For one Mississippi couple who caught Covid-19, their outcomes provide a growing contrast. The wife, who is vaccinated, recovered after 10 days. But her unvaccinated husband has been in the hospital for 22 days and counting.
"He's just trying so hard to get better and get home," Alicia Ball said about her husband, William, whose currently in an intensive care unit battling Covid-19. "We have a lot of people praying for us.
"He means so much to our family. He's the rock of our family."
At times holding back tears, she told CNN's Chris Cuomo on Thursday that she is "emotionally and mentally and physically exhausted."
Ball spoke to CNN from a hospital in Jackson, Mississippi, with her husband lying beside her in bed with an oxygen mask on. He is currently not on a ventilator.
"It's real. It's devastating. ... It's been really hard," she said. "I wouldn't want my worst enemy to go through this."
Ball added she and her husband were vaccine-hesitant, but she eventually got the vaccine under her doctor's care after fears regarding her asthma condition. She said she fell ill for 10 days when she contracted Covid-19 and had to visit an emergency room.
"But I didn't get put in here for 22 days and counting," she said.
Ball said her vaccine skepticism stemmed from not knowing just how badly the virus can affect her.
"We just didn't know the severity of the disease ... especially, this Delta variant. ... It just hadn't hit that close to home, yet," she said.
Mississippi has one of the nation's lowest vaccination rates, with 34.4% of the total population fully vaccinated, state data shows.
The state is also designated as an area with high transmission of Covid-19, according to federal health data. Over the past week, Mississippi saw 336 cases per 100,000 people, which is one of the highest rates in the US.
The Delta variant of Covid-19 has been spreading throughout the country, compounding concerns among health officials. Safety restrictions and mask guidances are making a return as cases rose by at least 10% in nearly every US state in the last week, according to Johns Hopkins University data.
The variant spreads quicker and more easily than the first coronavirus strain and can infect fully vaccinated people whose symptoms are usually milder.
Ball hopes sharing her Covid-19 experience will encourage her loved ones and others to get vaccinated.
"God, I hope so. I hope it's helped our family, our church, our friends, anybody that sees this broadcast. I hope it helps. That's why I'm doing it," she said.
TORONTO -- After federal COVID-19 modelling showed that the fall could bring about yet another surge in COVID-19 cases with the Delta variant spreading rapidly, doctors say that the best way to avoid a fourth wave is to vaccinate, test, trace and isolate.
Canada’s Chief Public Health Officer, Dr. Theresa Tam, released modelling on Friday that indicates cases are beginning to rise as a result of the more contagious Delta variant, but there is still time to flatten the curve.
“There's no summer vacation for getting second doses and first doses, because we don't have that leeway,” Dr. Lisa Barrett told CTV News Channel on Saturday.
She added that people who are delayed in getting their shots, first or second, need to make an effort to get it as soon as possible.
“Before we get into all of these back to school and other situations in a respiratory virus season like the fall, we’ve got to keep going,” she said.
While breakthrough cases have happened among vaccinated people, they remain rare and vaccines remain the best defense against COVID-19.
”It very much is that these vaccines are amazing, and the cornerstone of our prevention toolbox, and our control,” said Barrett. “The limiting of virus really, really depends on people getting two doses of this vaccine.”
There are other steps Canadians can take to continue protecting themselves, vaccinated or not, and they’re no different than what’s been urged since early on in the pandemic: masking and testing.
“There's some simple tools out there, in addition to vaccines, like masking and testing, that would reduce the risk of this being a disease of the unvaccinated,” Barrett said.
While the modelling shows the potential for a fourth wave in the fall, an infectious disease specialist said that models are only as good as the variables put into them, but that the possibility of another surge is possible.
“It's possible that we could have a sort of fourth wave. I would guess that it could be a muted fourth wave, because unlike previous waves, we do have vaccinated people,” Dr. Ronald St. John, former director-general of the Centre for Emergency Preparedness and Response, told CTV News Channel on Saturday.
While provinces begin to loosen restrictions, or in some cases do away with them altogether, one doctor says that it’s the unvaccinated population who will be hit hardest by a fourth wave.
“The fourth wave is certainly going to affect those who are unvaccinated, but I think what we really need to start looking at are, who are these unvaccinated populations?” Dr. Veronica McKinney, director of Northern Medical Services at the University of Saskatchewan, told CTV News Channel on Saturday.
She said that unvaccinated populations need to be identified in order for doctors and experts to work with them, so that they can be comfortable getting vaccinated to protect themselves and others.
“The way that it's been portrayed is that it's an individual choice and that people are just being resistant but I really believe that now is the time to look at what are the pieces that have led to this in the system?” she said.
Policies need to change to encourage people to get vaccinated, but also to take time off in the event they do get sick, added McKinney.
“We need to look at those policies that are making it difficult, those people who don't get sick time, who don't want to be tested because they don't want to be off work but also not necessarily trusting what is being presented,” she added.
Even with getting more shots in arms, McKinney said that provinces such as Saskatchewan and Alberta have lifted public health measures necessary to test, trace and isolate in a way to prevent a fourth wave.
“Part of the challenges that our communities are now dealing with is the fact that there are no longer public health orders that we can use to try to help in terms of keeping people isolated if they need be, testing, all of those pieces that were very helpful, but are no longer existent [Saskatchewan]," she said.
The COVID-19 pandemic has brought a remarkable shift in how we will prevent infections and autoimmune disorders in the future. The nucleic acid vaccines, including messenger RNA (mRNA) and DNA vaccines, have been under development for decades, but there was no opportunity to test their safety and efficacy; vaccines may take years and decades to provide sufficient proof of safety and efficacy. Then came COVID-19, caused by the SARS-CoV-2 virus. Fast data collection became possible because the virus was so widespread. Even with small infection numbers (n = 150) among study populations that averaged about 30,000 to 40,000, it was clear that mRNA vaccine efficacy was surprisingly high: 95% or better. The FDA would have approved the use of the mRNA vaccine at even at 50% efficacy.
