MOSCOW — Russian scientists have belatedly published first results from early trials into the experimental Sputnik V vaccine, which received government approval last month but drew considerable criticism from experts, as the shots had only been tested on several dozen people before being more widely administered.
In a report published in the journal Lancet on Friday, developers of the vaccine said it appeared to be safe and to prompt an antibody response in all 40 people tested in the second phase of the study within three weeks. However, the authors noted that participants were only followed for 42 days, the study sample was small and there was no placebo or control vaccine used.
One part of the safety trial included only men and the study mostly involved people in their 20s and 30s, so it is unclear how the vaccine might work in older populations most at risk of the more severe complications of COVID-19.
International experts remained cautious over the vaccine’s effectiveness and safety. Nevertheless, its Russian developers made some bold claims Friday after presenting the findings to reporters.
Professor Alexander Gintsburg, director of the Moscow-based Gamaleya Institute that developed the vaccine with assistance from Russia’s Defence Ministry, told reporters that the vaccine triggers “sufficient” immune response “to counteract any imaginable dose infecting (a person) with COVID-19.”
“We are ready to assert that the protective effect of this vaccine will be detectable and remain at a proper level for 2 years, or maybe even more,” Gintsburg said, without providing any evidence to back up the claim.
According to the Lancet report, the trials took place in two Russian hospitals involving healthy adults aged 18 to 60, who were required to self-isolate once they registered for the trial. They remained in the hospital for the first 28 days of the study after being vaccinated.
One part of the study involved a frozen formulation of the vaccine while another studied a freeze-dried variation. Scientists said the frozen vaccine would be suitable for current global vaccine supply chains while the freeze-dried version could be used in hard-to-reach areas.
Both vaccines used a modified version of the common cold-causing adenovirus to carry genes for the spike protein in the coronavirus, as a way to prime the body to react if a real virus causing COVID-19 comes along. That’s a similar technology to the vaccines being developed by China’s CanSino Biologics and Britain’s Oxford University and AstraZeneca.
Russian researchers said all 40 participants produced a neutralizing antibody response, molecules which are key to blocking infection. The vaccines also appeared to trigger a reaction in the body’s T-Cells, which help by destroying cells that have been invaded by the virus.
The most commonly reported side effects were pain at the injection site, fever, headache, and muscle or joint pain.
In an accompanying commentary, Dr. Naor Bar-Zeev of the Johns Hopkins Bloomberg School of Public Health and colleagues wrote that the studies were “encouraging but small.” They said that the immune reaction elicited by the vaccine “bodes well” but that “clinical efficacy for any COVID-19 vaccine has not yet been shown.”
Bar-Zeev and colleagues said that proving the safety of any coronavirus vaccine would be critical.
“Safety outcomes up to now are reassuring, but studies too date are too small to address less common, or rare serious adverse events,” they said. “Since vaccines are given to healthy people and during the COVID-19 pandemic, potentially to everyone after approval following (advanced) trials, safety is paramount.”
Dr. Ohid Yaqub, senior lecturer at the Science Policy Research Unit at the University of Sussex, said the limited study size was not enough for regulatory approval, which the vaccine received last month.
“In the context of regulatory approval, the design and size of (an early) study is not anywhere near sufficient for widely recognized standards of approval. The study was not randomized, and it was not large enough to detect rarer safety issues,” Yaqub said.
The vaccine was approved by the Russian government with much fanfare on Aug. 11. President Vladimir Putin personally broke the news on national television and said that one of his daughters had already been vaccinated, experienced slight side effects and developed antibodies. Since then, several high-profile officials also said they had taken the shots, including Moscow Mayor Sergei Sobyanin and Defence Minister Sergei Shoigu.
It remains unclear whether they were among the volunteers in clinical trials or accessed the vaccine in some other way.
Russian health authorities announced advanced trials of the vaccine among 40,000 volunteers last month. According to official records, it will be a randomized, double-blind, placebo-controlled study. Officials also mentioned that vaccination of risk groups, such as doctors and teachers, may be carried out “in parallel” — but it remains unclear whether it will be done as part of the study.
Michael Head, a senior research fellow in global health at Britain’s University of Southampton, agreed the Russian vaccine appeared to be “promising,” but that further studies were needed.
“At this stage, we do not actually know if the vaccine works,” he said. Head was not linked to the Russian research. “Public confidence in any vaccine is vital,” he said in a statement, calling suggestions from Russian and other authorities that a vaccine could be fast-tracked without the proper research “problematic.”
“Ultimately, we must not pour additional fuel on the anti-vaccine lobby fires,” he said.
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Cheng reported from London.
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Daria Litvinova And Maria Cheng, The Associated Press
The Canadian government says it will donate up to 200,000 vaccine doses to fight the mpox outbreak in Congo and other African countries.
It says the donated doses of Imvamune will come from Canada’s existing supply and will not affect the country’s preparedness for mpox cases in this country.
Minister of Health Mark Holland says the donation “will help to protect those in the most affected regions of Africa and will help prevent further spread of the virus.”
Dr. Madhukar Pai, Canada research chair in epidemiology and global health, says although the donation is welcome, it is a very small portion of the estimated 10 million vaccine doses needed to control the outbreak.
