Connect with us

Britain has been one of the countries hardest hit by the pandemic, with the highest death toll in Europe, and its government has been heavily criticized for its handling of the crisis.

But it has now leapfrogged both the European Union and the United States with this announcement.

Why was the UK first?

The vaccine was granted emergency authorization in the UK by its independent regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), which has played a crucial part in the process.

The MHRA began a rolling review of Pfizer and BioNTech data from October, with each “package” of data reviewed as soon as it became available. This allowed regulators to examine the data in detail before a final authorization application was submitted.

According to the MHRA, a rolling review “can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible.”

This approach helped accelerate the authorization process and a formal review of all the necessary information began in the UK on November 23, leading to Wednesday’s announcement.

“I think the advantage is that the MHRA has been undertaking a rolling review, which means that as Pfizer accumulated data on how they manufactured the vaccine … MHRA could keep pace with that,” David Salisbury, associate fellow in Chatham House’s Global Health Programme, told CNN. “That has allowed the MHRA to be nimble and keep pace.”

A similar rolling review approach is being used by the European Medicines Agency (EMA). The EMA began its review process of the Pfizer data on October 6 and BioNTech and Pfizer submitted an application to complete the review process on December 1. The EMA has said it will conclude its review by December 29 at the latest.

EU member states cannot distribute a Covid-19 vaccine until it has been authorized by the EMA and signed off by the European Commission, according to EMA rules.

The European Commission (EC) would then need a few days to prepare legal paperwork and discuss the authorization decision with member states, according to an EC spokesperson.

“The fact that the MHRA has been able to do this quickly will be a reflection at the pace of which Pfizer was interacting with them,” Salisbury added.

As well as the UK and the EU, Pfizer has also applied to the US Food and Drug Administration (FDA) for emergency use authorization for its vaccine candidate. The request was submitted on November 20.

The FDA’s Vaccines and Related Biological Products Advisory Committee, a panel of independent experts, is due to meet on December 10 to discuss Pfizer’s application.

According to a US Operation Warp Speed document obtained by CNN on Tuesday, the first shipments of Pfizer’s coronavirus vaccine will be delivered on December 15, if the vaccine is granted emergency authorization.

BioNTech’s Chief Medical Officer Özlem Türeci said the company expected EMA and FDA responses by mid-December.

Türeci said Wednesday that the rolling review process played “an important role” in the UK’s authorization. She said the process allowed authorities to “start right away to go through the dossiers, review the data, come back with questions which we can respond to immediately. And this massively accelerates the process of assessing in depth the data we have provided.”

When can I get the vaccine in the UK?

The UK will begin rolling out the vaccine next week, according to Health Secretary Matt Hancock. But emergency authorization is only the first stage of that process — doses will be assigned according to clinical priority.

Each recipient of the Pfizer/Biontech vaccine will need two doses.

An independent panel of experts, the Joint Committee on Vaccination and Immunization (JCVI), has recommended that care home residents and staff are vaccinated first.

The panel recommends that people should then be vaccinated according to age, starting with people older than 80 as well as frontline health workers.

Age will then continue to be the deciding factor, with older adults vaccinated down to those older than 50.

JCVI experts have also advised that workers in the UK’s National Health Service (NHS) and those considered clinically extremely vulnerable to coronavirus should be prioritized under the initial phase of vaccination.

Those considered vulnerable include patients with cancer, those who are on drugs that weaken the immune system and those who have severe lung disease, severe kidney disease and other health conditions.

Hancock said Wednesday that the timing of how many people can be vaccinated “will be determined by how rapidly (doses) can be manufactured.”

“We haven’t put a figure on the numbers before Christmas,” he said. “But what we do know is we can get started next week with that first load, and several millions will be coming throughout December. People will be contacted by the NHS when it’s their turn.”

“I urge you very strongly to come forward, because obviously being vaccinated is good for you,” he added. “It’s approved as clinically safe by the regulator and it’s good for your community as well to help get this virus finally under control once and for all.”

There are logistical challenges facing the rollout as the vaccine needs to be kept at temperatures of minus 70 degrees Celsius (minus 94 Fahrenheit) prior to use. Once defrosted, Pfizer says the vaccine can be stored for up to five days at 2 to 8 degrees Celsius in refrigeration units that are commonly available in hospitals.

Speaking to Sky News on Tuesday, Hancock said there would be “a combination of three modes of delivery.”

The vaccine will first go to hospitals — 50 of which are on standby to receive doses. This will be followed by vaccination centers, which Hancock said were being set up now, before a “community rollout” including doctors’ offices and pharmacists.

How does the mRNA vaccine work?

The Pfizer/BioNTech vaccine uses a new approach to making vaccines that uses messenger RNA, or mRNA.

mRNA is a single strand of the genetic code that cells can “read” and use to make a protein.

For this vaccine, the mRNA instructs cells in the body to make a particular piece of the virus’s spike protein. The immune system sees it, recognizes it as foreign, and is prepared to attack when actual infection occurs.

What are the side effects of the Pfizer vaccine?

An independent group has been keeping an eye on trial results and side effects from the vaccine.

Pfizer and BioNTech say there were no serious side effects during the large-scale trials.

To date, the Data Monitoring Committee for the study “has not reported any serious safety concerns related to the vaccine,” the companies said.

The only notable side effect was fatigue in some trial participants.

“The only Grade 3 (severe) solicited adverse event greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.7% following dose 2,” the companies said.

Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia, told CNN on Wednesday that some side effects are normal for vaccines.

“That means your immune response is working for you. You should feel good about that,” he said, while discussing side effects.

He added that should people experience side effects from the first dose, then there shouldn’t be “any difficulty coming back for that second shot, knowing that you’re now in a much better position to fight off this awful virus.”

Is it safe to take more than one vaccine?

Other drugmakers, Moderna and AstraZeneca, also have promising vaccine candidates.

The UK government says studies are underway to determine whether the AstraZeneca and Pfizer/BioNTech vaccines can be given interchangeably across the two doses, since “both … are based on the spike protein of the virus,” but so far it’s unclear whether this is effective.

“There is no evidence as to the interchangeability of the different COVID-19 vaccines although studies are underway. Therefore, every effort should be made to determine which vaccine the individual received and to complete with the same vaccine,” the UK government says, though exceptions are permitted.

The guidance adds that for people who have had one dose and “attend for vaccination at a site where the same vaccine is not available, or where the first product received is unknown, it is reasonable to offer a single dose of the locally available product,” though it adds that this option is preferred if the individual “is likely to be at immediate high risk or is considered unlikely to attend again.”

Correction: A previous version of this story misidentified Özlem Türeci. She is female.

CNN’s Amy Cassidy, James Frater and Lindsay Isaac contributed to this report.

Source link

0

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