As regulators race to approve Pfizer/BioNTech shot, some other vaccine candidates fall by the wayside
On Friday, British and French pharmaceutical giants GlaxoSmithKline and Sanofi Pasteur said the release of their vaccine would be pushed to late next year, while one of Australia’s four vaccine candidates was axed after trial participants returned false positive test results for HIV.
The announcements could present a potential setback in the global effort to gain control of the pandemic, given that experts believe that multiple vaccine options will be required to do so. But there could be a silver lining in stopping a trial, or deciding to move slower in another, as the pace of vaccine development has contributed to concerns in some populations.
Developers from GSK and Sanofi’s vaccine candidate announced they had hit a roadblock on Friday, saying that interim results of their vaccine’s data showed “insufficient immune response” in the elderly and that the release of their vaccine would be delayed until at least mid-2021, if not later.
“Insufficient response in older adults demonstrates the need to refine the concentration of antigen in order to provide high-level immune response across all age groups,” the companies said in a joint press release.
Thomas Triomphe, executive vice president of Sanofi Pasteur, said the companies were “disappointed by the delay,” but that they had identified a path forward.
The companies said they are now planning to run a new study in February using an improved antigen formula, which could be followed by a global Phase 3 study that could potentially start in April. The Phase 3 studies were initially expected to start this month.
This summer, GSK and Sanofi won a commitment from the US federal government to pay up to $2.1 billion to help them move forward with their candidate as part of Operation Warp Speed.
Roger Connor, president of GSK Vaccines, said that “the results of the study are not as we hoped,” and that it was now “clear that multiple vaccines will be needed to contain the pandemic.”
Spreading the risk
Meanwhile, in Australia, health experts have praised the University of Queensland researchers for ending the trial of their joint program with Australian biotech company CSL after participants returned false positive test results for HIV.
“Although it might seem counter-intuitive, from a research ethics viewpoint, this is a success,” said Diego Silva, an health ethics expert at the University of Sydney School of Public Health, in an emailed statement.
The vaccine had yet to progress beyond Phase 1 trials. Australia had hoped the vaccine would be available by mid-2021.
In a statement, CSL said that no serious adverse effects had been reported in the 216 trial participants, and the vaccine was shown to have a “strong safety profile.” However trial data revealed that antibodies generated by the vaccine interfered with HIV diagnosis and led to false positives on some HIV tests, CSL said.
If the vaccine was rolled out nationally, CSL said it could undermine public health in Australia by causing a wave of false positive HIV tests in the community.
“Follow up tests confirmed that there is no HIV virus present, just a false positive on certain HIV tests. There is no possibility the vaccine causes infection,” the statement added.
Morrison said that Australia had backed four vaccines that showed promise but “at no stage … believed that all four of those vaccines would likely get through that process.”
“So that’s why we spread our risk. That’s why we backed important projects. And that’s why we pre-prepared to ensure that we could deal with any issues along the way,” he said.
In addition to the University of Queensland vaccine, Australia had previously ordered a combined 73.8 million doses of the AstraZeneca and the Novavax vaccines.
Australian Minister for Health Greg Hunt said that following the announcement, Australia would be ordering an extra 20 million units from AstraZeneca and 11 million from Novovax.
A vaccine has to pass through three stages of trials before it can then be considered for approval for public use. Australia has yet to grant approval to a coronavirus vaccine candidate.
Adam Taylor, early career research leader in emerging viruses at Griffith University’s Menzies Health Institute, said in an emailed statement that the false positive HIV results were a result of the technology used to create the vaccine.
“The (vaccine’s) molecular clamp is made from a HIV protein, which on its own is harmless. The molecular clamp stabilizes the coronavirus spike protein and presents it to the body in a way that promotes a good immune response. This is why the clamp technology is so vital,” Taylor said.
He added that the clamp model vaccine had shown “good safety and immune response” against the coronavirus in early clinical trials, and the possibility for generating an HIV positive result had been thought to be low.
Pelosi to move forward with impeachment if Pence doesn’t act to remove Trump
“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.
Matt Hancock Scraps “Unnecessary Training Modules” Blamed For Slowing Vaccine Rollout
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.”
How South African police are tackling pangolin smugglers
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.
- Technology8 months ago
First iPhone jailbreak in four years released
- Technology6 months ago
Is OnePlus Nord the Best Phone Under Rs. 30,000?
- Technology8 months ago
The Complete Guide for Building a Website
- Technology8 months ago
Check out the new Gaming Leader: Playstation 5
- Entertainment6 months ago
Jack Harlow Denies JW Lucas’ Credit in Hit ‘Whats Poppin’ After Controversial Breonna Taylor Remarks
- Entertainment6 months ago
Gwyneth Paltrow Names Rob Lowe’s Wife as Her Mentor in Giving Blow Job
- Entertainment6 months ago
Billie Eilish Reflects on Self-Growth on Sweet New Song ‘My Future’
- Entertainment6 months ago
Grimes Slams Baby Daddy Elon Musk After He Tweets ‘Pronouns Suck’