Hahn pledges no politics in COVID vaccine decisions - Regulatory Focus | Canada News Media
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Hahn pledges no politics in COVID vaccine decisions – Regulatory Focus

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Posted 23 September 2020 | By Michael Mezher 

Testifying before the Senate Health, Education, Labor and Pensions Committee on Wednesday, US Food and Drug Administration (FDA) Commissioner Stephen Hahn said that politics will not play a part in the decision to approve or authorize a vaccine for coronavirus disease (COVID-19).
 
Hahn stressed that he supports science and has “100% confidence” in his staff, and said that, “FDA will not authorize or approve any COVID-19 vaccine before it has met the agency’s rigorous expectations for safety and effectiveness.”
 
“There won’t be politics that play any part in that decision,” Hahn added.
 
Hahn’s reassurances come amid reports from the Washington Post, Financial Times and New York Times that the agency is preparing to issue guidance on its expectations for a COVID-19 vaccine EUA that will ask for a median two months of monitoring after Phase 3 trial participants receive their last dose, making an EUA for a vaccine before the election unlikely.
 
Hahn and Center for Biologics Evaluation and Research (CBER) Director Peter Marks have both previously said that such guidance is coming but have not expressly disclosed what it would entail. (RELATED: Marks, Hahn confirm COVID vaccine EUA guidance coming, Regulatory Focus 11 September 2020).
 
The news of more stringent EUA guidance for vaccines follows criticism of the agency’s handling of previous EUAs for COVID-19 therapeutics, including the recent one issued for convalescent plasma and the now-revoked authorization for hydroxychloroquine and chloroquine. (RELATED: Lawmakers, experts raise questions after convalescent plasma EUA, Regulatory Focus 25 August 2020; FDA revokes EUA for hydroxychloroquine, chloroquine, Regulatory Focus 15 June 2020).
 
During the hearing, Hahn said that vaccine makers will be the ones to decide when to submit data to FDA and whether to seek full approval or an EUA for their vaccine. “This will be based upon the trial meeting prespecified success criteria that were established by that sponsor … they should also be consistent with FDA recommendations regarding those criteria,” he said.
 
While Hahn did not touch on any specifics raised in the recent news reports, he said that companies will have to demonstrate that they have met the statutory standards for an EUA.
 
“We expect that this would be demonstrated based on adequate manufacturing data to ensure a vaccine’s quality and consistency and data from at least one well-designed Phase 3 clinical trial that demonstrates its safety and efficacy in a clear and compelling manner,” Hahn said, adding that the agency will expect EUA requests to include a plan for long-term safety monitoring for individuals who receive the vaccine.
 
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Youri Chassin quits CAQ to sit as Independent, second member to leave this month

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Quebec legislature member Youri Chassin has announced he’s leaving the Coalition Avenir Québec government to sit as an Independent.

He announced the decision shortly after writing an open letter criticizing Premier François Legault’s government for abandoning its principles of smaller government.

In the letter published in Le Journal de Montréal and Le Journal de Québec, Chassin accused the party of falling back on what he called the old formula of throwing money at problems instead of looking to do things differently.

Chassin says public services are more fragile than ever, despite rising spending that pushed the province to a record $11-billion deficit projected in the last budget.

He is the second CAQ member to leave the party in a little more than one week, after economy and energy minister Pierre Fitzgibbon announced Sept. 4 he would leave because he lost motivation to do his job.

Chassin says he has no intention of joining another party and will instead sit as an Independent until the end of his term.

He has represented the Saint-Jérôme riding since the CAQ rose to power in 2018, but has not served in cabinet.

This report by The Canadian Press was first published Sept. 12, 2024.

The Canadian Press. All rights reserved.

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‘I’m not going to listen to you’: Singh responds to Poilievre’s vote challenge

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MONTREAL – NDP Leader Jagmeet Singh says he will not be taking advice from Pierre Poilievre after the Conservative leader challenged him to bring down government.

“I say directly to Pierre Poilievre: I’m not going to listen to you,” said Singh on Wednesday, accusing Poilievre of wanting to take away dental-care coverage from Canadians, among other things.

“I’m not going to listen to your advice. You want to destroy people’s lives, I want to build up a brighter future.”

Earlier in the day, Poilievre challenged Singh to commit to voting non-confidence in the government, saying his party will force a vote in the House of Commons “at the earliest possibly opportunity.”

“I’m asking Jagmeet Singh and the NDP to commit unequivocally before Monday’s byelections: will they vote non-confidence to bring down the costly coalition and trigger a carbon tax election, or will Jagmeet Singh sell out Canadians again?” Poilievre said.

“It’s put up or shut up time for the NDP.”

While Singh rejected the idea he would ever listen to Poilievre, he did not say how the NDP would vote on a non-confidence motion.

“I’ve said on any vote, we’re going to look at the vote and we’ll make our decision. I’m not going to say our decision ahead of time,” he said.

Singh’s top adviser said on Tuesday the NDP leader is not particularly eager to trigger an election, even as the Conservatives challenge him to do just that.

Anne McGrath, Singh’s principal secretary, says there will be more volatility in Parliament and the odds of an early election have risen.

“I don’t think he is anxious to launch one, or chomping at the bit to have one, but it can happen,” she said in an interview.

New Democrat MPs are in a second day of meetings in Montreal as they nail down a plan for how to navigate the minority Parliament this fall.

The caucus retreat comes one week after Singh announced the party has left the supply-and-confidence agreement with the governing Liberals.

It’s also taking place in the very city where New Democrats are hoping to pick up a seat on Monday, when voters go to the polls in Montreal’s LaSalle—Émard—Verdun. A second byelection is being held that day in the Winnipeg riding of Elmwood—Transcona, where the NDP is hoping to hold onto a seat the Conservatives are also vying for.

While New Democrats are seeking to distance themselves from the Liberals, they don’t appear ready to trigger a general election.

Singh signalled on Tuesday that he will have more to say Wednesday about the party’s strategy for the upcoming sitting.

He is hoping to convince Canadians that his party can defeat the federal Conservatives, who have been riding high in the polls over the last year.

Singh has attacked Poilievre as someone who would bring back Harper-style cuts to programs that Canadians rely on, including the national dental-care program that was part of the supply-and-confidence agreement.

The Canadian Press has asked Poilievre’s office whether the Conservative leader intends to keep the program in place, if he forms government after the next election.

With the return of Parliament just days away, the NDP is also keeping in mind how other parties will look to capitalize on the new makeup of the House of Commons.

The Bloc Québécois has already indicated that it’s written up a list of demands for the Liberals in exchange for support on votes.

The next federal election must take place by October 2025 at the latest.

This report by The Canadian Press was first published Sept. 11, 2024.

The Canadian Press. All rights reserved.

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Social media comments blocked: Montreal mayor says she won’t accept vulgar slurs

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Montreal Mayor Valérie Plante is defending her decision to turn off comments on her social media accounts — with an announcement on social media.

She posted screenshots to X this morning of vulgar names she’s been called on the platform, and says comments on her posts for months have been dominated by insults, to the point that she decided to block them.

Montreal’s Opposition leader and the Canadian Civil Liberties Association have criticized Plante for limiting freedom of expression by restricting comments on her X and Instagram accounts.

They say elected officials who use social media should be willing to hear from constituents on those platforms.

However, Plante says some people may believe there is a fundamental right to call someone offensive names and to normalize violence online, but she disagrees.

Her statement on X is closed to comments.

This report by The Canadian Press was first published Sept. 11, 2024.

The Canadian Press. All rights reserved.

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