Sinovac Biotech’s experimental coronavirus vaccine CoronaVac triggered a quick immune response but the level of antibodies produced was lower than in people who had recovered from the disease, according to preliminary trial results.
While the early to mid-stage trials were not designed to assess the efficacy of CoronaVac, researchers said it could provide sufficient protection, based on their experience with other vaccines and data from preclinical studies with macaques.
The study comes hot on the heels of upbeat news this month from U.S. drugmakers Pfizer and Moderna as well as Russia that showed their experimental vaccines were over 90 per cent effective based on interim data from large, late-stage trials
CoronaVac and four other experimental vaccines developed in China are currently undergoing late-stage trials to determine their effectiveness in preventing COVID-19.
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The Sinovac findings, published on Tuesday in a peer-reviewed paper in medical journal The Lancet Infectious Diseases, came from results in Phase I and Phase II clinical trials in China involving more than 700 participants.
“Our findings show that CoronaVac is capable of inducing a quick antibody response within four weeks of immunization by giving two doses of the vaccine at a 14-day interval,” Zhu Fengcai, one of the authors of the paper, said.
“We believe that this makes the vaccine suitable for emergency use during the pandemic,” Zhu said in a statement published alongside the paper.
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Researchers said the findings from large, late-stage studies, or Phase III trials, would be crucial to determine if the immune response generated by CoronaVac was sufficient to protect people from the coronavirus infection.
Sinovac is currently running three Phase 3 trials in Indonesia, Brazil and Turkey.
The results must be interpreted with caution until Phase III results are published, Naor Bar-Zeev, a professor from Johns Hopkins University who was not involved in the study, said.
“But even then, after Phase 3 trial completion and after licensure, we should prudently remain cautious,” he said.
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CoronaVac is one of three experimental COVID-19 vaccines China has been using to inoculate hundreds of thousands of people under an emergency use program.
The two other vaccines in China’s emergency program, both developed by institutes linked to Sinopharm, and another vaccine from CanSino Biologics, were also shown to be safe and triggered immune responses in early and mid-stage trials, peer-reviewed papers show.
Gang Zeng, a Sinovac researcher involved in the CoronaVac study, said the vaccine could be an attractive option because it can be stored at normal fridge temperatures of 2 to 8 degrees Celsius (36°-46°F) and may remain stable for up to three years.
“(It) would offer some advantages for distribution to regions where access to refrigeration is challenging,” the author said.
Vaccines developed by Pfizer/BioNTech and Moderna use a new technology called synthetic messenger RNA (mRNA) to activate the immune system against the virus and require far colder storage.
Pfizer’s vaccine must be stored and transported at -70C though it can be kept in a normal fridge for up to five days, or up to 15 days in a thermal shipping box. Moderna’s candidate is expected to be stable at normal fridge temperatures for 30 days but for storage of up to six months it needs to be kept at -20C.
CoronaVac is also being considered by Brazil and Indonesia for inoculations in the coming months.
Indonesia has sought emergency authorisation to start a mass vaccination campaign by the end of the year and vaccines produced by Sinovac and China’s Sinopharm are slated to be used in the early stages of the campaign.
Brazil’s Sao Paulo also plans to roll out CoronaVac as early as January and has agreed a supply deal with Sinovac.
“The excellent safety of CoronaVac, compared to other vaccines under development, makes for greater acceptance by the population,” Ricardo Palacios, trial manager of Brazil’s Butantan Institute biomedical center, which is testing CoronaVac, told Reuters.
— Additional reporting by Anthony Boadle, Reuters
© 2020 Reuters
Windsor's Frank W. Begley Public School reporting 37 confirmed COVID-19 cases – CTV News Windsor
WINDSOR, ONT. —
A Windsor school has seen a dramatic increase in COVID-19 cases.
The Windsor-Essex County Health Unit reported on Monday there are 37 confirmed cases and two probable cases at Frank W. Begley Elementary School.
According to the province’s website, it is the largest outbreak in an Ontario school.
WECHU says 29 students and eight staff members have tested positive.The presumed index case is believed to be a staff member.
“They could be the one who spread it to the rest of the school,” says Ahmed. “It’s not to blame that index case, that this happened because they didn’t follow anything, but I think it’s just how we are trying to work through an outbreak investigation.”
Ahmed says they can’t pinpoint where the presumed index case acquired the virus. The earliest case was reported on Nov. 8.
The health unit declared an outbreak at the school on Tuesday and students and staff members were dismissed.
“Dismissing the entire school really helped us from a control perspective, so there was no ongoing spread,” says Ahmed.
He adds they are still trying to paint a picture of how the cases spread between cohorts.
