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#EAPM heads for grand depart with newsletter and imminent ESMO round table

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Welcome, one and all, to the final European Alliance for Personalised Medicine (EAPM) update before le grand depart– before you go, do be sure to check out the EAPM newsletter, which is available here. And be sure to register in good time for the ESMO Virtual Congress 2020, at which EAPM will be organizing a round table on 18 September, bringing its stellar cast of specialists from the patients network, as well as experts from the oncology community and the European Medicine Agency (EMA) and European Parliament, writes EAPM Executive Director Denis Horgan. 

The agenda is available here, and you can register already here.

Bringing innovation to patients – choosing the right time to investigate transparency

A major pillar in bringing new, targeted medicines to patients is, of course, innovation. This, in the realm of health, means the translation of knowledge and insight into what we can call ‘value’. And that value covers the value to patients but also has to take into account value to healthcare systems, society and, of course, the manufacturers.  

Transparency and good governance is of course essential, but it must be asked whether, with all resources stretched to near breaking point, now is a good time for European Ombudsman Emily O’ Reilly to be requesting the European Centre for Disease Prevention and Control (ECDC) to provide a number of documents to evaluate its performance during the coronavirus pandemic. 

A request was made during the summer of 2017 when, again, in a similarly unpopular move, the European Ombudsman asked the European Medicines Agency to provide more information about its early dialogue procedures. O’Reilly’s  raises the issue of what the EU is trying to do with its own health regulation in bringing innovation to the patient, but is now really the right time? On verras… O’Reilly suggested a meeting between her inquiry team and the ECDC staff to further clarify and discuss any outstanding issues.

Surviving the pandemic – how different countries have fared

The latest statistics now available have provided one of the clearest pictures yet of how different countries have fared during the pandemic. It demonstrates that while the most devastating short-term and localized spikes in COVID-19 and other deaths were seen in Spain and Italy, England and the rest of the UK endured a longer period of convalescence, with significantly increased excess mortality – England had the highest levels of excess deaths of any country in Europe from January to June, according to a new analysis by the European Office for National Statistics (ONS). 

While Spain saw the worst weekly spike in deaths from all causes during the coronavirus pandemic, England had the “longest continuous period of excess mortality,” the ONS said. By the end of May, England had the highest cumulative mortality rate of any of the 23 countries for which data was available, followed by Spain, Scotland and Belgium. The worst local spike in Europe was in Bergamo, Italy in the week ending 20 March, where an excess mortality rate of 847% — or more than nine times the 2015 to 2019 average — was seen. The major city with the worst spike was Madrid, with excess mortality of 432% in the week ending 27 March.

Dancing, with tears in their eyes

Initially, sad news for everyone planning to put their cares aside with a good boogie – the Romanian government was supposedly planning to ban dancing on public terraces. But, according to Digi24, the powers that be pulled back from this potentially unpopular decision, choosing instead to announce new measures this past week to make wearing a mask mandatory in certain outdoor spaces, such as markets and boardwalks. Local authorities were mandated to decide the spaces and the time slots when people will be required to wear a mask.

France sets out COVID-19 vaccination planning

As the coronavirus pandemic continues, there is hope that one or more of the vaccines in development will be successful. France has revealed its early planning for implementation of a vaccine.  The Haute Autorité de Santé (HAS – High Authority for Health) said: “At the request of the Ministry of Solidarity and Health, the High Authority for Health is making preliminary recommendations to anticipate the development of the vaccine strategy against COVID-19 with a view to the future arrival of one or more vaccines.

Who to vaccinate? According to what scheme? By which professionals? To inform the public decision, the HAS draws the different possible vaccination strategies through four scenarios based on the level of circulation of the virus in the territory.”  

The strategy will be updated as the pandemic continues, ensuring the latest information is incorporated into the plan. In particular, the status and spread of the virus will be monitored.  What is clear now, however, is the need to prioritise medical and health professionals so that the risk of catching and passing on COVID-19 is reduced while essential work continues.

Dutch government not advising public to wear masks

On Wednesday (29 July) this week, the Dutch government said it will not advise the public to wear masks to slow the spread of coronavirus, asserting that their effectiveness has not been proven.The decision was announced by Medical Care Minister Tamara van Ark after a review by the country’s National Institute for Health (RIVM). The government will instead seek better adherence to social distancing rules after a surge in coronavirus cases in the country this week, Van Ark said at a press conference in The Hague. The decision bucks the current trend as many European countries have made masks mandatory in stores or crowded outdoor areas. Masks are currently required only on public transportation in the Netherlands and in airports.

WHO blames youth ‘letting their guard down’ 

Young people are relaxing on social distancing and other ant-coronavirus measures, and are part of the reason for the summer spikes in coronavirus, according to World Health Organization Director General Tedros Adhanom Ghebreyesus: “We have said it before and we’ll say it again: Young people are not invincible,” said Tedros. Countries across Europe are seeing increases in case numbers, with many fearing it’s the start of a second wave.