The safety of the mRNA vaccines was confirmed clearly in multiple studies across the globe. However, not all COVID-19 vaccines fared well. The third mRNA vaccine, by CureVac, failed because its developers chose not to follow the teachings of the common wisdom. mRNA vaccines work by introducing a harmless piece of the virus into the body and triggering an immune response that conditions the body to recognize and attack the true virus. Moderna and Pfizer–BioNTech vaccines use modified RNA (pseudouridine); CureVac chose not to modify the RNA, and its vaccine uses normal uridine. It produced lower levels of antibodies than the Moderna and Pfizer-BioNTech vaccines and was just 47% effective at preventing COVID-19 infection. Incidentally, the name Moderna comes from “modified RNA.”
The Chinese Sinopharm vaccine, a traditional inactivated virus vaccine, also failed. This failure brought great misery because the Chinese government had used this vaccine as a diplomacy tool, supplying billions of doses to developing countries. As of today, none of the non-mRNA COVID-19 vaccines have come close to the efficacy of the mRNA vaccines.
We have 2 mRNA vaccines approved under Emergency Use Authorization (BNT162b2, mRNA-1273/NAID), and I anticipate their full approval soon. Pfizer has filed for the modification of storage temperature, and Moderna has filed for the reduction of dose; the Pfizer dose is 30 mcg, and the Moderna dose, 100 mcg. There are now newer lipid nanoparticle (LNP) formulations that can provide better temperature stability allowing only refrigeration storage.
Incidentally, Moderna has permitted the use of its patented LNP technologies to any company. Although the challenges to overcome IP issues remain, the humanitarian considerations make these challenges manageable. The US government has proposed to remove patent exclusivity relating to the COVID-19 vaccines. This action will require EU cooperation that is yet to come. However, as a patent law practitioner, I am confident that we can make COVID-19 vaccines without any patent infringement that remains in our way. mRNA vaccines have been under development for decades, so much of the base technology is already in the public domain. Both Pfizer and Moderna have shared their clinical protocol, and that is a rare event, as these protocols cost millions to produce and billions to execute. No other vaccine developer has shared these protocols in public. The mRNA vaccine developers now have a clear understanding of the regulatory process required to approve new mRNA vaccines.
Regulatory Pathway
At the time of the enactment of the Biologics Price Competition and Innovation Act (BPCIA, 2010), there was no indication that the introduction of mRNA vaccines would create a dilemma for the FDA in deciding an appropriate regulatory pathway.
The FDA’s Center for Biologics Evaluation and Research (CBER) jurisdiction includes biological products such as prophylactic and therapeutic vaccines, whole blood and blood products, cellular products and exosomal preparations, gene therapies, tissue products, and live biotherapeutic agents. CBER also regulates selected drugs and devices used to test and manufacture our biological products. In keeping with that mission, product approval applications filed with CBER include 351(a) filings, which are for “standalone” or original products, rather than biosimilars (21 Code of Federal Regulations [CFR] 601.2). The biologics license application (BLA) is regulated under 21 CFR 600 – 680.
Many biological products are controlled by the Center for Drug Evaluation and Research (CDER), including biosimilar and interchangeable biologics. For example, in March 2020, insulin, glucagon, and human growth hormone regulated as drugs under the Food, Drug, and Cosmetic Act came into the CDER BLA program.
mRNA vaccines have a unique feature: They are manufactured chemically, not biologically, as are many other vaccines. As a result, the vaccine structure is completely known, unlike the therapeutic proteins. The variations in the secondary and tertiary structures and post-expression modifications require intensive evaluation of similarity to allow them a biosimilar status. A proposed biosimilar mRNA vaccine can provide a 100% match for a reference product sequence. Thus, mRNA vaccines are closer to generic chemical products than biological therapeutic proteins.
In my opinion, the traditional vaccines can stay within the jurisdiction of CBER, and the chemically synthesized vaccines be approved under BLA by CDER under the 351(k) filing where suitable.
Already, the FDA has issued a final guideline (February 2021) on the development of products for the treatment and prevention of COVID-19, which states:
“COVID-19 vaccine development may be accelerated based on knowledge gained from similar products manufactured with the same well-characterized platform technology, to the extent legally and scientifically permissible. Similarly, with appropriate justification, some aspects of manufacture and control may be based on the vaccine platform, and in some instances, reduce the need for product-specific data. Therefore, FDA recommends that vaccine manufacturers engage in early communications with [Office of Vaccines Research and Review] to discuss the type and extent of chemistry, manufacturing, and control information needed for development and licensure of their COVID-19 vaccine.”
This statement can be construed as pointing to the possibility of a biosimilar application filing for a licensed (BLA) product to meet all requirements of the BPCIA. If the sequence of a biosimilar mRNA vaccine matches a reference product sequence, then the need for extensive toxicology and efficacy testing can be reduced, on a case-by-case basis, depending on other factors of variation. In my earlier conversation with the FDA, I appreciated the broad encouragement I received to discuss the development plan in a Type B meeting first, where the possibilities of a modified 351(a) filing or a 351(k) filing for a biosimilar mRNA vaccine can be discussed; the 351(a) modified approach will be analogous to a 505(b)(2) new drug application under the FDC Act. I will keep my readers informed of any new indications from the FDA.
mRNA vaccines are now at the forefront of hundreds of possibilities, including preventing infections to preventing autoimmune disorders. Since the antigens focused on the design of mRNA vaccines cannot be patented, a biosimilar vaccine product may likely produce the product without any infringement issue. The testing proposal presented above will help expedite the approval of biosimilars without risking the safety and efficacy of biosimilar products.
For the first time, we have a scientific challenge to meet: how to classify mRNA vaccines as chemical drugs or as biosimilars rather than standalone biologics?
In contrast to chemically synthesized small molecular weight drugs, which have a well-defined structure and can be thoroughly characterized, biological products generally derived from living material (humans, animals, or microorganisms) are complex in structure and, thus, are usually not fully characterized. However, this last consideration does not apply to mRNA vaccines.
To promote the idea of creating a new category of products, biosimilar vaccines, I have filed a citizen petition to the FDA advising the agency on creating new guidance for this new class of biosimilar products. In my opinion, the agency will agree to many of my suggestions because the issue of structural similarity with a reference product is no longer an issue. Preclinical toxicology studies can be waived based on in vitro and situ studies, requiring only comparable antibody production in animal species. The immunogenicity—stimulation of immune response—is not a significant issue because vaccines are supposed to be antigenic. A limited trial in animal species capable of showing antibody response that is comparable to findings with the reference mRNA vaccine will suffice to establish equivalent safety with the reference product.
