BRITISH drug manufacturer AstraZeneca has withdrawn its application to hold clinical trials for its vaccine in the Philippines, according to the Food and Drug Administration (FDA). It comes after the drug maker accepted a proposal from Russia’s Gamaleya Research Institute to begin clinical trials of its AZD1222 vaccine alongside Sputnik V to study its efficacy since both use adenovirus vectors that contain the genetic material of the SARS-CoV2 virus spike protein.
In this file photo taken on November 17, 2020 An illustration picture shows vials with Covid-19 Vaccine stickers attached and syringes with the logo of British pharmaceutical company AstraZeneca. Pharmaceutical giant AstraZeneca’s Russian branch said on December 11, 2020 it would use part of Russia’s homemade Sputnik V vaccine in further clinical trials. / AFP / JUSTIN TALLIS
The AZD1222 vaccine, which the British manufacturer developed jointly with the University of Oxford, will now be used alongside Sputnik V in clinical trials before the end of the year. Gamaleya and Sputnik V vaccine financial backer, Russian Direct Investment Fund (RDIF), offered AstraZeneca to use one of the two components of the Sputnik Vaccine.
While both vaccines use adenovirus vectors that contain the genetic material of the SARS-CoV2 virus spike protein, they differ in the source of the vector, as AZD1222 used the adenovirus of the chimpanzee while Sputnik used human adenovirus vectors found in common cold.
According to the RDIF, the use of two different adenovirus vectors for a prime and boost immunization would be a “unique and ground-breaking discovery,” as this could raise efficacy and create long-term resistance to the virus.
“Scientific collaboration with Gamaleya Research Institute is important to explore the potential of vaccine combinations unlocking synergies in protection and accessibility through a portfolio approach.” the British drug maker said in a statement.
Sought for its reaction, FDA Director-General Rolando Enrique Domingo, in an email reply to The Manila Times, said AstraZeneca has “enough data” that convinced the developer to withdraw its application for clinical trials in the country.
He did not provide other details.
The drug manufacturer signed a deal with the Philippine government and the private sector for about 2.6 million doses of the vaccine, which will become available between May and June of 2021.
Presidential Adviser for Entrepreneurship and Go Negosyo founder Jose Maria “Joey” Concepcion 3rd, who rallied the private sector in securing the advanced commitment from AstraZeneca, declined to comment and would issue a statement next week.
Emergency use authorization
Despite withdrawing from the clinical trials, the vaccine developer can still apply for an emergency use authorization (EUA), which the FDA can grant by virtue of President Rodrigo Duterte’s Executive Order 121.
Before this, AZD1222 had been given approval by the country’s joint ethics review board and was awaiting approval from the Vaccine Experts’ Panel before being evaluated by the FDA.
AstraZeneca had separate clinical trials in the United Kingdom, Brazil, and South Africa, and had planned to do its trials in the country to see if the vaccine would encounter the same efficacy when injected on Asians, according to Jaime Montoya, executive director of the Department of Science and Technology-Philippine Council on Health Research and Development.
Aside from AstraZeneca and Gamaleya, other vaccines being considered for clinical trials are those by Sinovac Biotech Ltd., Janssen Pharmaceutica, and Clover Biopharmaceuticals. The Vaccine Expert Panel and the Ethics Review Board has approved the vaccine by Clover Biopharmaceuticals.
‘No graft in vaccine purchase’
The Presidential Anti-Corruption Commission (PACC) will act to ensure the country’s deal for the purchase of vaccines against Covid-19 would be corruption-free, its head Dante Jimenez said on Saturday, following reports that Chinese firm and vaccine frontrunner Sinovac had bribed regulators to secure approvals.
Jimenez made the statement after the Washington Post reported that Sinovac has “acknowledged” a bribery case involving its chief executive officer (CEO).
In a statement, Jimemez promised that the PACC would make people in any department accountable if there would be any such allegations forthcoming and would bring the matter to “the attention of the President.”
Not another Dengvaxia scandal
“We don’t want a repeat of the Dengvaxia scandal, where irregularity in transactions was highly tolerated by the previous administration,” Jimenez said.
Jimenez was referring to the controversy that arose in November 2017 after French pharmaceutical company Sanofi Pasteur, Dengvaxia’s manufacturer, issued a belated advisory that the vaccine may lead to more severe symptoms of dengue for patients who have never been infected by the virus prior to vaccination.
This prompted the Department of Health (DoH) to stop the school-based dengue immunization program that was enforced under the previous administration. Several criminal complaints in connection with deaths supposedly linked to Dengvaxia have been filed by the Public Attorney’s Office.
Last week, Washington Post reported that Sinovac was about to run clinical trials of a SARS vaccine and a swine flu vaccine in 2003 and 2009, respectively, when the bribery charges were made.
The company’s CEO admitted to giving more than $83,000 to a regulatory official from 2002 to 2011. In return, Sinovac’s vaccine certifications were reportedly expedited. Sinovac is one of the dozen or so companies that have already reached Phase 3 clinical trials.
Palace spokesman Harry Roque Jr. had said Duterte was confident that the FDA would be able to perform its functions properly amid the allegations against Sinovac.
‘Too early to celebrate’
Sen. Christopher Lawrence “Bong” Go said it was “too early to celebrate” the holiday season without risking the spread of Covid-19 to oneself and one’s loved ones.
In a radio interview last Thursday, Go said the initial success in controlling the outbreak was made possible by people’s commitment to act responsibly by following the health and safety protocols issued by the government, which includes social distancing.
On Saturday, the DoH recorded 1,301 new Covid-19 infections, for a total of 448,331 cases, 30,168 of which are active.
There were 111 new recoveries recorded for a total of 409,433 survivors. The death toll increased to 8,730, including the 35 fatalities that were tallied on Saturday.
The Philippine government is eyeing to inoculate around 24.7 million Filipinos in the first part of the vaccination program.
Some 1.76 million health workers are first on the list of priority beneficiaries, followed by senior citizens, indigent Filipinos and uniformed personnel.
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.
