Connect with us

media captionUS Covid vaccine: Three key questions answered

The US Food and Drug Administration has authorised the Pfizer-BioNTech coronavirus vaccine for emergency use.

The agency said the authorisation was a “significant milestone” in the pandemic, which taken more than 295,000 lives in the US.

The vaccine, which offers up to 95% protection against Covid-19, was deemed safe and effective by the FDA.

President Donald Trump said the first vaccinations will take place “in less than 24 hours”.

“Today our nation has achieved a medical miracle,” Mr Trump said. “We have delivered a safe and effective vaccine in just nine months.”

Before the announcement on Friday night, the FDA had come under intense pressure from the Trump administration to approve the vaccine’s use.

The head of the agency, Stephen Hahn, was told to approve it for emergency use by Friday or quit, US media reported, although he called this “untrue”.

Health and Human Services Secretary, Alex Azar, told reporters earlier on Friday that his department would work with Pfizer to get the mass vaccination programme started by Monday or Tuesday.

The Pfizer vaccine has already received regulatory approval in the UK, Canada, Bahrain and Saudi Arabia. Like those countries, the US will give its first doses of the vaccine to the elderly, health workers and emergency crew.

Coronavirus deaths have been rising sharply since November in the US. On Wednesday, the country recorded more than 3,000 deaths – the highest total in a single day anywhere in the world.

  • Covid: When can I get vaccinated in the US?

  • Safety data on Pfizer jab released by US
  • How does the Pfizer vaccine work?

What has the FDA said?

“The FDA’s authorisation for emergency use of the first Covid-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said Mr Hahn.

He said the authorisation came after “an open and transparent review process” that ensured the vaccine met the “FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality”.

image copyrightReuters

image captionThe Pfizer-BioNTech coronavirus vaccine is expected to be rolled out in the coming days

On Thursday, medical experts advising the FDA recommended the emergency-use authorisation. A 23-member panel concluded the vaccine’s benefits outweighed its risks.

Emergency use, the FDA said, is not the same as full approval, which would require Pfizer to file a separate application to secure.

“While not an FDA approval, today’s emergency use authorisation of the Pfizer-BioNTech Covid-19 Vaccine holds the promise to alter the course of this pandemic in the United States,” said Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research.

Has the FDA been leaned on?

On Friday, President Trump sent out an angry tweet calling the FDA a “big, old, slow turtle”, adding: “Get the dam vaccines out NOW, Dr Hahn. Stop playing games and start saving lives.”

The Washington Post said that White House chief of staff Mark Meadows had ordered Mr Hahn to approve the vaccine on Friday or submit his resignation, citing three sources.

image copyrightReuters
image captionUS media reported that FDA Commissioner Hahn had been ordered to approve the vaccine’s use by Friday

But Mr Hahn told US media he had only been “encouraged to continue working expeditiously” on the vaccine’s approval, and that the media representation of the chief of staff’s phone call was “untrue”.

Amid the reports of White House pressure, President-elect Joe Biden said he wanted to make it clear to the public that they should have confidence in the vaccine, adding: “There is no political influence.”

How does the vaccine work?

The Pfizer/BioNTech vaccine was the first coronavirus jab to show promising results in the latter stages of its testing process.

It is a new type called an mRNA vaccine that uses a tiny fragment of genetic code from the pandemic virus to teach the body how to fight Covid-19 and build immunity.

“The vaccine contains a small piece of the [Covid-19] virus’s mRNA that instructs cells in the body to make the virus’s distinctive ‘spike’ protein,” the FDA said.

media captionHow will the new Pfizer vaccine work?

“When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against [Covid-19].”

The vaccine is given as two injections, 21 days apart, with the second dose being a booster. Immunity begins to kick in after the first dose but reaches its full effect seven days after the second dose.

What could happen now it has been approved?

Operation Warp Speed says that vaccine deliveries will begin within 24 hours of approval.

“We have made sure that this vaccine will be free, for all Americans,” Mr Trump said in a recorded video posted to Twitter.

“We have already begun shipping the vaccine to every state and zip code in the country. The first vaccine will be administered in less than 24 hours.”

Pfizer plans to have 6.4 million doses ready for the US in its first rollout round in late December.

Because two injections are required per person, that is enough for three million people, out of a total US population of 330 million.

Federal officials at the Centers for Disease Control and Prevention (CDC) say the nation’s 21 million healthcare workers should be prioritised first, as well the three million elderly Americans living in long-term care homes.

But there is less consensus on how states should distribute it to other groups. The nation’s approximately 87 million essential workers are expected to be next in line for the jab, but it will be up to states to decide which industries to prioritise.

Mr Trump said vaccines “will vanquish the virus and return life back to normal”. But officials say vaccinations for groups that are not at a high risk are expected to take place in the spring of 2021.

A second vaccine, developed by Moderna and the National Institutes of Health, is also seeking emergency approval in the US. Like the Pfizer vaccine it requires a second round of injections.

Related Topics



Source link

0
Continue Reading

Politics

Pelosi to move forward with impeachment if Pence doesn’t act to remove Trump

210108 pelosi ap 773

“In protecting our Constitution and our Democracy, we will act with urgency, because this President represents an imminent threat to both,” Pelosi said in the letter to Democrats on Sunday night laying out next steps.