I have also developed several mRNA vaccines, including COVID-19, flu, HPV, HIV, and tuberculosis, that are under advanced stages of development across the globe, including one with a biosimilar status. Today, the world needs about 8 billion doses of COVID-19 vaccines that work. I have concluded that we can make 1 billion doses using 30 L bioreactors in 6 months with our cost of goods not exceeding $0.50 per dose in bulk and $0.90 in final packaging if the vaccine is manufactured in the United States; the costs can be lower if manufactured in developing countries. For example, the cost of Moderna single dose is $32 to $37, and Pfizer’s, $22 in final packaging. I can confirm these costs of manufacturing that make the commercial manufacturing of COVID-19 vaccines a highly profitable project.
While there is an excess of COVID-19 vaccine in the United States, the rest of the world is still starving for it. The WHO has also told me that the world needs 8 billion doses of COVID-19 vaccines and that they will be very proactive if anyone can supply the mRNA vaccines; the trust in all other vaccines has declined. This is a remarkable business opportunity for many companies since the capital expenditures (CAPEX) and operating expenditures (OPEX) are very small. In my next article on the topic, I will provide details of strategies to take the mRNA vaccines to market fast and reduce CAPEX and OPEX significantly. I want to enable newcomers to appreciate that mRNA technology will revolutionize health care, and there are many opportunities to join this revolution.
Summary
mRNA vaccines are chemically derived and have fixed chemical structures; it is possible to fully replicate a reference product sequence, reducing the burden of proving biosimilarity required for therapeutic proteins. The FDA has already suggested a new pathway for mRNA vaccines, but this path will only come into being when enough companies join in taking steps toward this strategy.
Watch for the second article in this series: Biosimilar mRNA Vaccines—Fast-to-Market Strategies.
Hundreds of thousands of COVID-19 vaccine doses have been saved from the trash after U.S. regulators extended their expiration date for a second time, part of a nationwide effort to salvage expiring shots to battle the nation's summer surge in infections.
The Food and Drug Administration on Wednesday sent a letter to shot maker Johnson & Johnson declaring that the doses remain safe and effective for at least six months when properly stored. The FDA's move gives the shots an extra six weeks as public officials press more Americans to get inoculated.
Similar efforts are happening in multiple states as public health officials try to ensure that soon-to-expire shots are put into arms before they must be discarded.
The surge in infections is largely due to the highly contagious delta variant of the coronavirus, which has spread rapidly, particularly among unvaccinated people. Inoculation rates have climbed only slightly after a steep fall from their April peak.
“It’s a critically important time — we have children headed back to school in just a few weeks’ time,” said Juliann Van Liew, director of the public health department in Wyandotte County, Kansas.
Federal health officials have shipped an additional 8 million doses of the J&J shot to states that have not yet been used, according to the Centers for Disease Control and Prevention's vaccine-tracking website. The company did not share specific expiration dates.
The J&J vaccine is not the only one facing expiration. States also report that many Pfizer and Moderna doses are approaching expiration, which is set at six months from the manufacturing date. In Louisiana, about 100,000 Pfizer doses are set to expire in about a week, for example.
Governors are pleading with the public to get vaccinated, and some are offering cash incentives — $100 payments in New Mexico and New York City, among other places.
Some states have set up marketplaces for shot providers or dedicated staff to redistributing about-to-expire vaccines to places that need them. Such efforts are underway in New Jersey, Washington and Wisconsin.
In Iowa and North Dakota, officials say they send vaccines approaching expiration to locations where they are most likely to be used.
“We have a lot of interest from the public in receiving J&J, so if we find doses that may go unused, we will transfer them to providers in need,” said Molly Howell, North Dakota's immunization director.
Lacy Fehrenbach, deputy director for COVID-19 response for the Washington state Department of Health, said officials want the doses used as efficiently as possible.
“Otherwise, we’re working with our providers to move them around, or, of course, the federal government to get them to other places that need it,” she said.
Dr. Clarence Lam, interim executive medical director of occupational health services at Johns Hopkins University, was encouraged by the extension for the J&J shots.
“We hate to see this supply go to waste, especially when there are areas of the world where this is needed,” Lam said. “But now I think we'll be able to better utilize the supply that's already been distributed here in the U.S.”
The J&J vaccine was eagerly anticipated because it involves just one shot and has easy refrigeration requirements.
But use of the vaccine has been hurt by several rare possible side effects. This month, U.S. health regulators added a warning about links to a potentially dangerous neurological reaction. That followed a break in its use in April after the shot was linked to a rare blood clot disorder. Government health advisers said the overall benefits of the shot still greatly outweigh the risks.
Also in April, a Baltimore vaccine factory was shut down by the FDA due to contamination problems, forcing the company to trash the equivalent of tens of millions of doses being made under contract for Johnson & Johnson.
Pfizer and Moderna have already supplied more than enough doses to vaccinate all eligible Americans. More than 150 million Americans have been fully vaccinated with the companies’ two-dose shots. By comparison, just 13 million, or 9%, have been vaccinated with the J&J shot.
All told, nearly 164 million people have been vaccinated, according to the CDC, or just over 49% of the U.S. population.
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Associated Press writers Scott Bauer in Madison, Wisconsin; Melinda Deslatte in Baton Rouge, Louisiana; Roxana Hegeman in Belle Plaine, Kansas; Rachel La Corte in Olympia, Washington; James MacPherson in Bismark, North Dakota; and Matthew Perrone in Washington contributed to this report.
A new study by the U.S. Centers for Disease Control and Prevention showed that three-quarters of individuals who became infected with COVID-19 at public events in a Massachusetts county had been fully vaccinated.
The study, published on Friday, showed that three-quarters of those infected were fully vaccinated, suggesting the Delta variant of the virus is highly contagious.
A separate CDC internal document, first reported by the Washington Post on Friday, described the Delta variant as being as transmissible as chickenpox and cautioned it could cause severe disease.
The new study's authors recommended that local health authorities consider requiring masks in indoor public settings regardless of vaccination status or the number of coronavirus cases in the community.
