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Political setbacks curb development of next-generation Covid vaccines

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A lack of funding and political will is hampering efforts to develop the next generation of vaccines that could protect millions of people from emerging new pathogens, experts have warned.

The next wave of vaccines is intended to improve on the Covid-19 jabs rolled out in late 2020 by offering longer-lasting or broader protection against a variety of variants and, potentially, other coronaviruses. The focus is on alternative products such as nasal sprays, inhalers and tablets, making them easier to administer, manufacture or distribute.

But the sense of urgency from politicians and policymakers that propelled the swift development of the first Covid-19 vaccines is not being replicated. Critics blame a mixture of public apathy, disputes over funding and the politicisation of the pandemic response.

US president Joe Biden’s declaration last month that “the pandemic is over” wiped more than $10bn off the value of Covid-19 vaccine manufacturers, undermining the chance of breakthroughs at a time when low uptake of booster jabs and waning immunity are pushing up infection rates.

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“The politics of Covid really impacts research all the way from funding availability to access to vaccines [for research purposes] and general public sentiment,” said Akiko Iwasaki, professor of immunobiology at Yale School of Medicine. “If you hear enough times that Covid is over, no one’s going to want to pursue the next-generation vaccines.”

Anthony Fauci warned that failure to approve new funding to fight Covid-19 could delay development of several promising vaccine candidates © Greg Nash/Bloomberg

A Yale team led by Iwasaki is developing a Covid-19 booster that is sprayed directly into the nose. Initial studies in mice produced encouraging results. But the huge cost of conducting clinical trials and regulatory hurdles are slowing progress on such projects, according to Iwasaki, who urges government intervention to break the logjam.

In the US, that seems to be a distant prospect. In early October, Congress blocked a request by the Biden administration for an extra $22.4bn to fight Covid-19. Biden’s chief medical adviser, Dr Anthony Fauci, has warned that failure to approve new funding could delay development of several promising vaccine candidates, which would otherwise be ready for large clinical trials within a year.

“If you really want to get into larger clinical trials of candidates, when you partner with industry . . . I cannot do that unless I do get resources from Congress,” he said.

Richard Hatchett, chief executive of the Coalition for Epidemic Preparedness Innovations, said his organisation had allocated about $200mn to support research into more broadly protective vaccines against a range of coronaviruses, while the US’s National Institutes of Health had earmarked $36.3mn.

However, he said it was “very surprising and disappointing” that “there isn’t a more concerted global effort to support that work. We aren’t seeing similarly scaled investments from the UK, the [European Commission], Japan and others”.

While it was “undeniable that most countries have moved into a different phase of their coexistence with the virus”, Hackett added that “there’s nothing to say that Sars-Cov-2, which has demonstrated its tremendous evolutionary potential on multiple occasions already, couldn’t mutate further to become more virulent or resistant to the vaccines we have”.

Some countries including Japan as well as the EU have set up bodies to strengthen their capacity to anticipate, and respond to, future threats, but Hatchett said more urgent action was needed to develop advanced vaccines.

Dame Kate Bingham
Dame Kate Bingham, who led the UK’s Vaccine Task Force for 7 months, says the UKHSA ‘doesn’t seem to have any power or money or accountability to engage with innovators’ © Charlie Bibby/FT

The commission said Horizon Europe, the EU’s research and innovation programme, had set aside funding of up to €40mn in 2022 for developing next-generation vaccines; research proposals were currently “under evaluation”, it said, declining to reveal further details. The earlier Horizon 2020 programme is also contributing €100mn to CEPI to support work on Covid-19 vaccines. A portion of this money may be allocated to the development of a broadly protective coronavirus vaccine candidate as part of the coalition’s $200mn programme.

The UK has sought to position itself at the forefront of vaccine development. In June, the government struck a deal with Massachusetts-based Moderna to build a UK research and manufacturing centre. A research facility opened by the Health Security Agency in February at Porton Down in Wiltshire has already been “crucial in testing their effectiveness” of new vaccines that attack two or more strains of coronavirus, said Dr Bassam Hallis, its deputy director of research and evaluation.

However, officials instrumental in the initial pandemic vaccine response suggested the political leadership and focus that characterised the first phase may have dissipated. Dame Kate Bingham, who led the UK’s Vaccines Task Force (VTF) for seven months from its formation in May 2020, was directly appointed by then prime minister Boris Johnson.

“The sense of urgency and fear in 2020 was completely different. The fact that they were willing to bring in a group from the outside, and allow me to hire a team . . . is quite unlike what government has usually done,” said Bingham.

Dr Eric Topol
Dr Eric Topol says the Biden administration had failed to confront the Republicans over their failure to approve new funding © Kirsty O’Connor/PA

The UK’s business department has handed the vaccine development portfolio to the UKHSA, with former VTF executive Philippa Harvey leading the vaccines unit. Bingham suggested the agency “doesn’t seem to have any power or money or accountability to engage with innovators”. She and her team had been “able to go to academics or companies, and say, ‘we’d like to work with you and we have the budget to do so’,” she added.

