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With Trump promising a COVID-19 vaccine 'very soon,' industry developers pledge to keep politics out of science – USA TODAY

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The heads of nine biopharmaceutical companies issued a letter early Tuesday pledging to fully vet their COVID-19 candidate vaccines before asking for federal approval to market them. 

“We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles,” the statement said.

The statement comes amid increasing concern among public health officials, scientists and doctors that the White House might bring significant political pressure to bear on the Food and Drug Administration to get a vaccine before the Nov. 3 presidential election.

All nine companies are individually or jointly developing a candidate COVID-19 vaccine supported at least in part with federal dollars, which so far amounts to more than $10 billion. They are: AstraZeneca, Johnson & Johnson, Moderna Inc., Novavax Inc., Merck, Sanofi and GlaxoSmithKline, and Pfizer Inc, which is developing a vaccine with BioNTech, another signatory.

‘Mind-boggingly complex’: What we know about how COVID-19 vaccine will be distributed when it’s approved

A widely-used vaccine will be essential for bringing the COVID-19 pandemic under control. Industry officials are worried that the current political climate is tarnishing the process and will make people more hesitant to get a vaccine when there is one.  

The leadership of the industry group Biotechnology Innovation Organization, or BIO, issued a similar statement late last week, calling for a testing process “conducted according to best practices to assure credibility of the data, as well as the ethical participation of a diverse population of subjects.” The BIO statement also called on the U.S. Food and Drug Administration to “maintain its historic independence as the gold-standard international regulatory body, free from external influence.”

The industry promise to stick to scientific principles and keep politics out of the approval process comes after a few weeks in which President Donald Trump repeatedly emphasized that a vaccine would likely be ready for public use before the Nov. 3 election.

At a White House news conference Monday, Trump said a vaccine “will be very safe and very effective, and it will be delivered very soon.” He added, “could even have it during the month of October.”

Why volunteer for a vaccine clinical trial? Duty, love and a willingness to experiment, participants say

Trump has also said that if a vaccine was not ready by then it was because of a “deep state” conspiracy against him. 

The fastest vaccine ever developed took four years, although work on a COVID-19 vaccine has been happening at a much faster pace, thanks to advances in technology, research done on similar but much smaller coronavirus outbreaks, a concerted effort by the companies, and federal support.

Three of the candidate vaccines are currently being tested in Phase 3 trials involving 30,000 people each, half of whom will get the active vaccine and half a placebo. 

Dr. Stephen Hahn, head of the U.S. Food and Drug Administration, has repeatedly said he would not approve a vaccine until it has been shown to be safe and effective. But he has also said there might be an intermediate endpoint — short of the completion of a 30,000-person trial — that could meet his standards for a so-called emergency use authorization.

Experts see progress on a COVID-19 vaccine. But they worry about who gets it first and how it gets to them

The statement from the vaccine developers did not address whether they would consider such an endpoint acceptable, but did say that they would “only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.”

None of the companies would comment Monday beyond what was in the statement. 

Such a statement from industry is unprecedented, said Dr. William Schaffner, an expert in infectious diseases and immunization policy at Vanderbilt University in Nashville.

“I’ve only been doing vaccines for 40 years and I’ve never heard of anything like this before,” he said. “Having the companies themselves issue this statement I think will offer some reassurance. Not completely, but some reassurance to the medical profession.”

Schaffner said he has heard repeated concerns from medical colleagues across the country about Trump and Hahn’s comments, which he said have created “an enormous amount of unease in the very professional people who would be expected to provide strong endorsement of the vaccine, promote it and often give it in their own offices and public health departments.”

Doctors and other medical professionals must be convinced that the vaccine is worthwhile, he said. “If they hold back, that could be an enormous impediment to widespread use of the vaccine.” 

More: Discipline against bad doctors plummets amid COVID-19 – and more medical errors may slip through cracks

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New Brunswick Premier Blaine Higgs kicks off provincial election campaign

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FREDERICTON – New Brunswick Premier Blaine Higgs has called an election for Oct. 21, signalling the beginning of a 33-day campaign expected to focus on pocketbook issues and the government’s provocative approach to gender identity policies.

The 70-year-old Progressive Conservative leader, who is seeking a third term in office, has attracted national attention by requiring teachers to get parental consent before they can use the preferred names and pronouns of young students.

