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EAPM – Advancing gene therapy with Advanced Therapy Medicinal Products

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Good afternoon, and welcome health colleagues to the first European Alliance for Personalised  Medicine (EAPM) update of the week, as we move delightedly towards Christmas. EAPM has just released a leading paper on gene therapy – more of this below, along with the customary updates, writes EAPM Executive Director Denis Horgan. 

ATMPs push forward prospects for tackling severe disease

EAPM has released a paper on gene therapy, based on its recent policy discussion, Propelling Healthcare with Advanced Therapy Medicinal Products’Challenges confront the sector, complicating the translation from research into patient access. Scientific, clinical development and regulatory issues are compounded by limited experience with clinical and commercial use, limited manufacturing know-how, high costs, and difficulties in accessing development funding and investment.

Pricing and reimbursement and market access issues are an additional challenge, particularly in Europe, where unfamiliarity with the technology and uncer- tainty over the use of real-world evidence induce caution among clinicians, health technology assessment bodies and payers. There is a need for a review of the suitability of the regula- tory and market access framework for these products, focused development of data, public/ private partnerships, and fuller collaboration governments, doctors, insurers, patients, and pharmaceutical companies.

This paper makes specific recommendations for all stakeholders, ranging from early dialogue on potential products, linking of clinical data, and patient registries or standardization of control frameworks, to a comprehensive approach to evidence generation, assessment, pricing, and payment for ATMPs. The paper is available here.

€5.1 billion secured for EU Health Programme 

On 14 December, the biggest ever EU Health Programme and the rules to distribute its €5.1 billion funds were agreed. Negotiators of the European Parliament and EU member states struck a deal on the law setting up the European Union’s so called 'EU4Health' Programme from 2021 onwards. 

"The COVID-19 pandemic has revealed that Europe was not equipped to deal with a serious health crisis. During the first peak of the pandemic, we not only lacked doctors, nurses and medical staff, but also medicines and medical equipment. It must never happen again that a doctor must choose who lives or dies because the hospital does not have resources to help all," said the EPP Group's Cristian Silviu Bușoi MEP, the lead negotiator for the European Parliament and a stronger support of EAPM.

"Therefore, the programme will allocate funds for the establishment of a reserve for essential crisis-relevant products, medical and healthcare staff, in synergy and complementarity with other EU instruments," he added. Requisite to the health programme that Bușoi negotiated is an increase in health funding in the new EU long-term budget. 

The EPP Group also wanted the programme to support the training of health staff, reduce health inequalities, support digitalization in the health-care sector, finance a masterplan against cancer and bring back the production of medicines to Europe.

WHO does not envisage COVID-19 vaccines being made mandatory

The World Health Organization (WHO) does not foresee countries making it mandatory for citizens to take the new COVID-19 vaccines which have been developed, an official said. “I don’t think we envisage any countries creating a mandate for vaccinations,” Kate O’Brien, the WHO’s director of immunization vaccines and biologicals, told a news conference.

Pressure mounts on EU drug regulator to approve COVID-19 vaccine

Europe’s drug regulator is under increasing pressure to quickly approve the COVID-19 vaccine  developed by Germany’s BioNTech, officials said, as inoculations get started in Britain and the United States. The push underscores the frictions between regulators and governments wishing to curb the pandemic that has killed more than 1.6 million people worldwide. Four EU sources said that the European Medicines Agency (EMA) has been under pressure from the European  Commission and EU governments to approve vaccines more quickly. One EMA official said on 14 December that pressure had increased on the agency from EU governments “through usual channels of communications” after 2 December, when the British regulator granted an emergency authorization to the Pfizer/BioNTech vaccine.

UK health secretary announces discovery of new coronavirus variant 

UK Health Secretary Matt Hancock appeared in the House of Commons on Monday (14 December) to give an urgent statement to MPs on the coronavirus pandemic in the UK. He said experts have identified a new variant of COVID-19 which may be responsible for the "faster spread" in south-east England. 