The House will try to pass a measure on Monday imploring Pence to invoke the 25th Amendment, through which he and the Cabinet declare Trump “incapable of executing the duties of his office, after which the Vice President would immediately exercise powers as acting president.” If Republicans object, as is virtually certain, Democrats will pass the bill via a roll call vote on Tuesday.

“We are calling on the Vice President to respond within 24 hours,” Pelosi wrote. “Next, we will proceed with bringing impeachment legislation to the Floor.”

But it’s not clear when exactly the Senate will take up the House’s measure. The Senate isn’t scheduled to return until Jan. 19, but will hold pro forma sessions on Tuesday and Friday. In theory, a senator could try to pass the House resolution by unanimous consent, but as of now it appears unlikely that it would pass.

On Monday, multiple House Democrats plan to introduce impeachment resolutions that would become the basis of any impeachment article considered by the House later this week.

Rep. David Cicilline (D-R.I.), who will introduce an article of impeachment against Trump on Monday, said on Sunday that roughly 200 Democrats have co-sponsored the measure.

Currently, 211 voting members (plus three nonvoting members) support Cicilline’s legislation, and they are hoping to reach 217 voting members by Monday morning, enough for the House to impeach Trump, one Democratic source familiar with the matter told POLITICO.

A small number of Democrats have opted not to co-sign the bill, but privately say they will vote to support the resolution on the floor, the source added.

The impeachment effort in the House is likely to be bipartisan, with Democrats expecting at least one GOP lawmaker — Rep. Adam Kinzinger of Illinois — to sign on. A handful of other House Republicans are seriously weighing it, according to several sources, though those lawmakers are waiting to see how Democrats proceed, and some are concerned about dividing the country even further.

Among the GOP members whom Democrats are keeping an eye on are Reps. John Katko of New York, Brian Fitzpatrick of Pennsylvania, Fred Upton of Michigan, Liz Cheney of Wyoming and Jaime Herrera Beutler of Washington.

Across the Capitol, at least two Republicans — Sens. Pat Toomey of Pennsylvania and Lisa Murkowski of Alaska — have called on Trump to resign. On Saturday, Toomey told Fox News, “I do think the president committed impeachable offenses,” but told CNN the next day that he does not believe there is enough time to impeach.

Sen. Ben Sasse (R-Neb.) has also said he would consider articles of impeachment.

Another option has emerged among some Republican and moderate Democratic circles — censuring Trump — though it remains highly unlikely to advance.

A censure resolution would gain far more support in the GOP than impeachment. Some Republicans have privately been pushing for that route and are trying to get Biden on board, according to GOP sources. That group of Republicans is also warning that impeachment could destroy Biden’s reputation with Republicans.

But censure is considered a nonstarter in an incensed House Democratic Caucus, where members see it as a slap on the wrist that gives Republicans an easy out.

The Democrats’ enormous step toward impeachment on Sunday comes after Pelosi and other top Democrats held a private call on Saturday night in which they discussed the potential ramifications that a lengthy impeachment trial could have on Biden’s presidency.

Democratic leaders discussed several options to limit the political effects on Biden’s first 100 days, with one option — floated by House Majority Whip Jim Clyburn (D-S.C.) — for the House to delay the start of an impeachment trial in the Senate by holding on to the article of impeachment.

Senate Majority Leader Mitch McConnell (R-Ky.) has sent out a memo to senators explaining that the Senate could not take up impeachment until Jan. 19 at the earliest, absent unanimous consent.

A final decision has not been made, and House Democrats will discuss the matter on a 2 p.m. caucus call on Monday.

Lawmakers are already privately expressing concerns about returning to the Capitol for multiple days this week, worried about both a potential coronavirus outbreak and whether the building is secure, given how easily an armed pro-Trump mob invaded on Wednesday.

The Capitol physician urged House lawmakers and staff to get tested in a memo Sunday, saying they might have been exposed to someone who had the virus while huddling for safety in a large committee room for hours on Wednesday. During the hourslong lockdown, several Republican members refused to wear masks despite being offered them by Democrats worried about the spread of the deadly virus.

Melanie Zanona, Olivia Beavers and Marianne LeVine contributed to this report.

Source link

0
Continue Reading

Politics

Matt Hancock Scraps “Unnecessary Training Modules” Blamed For Slowing Vaccine Rollout

PA 57409526 mk3qwz

Matt Hancock has agreed to remove some of the training modules required for volunteers to sign up to deliver the Covid-19 vaccine (PA)


5 min read

Matt Hancock said people will no longer need to undertake training including an anti-terrorism course to give the coronavirus jab after MPs said “bureaucratic rubbish” was delaying mass vaccination.

It comes as MPs called for the government to produce targets for the number of people given immunity before lockdown can be lifted.

The health secretary said a series of “unnecessary training modules” are being scrapped to speed up the process of getting people qualified to deliver the jab.

Speaking in the Commons, Sir Edward Leigh said he was shown by his fellow the Tory MP, a qualified GP, the “ridiculous form” he had filled out to start delivering the vaccine.