Windsor Regional Hospital set up dedicated clinics for the school community to get tested.There are about 430 students and staff members at the school. The health unit says 283 students, 47 staff and 141 family members have been tested as a result of this initiative.
There is also an outbreak at W. J. Langlois Catholic Elementary School, where two students and two staff members have tested positive for the virus. The school is also closed.
AstraZeneca says late-stage trials of its COVID-19 vaccine were 'highly effective' in preventing disease – CBC.ca
AstraZeneca said Monday that late-stage trials showed that its COVID-19 vaccine with Oxford University was up to 90 per cent effective in preventing disease. The vaccine is one of several that Canada has preordered.
The results are based on interim analysis of trials in the U.K. and Brazil of a vaccine developed by Oxford University and manufactured by AstraZeneca. No hospitalizations or severe cases of COVID-19 were reported in those receiving the vaccine, AstraZeneca said.
The trial looked at two different dosing regimens. A half dose of the vaccine followed by a full dose at least one month apart was 90 per cent effective. A second regimen using two full doses one month apart was 62 per cent effective. The combined results showed an average efficacy rate of 70 per cent.
“These findings show that we have an effective vaccine that will save many lives,” Prof. Andrew Pollard, chief investigator for the trial, said in a statement. “Excitingly, we’ve found that one of our dosing regimens may be around 90 per cent effective.”
AstraZeneca is the third major drug company to report late-stage results for its potential COVID-19 vaccine as public health officials around the world anxiously wait for vaccines that will end the pandemic that has killed almost 1.4 million people. Pfizer/BioNTech and Moderna last week reported preliminary results from late-stage trials showing their vaccines were almost 95 per cent effective.
Unlike the Pfizer and Moderna vaccines, the Oxford-AstraZeneca candidate doesn’t have to be stored at ultra-cold temperatures, making it easier to distribute, especially in developing countries. All three vaccines must be approved by regulators before they can be widely distributed.
“The Oxford vaccine can be stored in the fridge, as opposed to the freezer like the other two vaccines, which means it is a more practical solution for use worldwide,” said Peter Horby, professor of Emerging Infectious Diseases and Global Health at Oxford.
The results come as COVID-19 infection rates are rising in most U.S. states and in many countries, including Canada, amid a resurgence of the virus, which is once again prompting governments to shut down businesses and restrict social gatherings around the world. England is still in the middle of a four-week lockdown that has closed all non-essential shops, while in the U.S., the government’s top health agency has recommended that Americans not travel to visit family and friends over the Thanksgiving holiday this week.
AstraZeneca said it will immediately apply for early approval of the vaccine where possible, and it will seek an emergency use listing from the World Health Organization so it can make the vaccine available in low-income countries.
The vaccine uses a weakened version of a common cold virus that is combined with genetic material for the characteristic spike protein of the virus that causes COVID-19. After vaccination, the spike protein primes the immune system to attack the virus if it later infects the body.
Incredibly exciting news the Oxford vaccine has proved so effective in trials. There are still further safety checks ahead, but these are fantastic results. <br><br>Well done to our brilliant scientists at <a href=”https://twitter.com/UniofOxford?ref_src=twsrc%5Etfw”>@UniofOxford</a> & <a href=”https://twitter.com/AstraZeneca?ref_src=twsrc%5Etfw”>@AstraZeneca</a>, and all who volunteered in the trials. <a href=”https://t.co/84o8TKhQga”>https://t.co/84o8TKhQga</a>
The vaccine can be transported under “normal refrigerated conditions” of 2 C to 8 C, AstraZeneca said. By comparison, Pfizer plans to distribute its vaccine using specially designed “thermal shippers” that use dry ice to maintain temperatures of minus -70 C.
Smaller dose may reduce costs
Peter Openshaw, professor of experimental medicine at Imperial College London, said the finding that a smaller initial dose is more effective than a larger one is good news because it may reduce costs and mean more people can be vaccinated.
“The report that an initial half-dose is better than a full dose seems counterintuitive for those of us thinking of vaccines as normal drugs. With drugs, we expect that higher doses have bigger effects, and more side-effects,” he said. “But the immune system does not work like that.”
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Dr. Christopher Labos, a cardiologist in Montreal trained in epidemiology, said vaccines do not have to be perfect or prevent every case of COVID-19.
“The point is to drastically reduce the caseload, to drastically reduce the number of new infections so that we don’t have these outbreaks, so we don’t have the hospital systems overwhelmed,” Labos said Monday on CBC News Network.
“That’s the main take-home message from a lot of these vaccines. Not only do they prevent cases but they seem to prevent serious cases of COVID-19.”
Labos said he suspects because the Pfizer/BioNTech and Moderna vaccines need to be stored at low temperatures, they are probably going to be reserved for institutions, while the Oxford/AstraZeneca one might be rolled out in the community.
