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EU pharma rules, EAPM newsletter and treaties

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Another Easter is around the corner, a further EAPM dispatch for your delight and delectation…and more developments in the current COVID-19 crisis as a new holiday looms. With the aforementioned Easter weekend coming up, it will be interesting to see how many Europeans defy strong recommendations to stay at home. And taking into account the day that it is, EAPM’s newsletter is available here, writes European Alliance for Personalised Medicine Executive Director Dr. Denis Horgan.

In other news....

Changes to EU pharma rules en route

The European Commission has inched a little closer to the wide-ranging changes to EU pharma rules envisioned in its Pharmaceutical Strategy, publishing today (30 March) a document that sets out the objectives of upcoming policy reports and proposals on the topic. 

Plans to cut the time it takes to gain regulatory approval for medicines and medical devices, and drive the development of new antibiotics and other products for treating rare diseases, have been outlined in a wide-ranging new pharmaceutical strategy for Europe.

The strategy, developed by the European Commission, is patient-focused and seeks to build on the collaborative efforts of industry seen during the coronavirus crisis. The Commission hopes to deliver the strategy over a number of years.

Its new Pharmaceutical Strategy seeks "to ensure affordable, safe, quality, innovative and solutions-oriented pharmaceuticals for all citizens in the EU", Vice President Margaritis Schinas announced at the strategy's unveiling.  The 25-page document is packed with technical suggestions to fine-tune Europe's pharma system, but the challenge will be to translate these into tangible changes for European consumers. Experts think the strategy — if properly implemented — has the potential to make drugs more affordable, boost the variety of treatments available, drive forward innovation and firm up supply chain resilience. 

COREPER vaccine controversies

An internal squabble with COREPER over extra vaccines was just the latest controversy as the EU tries to speed its inoculation campaign. The decision to seek arbitration among the ambassadors came after Austrian Chancellor Sebastian Kurz virtually sabotaged the meeting by insisting that his country receive extra doses, even though European Commission data shows Austria faring relatively well among EU nations in terms of vaccine supplies. 

Kurz in a corner

A discussion tomorrow (31 March) will focus on Austrian Chancellor Sebastian Kurz’s attempt to get more vaccines. On 12 March, the 34-year-old vehemently accused the EU of unfairly distributing vaccine doses among its 27 member states. 

Lashing out at the ‘EU bazaar’, he demanded adjustments in favor of member states that received less doses than others. Kurz took the dispute all the way to the European Council meeting in Brussels last week, taking precious time away from pressing issues on the agenda—transatlantic relations, a common vaccination “passport,” and possible vaccine export bans. German Chancellor Angela Merkel reportedly got so annoyed with Kurz that she reminded the group that vaccine contracts were signed by member states themselves “and not by some stupid bureaucrats” in Brussels.

Pandemic treaty push

Leaders from 23 countries, the EU and WHO today (30 March) backed a push for a new global treaty to better prepare the world to tackle future pandemics. The call came in an op-ed published internationally that was signed off by leaders from five continents, including Germany’s Angela Merkel, Britain’s Boris Johnson, France’s Emmanuel Macron, South Korea’s Moon Jae-in and South Africa’s Cyril Ramaphosa. “We believe that nations should work together towards a new international treaty for pandemic preparedness and response,” the op-ed said. 

“Such a renewed collective commitment would be a milestone in stepping up pandemic preparedness at the highest political level.”The push to bolster common efforts comes as the planet struggles to combine forces to overcome the COVID-19 pandemic that has killed almost 2.8 million people worldwide. 

The spread of the virus has seen blame traded between capitals and accusations that rich nations have hoarded vaccines as economies around the globe have been battered.

“Together, we must be better prepared to predict, prevent, detect, assess and effectively respond to pandemics in a highly coordinated fashion,” the leaders said. “At a time when COVID-19 has exploited our weaknesses and divisions, we must seize this opportunity and come together as a global community for peaceful cooperation that extends beyond this crisis.”

ECDC – immune transmission

More than one year into the SARS-CoV-2 pandemic, over 120 million people have been infected with the virus across more than 200 countries. Reinfections following natural infections with the same or a new SARSCoV-2 variant have been reported sporadically and questions remain concerning the duration of immunity following natural infection, and whether asymptomatic reinfected individuals may be able to transmit the virus.

COVID-19 vaccines have been evaluated for their efficacy and effectiveness against symptomatic COVID-19 infection and for reducing and/or preventing mild, moderate, or severe COVID-19 disease, including mortality. However, the vaccine trials have not been designed to measure reduction in transmission risk from infected vaccinated individuals to susceptible contacts.

In this context, it is important to understand the available scientific evidence on the extent to which previous SARS-CoV-2 infection or COVID-19 vaccination prevents onward transmission from infected individuals to susceptible contacts. Therefore, ECDC has conducted a review of published and pre-print literature on duration and characteristics of immunity following a natural SARS-CoV-2 infection due to any variant or after COVID-19 vaccination with any of the EU-authorized vaccines now available.