Vaccine donations from wealthier countries have only recently started arriving in Africa, almost a month after the World Health Organization declared the mpox outbreak a public health emergency of international concern.
A few days after the declaration in August, Global Affairs Canada announced a contribution of $1 million for mpox surveillance, diagnostic tools, research and community awareness in Africa.
On Thursday, the Africa Centres for Disease Control and Prevention said mpox is still on the rise and that testing rates are “insufficient” across the continent.
Jason Kindrachuk, Canada research chair in emerging viruses at the University of Manitoba, said donating vaccines, in addition to supporting surveillance and diagnostic tests, is “massively important.”
But Kindrachuk, who has worked on the ground in Congo during the epidemic, also said that the international response to the mpox outbreak is “better late than never (but) better never late.”
“It would have been fantastic for us globally to not be in this position by having provided doses a much, much longer time prior than when we are,” he said, noting that the outbreak of clade I mpox in Congo started in early 2023.
Clade II mpox, endemic in regions of West Africa, came to the world’s attention even earlier — in 2022 — as that strain of virus spread to other countries, including Canada.
Two doses are recommended for mpox vaccination, so the donation may only benefit 100,000 people, Pai said.
Pai questioned whether Canada is contributing enough, as the federal government hasn’t said what percentage of its mpox vaccine stockpile it is donating.
“Small donations are simply not going to help end this crisis. We need to show greater solidarity and support,” he said in an email.
“That is the biggest lesson from the COVID-19 pandemic — our collective safety is tied with that of other nations.”
This report by The Canadian Press was first published Sept. 13, 2024.
Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.
HALIFAX – The Nova Scotia government says it could be months before it reveals how many people are on the wait-list for a family doctor.
The head of the province’s health authority told reporters Wednesday that the government won’t release updated data until the 160,000 people who were on the wait-list in June are contacted to verify whether they still need primary care.
Karen Oldfield said Nova Scotia Health is working on validating the primary care wait-list data before posting new numbers, and that work may take a matter of months. The most recent public wait-list figures are from June 1, when 160,234 people, or about 16 per cent of the population, were on it.
“It’s going to take time to make 160,000 calls,” Oldfield said. “We are not talking weeks, we are talking months.”
The interim CEO and president of Nova Scotia Health said people on the list are being asked where they live, whether they still need a family doctor, and to give an update on their health.
A spokesperson with the province’s Health Department says the government and its health authority are “working hard” to turn the wait-list registry into a useful tool, adding that the data will be shared once it is validated.
Nova Scotia’s NDP are calling on Premier Tim Houston to immediately release statistics on how many people are looking for a family doctor. On Tuesday, the NDP introduced a bill that would require the health minister to make the number public every month.
“It is unacceptable for the list to be more than three months out of date,” NDP Leader Claudia Chender said Tuesday.
Chender said releasing this data regularly is vital so Nova Scotians can track the government’s progress on its main 2021 campaign promise: fixing health care.
The number of people in need of a family doctor has more than doubled between the 2021 summer election campaign and June 2024. Since September 2021 about 300 doctors have been added to the provincial health system, the Health Department said.
“We’ll know if Tim Houston is keeping his 2021 election promise to fix health care when Nova Scotians are attached to primary care,” Chender said.
This report by The Canadian Press was first published Sept. 11, 2024.
ST. JOHN’S, N.L. – Newfoundland and Labrador‘s chief medical officer is monitoring the rise of whooping cough infections across the province as cases of the highly contagious disease continue to grow across Canada.
Dr. Janice Fitzgerald says that so far this year, the province has recorded 230 confirmed cases of the vaccine-preventable respiratory tract infection, also known as pertussis.
Late last month, Quebec reported more than 11,000 cases during the same time period, while Ontario counted 470 cases, well above the five-year average of 98. In Quebec, the majority of patients are between the ages of 10 and 14.
Meanwhile, New Brunswick has declared a whooping cough outbreak across the province. A total of 141 cases were reported by last month, exceeding the five-year average of 34.
The disease can lead to severe complications among vulnerable populations including infants, who are at the highest risk of suffering from complications like pneumonia and seizures. Symptoms may start with a runny nose, mild fever and cough, then progress to severe coughing accompanied by a distinctive “whooping” sound during inhalation.
“The public, especially pregnant people and those in close contact with infants, are encouraged to be aware of symptoms related to pertussis and to ensure vaccinations are up to date,” Newfoundland and Labrador’s Health Department said in a statement.
Whooping cough can be treated with antibiotics, but vaccination is the most effective way to control the spread of the disease. As a result, the province has expanded immunization efforts this school year. While booster doses are already offered in Grade 9, the vaccine is now being offered to Grade 8 students as well.
Public health officials say whooping cough is a cyclical disease that increases every two to five or six years.
Meanwhile, New Brunswick’s acting chief medical officer of health expects the current case count to get worse before tapering off.
A rise in whooping cough cases has also been reported in the United States and elsewhere. The Pan American Health Organization issued an alert in July encouraging countries to ramp up their surveillance and vaccination coverage.
This report by The Canadian Press was first published Sept. 10, 2024.