The UKHSA said it would continue “to work closely with vaccine developers, experts and academia” on early detection and response initiatives.

Back in the US, Eric Topol, founder of the Scripps Research Translational Institute, said the Biden administration had failed to confront the Republicans over their failure to approve new funding.

He added that, on some measures, the US had been overtaken by India and China, which had approved nasal and oral vaccines. India’s Bharat Biotech this month said it had received approval for emergency use of its two-dose nasal vaccine for use by people aged 18 years and over.

“You’ve got to pursue all paths to take control of the pandemic, get ahead of it and contain the virus,” said Topol. “That is not being done.”

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B.C. promises weekly updates on flu deaths as 6 children confirmed dead this fall – CBC.ca

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B.C.’s provincial health officer is promising weekly updates on the number of children who’ve died after contracting influenza following confirmation that six deaths have already been reported so far this fall.

Dr. Bonnie Henry said the deaths this year include one child under the age of five, three between the ages of five and nine and two teenagers between the ages of 15 and 19.

“My thoughts are with families and communities impacted by the loss of a loved one,” Henry said in a statement.

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“Early findings indicate some of the children experienced secondary bacterial infections contributing to severe illness, which can be a complication of influenza.”

She added that deaths have been rare in “previously healthy children” and that infants and toddlers, children with chronic medical conditions, kids who need to take Aspirin or ASA for long periods of time and very obese children are most at risk.

“Parents of all children should seek care if your child experiences difficulty breathing or if your child’s fever goes away and comes back or persists longer than five days. This may indicate a possible bacterial infection,” Henry said.

She described the flu season so far as an “unusual season with unusual characteristics,” including an early and serious surge in cases. As a result, the B.C. Centre for Disease Control will be posting weekly updates on pediatric flu-related deaths on its website.

B.C. health officials have urged parents to have children vaccinated against the flu, citing a “dramatic increase” in cases of influenza A, a strain which can cause severe illness in children. 

Historical data provided by the B.C. Coroners Service showed the number of deaths this year to be well above previous flu seasons before the COVID-19 pandemic. 

Between 2015 and 2019, B.C. recorded two to three influenza-related deaths in people aged 18 or younger annually. In 2020, the province recorded one death, while none were recorded in 2021.

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At least five B.C. children died from influenza last month, as mortalities spike

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At least five children died last month in British Columbia from influenza as a rise of early season respiratory illnesses added strain to the beleaguered healthcare system.

The figure marks a departure from the average of two to three annual flu deaths among children in the province between 2015 and 2019, data from the BC Coroners Service shows.

“Public health is monitoring the situation closely and is reminding people of the steps they can take to protect themselves, their children and their loved ones against the flu,” the B.C. Centre for Disease Control said in a statement.

“It is important to know that death associated with influenza in previously healthy children continues to be rare.”

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The centre said it is aware of a sixth reported flu death among children and youth under 19, but it was not immediately clear why the sixth wasn’t included in the coroners’ figures.

Provincial Health Officer Dr. Bonnie Henry said the children who died included one who was younger than five years old, three who were between five and nine, and two adolescents who were between 15 and 19.

“Early findings indicate some of the children experienced secondary bacterial infections contributing to severe illness, which can be a complication of influenza,” Henry said in a statement Thursday.

The deaths in British Columbia suggest figures could tick up across the country given the common challenges facing health systems this respiratory season. Alberta has also recorded the deaths of two children with influenza so far this season.

Before the COVID-19 pandemic, an average of five to six kids died per flu season across Canada, data collected from 12 hospitals across the country shows.

The national data was collected between 2010 and 2019 by IMPACT, a national surveillance network administered by the Canadian Paediatric Association. It was included in a research paper published in March in “The Lancet Regional Health — Americas” journal that also found no deaths from the flu among children in either 2020 or 2021.

No one from either IMPACT or the B.C. Centre for Disease Control was immediately available for an interview.

On Monday, Henry said that after two years of low flu rates, mostly due to COVID-19 pandemic restrictions, the province is seeing a “dramatic increase” in illness and it arrived sooner than normal.

She urged parents to get their children vaccinated against the flu.

On Thursday, British Columbia’s Health Ministry announced a “blitz” of walk-in flu clinics that will open across the province Friday through Sunday. Flu vaccines are free to all kids aged six months and older in B.C.

The B.C. Centre for Disease Control said getting the shot is particularly important for those at risk of severe outcomes, including those with chronic medical conditions like heart, lung, kidney or liver disorders and diseases, those with conditions that cause difficulty breathing or swallowing, those who need to take Aspirin for long periods of time and those who are very obese.

The BC Coroners Service said its data is preliminary and subject to change while investigations are completed.

The cases include those where influenza was identified as an immediate, pre-existing or underlying cause of death, or as a significant condition.

Henry said updates on pediatric influenza-related deaths will be posted weekly as part of the respiratory surveillance summaries on the B.C. Centre for Disease Control website.

This report by The Canadian Press was first published Dec. 8, 2022.

