Small gatherings for funerals, burials and weddings had already been allowed with a limit of 10 people following physical distancing rules. However, parties or other social gatherings are still banned.
Outdoor games of tennis have been allowed to resume, though players must bring their own equipment, and not share it.
Pet grooming services began operating May 25, with companies ordered to ensure their employees have personal protective equipment.
Municipal parks, golf courses and driving ranges can open and recreational hunting and fishing are permitted.
The province is in “alert level four” in its five-level reopening plan, allowing some businesses such as law firms and other professional services to reopen along with regulated child-care centres, with some restrictions.
At Level 3, private health clinics, such as optometrists and dentists, will be allowed to open, as well as medium-risk businesses such as clothing stores and hair salons. Overnight camping will also be permitted at level three, though there’s no word yet when that will happen.
At Level 2, some small gatherings will be allowed, and businesses with performance spaces and gyms are to reopen.
Level 1 would represent “the new normal.”
On May 29 Premier Stephen McNeil announced a new gathering limit of 10 people, doubling the limit of five that was imposed in late March.
Physical distancing of two metres is still required, except among members of the same household or family “bubble.” The limit is the same indoors and outdoors, with exceptions for outdoor weddings and funeral services which can have 15 people.
The gathering limit also applies to arts and culture activities such as theatre performances and dance recitals, faith gatherings, and sports and physical activity. Businesses such as theatres, concerts, festivals and sporting activities also must adhere to the 10-person limit.
Private campgrounds can reopen, but only at 50 per cent capacity and they must ensure public health protocols are followed, including adequate distancing between campsites.
Provincial campgrounds are scheduled to open June 15 at reduced capacity to ensure a minimum of six metres between individual sites.
Most businesses ordered shut in late March will be allowed to reopen June 5, if they have a plan that follows physical distancing protocols. The list of businesses includes bars and restaurant dining rooms, hair salons, barber shops, gyms and yoga studios, among others.
Some health providers will also be able to reopen, including dentistry, optometry, chiropractic and physiotherapy offices. Veterinary services will be allowed to operate along with some unregulated professions, such as massage therapy, podiatry and naturopathy.
McNeil earlier announced there would be no return to school this year, and a decision on reopening daycares would be made by June 8.
Trails and provincial and municipal parks can now reopen along with garden centres, nurseries and similar businesses, but playground equipment is still off limits.
Public beaches have reopened along with outdoor activities like archery, horseback riding, golf, paddling, boating and tennis, with the proviso that social distancing and hygiene be maintained. Sportfishing is permitted and people can attend boating, yacht or sailing clubs for the purpose of preparing boats for use.
Drive-in religious services are now allowed, if people stay in their cars, park two metres apart and there are no interactions between people.
Prince Edward Island
Prince Edward Island has extended its public health emergency until June 14.
Premier Dennis King says people wanting to travel to seasonal residences must apply beginning June 1, and those will be put through a risk assessment before approval. Seasonal residents will also be tested for COVID-19 before completing the two weeks they must spend in self-isolation after arriving in the province.
The province moved into the third phase of its reopening plan June 1, which allows such things as in-house dining at restaurants, small groups to participate in recreational and some sporting activities and libraries to reopen. Phase three also allows gatherings of up to 15 people indoors and 20 people outdoors and the reopening of child-care centres.
As well, family and friends can visit residents at long-term care homes. The visits require an appointment and must take place outdoors.
Under phase 2, non-contact outdoor recreational activities were permitted, and retail businesses could reopen with physical distancing measures in place.
Priority non-urgent surgeries and select health-service providers, including physiotherapists, optometrists and chiropractors, resumed on May 1.
The P.E.I legislature resumed May 26.
New Brunswick moved to the “yellow phase” of its COVID-19 recovery plan on May 22, allowing barbers and hair stylists to reopen as well as churches and fitness facilities. Dental care, massage, chiropractors and other “close contact” businesses and services could also reopen.
