Malaria vaccine ... could save millions of lives

Malaria vaccine combined with other drugs could save millions of lives

 

Charlotte Mitchell For Mailonline

 

4 hrs ago

Scientists have found a potential new approach to tackling malaria that could save the lives of millions of children. 

A study by a team from the London School of Hygiene & Tropical Medicine (LSHTM) found that giving young children a vaccine as well as antimalarial drugs cut hospital admissions with severe disease and deaths by almost three quarters. 

Using the combined approach, incidents of clinical malaria and hospital admissions with a severe form of the disease were reduced by 62.8 per cent and 70.5 per cent respectively.

Deaths from malaria were reduced by 72.9 per cent.

The researchers said the results were 'striking' and even better than they had expected. 

Their work, published in the New England Journal of Medicine, was carried out alongside researchers in Burkina Faso and Mali.

The trial followed some 6,000 children aged between five months and 17 months in the two West African countries, both of which have a high burden of malaria.

They found that a combination of giving them the world's first malaria vaccine (RTS,S/AS01E) - made by Brentford-based GSK - and seasonal administration of antimalarials (SMC) was more effective than either approach on its own. 

SMC, which involves giving anti-malarial drugs sulfadoxine-pyrimethamine and amodiaquine to young children every month during the rainy season, is the approach used in both countries. 

The researchers hope this new combination approach has the potential to prevent malaria in large parts of Africa where cases remain high and where the disease is transmitted seasonally.

They said seasonal vaccination with RTS,S/AS01E was also found to be as effective as four annual courses of SMC in protecting against clinical malaria.

Professor Brian Greenwood from LSHTM said while there have been 'great strides' in tackling malaria, progress has slowed in recent years.

He said: 'We urgently need new interventions, particularly in many parts of the Sahel and sub-Sahel where the burden of malaria remains very high.

'We aimed to find out if RTS,S/AS01E (the vaccine) could be more effective in areas with seasonal transmission by giving children three doses of the vaccine before the malaria transmission season, and then a booster dose before the rainy season over subsequent years.

'The results are very striking and could pave the way for a potential new approach to malaria control.'

Professor Daniel Chandramohan from LSHTM and a member of the research team said the combined treatment had the potential to be a 'game-changer,' adding: 'The results of the trial were much more successful than we had anticipated.

'Our work has shown a combination approach using a malaria vaccine seasonally - similar to how countries use influenza vaccine - has the potential to save millions of young lives in the African Sahel.

'Importantly, we didn't observe any new concerning pattern of side effects.

'Further research is now needed to examine how seasonal malaria vaccination could be delivered most effectively at scale.'

Professor Alassane Dicko, of the Malaria Research and Training Centre in (MRTC) Bamako, Mali, said: 'This new malaria tackling tool could mean the disease is no longer the primary cause of death or hospital admissions in our settings for the very first time.

'This is wonderful news for malaria control. We look forward to a quick policy decision and addition of this new tool to reduce the intolerable burden of malaria in our region.'

Professor Jean-Bosco Ouedraogo, Institut de Recherche en Sciences de la Sante in Burkina Faso, said: 'I am really proud of the contribution of our African research teams to these fantastic results.

'I hope that this evidence will be taken into account by decision-makers as a new additional strategy for saving children's lives in Africa.'

Gareth Jenkins, director of advocacy at the Malaria No More charity, said: 'Today's RTS,S result is yet another example of the fruits of UK science leadership and funding in collaboration with international partners on the global stage.

