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EMA sets out proposals to reform EU’s clinical trials framework

The European Commission, EMA and national regulators within the EU have launched an initiative to change the way
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The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an international “focal point” for clinical research.

The broad strokes of the proposals are laid out in a document entitled Accelerating Clinical Trials in the EU (ACT EU) that lists priority actions that will be taken, including measures to allow greater use of innovative clinical trial designs.

One objective is to increase the number of larger, multinational trials – specifically in the academic setting – that can take advantage of the scale afforded by organisations across member states acting together.

The paper notes that the COVID-19 pandemic has exposed that there are relatively few multi-member state trials, with most still being carried out at a national level, as well as “disharmony” between regulatory requirements between EU countries.

The result is slower trial authorisations, and higher costs, which may be the reason why analyses of centralised marketing authorisation applications have revealed a fall in the inclusion of trial results generated within the EU, it suggests.

“The aim is to further develop the EU as a focal point for clinical research, further promote the development of high quality, safe and effective medicines, and to better integrate clinical research in the European health system,” according to the EMA.

Top of the list of recommendations is to develop a new governance strategy for studies, drawing on existing initiatives if possible, and to develop key performance indicators and a dashboard that can be used to track the performance of the EU clinical trial environment.

The aim is to bring as many voices into the discussion as possible, including patients, says the document.

There’s also a proposal for the EMA and other EU regulators to work on new guidance for innovative trials designs, such as those that use artificial intelligence and machine learning, as well as complex and decentralised designs.

The initiative will build on the EU’s 2014 Clinical Trials Regulation (CTR) and the launch of the Clinical Trials Information System (CTIS), which will come into force at the end of this month, having been delayed from its earlier deadline of September 2018.

The CTIS – which is operated by the EMA – will contain the centralised EU portal and database for clinical trials covered by the CTR, is designed to make it easier for trials to be conducted in across EU member states and to increase transparency around studies for the public.

“ACT EU will strengthen the European environment for clinical trials, whilst maintaining the high level of protection of trial participants, data robustness and transparency that EU citizens expect,” said the EMA.

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European outbreak of monkeypox: what you need to know

There are some concerns of human-to-human transmission.

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May 18, 2022

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Four new cases of monkeypox have been reported in the UK, bringing the total number of confirmed cases to seven. The UK Health Security Agency (UKHSA) is urgently looking for the source of the outbreak.

The first case in the current outbreak was confirmed on May 6. But this is not the first time monkeypox has been reported in the UK. Three cases were also reported in 2021 and one in 2018. However, these infections are rarely seen in the UK and are overwhelmingly linked to international travel from endemic areas, including parts of west and central Africa.

On May 18 five cases of monkeypox were reported in Portugal, with investigations into 20 further suspected cases. On the same day, the Spanish health authorities reported eight suspected cases in men who have sex with men.

This is the largest monkeypox outbreak ever seen in Europe. It is not known if the cases are linked.

Misnomer

Monkeypox, as the name suggests, was first found in laboratory monkeys in the late 1950s. However, scientists aren’t sure if monkeys are the main animal reservoirs (carriers of the virus), so the name may be a bit of a misnomer. The latest thinking is that the main reservoir is probably smaller animals, such as rodents.

Reservoirs of monkeypox have been found in rodents, such as the Gambian pouched rat. Laëtitia Dudous/Wikimedia Commons, CC BY-SA

Unlike COVID, monkeypox does not spread easily from human to human. It typically requires interaction with animals that carry the virus, or being in very close contact with infected people, or having contact with “fomites” (such as contaminated clothes, towels or furniture). Also unlike COVID, monkeypox is not known to spread asymptomatically. However, the evidence on monkeypox is thin, and the current outbreaks will provide new knowledge around its impact and transmission.

Monkeypox belongs to the same family of viruses as smallpox, but is less transmissible. People who catch it typically develop a fever and a distinctive rash and blisters. The disease is usually self-limiting, with symptoms disappearing after a few weeks. However, monkeypox can cause severe illness, with outbreaks typically showing a case-fatality rate (the proportion of people with the disease who die from it) of between 1% and 15%, with severe disease and death more likely among children.

Sexually transmitted?

