Development of Therapeutics and Vaccines

EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2  by BioNTech and Pfizer (01/12/2020)

EMA has received an application for conditional marketing authorisation (CMA) for BNT162b2, a COVID‑19 mRNA vaccine developed by BioNTech and Pfizer. The assessment of BNT162b2 will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine.

Such a short timeframe is only possible because EMA has already reviewed some data on the vaccine during a rolling review. During this phase, EMA assessed data on the vaccine’s quality (such as information about its ingredients and the way it is produced) as well as results from laboratory studies. EMA also looked at results on the vaccine’s effectiveness and initial safety data emerging from a large-scale clinical trial as they became available. Read more>>> 

Global regulators urge continuation of COVID-19 vaccine trials for longer-term safety and efficacy follow-up (27/11/2020)

EMA has endorsed a statement by the International Coalition of Medicines Regulatory Authorities (ICMRA) that urges all stakeholders, including vaccines researchers and investigators, academia, regulators and the pharmaceutical industry, to continue COVID-19 vaccine trials beyond the time when the pre-defined cases of COVID-19 disease for final analysis in a trial have been reached. This can provide important additional and more precise information on longer-term safety and efficacy of a vaccine against COVID-19.

Update on remdesivir - EMA will evaluate new data from Solidarity trial (20/11/2020)

The World Health Organization (WHO) has updated its guidelines advising against the use of remdesivir in hospitalised patients with COVID-19, regardless of disease severity based on a recent meta-analysis.

EMA has requested the full Solidarity data from WHO and the marketing authorisation holder. Once the data are available, EMA will assess the evidence, together with other relevant data, to see if any changes are needed to the marketing authorisation of Veklury (remdesivir) in the EU.                    Read more>>>

EMA considerations on COVID-19 vaccine approval (19/11/2020)

The European Medicines Agency laid out today the kind of data it needs to approve a coronavirus vaccine. The agency recommends having at least one large-scale Phase 3 clinical trial. The study’s main goal should be to assess whether the vaccine protects people from contracting the virus, but the trials should also estimate the protection against symptomatic and severe cases of COVID-19 — not just whether participants test positive or negative for the virus. Moreover, it called on vaccine developers to provide at least six weeks of safety data.

EMA also announced it’ll hold a public consultation on the safety of vaccines on December 11 to inform citizens about the process for approving coronavirus vaccines. Those who want to speak during the consultation can fill out a form before November 27. Read full considerations>>>

EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain (16/11/2020)

EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a vaccine for COVID-19 known as mRNA-1273, which is being developed by Moderna Biotech Spain, S.L. (a subsidiary of Moderna, Inc.).

The CHMP’s decision to start the rolling review of mRNA-1273 is based on preliminary results from non-clinical studies and early clinical studies in adults which suggest that the vaccine triggers the production of antibodies and T cells (cells of the immune system, the body’s natural defences) that target the virus. Read more>>>

EMA publishes safety monitoring plan and guidance on risk management planning for COVID-19 vaccines (13/11/2020)

EMA and the national competent authorities (NCAs) in EU Member States have prepared a  safety monitoring plan for COVID-19 vaccines. The plan outlines how relevant new information emerging after the authorisation and uptake of COVID-19 vaccines in the pandemic situation will be collected and promptly reviewed.

The safety of COVID-19 vaccines will be monitored according to the guidance set out by EMA and NCAs in the good pharmacovigilance practices (GVP), that applies to all medicines. In view of the extraordinary circumstances, though, EU authorities have planned several activities that will apply specifically to COVID-19 vaccines. Read more>>>

BioNTech and Pfizer raise hopes with breakthrough Covid-19 vaccine (09/11/2020)

A coronavirus vaccine developed by Pfizer is more than 90 percent effective, according to the first look at data from a late-stage U.S. trial involving nearly 44,000 participants.

An analysis of 94 trial participants who contracted COVID-19 showed that the vaccine was 94 percent effective, the company and its partner BioNTech said in a press release Monday.

The pair added that they expect to apply to the FDA for an emergency-use authorization before the end of the month, after they have collected sufficient data on the vaccine’s safety. The better-than-expected result is the first Phase III data from any of the four candidates now in the final stage of testing in the U.S.

Extra transparency measures for COVID-19 vaccines and therapeutics (30/10/2020)

The European Medicines Agency (EMA) has implemented two further extra transparency measures for COVID-19 medicines, by publishing both the clinical data in support of the authorisation of Veklury (remdesivir) and information on the COVID-19 treatments and vaccines that have received scientific advice or informal guidance from EMA’s pandemic Task Force (COVID-ETF).

These are the latest measures in EMA’s drive to maximise the transparency of its regulatory activities on treatments and vaccines for COVID-19.

EMA starts first rolling review of a COVID-19 vaccine in the EU (01/10/2020)

EMA’s human medicines committee has started the first ‘rolling review’ of a COVID-19 vaccine, which is being developed by the company AstraZeneca in collaboration with the University of Oxford. 

The start of the rolling review means that the committee has started evaluating the first batch of data on the vaccine, which come from laboratory studies (non-clinical data). This does not mean that a conclusion can be reached yet on the vaccine’s safety and effectiveness, as much of the evidence is still to be submitted to the committee.

EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation (19/09/2020)

EMA’s human medicines committee (CHMP) has completed its review of results from the RECOVERY study arm that involved the use of the corticosteroid medicine dexamethasone in the treatment of patients with COVID-19 admitted to hospital, and has concluded that dexamethasone can be considered a treatment option for patients who require oxygen therapy (from supplemental oxygen to mechanical ventilation).

Based on the review of available data, EMA is endorsing the use of dexamethasone in adults and adolescents (from 12 years of age and weighing at least 40 kg) who require supplemental oxygen therapy. Dexamethasone can be taken by mouth or given as an injection or infusion (drip) into a vein. In all cases, the recommended dose in adults and adolescents is 6 milligrams once a day for up to 10 days.

Remdesivir wins conditional EU approval for COVID-19 (03/07/2020)

The European Commission today granted conditional approval for Gilead’s remdesivir to treat COVID-19, as a key MEP warned the EU is prepared to take aggressive measures to access the therapy. Early studies suggest it could help speed recovery time for seriously ill patients without causing unacceptable side effects. However, the drugmaker must submit final reports from clinical trials to the European Medicines Agency by December.

The Commission touted the speed of the decision, delivered less than a month after Gilead submitted a formal application.

EMA receives application for conditional authorisation of first COVID-19 treatment in the EU (08/06/2020)

EMA has now received an application for conditional marketing authorisation (CMA) of the antiviral medicine remdesivir for the treatment of COVID-19 and has formally started its evaluation. The assessment of the benefits and risks of remdesivir is being performed under a reduced timeline and an opinion could be issued within weeks, depending on the robustness of the data submitted and whether further information is required to support the evaluation. Read More>>>

COVID-19: reminder of the risks of chloroquine and hydroxychloroquine (29/05/2020)

EMA is reminding healthcare professionals to closely monitor patients with COVID-19 who are receiving chloroquine or hydroxychloroquine, given the serious side effects that can result from treatment with these medicines. Both chloroquine and hydroxychloroquine, which are authorised for malaria and certain autoimmune diseases, have been used to treat patients with COVID-19 but their beneficial effects in this patient population are not established. Read More>>>

EMA recommends expanding remdesivir compassionate use to patients not on mechanical ventilation (15/05/2020)

EMA’s human medicines committee (CHMP) has recommended expanding the compassionate use of the medicine remdesivir so that more patients with severe COVID‑19 can be treated. The updated recommendations are based on preliminary results from the NIAID-ACTT study, which suggest a beneficial effect of remdesivir in the treatment of hospitalised patients with severe COVID-19. EMA is currently evaluating these data. Read more>>>

How EMA fast-tracks development support and approval of medicines and vaccines (04/05/2020)

As researchers race to develop vaccines and therapeutics against COVID-19, EMA has published an overview of how the Agency will accelerate its regulatory procedures so that marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible. The rapid procedures described in the the inventory can accelerate every step of a medicine’s regulatory pathway and the Agency is fully mobilised to deliver these fast-track assessments in the shortest possible timeframes while ensuring robust scientific opinions are reached. Read more>>>

EMA starts rolling review of remdesivir for COVID-19 (30/04/2020)

EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the use of the investigational antiviral medicine remdesivir for the treatment of coronavirus disease (COVID-19). A rolling review is one of the regulatory tools available to the Agency to speed up the assessment of a promising investigational medicine during a public health emergency, such as the ongoing pandemic. Read Full Article>>>

Guidance on how to manage clinical trials during the COVID-19 pandemic (28/04/2020)

This version contains key changes based also on the feedback from different stakeholders’ groups (patients’ organisations, academia and industry) before and during the drafting process.  Read full guidance here>>>

The EMA warns against using unproven cell-based therapies (28/04/2020)

EMA’s Committee for Advanced Therapies (CAT) is advising patients and the general public against using unregulated cell-based therapies which may not be safe or effective. The CAT’s advice is in response to individuals, companies and hospitals promoting unproven cell-based therapies as cures for a broad range of conditions including cancer, cardiovascular diseases, autism, cerebral palsy, muscular dystrophy and vision loss. These treatments can pose serious risks to patients for little or no benefit. Read more here>>> and read more about advanced therapy medicinal products here.

Reporting suspected side effects of medicines in patients with COVID-19 (24/04/2020)

EMA and the national competent authorities are reminding patients with confirmed or suspected coronavirus disease (COVID-19) to report suspected side effects that they experience with any of the medicines they are taking. Patients are reminded that there are currently no medicines authorised to treat COVID-19. Patients and healthcare professionals should report suspected side effects directly to their national authority via the contact details available here>>>

COVID-19: reminder of risk of serious side effects with chloroquine and hydroxychloroquine (23/04/2020)

Chloroquine and hydroxychloroquine are currently authorised for treating malaria and certain autoimmune diseases. In addition to side effects affecting the heart, they are known to potentially cause liver and kidney problems, nerve cell damage that can lead to seizures (fits) and low blood sugar (hypoglycaemia). These medicines are being used in the context of the ongoing pandemic for treating patients with COVID-19 and investigated in clinical trials. However, clinical data are still very limited and inconclusive, and the beneficial effects of these medicines in COVID-19 have not been demonstrated. Read more here>>>

Guidance on regulatory requirements in the context of the COVID-19 pandemic (10/04/2020)

 The European Commission, EMA and the European medicines regulatory network have developed a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic, with a particular focus on crucial medicines for use in COVID-19 patients.