'This government could be the government that helps end malaria for good but, to claim that mantle, it must continue to invest in the research projects our brilliant scientists and institutions need.'

https://www.msn.com/en-gb/health/medical/malaria-vaccine-combined-with-other-drugs-could-save-millions-of-lives/ar-AANKmqe?ocid=msedgntp

AstraZeneca boss Pascal Soriot plots the way to a post-virus world

We will give two billion doses by end of the year: After a pandemic which has tested AstraZeneca to the limit, boss Pascal Soriot plots the way forward to a post-virus world

• In contrast to more mercenary rivals at Pfizer and Moderna, the UK pharma group has supplied the jab to the NHS and overseas customers at close to cost 
• Yet for all AZ's efforts to benefit humanity, Soriot has been vilified in Europe 
• In spite of the setbacks in the EU, the French chief executive is unfazed 
• This autumn, AZ's £1bn-plus research centre opens in Cambridge 

By ALEX BRUMMER FOR THE DAILY MAIL

PUBLISHED: 22:03 BST, 5 August 2021 | UPDATED: 22:03 BST, 5 August 2021

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Pascal Soriot is the visionary CEO of AstraZeneca

Pascal Soriot has had a bruising time since the start of the pandemic. The visionary chief executive of AstraZeneca has helped save tens of thousands of British and overseas lives with the rapid roll-out of the Oxford Covid-19 vaccine. 

In contrast to more mercenary rivals at Pfizer and Moderna, the UK pharma group has supplied the jab to the NHS and overseas customers at close to cost. Yet for all AZ's efforts to benefit humanity, Soriot has been vilified in Europe and found his company on the wrong side of vaccine nationalism in the United States. 

In spite of the setbacks and legal challenges in the EU, the French chief executive is unfazed. 'We are in discussions with the EU to ensure a settlement and want to move on,' he says. 'Despite all this criticism we are the second largest supplier of vaccine to Europe.' 

In the US, Astra has never received the emergency approvals bestowed on the big three American vaccine providers Pfizer, Moderna and Johnson & Johnson. Soriot notes wryly that in the banking crisis of a decade ago, the US 'defended its banks very aggressively'. 'America First', former President Trump's slogan, might well explain the hold-ups that AZ confronted in winning fast-track approval in Washington. 

Soriot has now decided to forget the hold-up and go for full approval. AZ will offer US regulators 'tens of thousands of pages of data' from studies in the US, South Africa, Japan, India and elsewhere, demonstrating the OxfordAZ vaccine's efficacy and safety. 

In an interview from AZ's Continental hub in Zurich, Soriot, 62, is relaxed in sports jacket and open-neck shirt. He is proud that from a standing start, AZ, with limited vaccine history, has managed to produce and distribute 1bn doses and is promising at least 1bn more before it thinks about charging a market-driven price. 

He says: 'We went into this with our eyes wide open knowing what we were doing. That enabled us to deliver so many doses to a lot of countries. Some 60pc of the data [on how the vaccine has worked on individuals] is going to be recovered, which is very rare and we are very excited by it. We think we will get in excess of 2bn doses this year.' 

He adds that all that AZ has done was for 'humanitarian reasons' and in spite of its success he and his team have not yet decided whether they want to do more in the vaccine business long term. What is clear from recently published financial results is the revenue and profits sacrifice that AstraZeneca and its Oxford partners have made. Pfizer has projected income of £21.4bn over the full year for its vaccine and last month raised the price to countries buying booster shots. 

In contrast, in the second quarter of the year AZ reported a modest £643m revenue from its vaccine sales. Soriot has based himself in Zurich for the time being because the highly regulated Heathrow-US air corridor makes it difficult to travel to America's east coast. 

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In contrast to more mercenary rivals at Pfizer and Moderna, the UK pharma group AZ has supplied the jab to the NHS and overseas customers at close to cost

Earlier this year, the AZ chief found himself under fire for spending months at his family home in Sydney while controversy was swirling around the efficacy of the vaccine and deliveries. The Astra chief is unrepentant. 

'I wanted to be there [in Australia] for Christmas. I didn't see my family for ten months and now I am not sure when I will see them again. The pandemic is raging in Australia. I'm not sure when they are going to re-open the border.' 

Now that the controversy has faded, Soriot, a scientist by training, delights in quoting from studies of vaccine efficacy which undermine European and American scepticism. The monumental amount of data is very encouraging, he says: 'It shows the vaccine is safe and has great effectiveness.' 