The study identified 469 people with COVID-19, 74% of whom were fully vaccinated, following large public events in the state's Barnstable County. Testing identified the Delta variant in 90% of virus specimens from 133 people.
The viral load was similar in people who were fully vaccinated and those who were unvaccinated, the CDC said.
High viral loads suggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infected with Delta can transmit the virus, it said.
The finding of the report "is concerning and was a pivotal discovery leading to CDC’s updated mask recommendation," CDC director Rochelle Walensky said in a statement.
On Tuesday, the CDC reversed course on guidance for mask wearing, calling for their use in areas where cases are surging as a precaution against the possible transmission of the virus by fully vaccinated people.
"The masking recommendation was updated to ensure the vaccinated public would not unknowingly transmit virus to others, including their unvaccinated or immunocompromised loved ones," Walensky said in a statement.
Reporting by Manas Mishra in Bengaluru; Editing by Howard Goller
Ethical vegans may be exempt from being forced by their employers to be vaccinated because their lifestyle beliefs are protected by law, a legal firm has claimed.
Last year, a judge presiding over an employment tribunal ruled that ethical veganism — where a vegan avoids all animals products, products that used animals in testing, or services associated with animal exploitation — was a “philosophical belief”, making it a protected characteristic like race, religion, or sexuality, with its adherents covered under the Equality Act 2010.
Referencing the case, a spokesman from law firm Lewis Silkin said, according to The Telegraph: “Some ethical vegans may disagree with vaccinations on the basis that they will inevitably have been tested on animals. Ethical veganism has previously been found by an [employment tribunal] to amount to a belief, capable of being protected.”
The remarks come weeks after the government passed legislation to force all care home staff to be vaccinated against the Chinese coronavirus. Silkie Carlo, the director of the privacy and civil liberties pressure group Big Brother Watch, warned that the passing of the law could embolden employers to make similar demands, leaving “millions” of employers to face a choice between a jab and their job.
Some employers have been considering introducing mandatory vaccines for several months, including the anti-Brexit Charlie Mullins of Pimlico Plumbers, who vowed in January to impose a “no vaccine, no job” rule.
Mr Mullins is not alone, however, according to a recent poll by the British Chambers of Commerce of large businesses employing more than 50 people.
Around one-third of large businesses said they were considering introducing vaccine demands, with eight per cent saying they would “likely” do so in the future. Nearly one in ten (nine per cent) said they already had required employees to prove their vaccination status.
Threat of Vaccine Passports Just ‘a Little Bit of Coaxing and Cajoling’, Claims Senior Minister https://t.co/JzPBEL1Dyl
A senior figure in the British government appeared to give his tacit approval for employers to demand mandatory vaccination of staff. Foreign Secretary Dominic Raab told Sky News on Thursday: “We want everyone to be double-jabbed.”
“I can understand why employers think that that would be a smart policy or approach to encourage, whether or not there should be hard and fast legal rules I think we need to look at carefully. But our message overwhelmingly is get the jab,” he said.
Transport Minister Grant Shapps was forced to confirm on Friday that the government would not be mandating vaccines in order for people to return to work, but again expressed that it was a “good idea” and some employers may decide to do so.
“We are not going to make that legislation, that every adult has to be double vaccinated before they go back to the office, but yes it is a good idea and yes some companies will require it,” Mr Shapps said.
The Telegraph notes that ethical vegans could take their employers to court if they claim they were forced to resign if faced with an order to be vaccinated.
There are some 500,000 vegans in the United Kingdom, and around 100 have already contacted the Vegan Society over concerns they could be asked to be vaccinated at work.
However, others may challenge company policies on vaccination included so-called “anti-vaxxers” on the grounds that their beliefs should be protected in the same way that ethical vegans’ philosophies are.
Solicitor Clare Chappell from Peacock & Co noted that “somebody at some point who is an anti-vaxxer is going to bring a claim that an anti-vax belief is a philosophical belief.
“I think it’s going to throw a lot of interesting developments into discrimination law over the coming months and years.”
More Than 50 Tory Rebels to Vote Against Discriminatory Vaccine Passports: Report https://t.co/tBolVlYEG9
Canada is seeing an increase in new COVID-19 cases.
Community-wide contact rates increase too quickly with ongoing reopening efforts.
The epidemic trajectory may evolve through early September.
Canada’s Chief Public Health Officer warned that the country is apparently at the start of the Delta-driven fourth wave of COVID-19 pandemic.
Canada’s Chief Public Health Officer Theresa Tam
“The updated longer-range forecast shows how the epidemic trajectory may evolve through early September. It suggests that we are at the start of the Delta-driven fourth wave, but that the trajectory will depend on ongoing increases in fully vaccinated coverage, and the timing, pace and extent of reopening,” Theresa Tam said at a press conference in Ottawa.
“I think we are in a slightly precarious period at the moment, in between these people trying to get the vaccines in and reopening,” she said.
“As soon as that balance is tipped, and it wouldn’t take very much with a highly transmissible virus, you’re going to see an uptick in cases.”
After weeks of sustained decline in new cases of COVID-19, Canada is seeing an increase in new COVID-19 cases, and thousands more infections are predicted if contacts aren’t contained, according to national modelling released by the Public Health Agency of Canada (PHAC) on Friday.
The seven-day moving average of 594 new cases reported daily (July 22-28) showed an increase of 39 percent over the previous week, said the PHAC on Thursday.
The national modelling released by the PHAC on Friday showed the serious threat the highly contagious Delta variant is posing, and the risk that the unvaccinated may be to the country being thrust into the fourth wave.
The region's vaccine task force is out with new statistics. On average, over the past week, there were 4,700 doses given out per day in Waterloo Region; 32,862 overall.
However, local officials mentioned the rate of vaccination has slowed since the highest volume earlier in July.
"We need to vaccinate 33,986 to reach the provincial target of 75 per cent of the 12 and older population fully vaccinated," said Vickie Murray, integrated director of pharmacy at Grand River Hospital.
In order to reach that target, regional officials are making it easier, "(as) all Waterloo Region vaccine clinics are now open to both first and second dose walk-ins, while appointments are available, they are not required, and the clinics are happy to accommodate people who arrive without an appointment," said Murray.