Coronavirus vaccine ‘not available this year’, WHO warns 

Hopes of a coronavirus vaccine before Christmas have been dashed by a World Health Organization (WHO) expert.   Mike Ryan, head of WHO's emergencies programme, said the first use of a COVID-19 vaccine cannot be expected until early 2021. He noted that several vaccines are now in phase three trials and none have failed so far in terms of safety or ability to generate an immune response. His comments come after Oxford University — one of the frontrunners in a race for a vaccine —  claimed there was still a chance it could deliver its experimental jab by Christmas if tests keep going according to plan.     One of the researchers working on the project had said that people in the most at-risk groups could get the first jabs in the winter. 

A vaccine is considered crucial for getting out of the coronavirus pandemic because it would be the only way to secure protection against catching it. It would work by injecting either a tiny piece of the virus into the body –  which would not make someone sick – or a clone of its DNA. This triggers an immune response which has long-term memory, so if a person is exposed to the coronavirus in real life, their body knows how to fight it quickly.  

Here is the link the newsletter again for the ESMO Agenda and to register

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German vaccine seekers getting aggressive, doctors say

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Germans desperate to be vaccinated against the coronavirus are becoming increasingly aggressive, doctors said on Wednesday (12 May), as frustration mounts after six months of lockdowns even though infection rates are now falling.

"The pressure on vaccination centres and doctors' practices is growing. People pushing for vaccination are becoming more demanding," Anke Richter-Scheer, the deputy head of the German association of family doctors, told the Funke media group.

As Germany extends priority for vaccines to more groups, it is becoming less comprehensible to many people why they should have to wait behind others, Richter-Scheer said.

People are showing up at doctors' practices and trying to get vaccines even though it is not their turn, with the mood getting more aggressive, she said.

Some people are also demanding their second shot early so they can go on holiday or profit from advantages such as shopping without needing a COVID-19 test.

​ Older patients who have been assigned AstraZeneca are also demanding a different vaccine.

After a sluggish start, Germany has been ramping up its vaccination campaign and has now given a first dose to a third of the population, with about 10% fully vaccinated.

It started by vaccinating its oldest citizens and has been gradually expanding shots to younger groups and other priority professions such as teachers, journalists and those working in critical infrastructure.

Several German states, including the capital city Berlin, announced plans on Tuesday planning to loosen coronavirus restrictions in coming days as the number of new infections keeps dropping nationwide. read more

On Wednesday, another 14,909 new cases were reported, bringing the total to 3,548,285, while the death toll rose by 268 to 85,380. However the seven-day incidence per 100,000 people dropped to 108 from 115 on Tuesday.

The government should give citizens clear guidelines on whether and where they can go on holiday by the end of May, Finance Minister Olaf Scholz told the Rheinische Post newspaper.

Holidays should be possible within Germany and in some other countries due to rising vaccinations and falling infections, he said. The northern state of Mecklenburg-Vorpommern, popular with holidaymakers, will open up its tourism sector from June 14.

However, Germany's vaccine committee, known as STIKO, dampened expectations for a speedy approval for vaccination of children and adolescents.

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Delaying second COVID-19 vaccine doses can help reduce deaths - study

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Vials with Pfizer-BioNTech and Moderna coronavirus disease (COVID-19) vaccine labels are seen in this illustration picture taken March 19, 2021. REUTERS/Dado Ruvic/File Photo
A medical worker prepares a dose of the "Comirnaty" Pfizer-BioNTech COVID-19 vaccine inside the exhibition palace transformed into a vaccination center in Nice as part of the coronavirus disease (COVID-19) vaccination campaign in France, April 29, 2021.  REUTERS/Eric Gaillard/File Photo
A phial of the Pfizer/BioNTech COVID-19 vaccine concentrate is diluted with 1.8ml sodium chloride ready for use at Guy's Hospital. Victoria Jones/Pool via REUTERS

Giving a first dose of COVID-19 vaccine but delaying a second dose among people younger than 65 could lead to fewer people dying of the disease, but only if certain conditions are met, a predictive modelling study showed.

As the coronavirus pandemic continues, there is debate over whether to extend the gap between doses to give as many people as possible some protection, or stick to the intervals designated in clinical trials.

For example, Pfizer (PFE.N) has said there is no clinical evidence to support Britain’s decision to extend the gap between doses of its vaccine to 12 weeks, but data from the rollout in England shows protection against death of around 80% from one dose, with a 70% decline in infections.

The US study, published in the BMJ British medical journal, used a simulation model based on a "real-world" sample of 100,000 US adults and ran a series of scenarios to forecast potentially infectious interactions under different conditions.

These included varying levels of vaccine efficacy and immunisation rates, and varying assumptions as to whether the vaccine prevents transmission and serious symptoms or only prevents serious symptoms, including death.