Hancock said: "Over the last few days, thanks to our world-class genomic capability in the UK, we have identified a new variant of coronavirus which may be associated with the faster spread in the south of England." 

He added: "Initial analysis suggests that this variant is growing faster than the existing variants. We've currently identified over 1,000 cases with this variant predominantly in the South of England although cases have been identified in nearly 60 different local authority areas."

When asked if the new variant will impact the effectiveness of the vaccine, Hancock said: "The medical advice that we have is that it is highly unlikely that this new variant will impinge the vaccine and the impact of the vaccine. But we will know that in the coming days and weeks as the new strand is cultured at Porton Down and then the tests conducted upon it.”

WHO a touch more circumspect

The World Health Organization is aware of the new variant of COVID-19 that has emerged in Britain, but there is no evidence the strain behaves differently to existing types of the virus, it said on Monday (14 December).“We are aware of this genetic variant reported in 1,000 individuals in England,” the WHO’s top emergencies expert Mike Ryan told a news briefing in Geneva. “Authorities are looking at its significance. We have seen many variants, this virus evolves and changes over time.”

FDA authorizes vaccine following extreme Trump pressure 

The US Food and Drug Administration (FDA) on Friday (11 December) gave emergency use authorization to the nation’s first coronavirus vaccine, launching what scientists hope will be a critical counteroffensive against a pathogen that has killed more than 290,000 Americans, shredded the nation’s social and political fabric and devastated the economy. 

The historic authorization of the  vaccine from Pfizer and BioNTech for people age 16 and older, just 336 days after the genetic blueprint of a novel coronavirus was shared online by Chinese scientists, sets in motion a highly choreographed and complex distribution process aimed at speeding vaccines throughout the United States to curb the pandemic. 

US President Donald Trump had put the FDA under extreme pressure to approve the vaccine, describing the organization as a “slow, old turtle” in a tweet. The FDA action came after White House Chief of Staff Mark Meadows on Friday told FDA commissioner Stephen Hahn to be prepared to submit his resignation if the agency did not clear the vaccine by day’s end, according to people familiar with the situation who spoke on the condition of anonymity because they were not authorized to discuss what happened. 

And that is everything for the start of the week from EAPM – don’t forget to check our gene therapy paper herehave an excellent week.

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Coronavirus disinformation: Online platforms took more actions fighting vaccine disinformation

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The Commission has published the new reports by Facebook, Google, Microsoft, Twitter, TikTok and Mozilla, signatories of the Code of Practice on Disinformation. They provide an overview of the evolution of the measures taken in January 2021. Google expanded its search feature providing information and a list of authorised vaccines in user's location in response to related searches in 23 EU countries, and TikTok applied the COVID-19 vaccine tag to over five thousand videos in the European Union. Microsoft co-sponsored the #VaxFacts campaign launched by NewsGuard providing a free browser extension protecting from coronavirus vaccines misinformation. Additionally, Mozilla reported that curated authoritative content from its Pocket (read-it-later) application gathered more than 5.8 billion impressions across the EU.

Values and Transparency Vice President Věra Jourová said: “Online platforms need to take responsibility to prevent harmful and dangerous disinformation, both domestic and foreign, from undermining our common fight against the virus and the efforts towards vaccination. But platforms' efforts alone will not suffice. It is also crucial to strengthen co-operation with public authorities, media and civil society to provide reliable information.”

Internal Market Commissioner Thierry Breton added: “Disinformation poses a threat that needs to be taken seriously, and platforms' response must be diligent, robust and efficient. This is particularly crucial now, when we are acting to win the industrial battle for all Europeans to have a fast access to safe vaccines.”

The monthly reporting programme has been recently extended and will continue until June as the crisis still unfolds. It is a deliverable under the 10 June 2020 Joint Communication to ensure accountability towards the public and discussions are ongoing on how to further improve the process. You will find more information and the reports here.