The UKHSA says that some cases in the May 2022 outbreak cannot be explained by recent international travel, suggesting that there has probably been some “community transmission”. Four of the seven cases are in people who identify as gay, bisexual or other men who have sex with men. A UKHSA epidemiologist tweeted that this is “highly suggestive of spread in sexual networks”. The cases in Spain may also fall under similar consideration.

So the transmission here may be a little unusual compared with previous outbreaks. While there is a lot we don’t know about monkeypox, we do know the virus can be transmitted via close contact, for example, including prolonged skin-to-skin contact.

There is no evidence that it is a sexually transmitted infection in the manner of HIV or chlamydia. It’s more that, in the UK outbreak, the close contact during sexual or intimate activity may have been a key factor during transmission.

This may be the first time transmission of monkeypox via sexual contact or intimate activity has been documented. But the implications are not so significant in that we know close contact is required for transmission. The social dynamics around the transmission of infectious diseases means this finding may be most useful for the public health teams involved in “contact tracing” – finding other people who may have been exposed to the virus.

Very low risks for the general public

The monkeypox risks to the wider UK public are extremely low, and the NHS has specialist units that focus on treating these sorts of tropical infections. And, thankfully, there are ways of bringing the virus to heel.

The US Centers for Disease Control and Prevention highlights how the smallpox vaccine, cidofovir (an anti-viral drug), and vaccinia immune globulin can be used to control a monkeypox outbreak.

However, beyond the smallpox vaccine, there is no specific vaccine to protect against monkeypox. Some experts have suggested that stopping widespread vaccination against smallpox might have lowered population immunity against monkeypox, thus making cases and outbreaks more likely.

A 2019 meeting at Chatham House in London suggested that an unintended consequence of smallpox eradication could be that “emergent or re-emergent human monkeypox might fill the epidemiological niche vacated by smallpox”.

However, these imported monkeypox cases and other tropical infections (such as Ebola, malaria and Lassa fever) indicate a wider burden of disease elsewhere in the world, typically in low-income countries with limited access to healthcare. It may be that in a post-pandemic environment, we should give more consideration to understanding the local and global implications of Lassa, monkeypox, Ebola and other rare but serious pathogens.

Michael Head has received funding from the Bill & Melinda Gates Foundation and the UK Department for International Development.

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Study: mRNA vaccines perform better against COVID-19 variants of concern

In a peer-reviewed study published May 17 in PLOS Medicine, scientists found that mRNA-based COVID-19 vaccines were superior to adenovirus vector-based…

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May 18, 2022

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Study: mRNA vaccines perform better against COVID-19 variants of concern

Published: May 18, 2022

By Vanessa Doctor, RN

BioSpace

In a peer-reviewed study published Tuesday in PLOS Medicine, scientists found that mRNA-based COVID-19 vaccines were superior to adenovirus vector-based ones across major variants of the SARS-CoV-2 virus.

The team collected data from a cohort of 165 SARS-CoV-2 naive health care workers in the Netherlands who were administered different vaccine types from January to May 2021. They received either BNT162b2 (Pfizer–BioNTech), mRNA-1273 (Moderna), AZD1222 (AstraZeneca) or Ad.26CoV2.S (Janssen).

After three weeks from the first dose, blood samples were collected from the participants, and then again four weeks after receiving the second dose. Blood samples from those given Ad.26CoV2.S (Janssen) were collected around four to five weeks and then eight weeks after their first and second doses. 

Courtesy of BioSpace

Months after, from October 2021 to January 2022, the same group was again asked to participate in serum collection before and after receiving a BNT162b2 booster dose. The researchers compared the ability of sera to spot and neutralize various SARS-CoV-2 variants of concern, including Alpha, Beta, Gamma, Delta and Omicron.

At the close of the study, the researchers found that SARS-CoV-2 wild-type neutralizing antibodies were highest among those who received mRNA-1273, followed by those who got BNT162b2, respectively. The group that received AZD1222 and Ad26.COV2.S demonstrated substantially lower antibody titers, at only 18 and 14. In addition, when the participants were given a booster months after, all groups saw a significant increase in antibody titers against VOCs.