Starting Saturday, there will be two buses "on the road" at a variety of locations, including St. Jacobs Market, Fairview Park Mall, Conestoga Mall, Downtown Elmira, and select community locations based on vaccination data, COVID-19 positivity rates, and engagement initiatives.
Murray mentioned regular mobile clinics will continue and have plans to go back to shelters, refugees, and Indigenous clinics.
It's the word on everyone's mind right now when it comes to the COVID-19 pandemic: Delta.
The highly contagious variant, which was first discovered in India in late 2020, has spread around the world and now accounts for the majority of cases in Canada and various other countries.
The recent spread in the United States has led the U.S. Centers for Disease Control and Prevention (CDC) to recommend that Americans wear masks in areas with substantial transmission "regardless of vaccination status."
So, why is this particular variant spreading so rapidly? And what's the mechanism at play behind its apparent success at infecting human hosts?
The answers are complicated, and there are still unknowns around how, exactly, the delta variant was able to take hold at such a brisk pace, throwing a wrench in global efforts to wind down the pandemic.
But we are getting closer to understanding how it works — and why vaccines, thankfully, still hold up.
How contagious is delta?
The delta variant is thought to be significantly more contagious than the early strain of SARS-CoV-2, the virus which first swept around the world. Delta has been dubbed a variant of concern by the World Health Organization (WHO).
"We are fighting the same virus but a virus that has become fitter and better adapted to transmitting amongst us humans," said Dr. Michael Ryan, executive director of the WHO's health emergencies program, during a Friday briefing.
Scientists estimate it's spreading roughly 50 per cent faster than the alpha variant, which was 50 per cent more contagious than the original virus strain, according to the Yale School of Public Health.
That means every person infected is capable of passing the virus on to more people than before, helping this variant spread through populations quickly — and even faster among those whose immune systems aren't already on high alert due to a previous COVID-19 infection or vaccination.
WATCH | COVID-19 delta variant a 'dangerous virus,' warns WHO:
The World Health Organization says the trajectory for the COVID-19 delta variant in some countries is almost 'vertical' and warns that even partially vaccinated countries are at great risk because of its high transmissibility. (Willy Kurniawan/Reuters) 0:56
Why is it more transmissible?
While the exact mechanism making delta more transmissible isn't entirely clear, emerging research is hinting at possible reasons why it's so infectious.
One lab-based study published in the journal Cell Host & Microbe, from researchers at the Kumamoto University and Weizmann Institute of Science, suggests mutations on the spike protein of this SARS-CoV-2 variant can evade cellular immunity and may increase its infectivity.
The spike protein is a crucial feature on the surface of the coronavirus that allows it to gain access to our cells, explained University of Ottawa epidemiologist Raywat Deonandan.
"It fits into a receptor on our cells and then it enters the cell via that receptor. Something about the mutation has changed the shape or a feature on the spike protein that makes it fit a bit better," he said.
"As a result, you need fewer viruses present to achieve infection."
People wear masks while walking in Grand Central Terminal in New York City on July 27. Due to the rapidly spreading delta variant, the U.S. Centers for Disease Control and Prevention now recommends that fully vaccinated people begin wearing masks indoors again in places with high COVID-19 transmission rates. (Spencer Platt/Getty Images)
Another study from a team in China, which has not yet been peer-reviewed, found people infected with the delta variant carried, on average, a more than 1,000 times higher amount of virus in their nose compared to the original strain — which likely means they're shedding more of it.
The researchers also found people carrying this variant test positive faster: around four days after exposure, compared to around six for the original strain. That suggests delta replicates at a quicker pace inside someone's body.
"You may actually excrete more virus and that's why it's more transmissible," microbiologist Sharon Peacock, who runs the U.K.'s efforts to sequence the genomes of coronavirus variants, recently told Reuters.
How well do vaccines protect against it?
If carrying around delta means people may be shedding more of the virus and transmitting it to others more easily, vaccines definitely have a tougher task — since people's immune systems are now facing a larger army and need to ramp up to mount a defence.
In the U.S., the CDC warned Friday that emerging data from a county in Massachusetts suggests the higher viral loads could mean vaccinated people can still transmit delta to others.
But the good news is that leading vaccines, including those approved for use in Canada, do seem to ward off serious disease that can lead to hospitalization or death.
A recent study in the New England Journal of Medicine found two doses of the Pfizer-BioNTech vaccine were 88 per cent effective against the delta variant, while two shots of the AstraZeneca-Oxford vaccine were 67 per cent effective.
It marked a drop in the vaccines' ability to curb infections of any severity level — whether mild or more severe — when compared to the earlier alpha variant, but the researchers said there were only "modest differences."
Health-care providers administer the Pfizer-BioNTech COVID-19 vaccine at a pop-up clinic in Toronto on July 27. Leading vaccines do seem to ward off serious disease that can lead to hospitalization or death, even against the delta variant. (Evan Mitsui/CBC)
Recent data from Israel also shows the Pfizer shot reduced the risk of severe disease by a whopping 91 per cent, and hospitalization by 88 per cent. The level of protection against symptomatic infections in general was less than half that, but there are questions about how the government collected its data and how many infections were involved.
Still, it's a hopeful real-world snapshot of how a leading mRNA vaccine is warding off serious illness, and it is likely the highly similar Moderna shot also being used in Canada would fare similarly.
"I don't want to minimize the risk of things like 'long COVID,' but one of the biggest risks is how likely you'll develop serious disease after being infected," stressed Angela Rasmussen, a virologist with the University of Saskatchewan's Vaccine and Infectious Disease Organization.
"The bottom line there," she said, "is vaccination is still very protective."
How widespread is delta?
This variant has definitely taken hold around the world since being first reported in October 2020 in India, with other countries later reporting high levels as well.
"It's out-competing all other viruses, because it just spreads so much more efficiently," virologist Shane Crotty, of the La Jolla Institute for Immunology in San Diego, told Reuters.
In the U.S., delta now represents more than 80 per cent of new infections. Cases are spiking in many areas with low vaccination rates, and data shows unvaccinated individuals total nearly 97 per cent of all severe cases.
Across Africa, meagre vaccination rates, coupled with the rise of the delta variant, are putting major pressure on various countries' hospital systems.
The variant is now being found in at least 26 African nations, and 21 countries have seen cases rise by more than 20 per cent for at least two weeks running, the WHO announced in late July.
