Health

The public science behind the 'Merck' Ebola vaccine – STAT

Published

5 years ago

January 16, 2020

The U.S. Food and Drug Administration recently approved an important vaccine against Ebola, five years after an epidemic in West Africa killed 11,310 people and after more than 2,200 have died of it in the Democratic Republic of Congo in the last 18 months.

Alex Azar, who heads the U.S. Department of Health and Human Services, quickly congratulated his department’s funding and “American global health leadership” for the vaccine, which is called Ervebo. As recently detailed in STAT, the reality is quite different: Canadian public institutions and funding outside the United States were primarily responsible for the vaccine. Without the work of one Canadian government laboratory in particular, more lives would surely have been lost.

A search that we performed across thousands of documents obtained through a freedom of information request revealed that a small group of scientists working at Canada’s National Microbiology Laboratory in Winnipeg, Manitoba, with limited support from U.S. researchers funded by the U.S. Department of Defense, not only discovered the vaccine in 2001, but proved it safe and highly effective in animals in 2005. These Canadian scientists developed clinical-grade vaccine suitable for clinical trials, sought and obtained Canadian government funding for this research, and did all the development work.

Meanwhile, the private sector promised much and delivered little. In 2007, a small Iowa company called BioProtection Systems Corporation approached the Canadian lab to obtain rights to the vaccine in return for helping manufacture larger quantities of high-quality vaccine, conducting expensive clinical experiments, and obtaining regulatory approval.

Our analysis, published Thursday in the Journal of Law and the Biosciences, of more than 1,600 pages of Canadian government records, however, reveals that the company did little more than participate in teleconferences and meet with officials at the U.S. FDA to gain insight into the agency’s expectations regarding the vaccine.

Many scientists at the Canadian lab, facing funding and other constraints, sought greener pastures and left the lab. By late 2010, the lab contemplated halting work on the vaccine. If not for the efforts of a single scientist, Judie Alimonti — working on a nonpermanent contract — who set up a skunk works operation at the lab, it is doubtful that a clinical-grade vaccine suitable for clinical trials would have been produced.

In the end, it was a combination of funding by the Canadian government, work by Canada’s National Microbiology Laboratory, and persistence by Alimonti that made it possible for Canada to contribute clinical-grade vaccine during and following the Ebola epidemic in West Africa from 2014 to 2016.

In collaboration with the World Health Organization, Guinea’s Ministry of Health, Doctors Without Borders, and other nongovernmental organizations on the ground in West Africa and the Democratic Republic of Congo, public-sector science also designed, paid for, and carried out the clinical trials that ensured last month’s approval of Ervebo.

Far from American leadership, this was a collective effort to improve global health.

Azar’s false claim of credit matches another reality, however: It was BioProtection Systems that garnered the financial benefit from these public investments when it sold the patent rights to Merck for $50 million in 2014 at the height of the West African epidemic, and it is Merck that is now being credited for bringing the vaccine to market.

The real issue is neither the money that BioProtection Systems made nor the credit given to Merck. Rather, it is the general assumption that only the private sector can advance drug and vaccine development.

There is little market interest in diseases like Ebola that disproportionately affect the world’s poor. Still, we turn to the private sector to commercialize a vaccine on the strength of the assumption that it is better positioned to bring such therapies to market even when most small-to medium-sized biotech companies, including BioProtection Systems, have never done so and likely never will. For four years before the Ebola epidemic in West Africa, BioProtection Systems failed to deliver a single written report of its progress. And we found no evidence it ever conducted even a single scientific experiment with the vaccine.

The story of Ervebo offers several lessons. It illustrates that health research is international and that the United States does not always lead. It shows how even precarious public-sector science can do so much more than pure discovery research. It reveals how tired our approach to medical innovation has become. And it underscores growing concerns that important interventions like lifesaving vaccines may be neglected, delayed in development, or priced beyond reach unless and until we entertain alternative ways of bringing innovations to market.

Matthew Herder is director of the Health Law Institute at Dalhousie University in Halifax. Janice E. Graham is a university research professor of medicine at Dalhousie University. Richard Gold is a professor of medicine and law at McGill University in Montreal.

Let’s block ads! (Why?)

Source link

Health

Canada to donate up to 200,000 vaccine doses to combat mpox outbreaks in Africa

Published

23 hours ago

September 13, 2024

Anne Joseph

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.

Source link

Health

How many Nova Scotians are on the doctor wait-list? Number hit 160,000 in June

Published

2 days ago

September 11, 2024

Anne Joseph

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.

Source link

Health

Newfoundland and Labrador monitoring rise in whooping cough cases: medical officer

Published

3 days ago

September 10, 2024

Anne Joseph

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.

Source link