More recently, however, the former Irving Oil executive has tried to win over inflation-weary voters by promising to lower the provincial harmonized sales tax by two percentage points to 13 per cent if re-elected.

At dissolution, the Conservatives held 25 seats in the 49-seat legislature. The Liberals held 16 seats, the Greens had three and there was one Independent and four vacancies.

J.P. Lewis, a political science professor at the University of New Brunswick, said the top three issues facing New Brunswickers are affordability, health care and education.

“Across many jurisdictions, affordability is the top concern — cost of living, housing prices, things like that,” he said.

Richard Saillant, an economist and former vice-president of Université de Moncton, said the Tories’ pledge to lower the HST represents a costly promise.

“I don’t think there’s that much room for that,” he said. “I’m not entirely clear that they can do so without producing a greater deficit.” Saillant also pointed to mounting pressures to invest more in health care, education and housing, all of which are facing increasing demands from a growing population.

Higgs’s main rivals are Liberal Leader Susan Holt and Green Party Leader David Coon. Both are focusing on economic and social issues.

Holt has promised to impose a rent cap and roll out a subsidized school food program. The Liberals also want to open at least 30 community health clinics over the next four years.

Coon has said a Green government would create an “electricity support program,” which would give families earning less than $70,000 annually about $25 per month to offset “unprecedented” rate increases.

Higgs first came to power in 2018, when the Tories formed the province’s first minority government in 100 years. In 2020, he called a snap election — the first province to go to the polls after the start of the COVID-19 pandemic — and won a majority.

Since then, several well-known cabinet ministers and caucus members have stepped down after clashing with Higgs, some of them citing what they described as an authoritarian leadership style and a focus on policies that represent a hard shift to the right side of the political spectrum.

Lewis said the Progressive Conservatives are in the “midst of reinvention.”

“It appears he’s shaping the party now, really in the mould of his world views,” Lewis said. “Even though (Progressive Conservatives) have been down in the polls, I still think that they’re very competitive.”

Meanwhile, the legislature remained divided along linguistic lines. The Tories dominate in English-speaking ridings in central and southern parts of the province, while the Liberals held most French-speaking ridings in the north.

The drama within the party began in October 2022 when the province’s outspoken education minister, Dominic Cardy, resigned from cabinet, saying he could no longer tolerate the premier’s leadership style. In his resignation letter, Cardy cited controversial plans to reform French-language education. The government eventually stepped back those plans.

A series of resignations followed last year when the Higgs government announced changes to Policy 713, which now requires students under 16 who are exploring their gender identity to get their parents’ consent before teachers can use their preferred first names or pronouns — a reversal of the previous practice.

When several Tory lawmakers voted with the opposition to call for an external review of the change, Higgs dropped dissenters from his cabinet. And a bid by some party members to trigger a leadership review went nowhere.

This report by The Canadian Press was first published Sept. 19, 2024.

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New Brunswick Premier Blaine Higgs expected to call provincial election today

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FREDERICTON – A 33-day provincial election campaign is expected to officially get started today in New Brunswick.

Progressive Conservative Premier Blaine Higgs has said he plans to visit Lt.-Gov. Brenda Murphy this morning to have the legislature dissolved.

Higgs, a 70-year-old former oil executive, is seeking a third term in office, having led the province since 2018.

The campaign ahead of the Oct. 21 vote is expected to focus on pocketbook issues, but the government’s provocative approach to gender identity issues could also be in the spotlight.

The Tory premier has already announced he will try to win over inflation-weary voters by promising to lower the harmonized sales tax by two percentage points to 13 per cent if re-elected.

Higgs’s main rivals are Liberal Leader Susan Holt and Green Party Leader David Coon, both of whom are focusing on economic and social issues.

This report by The Canadian Press was first published Sept. 19, 2024.

The Canadian Press. All rights reserved.

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NDP flips, BC United flops, B.C. Conservatives surge as election campaign approaches

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VICTORIA – If the lead up to British Columbia‘s provincial election campaign is any indication of what’s to come, voters should expect the unexpected.

It could be a wild ride to voting day on Oct. 19.

The Conservative Party of B.C. that didn’t elect a single member in the last election and gained less than two per cent of the popular vote is now leading the charge for centre-right, anti-NDP voters.

The official Opposition BC United, who as the former B.C. Liberals won four consecutive majorities from 2001 to 2013, raised a white flag and suspended its campaign last month, asking its members, incumbents and voters to support the B.C. Conservatives to prevent a vote split on the political right.