Evidence from studies specifically designed to assess the impact of previous infection on the risk of transmission is currently lacking. Infection with SARS-CoV-2 does not provide sterilising immunity for all individuals and some who are reinfected might still be able to transmit SARS-CoV-2 infection to susceptible contacts. 

There is evidence that reinfection remains a rare event. Results from cohort studies confirm that the protective effect of previous SARS-CoV-2 infection ranges from 81% to 100% from Day 14 following initial infection, for a follow-up period of five to seven months. Protection against reinfection is lower in individuals aged 65 years and older. 

As the number of individuals acquiring natural immunity increases, the total number of infections is expected to decrease significantly, leading to decreased transmission overall, unless the genetic changes in the circulating variants induce significant immune escape. 

Brain on centre stage

The launch of the OneNeurology Partnership, a new initiative from the European Federation of Neurological Associations (EFNA), has taken place — together with the European Academy of Neurology, European Brain Council, World Stroke Organisation and Alzheimer’s Disease International, the partnership is aiming to raise the profile of brain diseases. The goal is “to build political interest” so that the Commission and member countries pay attention to the disease group and start formulating national-level neurology plans. The Commission can act as an organizer and facilitator to co-ordinate different national plans. 

EU vaccine chief says vaccine passports to be launched in June

Internal Market Commissioner Thierry Breton, who back in February this year was put in charge of the new vaccine production task force by the Commission, has unveiled the prototype of the announced EU vaccine passports.

During an interview for RTL radio and TV channel LCI, Commissioner Breton also said that the new documents which will prove that the traveller has been vaccinated, recovered from COVID-19, or his/her test results in case none of the two first has taken place, will be issued to EU citizens somewhere in mid-June ideally.

“From the moment we can be sure that every European who wants to be vaccinated will have fair access to the vaccine, as will be the case in the next two to three months – it will be good to have a health certificate that demonstrates your condition,” the commissioner said.

The Commission brought forward its proposal for the creation of a Digital Green Certificate in a bid to restore travel amid COVID-19 for those who have been vaccinated against the virus, SchengenVisaInfo.com reports.

And that is all from EAPM for now – don’t forget to have a read of our newsletter here, and our very best wishes to you all for a safe and happy Eastertide. Here is the link to our newsletter again. 

Stay safe until next time.

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What you need to know about the coronavirus right now

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Here’s what you need to know about the coronavirus right now, writes Linda Noakes.

Brazil deaths on track to pass worst of US wave

Brazil’s brutal surge in COVID-19 deaths will soon surpass the worst of a record January wave in the United States, scientists forecast, with fatalities climbing for the first time above 4,000 in a day on Tuesday as the outbreak overwhelms hospitals.

Brazil’s overall death toll trails only the US outbreak, with nearly 337,000 killed, according to Health Ministry data, compared with more than 555,000 dead in the United States.

But with Brazil’s health-care system at the breaking point, the country could exceed total US deaths, despite having a population two-thirds that of the United States, two experts told Reuters.

India posts record cases

India’s second wave of infections continued to swell as it reported a record 115,736 new cases on Wednesday (7 April), a 13-fold increase in just over two months.

The federal government has asked states to decide on local curbs to control the spread of the virus, but has so far refused to impose any national lockdown after the last one in 2020 devastated its economy.

The total number of cases since the first recorded infection in India just over a year ago now stands at 12.8 million, making it the third worst hit country after the United States and Brazil.

Japan’s Osaka cancels Olympic torch run

Japan’s western region of Osaka on Wednesday cancelled Olympic torch events scheduled across the prefecture, as record infections prompted its government to declare a medical emergency.

Health authorities fear a virus variant is unleashing a fourth wave of infections just 107 days before the Tokyo Olympics begin, with a vaccination drive still at an early stage.

The prefecture reported 878 new infections on Wednesday, a second-straight day of record numbers. Severe cases have filled about 70% of hospital beds in the region.

UK begins rollout of Moderna vaccine

Britain begins rolling out Moderna’s COVID-19 vaccine on Wednesday in Wales and expects to be using it in the rest of the United Kingdom in the coming days in a boost to the country’s health system after supplies of shots started to slow.

Moderna will become the third vaccine to be used in Britain after the Oxford-AstraZeneca and Pfizer jabs and comes as the supply of shots from Astra starts to slow due to manufacturing issues including at a site in India.

The United Kingdom has vaccinated 31.6 million people with a first dose of a COVID-19 vaccine - and administered 5.5 million second doses. It will soon have vaccinated half of its total population.

A third of survivors suffer neurological or mental disorders

One in three COVID-19 survivors in a study of more than 230,000 mostly American patients were diagnosed with a brain or psychiatric disorder within six months, suggesting the pandemic could lead to a wave of mental and neurological problems, scientists said on Tuesday (6 April).

Researchers who conducted the analysis said it was not clear how the virus was linked to psychiatric conditions such as anxiety and depression, but that these were the most common diagnoses among the 14 disorders they looked at.