The most important pieces of information [from all the vaccines] are about what is the long term effect on your heart

He points to a Spanish study just published in the Lancet, funded by the European Medicines Agency, which shows that the Americans also have a rare side-effect danger with their vaccines, and the outcomes are very similar. H e says: 'The most important pieces of information [from all the vaccines] are about what is the long term effect on your heart.' 

It's very rare, but patients need to watch symptoms and get platelets measured if they develop headaches, which could indicate that a medical check is needed. The good news for those who have received the Astra jab, based on traditional vaccine science, is that it may well be better at protecting against infection over the longer term than the Pfizer and Moderna shots. 

Studies suggest that there is a slight decline in the efficacy of Pfizer over six months, hence the need for a booster programme. Soriot is hopeful that the AZ immunisation provides longer term protection. Studies from a similar vaccine used to tackle the Zika virus show that the so called T-cells kick in and 'provide years of protection'. 

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Soriot has steered AZ’s vaccine programme with surety, with consignments being distributed all over the world

These results are echoed by a study at Birmingham University which Soriot says 'shows our vaccine stimulates T-cells more'. He expects to have full data on this by October/November, when large numbers of people in the UK and elsewhere will have been double vaccinated for six months. But the early results are promising. 

What the pandemic has done is focus attention in the UK and on overseas markets on the rise and rise of AZ under Soriot's tutelage since it successfully fought off a takeover approach from Pfizer in 2014. The Frenchman is proud of the way in which he and the board of directors fought off an unwanted overture. He is scathing about what happens in takeovers. 

'When you accept an offer you make some money as a manager and the shareholders are happy because they got a premium. The problem is the ecosystem goes. The company disappears and becomes a branch, then the substance [the intellectual property behind the company] disappears.' 

By staying independent, AZ has grown by leaps and bounds, developing a whole range of new medicines to fight cancer. In the pandemic, Soriot quietly engineered one of the biggest recent takeovers by a UK firm when he bought the Boston-based rare disease group Alexion for £28bn. 

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Professor Sarah Gilbert designed the Oxford vaccine

He believes the expertise bought fits in with AZ's ground-breaking work on immunology treatments, where the body's own defences fight disease, and could be valuable in advancing its already promising work on kidney diseases. For someone who has been chief executive for nearly a decade, and steered AZ into the enviable position of being the UK's most valuable company, Soriot shows no sign of tiring of the excitement. 

This autumn another of his dreams will be fulfilled when AZ's £1bn-plus research centre opens in Cambridge. Soriot wants it to be a temple of science and medicine, working alongside the nearby Addenbrooke's Hospital and Laboratory of Molecular Biology, which has the 'highest density' of Nobel prize-winners of any research institute in the world. Unusually, the AZ facility will offer secure research facilities to scientists with great ideas from outside the company. Just like the embrace of Professor Sarah Gilbert's (pictured) Oxford vaccine, he regards the new research centre as another noble cause. 

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AstraZeneca boss Pascal Soriot plots the way forward to a post-virus world

Stand firm against activists, Emma! Pascal Soriot from rival AstraZeneca gives backing to besieged Glaxo boss

• Emma Walmsley of Glaxosmithkline is facing an assault from activist investors 
• Pascal Soriot's intervention in defence of a rival is largely based on his own experience and that of his board in repelling a bid from US pharma giant Pfizer
• He rejected the claim from Elliott Advisers that Walmsley was unsuited to heading GSK's pharma and vaccines arm because she isn't a scientist

By ALEX BRUMMER FOR THE DAILY MAIL

PUBLISHED: 21:58 BST, 5 August 2021 | UPDATED: 21:58 BST, 5 August 2021

 
 
 
 
 
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Emma Walmsley of Glaxosmithkline

AstraZeneca boss Pascal Soriot is urging Emma Walmsley to stand firm and stick with her plans for Glaxosmithkline amid an assault from activist investors. His unusual intervention in defence of a rival is largely based on his own experience and that of his board in repelling a bid from US pharma giant Pfizer in 2014.