Countries from the U.K. to Singapore are also dealing with delta surges — including Canada. Variants of this virus now make up the bulk of our SARS-CoV-2 infections.
By early July, delta made up roughly 70 per cent of the country's cases, according to the latest available whole genome sequencing data from the Public Health Agency of Canada.
That marked a massive jump from early May, when delta still represented less than 10 per cent of sequenced infections.
So what does this all mean for Canada?
There are now growing signs that the rise of delta could spark another overall surge in cases — even though nearly six in 10 Canadians are now fully vaccinated, millions still remain unprotected.
WATCH | Alberta removing most COVID-19 isolation, testing requirements:
Alberta will be pulling back on requirements for COVID-19 testing, contact tracing and quarantines, despite rising cases in the province. 2:05
Even if overall case growth starts to spike, some experts are hopeful Canada, as a whole, will avoid the most dire outcomes, including overwhelming pressure on the country's hospital networks and a death toll similar to earlier waves.
Most people may still be able to avoid getting infected if they're both vaccinated and playing it safe, even in high-density, urban areas, Rasmussen said, though she does expect school outbreaks if mitigation measures aren't in place.
Many Canadians are still wearing masks and taking precautions in social settings, said Deonandan.
"I'm fairly optimistic that if this good decision-making continues, we could be world leaders in this endeavour."
Canada is at the start of the Delta-driven fourth wave of Covid-19, Canada's Chief Public Health Officer Theresa Tam said on Friday.
"The updated longer-range forecast shows how the epidemic trajectory may evolve through early September. It suggests that we are at the start of the Delta-driven fourth wave, but that the trajectory will depend on ongoing increases in fully vaccinated coverage, and the timing, pace and extent of reopening," Tam said at a press conference in Ottawa.
"I think we are in a slightly precarious period at the moment, in between these people trying to get the vaccines in and reopening," she said.
"As soon as that balance is tipped, and it wouldn't take very much with a highly transmissible virus, you're going to see an uptick in cases." After weeks of sustained decline in new cases of Covid-19, Canada is seeing an increase in new Covid-19 cases, and thousands more infections are predicted if contacts aren't contained, according to national modelling released by the Public Health Agency of Canada (PHAC) on Friday, the Xinhua news agency reported.
The seven-day moving average of 594 new cases reported daily (July 22-28) showed an increase of 39 per cent over the previous week, said the PHAC on Thursday.
The national modelling released by the PHAC on Friday showed the serious threat the highly contagious Delta variant is posing, and the risk that the unvaccinated may be to the country being thrust into the fourth wave.
As of Friday, 80.5 per cent of those eligible have received the first dose in Canada, while 65.8 per cent are now fully vaccinated.
The PHAC warned that if community-wide contact rates increase too quickly with ongoing reopening efforts, the long-term forecast indicates Canada could experience a "stronger resurgence" of the virus.
The Delta variant "underscores the need for high vaccination coverage and continued caution as restrictions are eased," according to the modelling.
The modelling predicts that in the short term, the case count will continue to increase, meaning the country could see between 2,700 and 11,800 new cases over the next week or so.
As of Friday afternoon, Canada reported a cumulative total of 1,430,289 Covid-19 cases, including 26,589 deaths, according to CTV. — IANS
People register to get vaccinated in front of "vaccine buses" at Tsawwassen Ferry Terminal in Delta, British Columbia, Canada, on July 30, 2021. The "vaccine bus" is part of "Vax for B.C." campaign in British Columbia aimed at boosting up the vaccination rate. (Photo by Liang Sen/Xinhua)
OTTAWA, July 30 (Xinhua) -- Canada is at the start of the Delta-driven fourth wave of COVID-19, Canada's Chief Public Health Officer Theresa Tam said on Friday.
"The updated longer-range forecast shows how the epidemic trajectory may evolve through early September. It suggests that we are at the start of the Delta-driven fourth wave, but that the trajectory will depend on ongoing increases in fully vaccinated coverage, and the timing, pace and extent of reopening," Tam said at a press conference in Ottawa.
"I think we are in a slightly precarious period at the moment, in between these people trying to get the vaccines in and reopening," she said.
"As soon as that balance is tipped, and it wouldn't take very much with a highly transmissible virus, you're going to see an uptick in cases."
After weeks of sustained decline in new cases of COVID-19, Canada is seeing an increase in new COVID-19 cases, and thousands more infections are predicted if contacts aren't contained, according to national modelling released by the Public Health Agency of Canada (PHAC) on Friday.
The seven-day moving average of 594 new cases reported daily (July 22-28) showed an increase of 39 percent over the previous week, said the PHAC on Thursday.
The national modelling released by the PHAC on Friday showed the serious threat the highly contagious Delta variant is posing, and the risk that the unvaccinated may be to the country being thrust into the fourth wave.
As of Friday, 80.5 percent of those eligible have received the first dose in Canada, while 65.8 percent are now fully vaccinated.
The PHAC warned that if community-wide contact rates increase too quickly with ongoing reopening efforts, the long-term forecast indicates Canada could experience a "stronger resurgence" of the virus.
The Delta variant "underscores the need for high vaccination coverage and continued caution as restrictions are eased," according to the modelling.
The modelling predicts that in the short term, the case count will continue to increase, meaning the country could see between 2,700 and 11,800 new cases over the next week or so.
As of Friday afternoon, Canada reported a cumulative total of 1,430,289 COVID-19 cases, including 26,589 deaths, according to CTV. Enditem
Federal officials are warning Canada could be on the brink of a fourth wave of COVID-19 driven by the Delta variant if the country opens too fast before enough people have been vaccinated.
Long-term forecasts released Friday indicate a hasty reopening could lead to a sharp resurgence of the virus by the end of summer, Canada's chief public health officer said as provinces including Alberta continued to ease restrictions.
Dr. Theresa Tam also urged younger adults to become fully vaccinated as soon as possible, noting they continue to lag among age groups but are associated with highest rates of disease transmission.
While robust vaccination rates are already credited with dropping hospitalizations and deaths, she said inoculations must rise further to avoid renewed strain on hospitals and the health-care system.
"Almost 6.3 million people are not yet vaccinated with a first dose ... plus over five million people have not received the second dose," Tam told a news briefing in Ottawa.