“When he’s inoculating an old lady, he’s not going to ask her if she’s come into contact with Jihadis or whatever, so the Secretary has got to cut through all this bureaucratic rubbish,” he said.

In response Mr Hancock said: “I am a man after Sir Edward’s heart and I can tell the House that we have removed a series of the unnecessary training modules that had been put in place, including fire safety, terrorism and others.

“I’ll write to him with the full panoply of the training that is not required and we have been able to remove, and we made this change as of this morning and I am glad to say it is enforced.

“I am a fan of busting bureaucracy and in this case I agree with him that it is not necessary to undertake anti-terrorism training in order to inject vaccines.”

Dr Fox had earlier challenged Boris Johnson to drop the “bureaucracy” and “political correctness” of the forms vaccine volunteers must fill out.

He told MPs: “As a qualified but non-practising doctor, I volunteered to help with the scheme and would urge others to do the same. 

“But, can I ask the Prime Minister why I’ve been required to complete courses on conflict resolution, equality, diversity and human rights, moving and handling loads and preventing radicalisation in order to give a simple Covid jab?”

Mr Johnson said he had been “assured by the Health Secretary that all such obstacles, all such pointless pettifoggery has been removed”.

The government has been attempting to recruit thousands of volunteers to help with a mass vaccination programme, and with the recent approval of the more easily deliverable Oxford/AstraZeneca version has today revealed the location of seven mass vaccination centres set to open next week.

The Prime Minister’s official spokesman told journalists at a briefing they would be at Robertson House in Stevenage, the ExCel Centre in London, the Centre for Life in Newcastle, the Etihad Tennis Centre in Manchester, Epsom Downs Racecourse in Surrey, Ashton Gate Stadium in Bristol and Millennium Point in Birmingham, and it is expected they will be run with a combination of NHS staff and volunteers.

But so far the government has not said how many people need to be inoculated before it has an impact on the coronavirus restrictions.

Mr Hancock was asked by a number of MPs if the measures could be eased once the top few tiers in the vaccine priority list had been clear.

Former Conservative chief whip Mark Harper said once the top four groups, which includes care home residents and staff, frontline NHS workers, the clinically extremely vulnerable and everyone over 70 “we’ve taken care therefore of 80% of the risk of death”.

Adding: “What possible reason is there at that point for not rapidly relaxing the restrictions that are in place on the rest of our country?”

The health secretary replied: “We have to see the impact of that vaccination on the reduction in the number of deaths, which I very much hope that we will see at that point, and so that is why we will take this – an evidence-led move down through the tiers, when we’ve broken the link, I hope, between cases and hospitalisations and deaths.”

The ex-Tory minister and another doctor, Andrew Murrison, said: “The logic of anticipating what is going to happen in two or three or four weeks’ time from the number of cases we are getting at the moment is that we can do the same in reverse.

“That is to say, when we have a sufficient number of people vaccinated up we can anticipate in two or three or four weeks’ time how many deaths have been avoided. 

“That means, since it cuts both ways he will be able to make a decision on when we should end these restrictions.”

Mr Hancock replied: “The logic of the case that Dr Murrison makes is the right logic and we want to see that happen in empirical evidence on the ground.

“This hope for the weeks ahead doesn’t take away, though, from the serious and immediate threat posed now.”

The Cabinet minister said the challenge for the government is to increase the amount of doses available, claiming “the current rate-limiting factor on the vaccine rollout is the supply of approved, tested, safe vaccine”.

He added: ”We are working with both AstraZeneca and Pfizer to increase that supply as fast as possible and they’re doing a brilliant job.”

But Labour’s shadow health secretary Jonathan Ashworth called for the government to ramp up its vaccination programme to six million doses a week.

He told the Commons: “The Prime Minister has promised almost 14 million will be offered the vaccine by mid-Feb. That depends on around two million doses a week on average.

“Both [Mr Hancock] and the Prime Minister have reassured us in recent days that it’s doable based on orders.

“But in the past ministers have told us that they had agreements for 30 million AstraZeneca doses by September 2020 and 10 million of Pfizer doses by the end of 2020.

“So, I think people just want to understand the figures and want clarity. Can ministers tell us how many of the ordered doses have been manufactured?”

Mr Ashworth added: “Two million a week would be fantastic but it should be the limit of our ambitions, we should be aiming to scale up to three, then five, then six million jabs a week over the coming months.”

Source link

0
Continue Reading

Politics

How South African police are tackling pangolin smugglers

p093hmc8

Quiet, solitary and nocturnal, the pangolin has few natural enemies, but researchers believe it is the most trafficked mammal in the world. The tough scales covering its body are sought after for use in Chinese medicine, in the erroneous belief that they have healing properties.

The animal has also been of interest to researchers during the coronavirus pandemic. Related viruses have been found in trafficked pangolins, though there is continued uncertainty around early theories that pangolins were involved in the transmission of the virus from animals to humans.

After South African police seized a pangolin from suspected smugglers, BBC Africa correspondent Andrew Harding witnessed how vets tried to save the animal’s life.

Source link

0
Continue Reading

Trending