But the Campbellton region, which extends from Whites Brook to the Belledune, had to take a step backwards to the “orange” level on May 27. Residents were told to once again avoid contacts outside their two-household bubble. Non-regulated health professionals and personal service businesses that opened May 22 also had to close again. And people should only be travelling in and out of Zone 5 for essential reasons.
Restrictions in the yellow phase of the province’s recovery plan will be lifted beginning June 5. The activities include outdoor gatherings of up to 50 people, indoor religious services of up to 50 people, low-contact team sports and the opening of a long list of facilities including swimming pools, gyms, rinks, water parks, and yoga and dance studios.
Licensed daycares started reopening May 19. Children don’t have to wear masks or maintain physical distancing but are being kept in small groups.
Anyone who has travelled outside of New Brunswick will not be allowed to visit early learning and child-care facilities for 14 days.
Retail businesses, offices, restaurants, libraries, museums and seasonal campgrounds were earlier allowed to reopen providing they have clear plans for meeting public health guidelines. The resumption of elective surgeries was also part phase two of the province’s reopening plan.
Phase one, which started on April 24, allowed limited play on golf courses as well as fishing and hunting. Post-secondary students could return if it was deemed safe by the school, and outdoor church services were again permitted, providing people remain in their vehicles and are two metres apart.
The final phase, which will probably come only after a vaccine is available, will include large gatherings.
Quebec began allowing outdoor gatherings with a maximum of 10 people from three families with social distancing in place on May 22.
On May 25 some retail businesses reopened in the greater Montreal area. Quebec reopened retail stores outside Montreal on May 11.
Parks and pools can reopen across the province but are still be subject to physical distancing and other health measures
Day camps across the province will be allowed to open as of June 22, with physical distancing and other COVID-19 health measures in effect. That means smaller groups of children and frequent handwashing. Sleep-away summer camps won’t be allowed to reopen until next year.
Lottery terminals are also reopening after being shut down on March 20 with sales moving to online only.
Quebec’s construction and manufacturing industries have resumed operations with limits on the number of employees who can work per shift. Elementary schools and daycares outside Montreal reopened on May 11, but high schools, junior colleges and universities will stay closed until September.
Elementary schools in the greater Montreal area will remain closed until late August.
Courthouses across the province were permitted to reopen starting June 1, with limited seating capacity and Plexiglas barriers protecting clerks and judges.
Camping is now allowed outside the Montreal and Joliette regions, as are cottage rentals.
Shopping malls, nail salons and other personal care centres are also reopening, but only outside Montreal.
Hairdressers, nail salons and other personal care businesses will be able to open in the Montreal area on June 15.
Meanwhile, checkpoints set up to slow the spread of COVID-19 came down on May 18 in various parts of Quebec, including between Gatineau and Ottawa.
Ontario began its first stage of reopening May 19 including lifting restrictions on retail stores and surgeries.
The province says workplaces can begin to reopen but working from home should continue as much as possible.
The Royal College of Dental Surgeons of Ontario says the profession is currently in Stage 2 of its three-phase reopening plan. Dentists had previously only been allowed to practice emergency or urgent care on patients in-person but can now offer other essential services with enhanced precautions.
All construction can resume, with limits also lifted on maintenance, repair and property management services, such as cleaning, painting and pool maintenance.
Most retail stores with a street entrance can reopen with physical distancing restrictions, and curbside pickup and delivery.
Golf courses can reopen though clubhouses can only open for washrooms and take-out food. Marinas, boat clubs and public boat launches can also open, as can private parks and campgrounds for trailers and RVs whose owners have a full season contract, and businesses that board animals.
Other businesses and services included in the stage one reopening include regular veterinary appointments, pet grooming, pet sitting and pet training; libraries for pickup or deliveries; and housekeepers and babysitters.
Drive-in movie theatres and batting cages reopened May 31 with physical distancing measures in effect.
