New Delhi: The Pune-based Serum Institute of India (SII) — one of the world’s largest manufacturers of vaccines — has reached out to the Drug Controller General of India (DCGI), highlighting the difficulties it is facing in continuing clinical trials of non-Covid-19 vaccines, ThePrint has learnt.
The company, which produces 1.5 billion doses of vaccines annually, has highlighted difficulties in continuing clinical trials for at least three of its non-Covid vaccines due to the pandemic.
The company has told the DCGI, the apex body that approves vaccines and their clinical trials in India, about difficulties in conducting trials on Tdap (Tetanus, Diphtheria and Pertussis) vaccine, Hexavalent vaccine and Quadrivalent Human Papillomavirus Vaccine (HPV). Hexavalent vaccine, as the name suggests, gives immunity against six diseases, whereas HPV protects against various cancers, including cervical cancer.
“The firm presented the difficulties in continuing the clinical trial due to the prevailing Covid-19 pandemic and also presented proposed amendment in Phase II/III clinical trial… in already enrolled subjects,” according to the minutes of the meeting of the Subject Expert Committee (SEC), accessed by ThePrint. The SEC has been appointed by the DCGI to review proposals related to clinical trials and advise the regulator on them.
The meeting was held on 6 July and the DCGI has granted the “proposed amendments”.
The SII is among the top companies in the world working on three vaccine candidates for Covid-19. It is working on vaccine candidates developed by the University of Oxford, US-based Codagenix and Austrian biotech firm, Themis.
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What are the difficulties?
Adar Poonawalla, chief executive officer of the SII, told ThePrint: “Due to Covid-19 pandemic, the hospital authorities have restricted clinical trial activities affecting new enrollment of subjects in clinical trials.”
“Also, some of the hospitals have started Covid wards or have become Covid hospitals, thus affecting the enrollment of subjects in the ongoing clinical trials,” he added.
Poonawalla, who is also the president of Indian Vaccine Manufacturers’ Association, said: “Due to Covid-19 pandemic, parents or subjects are scared to come for further follow-up visits.”
He added, “The subsequent dosing of the enrolled subjects has been delayed, thus having an impact on the vaccination schedule given in the protocol. Moreover, follow-up visits for vaccination, safety assessment as well as blood withdrawal are delayed.”
What can be done to avoid delay?
Poonawalla said that “fear psychosis about visiting hospitals should be removed” to avoid delay in trials of non-Covid vaccines.
“People should be encouraged to take part in trials. Hospital authorities should be encouraged to continue routine clinical trials and give adequate support for them. Regulators should adopt a flexible approach,” he said.
Poonawalla also said it’s not only the SII, but “all companies (vaccine makers) must be facing the same issues, not just in India but everywhere in the world”.
What has the government suggested?
Poonawalla told ThePrint the government is “fully cognisant about the ground reality and have been very supportive”.
The DCGI committee has reviewed the company’s challenges and granted the “extension of window period for follow-up visits”, among other changes requested in the designed protocol, he said.
According to the minutes of the meeting, “after detailed deliberation, the committee recommended for grant of approval for proposed amendments with respect to the subjects already enrolled in the study”.
It has also advised the company that “further subject recruitment should be carried out after assessing the feasibility of conducting and continuing the study due to the prevailing Covid situation”.
It also said: “The statistical evaluation of the subjects who are continuing in the study after the delayed vaccination should be presented separately.”
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30 new coronavirus cases confirmed in Simcoe Muskoka, local total reaches 1,983 – Global News
The Simcoe Muskoka District Health Unit confirmed 30 new novel coronavirus on Thursday, bringing the local total number of cases up to 1,983, including 52 deaths.
Fourteen of the new cases are in Barrie, while six are in New Tecumseth, three are in Bradford and two are in Springwater.
The rest are in Collingwood, Essa, Innisfil and Tiny Township.
Twelve of the new cases are a result of close contact with another positive COVID-19 case, while seven are community-acquired. Two of the new cases are related to an educational setting outbreak, while on is travel-related.
The rest of the new cases are all under investigation.
This week, the health unit has reported 149 new coronavirus cases.
Last week, there were 200 new COVID-19 cases in the region, marking the highest number of cases reported in a single week since the start of the pandemic.
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Of the region’s total 1,983 coronavirus cases, 87 per cent — or 1,717 — have recovered, while 13 people remain in hospital.
There are 13 total COVID-19 outbreaks in the region — at four schools, two long-term care facilities, two congregate settings, two workplaces, one retirement home and two community settings.
The school outbreaks are at St. Joan of Arc Catholic High School, Willow Landing Elementary School and Warnica Public School, all of which are in Barrie, as well as Nottawasaga Pines Secondary School in Angus.
There has been 61 outbreaks in Simcoe Muskoka since the start of the pandemic — at 20 long-term care facilities, 14 workplaces, 10 retirement homes, eight educational settings, six congregate settings and three community settings.
According to the province of Ontario, 14 schools under the public Simcoe County school board and the Catholic Simcoe Muskoka school board are reporting at least one case of COVID-19.
The affected schools are:
- Warnica Public School in Barrie
- Innisdale Secondary School in Barrie
- Monsignor Clair Catholic School in Barrie
- St. Joseph’s Catholic School in Barrie
- Willow Landing Elementary School in Barrie
- St. Joan of Arc Catholic High School in Barrie
- Bradford District High School
- Fieldcrest Elementary School in Bradford
- Nottawasaga Pines Secondary School in Essa
- Our Lady of Grace School in Essa
- Boyne River Public School in New Tecumseth
- St. Paul’s Catholic School in New Tecumseth
- Holy Family Catholic School in New Tecumseth
- Nantyr Shores Secondary School in Innisfil
On Thursday, Ontario reported 1,373 new coronavirus cases, bringing the provincial total to 107,883, including 3,554 deaths.
