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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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Snap election averted as Liberal government survives confidence vote in Commons – CBC.ca

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Canadians will not be heading to the polls for a snap fall election now that the Liberal government has survived a confidence vote on a Conservative motion to create a special committee to probe the government’s ethics and pandemic spending.

MPs voted 180-146 to defeat the opposition motion.

Earlier today, NDP Leader Jagmeet Singh said that his party would not give Prime Minister Justin Trudeau an “excuse” to send Canadians to the polls in the middle of a global pandemic — signalling that Trudeau’s government would survive today’s confidence vote.

In a news conference just two hours before a crucial confidence vote, Singh declined to say exactly how his MPs would vote or whether they might abstain.

“We are voting for Canadians. We are voting against an election,” he said.

Singh said the NDP will still work to get answers on the WE Charity scandal through the Commons ethics committee, and that his party will push the government for more pandemic support for Canadians.

“People need help right now. They need confidence in the future. They’re not looking for an election,” he said.

“So New Democrats will not give Prime Minister Trudeau the election he’s looking for. We’re not going to be used as an excuse or a cover. We’re going to continue to do the work that we need to do.”

The Bloc Québécois had already confirmed it will support the Conservative motion, while the Green Party indicated that its three MPs would vote against the motion.

The vote is expected to happen around 3:15 p.m. ET and CBCNews.ca is carrying it live.

The opposition day motion would have created a special committee to probe the Trudeau government’s ethics and spending in response to the pandemic — including the controversial WE Charity contract to administer a student volunteer grant program.

Prime Minister Justin Trudeau did not recuse himself from talks on the agreement, even though several of his family members had been paid for speaking engagements by the organization.

The Liberal government has declared the vote on the Conservative motion a matter of confidence that could trigger an election — a high-stakes move that NDP Leader Jagmeet Singh called a “farce.”

In a news conference before the vote, Conservative Leader Erin O’Toole said if the motion doesn’t pass, he would continue to work with other parties to hold the government to account. He criticized the government and Trudeau for framing the vote as a confidence matter.

“His designation of this vote as a confidence vote shows that he’s willing to put the electoral fortunes of the Liberal Party ahead of the health, safety and well-being of Canadians,” he said.

“Most Canadians would think that’s unacceptable.”

WATCH / Erin O’Toole on confidence vote:

Conservative Leader Erin O’Toole spoke with reporters just after NDP Leader Jagmeet Singh stated that the NDP would not bring down the government in the confidence vote. 0:56

Speaking to reporters after the Liberal caucus meeting, Deputy Prime Minister Chrystia Freeland said the government needs the confidence of the House to do its job.

“I really believe at the end of the day common sense will prevail and we’re going to get through this,” she said.

Freeland also said that legislation for several new pandemic supports for Canadians and businesses needs to be passed and an election could jeopardize that.

WATCH / Deputy Prime Minister Chrystia Freeland on possible election:

Deputy Prime Minister and Finance Minister Chrystia Freeland says she’s focused on passing legislation to support Canadians during the pandemic as a confidence vote looms in Parliament today.  1:39

Heading into their weekly caucus meeting this morning, NDP MPs said they had not yet decided on a path forward and would talk about how to proceed behind closed doors.

“At the end of the day we have a lot of moving parts and we’re still in a pandemic and we’re still committed to fighting for Canadians and we’re going to continue to do that,” said Ontario NDP MP Matthew Green.

“We have to look at what all the variables are going in to this discussion and do what’s best for the country.”

Asked by reporters if the NDP had an obligation to support the Conservative motion, NDP ethics critic Charlie Angus said, “There’s many ways to skin a cat, my friends.”

WATCH / NDP MPs on today’s confidence vote:

NDP MPs arrived for their weekly caucus meeting in Ottawa on Wednesday. 1:26

Conservative House leader Gérard Deltell said the ethical questions surrounding the government require a special committee with a clear mandate. He said it’s the “duty” of opposition parties to hold the government to account.

“This is what the issue is all about with this motion, and what we see right now is a prime minister who will do whatever it takes to call an election,” he said.

“The only Canadian who would like to have an election today is the prime minister. The only Canadian who would like to freeze the government for a few months is the prime minister by calling an election.”

The Conservatives amended the original motion to state that voting to launch the committee should not be considered grounds to order an election.

It also dropped the “anti-corruption committee” label it initially proposed.

Bloc Québécois House leader Alain Therrien said the WE Charity issue is so complex that it requires a special committee to get answers.

He said the Liberals’ “scorched-earth” approach to politics is the product of a “club of cronyism” and renders compromise impossible.

He also criticized the NDP, suggesting the party’s MPs have obediently followed Liberal demands.