“This study shows that the mRNA vaccines appear superior to adenovirus vector-based vaccines in inducing neutralizing antibodies against VOCs four weeks after initial vaccination and after booster vaccination, which implies the use of mRNA vaccines for both initial and booster vaccination,” the researchers stated.

The findings are not totally conclusive, as the scientists admitted, noting that there were more female than male participants in the study. Other factors that might affect the finality of their observations were the unidentical age distribution among the four groups and the fact that long-term measurements post-booster were not included in the evaluation.

“The implication of our results is that individuals receiving one of the adenovirus vector-based vaccines are more vulnerable to infection with the VOCs, which is consistent with the lower efficacy of these vaccines against symptomatic infection with VOCs compared to the mRNA vaccines, although all vaccines are highly effective at preventing severe disease by VOCs. While circulating antibodies might be unable to neutralize such emerging viruses, memory B cells are still likely to recognize them and undergo new rounds of affinity maturation, resulting in new neutralizing antibodies that should kick-in in time to prevent severe disease after infection,” the researchers said.

 

BioSpace source:

https://www.biospace.com/article/moderna-pfizer-covid-19-vaccines-superior-across-key-vocs-study

 

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Spread & Containment

Researchers may have unlocked mechanism driving inflammation in rheumatoid arthritis

Researchers at Hokkaido University in Japan, in a collaboration with American scientists, may have identified neural crosstalk as the mechanism that drives…

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May 18, 2022

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Researchers may have unlocked mechanism driving inflammation in rheumatoid arthritis

Published: May 18, 2022

By Jazmine Colatriano

BioSpace

Researchers at Hokkaido University in Japan, in a collaboration with American scientists, may have unlocked the mechanism that drives widespread inflammation in inflammatory diseases, such as rheumatoid arthritis (RA), psoriasis and atherosclerosis. Hypothesis testing used mouse models with RA and confirmed that the inflammatory response spread is linked to neural crosstalk. The findings were published today in ScienceDaily.

Inflammatory diseases, including RA, are lifelong conditions in which the body attacks its own healthy cells and causes an overabundance of inflammation. These diseases are also described as autoimmune disorders. In RA, inflammation is primarily seen in joints. The inflammatory response spreads throughout the body, but until now, the mechanism that enables remote inflammation had not been identified.

Courtesy of BioSpace

The answer to remote inflammation was found deep within already established research on the gateway reflex. This reflex involves the secretion of adenosine triphosphate (ATP) neurotransmitters to mediate the flow of immune cells across the blood-brain barrier and into tissue. To make this journey, the immune cells travel through blood vessels that adjust according to the direction relayed through neural crosstalk during the gateway reflex. A review of this previous research led to the hypothesis that neural crosstalk is how inflammation spreads to the entire body.

The mouse models used for hypothesis testing were divided into experimental and control groups. Both of these groups had RA induced in the left ankle. The experimental group alone had the sensory neural circuit disrupted between the right and left ankles to observe the effects on the inflammatory spread. In the control group, inflammation migrated to the right ankle, as is seen in typical RA remote inflammation. However, in the experimental group, remote inflammation was inhibited. Additional research will be necessary to determine whether this discovery applies to humans as well as mice.

Hokkaido University has been involved in other research centered around the COVID-19 pandemic. One of these collaborations was conducted with Shionogi & Co., Ltd. and led to the formulation of a novel COVID-19 antiviral therapeutic, S-217622. After the identification of the 3CL protease enzyme, the research team began formulating S-217622 to selectively inhibit the 3CL protease replication cycle. Clinical trials for the therapeutic began in July of 2021.

To determine how age affects the mortality and severity of COVID-19 infection, Hokkaido University researchers modeled data from three countries. The model showed that, while age isn’t specifically a factor, the likelihood of infection related to age and the likelihood that a patient would be infected by a severe form of COVID-19 are both factors in elderly mortality.

In an effort to look deeper into the Delta variant, as it became one of the most prominent COVID-19 virus variants to circulate the globe, Hokkaido University researchers got to work predicting how dominant the variant would become. The research was designed to be conducted ahead of the Tokyo Olympic Games that occurred in July of 2021. The team’s research showed that the Delta variant is up to 40% more transmissible than the Alpha variant that preceded it.

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