© 2020 Global News, a division of Corus Entertainment Inc.
Health unit reports 29 new COVID cases in Simcoe County today – OrilliaMatters
The Simcoe Muskoka District Health Unit is reporting 30 new COVID-19 cases in the region today, at least 29 of which are Simcoe County residents.
Almost half of the new cases reported today are Barrie residents with 14 new cases in the city.
Of those 14 cases, nine are between the ages of 18 and 34 (one female and eight males). The transmission source is reported as close contact for five of those cases, one community-acquired, and one travel. The rest are still under investigation.
The remaining five Barrie cases include a woman between 35 and 44 years old, and two women and two men between 45 and 64 years old. The transmission sources for those cases include three community-acquired, one close contact, and one under investigation.
The health unit is also tracking a community setting outbreak in Barrie involving a hockey team. There are at least eight positive cases linked to the outbreak.
There are three new cases in Bradford West Gwillimbury, all linked to close contact. The cases include two men between 45 and 64 years old and a woman over the age of 80.
Among the new cases is a Collingwood man aged 65 to 79 years old. His case transmission is still under investigation. This is the fifth local case since Nov. 20, and the other four cases have been linked to close contact or community transmission.
There is also one new case in Innisfil today, a woman between 65 and 79 years old, and it remains under investigation.
There are two new cases in Springwater, including a boy under 18 and a man between 35 and 44 years old. The boy’s case is linked to close contact and the man’s case is linked to an educational setting outbreak.
There are six new cases in New Tecumseth, including one woman and two men between 18 and 34 years old, a man between 35 and 44 years old, and a woman and a man between 45 and 64 years old. The case transmission sources include two close contact, one community-acquired, and one linked to an educational setting outbreak out of the region. The remaining cases are under investigation.
The health unit has confirmed one new case in Tiny, a man between 18 and 34 years old, which is reported as community-acquired.
There is one new case in Essa today, a man between 18 and 34 years old, which is reported as community-acquired.
Lastly, the health unit has reported one case, a man between 35 and 44, whose transmission source and location information is still pending.
The Simcoe Muskoka District Health Unit has reported a total of 1,983 cases of COVID-19, with 1,891 of those in Simcoe County. There are 1,717 cases listed as recovered in the region. Thirteen people are currently hospitalized, all are Simcoe County residents. The health unit has confirmed 52 deaths since March.
The incidence rate for Simcoe County is 358 cases per 100,000 people. With a seven-day average of 29.2 cases per 100,000 people in a week. The region’s reproductive rate shows every person who contracts COVID-19 transmits it to 1.1 other people, and testing data shows 2.1 per cent of people who are tested in the region test positive for COVID-19.
|Municipality||Total cases**||Recoveries||Deaths||In Hospital||Last case reported||Incidence rate*|
|Bradford W-G||347||300||12||1||Nov. 26||808|
|New Tecumseth||337||289||12||1||Nov. 26||813|
|Wasaga Beach||35||31||1||Nov. 23||152|
|Georgian Bay||9||8||Nov. 24||319|
*Incidence rate is number of cases per 100,000 people in the local population.
**Total cases includes the number of cases currently recovering at home as well as any that have recovered, died, or are in hospital
Another record-breaking COVID-19 update: B.C. adds 887 cases, 13 deaths – CTV News Vancouver
British Columbia added 887 cases of COVID-19 to its total on Thursday, setting a new daily record for the province.
Health officials also announced 13 deaths in their written statement on B.C.’s response to the disease. That ties the record set on Wednesday.
“We offer our condolences to everyone who has lost their loved ones during the COVID-19 pandemic,” said provincial health officer Dr. Bonnie Henry and Health Minister Adrian Dix in their statement.
The province has now seen 29,973 cases and 384 deaths since the pandemic began.
As of Thursday, there are 7,899 active cases of the coronavirus in B.C., which is also a record. That total includes 294 people who are hospitalized, 64 of whom are in intensive care.
The update comes the day after health officials revised several previous reports on B.C.’s COVID-19 caseload because of technical errors in the Fraser Health region.
The province had previously announced 941 new cases on Tuesday, which was a record, but some of those cases actually should have been reported earlier in the month.
The changes meant B.C.’s record for new cases in a day was actually 835, which should have been the total reported for Saturday, Nov. 21. B.C. initially reported 713 for that day.
In Thursday’s update, Dix and Henry also announced two new outbreaks of COVID-19 at health-care facilities – at Royal Ascot Care Centre in Vancouver and Amica White Rock.
Three other outbreaks – at Hamlets at Westsyde in Kamloops, Peace Portal Seniors Village in Surrey and Village by the Station in Penticton – are over, the health officials said.
“Slow and steady is what we need with COVID-19 and it is how we will get through this second wave,” Henry and Dix said. “The efforts we make each day make a difference.”
The pair repeated their request that British Columbians do what they can to help public health teams do their jobs. Those teams are currently following up regularly with 10,307 people who have been exposed to confirmed cases of COVID-19.
“Exposures and transmission can happen anywhere,” Dix and Henry said. “By paying attention to the places we go and the people we see, we can help contact tracers contain the further spread if that does occur.”
Most of Thursday’s new cases are located in the Fraser Health region, where 612 infections have been confirmed in the last 24 hours. Vancouver Coastal Health has recorded 168 cases in that time.
Elsewhere in B.C., there have been 65 cases in Interior Health, 24 in Northern Health and 18 in Island Health.
Nearly 20,000 people – 19,998 as of Thursday – who have tested positive for COVID-19 in B.C. are now considered recovered.
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