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Serum Institute tells Modi govt how pandemic is affecting clinical trials of non-Covid drugs – ThePrint

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Serum Institute of India produces 1.5 billion doses of vaccines annually | Twitter | @SerumInstIndia

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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.

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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.


Also read: ICMR Covid vaccine trial protocol unclear, not enough time, say scientists tasked with job

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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.”


Also read: All you need to know about CanSino’s Covid vaccine approved for military use in China


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Kevin Neil Friesen Obituary 2024 – Crossings Funeral Care

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It is with heavy hearts that we announce the peaceful passing of Kevin Neil Friesen age 53 on Thursday, March 28, 2024 at the Bethesda Regional Health Centre.

A funeral service will be held at 2:00 pm on Thursday, April 4, 2024 at the Bothwell Christian Fellowship Church, with viewing one hour prior to the service.

A longer notice to follow.  

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Spring allergies: Where is it worse in Canada? – CTV News

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The spring allergy season has started early in many parts of Canada, with high levels of pollen in some cities such as Toronto, Ottawa and Montreal.

Daniel Coates, director of Aerobiology Research Laboratories in Ottawa, expects the elevated amounts to continue next week for places, such as most of Ontario, if the temperature continues to rise. Aerobiology creates allergen forecasts based on data it collects from the air on various pollens and mould spores.

Pollens are fertilizing fine powder from certain plants such as trees, grass and weeds. They contain a protein that irritates allergy sufferers.

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Although pollen levels declined after a cold spell in some places, he said they are soaring again across parts of Canada.

“So the worst is definitely British Columbia right now, followed by Ontario and Quebec and then the Prairies and Atlantic Canada for the upcoming weeks,” said Coates in a video interview with CTVNews.ca. “We are seeing pollen pretty much everywhere, including the Maritimes.”

He said pollen has increased over the past 20 years largely due to longer periods of warm weather in Canada.

Meanwhile, the Maritimes is one of the best places to live in Canada if you have seasonal allergies, in part because of its rocky territory, Coates said.

With high levels of cedar and birch pollen, British Columbia is the worst place for allergy sufferers in Canada, he added.

“British Columbia is going strong,” Coates explained, noting the allergy season started “very early” in the province in late January. “It has been going strong since late January, early February and it’s progressing with high levels of pollen, mostly cedar, but birch as well, and birch is highly allergenic.”

Causes of high pollen levels

Coates expects a longer allergy season if the warm weather persists. He notes pollen is increasing in Canada and worldwide, adding that in some cases the allergy season is starting earlier and lasting longer than 15 years ago.

He says tree pollen produced last year is now being released into the air because of warmer weather.

“Mother nature acts like a business,” he said. “So you have cyclical periods where things go up and down. … So when it cooled down a little bit, we saw (pollen) reduce in its levels, but now it’s going to start spiking.”

Along with warmer weather, another factor in higher pollen levels is people planting more male trees in urban areas because they don’t produce flowers and fruits and are less messy as a result, he said. But male trees produce pollen while female ones mostly do not.

Moulds

Coates said moulds aren’t as much of a problem.

“They’ve been mainly at lower levels so far this season,” he explained. “Moulds aren’t as bad in many areas of Canada, but they’re really, really bad in British Columbia.”

In B.C., moulds are worse because of its wet climate and many forested areas, he said.

Coping with allergies

Dr. Blossom Bitting, a naturopathic doctor and herbal medicine expert who works for St. Francis Herb Farm, says a healthy immune system is important to deal with seasonal allergies.

“More from a holistic point of view, we want to keep our immune system strong,” she said in a video interview with CTVNews.ca from Shediac, N.B. “Some would argue allergies are an overactive immune system.”

Bitting said ways to balance and strengthen the immune system include managing stress levels and getting seven to nine hours of restful sleep. “There is some research that shows that higher amounts of emotional stress can also contribute to how much your allergies react to the pollen triggers,” Bitting said.

Eating well by eating more whole foods and less processed foods along with exercising are also important, she added. She recommends foods high in Omega-3 Fatty Acids such as flaxseeds, flaxseed oil, walnuts and fish. Fermented foods with probiotics such as yogurt, kimchi and miso, rather than pasteurized ones, can keep the gut healthy, she added. Plant medicines or herbs such as astragalus, reishi mushrooms, stinging nettle and schisandra can help bodies adapt to stressors, help balance immune systems or stabilize allergic reactions, she said.

To cope with allergies, she recommends doing the following to reduce exposure to pollen:

  • Wear sunglasses to get less pollen into the eyes;
  • Wash outdoor clothes frequently, use outer layers for outside and remove them when you go inside the house;
  • Use air purifiers such as with HEPA (high efficiency particulate air) filters;
  • Wash pets and children after they go outside;
  • Keep the window closed on days with high pollen counts.

Mariam Hanna, a pediatric allergist, clinical immunologist and associate professor with McMaster University in Hamilton, Ont., says immunotherapy can help patients retrain their bodies by working with an allergist so they become more tolerant to pollens and have fewer symptoms.

“Some patients will need medications like over-the-counter antihistamines or speaking with their doctor about the right types of medications to help with symptom control,” she said in a video interview with CTVNews.ca.

Coates recommends people check pollen forecasts and decrease their exposure to pollen since no cure exists for allergies. “The best is knowing what’s in the air so that you can adjust your schedules, or whatever you’re doing, around the pollen levels.”