Post-COVID cases of stroke, dementia and other neurological disorders were rarer, the researchers said, but were still significant.

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IMF says more vaccine spending is fastest way to shore up public finances

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The COVID-19 pandemic will continue to swell global public debt in 2021, but spending more money to accelerate vaccinations is the fastest way to start to normalize government finances, the International Monetary Fund said on Wednesday (7 April), writes David Lawder.

The IMF said in its 2021 Fiscal Monitor report that if faster global vaccinations bring the virus under control sooner, more than $1 trillion in additional global tax revenue could be collected through 2025 in advanced economies.

If that same upside scenario in the Fund’s economic forecasts materializes, global GDP output could increase by $9 trillion during the same period as businesses reopen and hire more quickly, the IMF said.

“Vaccination will, thus, more than pay for itself, providing excellent value for public money invested in ramping up global vaccine production and distribution,” the IMF said in the report.

The IMF and the World Bank during their virtual Spring Meetings this week are urging member countries to keep up fiscal support for their economies and vulnerable citizens and businesses until the pandemic is firmly under control.

The Fund estimated governments have deployed some $16 trillion in pandemic-related fiscal support since the pandemic started through March 17 this year. That includes $10 trillion from additional spending and foregone revenue, and $6 trillion worth of government loans, guarantees and capital injections for businesses.

In 2021, the Fund projects fiscal deficits will shrink slightly in most countries as pandemic-related support expires or winds down, unemployment claims drop and revenues start to recover as businesses reopen.

Average overall budget deficits reached 11.7% of GDP for advanced economies in 2020 -- quadruple their 2.9% share in 2019 -- but they should narrow to 10.4% in 2021, the IMF said.

Deficits in emerging economies will also shrink slightly in 2021 to 7.7% of GDP for emerging market economies and to 4.9% for low-income economies.

Average worldwide public debt is projected to hit a record 99% of GDP in 2021 and to stabilize at that level after rising slightly from 97% in 2020. For advanced economies, debt will peak at 122.5% in 2021, up from 120.1% in 2020.

The IMF called for more targeted support for vulnerable households, including minorities, women and workers in low-paying jobs in the informal sectors of many economies. More focused support for small businesses was also needed, it said.

But it said some advanced countries with high debt levels may need to start rebuilding fiscal buffers to prepare for future shocks. It said those countries should develop multi-year frameworks for increasing revenues and rationalizing spending, giving priority to investments to fight climate change and reduce economic inequality.

In a Fiscal Monitor chapter released last week, the IMF said advanced economies could use more progressive income taxes, inheritance and property taxes, and taxes on “excess” corporate profits to help reduce inequalities exposed by the COVID-19 pandemic.

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A third of COVID survivors suffer neurological or mental disorders: study

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One in three COVID-19 survivors in a study of more than 230,000 mostly American patients were diagnosed with a brain or psychiatric disorder within six months, suggesting the pandemic could lead to a wave of mental and neurological problems, scientists said this week, writes Kate Kelland.

Researchers who conducted the analysis said it was not clear how the virus was linked to psychiatric conditions such as anxiety and depression, but that these were the most common diagnoses among the 14 disorders they looked at.

Post-COVID cases of stroke, dementia and other neurological disorders were rarer, the researchers said, but were still significant, especially in those who had severe COVID-19.

“Although the individual risks for most disorders are small, the effect across the whole population may be substantial,” said Paul Harrison, a professor of psychiatry at Oxford University who co-led the work.

Max Taquet, also an Oxford psychiatrist who worked with Harrison, noted that the study was not able to examine the biological or psychological mechanisms involved, but said urgent research is needed to identify these “with a view to preventing or treating them”.

Health experts are increasingly concerned by evidence of higher risks of brain and mental health disorders among COVID-19 survivors. A previous study by the same researchers found last year that 20% of COVID-19 survivors were diagnosed with a psychiatric disorder within three months.

The new findings, published in the Lancet Psychiatry journal, analysed health records of 236,379 COVID-19 patients, mostly from the United States, and found 34% had been diagnosed with neurological or psychiatric illnesses within six months.

The disorders were significantly more common in COVID-19 patients than in comparison groups of people who recovered from flu or other respiratory infections over the same time period, the scientists said, suggesting COVID-19 had a specific impact.

Anxiety, at 17%, and mood disorders, at 14%, were the most common, and did not appear to be related to how mild or severe the patient’s COVID-19 infection had been.

Among those who had been admitted to intensive care with severe COVID-19 however, 7% had a stroke within six months, and almost 2% were diagnosed with dementia.

Independent experts said the findings were worrying.

“This is a very important paper. It confirms beyond any reasonable doubt that COVID-19 affects both brain and mind in equal measure,” said Simon Wessely, chair of psychiatry at King’s College London.

“The impact COVID-19 is having on individuals’ mental health can be severe,” said Lea Milligan, chief executive of the MQ Mental Health research charity. “This is contributing to the already rising levels of mental illness and requires further, urgent research.”

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