'If you are challenged by another company, the key is to have a good plan and stick to it and implement,' Soriot told the Daily Mail. 

He rejected the claim from Elliott Advisers that Walmsley, one of a handful of FTSE100 women chief executives, was unsuited to heading GSK's freestanding pharma and vaccines arm because she isn't a scientist. 

'It's important that the pharmaceutical companies understand every aspect of the firm. You don't necessarily need to be a scientist. Over the years very smart people will gain the knowledge and be able to be fluent in discussions with scientists,' Soriot says. 

At a time when it seems that much of the FTSE is under siege from private equity and overseas buyers, Soriot urged directors to be tougher. 'It's a sad story for the board. It's much easier to take a premium. In AZ's case, when it came under siege we had a chairman [Leif Johansson] who, when he says no, it's no.'

Having seen Pfizer in action in the past, Soriot, 62, did not want to contemplate selling. 'I have seen the cost cutting which follows and the disorganisation in the [drugs] pipeline.' 

He wanted to rebuild AZ's drug development, and in particular the company's cancer fighting capacity. He said: 'We thought if we derail this development, it's going to impact our patients and our shareholders.' 

At a time when so much of the UK's aerospace, engineering and tech sector is under siege the AZ boss has no doubt about the consequences. He said: 'First the company disappears, it becomes a branch. Then the substance [the R&D and science] disappears. It takes five years but it happens.' 

He and the AZ board, having stood up to a predator, find it hard to understand why the independent directors in other sectors have failed to put up a more robust defence. 'Senior non-executives seem not to have stood up.' His advice to Walmsley and the GSK board is 'do what you think is right'. 

https://www.thisismoney.co.uk/money/markets/article-9865989/Stand-firm-against-activists-Emma-Rival-Soriot-gives-backing-besieged-Glaxo-boss.html

27.05.21 Sanofi, GSK kick off Phase Three trial for Covid-19 shot

 THU, MAY 27, 2021 - 4:50 PM

France's Sanofi and Britain's GlaxoSmithKline launched a late-stage human trial for a recombinant Covid-19 vaccine candidate on Thursday which they hope to get approved by the end of 2021. 

PHOTO: REUTERS

[PARIS] France's Sanofi and Britain's GlaxoSmithKline launched a late-stage human trial for a recombinant Covid-19 vaccine candidate on Thursday which they hope to get approved by the end of 2021.

The study initiated by Sanofi and GSK is one of the first late stage trials that combines tests for boosters and variants, as drugmakers adapt their strategies to deal with an evolving coronavirus.

The two drugmakers, which earlier this month reported positive interim results, confirmed their double-blind, placebo-controlled, Phase Three study would include more than 35,000 adults in the United States, Asia, Africa, and Latin America.

"In a two-stage approach, the study will initially investigate the efficacy of a vaccine formulation targeting the original virus, while a second stage will evaluate a second formulation targeting the B.1.351 virus," Sanofi said.

The virus lineage known as B.1.351 was first detected in South Africa.

"Recent scientific evidence shows that antibodies created against the B.1.351 variant may provide broad cross-protection against other more transmissible variants," Sanofi said.

"The design of the Phase Three, conducted across a broad diversity of geographies, also allows evaluation of the efficacy of the candidate against a variety of circulating variants," the French drugmaker added in a statement.

Sanofi also confirmed it would begin clinical studies in the coming weeks to assess the efficacy of the vaccine as a booster, regardless of what vaccine a subject may have received first.

Pending a positive Phase Three outcome, the vaccine could be approved in the fourth quarter after it was initially targeted for the first half of the year before a setback.

Sanofi and GSK were forced to restart their trial in December when the vaccine showed a low immune response in older adults as a result of a weak antigen formulation.