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Merkel says COVID variants risk third virus wave, must proceed carefully

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New variants of COVID-19 risk a third wave of infections in Germany and the country must proceed with great care so that a new nationwide shutdown does not become necessary, Chancellor Angela Merkel (pictured) told the Frankfurter Allgemeine Zeitung, writes Paul Carrel.

The number of new daily infections has stagnated over the past week with the seven-day incidence rate hovering at around 60 cases per 100,000. On Wednesday (24 February), Germany reported 8,007 new infections and 422 further deaths.

“Because of (variants), we are entering a new phase of the pandemic, from which a third wave may emerge,” Merkel said. “So we must proceed wisely and carefully so that a third wave does not necessitate a new complete shutdown throughout Germany.”

Merkel and state premiers in Germany, Europe’s most populous country and largest economy, have agreed to extend restrictions to curb the spread of the coronavirus until 7 March.

Hair salons will be allowed to reopen from 1 March, but the threshold for a gradual reopening of the rest of the economy targets an infection rate of no more than 35 new cases per 100,000 people over seven days.

Vaccines and comprehensive testing could allow for “a more regionally differentiated approach”, Merkel said in the newspaper interview, published online on Wednesday.

“In a district with a stable incidence of 35, for example, it may be possible to open all schools without causing distortions in relation to other districts with a higher incidence and schools that are not yet open,” she added.

“An intelligent opening strategy is inextricably linked with comprehensive quick tests, as it were as free tests,” she said. “I cannot say exactly how long it will take to install such a system. But it will be in March.”

Merkel described Anglo-Swedish firm AstraZeneca’s COVID-19 vaccine, which some essential workers have refused, as “a reliable vaccine, effective and safe.”

“As long as vaccines are as scarce as they are at the moment, you can’t choose what you want to be vaccinated with.”

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India warns of worsening COVID-19 situation, vaccinations to expand

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India announced an expansion of its vaccination programme on Wednesday (24 February) but warned that breaches of coronavirus protocols could worsen an infection surge in many states, write Krishna N. Das and Neha Arora.

Nearly a month after the health minister declared that COVID-19 had been contained, states such as Maharashtra in the west and Kerala in the south have reported a surge in cases, as reluctance grows over mask-wearing and social distancing.

India’s infections are the second highest in the world at 11.03 million, swelled in the past 24 hours by 13,742, health ministry data shows. Deaths rose by a two-week high of 104 to 156,567.

“Any laxity in implementing stringent measures to curb the spread, especially in view of new strains of virus ... could compound the situation,” the ministry said in a statement singling out nine states and a federal territory.

India has confirmed the long-time presence of two mutant variants - N440K and E484Q - in addition to those first detected in Brazil, Britain and South Africa.

The ministry said that while cases in the states of Chhattisgarh, Gujarat, Kerala, Maharashtra, Madhya Pradesh and Punjab, as well as the federal territory of Jammu and Kashmir, were rising, the proportion of high-accuracy RT-PCR tests in those places was falling. Cases have also risen in Karnataka, Tamil Nadu and West Bengal.

In the past week, a third of India’s 36 states and union territories have reported an average of more than 100 new cases each day, with Kerala and Maharashtra both reporting more than 4,000, in a trend experts link to the reopening of schools and suburban train services.

The government has also asked states to speed vaccinations for healthcare and frontline workers. Just about 11 million people have received one or two doses in a campaign that began on Jan. 16, versus a target of 300 million by August.

From March 1, India will start vaccinating people above 60 and those older than 45 with health conditions free of charge in about 10,000 government hospitals and for a fee in more than 20,000 private facilities, the government said.

Earlier on Wednesday, a regulatory panel sought more data from drugmaker Dr. Reddy’s Laboratories for emergency authorisation of Russia’s Sputnik V COVID-19 vaccine, a senior official with direct knowledge of the discussions said.

The Central Drugs Standard Control Organization did not immediately reply to a Reuters request for confirmation.

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