"The results suggest that under specific conditions a decrease in cumulative mortality, infections, and hospital admissions can be achieved when the second vaccine dose is delayed," wrote the researchers, led by the Thomas C Kingsley of the Mayo Clinic in Rochester, Minnesota.

The specific conditions include having a vaccine with a one dose efficacy of at least 80% and having daily immunisation rates of between 0.1% and 0.3% of a population - but if they are met, a delayed second-dose strategy could prevent between 26 and 47 deaths per 100,000 people compared to the usual schedule.

The study did not recommend an optimum schedule.

"Decision makers will need to consider their local vaccination rates and weigh the benefits of increasing these rates by delaying a second dose versus the risks associated with the remaining uncertainty in this strategy," the team said.

Separately, an Oxford University-led study on giving shots from different manufacturers for the two doses reported its first findings - on the frequency of common post-vaccination symptoms such as sore arm, chills or fatigue.

It found that people vaccinated with a shot of Pfizer's vaccine followed by a dose of AstraZeneca's, or vice versa, were more likely to report mild or moderate symptoms such as headaches or chills than if they received two of the same type.

Pfizer and AstraZeneca were the first vaccines available in Britain to be trialled in the “mix-and-match” study. Shots by Novavax and Moderna have since been added to the research.

Key data on immune responses generated by the different combinations of mixed or regular dose schedules is expected to be reported in the coming months, according to Matthew Snape, the Oxford University professor leading the trial.

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Airline launches airbridge to bring relief to virus-stricken India

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The airline Emirates has set up a humanitarian airbridge between Dubai and India to transport urgent medical and relief items, to support India in its fight to control the serious COVID-19 situation in the country, writes Martin Banks.

Emirates will offer cargo capacity free of charge on an “as available” basis on all of its flights to nine cities in India, to help international NGOs deliver relief supplies rapidly to where it is needed.

In the past weeks, Emirates SkyCargo has already been transporting medicines and medical equipment on scheduled and charter cargo flights to India. This latest airbridge initiative takes Emirates’ support for India and for the NGO community to the next level.

HH Sheikh Ahmed bin Saeed Al Maktoum, Emirates’ Chairman and Chief Executive, said: “India and Emirates are deeply connected, since our first flights to India in 1985. We stand with the Indian people and will do all we can to help India get back on its feet. Emirates has a lot of experience in humanitarian relief efforts, and with 95 weekly flights to 9 destinations in India, we will be offering regular and reliable widebody capacity for relief materials. The International Humanitarian City in Dubai is the largest crisis relief hub in the world and we will work closely with them to facilitate the movement of urgent medical supplies.”

The first shipment sent as part of the Emirates India humanitarian airbridge is a consignment of over 12 tons of multi-purpose tents from the World Health Organization (WHO), destined for Delhi, and coordinated by the IHC in Dubai.

Giuseppe Saba, CEO of International Humanitarian City, said: “His Highness Sheikh Mohammed bin Rashid built the International Humanitarian City (IHC), so Dubai, in coordination with humanitarian agencies, would be able to assist communities and families, most in need – around the world. The creation of the humanitarian airbridge between Dubai and India, facilitated by Emirates SkyCargo, Dubai’s International Humanitarian City and UN agencies, to transport urgent medical and relief items, is another example of His Highness Sheikh Mohammed bin Rashid’s vision for the IHC, being brought to life. Last year over 1,292 shipments were dispatched from the IHC in Dubai, setting the standard for humanitarian response globally. We appreciate the great efforts by IHC’s partner Emirates SkyCargo establishing this humanitarian airbridge between Dubai and India in this time of need”.

The freight division of Emirates has a close partnership with IHC, developed over several years of delivering relief materials to communities across the world impacted by natural disasters and other crises. IHC will support Emirates SkyCargo in channelling relief efforts to India through the airbridge.

Following the Port of Beirut blasts in August 2020, Emirates also leveraged its expertise in humanitarian logistics to set up an airbridge to Lebanon to assist with relief efforts.

Emirates has led the aviation and air cargo industry in its efforts to help markets around the world combat the COVID-19 pandemic. The air cargo carrier has helped transport thousands of tonnes of urgently required PPE and other medical supplies across six continents over the last year by rapidly adapting its business model and introducing additional cargo capacity through its modified mini freighters with seats removed from Economy Class on Boeing 777-300ER passenger aircraft along with loading cargo on seats and in overhead bins inside passenger aircraft to transport urgently required materials.

In addition, Emirates SkyCargo has partnered with UNICEF and other entities in Dubai through the Dubai Vaccine Logistics Alliance, to transport COVID-19 vaccines rapidly to developing nations through Dubai. So far, close to 60 million doses of COVID-19 vaccines have been transported on Emirates’ flights, equating to nearly 1 in 20 of all COVID-19 vaccine doses administered around the world.

Through its scheduled cargo flights to close to 140 destinations across six continents, Emirates helps maintain unbroken supply chains for vital commodities such as medical supplies and food.

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