Backcountry campers returned to provincial parks June 1 with certain stipulations. No more than five people can occupy a single campsite, unless they live in the same household. Provincial parks will also expand permission for picnics and off-leash pet areas.
Premier Doug Ford earlier announced that Ontario schools would remain closed for the rest of the school year.
Meanwhile, this summer’s Honda Indy Toronto has been cancelled.
The Manitoba government has lifted its one-month limit on people’s prescription drug supplies, allowing people to again get prescriptions filled or refilled for 90 days.
Its health offices, including dentists, chiropractors and physiotherapists can also reopen. Retail businesses can reopen at half occupancy providing they ensure physical spacing.
Museums and libraries can reopen, but with occupancy limited to 50 per cent.
Playgrounds, golf courses and tennis courts have reopened as well, along with parks and campgrounds.
On May 22 the province began allowing groups of up to 25 people indoors and 50 people outdoors.
On June 1, the province eased a ban on people visiting loved ones in personal care homes.
Homes can now offer outdoor visits with a maximum of two guests per resident. Visitors will be screened upon arrival and must practice physical distancing.
Community centres and seniors’ clubs are also getting the go-ahead with limits on customer capacity and rules for physical distancing.
Bars, tattoo parlours, dine-in restaurants, fitness clubs and pools could reopen June 1 under limited capacity.
Elementary and high schools stopped in-class instruction in March and will not reopen this school year. But they were allowed, as of June 1, to offer tutoring or student assessments in small groups. Some extracurricular sports and other activities can restart.
At universities and colleges, some specific instruction such as labs and arts studios will be able to resume for up to 25 students and staff at a time.
Amateur sports and recreation programs, as well as bowling alleys, are on the list to resume operations.
A ban on non-essential travel to the province’s north was also eased starting June 1. Southern residents can now travel directly to cottages, campgrounds and parks, but are being told to avoid visiting northern communities.
Film productions can also resume, as well outdoor religious services with no crowd limits providing people stay in their vehicles.
Movie theatres and casinos must remain closed. Concerts, professional sporting events and other large public gatherings won’t be considered until at least September.
Manitoba has extended a province-wide state of emergency until mid-June, to help prevent the spread of COVID-19.
The Saskatchewan government’s five-phase plan to reopen its economy started May 11 with dentists, optometrists and other health professionals allowed to resume services. Phase 1 also includes reopened golf courses and campgrounds.
Under phases 2 and 3 the province says restaurants, gyms and nail salons can start reopening on June 8. Restaurants will be allowed to operate at half capacity and restrictions will also lift on some personal care services, childcare centres and places of worship. The government also plans to increase its 10-person gathering limit to 15 people indoors and to 30 for those outdoors.
Phase 4 could see arenas, swimming pools and playgrounds opening, while in Phase 5, the province would consider lifting restrictions on the size of public gatherings.
Alberta has completed the first phase of its economic relaunch. Retail shops, restaurants, day cares, barber shops, hair salons, farmers markets and places of worship have reopened with some conditions.
Outdoor gatherings are currently limited to 50 people, and indoor gatherings to 15.
The next phase is scheduled to begin June 19 with the reopening of stage and movie theatres, spas and services like manicures, pedicures and massages.
Alberta allowed some scheduled, non-urgent surgeries to start on May 11.
Service provided by dentists, physiotherapists and other medical professionals are also permitted. Golf courses reopened May 2, though pro shops and clubhouses remain shuttered.
The provincial government allowed a partial reopening of the B.C. economy starting May 19.
The reopening plans are contingent on organizations and businesses having plans that follow provincial guidelines to control the spread of COVID-19. Hotels, resorts and parks will follow in June.
Parents in B.C. were given the choice of allowing their children to return to class on a part-time basis starting June 1. The government says its goal is for the return of full-time classes in September, if it’s safe.