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Cough and cold medication shortage to end next year, pharmacists association says – The Daily Press

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Children’s Tylenol returning slowly to retail outlets in town

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Parents with sick kids might be able to take a break from crushing adult Tylenol and mixing it with apple sauce if they hurry quickly to a local pharmacy.

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Children’s Tylenol (acetaminophen) in liquid form began arriving at retail outlets in late November, but in such limited quantities that pharmacists are keeping them behind the counter and limiting them to one bottle per customer.

A Shopper’s Drug Mart pharmacist The Daily Press spoke with on Tuesday wouldn’t say how much they’d received but advised to hurry while quantities last. A Rexall pharmacist is only selling children’s Tylenol to parents with sick kids, not to those just preparing for a rainy day.

Adam Chappell, owner and pharmacist at Parma Right in The 101 Mall, told The Daily Press he was expecting nine retail-sized bottles of children’s Tylenol last Wednesday, which he also planned to keep behind the counter and limit to one bottle per customer.

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He predicts that more will become available, but that there will be extended shortages in the short term. Pharmacies are being allocated small amounts by the manufacturers, to spread out supply.

The shortage makes it difficult for parents to control fevers in their children, leading to more doctor visits, he said.

“We had more public health measures in place with COVID, so we had 1½ to two years where we really didn’t see much influenza or common cold,” said Chappell, whose independent pharmacy opened in November.

“So now we’re seeing everything all at once because we’re now socializing more. It’s that time of year, so we’re starting to see more influenza, cough and colds and COVID is still circulating. I think it’s a combination of higher use and some lingering logistical issues.”

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Shelves sit half empty in the adult cough and cold section at the Shopper’s Drug Mart at 227 Algonquin Blvd. E. on Tuesday. The shortage is expected to end between January and March of 2023, said Jen Belcher with the Pharmacists Association of Ontario. The timing would coincide with the end of the cold and flu season.NICOLE STOFFMAN/The Daily Press
Shelves sit half empty in the adult cough and cold section at the Shopper’s Drug Mart at 227 Algonquin Blvd. E. on Tuesday. The shortage is expected to end between January and March of 2023, said Jen Belcher with the Pharmacists Association of Ontario. The timing would coincide with the end of the cold and flu season.NICOLE STOFFMAN/The Daily Press jpg, TD

A children’s drug shortage began in the spring and worsened in the summer when an early onset of flu and respiratory syncytial virus was made worse by COVID-19, which presents as a cold. Parents began stocking up.

When local manufacturers could not keep up with demand, Health Canada arranged to import supply from the United States and Australia, whose first shipment in early November went straight to hospitals, in part because the labels were not bilingual, Postmedia reported.

Health Canada has authorized 500,000 bottles of imported children’s acetaminophen for retail to arrive in December, and domestic supply is starting to recover, Jen Belcher with the Ontario Pharmacists Association told The Daily Press in a telephone interview.

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“The demand really hasn’t abated, and manufacturing really hasn’t been able to keep up from a straight capacity standpoint, rather than a supply interruption with a lack of ingredients,” she said, when asked to respond to a claim by the German pharmacist’s association.

That organization asserts pandemic lockdowns in China are blocking exports of the raw ingredients used for medications, Postmedia reported Nov. 16.

If lockdowns in China continue, however, she conceded it could interrupt the ingredient supply in the long-term.  There is also a global reliance on India for the raw ingredients used in over-the-counter medication.

Canadian manufacturers can tap various international suppliers if approved by Health Canada, Belcher said.

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Children’s Advil (ibuprofen), an anti-inflammatory, continues to be in short supply in pharmacies, but available in hospital. Neither Belcher nor Chappell has heard reports of Health Canada planning to import it for retail outlets.

Adult Tylenol and Advil remain plentiful.

Chappell recommends that parents speak to their pharmacist to determine a dosage of adult pills based on the child’s weight and symptoms. They can be crushed and added to yogurt, apple sauce or chocolate syrup.

If parents can wait a few days for the package to arrive, they can order a supply for their child from a compounding pharmacist, who is qualified to make custom medications including liquid formulations. There are several compounding pharmacists in Sudbury, but none in Timmins.

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Adults in Timmins who have come down with a cold or flu lately may also have been surprised to see empty shelves in the adult cough and cold section of their local pharmacy.

“When it comes to cough and cold medication for both adults and children, we’re not seeing an imported supply of those. Those are short and have been for quite some time due to this high level of demand, small amounts have been trickling through the supply chain but it hasn’t been enough to keep up with demand,” said Belcher.

She expects the adult cough and cold medication shortage to end sometime between January and March, 2023, just in time for the end of flu season.

A quick check of the adult cough and cold section of four downtown pharmacies on Tuesday showed partially empty shelves, but there was still a variety of medication to choose from.

Belcher said pharmacists have lots of experience finding alternatives for patients, if necessary.

“While the over-the-counter medications in short supply are the most visible representation of the challenges to our supply chain, pharmacy teams have been managing very high levels of drug shortages, some critical, where there are really few or no alternative options,” she said, adding that up to 20 per cent of the team’s day is spent managing shortages.

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