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Do you need a spring COVID-19 vaccine? Research backs extra round for high-risk groups

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Recent studies suggest staying up-to-date on COVID shots helps protect high-risk groups from severe illness

New guidelines suggest certain high-risk groups could benefit from having another dose of a COVID-19 vaccine this spring — and more frequent shots in general — while the broader population could be entering once-a-year territory, much like an annual flu shot.

Medical experts told CBC News that falling behind on the latest shots can come with health risks, particularly for individuals who are older or immunocompromised.

Even when the risk of infection starts to increase, the vaccines still do a really good job at decreasing risk of severe disease, said McMaster University researcher and immunologist Matthew Miller.

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Who needs another COVID shot?

Back in January, Canada’s national vaccine advisory body set the stage for another round of spring vaccinations. In a statement (new window), the National Advisory Committee on Immunization (NACI) stated that starting in spring 2024, individuals at an increased risk of severe COVID may get an extra dose of the latest XBB.1.5-based vaccines, which better protect against circulating virus variants.

That means:

  • Adults aged 65 and up.
  • Adult residents of long-term care homes and other congregate living settings for seniors.
  • Anyone six months of age or older who is moderately to severely immunocompromised.

The various spring recommendations don’t focus on pregnancy, despite research (new window) showing clear links between a COVID infection while pregnant, and increased health risks. However, federal guidance does note that getting vaccinated during pregnancy can protect against serious outcomes.

Vaccinated people can also pass antibodies to their baby through the placenta and through breastmilk, that guidance states (new window).

What do the provinces now recommend?

Multiple provinces have started rolling out their own regional guidance based on those early recommendations — with a focus on allowing similar high-risk groups to get another round of vaccinations.

B.C. is set to announce guidance on spring COVID vaccines in early April, officials told CBC News, and those recommendations are expected to align with NACI’s guidance.

In Manitoba (new window), high-risk individuals are already eligible for another dose, provided it’s been at least three months since their latest COVID vaccine.

Meanwhile Ontario’s latest guidance (new window), released on March 21, stresses that high-risk individuals may get an extra dose during a vaccine campaign set to run between April and June. Eligibility will involve waiting six months after someone’s last dose or COVID infection.

Having a spring dose is particularly important for individuals at increased risk of severe illness from COVID-19 who did not receive a dose during the Fall 2023 program, the guidance notes.

And in Nova Scotia (new window), the spring campaign will run from March 25 to May 31, also allowing high-risk individuals to get another dose.

Specific eligibility criteria vary slightly from province-to-province, so Canadians should check with their primary care provider, pharmacist or local public health team for exact guidelines in each area.

WATCH: Age still best determines when to get next COVID vaccine dose, research suggests:

 

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Age still best determines when to get COVID vaccines, new research suggests

It’s been four years since COVID-19 was declared a pandemic, and new research suggests your age may determine how often you should get a booster shot.

Why do the guidelines focus so much on age?

The rationale behind the latest spring guidelines, Miller said, is that someone’s age remains one of the greatest risk factors associated with severe COVID outcomes, including hospitalization, intensive care admission and death.

So that risk starts to shoot up at about 50, but really takes off in individuals over the age of 75, he noted.

Canadian data (new window) suggests the overwhelming majority of COVID deaths have been among older adults, with nearly 60 per cent of deaths among those aged 80 or older, and roughly 20 per cent among those aged 70 to 79.

People with compromised immune systems or serious medical conditions are also more vulnerable, Miller added.

Will people always need regular COVID shots?

While the general population may not require shots as frequently as higher-risk groups, Miller said it’s unlikely there will be recommendations any time soon to have a COVID shot less than once a year, given ongoing uncertainty about COVID’s trajectory.

Going forward, I suspect for pragmatic reasons, [COVID vaccinations] will dovetail with seasonal flu vaccine campaigns, just because it makes the implementation much more straightforward, Miller said.

And although we haven’t seen really strong seasonal trends with SARS-CoV-2 now, I suspect we’ll get to a place where it’s more seasonal than it has been.

In the meantime, the guidance around COVID shots remains simple at its core: Whenever you’re eligible to get another dose — whether that’s once or twice a year — you might as well do it.

What does research say?

One analysis, published in early March in the medical journal Lancet Infectious Diseases (new window), studied more than 27,000 U.S. patients who tested positive for SARS-CoV-2, the virus behind COVID, between September and December 2023.

The team found individuals who had an updated vaccine reduced their risk of severe illness by close to a third — and the difference was more noticeable in older and immunocompromised individuals.

Another American research team from Stanford University recently shared the results from a modelling simulation looking at the ideal frequency for COVID vaccines.

The study in Nature Communications (new window) suggests that for individuals aged 75 and up, having an annual COVID shot could reduce severe infections from an estimated 1,400 cases per 100,000 people to around 1,200 cases — while bumping to twice a year could cut those cases even further, down to 1,000.

For younger, healthier populations, however, the benefit of regular shots against severe illness was more modest.

The outcome wasn’t a surprise to Stanford researcher Dr. Nathan Lo, an infectious diseases specialist, since old age has consistently been a risk factor for severe COVID.

It’s almost the same pattern that’s been present the entire pandemic, he said. And I think that’s quite striking.

More frequent vaccination won’t prevent all serious infections, he added, or perhaps even a majority of those infections, which highlights the need for ongoing mitigation efforts.

Lauren Pelley (new window) · CBC News

 

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