Under the part-time plan, for kindergarten to Grade 5, most students will go to school half time, while grades 6 to 12 will go about one day a week. A mix of online and classroom post-secondary education is planned for September.
Conventions, large concerts, international tourism and professional sports with a live audience will not be allowed to resume until either a vaccine is widely available, community immunity has been reached, or effective treatment can be provided for the disease.
The Northwest Territories announced on May 12 a three-phase reopening plan, but the government didn’t say when it would be implemented.
The plan includes more gatherings and the possible reopening of some schools and businesses. However, the territory’s borders remain closed indefinitely to non-residents and non-essential workers.
There are several requirements that must be met before any measures are relaxed: there must be no evidence of community spread; travel entry points in the territory are strong and secure; risks are reduced from workers coming into the territory; and expanded community testing is available.
Travel restrictions will be lifted between Yukon and B.C. after July 1 under the second phase of the territory’s pandemic restart plan.
After that date, travellers between the province and territory will no longer be required to self-isolate for 14 days.
The territory says monitoring the status of neighbouring jurisdictions will determine if it’s safe to further lift restrictions.
Yukon has been gradually easing pandemic restrictions since May 15 with dine-in restaurants, day cares and recreational centres reopening.
Territorial parks and campgrounds will open for the summer next week.
Two households of up to 10 people in total are currently able to interact with each other as part of a “household bubble.”
The territory’s reopening plan outlines five phases including a period after a vaccine is available.
This report by The Canadian Press was first published June 3, 2020
The Canadian Press
What social science says about convincing people to wear masks during the COVID-19 pandemic – CBC.ca
Mandating, not just recommending, the use of non-medical masks will help convince more Canadians to wear them as the economy reopens, just as wearing seatbelts is now the norm, some social scientists and physicians say.
In Canada’s largest city, wearing non-medical masks is now mandatory for people riding with the Toronto Transit Commission, with certain exemptions, to prevent the spread of the novel coronavirus. A bylaw extending the rule to indoor public spaces goes into effect on July 7. Similarly, mayors in Peel Region, which includes Mississauga and Brampton, west of Toronto, and York Region to the north also plan to introduce such bylaws.
In Quebec, Premier François Legault announced that public transit users in the province will be required to wear masks starting on July 13.
Governments are passing laws that require the wearing of masks, but they’re difficult to enforce. That’s why behavioural scientists say it’s so important for the public to get on board with many health authorities who now consider face coverings a necessity.
Kim Lavoie, a professor of psychology in behavioural medicine at the University of Quebec at Montreal, is among the experts calling for governments in Canada to consult social scientists on preventive measures like wearing masks as lockdowns lift in the absence of vaccines or effective treatments for COVID-19.
“Wearing a mask is something we control. Washing our hands, staying home, skipping that party are all things we control,” Lavoie said.
“People forget that the virus isn’t more powerful than our collective will to get rid of it, and there are things we can do. But right now, they’re behavioural.”
Dr. David Fisman, an epidemiologist at the University of Toronto’s Dalla Lana School of Public Health, said masks could help more people get back to business and “regular life.”
“We think it’s sort of low-hanging fruit and a no-brainer,” Fisman said.
“Me wearing a mask protects you. If I have COVID, you wearing a mask also protects you from breathing in my virus,” Fisman said.
But with COVID-19, one person’s behaviour affects the next person — the basis for secondhand smoke laws.
“It’s no more [an infringement] than asking you to wear a seatbelt,” Lavoie said. “You’re not free to drink yourself under the table and then get behind the wheel. If you don’t have a PCR test at your house to test yourself negative, then you have to consider the possibility that you might be infected and not know it and be putting us all at risk.”
Protecting yourself a major motivator
Lavoie is one of the researchers behind a large study called iCARE (International assessment of COVID-19-related attitudes, concerns, responses and impacts). Together with collaborators from Johns Hopkins University’s project on cases and Oxford’s policy tracker, they’re regularly surveying Canadians and people around the world on how they feel about and adhere to policies.