Reducing COVID-19 transmission from potentially asymptomatic or pre-symptomatic people through the use of face masks (08/04/2020)

ECDC provides its opinion on the suitability of face masks and other face covers in the community by individuals who are not ill in order to reduce potential pre-symptomatic or asymptomatic transmission of COVID-19 from the mask wearer to others. Read their report>>>

EMA establishes task force to take quick and coordinated regulatory action related to COVID-19 medicines (09/04/2020)

As part of its health threat plan activated to fight COVID-19, the EMA has finalised and published the composition and objectives of its COVID-19 EMA pandemic Task Force (COVID-ETF), which draws on the expertise of the European medicines regulatory network and ensures a fast and coordinated response to the COVID-19 pandemic. Read their full mandate>>>

EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemic (06/04/2020)

The continued availability of medicines, in particular those used for patients with COVID-19, is ofcritical concern for EMA and its partners in the European medicines regulatory network in light of the medical emergency presented by the pandemic. This discusses the role of EMA in actively supporting prevention and management actions during this crisis. Read full article>>>

EMA recommendations on compassionate use of remdesivir for COVID-19 (03/04/2020)

During an extraordinary virtual meeting held on 2 April 2020, EMA’s human medicines committee (CHMP) gave recommendations on how the investigational antiviral medicine remdesivir should be used for treating coronavirus disease (COVID-19) in compassionate use programmes in the European Union. Read full article>>>

COVID-19: chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes (01/04/2020)

The EMA advised patients and healthcare professionals to only use chloroquine and hydroxychloroquine medicines for their authorised indications or as part of clinical trials or national emergency use programmes for the treatment of COVID-19. This is to ensure patient safety and the best use of available supplies. Read full article>>>

Update on treatments and vaccines against COVID-19 under development (31/03/2020)

EMA’s COVID-19 response team has been in contact with developers of around 40 therapeutic medicines, allowing better understanding of potential treatments. EMA’s response team will continue to interact with developers of potential therapeutics or vaccines against COVID-19. The aim is to provide advice on regulatory requirements so that any promising medicinal product can be made available as rapidly as possible to patients, initially in the clinical trial setting and then, once authorised, on the market. Read Full Article>>>

Preserving Clinical Trial Integrity During the Coronavirus Pandemic (25/03/2020)

Clinical trials typically require years to design, fund, conduct, and complete but are essential for improving health and preventing and managing disease. The real effects of the coronavirus pandemic on randomized trials are as yet unknown but will hopefully be short-lived as they could be damaging to the long-term benefits of these trials to millions of people who will continue to live with devastating medical diseases after the crisis ends. This article discusses that creativity and persistence are required to preserve clinical trial integrity, especially during these unprecedented and uncertain times. Read Full Article>>>

Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic (27/03/2020)

The impact of the COVID-19 pandemic on European health systems and more broadly on society, will make it necessary for sponsors to adjust how they manage clinical trials and the people who participate in these trials. As a result, The European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published new recommendations for sponsors on how to manage clinical trials in the context of the coronavirus disease (COVID-19) pandemic. Read Full Article>>>

EMA’s Statement: Beware of falsified medicines from unregistered websites (24/03/2020)

EMA is urging the general public not to buy medicines from unauthorised websites and other vendors aiming to exploit fears and concerns during the ongoing pandemic of coronavirus disease (COVID-19). Read their Full Statement>>>

MHRA Advice for Management of Clinical trials in relation to Coronavirus (12/03/2020)

The UK Medicines and Healthcare products Regulatory Agency (MHRA) are aware that there are challenges arising in relation to Coronavirus and the effect this is having on the conduct of clinical trials. As a result, they have taken the time to offer advice for patients and organisations during this difficult time. Read MHRA’s Advice>>>

COVID-19 infection: the perspectives on immune responses (23/03/2020)

SARS-CoV-2 infection can be roughly divided into three (3) stages: stage I, an asymptomatic incubation period with/without detectable virus; stage II, non-severe symptomatic period with the presence of virus; stage III, severe respiratory symptomatic stage with high viral load. This article proposes some approaches to the treatment of COVID-19 patients, believing that a two-phase division is very important. Read Full Article>>>

ESPEN Expert Statements and Practical Guidance for Nutritional Management of Individuals with SARS_CoV-2 (24/03/2020)

In the current document, the European Society for Clinical Nutrition and Metabolism (ESPEN) aims to provide concise guidance for nutritional management of COVID-19 patients by proposing 10 practical recommendations. The practical guidance is aimed at those in an ICU setting or in the presence of older age and polymorbidity, which are independently associated with malnutrition and its negative impact on patient survival. Read Full Article>>>