“The NDP have acted in the last little while a little like the Liberals’ lap dog,” he said.

‘Unwelcome drama’: Paul

Green Party Leader Annamie Paul issued a statement urging the parties to cool their jets, calling the brinkmanship “unwelcome drama.” 

“The Liberal and Conservative parties’ high-stakes, high-tech game of chicken can have no winner,” she said. 

“They should leave such games outside of Parliament, and focus on the urgent needs of people in Canada. I ask members of Parliament to dial down the rhetoric, which is not in keeping with the seriousness of this unprecedented moment, so that we can get back to working on the critical matters at hand.”

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Strategies Can Help Teach Students to Discuss Politics – NC State News

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The election is underway and the holidays are around the corner, so it’s good news that researchers are working on strategies to help adults and young people productively discuss political differences.

In the journal Social Education, researchers from NC State described efforts to launch an event series called “Dinner with Democracy” to get students involved in political discussions and help train future social studies teachers. This year, the event will be held virtually Oct. 21. Through these events, researchers hope to help students develop skills valuable to life in a democracy.

“Democracy is grounded on the idea that we will talk to each other and work through our problems,” said the study’s lead author Paula McAvoy, an assistant professor in NC State’s College of Education. “So my research has been about engaging students in controversial political issues in the classroom.”

McAvoy was lead author of the paper, which was co-authored by Christy Byrd, assistant professor at NC State, and graduate students Arine Lowery and Nada Wafa. The Abstract sat down with McAvoy to talk about engaging students in political discussions in advance of the virtual Dinner with Democracy event.

The Abstract: You talk about disagreement being a fundamental part of democracy. What do you mean?

McAvoy: Democracies are founded on the idea that people should be given an opportunity to participate in the creation of the laws that govern them and that people can work together to come up with solutions that they can all live with. Inherent in that is you’re going to disagree. We have to get used to the idea that we disagree, there are good reasons to disagree and we need to learn how to give reasons to each other and hear each other.

TA: Why did you want to highlight Dinner with Democracy?

McAvoy: What I liked with Dinner with Democracy is that it’s a multigenerational approach to not only to help young people talk about issues in the classroom, but also to help parents join in the discussion. We can show how we can talk about our differences, hear each other and be willing to be kind to one another.

TA: How did this come about?

McAvoy: Two teachers heard about the concept at the North Carolina Council for Social Studies conference from a teacher who had students find an adult to have a meal with, talk about political issues with that person and report back. After hearing that, the two teachers decided to make it a school event by inviting parents and students to a potluck where students presented discussion questions for each course of the meal. We took that idea to NC State and made it a public event for middle and high school students, teachers, NC State students, faculty and the community.

TA: What was the structure of your event?

McAvoy: In an event like this, you want people to be able to listen to each other. We did several rounds of small group discussions with a facilitator that began with a three-to-five minute setup of the question they were going to talk about.

At the beginning of the discussion, everyone shared personal reflections. The rule was that everyone had to listen to your answer without interrupting or arguing; everyone had to hear from everyone in the group. That did two things: It first promotes the idea that we’re all going to listen to one another, and second, it puts everyone’s humanity into the discussion so we know where we are coming from. So it promotes empathy. You bring yourself first, and political views second.

Then we used a discussion strategy called the “Tug-of-War,” which asks the group to collectively think of reasons for and against an issue. That puts everyone on the same side – we’re working together to come up reasons for and against.

The last thing you do is try to explain what you think about the issue.

TA: How did participants respond?

McAvoy: I was very happy that in the evaluations, the participants said they felt their discussions were productive and fair and there was a sense of civility. 

TA: What lessons can teachers and students learn from this? 

McAvoy: There are different ways to have classroom discussions or engage with students.

One thing that’s tempting is to have students debate. A debate is what you associate with elections. In today’s polarized climate, the debate format exacerbates our differences, and it teaches people to get a view and hold onto it. You teach people to become entrenched in their views.

The activities that we did promote deliberation, which is a different type of discussion. That’s what we model in Dinner with Democracy. Deliberation is about trying to come to a common understanding rather than winning.

In the classroom today, I hear from a lot of teachers that parents are leery, teachers are leery; they don’t want things to get out of hand. We are trying to show that being very careful and intentional about how you are going to have your discussions is essential for having them go well.

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NDP won't give Trudeau 'excuse' for election, Singh says ahead of confidence vote in Commons – CBC.ca

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NDP Leader Jagmeet Singh said today that his party will not give Prime Minister Justin Trudeau an “excuse” to send Canadians to the polls in the middle of a global pandemic — an apparent signal that Trudeau’s government will survive today’s confidence vote.

