

December COVID Vaccine U.S. Rollout

Pfizer and its partner BioNTech announced this week that the vaccine was 95 percent effective and that it worked well in older people and in preventing severe Covid-19.   Credit...Bebeto Matthews/Associated Press

"Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine."

"[Throughout the vaccine development process I wasn't certain Pfizer could produce a safe and effective vaccine ready for FDA review in less than a year.] Conviction is a part of it, so I was always telling [our teams] that we will make it, and we will make it by October, and if not us, then who?:

"But I knew that it was an extremely risky suggestion, I knew it was going to be difficult, and the stars needed to be aligned all the way to the end."

"[The partnership with BioNTech is built on a mutual focus on advancing science; the two companies began work, including sharing confidential information, before signing a formal contract, since those agreements can take months]. In fact, we are still finalizing the contractual obligations we have that we need to sign with them. It’s the perfect relationship for me."

"Ugur [Sahin, BioNTech’s co-founder and chief executive] is a wonderful human being, and a great scientist. He shares the same passion [as I do] about saving lives and I’m very optimistic that not only will we do very well together bringing a COVID-19 vaccine to the world, but later hopefully a flu vaccine."

Albert Bouria, chief executive officer, Pfizer Inc.

"[If the data is solid], we literally could be weeks away from the authorization of a 95 percent effective vaccine."

U.S.Health Secretary Alex Azar

 

"Within 24 hours from the approval, the vaccine will be moving and located in the areas where each state will have told us where they want the vaccine doses."

Dr. Moncef Slaoui, chief scientific adviser, US "Operation Warp Speed" vaccine program

Dado Ruvic/Reuters 

Some Americans could "hopefully" receive the vaccine for COVID-19 as soon as December 11 or 12

A date has been set for an FDA advisory committee to meet and discuss plans surrounding the COVID vaccine developed by Pfizer and BioNTech. That date is between the 8th and tenth of December. Leading to speculation that as early as December 11 the vaccines could be rolled out and distribution initiated. Pfizer has been busy long before the final Phase Three test results were arrived out, producing the vaccine. It is now prepared to apply to U.S. health regulators for emergency use authorization.

 

This will be the first of several and perhaps many such applications. Moderna will be certain to follow closely, since the announcement was made public that its COVID-19 vaccine had passed the Third Stage tests with similar results to Pfizer's. AstraZeneca is another contender whose vaccine appears ready for approval, production, distribution and inoculation. These vaccines tested in the amazing 95 percent effective rate with no major safety concerns emerging. 

 

The market responded as affirmatively as the public and government leaders around the globe at the news of the test results, seeing Pfizer's shares rise 1.6 percent and BioNTech's 6 percent. Hopes have been raised for the end of the pandemic responsible for claiming over a quarter of a million lives of people in the United States, and 1-1/3 million lives lost to COVID's complications around the world. Moreover, case numbers are now again steadily rising alarmingly. 

 

Pfizer's COVID-19 vaccine clinical trial  The Associated Press

Safety data on around 100 children ages between 12 and 15 were included with the application, the company attesting that 45 percent of U.S. trial participants fell between the ages of 56 and 85, both groups representing the demographics hit hardest by the virus. Agreement for the EUA by the FDA is anticipated by mid-December, Pfizer claiming it is prepared to begin shipping doses as soon as agreement is received, expecting to have 50 million doses ready for use this year, which would protect 25 million people in a two-dose protocol.

 

The Pfizer vaccine provided a level of protection evenly across different ages and ethnic backgrounds, vital news since the virus disproportionately harms the elderly and minority groups. In Pfizer's trial with over 43,000 people participating, there were 170 volunteers who contracted COVID-19, 162 of whom had received a placebo only; the vaccine was adjudged to be 95 percent effective based on those results, eclipsing expectations for a success rate.The FDA had considered a minimum bar for efficacy of 50 percent.

 

Close to 42 percent of global participants and 30 percent of U.S. participants in the Phase 3 study were of racial and ethnically diverse backgrounds, Pfizer had announced. Next in line at this juncture to seek a U.S. emergency use approval for a COVID-19 vaccine is contender Moderna, and from there the sky's the limit as one health expert after another speaks with a tremor of relief, of "a light at the end of the tunnel". 

 

FDA vaccine advisors reportedly will meet Dec. 10 to discuss approving vaccines. (AFP)

 

Time-Anxiety in COVID-Vaccine Release, Efficacy, Safety

"Certainly there can be a lot of damage done between now and when vaccine programs are rolled up."

"So, we really hope that the provinces and municipal, political and public health leaders take steps to protect people. And I hope people take steps to protect themselves and their communities."