New Democrat Leader David Eby delivered a few political surprises of his own in the days leading up to Saturday’s official campaign start, signalling major shifts on the carbon tax and the issue of involuntary care in an attempt to curb the deadly opioid overdose crisis.

He said the NDP would drop the province’s long-standing carbon tax for consumers if the federal government eliminates its requirement to keep the levy in place, and pledged to introduce involuntary care of people battling mental health and addiction issues.

The B.C. Coroners Service reports more than 15,000 overdose deaths since the province declared an opioid overdose public health emergency in 2016.

Drug policy in B.C., especially decriminalization of possession of small amounts of hard drugs and drug use in public areas, could become key election issues this fall.

Eby, a former executive director of the B.C. Civil Liberties Association, said Wednesday that criticism of the NDP’s involuntary care plan by the Canadian Civil Liberties Association is “misinformed” and “misleading.”

“This isn’t about forcing people into a particular treatment,” he said at an unrelated news conference. “This is about making sure that their safety, as well as the safety of the broader community, is looked after.”

Eby said “simplistic arguments,” where one side says lock people up and the other says don’t lock anybody up don’t make sense.

“There are some people who should be in jail, who belong in jail to ensure community safety,” said Eby. “There are some people who need to be in intensive, secure mental health treatment facilities because that’s what they need in order to be safe, in order not to be exploited, in order not to be dead.”

The CCLA said in a statement Eby’s plan is not acceptable.

“There is no doubt that substance use is an alarming and pressing epidemic,” said Anais Bussières McNicoll, the association’s fundamental freedoms program director. “This scourge is causing significant suffering, particularly, among vulnerable and marginalized groups. That being said, detaining people without even assessing their capacity to make treatment decisions, and forcing them to undergo treatment against their will, is unconstitutional.”

While Eby, a noted human rights lawyer, could face political pressure from civil rights opponents to his involuntary care plans, his opponents on the right also face difficulties.

The BC United Party suspended its campaign last month in a pre-election move to prevent a vote split on the right, but that support may splinter as former jilted United members run as Independents.

Five incumbent BC United MLAs, Mike Bernier, Dan Davies, Tom Shypitka, Karin Kirkpatrick and Coralee Oakes are running as Independents and could become power brokers in the event of a minority government situation, while former BC United incumbents Ian Paton, Peter Milobar and Trevor Halford are running under the B.C. Conservative banner.

Davies, who represents the Fort St. John area riding of Peace River North, said he’s always been a Conservative-leaning politician but he has deep community roots and was urged by his supporters to run as an Independent after the Conservatives nominated their own candidate.

Davies said he may be open to talking with B.C. Conservative Leader John Rustad after the election, if he wins or loses.

Green Leader Sonia Furstenau has suggested her party is an option for alienated BC United voters.

Rustad — who faced criticism from BC United Leader Kevin Falcon and Eby about the far-right and extremist views of some of his current and former candidates and advisers — said the party’s rise over the past months has been meteoric.

“It’s been almost 100 years since the Conservative Party in B.C. has won a government,” he said. “The last time was 1927. I look at this now and I think I have never seen this happen anywhere in the country before. This has been happening in just over a year. It just speaks volumes that people are just that eager and interested in change.”

Rustad, ejected from the former B.C. Liberals in August 2022 for publicly supporting a climate change skeptic, sat briefly as an Independent before being acclaimed the B.C. Conservative leader in March 2023.

Rustad, who said if elected he will fire B.C.’s provincial health officer Dr. Bonnie Henry over her vaccine mandates during the COVID-19 pandemic, has removed the nominations of some of his candidates who were vaccine opponents.

“I am not interested in going after votes and trying to do things that I think might be popular,” he said.

Prof. David Black, a political communications specialist at Greater Victoria’s Royal Roads University, said the rise of Rustad’s Conservatives and the collapse of BC United is the political story of the year in B.C.

But it’s still too early to gauge the strength of the Conservative wave, he said.

“Many questions remain,” said Black. “Has the free enterprise coalition shifted sufficiently far enough to the right to find the social conservatism and culture-war populism of some parts of the B.C. Conservative platform agreeable? Is a party that had no infrastructure and minimal presence in what are now 93 ridings this election able to scale up and run a professional campaign across the province?”

This report by The Canadian Press was first published Sept. 19, 2024.

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