The goal of the research is to disentangle what motivates people of different ages and socioeconomic backgrounds to change their behaviour to inform health-care policy and messaging.
Based on 50,000 responses since the end of March, Lavoie said the findings to this point suggest that concern about getting infected with the virus is a major motivator.
“One thing people don’t realize is how contagious it is,” she said.
Most people recover at home, but people of all ages have also been severely sickened, some for months, says the Public Health Agency of Canada. Patients say long-term symptoms and consequences such as heart damage are coming to the fore.
An urgent need
While making mask wearing the norm would help prevent transmission, Fisman said mixed messaging and “dithering” by Ontario’s government have hindered mask use from becoming commonplace.
“Once the signal comes from our public health leaders that this is the expectation and this is how we’re going to move forward, I think people will fall in line pretty fast,” he said.
Wearing masks could be considered a behaviour that needs to be adopted urgently and collectively, Lavoie said.
She pointed to how behavioural change boils down to three factors:
- Awareness of the need to wear masks.
- Motivation, such as protecting yourself, loved ones or neighbours who may be vulnerable to serious complications.
- Confidence in the ability to execute the behaviour.
Cost can be a barrier. That’s why Alberta’s government is distributing 20 million non-medical masks at drive-thru restaurants.
Shift from self-consciousness to the norm
Mitsutoshi Horii, a professor of sociology at Chaucer College in Canterbury, England, studied the uptake of masks in Japan during the 1918 flu pandemic. The practice continues in Japan during flu and hay fever season, as well as during COVID-19.
Horii said when the 1918 flu pandemic hit, the Japanese government prohibited traditional folk rituals around health as part of its efforts to promote modernization and to avoid colonization.
“Then the mask came in and that gave people a sense of direction. When you’re facing uncertainty, you want to do something. By doing something, we establish a sense of control,” he said.
WATCH | Canada’s patchwork of mask measures:
Horii contrasts that with his experience in the U.K. now, where wearing masks is not common.
He said he thinks changing the rules would encourage him and others to overcome self-consciousness.
“At the same time, I bought some masks and we’re ready to wear [them] at any time. We just need a bit of a push to do it.”
How Moderna executives are cashing in on COVID-19 vaccine stock speculation – Reuters
(Reuters) – Biotech firm Moderna Inc could reap tens of billions of dollars in sales and stock appreciation if it wins the race for a COVID-19 vaccine. If it loses, the early-stage company’s value could crash.
FILE PHOTO: A sign marks the headquarters of Moderna Inc, which is developing a vaccine against the coronavirus disease (COVID-19), in Cambridge, Massachusetts, U.S., May 18, 2020. REUTERS/Brian Snyde
In the meantime, the firm’s chief executive is pocketing millions of dollars every month by selling shares that have tripled in price on news of Moderna’s development progress, a Reuters analysis of corporate filings shows. The sales – by CEO Stéphane Bancel, his childrens’ trust and companies he owns – amount to about $21 million between January 1 and June 26, including $6 million in May.
The company’s chief medical officer, Tal Zaks, has cashed out the majority of his available stock and options, netting over $35 million since January, the filings show.
The lucrative liquidations highlight the unusually powerful incentives for biotech executives to highlight development milestones for drugs that often never get approved or sold, according to interviews with seven executive-compensation experts. Optimistic corporate statements on coronavirus vaccines, they said, could cause investors to overpay for company shares or create false hope among the public and health officials seeking new weapons to fight the pandemic.
Bancel set a fixed schedule for his share sales – known as a 10b5-1 plan – long before the pandemic hit. Such executive share-sale plans are meant to guard against insider trading, avoiding the potential for executives to sell in advance of bad news they know is coming, or to put off selling until after a positive announcement.