In a news conference just two hours before a crucial confidence vote, Singh declined to say exactly how his MPs would vote or whether they might abstain.

“We are voting for Canadians. We are voting against an election,” he said.

Singh said the NDP will still work to get answers on the WE Charity scandal through the Commons ethics committee, and that his party will push the government for more pandemic support for Canadians.

“People need help right now. They need confidence in the future. They’re not looking for an election,” he said.

“So New Democrats will not give Prime Minister Trudeau the election he’s looking for. We’re not going to be used as an excuse or a cover. We’re going to continue to do the work that we need to do.”

The Bloc Québécois had already confirmed it will support the Conservative motion, leaving the outcome in the hands of the NDP.

The vote is expected to happen around 3:15 p.m. ET and CBCNews.ca will carry it live.

The opposition day motion would create a special committee to probe the Trudeau government’s ethics and spending in response to the pandemic — including the controversial WE Charity contract to administer a student volunteer grant program.

Prime Minister Justin Trudeau did not recuse himself from talks on the agreement, even though several of his family members had been paid for speaking engagements by the organization.

The Liberal government has declared the vote on the Conservative motion a matter of confidence that could trigger an election — a high-stakes move that NDP Leader Jagmeet Singh has called a “farce.”

In a news conference before the vote, Conservative Leader Erin O’Toole said if the motion does not pass, he will continue to work with other parties to hold the government to account. He criticized the government and Trudeau for framing the vote as a confidence matter.

“His designation of this vote as a confidence vote shows that he’s willing to put the electoral fortunes of the Liberal Party ahead of the health, safety and well-being of Canadians,” he said.

“Most Canadians would think that’s unacceptable.”

WATCH / Erin O’Toole on confidence vote:

Conservative Leader Erin O’Toole spoke with reporters just after NDP Leader Jagmeet Singh stated that the NDP would not bring down the government in the confidence vote. 0:56

Speaking to reporters after the Liberal caucus meeting, Deputy Prime Minister Chrystia Freeland said the government needs the confidence of the House to do its job.

“I really believe at the end of the day common sense will prevail and we’re going to get through this,” she said.

Freeland also said that legislation for several new pandemic supports for Canadians and businesses needs to be passed and an election could jeopardize that.

WATCH / Deputy Prime Minister Chrystia Freeland on possible election:

Deputy Prime Minister and Finance Minister Chrystia Freeland says she’s focused on passing legislation to support Canadians during the pandemic as a confidence vote looms in Parliament today.  1:39

Heading into their weekly caucus meeting this morning, NDP MPs said they had not yet decided on a path forward and would talk about how to proceed behind closed doors.

“At the end of the day we have a lot of moving parts and we’re still in a pandemic and we’re still committed to fighting for Canadians and we’re going to continue to do that,” said Ontario NDP MP Matthew Green.

“We have to look at what all the variables are going in to this discussion and do what’s best for the country.”

Asked by reporters if the NDP had an obligation to support the Conservative motion, NDP ethics critic Charlie Angus said, “There’s many ways to skin a cat, my friends.”

WATCH / NDP MPs on today’s confidence vote:

NDP MPs arrived for their weekly caucus meeting in Ottawa on Wednesday. 1:26

Conservative House leader Gérard Deltell said the ethical questions surrounding the government require a special committee with a clear mandate. He said it’s the “duty” of opposition parties to hold the government to account.

“This is what the issue is all about with this motion, and what we see right now is a prime minister who will do whatever it takes to call an election,” he said.

“The only Canadian who would like to have an election today is the prime minister. The only Canadian who would like to freeze the government for a few months is the prime minister by calling an election.”

The Conservatives amended the original motion to state that voting to launch the committee should not be considered grounds to order an election.

It also dropped the “anti-corruption committee” label it initially proposed.

Bloc Québécois House leader Alain Therrien said the WE Charity issue is so complex that it requires a special committee to get answers.

He said the Liberals’ “scorched-earth” approach to politics is the product of a “club of cronyism” and renders compromise impossible.

He also criticized the NDP, suggesting the party’s MPs have obediently followed Liberal demands.

“The NDP have acted in the last little while a little like the Liberals’ lap dog,” he said.

‘Unwelcome drama’: Paul

Green Party Leader Annamie Paul issued a statement urging the parties to cool their jets, calling the brinkmanship “unwelcome drama.” 

“The Liberal and Conservative parties’ high-stakes, high-tech game of chicken can have no winner,” she said. 

“They should leave such games outside of Parliament, and focus on the urgent needs of people in Canada. I ask members of Parliament to dial down the rhetoric, which is not in keeping with the seriousness of this unprecedented moment, so that we can get back to working on the critical matters at hand.”

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