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India OKs AstraZeneca and locally made COVID-19 vaccines – The Reminder

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NEW DELHI — India authorized two COVID-19 vaccines on Sunday, paving the way for a huge inoculation program to stem the coronavirus pandemic in the world’s second most populous country.

The country’s drugs regulator gave emergency authorization for the vaccine developed by Oxford University and U.K.-based drugmaker AstraZeneca, and another developed by the Indian company Bharat Biotech.

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Drugs Controller General Dr. Venugopal G. Somani said that both vaccines would be administered in two dosages. He said the decision to approve the vaccines was made after “careful examination” by the Central Drugs Standard Control Organization, India’s pharmaceutical regulator.

Prime Minister Narendra Modi called the vaccine approval a “decisive turning point to strengthen a spirited fight.”

“It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India!” Modi tweeted.

AstraZeneca has contracted Serum Institute of India, the world’s largest vaccine manufacturer, to make 1 billion doses of its vaccine for developing nations, including India. On Wednesday, Britain became the first country to approve the shot.

India, however, will not allow the export of the Oxford University-AstraZeneca vaccine for several months, Adar Poonawalla, Serum Institute’s CEO, said Sunday. The ban on exports means that poorer nations will probably have to wait a few months before receiving their first shots.

The move was made to ensure that vulnerable populations in India are protected and to prevent hoarding, Poonawalla said in an interview with The Associated Press.

But questions have been raised by health experts over the vaccine developed by Bharat Biotech. They point out that clinical trials began only recently, making it almost impossible for the firm to have analyzed and submitted data showing that its shots are effective in preventing illness from the coronavirus.

India has confirmed more than 10.3 million cases of the virus, second in the world behind the U.S., though its rate of infection has come down significantly from a mid-September peak. It also has reported over 149,000 deaths.

The country’s initial immunization plan aims to vaccinate 300 million people — healthcare workers, front-line staff including police, and those considered vulnerable due to their age or other diseases — by August 2021. For effective distribution, over 20,000 health workers have been trained so far to administer the vaccine, the Health Ministry said.

But the plan poses a major challenge. India has one of the world’s largest immunization programs, but it isn’t geared around adults, and vaccine coverage remains patchy. Still, neither of the approved vaccines requires the ultra-cold storage facilities that some others do. Instead they can be stored in refrigerators, making them more feasible for the country.

Although Serum Institute of India doesn’t have a written agreement with the Indian government, its chief executive, Adar Poonawalla, said India would be “given priority” and would receive most of its stockpile of around 50 million doses.

Partial results from studies for the Oxford-AstraZeneca shot in almost 24,000 people in Britain, Brazil and South Africa suggest that the vaccine is safe and about 70% effective. That isn’t as good as some other vaccine candidates, and there are also concerns about how well the vaccine will protect older people.

The other vaccine, known as COVAXIN, is developed by Bharat Biotech in collaboration with government agencies and is based on an inactivated form of the coronavirus. Early clinical studies showed that the vaccine doesn’t have any serious side effects and produces antibodies for COVID-19. But late clinical trials began in mid-November. The second shot was to be given 28 days after the first, and an immune response prompted two weeks later.

That time frame means that it isn’t possible that the company submitted data showing that the shots are effective in preventing infection from the virus, said Dr. Gagandeep Kang, an infectious diseases expert at the Christian Medical College at Vellore.

All India Drug Action Network, a public health watchdog, issued a statement demanding greater transparency.

Somani, the regulator, said that “the vaccine has been found to be safe,” but refused to say whether any efficacy data was shared.

The Health Ministry said in a statement that permission was granted for Bharat Biotech’s shot for restricted use in the “public interest as an abundant precaution in clinical trial mode, especially in the context of infection by mutant strains.”

But Kang said that the claim that the vaccine could help against a mutant variant of the virus was “hypothetical” and without any evidence.

Indian regulators are still considering approvals for other vaccines, including one made by Pfizer.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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

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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.

The Canadian Press. All rights reserved.

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

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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.

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

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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.

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