Isaac Bogoch, infectious disease specialist, Temerty Faculty of Medicine, University of Toronto

"[The preliminary results for both  Pfizer and Moderna vaccines are] incredibly exciting. Both have reported over 90 per cent efficacy, which is really extraordinary and really meaningful. But we do have to remember that these are both based on short-term results after having been immunized.… Would that efficacy hold up over a period of weeks, months or even years?"                                                          "We think we see the light at the end of the tunnel here. We think that there's something that can be added to the toolbox that can really make a difference and change the shape of this curve and the experience that we've all been living through."                                                                                                                "Those are the things that will be huge game changers [whether these vaccines alter the transmission of the virus, including the length of infection, the level of virus in the body and how likely an infected individual is to transmit to someone else]. If the vaccine can alter any of those attributes of the virus."                                             Kate O'Brien, director of the immunization department, World Health Organization (WHO)

"... It’s not a ‘recipe’ that you can make the material out of. It took us years to learn how to make the vaccine and months to train the Lonza people [Moderna’s European manufacturing plant, which is owned by Switzerland-based Lonza] on how to produce it. We’re sending our best people to teach the process and like any young technology, it takes time; it’s a difficult project that involves a lot of transfer of patents. A lot depends on the raw materials and the production efficiency and this is the first time the vaccine is being produced."

"All of that [trust in the trial results and decision to release results] is managed by an independent committee that examines the data and decides when to approve publication. The figures were clear even when there were 53 Covid-19 cases in the experiment, but we waited until we had 95."

"The [test] subjects are living completely ordinary lives, some even work in the healthcare sector. They are all exposed to the virus. In any case, the results are clear and indicate the vaccine is 94.5% effective."

"At this stage, it is too early to tell [whether people who have been vaccinated can no longer transmit the virus], these are figures that we’ll have to examine when we test the blood of vaccinated people for antibodies."

I don’t think that’s reasonable [conjecture that the vaccine might last only 3 months], there are very high levels of antibodies in the blood that we saw in the clinical trials, and that provides a sense of security and optimism. Of course, we will have to monitor the test subjects, but the high effectiveness rates offer a light at the end of the tunnel."

Dr. Tal Zaks, chief medical officer, Moderna

Staff are seen Sept. 29 setting up a production line in Visp, Switzerland, where the Moderna mRNA coronavirus disease (COVID-19) vaccine will be produced. (Denis Balibouse/Reuters)

So the pot of gold at the end of the rainbow might be in sight, once the storm of COVID-19 assaults meets what will be its nemesis, arming vulnerable human beings against the onslaught of SARS-CoV-2 virus causing COVID. The actual proof of its long-lasting effectiveness safely encountered will have to stand the test of time. And in the meanwhile, a restive and fearful, angry and resentful, anguished and bewildered population must bide its time while continuing to follow medical instructions to maintain physical distance, wear face masks and observe carefully protective hygiene protocols.

 

The normal course of developing effective, safe vaccines has been reduced dramatically in the face of this fast-moving, volatile and changeable virus that hasn't obeyed the hitherto-observed behaviours of predecessor viruses, leaving the scientific-medical community bemused and challenged to develop protocols of protective behaviours, asking entire populations to undergo dramatic modifications of what has always been considered 'normal' life. Long engrained habits have had to be abandoned. Social contacts of immense value brought to an abrupt halt.

But the good news is that following Pfizer's announcement that its vaccine has proven hugely successful and the pharmaceutical company is prepared to ask for emergency title to begin production and distribution, Moderna too has released similar triumphant news. And this at a time when the world is overdue for good news, while the second wave of COVID infection has proven to be far excessive of the original in its viciously predatory infectiousness. 

Moderna scientists used an innovative technique for developing the vaccine so quickly    Moderna

Preliminary data of Moderna's Third-Stage trials give its mRNA-1273 vaccine a 94.5 percent effective rating, outdistancing even the unheard-of 90 percent effectiveness of Pfizer's vaccine. With an added advantage that Moderna's vaccine requires only typical refrigeration, and not the complicated -70C refrigeration of Pfizer's vaccine, making it easier to safely distribute and store. Both pharmaceutical companies' vaccines are pending additional safety data and regulatory review leading to a sooner-than-later authorization in the United States for emergency use, perhaps by December.

 

Both companies, apart from awaiting the verdict of the U.S. Food and Drug Administration in advancing their vaccines' permission to proceed to production and distribution have also asked Health Canada to review their products with a mind to similarly manufacturing and distributing for Canadian use, at a critical junction where infection case rates have been soaring in Canada, yet nowhere near the astronomical heights of infection seen in the United States. 

 

"We are going to have a vaccine that can stop COVID-19", Moderna's president Stephen Hoge said with confidence. Only five infections were seen to occur in volunteers who received the two-shot (28 days apart) mRNA-1273 vaccine, out of a total of 95 receiving the vaccine or an alternative placebo. The company is confident that it will be in possession of sufficient safety data for U.S. authorities within the week or more to enable them to file for emergency use in coming weeks. 

 

No one should be surprised, interjects infectious disease specialist Isaac Bogoch, if things don't exactly run as smoothly as expectations lead people to anticipate, while questions are left dangling awaiting answers; how long the vaccine may last, and how effective the inoculation will be in a real-world setting.