"This 'call for arms' is to shoot for the stars in vaccination coverage. With just over five weeks until Labour Day in Canada, this time is crucial for building up protection before we gather in schools, colleges, university and workplaces this fall."
As of last Saturday, 89 per cent of seniors aged 70 or older had received two doses of COVID-19 vaccines, according to the government's figures.
But only 46 per cent of Canadians aged 18 to 29 were fully vaccinated, as were 54 per cent of those aged 30 to 39.
Tam said vaccine coverage must be more than 80 per cent in all age groups to establish better protection.
She said the more infectious Delta variant is expected to gain steam among younger unvaccinated people, fueling a resurgence that could overwhelm health-care capacity if personal contacts also rise.
Current COVID-19 case counts have plummeted by 93 per cent since the peak of the third wave, for an average of 640 new infections being reported daily over the past seven days, Tam said.
But there are early signs of epidemic growth in some parts of the country, said Tam, predicting cases will rise further as public health measures ease.
Deputy chief public health officer Howard Njoo added that Canada's robust vaccination rate means any uptick in infections would likely not correspond to a marked rise in deaths and hospitalizations, noting "it's not the same as before."
Nevertheless, he warned that millions of unvaccinated Canadians "are really at risk of serious outcomes," and asked: "What are you waiting for?"
The warnings come as a chorus of health experts express concerns about Alberta's decision earlier this week to end isolation requirements for those who test positive for COVID-19, or who have been in close contact with someone who has.
Tam reiterated the importance of quarantines to prevent the spread of COVID-19, urging Albertans to continue to isolate, get tested and inform their close contacts even if it is no longer required.
There are hundreds of thousands of unvaccinated people in Alberta, Tam said, and there's the potential for large COVID-19 clusters and outbreaks.
"The bottom line is get vaccinated. There's still a ways to go in Alberta.''
This report by The Canadian Press was first published July 30, 2021.
Chief Public Health Officer Dr. Theresa Tam provides an update on the COVID-19 pandemic during a press conference in Ottawa, November 2020.
Sean Kilpatrick/The Canadian Press
Canada is in a race against the clock to vaccinate enough people to avoid the worst-case scenarios of a fourth wave of the coronavirus pandemic, driven by the highly contagious Delta variant.
Chief Public Health Officer Theresa Tam and her deputy Howard Njoo presented the monthly modelling update at a news conference on Friday, showing an uptick in COVID-19 cases. They outlined the potential for numbers to surge in the next month past those seen in the last wave of the pandemic, even if vaccinations increase. However, they said the increase may not lead to a comparable surge in hospitalizations and deaths.
“I think we are in a slightly precarious period at the moment in between these people trying to get the vaccines in and reopening,” Dr. Tam said.
The five-week countdown to Labour Day is the key focus for the government’s vaccination push, she said. The modelling from the Public Health Agency of Canada says more than 80 per cent of eligible people need to be fully vaccinated to avoid overwhelming hospitals in the case of a fourth wave. According to COVID-19 Tracker Canada, 81 per cent of eligible Canadians have received their first shot and 66 per cent are fully vaccinated. Health Canada has approved vaccines for people 12 and over.
The unofficial end of summer in Canada is also when colder weather and a return to classrooms will start driving more people inside. “This time is crucial for building up protection before we gather in schools, colleges, university and workplaces,” she said.
Some infectious disease specialists have said Canada should aim for at least a 90 per cent vaccination rate for eligible people in order to limit the impact of the fourth wave. Dr. Tam said her agency put the focus on protecting hospitals, but added vaccination shouldn’t stop at 80 per cent coverage.
“If we can get to 90, I’ll be popping open the champagne,” Dr. Tam said.
Getting to that level is no easy task and will require much more targeted outreach, said Noni MacDonald, a professor of pediatric infectious diseases at Dalhousie University and Halifax’s IWK Health Centre. Dr. MacDonald, who researches vaccine safety and hesitancy, said Canada has come close to but never fully hit the targets for other vaccines, but noted the context for COVID-19 is different because of how front-and-centre the disease is in daily life.
About 5 per cent of adults are hardliners who won’t get the vaccine, Dr. MacDonald said, but there is a “movable middle” group of people – including those looking for more information and others who face barriers owing to a disability, lack of trust in the the system, geographic challenges, irregular work schedules and even needle phobias. All those issues can be addressed, she said, pointing to B.C.’s effort to send mobile vaccination clinics to where people already are – namely beaches and summer camps.
“Barriers of access is a big deal ... you’ve got to actively think about those barriers, and how as a health care program you can overcome them,” Dr. MacDonald said.
To reach higher vaccination levels, peer groups and neighbours can also play an important role in normalizing vaccinations and helping others access the shot, she added.
The Friday modelling also showed that even with 85 per cent full vaccination coverage, cases could surge to about 7,500 a day by the start of September if individual contacts increase by 25 per cent. If the number of people we come in contact with stays unchanged, the modelling predicts about 1,300 daily new cases by September. The trajectory will depend on how high Canada can push its vaccination coverage and “the timing, pace and extent of reopening,” Dr. Tam said.
Of the provinces, Alberta is taking the most aggressive approach to reopening, already ending the majority of its COVID-19 health measures and no longer requiring masks indoors. It will soon lift the self-isolation mandate and stop widespread testing and contact tracing. On Friday, Ontario said once it has met its remaining vaccination targets, it will end the vast majority of public-health measures, including capacity limits at events. However, it will still require masks indoors.
When asked about Alberta’s decision, Dr. Tam said she firmly believes in isolating cases and that the province’s decision puts more onus on individuals.
In June, the public-health agency’s modelling said Canada needed to hit 83 per cent full vaccination coverage to avoid overwhelming hospitals. On Friday, Dr. Tam didn’t explain why that figure was removed from the latest update. She said it was a “very granular number,” but added she does expect that Canada’s vaccination coverage will pass 83 per cent.
Younger people have had less time to book vaccine appointments than older populations who are more vulnerable to COVID-19 and were prioritized earlier in provincial and territorial vaccination campaigns. The Friday modelling underscored the need for many more 18-to-39-year-olds to get their jabs to protect hospitals in the next wave of the pandemic.