Zaks sharply increased the pace of his sales with a new plan he put in place on March 13. That was three days before Moderna announced it had dosed the first human with a vaccine candidate, news that sent its stock price up 24% and signaled that future development milestones might push the shares higher.
The sales give the firm’s executives an unusual opportunity to lock in big profits on what could be fleeting market optimism, said Jesse Fried, a Harvard Law School professor who wrote a book about executive compensation.
“This may be their one shot at making a boatload of money if the vaccine doesn’t work out,” Fried said. Executives have wide discretion in releasing information, he said, and Moderna’s chiefs have a powerful motivation to “keep the stock price up.”
Reuters found no evidence that Bancel, Zaks or Moderna has exaggerated the company’s vaccine progress.
Many news outlets have reported sales by Moderna executives in the wake of positive news on its vaccine efforts. Reuters is the first to report that Bancel and affiliated entities are selling 90,000 shares every month and that Zaks moved to sharply increase his sales in March, three days before Moderna released market-moving news.
A Moderna spokesman said that Bancel is liquidating only a small portion of his holdings and that “substantially all of his family’s assets remain invested in Moderna.” This stakeholding reflected Bancel’s “long-term commitment” to the firm, the spokesman said. Bancel, his companies and his children’s trust own more than 24 million Moderna shares, making him the second largest stockholder, owning about 8% of the firm, down slightly from the beginning of the year.
Zaks did not respond to requests for comment, and Moderna did not comment on his share sales.
The high frequency, volume and profits of Bancel’s transactions – at about 90,000 shares monthly – are unique among the CEOs of 26 companies identified by Reuters as developing COVID-19 vaccines or treatments and that regularly publish information on executive trades of company shares.
Twenty-one of the firms have seen their stock rise since the end of January, just before coronavirus spread globally, and ten of those, including Moderna, have seen share prices at least double. But just four of the CEOs of those firms, including Bancel, have sold company stock. Only one – Chad Robins of Adaptive Biotech – made substantial, regular sales under a 10b5-1 plan, like Moderna’s Bancel. Adaptive Biotech, however, has seen a far smaller recent stock-price increase – about 50% – than Moderna. During May and June, Robins sold about $12 million in stock after Adaptive’s stock price rose on news that it is researching antibody therapies and a coronavirus test that delivers faster results.
Adaptive Biotech declined to comment and referred to a company filing that said Robins sold the stock to diversify his investments.
Most of Bancel’s sales have been carried out through plans in place since December 2018, the filings show. The transactions started in November 2019, when a trust belonging to his children began selling 11,046 shares each week. This January, Bancel and two companies he controls started selling stock regularly. Since then, they have collectively sold about 90,000 Moderna shares each month.
HIGH RISKS, REWARDS
Such scheduled sales are more common at early-stage biotech companies such as Moderna – which face intense risk-reward scenarios – than at more established and diversified drug firms, where executives frequently hold their equity until they leave the company.
Executives’ ongoing sales are an effective hedge against the bigger downside risk faced by companies like Moderna. Based in Cambridge, Massachusetts, the firm has more than 20 therapies and vaccines in development – but none near approval. Investors view the firm as a frontrunner in creating a COVID-19 vaccine, but it faces 17 serious competitors with candidates in clinical evaluations and 129 others in earlier development stages, according to the World Health Organization. Only a very small number of companies are expected to get vaccines to market, biotech executives and health experts say.
If Moderna successfully launches its coronavirus vaccine and a dozen other of its most promising trial medicines, its stock price could rise to $279 based on the new revenues, according to Morgan Stanley analysts. That would yield Bancel a fortune of about $10 billion including currently unvested share options, the Reuters analysis shows.
The firm’s stock has soared from $18 in late February – just before it announced it had shipped its vaccine candidate to the U.S. government for trials – to close at $56.57 on July 2, down 5%, after a report that the start of its large vaccine trial would be delayed. That gives the company a market capitalization of nearly $23 billion. The stock hit a high of $80 in May.