The results reported Monday come from trials in the U.K. and Brazil that involved 23,000 people. Late-stage trials are also underway in the U.S., Japan, Russia, South Africa, Kenya and Latin America, with further trials planned for other European and Asian countries.
AstraZeneca reported two pauses in the Phase 3 clinical trial of its vaccine candidate, AZD1222. “No serious safety events related to the vaccine have been confirmed,” the company said in a release.
AstraZeneca has been ramping up manufacturing capacity, so it can supply hundreds of millions of doses of the vaccine starting in January, chief executive Pascal Soriot said earlier this month.
Soriot said Monday that the Oxford vaccine’s simpler supply chain and AstraZeneca’s commitment to provide it on a non-profit basis during the pandemic mean it will be affordable and available to people around the world.
“This vaccine’s efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency,” Soriot said.
Now that AstraZeneca has released its interim results, regulators must approve the vaccine before it can be widely distributed.
‘Great sense of relief’
Britain has ordered 100 million doses of the Oxford vaccine, and the government says several million doses can be produced before the end of the year if it gains approval from the regulator. Canada has ordered 20 million doses, enough for 10 million people.
British Health Secretary Matt Hancock said he felt “a great sense of relief” at the news of the AstraZeneca vaccine’s effectiveness.
He said just months ago, as the virus raged, “the idea that by November we would have three vaccines, all of which have got high effectiveness, I would have given my eye teeth for.”
Record number of new coronavirus cases reported in Ontario as lockdowns begin in Toronto, Peel – CP24 Toronto's Breaking News
Ontario is reporting a record number of new cases of COVID-19 just as Toronto and Peel enter a lockdown to control the rapid spread of the virus.
The Ministry of Health says that there were 1,589 new instances of the disease caused by the novel coronavirus confirmed on Sunday as we all as another 19 deaths, 11 of which involved residents of long-term care facilities.
It is a new record caseload for any single 24-hour period, just barely topping the previous high of 1,588 that was reported on Saturday. It also represent a more sizeable increase on the 1,487 new cases that were reported last Monday.
Meanwhile, the seven-day average of new cases increased again and now stands at 1,429. That, however, is still down from this point last week when it stood at 1,443.
The latest positive cases came on just 37,471 tests, repeating a trend that typically sees the province report fewer results at the beginning of the week due to a drop off in testing over the weekend.
The positivity percentage over the last 24 hours was 4.6 per cent. It is the highest that number has been since last Tuesday.
The vast majority of the new cases do continue to be clustered in Peel (535 cases), Toronto (336 new cases) and York (205 new cases) with those three regions accounting for more than two-thirds of all new infections.
But the transmission of the virus does seem to be accelerating in communities across Ontario, as officials have warned.
On Monday there were 83 new cases reported in Waterloo, as the region officially moved into the red zone in Ontario’s COVID-19 framework. There was also another 41 new cases in Durham, 53 in Halton and 61 in Hamilton.
“The main thing people can do now is please stay home,” Toronto Mayor John Tory told CP24 on Monday morning. “It matters less in the context of achieving the result which kind of stores are closed and not closed. It matters more whether people decide to follow the advice, which is if it is at all possible just stay home.”
Modelling had warned of higher case counts by now
Modelling released earlier this month had warned that Ontario could see about 2,000 to 2,500 cases a day by this point en-route to 3,500 to 6,500 daily cases by mid-December but it would appear that we have fallen off that pace somewhat.
There are, however, still alarming indicators that point to challenging days on the horizon.
There are now 156 COVID-19 patients receiving treatment in the ICU and some hospitals have already had to cancel some elective surgeries and procedures to accommodate the influx.
Deaths are also steadily increasing after lagging behind the rise in case counts for months.
Over the last seven days an average of 19 COVID patients have died each day, up slightly from this time last week when the seven-day average was 18.
If there is reason for optimism, it comes in the form of encouraging news on the vaccine development front.
On Monday morning AstraZeneca reported that its vaccine appeared to be up to 90 per cent effective in late-stage trials. Moderna Inc. and Pfizer have also reported that their vaccines are more than 90 per cent effective with the latter having recently applied for emergency use authorization from U.S. officials.
“With these vaccine studies it is great news and it is always OK to take a stop along the way and smell the roses and a have a small celebration but we have to stay the course,” infectious diseases expert Dr. Issac Bogoch told CP24 on Monday, prior to the release of the latest numbers. “Our masks, our distancing, our hand sanitization, getting vaccinated for the flu. Just continue to adhere to these public health measures and it is clear that things are going to get better and better and better but we are not there yet. So just double down, hold the fortress, continue to practice our public health measures and we will be ok. We really will.”
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