Euro Roundup: EFPIA ‘deeply disappointed’ by COVID vaccine TRIPS waiver

The World Trade Organization’s (WTO) agreement to a partial patent waiver for COVID-19 vaccines “sends a dangerous signal” to the pharmaceutical industry and all other innovative sectors, according to EFPIA, which expressed deep disappointment in the decision.
 
Twenty months after India and South Africa proposed an agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) on COVID-19 vaccine patents, WTO has finalized the terms of a deal that will allow governments to issue compulsory licenses to domestic manufacturers while compensating patent holders. WTO Director-General Ngozi Okonjo-Iweala hailed the deal as a compromise that “will contribute to ongoing efforts to deconcentrate and diversify vaccine manufacturing capacity, so that a crisis in one region does not leave others cut off.”
 
Similarly, the European Council approved the ministerial declaration on the WTO response to the COVID-19 pandemic and preparedness for future pandemics. Others criticized the deal, both for going too far and for not going far enough.
 
The European Federation of Pharmaceutical Industries and Association (EFPIA) joined with Vaccines Europe to object to what Nathalie Moll, its director-general, described as a “serious retrograde step in our collective ability to tackle the COVID-19 pandemic and future global health threats.” Moll’s position reflects a belief that, rather than being a barrier to access, the existing intellectual property framework supported the speedy development and rollout of COVID-19 vaccines.
 
“It is not our ability to manufacture doses that stands in the way of vaccine equity but the capacity and infrastructure to deliver vaccination programmes around the world and, at times, trade barriers. Those are the issues that would need to be addressed by the international community, rather than removing a key driver for innovators to discover, develop and deliver solutions for this, and future pandemics,” Moll said.
 
Moll’s views were echoed by other biopharma groups including the International Federation of Pharmaceutical Manufacturers (IFPMA) and BioIndustry Association (BIA), both of which said the TRIPS waiver has weakened the intellectual property framework that enabled the COVID-19 vaccine response while failing to address what they perceive to be the true causes of limited access in parts of the world. 
 
On the other side of the argument, Max Lawson, co-chair of the People’s Vaccine Alliance and head of inequality policy at Oxfam, said the deal “is absolutely not the broad intellectual property waiver the world desperately needs to ensure access to vaccines and treatments for everyone, everywhere.” Lawson accused rich countries of “utterly shameful” conduct at the WTO, singling out the European Union for blocking “anything that resembles a meaningful intellectual property waiver.”
 
EFPIA Statement
 
HPRA publishes guide to running in vitro diagnostic performance studies in Ireland
 
The Health Products Regulatory Authority (HPRA) has released a guide for sponsors who want to run performance studies involving in vitro diagnostics (IVDs) in Ireland. HPRA created the guide in response to changes to the ethical and scientific review of performance studies that the EU implemented as part of the In Vitro Diagnostic Regulation (IVDR).
 
IVDR defines performance studies as those undertaken to establish or confirm the analytical or clinical performance of a device. The definition covers CE-marked and non-CE-marked devices, although the application process differs based on a number of factors.
 
HPRA has created a flowchart to help sponsors determine what application or notification they need to make. The guide then outlines the process for applying to HPRA to run or modify a performance study, as well as the steps involved if the sponsor only needs to notify the Irish regulatory authority. HPRA wants sponsors that need to make applications to arrange pre-submission meetings.
 
The guide also addresses the areas HPRA will focus on in its review. The authority wants sponsors of studies “where the specimen collection does not represent a major clinical risk” to provide a “detailed justification” in the application form, adding that it “reserves the right to seek additional clarification” on the topic.
 
HPRA will provide the outcome of its assessment within 45 calendar days, although it will take an additional 20 days if an expert consultation is needed. When HPRA refuses to authorize a study, the sponsor has the right to appeal, as per the procedure set out in the authority’s existing document on the subject.
 
HPRA Guide
 
EMA starts rolling review of Moderna’s bivalent, omicron adapted COVID vaccine
 
The European Medicines Agency (EMA) has started a rolling review of Moderna’s omicron-adapted form of Spikevax, its COVID-19 vaccine. Moderna has designed the bivalent vaccine to protect against both the original strain of SARS-CoV-2 and the omicron variant of concern.
 
Initially, EMA will focus on nonclinical and chemistry, manufacturing and controls data. As Moderna generates more data, the review will expand to cover analysis of the immune response against omicron and the original strain. EMA will continue reviewing the results on a rolling basis until Moderna has the data to make a formal application.
 
The initiation of the rolling review comes shortly after the variant-adapted vaccine from Pfizer/BioNTech reached that stage in the process.
 
EMA Notice
 
France’s ANSM posts opinion on vaccination against monkeypox, sees need for new data
 
France’s National Agency for Medicines and Health Products Safety (ANSM) has issued an opinion on the benefits and risks of using smallpox vaccines to protect certain groups from the monkeypox virus.
 
ANSM’s opinion covers the use of Bavarian Nordic’s Imvanex and Jynneos vaccines in individuals vaccinated against smallpox in childhood, and in unvaccinated people aged under 18 years. In individuals previously vaccinated with older smallpox prophylactics, ANSM determined that the limited clinical immunogenicity and safety data support a single booster dose.
 
However, ANSM found the data insufficient to fully rule on the benefit-risk profile. As such, the agency is looking to real-world studies for more evidence. ANSM also wants more evidence on the use of the vaccines in children, particularly when used after an individual is exposed to the monkeypox virus.
 
ANSM Notice (French)
 
Spain’s AEMPS reports 65% fall in COVID-related supply problems in second half of 2021
 
The Spanish Agency of Medicines and Medical Products (AEMPS) has reported a 65% decline in supply problems caused by COVID-19. AEMPS saw the fall in the second half of last year.
 
In the first half of the year, AEMPS saw 68 supply problems related to COVID-19. The figure fell to 23 in the second half of the year. Despite the decline in COVID-19-related issues, the total number of supply problems rose from 801 to 842 between the first and second halves of 2021.
 
COVID-19 accounted for 2.4% of disruptions in the second half of the year. The top cause, with 32.3%, was manufacturing issues not derived from quality problems. Increased demand, 22.1%, and plant capacity problems, 16.3%, occupied the next to spaces on the list. Nervous system drugs were the most affected by supply problems for the second reporting period in a row.
 
AEMPS Notice (Spanish)