But Morgan Stanley also has a “bear case,” in which the company would be worth only as much as the cash on its balance sheet if all of its vaccine and drug candidates don’t make it to market.
‘SCIENCE BY PRESS RELEASE’
Bancel and Zaks have been bullish on Moderna’s prospects in public statements.
Bancel calls the mRNA technology the company uses for all vaccine development the “software of life,” with potential to create “a new class of medicines.” He has also said Moderna’s process can create vaccines much faster and with a better chance of “technical success” – and, by implication, regulatory approval – than other firms.
“We are not aware of anybody else who can do this at this scale, with this focus, at this speed,” he told investors on June 2. Earlier, in a May 7 earnings call, Bancel said he had “never been as excited and optimistic about the future of Moderna.”
Many investors and analysts are optimistic as well but say it is difficult to evaluate Moderna’s prospects given the early stages of trials.
The company drew criticism from scientists for releasing incomplete data from a trial being conducted by the U.S. National Institutes of Health (NIH). On May 18, Moderna announced that its vaccine candidate had produced protective antibodies in a small subset of healthy trial volunteers. The news pushed Moderna stock up 20% to its peak of $80.
Some scientists suggested Moderna should have held off publishing until it had all test subjects’ results. “This was science by press release,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia. Without complete data, he said, “you’re left to read the tea leaves.”
Dr. Anthony Fauci – the nation’s top infectious disease expert – shared the test results with U.S. governors, Vice President Mike Pence said in a Twitter post the day of Moderna’s announcement. But Fauci – who is running the Moderna trial – later said he didn’t like the company’s early release of incomplete data, according to an interview published by the STAT health news service. A spokeswoman for Fauci’s agency, the National Institute of Allergy and Infectious Diseases, did not comment beyond what Fauci said in the interview.
Bancel told investors at a June conference that Moderna’s leadership worried the information had been seen by too many people, including at the NIH. He said the company made the partial findings public because it worried the data would get leaked – and it considered the incomplete results material information that all investors should receive at the same time. A company spokesman told Reuters the company believed it needed to release the information to comply with Securities and Exchange Commission rules.
The day after the May 18 announcement, Zaks sold 125,000 shares – netting him nearly $10 million – at a price of $78, up from $66 on the Friday before the Monday press release. Company filings show the sale was executed in accordance with the plan that Zaks put in place on March 13.
Reporting by Tom Bergin and Robin Respaut; Editing by Tom Lasseter and Brian Thevenot
Johnson & Johnson Prepares For COVID-19 Vaccine Human Trials – Verywell Health
- Janssen Pharmaceutical Companies, a division of Johnson & Johnson, plans to begin human trials of its COVID-19 vaccine this month.
- The first clinical trial participants will be healthy adults.
- Moving to the next phase of clinical trials depends on both the results of this phase and the progression of the pandemic.
Clinical trials are well underway for three COVID-19 vaccine candidates being funded by the United States. Moderna and AstraZeneca have begun human trials, and Johnson & Johnson plans to do so by the end of July.
Even with over $2 billion worth of funding from the government’s Biomedical Advanced Research and Development Authority (BARDA), getting a vaccine through human trials isn’t easy. Large-scale testing must show a vaccine is both safe and can actually provide immunity against the SARS-CoV-2 virus that causes COVID-19.
Verywell talked to Jerome Custers, Senior Scientific Director of Vaccine Research at Johnson & Johnson, to learn what the process involves and what will make human trials successful.
Markers of Success
The most important parameter in a human trial, according to Custers, is safety.
“In our first clinical trial, we will vaccinate healthy adults, and those people will be monitored very strictly for safety,” Custers says. “In addition to that, we’re looking to see if our vaccine is able to induce a strong immune response and produce antibodies against the coronavirus.”
Custers says antibodies can be measured from blood samples. Researchers will take blood samples from trial participants before they are given the vaccine, a week or two after vaccination, and then at regular intervals after that.