If only 72 per cent of that age group are fully vaccinated, then hospitals could again be overwhelmed. According to the models, that risk is greatly reduced if full vaccination coverage in that age group hits 80 per cent.
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As of midnight, COVID-19 restrictions will lift in New Brunswick, eliminating mask mandates, provincial border controls and gathering limits in that province.
However, a local infectious disease expert believes the move is coming too soon.
"Clearly we don't have a lot of cases in the Atlantic right now, but we haven't quite hit our vaccination targets yet," said Dalhousie University's Dr. Lisa Barrett.
"I don't expect catastrophe, but do I think it's necessary to get rid of all masks in all places all the time, and to open up with other measures at the same time? It's probably a little more risky than I was expecting."
New Brunswick Premier Blaine Higgs had said pandemic restrictions would only lift when 75 per cent of the province's eligible population had received both doses of COVID-19 vaccine, however as of Friday, only 66.7 per cent of those 12 and older are fully vaccinated.
Barrett says mask requirements are a cheap and easy way to reduce transmission of the virus, and she doesn't see the advantage of getting rid of them at this stage.
"This really isn't just a common cold, there are a lot of people who have, even after a mild infection with COVID, some long term side effects," she told NEWS 95.7 fill-in host Todd Veinotte.
Although Barrett isn't necessarily expecting cases to surge out of control in our neighbouring province, she said removing restrictions could result in people unnecessarily contracting COVID-19, especially as the more transmissible Delta variant spreads throughout the country.
"We're not at vaccine targets, vaccines aren't perfect and we don't know exactly what the virus does," she explained. "I just think it's a little fast, and don't forget, these experiments, when they go wrong, they're not cases, they're people."
"That means somebody else that's out there is going to have potentially longer term effects from this or get severely ill," Barrett added. "So if we have easy things that we can keep doing that still allow us to socialize, and still allow us to go out and still allow the economy to open, why would we get rid of them right away? I don't understand that part."
Nova Scotia tracks its vaccination rate differently than New Brunswick. While our neighbours calculate how much of their eligible population has received the shots, we keep count of how many in our overall population have been immunized. COVID-19 vaccines have not yet been approved for those under the age of 12.
As of July 30, 76 per cent of Nova Scotians have had one or more doses, while 62.5 per cent are fully vaccinated.
Our province's chief medical officer of health has said more restrictions will be lifted here once 75 per cent of our entire population has had both doses of vaccine.
In Nova Scotia, there have been 4,200 cases from March 15 to July 27, 2021. Of those:
Good evening, we’re updating the coronavirus newsletter to better reflect the pandemic as it changes. What would you like to see included? Send your thoughts to audience@globeandmail.com
Top headlines:
Could Canada be on the brink of a fourth wave? Dr. Theresa Tam says COVID-19 cases could surge, fuelled by the highly transmissible Delta variant if the country opens too fast before enough people have been vaccinated
Ottawa will extend pandemic aid by an extra month, citing an uneven rebound
Masks will stay on after Step 3 of Ontario’s reopening as capacity limits are dropped
In the past seven days, 4,203cases were reported, up 34 per cent from the previous seven days. There were 48 deaths announced, down 13 per cent over the same period. At least 387 people are being treated in hospitals and 1,397,080 others are considered recovered.
Sources: Canada data is compiled from government websites, Johns Hopkins and COVID-19 Canada Open Data Working Group; international data is from Johns Hopkins University.
A woman costumed as Minnie Mouse wears a mask to prevent against the spread of coronavirus disease (COVID-19), as the highly transmissible Delta variant has led to a surge in infections in New York City, July 30, 2021.
EDUARDO MUNOZ/Reuters
Coronavirus in Canada
Canada’s top doctors say Alberta’sdecision to end isolation requirements for those who test positive for COVID-19 could have ripple effects across the country. “I firmly believe that quarantine and isolation can help prevent the spread of COVID-19, especially in light of the spread of the Delta variant,” Dr. Theresa Tam, the country’s chief public health officer, said Friday.
Ontario won’t lift its mask mandate in the next phase of reopening, the province announced Friday, even as it plans to drop most other public health measures meant to curb the spread of COVID-19.
As word of the Prince Edward Island’s loosened restrictions spreads throughout Canada, hotel and resort operators in the province say they are looking forward to once again welcoming out-of-province guests.
The decision means that wage and rent subsidies for businesses will last until Oct. 23. Ottawa said it would also extend income support for unemployed workers, those who need to take time off to care for family and those who have to stay home sick.
Similarly, the three “recovery” benefits for workers will keep paying out at $300 per week, and four more weeks of eligibility will be added, to a maximum of 54 weeks.
The brink of a fourth wave: Long-term forecasts released Friday indicate that a hasty reopening across Canada could lead to a sharp resurgence of the virus by the end of summer.
Coronavirus around the world
The United States Centers for Disease Control and Prevention (CDC) has described the Delta variant as being as transmissible as chickenpox and cautioned it could cause severe disease. Plus, two U.S. travellers have been fined nearly $20,000 each for providing fake COVID-19 proof of vaccination documents and lying about pre-departure tests.
Japan has expanded its coronavirus state of emergency to four more areas following record spikes in infections as Tokyo hosts the Olympics. Prime Minister Yoshihide Suga declared an emergency in Saitama, Kanagawa and Chiba, as well as in the western city of Osaka, effective until Aug. 31.
Millions of children in Nepal are now at greater risk of suffering from malnutrition as the socio-economic fallout brought about by COVID-19 disrupts essential health services and much-needed food supplies.
Leaders in Myanmar are “weaponizing” the COVID-19 pandemic to consolidate power and crush opposition, according to allegations from human rights activists.
Statistics Canada said its estimate is that real gross domestic product grew at an annualized rate of 2.5 per cent between April and June.
Restrictions are rolling back in much of the country as vaccination rates rise. With early indications suggesting a boost in activity, the country should see a pretty strong rebound in the third quarter absent any hiccups, said Desjardins Group chief economist Jimmy Jean.
Also today: The federal government ran a $24-billion deficit in April and May, a sharp drop from one year earlier at the start of the COVID-19 pandemic.
Sources: Canada data are compiled from government websites, Johns Hopkins University and COVID-19 Canada Open Data Working Group; international data are from Johns Hopkins.
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