REUTERS

https://www.businesstimes.com.sg/consumer/sanofi-gsk-kick-off-phase-three-trial-for-covid-19-shot

26 Apr 21 UK Covid vaccines and ones in the works

What Covid vaccines does the UK have and which are in the works?

As Valneva recruits volunteers for final stage trials of its vaccine, here is the current state of play in Britain

Ian Sample Science editor

@iansample

Mon 26 Apr 2021 00.01 BST

A nurse prepares a dose of the Moderna Covid-19 vaccine at West Wales general hospital in Carmarthen. Photograph: WPA/Getty Images

Vaccines to protect against the coronavirus were designed, tested and manufactured in record time, and several have been approved for use in the UK vaccination programme, with a number of others under consideration.

Pfizer/BioNTech

The vaccines taskforce secured 40m doses of the Pfizer/BioNTech vaccine, the first coronavirus shot to be approved by the medicines regulator. The NHS vaccine rollout began on 8 December 2020 when 90-year-old Margaret Keenan became the first person in the world to receive the jab as part of a mass vaccination programme. This is one of the cutting-edge mRNA vaccines that smuggles the genetic instructions for making the coronavirus spike protein into muscle cells. Coronavirus is covered in spike proteins, so making human cells manufacture it primes the immune system to attack the virus should it invade.

Oxford/AstraZeneca

With 100m doses on order, the Oxford/AstraZeneca vaccine is a major pillar of the national immunisation programme. The first shot outside trials was given on 4 January 2021. The vaccine is based on a virus that causes common colds in chimps. The virus is engineered to ensure it cannot replicate in humans and modified further to include the genetic instructions to make the coronavirus spike protein.

NIH/Moderna

The second mRNA vaccine to reach the market joined the country’s vaccination programme less than three weeks ago, on 7 April. The government has ordered 17m doses of the Moderna jab. In response to the very rare blood clots seen in some people who receive the Oxford/AstraZeneca vaccine, people under 30 in the UK are offered Moderna or Pfizer shots instead.

Novavax

The UK medicines regulator is expected to approve the Novavax vaccine imminently. It is known as a protein subunit vaccine and incorporates a lab-made coronavirus spike protein and an ingredient called an adjuvant that makes the body’s immune response stronger. The UK has ordered 60m doses. While Novavax is a US company, supplies for the mass vaccination programme will be made in Stockton-on-Tees with the final “fill and finish” step at GlaxoSmithKline’s plant in Barnard Castle, County Durham.

Covid-19 in the UK

Mar

Daily cases

1,907

-154  vs last week

Daily deaths

7

Total deaths

127,524

Vaccination rollout

Dec

Daily vaccinations

535,113

-65,688  vs last week

Received 1st dose

51.4%

Received 2nd dose

22.4%

Cases and deaths as published 1 May 2021, vaccinations as published 30 Apr 2021. Daily vaccinations includes both doses, % is of total population. Weekly change shows difference from 7 days ago. Source: data.gov.uk.

Janssen/Johnson & Johnson

The UK medicines regulator is conducting a rolling review of the Janssen vaccine, which is based on similar “viral vector” technology to the Oxford/AstraZeneca shot. US health officials lifted a short pause in administering the Janssen vaccine on Saturday after deciding that the benefits outweighed the low risk of blood clots that resemble those seen in small numbers of people who received the Oxford/AstraZeneca shot. A major advantage of the Janssen vaccine is that it requires only one dose while the others need two. The UK vaccines taskforce has ordered 30m doses.

Others

If it performs well in final stage trials, Valneva’s vaccine, which uses an inactivated whole virus and an adjuvant to strengthen the immune response, could be approved for use as a booster this autumn. The government has secured up to 100m doses. Further orders are in for 60m doses of a GSK/Sanofi vaccine and 50m doses of another mRNA vaccine from the German company CureVac. Both are still in trials.

https://www.theguardian.com/society/2021/apr/26/what-covid-vaccines-does-uk-have-valneva