“We have data from animals—monkeys, mice, and hamsters—that confirmed what we thought we would see and are encouraging us to continue in this direction.”
Creating and Testing a Vaccine
The direction Custers refers to is the use of something called AdVac technology. Using this vaccine platform, Johnson & Johnson scientists remove a piece of the genetic sequence from the adenovirus, which causes the common cold. Then, they insert genetic code from COVID-19.
Johnson & Johnson has used the same AdVac platform to develop vaccines for Ebola, HIV, RSV, and Zika, which combined, have been trialed safely in over 50,000 people. With COVID-19, however, the company is trying to do it on a much larger scale and a much more abbreviated timeline.
“A billion vaccines is still the goal,” Custers says.
While the first in-human clinical trials were initially slated for September, the company announced on June 10 that it would bump them up to the second half of July. This phase, considered a Phase 1/2a clinical trial, will involve 1,045 volunteers. Typically, this takes several months to years. But Johnson & Johnson is already looking ahead to Phase 3, which Moderna and AstraZeneca plan to enter this summer.
Beginning Phase 3 clinical trials is contingent on good results from Phase 1/2a.
“We are thinking that Phase 3 trials will include several tens of thousands of people,” Custers says. “But that will largely depend on how that pandemic develops. The incident rate of infection is going down.”
Currently, Phase 1/2a clinical trials are planned to take place in the U.S. and Belgium. Belgium has seen a steady decline in confirmed COVID-19 cases since April, when cases peaked at over 2,000 on a single day. Throughout the month of June, new cases hovered around 100 per day.
“Of course, we are happy that’s happening, but it will also make showing that the vaccine can prevent infection much more difficult,” Custers says. “You need a certain incidence rate to be able to do that.”
Custers says that, if needed, Johnson & Johnson could move testing to areas where infection rates are still high.
“It’s very hard to assess what the situation will be like in a couple months when we actually need to decide,” Custers says. “We’re monitoring the situation. We think it will be a potential issue for all the COVID-19 vaccines in development.”
Learning From Other Vaccines
In addition to the vaccines receiving BARDA funding in the US, there are approximately 140 COVID-19 vaccines in development around the world. Custers explains the race for a vaccine isn’t a competition—it’s a collaboration.
“No one knows who will be successful, so it’s important for the world to have multiple shots on goal, as we tend to say,” he says. “It’s also important because we learn from each other. We’re all in different stages and have slightly different approaches. The data we generate—in preclinical data, animal studies, and clinical studies—will enable all of us to move as quickly as possible.”
While Johnson & Johnson and other biopharmaceutical companies are working as quickly as possible to create a usable vaccine, a definitive timeline is still impossible to give.
Custers says a number of factors influence timing. “Will the vaccines currently in development be successful?” he says. “Will we be able to show those vaccines work—is the COVID-19 incidence somewhere in the world high enough to be able to show the vaccine can protect people sufficiently?”
Even if both of those answers are yes, the scale of production is another challenge.
“We need to make a sufficient amount of vaccine,” Custers says. “At the beginning, there won’t be enough of the vaccine to offer it to the general public. I imagine healthcare workers and people at an increased risk of contracting COVID-19 will get the vaccine first. It’s not really up to us as a company.”
Custers says deploying a vaccine—assuming it has proven safe and effective—depends on when Johnson & Johnson receives emergency use authorization at a government level, like from the Food and Drug Administration.
Custers says his team is working hard to meet these supply demands.
“We are doing things in parallel. Manufacturing is ongoing, and we’re upscaling to be able to make as many vaccine doses as soon as possible,” he says. “Usually, you only do that when you know the vaccine is working.”
He says that while much remains uncertain, Johnson & Johnson is optimistic about their vaccine candidate.
“It’s very rewarding and motivating to work on this vaccine and be able to contribute something,” he says. “It’s a once in a lifetime opportunity—hopefully.”
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